1-9 A-D E-G H-M N-P Q-S T-Z

PASSIFLORA INCARNATA OIL

Passiflora Incarnata Oil
CAS NO 97676-26-1
METATAGS:granadilla incarnata seed oil; oil expressed from the seeds of passion flower; passiflora incarnata l.; passifloraceae; passiflora edulis var. kerii seed oil;passiflora incarnata; integriloba seed oil; passiflora kerii seed oil; passion flower seed oil (passiflora incarnata); passion fruit seed oil (passiflora incarnata); passionfruit seed oil (passiflora incarnata); PASSIFLORA EDULIS SEED OIL; PASSIFLORA INCARNATA SEED OIL; Oils; passionflower; PASSIONFLOWERPOWDEREXTRACT; PASSION FRUIT OIL PASSIFLORA EDULIS SEED OIL; Passiflora Incarnata Seed Oil; Unessoft PFO; Oil of passionflower; Passionflower alcoholic extract; Passionflower herb solid extract; Anthactinia Bory ex M.Roem. Asephananthes Bory; Astrophea Lam. ex M.Roem.; Baldwinia Raf.;Ceratosepalum Oerst.; Cieca Medik.; Decaloba M.Roem.;Disemma Labill.; Granadilla Mill.; Hollrungia K.Schum.;Monactineirma Bory; Murucuja Medik.; Pentaria M.Roem.;Poggendorffia H.Karst.; Tacsonia Juss.; Tetrapathaea (DC.) Rchb.;Tetrastylis Barb.Rodr. PASSİFLORA; PASS FLORA; PASSİFLOURA; PASSIFLOURA; PASSİFLOURE; PASSIFLOURE; PASSİFLOURA INCARNATA; PASSİFLOURA INCARNATA; PASSİFLORA INCARNATA; PASSIFLORA INCARNATA; INCARNATA; İNCARNATA; OIL; OİL; INCARNATA OİL; INCARNATA OIL; İNCARNATA OIL; İNCARATA OİL; PASSİFLORA INCURNATA OIL; PASSIFLORA OIL; PASSİFLORA OİL; PASSİFLORA OIL; PASİFLORA; PASIFLORA; PASIFLORA INCENATA; PASİFLORA İNCARNATA; PASİFLORA INCERNATA OIL; PASİFLORA İNCERNATA OİL; PASİFLORA OİL; PASİFLORA OIL; PASIFLORA OIL; PASIFLORA OİL; PASİ FLORA OIL; PASİ FLORA OİL; ÇARKIFELEK YAĞI; ÇARKIFELEK; ÇARKI FELEK; ÇARKI FELEK YAĞI; ÇARKIFELEK YAG; ÇARKI FELEK YAĞ; ; flora; passifloura; passıfloura; passifloure; passıfloure; passifloura ıncarnata; passifloura ıncarnata; passiflora ıncarnata; passıflora ıncarnata; ıncarnata; incarnata; oıl; oil; ıncarnata oil; ıncarnata oıl; incarnata oıl; incarata oil; passiflora ıncurnata oıl; passıflora oıl; passiflora oil; passiflora oıl; pasiflora; pasıflora; pasıflora ıncenata; pasiflora incarnata; pasiflora ıncernata oıl; pasiflora incernata oil; pasiflora oil; pasiflora oıl; pasıflora oıl; pasıflora oil; pasi flora oıl; pasi flora oil; çarkıfelek yağı; çarkıfelek; çarkı felek; çarkı felek yağı; çarkıfelek yag; çarkı felek yağ;; ÇARKIFELEK OIL; ÇARKIFELEK OİL; CARKIFELEK OİL; CARKIFELEK OİL

100ml Passion Flower oil (refined) - Passiflora Incarnata Seed Oil by Oils4life Limited
Product description
Rich in Omega 6 and other essential fatty acids;Has relaxing properties;Originates from South Africa;Macerated oil which is of particular importance in aromatherapy;Obtained from the seeds by expression
Product details Item Weight: 3.52 ounces Shipping Weight: 3.5 ounces ASIN: B00V2DY7YO
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Maracuja, çarkıfelek meyvesi veya tutku meyvesi olarak bilinir. Meyve tohumlarından veya çiçeklerinden, bir dizi sağlık faydası sunan egzotik, güzel bir çiçekten elde edilir. Cilt, saç ve tırnakları iyileştirmek için kullanır, ancak zihin ve beden içinde faydaları bulunmaktadır. Pahalı olmasına rağmen popüler hale gelmektedir.
Çarkıfelek meyveleri, Güney Pasifik, Orta Amerika, Ortadoğu, Akdeniz ve diğer subtropikal bölgeler gibi dünya genelindeki hemen hemen her yıl don olmayan her sıcak iklimde yetişir. Bitki Avrupa'ya geldikten sonra geniş çapta yetiştirildi ve Avrupa tıbbında tanıtıldı.
Çarkıfelek meyvesi, çoğunlukla meyve suyu halinde kahvaltıda sunulur, salsa, salatalar ve tatlılara egzotik bir lezzet kazandırır.
Maracuja veya Çarkıfelek meyvesi yağı, antioksidanların, vitaminlerin, minerallerin ve gerekli antioksidanların zengin bir kaynağıdır. Tutku çiçeğindeki Quercetin, bilinen en güçlü koruyucu bileşiklerden biri olarak kabul edilir ve güçlü antioksidan, anti-inflamatuar ve anti-kanser özellikleri de dahil olmak üzere sayısız yararlı bileşikler sunar.
Bu yağ kapsamlı bir şekilde incelenmemesine rağmen, nasıl yardımcı olabileceğini gösteren birkaç çalışma yapılmıştır. Uluslararası Gıda Bilimleri ve Beslenme Dergisinde yayınlanan araştırmalar, çarkıfelek meyvesinin tohumlarından ekstrakte edilen yağın, cilt sağlığının desteklenmesinde önemli bir rol oynayan esansiyel yağ asitlerinden biri olan linoleik asidin zengin olduğunu gösterdi. Nitekim, yüzde 72.6 linoleik asit içermektedir ve bu da gezegendeki esansiyel yağ asidinin en iyi kaynaklarından biridir.
Çarkıfelek Yağının Faydaları
Rahatlamış Kuru Cilt
Maracuja yağı olağanüstü bir yumuşatıcı olduğundan, kuru ciltler için özellikle etkilidir. Bazı insanlar hassas olabileceğinden, önce cildin küçük bir alanı üzerinde bir test yapmak en iyisidir. Tahriş belirtisi yoksa, yağın inceltilmemiş haliyle güvenle uygulayabilirsiniz.
Akne Maracuja yağı, tıkanmayan nemlendirme etkisinden dolayı sivilce eğilimli cildi için de iyi olabilir, ancak bazılarında ters etki gösterebilir. Bu nedenle cildinizi nasıl etkileyeceğini bilene kadar küçük bir alanda az miktarda kullanın.
Güneş Tarafından Hasar Gören Cildi Tedavi Etmek
Maracuja yağı, yaşlanmaya ve güneş ışınlarından korumaya yardımcı olur. Muhtemelen iyi bildiğiniz gibi, koruma olmadan güneşe uzun süre maruz kalmak bizi zararlı UV ışınlarına maruz bırakır. Zamanla cilt hasarına, kırışıklıklara, yaş veya koyu renk lekeler gibi hızlandırılmış yaşlanmanın temel bir özelliğine neden olurlar. Bu kısmen antienflamatuar özelliklerinden dolayıdır ve ayrıca, kollagen üretiminde esas bir vitamin olan C vitamini içeriğine bağlı olabilir. Yağdaki C vitamini içeriği cildinizi daha parlak görünmesine yardımcı olabilir ve kalsiyum ve fosfor birlikte çalışarak sağlıklı görünümünü arttırırken cildi besler.
Kollagen cildimizin esnekliği ve rejenerasyonu için merkezi olan bir proteindir. Cildin sıkı, tombul, pürüzsüz ve daha genç görünmesini sağlamaktan sorumludur. Yaklaşık 20 yaşından sonra, doğal kollagen üretimimiz her yıl yüzde bir oranında azalır, bu nedenle cildimizdeki yaşlanmanın en erken belirtilerini görmeye başlıyoruz. 40 yaşına geldiğimizde derimiz artık kollagen üretmiyor ve elastikiyetini kaybetmeye başlıyor. Yaklaşık 50 yaş ilerledikçe sarkma ve daha derin kırışıklıklar gibi daha yaşlı etkiler ortaya çıkıyor. Cilt artık çok daha incedir ve hasar görme eğilimi daha yüksektir.
Neyse ki maracuja yağı yardımcı olabilir. Likopen gibi besinler ve daha önce tartıştığımız linoleik asit, cildin güneşten kaynaklanan hasardan kurtulma ve kollagen üretimini artırmada yardımcı olur. Yağı cildin etkilenen alanlarına sürtün.
Destek Çarkıfelek Tohumu Yağıİçeriği: %100 Saf Çarkıfelek Tohumu Yağı *Koruyucu ve katkı maddesi içermez, %100 doğaldır.
Ambalaj: 20ml Kas Ağrıları Maracuja yağı, cilt bakımında topikal kullanımına ek olarak, artritik eklem ağrılarının ve kas ağrısının hafifletilmesine yardımcı olmak için bir masaj yağı olarak da kullanılabilir. Maracuja anti-inflamatuar olduğu için, ağrılı kaslara neden olan bu fazla iltihaplanmayı azaltabilir. Zengin linoleik asit içeriği, maksimum rahatlama için iltihaplanmayı düşürmeye yardımcı olur.
Uyku Halinde Dinlemeye Teşvik Edici
Bu yağı sık sık göz ardı edilen özelliklerden birisi yatıştırıcı olarak işlev gören harman da dahil olmak üzere tıbbi alkaloidler içermesidir. Bu bileşik huzursuzluk ve uykusuzluğun azalmasıyla bağlantılıdır. Anti-anksiyete yetenekleri, birinin iyi bir uyku çekmesini engelleyebilen sinir kaygısını önlemek için de çalıştığı anlamına gelir.
Sakinleştirici Maracuja yağı, mükemmel bir uykuya geçişte yardımcı olmasının yanı sıra, stresli bir günün ardından dinlenip gevşeyebilecek kadar mükemmel bir sakinleştirici madde olarak düşünülür. Sinirlerin sakinleşmesi için inanılmaz derecede etkili olduğu gerçeğine rağmen, bitki patentli olamayacağından çoğu insan bunun farkında değildir.
Saç Derisi Ve Saç Sağlığını İyileştirin
Kafa derisine maracuja yağı uygulamak, saç büyümesini desteklediği gibi kuru veya hasar gören saçları da tedavi ettiği söylenir. Kaşıntı önleyici özellikleri sayesinde, kepek ve diğer kafa derisi kaşıntılarının rahatlamasına yardımcı olur.
Solunum Koşullarının ve Astım Belirtilerinin Rahatlatılması
Çarkıfelek meyvesinden elde edilen ekstraktların, solunum sisteminde yatıştırıcı, balgam söktürücü, astım atakları, hırıltılı solunum ve boğmaca semptomlarını azaltmaya yardımcı olan eşsiz biyo flavonoid kombinasyonunu içerir.
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Legal Disclaimer
Statements regarding dietary supplements have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease or health condition.

Passion flower is rich in Omega 6 and other essential fatty acids . It has relaxing properties and is often used in massage preparations for aiding a goods nights sleep. Oils4life Passion Flower oil originates from South Africa and is cold pressed and refined.

Passion flower is also known as apricot vine, granadilla, maypop, passiflora or passion vine and is so called because the stigma, stamens and sepals are likened to the instruments associated with Christs passion and crucifixion. This oil is used in the food and cosmetic industries. It is the macerated oil which is of particular importance in aromatherapy.

Passion flower oil is obtained from the seeds by expression, the seed hulls and kernals releasing the crude oil, which is then refined to remove sediment and impurities.

passiflora incarnata seed oil
oil expressed from the seeds of passion flower, passiflora incarnata l., passifloraceae

Name: passiflora incarnata l. seed oil
CAS Number: 72968-47-9
ECHA EC Number: 277-142-7
Also Contains: fruit cocktail fragrance
Category:cosmetic ingredient for skin protecting

US / EU / FDA / JECFA / FEMA / FLAVIS / Scholar / Patent Information:
Google Scholar: Search
Google Books: Search
Google Scholar: with word "volatile" Search
Google Scholar: with word "flavor" Search
Google Scholar: with word "odor" Search
Google Patents: Search
US Patents: Search
EU Patents: Search
PubMed: Search
NCBI: Search

Physical Properties:
Appearance: yellow to yellow orange liquid (est)
Food Chemicals Codex Listed: No
Soluble in:
oils
water, 9.967e-020 mg/L @ 25 °C (est)
Insoluble in:
water

Organoleptic Properties:
Odor and/or flavor descriptions from others (if found).

Cosmetic Information:
CosIng: cosmetic data
Cosmetic Uses: skin protecting agents

Suppliers:
Bristol Botanicals
Passion Flower oil Passiflora incarnata
Charkit Chemical
PASSION FRUIT OIL
Earthoil
Passionfruit Seed Oil - Fruit Seed Oil Organic
R C Treatt & Co Ltd
Passion Oil Refined
R C Treatt & Co Ltd
Passion Oil

Safety Information:
European information :
Most important hazard(s):
None - None found.
S 02 - Keep out of the reach of children.
S 24/25 - Avoid contact with skin and eyes.

Hazards identification

Classification of the substance or mixture
GHS Classification in accordance with 29 CFR 1910 (OSHA HCS)
None found.
GHS Label elements, including precautionary statements

Pictogram

Hazard statement(s)
None found.
Precautionary statement(s)
None found.
Oral/Parenteral Toxicity:
Not determined
Dermal Toxicity:
Not determined
Inhalation Toxicity:
Not determined

Safety in Use Information:
Category: cosmetic ingredient for skin protecting
Recommendation for passiflora incarnata seed oil usage levels up to:
not for fragrance use.

Recommendation for passiflora incarnata seed oil flavor usage levels up to:
not for flavor use.

Safety References:
EPI System: View
EPA Substance Registry Services (TSCA):72968-47-9
EPA ACToR:Toxicology Data
EPA Substance Registry Services (SRS):Registry
National Institute of Allergy and Infectious Diseases:Data
WGK Germany:1
passiflora incarnata l. seed oil
Chemidplus:072968479
Latince Adi : Passiflora incarnata
Familya :

Genel Bilgiler
Çarkıfelekgiller familyasının örnek bitkisidir. Anayurdu Tropikal Amerikadır. Oradan dünyaya yayılmış 400 kadar türü vardır. Ülkemizde bazı yerlerde süs bitkisi olarak kimi türleri yetiştirilmektedir. Gölgeli ve nemli duvar dipleri ve kameryeleri sevip sarmaşarak yetişen otsu ya da ağaçsı sarmaşıktır. 5-7 parçalı koyu yeşil yaprakları almaşık dizilişli: yaz boyunca açan tekerlek biçimindeki gösterişli çiçekleri erguvani, pembe ya da kırmızı renkte ve iridir. Bitki, tohumuyla ya da gövde çelikleriyle çoğaltılır.
Çarkıfelek bitkisi harmin, harmol, harman ve passiflora adı verilen alkaloitleri: flavon, glisosit ve sterol adlı diğer maddeleri içerir. Bazı türlerinin meyveleri çiğ olarak yenebildiği gibi, içki ve şerbet yapımında da yararlanılır.

Tibbi Kullanimi
Zehir ve insan bedenine zararlı olabilecek maddeler içermeyen çarkıfelek bitkisi, güvenle kullanılarak şu tıbbi etkileri sağlar:
• Kişinin yaşadığı gerginlik ve endişelilik hallerini giderir.
• Sinirleri yatıştırır.
• Sinirsel ve kronik uykusuzluklara deva olur.
• Parkinson hastalığı ve isteri gibi durumlarda sinirsel nöbetleri gidericidir.
• Zona hastalığı gibi sinir ağrılarında da yatıştırıcı olur.
Bütün böyle durumlar için ilkbahar sonu ile yaz ortası arasında bitkinin çiçek açmamış ya da çiçekleri olgunlaşıp meyveye dönüşmüş dallarından toplanan yaprakları, gölge ve havadar bir yerde kurutulur ve infüzyonu hazırlanır: 1 tatlı kaşığı kuru yaprak üzerine 1 bardak kaynar su dökülerek 15 dakika süreyle demlendirilir. Uykusuzluğu gidermek için, akşamları yatmadan önce bu infüzyondan bir bardak: rahatlama sağlanması ve diğer şikâyetlerin giderilmesi için istendiği zaman alınmak üzere, günde iki bardak içilir.

References:
passiflora incarnata l. seed oil
Canada Domestic Sub. List: 72968-47-9
Pubchem (sid): 135335921

Other Information:
Wikipedia: View

Potential Blenders and core componentsnote
None Found

Potential Uses:
None Found

Occurrence (nature, food, other):note
apricot wild apricot
Search Trop Picture

Synonyms:
granadilla incarnata seed oil
oil expressed from the seeds of passion flower, passiflora incarnata l., passifloraceae
passiflora edulis var. kerii seed oil
passiflora incarnata var. integriloba seed oil
passiflora kerii seed oil
passion flower seed oil (passiflora incarnata)
passion fruit seed oil (passiflora incarnata)
passionfruit seed oil (passiflora incarnata)

Articles:
PubMed:Sexual selection in a hermaphroditic plant through female reproductive success.
PubMed:Phytotherapy of alcoholism.
PubMed:A case of beta-carboline alkaloid intoxication following ingestion of Peganum harmala seed extract.
PubMed:In vitro susceptibility of Helicobacter pylori to botanical extracts used traditionally for the treatment of gastrointestinal disorders.
PASSIFLORA INCARNATA SEED OIL
PASSIFLORA INCARNATA SEED OIL is classified as :
Skin protecting
CAS Number 97676-26-1
COSING REF No: 57019
Chem/IUPAC Name: Passiflora Incarnata Seed Oil is the oil expressed from the seeds of Passion Flower, Passiflora incarnata L., Passifloraceae
Products ( 4)
4 Cosmetics Ingredients containing PASSIFLORA INCARNATA SEED OIL
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Hair care (Shampoos, Conditioners & Styling) (2)
Skin care (Facial care, Facial cleansing, Body care, Baby care) (3)
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SCC 73rd Annual Meeting and Technology Showcase 2019
ABSTRACT
The volatile constituents of the essential oil of Passiflora incarnata L. were investigated by GC, GC/MS and GC/FTIR. The main compounds of the oil were hexanal (1.4%), benzyl alcohol (4.1%), linalool (3.2%), 2-phenylethyl alcohol (1.2%), 2-hydroxy benzoic acid methyl ester (1.3%), carvone (8.1%), trans-anethole (2.6%), eugenol (1.8%), isoeugenol (1.6%), β-ionone (2.6%), α-bergamotol (1.7%), phytol (1.9%) and the two fatty acids-palmitic (7.2%) and oleic acid (6.3%). More than 150 minor components were also identified in this essential oil by analysis with these GC systems.

Volatile Constituents of the Essential Oil of Passiflora incarnata L.
100% Pure, Cold Pressed and Refined Oil.

Origin: South Africa

* SPECIALITY OIL *

50mls supplied in a blue PET plastic bottle with a black flip top lid.
100mls supplied in a cobalt blue glass bottle.
250ml is supplied in a blue PET plastic bottle with a black solid lid.

Passion Flower Seed Oil is non-sticky and light. It is cold-pressed from the seeds of the passion fruit and is rich in Omega 6 & 9 essential fatty acids.

It is said to act as a toner and improve elasticity of the skin.

Passion flower seed oil can be used directly on the skin or blended with other oils to make your own moisturising skincare products.

The oil should be used within 18 months of purchase.
Assessment report on Passiflora incarnata L., herba
Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC as amended (traditional
use)
Herbal substance(s) (binomial scientific name of
the plant, including plant part)
Passiflora incarnata L; herba
Herbal preparation(s) a) Comminuted herbal substance
b) Powdered herbal substance
c) Liquid extract (DER 1:8) extraction
solvent ethanol 25% V/V
d) Liquid extract (DER 1:8) extraction
solvent ethanol 45% V/V
e) Liquid extract (DER 1:3.6) extraction
solvent ethanol 60% V/V
f) Liquid extract (DER 1:1) extraction
solvent ethanol 25% V/V
g) Liquid extract (DER 1:1) extraction
solvent ethanol 70% V/V
h) Liquid extract (DER 1:3.8-4.3) extraction
solvent ethanol 54% m/m, glycerine 4%
m/m, water 60%
Dried extracts corresponding to the tea and
liquid extracts above.
Pharmaceutical forms Comminuted herbal substance as herbal tea for
oral use.
Herbal preparations in solid and liquid dosage
forms for oral use.
Rapporteur P. Claeson
Assessor(s) P. Claeson and H. Green
1. Introduction
1.1. Description of the herbal substance(s), herbal preparation(s) or
combinations thereof
• Herbal substance(s)
• Passiflora incarnata L., herba is the fragmented or cut/dried aerial parts of Passiflora incarnata L. It
may contain flowers and/or fruits. Content: minimum 1.5% of total flavonoids, expressed as
vitexin (dried drug) (European Pharmacopoeia, 2012).
• Passiflora incarnata L., herba extract is the dry extract of Passiflora incarnata L., herba, prepared
with ethanol (40% - 90% V/V) or methanol (60% V/V), or acetone (40% V/V), and containing a
minimum of 2.0% flavonoids, expressed as vitexin (European Pharmacopoeia, 2012).
Constituents:
Flavonoids, mainly C-glycosides of apigenin and luteolin, e.g. isovitexin, isoorientin and their 2"-β-Dglucosides, schaftoside, isoschaftoside, vicenin-2 and swertisin, with considerable variation in
qualitative and quantitative composition according to source (Hänsel et al., 1994; Bradley, 1992;
Wichtl, 2004; Barnes et al., 1996; 2007; ESCOP, 2003; PDR for herbal medicines, 1998; Weniger &
Anton, 1996).
Maltol which, however, may be an artefact (Hänsel et al., 1994; Bradley, 1992; Barnes et al., 1996
and 2007; ESCOP, 2003; Weniger & Anton, 1996).
Essential oil in trace amounts comprising more than 150 components (Hänsel et al., 1994; Bradley,
1992; Wichtl, 2004; Barnes et al., 1996 and 2007; ESCOP, 2003; PDR for herbal medicines, 1998;
Weniger & Anton, 1996).
Gynocardin (a cyanogenic glycoside) (Hänsel et al., 1994; Bradley, 1992; Wichtl, 2004; ESCOP, 2003;
PDR for herbal medicines, 1998; Weniger & Anton, 1996).
β-carboline alkaloids (e.g. harman, harmol, harmalol) may be present in traces. However, these
alkaloids are undetectable in most commercial materials (ESCOP, 2003).
A tri-substituted benzoflavone derivative (Dhawan et al., 2004). The presence of this substance in
Passiflora incarnata has later been questioned by Holbik et al.,2010, who were unable to repeat
isolation of the substance from plant materials of three different geographical origins.
• Herbal preparation(s)
• Comminuted herbal substance
• Powdered herbal substance
• Liquid extract (DER 1:8) extraction solvent ethanol 25% V/V
• Liquid extract (DER 1:8) extraction
solvent ethanol 45% V/V
• Liquid extract (DER 1:3.6) extraction solvent ethanol 60% V/V
• Liquid extract (DER 1:1) extraction
solvent ethanol 25% V/V
Assessment report on Passiflora incarnata L., herba
EMA/HMPC/669738/2013 Page
3/22
• Liquid extract (DER 1:1) extraction solvent ethanol 70% V/V
• Liquid extract (DER 1:3.8-4.3) extraction solvent ethanol 54% m/m, glycerine 4% m/m,
water 60%
Dried extracts corresponding to the tea and liquid extracts above.
• Combinations of herbal substance(s) and/or herbal preparation(s) including a
description of vitamin(s) and/or mineral(s) as ingredients of traditional
combination herbal medicinal products assessed, where applicable.
Not applicable.
1.2. Information about products on the market in the Member States
Regulatory status overview
Member State Regulatory Status Comments
Austria MA TRAD Other TRAD Other Specify:
Belgium MA TRAD Other TRAD Other Specify:
Bulgaria MA TRAD Other TRAD Other Specify: No products on the
market
Cyprus MA TRAD Other TRAD Other Specify:
Czech Republic MA TRAD Other TRAD Other Specify: Only combination
products
Denmark MA TRAD Other TRAD Other Specify: HMPs on the market
until 2004. Probably
products marketed as
food supplements
Estonia MA TRAD Other TRAD Other Specify:
Finland MA TRAD Other TRAD Other Specify: No products on the
market
France MA TRAD Other TRAD Other Specify:
Germany MA TRAD Other TRAD Other Specify: Also authorised and
registered combination
products on the market
Greece MA TRAD Other TRAD Other Specify:
Hungary MA TRAD Other TRAD Other Specify: Only combination
products
Iceland MA TRAD Other TRAD Other Specify:
Ireland MA TRAD Other TRAD Other Specify: Only combination
products
Italy MA TRAD Other TRAD Other Specify:
Latvia MA TRAD Other TRAD Other Specify: Only authorised
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Member State Regulatory Status Comments
Food supplements combination products
Liechtenstein MA TRAD Other TRAD Other Specify:
Lithuania MA TRAD Other TRAD Other Specify:
Luxemburg MA TRAD Other TRAD Other Specify:
Malta MA TRAD Other TRAD Other Specify: No products on the
market
The Netherlands MA TRAD Other TRAD Other Specify: One combination product
Norway MA TRAD Other TRAD Other Specify:
Poland MA TRAD Other TRAD Other Specify:
Portugal MA TRAD Other TRAD Other Specify: No products on the
market. No information
concerning food
supplements.
Romania MA TRAD Other TRAD Other Specify:
Slovak Republic MA TRAD Other TRAD Other Specify:
Slovenia MA TRAD Other TRAD Other Specify:
Spain MA TRAD Other TRAD Other Specify: Also combination
products.
Sweden MA TRAD Other TRAD Other Specify:
United Kingdom MA TRAD Other TRAD Other Specify:
MA: Marketing Authorisation
TRAD: Traditional Use Registration
Other TRAD: Other national Traditional systems of registration
This regulatory overview is not legally binding and does not necessarily reflect the legal status of the
products in the MSs concerned.
1.3. Search and assessment methodology
Two major electronic databases, PubMed and Toxline, were searched on 20 June 2006 with the search
term "passiflora". For the revision of the monograph the same databases were searched on 24 April
2013 (search term "passiflora incarnata").
Results:
PubMed: 160 references obtained in 2006 and 41 additional references in 2013.
Toxline: 37 references obtained in Toxline Core on PubMed and 68 references in Toxline Special in
2006 and 11 additional references in 2013.
The abstracts of the references found were screened manually and all articles deemed relevant were
accessed and included in the assessment report.
2. Historical data on medicinal use
2.1. Information on period of medicinal use in the Community
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Traditional medicinal use of Passiflora incarnata L., herba in the form of powdered herbal substance,
herbal tea or ethanol extracts, for the relief of mild symptoms of mental stress and to aid sleep has
been documented continuously in recognised handbooks dating e.g. from 1938, 1958, 1977 and 2003
(Madaus, 1938; Hoppe, 1958; List & Hörhammer, 1977; ESCOP, 2003). It is often used in
combinations with other sedative herbal substances.
The following information about products currently on the market was obtained from the Member
states following a new request.
Austria
No Preparation Period of
medicinal use
Dosage
form
Posology Indication
1 Comminuted
herbal
substance
Registered in
2009
Tea bag (2 g
comminuted
herbal
substance )
According to
HMPC monograph
According to HMPC
monograph
2 Liquid extract
DER 1:3.6
extraction
solvent ethanol
60% V/V
On the market
since 1981
Oral liquid 0.89 g herbal
preparation x3-5
= 1 ml herbal
preparation x3-5
According to HMPC
monograph
3 Dry extract DER
5-7:1,
extraction
solvent ethanol
50% V/V
Registered in
2007
Coated
tablet
(1 coated
tablet
contains 425
mg dry
extract)
According to
HMPC monograph
According to HMPC
monograph
4 Liquid extract,
DER 1:3.8-4.3,
extraction
solvent ethanol
54% m/m,
glycerine 4%
m/m, water
60%
On the market
since 1963
Oral liquid Adults: 0.3-0.4
ml herbal
preparation x 3-5
Adolescents: 0.3-
0.4 ml herbal
preparation x 3
According to HMPC
monograph
Belgium
No Preparation Period of
medicinal use
Dosage
form
Posology Indication
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1 Dry extract, DER
3.5-5, extraction
solvent ethanol
60% V/V
Registered in
2011
Coated
tablet
(200 mg dry
extract per
coated
tablet)
Adults and
children from 12
years: 1 to 2
tablets 2 times a
day to alleviate
mental stress
(max 8 tablets a
day)
1 to 2 tablets half
an hour before
going to sleep to
aid sleep.
Traditional herbal
medicinal product
used to relieve the
mild symptoms of
mental stress, such as
nervousness, worrying
or irritability and to
aid sleep.
France
No Preparation Period of
medicinal use
Dosage
form
Posology Indication
1 Dry extract, DER
4-6:1,
extraction
solvent ethanol
70% V/V
On the market
since 1986
Hard capsule
(1 capsule
contains 200
mg of
extract)
Adults and
adolescents over
12 years of age:
1 to 2 hard
capsules 2 times
daily.
Traditionally used in
the symptomatic
treatment of
neurotonic conditions
of adults and children,
notably in cases of
mild disorders of
sleep.
2 Dry extract, DER
4-7:1,
extraction
solvent ethanol
60% V/V
Registered in
2008
Coated
tablet (One
tablet
contains 300
mg of
extract)
Adults and
adolescents over
12 years of age:
2 tablets daily
Traditionally used in
the symptomatic
treatment of
neurotonic conditions
of adults and children,
notably in cases of
mild disorders of
sleep.
3 Powder On the market
since 1981
Hard capsule
(1 capsule
contains 300
mg of
powdered
drug)
Adults: 2 hard
capsules 2 times
daily
Adolescents over
12 years of age:
1 hard capsule 2
times daily
Traditionally used in
the symptomatic
treatment of
neurotonic conditions
of adults and children,
notably in cases of
mild disorders of
sleep.
Germany
No Preparation Period of
medicinal use
Dosage
form
Posology Indication
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1 Dry extract, DER
5-7:1,
extraction
solvent ethanol
50% V/V
On the market
since 2004
Coated
tablet
(425 mg
extract per
tablet)
Adolescents over
12 years of age,
adults, elderly: 1
coated tablet 2-3
times daily
Herbal medicinal
product for the relief
of mild nervous
tension
2 Liquid extract,
DER 1:1,
extraction
solvent ethanol
70% V/V
At least since
1978
Oral liquid Adolescents over
12 years of age,
adults, elderly: 2
ml 3 times daily
Herbal medicinal
product for the relief
of mild nervous
tension
3 Dry extract, DER
5-7:1.
extraction
solvent
methanol 60%
V/V
On the market
since 1999
Hard capsule
(260 mg
extract per
capsule)
Adolescents over
12 years of age,
adults, elderly: 2
hard capsules 2
times daily
Herbal medicinal
product for the relief
of mild nervous
tension
4 Dry extract, DER
5-7.5:1.
extraction
solvent ethanol
60% V/V
On the market
since 1994
Coated
tablet
(175 mg
extract per
tablet)
Adolescents over
12 years of age,
adults, elderly: 2
coated tablets 2-
4 times daily
Herbal medicinal
product for the relief
of mild nervous
tension
5 Liquid extract,
DER 1:1.
extraction
solvent ethanol
37% V/V
On the market
since 1993
Oral liquid Adolescents over
12 years of age,
adults, elderly:
1.9 ml 3 times
daily
Herbal medicinal
product for the relief
of mild nervous
tension
6 Dry extract, DER
5-7:1.
extraction
solvent
methanol 60%
V/V
On the market
since 1992
Hard capsule
(260 mg
extract per
capsule)
Adolescents over
12 years of age,
adults, elderly: 1-
2 hard capsules 3
times daily
Herbal medicinal
product for the relief
of mild nervous
tension
7 Dry extract, DER
5-7:1.
extraction
solvent
methanol 60%
V/V
On the market
since 2002
Coated
tablet
(360 mg
extract per
tablet)
Adolescents over
12 years of age,
adults, elderly: 1
coated tablet 3
times daily
Herbal medicinal
product for the relief
of mild nervous
tension
8 Passiflorae
herba, cut
Registered in
2010
Herbal tea has
been on the
market since
Herbal tea
(2g per tea
sachet)
Adults and
adolescents over
12 years: 1 cup
of tea from 1 tea
sachet 2-4 times
daily
Traditional herbal
medicinal product to
improve general
condition in mental
stress and to aid sleep
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1986
9 Dry extract, DER
5-8:1,
extraction
solvent ethanol
25% m/m
Registered in
2010
Film-coated
tablet
(108 mg
extract per
tablet)
Adults and
adolescents over
12 years: ½-1
tablet 2-4 times
daily
Traditional herbal
medicinal product to
improve general
condition in mental
stress and to aid sleep
10 Dry extract, DER
3-5:1,
extraction
solvent water
Registered in
2012
Instant
herbal tea
(1.2 g per
measuring
spoon
contains 240
mg dry
extract)
Adults and
adolescents over
12 years: 1-2
measuring
spoons instant
herbal tea in 150
ml hot water 1-4
times daily
Traditional herbal
medicinal product to
improve general
condition in mental
stress and to aid sleep
Spain
No Preparation Period of
medicinal use
Dosage
form
Posology Indication
1 Dry extract, DER
5-7:1,
extraction
solvent ethanol
60% V/V
On the market
since 2002
Film coated
tablet
(200 mg
extract per
tablet)
Adults and
adolescents over
12 years of age:
400 mg (2
tablets per day)
For relief of mild
symptoms of mental
stress
2 Dry extract, DER
5:1, extraction
solvent ethanol
50% V/V
Registered in
2007
Film coated
tablet
(425 mg
extract per
tablet)
Adults and
adolescents over
12 years of age:
1275 mg (2-3
tablets per day)
Traditional herbal
medicinal product for
relief of mild
symptoms of mental
stress and to aid sleep
3 Passiflora
incarnata L.,
herba
Registered in
2009
Hard capsule
(300
mg/capsule
Adults and
adolescents over
12 years of age:
600 mg-1800 mg
(2-6 capsules per
day)
Traditional herbal
medicinal product for
relief of mild
symptoms of mental
stress and to aid sleep
4 Passiflora
incarnata L.,
herba
Registered in
2012
Hard capsule
(250 mg/
capsule
Adults and
adolescents over
12 years of age:
500 mg- 2 g (2-8
capsules per day)
Traditional herbal
medicinal product for
relief of mild
symptoms of mental
stress and to aid sleep
5 Passiflora
incarnata L.,
Registered in Tablet Adults and
adolescents over
Traditional herbal
medicinal product for
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herba 2012 (400
mg/tablet)
12 years of age:
400 mg - 2 g (1-
4 tablets per day)
relief of mild
symptoms of mental
stress and to aid sleep
Sweden
No Preparation Period of
medicinal use
Dosage
form
Posology Indication
1 Dry extract, DER
5-7:1,
extraction
solvent ethanol
50% V/V
Registered in
2011
Coated
tablet
(425 mg dry
extract per
coated
tablet)
Adults and
children from 12
years: 2-3 tablets
daily for the relief
of mild anxiety.
1-2 tablets half
an hour before
bedtime to aid
sleep (max 3
tablets a day)
Traditional herbal
medicinal product
used for the relief of
mild anxiety and
temporary difficulties
in falling asleep.
UK
No Preparation Period of
medicinal use
Dosage form Posology Indication
1 Passion flower
herb
Registered in
2011
Hard capsules
(300mg/capsule)
Adults (over 18
years) and the
elderly: For relief of
symptoms of mild
anxiety 1-2
capsules 3 times a
day. To aid sleep,
take 2 capsules 30
minutes before
bedtime with an
earlier dose of 2
capsules earlier in
the evening if
necessary.
Maximum daily
dose: 8 single
doses
A traditional herbal
medicinal product
for the temporary
relief of mild
anxiety and to aid
sleep, based on
traditional use
only.
2 Passion flower
herb
Registered in
2010
Hard capsule
(300
mg/capsule)
Adults (over 18
years) and the
elderly: 2 capsules
after evening meal
and 2 capsules
A traditional herbal
medicinal product
used for the
temporary relief of
symptoms
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before going to
sleep. Up to 6
capsules daily.
associated with
stress such as mild
anxiety and to aid
sleep, based on
traditional use
only.
3 Dry extract,
DER 7:1,
extraction
solvent ethanol
60% V/V
Registered in
2013
Film-coated
tablet
(71.4 mg of
extract/tablet)
Adults (over 18
years)and elderly:
One tablet to be
taken three times a
day with meals. If
required a further
tablet may be taken
at bedtime.
A traditional herbal
medicinal product
used for the
temporary relief of
symptoms
associated with
stress such as mild
anxiety, based on
traditional use
only.
4 Dry extract,
extraction
solvent
methanol 80%
Registered in
2012
Tablet
(36 mg of
extract/tablet)
Adults (over 18
years) and elderly:
Take 2 tablets early
evening and 2 at
bedtime.
A traditional herbal
medicinal product
used to aid to
sleep, based on
traditional use
only.
5 Dry extract,
DER 5-7:1,
extraction
solvent ethanol
50% V/V
Registered in
2009
Coated tablet
(425 mg extract
per tablet)
Adults (over 18
years) and the
elderly: For the
temporary relief of
symptoms of mild
anxiety take 1
tablet 2 to 3 times
a day.
To aid sleep take 1
to 2 tablets 30 min
before bedtime. The
maximum daily
dose is 3 tablets.
A traditional herbal
medicinal product
used for temporary
relief of mild
anxiety and to aid
sleep, based on
traditional use
only.
6 Dry extract,
DER 5-7:1,
extraction
solvent ethanol
50% V/V
Registered in
2009
Coated tablet
(425 mg of
extract/tablet)
Adults (over 18
years) and the
elderly: 1 tablet
daily.
A traditional herbal
medicinal product
used for the
temporary relief of
symptoms
associated with
stress such as mild
anxiety, based on
traditional use
only.
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2.2. Information on traditional/current indications and specified
substances/preparations
Medicinal use of Passiflora incarnata L., herba for the relief of mild symptoms of mental stress and to
aid sleep has been recorded e.g. in the following handbooks:
Lehrbuch der Biologischen Heilmittel Daily dose: 30-50 drops or 0.250-0.375 g fresh plant material
("Teep"-tablets) before bedtime. Duration of use: No information. (Madaus, 1938)
Martindale Extra Pharmacopoeia Single dose: liquid extract (1 in 1): 0.5-1 ml; tincture (1 in 5): 0.5-2
ml. (Todd, 1967).
British Herbal Pharmacopoeia, 1976. Dosage (3 times daily): 0.25-1 g (by infusion); 0.5-1 ml liquid
extract (1:1 in 25% alcohol); 0.5-2 ml tincture (1:8 in 45% alcohol).
Hagers Handbuch. Single dose: 2 gas infusion. (List & Hörhammer, 1977.
Hagers Handbuch. Daily oral dose: 4 - 8 g of the crude drug or the corresponding amount of the
extract. For tea: 15 g crude drug in 150 ml of water. Used mostly in combinations with Valeriana
officinalis L., root, Humulus lupulus L., cone or Melissa officinalis L., leaf. Also combinations with
Pimpinella anisum L., fruit, Lavandula angustifolia Mill., flower, Citrus aurantium L., flower or Mentha
piperita L., leaf are used. Duration of use: No information. (Hänsel et al., 1994).
British Herbal Compendium Daily oral dose: crude drug: 2 - 8 g. Liquid extract (1:1, 25% ethanol) 2 -
8 ml. Tincture (1:8, 25% ethanol) 8 - 16 ml. Duration of use: No information. (Bradley, 1992).
Herbal Drugs and Phytopharmaceuticals. Daily oral dose: 6 g. Duration of use: No information. (Wichtl,
2004).
Herbal Medicines. Daily oral dose: crude drug: 1,25 - 8 g. Liquid extract (1:1, 25% ethanol) 1.5 - 3.0
ml. Tincture (1:8, 45% ethanol) 1.5 - 6.0 ml. Duration of use: No information.(Barnes et al., 1996).
Commission E Monograph.For restlessness and resulting irritability and insomnia, and nervous tension
0.5-1 g of dried plant equivalent three times daily (Mills); 4-8 g herb daily . (Barnes et al., 2007).
For tenseness, restlessness and irritability with difficulty falling asleep: 0.5-2 g of drug three to four
times daily: 2.5 g of drug as an infusion three to four times daily; 1-4 mL of tincture (1:8) three to
four times daily . Duration of use: No information. (ESCOP, 2003).
Handbook of Medicinal Herbs. Daily oral dose: 2 - 8 g. Duration of use: No information. (Duke, 2002).
Daily oral dose: crude drug: 2 - 8 g. As infusion: crude drug 10 g. Tincture (1:8) 4 - 16 ml. Duration
of use: No restriction. (ESCOP, 2003).
PDR for Herbal Medicines,1998. Daily oral dose: 3 teaspoons (~ 6 g) for tea preparation. Duration of
use: No information.
Acupuncture & Médicine traditionelle chinoise . Daily oral dose: 6 - 9 g for tea preparation. Powdered
crude drug: 0.5 - 1 g. Duration of use: No information. (Weniger & Anton, 1996).
Drogenkunde. Daily oral dose: No information. Duration of use: No information. (Hoppe, 1958).
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Précis de Matière Médicale. Daily oral dose: tincture or fluid extract 2 - 5 g (unclear if this amount
relates to the crude drug). Duration of use: No information. (Paris & Moyse, 1981).
Phytothérapie. Les données de l´évaluation Daily oral dose: No information. Duration of use: No
information.(Bruneton, 2002).
Commission E Monographs. Daily oral dose: 4 - 8 g. Equivalent amount of preparations. Duration of
use: No information. (Blumenthal et al., 1998).
Commission E monographs. Daily oral dose: 4 - 8 g. Equivalent amount of preparations. Duration of
use: No information. (Blumenthal et al., 2000).
WHO Monographs. Daily dose, adults: as a sedative: 0.5-2.0 g of aerial parts three to four times; 2.5 g
of aerial parts as an infusion three to four times; 1.0-4.0 ml tincture (1:8) three to four times; other
equivalent preparations accordingly.
Liquid extract (DER 1:3.6 extraction solvent ethanol 60%) has been on the Austrian market since
1981. Oral dose: 20 drops, 3-5 times daily. (Austria).
Liquid extract (DER 1:3.8-4.3; extraction solvent ethanol 54% m/m, glycerine 4% m/m, water 60%)
has been on the Austrian market since 1963. Oral dose: 15-20 drops, 3-5 times daily; adolescents 3
times daily. (Austria).
No information on medicinal use of acetone extracts have been found in the literature or received from
the Member States.
Extracts prepared with acetone are included in the European Pharmacopoeia but data on traditional use
(30 years) of these extracts have neither been found in the literature, nor reported by Member States.
Methanol extracts are also included in the European Pharmacopoeia and have been authorised in
Germany since 1992. As the required 30 years of medicinal use have not elapsed, acetone and
methanol extracts cannot be included in a Community herbal monograph.
Medicinal and traditional use for the relief of mild symptoms of mental stress and to aid sleep is also
described in a number of reviews (Bizet & Roubaudi, 1998; Brasseur & Angenot, 1984; Lutomski et al.,
1981; Meier, 1995). Only one reference (Lutomski et al., 1981) contains information on dosage and
quotes the information from Commission E and ESCOP. None of the reviews contains any information
on the duration of use. An extensive review of the botany, chemistry, pharmacology and clinical use of
plants of the genus Passiflora, including Passiflora incarnata has been published (Dhawan et al., 2004).
The herbal preparations included in the revised Community monograph have been in medicinal use for
30 years or more according to literature information or according to information on approved products
obtained from the Member States.
As seen in section 2.1 above, several additional herbal medicinal products, containing herbal
preparations considered corresponding to the ones in the monograph, have been registered in Member
States. These herbal preparations have not been included in the revised monograph as the
documentation showing that they are ‘corresponding products' is not public (i.e. available only to the
competent authorities concerned).
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2.3. Specified strength/posology/route of administration/duration of use
for relevant preparations and indications
For relief of mild symptoms of mental stress and to aid sleep the following oral dosages have been
recorded:
For herbal tea, a daily dosage of 1 - 8 g of herbal substance is used to make an infusion.
The daily dosage ranges from 0.5 - 8 g of herbal substance as powder.
For liquid extracts (DER 1:8, extraction solvent 25% ethanol), the dose range from 8 - 16 ml daily in
divided doses.
For liquid extracts (DER 1:8, extraction solvent 45% ethanol), the dose range from 2 - 6 ml daily in
divided doses.
For liquid extract (DER 1:3.6, extraction solvent ethanol 60%), the dose is 1 ml 3-5 times daily.
For liquid extracts (DER 1:1, extraction solvent 25% ethanol), a daily dose ranging between 0.5 and 8
ml.
For liquid extracts (DER 1:1, extraction solvent 70% ethanol), a daily dose of up to 3 times 2 ml.
For the liquid extract (DER 1:3.8-4.3, extraction solvent ethanol 54% m/m, glycerine 4% m/m, water
60%), the dose for adults is 0.3-0.4 ml 3-5 times daily and 0.3-0.4 ml 3 times daily for adolescents.
Doses of dried extracts corresponding to the posologies of tea and liquid extracts above.
3. Non-Clinical Data
3.1. Overview of available pharmacological data regarding the herbal
substance(s), herbal preparation(s) and relevant constituents thereof
Primary Pharmacodynamics
In-vitro
In vitro studies indicated that pharmacological effects of Passiflora incarnata (dry extract DER 5-7:1;
extraction solvent 50% ethanol (V/V), at concentrations of the extract up to 1000 µg/ml) are mediated
via modulation of the GABA system including affinity to GABAA (IC50 101µg/ml) and GABAB (IC50 120
µg/ml) receptors and inhibiting effects (EC50 95.7 µg/ml) on GABA uptake (Appel et al., 2011).
In-vivo
A number of early pharmacological studies have been reviewed by Hänsel et al., 1994, most of which
are said to be of poor quality. Newer studies are reviewed in the ESCOP 2003 monograph, which
indicate, a sedative effect in rodents of hydroethanolic extracts, including reduction of spontaneous
locomotor activity and prolongation of pentobarbital-induced sleeping time at doses of 50 - 400 mg/kg
administered intraperitoneally or per os. The authors conclude that the available pharmacodynamic
studies generally support, with some conflicting results, the empirically acknowledged sedative and
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anxiolytic effects of passion flower but it is not yet clear which constituents are responsible for these
effects.
A tri-substituted benzoflavone derivative, comprising a benzene ring fused at positions 6, 7 of a
flavone compound has been isolated and claimed to be the main bioactive phyto-constituent of
Passiflora incarnata. It exhibits significant anxiolytic activity at an oral dose of 10 mg/kg in mice. It
also causes reversal of morphine tolerance in mice (dose 10 - 100 mg/kg), prevention of nicotine
addiction in mice (10 - 20 mg/kg), prevention of Δ9-THC dependence and tolerance in mice (10 - 20
mg/kg) and prevention of ethanol dependence in mice (10 - 50 mg/kg). The compound was also found
to counteract dependence on benzodiazepines in mice and to increase libido in aged rats and to
prevent loss of libido induced by ethanol, Δ9-THC or nicotine. The authors postulate that the
mechanism for all these effects is inhibition of the enzyme aromatase (a member of the cytochrome P450 family), resulting in inhibition of the metabolic conversion of androgens to oestrogens thereby
increasing free testosterone and decreasing free oestrogen (Dhawan et al., 2004).
The validity of these findings was questioned by Holbik et al., 2010. These authors could not find the
benzoflavone moiety in Passiflora incarnata cultivated in India and France and only trace amounts in an
Italian material.
The anxiolytic properties of a commercial extract of Passiflora incarnata (dry extract DER 5-7:1;
extraction solvent 50% ethanol (V/V)) was investigated in the elevated plus maze test in mice. Using
an HPLC method the flavonoids homoorientin, orientin, vitexin and isovitexin were identified as major
compounds in the extract. Following oral administration, the extract exerted an anxiolytic effect that
was comparable to diazepam (1.5 mg/kg) at a dose of 375 mg/kg. Neither a lower (150 mg/kg) nor a
higher (600 mg/kg) dose showed any anxiolytic activity, indicating a U-shaped dose-response
according to the authors. In addition, antagonism studies using the GABAA/benzodiazepine receptor
antagonist flumazenil and the 5-HT1A-receptor antagonist WAY-100635 were conducted. The anxiolytic
effect observed at a dose of 375 mg/kg was effectively antagonised by flumazenil, but not by WAY100635. This implies that the anxiolytic effects are mediated via the GABAergic system (Grundmann et
al., 2008).
Whole Passiflora extract induced dose-dependent direct GABAA currents in hippocampal slices, but the
expected modulation of synaptic GABAA currents was not seen. GABA was found to be a prominent
ingredient in Passiflora extract, and GABA currents were absent when amino acids were removed from
the extract. Five different extracts, prepared from a single batch of Passiflora incarnata (hot and cold
extraction methods with water or ethanol 65%: fresh or dried herb), were administered to CF-1 mice
for 1 week in their drinking water prior to evaluation of their behavioural effects. Anticonvulsant effects
against PTZ-induced seizures were seen in mice that received 2 of the 5 Passiflora extracts. Instead of
the anxiolytic effects described by others, anxiogenic effects in the elevated plus maze were seen in
mice receiving any of the 5 passiflora extracts (Elsas et al., 2010).
Secondary Pharmacodynamics
In -vivo
The anticonvulsant effect of a hydroethanolic extract from the aerial parts of Passiflora incarnata was
investigated in mice using the pentylentetrazole model. The flavonoid content was 4% (w/w) including
vitexin and rutin. Passiflora extract, diazepam and normal saline were administered intraperitoneally at
the doses 0.05-0.4 mg/kg, 0.5-1 mg/kg and 10 ml/kg respectively 30 minutes before PTZ (90 mg/kg,
i.p.). Flumazenil and naloxone were also injected 5 minutes before the extract to groups of mice. At
the dose of 0.4 mg/kg the Passiflora extract prolonged the onset time of seizure and decreased the
duration of seizures compared to the saline group. The selective benzodiazepine receptor antagonist
flumazenil and the opioid receptor antagonist naloxone could suppress anticonvulsant effects of the
Passiflora extract (Nassiri-Asl et al., 2007).
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The anticonvulsant effects of a commercially available preparation of a hydro-alcoholic extract of
Passiflora incarnata (total flavonoid content 4%) was investigated in rats after intracerebroventricular
injections of 0.125-1.5 µg Pasipay. The extract could dose-dependently and significantly affect minimal
clonic seizures and generalised tonic-clonic seizures induced by pentylenetetrazole. Additionally,
pretreatment with flumazenil could abolish the anticonvulsant effects. The authors concluded that the
results indicate that this passiflora extract has anticonculsant effects in the brain, possibly through
modulation of the GABAA receptor complex via interaction at the benzodiazepine site (Nassiri-Asl et al.,
2008).
In a study designed to investigate the protective effect of a hydroethanolic extract of Passiflora
incarnata in pentylenetetrazol (PTZ)-induced seizure and associated post-ictal depression in mice,
different groups of mice were administered repeated sub-convulsive doses of PTZ (50 mg/kg; i.p.) at
an interval of 5 days for 15 days. From 5th to 15th day the animals in different groups were given daily
varying doses of the hydroethanolic extract of Passiflora incarnata (150, 300 and 600 mg/kg; i.p),
diazepam (2 mg/kg; i.p.) and vehicle. Treatment with the extract significantly reduced the seizure
severity and immobility period as compared to vehicle control, in a dose and time-dependent manner.
At a dose of 600 mg/kg, the extract showed similar anticonvulsant effects as that of diazepam.
However, diazepam treatment worsened the depressive condition, indicated by increased immobility
period. Moreover, the extract treatment retained the serotonin and noradrenaline levels of the brain
(Singh et al., 2012).
3.2. Overview of available pharmacokinetic data regarding the herbal
substance(s), herbal preparation(s) and relevant constituents thereof
No data available.
3.3. Overview of available toxicological data regarding the herbal
substance(s)/herbal preparation(s) and constituents thereof
Acute toxicity:
Dry hydroalcoholic extract (not further specified): mice, i.p., 900 mg/kg. LD50: oral: >15 g/kg (mice
and rats), i.p.: 3510 mg/kg (rats), 3140 mg/kg (mice), s.c.: >10 g/kg (rats), 8300 mg/kg (mice)
(Committee of experts on cosmetic products, 2001).
Maltol: LD
50
s.c., mice 820 mg/kg (Hänsel et al., 1994), i.p., mice 820 mg/kg, (Committee of experts
on cosmetic products, 2001).
Ethylmaltol: LD
50 i.p., mice 910 mg/kg (Committee of experts on cosmetic products, 2001).
Repeated dose toxicity:
Hydroethanolic extract (not further specified): male rats, oral, 10 ml/kg body weight = 5 g/kg dried
herb, 21 days, no change in weight, rectal temperature and motor coordination (ESCOP, 2003). An oral
daily dose of 600 mg/kg for 4 weeks did not give any toxic symptoms in rats (Weniger & Anton, 1996).
Genotoxicity:
No genotoxic effects in the diploid strain Aspergillus nidulans D-30 of 1.30 mg/ml of a fluid extract
(16.2% dry matter, 0.32% ethanol) (ESCOP, 2003).
Carcinogenicity, reproductive and developmental toxicity:
No studies concerning carcinogenicity, reproductive and developmental toxicity are available.
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3.4. Overall conclusions on non-clinical data
Published data on the pharmacodynamics of Passiflora extracts and its constituents, particularly the trisubstituted benzoflavone derivative, give some support to the traditional use of Passiflora for the relief
of mild symptoms of mental stress and to aid sleep. The chemical structure of the benzoflavone
derivative does not appear to be known and the amounts of substance present in the herbal
substance/preparations have not been reported in the literature. Subsequently, the validity of these
findings has been questioned by Holbik et al.,2010. These authors could not find the benzoflavone
derivative in plant materials of Passiflora incarnata cultivated in India and France, and only in trace
amounts in an Italian plant material.
In summary, the doses employed in the animal experiments seem high compared to the doses of
Passiflora extracts that humans are exposed to during use of herbal medicinal products containing
Passiflora. The mechanism of action cannot, at present, be regarded as clarified although more recent
studies imply that the anxiolytic effects may be mediated via modulation of the GABA system.
The non-clinical information indicates that the acute and repeated dose toxicity is low. As there is no
information on reproductive and developmental toxicity the use during pregnancy and lactation cannot
be recommended. Minimum required data on mutagenicity (Ames test) are not available.
4. Clinical Data
4.1. Clinical Pharmacology
4.1.1. Overview of pharmacodynamic data regarding the herbal
substance(s)/preparation(s) including data on relevant constituents
No data available.
4.1.2. Overview of pharmacokinetic data regarding the herbal
substance(s)/preparation(s) including data on relevant constituents
No data available.
4.2. Clinical Efficacy
4.2.1. Dose response studies
No data available.
4.2.2. Clinical studies (case studies and clinical trials)
In order to evaluate the efficacy and safety of Passiflamin (Passiflora extract) a multicentre, doubleblind study in comparison with mexazolam was carried out in 28 institutions in Japan. The
administration period was 4 weeks and the initial dose was 3 tablets/per day (90 mg of Passifamin or
1.5 mg of mexazolam), which was increased to 6 tablets/day after 1 week. Sixty-three patients
received Passiflamin and 71 received mexazolam. With efficacy on the major neurotic symptoms as
assessed with PNR-D, passiflamin showed a significant effect on 4 items (including anxiety, tenseness,
irritation) of the 8 items, and mexazolam showed in all 8 items (Mori et al., 1993).
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In one small pharmacological screening study (12 healthy female volunteers), the effect of a passion
flower extract (1.2 g) was compared with that of placebo and diazepam (10 mg). Alertness was rated
by the subjects on a VAS scale after receiving the medication and after challenge with 100 mg of
caffeine. Diazepam and, to an apparent lesser degree, placebo and passion flower extract, all
decreased mental alertness. The effects of the passion flower extract on qualitative EEG signals could
not be distinguished from placebo (Schulz et al., 1998).
The effect of an extract (45 drops/day) of passion flower on patients with general anxiety was
compared with the effect of oxazepam (30 mg/day) in a study during 28 days. Eighteen patients were
treated with passion flower extract and 18 with oxazepam. Patients were assessed by a psychiatrist at
baseline and days 4, 7, 17, 21 and 28 after the medication started. The score on the Hamilton anxiety
rating scale was the same for both groups on days 0, 21 and 28. The authors concluded that the
extract was equally effective as oxazepam (Akhondzadeh et al., 2001a).
Another study by Akhondzadeh et al., 2001b comprised 65 opiate addicts undergoing withdrawal.
Treatment was 60 drops of an extract of passion flower + 0.8 mg of clonidine or placebo + the same
dose of clonidine for 14 days. Both treatments were equally effective with regard to the physical
symptoms of withdrawal. However, the combination of passion flower and clonidine was superior to
clonidine alone with respect to psychological symptoms.
Sixty patients (25-45 years) were randomised into two groups to receive either oral Passiflora
incarnata (500 mg tablet containing 1.01 mg benzoflavone) or placebo as premedication, 90 min
before surgery. A numerical rating scale (NRS) was used to assess anxiety and sedation before and 10,
30, 60 and 90 min after premedication. Psychomotor function was assessed with the Trieger Dot test
and Digit-Symbol Substitution test at arrival in the operating room. The NRS anxiety scores were
significantly lower in the passiflora group than in the control group. The authors concluded that oral
premedication with Passiflora incarnata 500 mg reduces preoperative anxiety without inducing sedation
or changing psychomotor function (Movafegh et al., 2008).
In a Cochrane review of Passiflora incarnata for anxiety disorder, two studies with a total of 198
participants were eligible for inclusion in the review (Mori et al., 1993 ; Akhondzadeh et al., 2001a).
The author concluded that relevant randomised clinical trials examining the effectiveness of passiflora
for anxiety are too few in number to permit any conclusions to be drawn. Clinical trials with larger
samples that compare the effectiveness of passiflora with placebo and other types of medication,
including antidepressants, are needed (Miyasaka et al., 2009).
In a double-blind, placebo-controlled study in 41 healthy volunteers (18-35 years) the effects of
Passiflora incarnata on sleep quality was investigated. Treatment was passionflower tea (teabags
containing 2 g of dried Passiflora incarnata leaves, stems, seed and flowers in 250 ml boiling water for
10 min). Placebo teabags contained 2 g of dried parsley. The participants were exposed to each
treatment for a week and consumed a cup of tea one hour before bedtime and filled out a sleep diary
for 7 days and completed Spielberger´s state-trait anxiety inventory on the seventh morning. Ten
participants also underwent overnight polysomnography (PSG) on the last night of each treatment
period. Passiflora incarnata produced no significant changes in any of the PSG parameters (EEG,
EOG,EMG). Amongst the PSG and subjective sleep parameters analysed, only subjective sleep
quality,was found to be significantly better than placebo (mean increase of 5.2% relative to placebo).
Significant positive correlations between the subjective and PSG measures of quantitative sleep were
found for sleep-onset latency and sleep efficiency, but not for total sleep time and nocturnal
awakenings (Ngan & Conduit, 2011).
The effect of preoperative oral administration of Passiflora incarnata on anxiety, psychomotor functions,
sedation and hemodynamics in 60 patients (25-55 years) undergoing spinal anesthesia was
investigated in a prospective, randomised, double-blind and placebo-controlled study. An aqueous
extract of Passiflora incarnata containing 2.8 mg benzoflavone per 5 ml extract was given to the
patients 30 min before spinal anaesthesia at a dose of 700 mg/5ml. The same volume (5 ml) of
mineral water was given to the placebo-group. There was a statistically significant, but small,
difference between the two groups for the increase in State Anxiety Inventory (STAI-S) score obtained
just before spinal anesthesia when compared to the baseline. There was no significant difference
between the two groups in psychomotor function, sedation score, hemodynamics and side effects. The
authors concluded that oral preoperative administration of Passiflora incarnata suppresses the increase
in anxiety before spinal anesthesia without changing psychomotor function test results, sedation level
or hemodynamics (Aslanargun et al., 2012).
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4.2.3. Clinical studies in special populations (e.g. elderly and children)
In a randomised, double-blind study in 34 children (between 6 and 13 years of age) recently diagnosed
with ADHD, the efficacy of passion flower tablets was compared with methylphenidate (Akhondzadeh
et al., 2005). Seventeen children were treated with passion flower tablets (0.04 mg/kg/day) for 8
weeks. A control group of 17 children received methylphenidate (1 mg/kg/day). The primary efficacy
parameter was outcome on a parent and teacher ADHD rating scale that has been extensively used in
Iran in school-age children. Both groups improved significantly over the 8 weeks trial compared to the
baseline value. There was no statistically significant difference in treatment result between the two
groups. No placebo group was employed.
4.3. Overall conclusions on clinical pharmacology and efficacy
In the study in 12 healthy volunteers (Schulz et al., 1998), the effect of passion flower could not be
distinguished from that of placebo. No statistical evaluation of the results was performed.
In the study by Akhondzadeh et al., 2001a, major deficiencies in methodology include that the type of
herbal preparation and details of the posology are unclear. Concerning the design of the study, the
number of patients involved (18 treated with passion flower) is too small to provide robust information.
No placebo group was used, but the patients visited a psychiatrist 6 times during the 28 days trial. It
appears very reasonable to assume that this extensive contact with a doctor may in itself have a
beneficial effect on patients with general anxiety. In the absence of a placebo group, the intrinsic effect
of the medication cannot be assessed. The trial has been discussed in the literature, and it has been
pointed out that the study was not designed as an equivalence study and conclusions about efficacy
cannot be drawn (Ernst, 2006). This study does not give conclusive evidence of efficacy of passion
flower extract for treatment of anxiety, but as a pilot study it may be seen as supportive of the
traditional use to relieve mild symptoms of mental stress.
The study by Akhondzadeh et al., 2001b is a report of the use of passion flower as an adjuvant to
clonidine in the treatment of opiate withdrawal symptoms in opiate addicts. The type of herbal
preparation was not reported. The indication and study population used in this study cannot be
considered relevant for evaluation of the traditional use of passion flower. This is the first report of the
use of passion flower in the treatment of opiate withdrawal symptoms. Medicinal use of passion flower
in this indication cannot be recognised as well-established nor as traditional in the Community.
In the study where the effect of preoperative oral administration of Passiflora incarnata was
investigated (Movafegh et al., 2008) the type of herbal extract in the tablet was not reported. In the
second study by Aslanargun et al.,2012 there was small differences in the STAI scores but also
difficulties in producing a placebo with the same taste and colour as Passiflora. The trials must be
considered pilot studies. Medicinal use of passion flower in this indication cannot be recognised as wellestablished/traditional in the Community.
In the study where sleep quality was investigated (Ngan & Conduit, 2011) the sample size was too
small and participants with sleep disorders were excluded.
In the Cochrane review (Miyasaka et al., 2009) the author concluded that relevant randomised clinical
trials examining the effectiveness of passiflora for anxiety are too few in number to permit any
conclusions to be drawn. Clinical trials with larger samples that compare the effectiveness of passiflora
with placebo and other types of medication, including antidepressants, are needed.
In a study by Akhondzadeh et al., 2005 in children with ADHD, the efficacy of passion flower was
compared to metylphenidate. The type of herbal preparation was not reported, but apparently the dose
(0.04 mg/kg/day) is several orders of magnitude lower than the doses used in traditional European
phytotherapy (approximately 10 - 100 mg/kg/day; 70 kg body weight assumed). There are a number
of limitations of the study, which the authors themselves point out. These include e.g. the lack of
placebo group and the small number of patients involved. The trial must be considered as a pilot study.
This is the first report of the use of passion flower in the treatment of ADHD. Medicinal use of passion
flower in this indication cannot be recognised as well-established/traditional in the Community.
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All clinical studies retrieved from literature suffer from serious deficiencies from the efficacy point of
view such as too small number of patients involved, lack of adequate statistical design/treatment of
the results, undefined testing medication or therapeutic indications of doubtful relevance to the
traditional medicinal use. Clinical data have recently been reviewed by Miroddi et al., 2013. They
concluded that published clinical studies revealed crucial weaknesses such as limited patient samples,
no description of blinding and randomisation procedures and little information regarding the extract
used. To conclude, the clinical data cannot be considered to fulfil the criteria required for "wellestablished medicinal use" according to Directive 2001/83/EC as amended.
5. Clinical Safety/Pharmacovigilance
5.1. Overview of toxicological/safety data from clinical trials in humans
No signals of safety concern were identified in the published clinical trials reported under 4.2.2 and
4.2.3.
5.2. Patient exposure
Products containing Passiflora incarnata L., herba are currently available in most Member States. The
products have various regulatory statuses. A considerable patient/consumer exposure must be
assumed although no exact figures can be given.
5.3. Adverse events and serious adverse events and deaths
Hypersensitivity is possible in very rare cases (ESCOP, 2003). One case of hypersensitivity vasculitis
has been reported (Smith et al., 1993).
One case of ventricular tachycardia accompanied by severe nausea, vomiting, drowsiness and
prolonged QT interval required hospital admission for cardiac monitoring and intravenous fluid therapy
(Fisher et al., 2000). The daily ingested dose corresponded to 1.5 g respectively 2 g crude drug during
2 days. Causality cannot be assessed with certainty due to incomplete data.
For unregistered products containing Passiflora incarnata as single active ingredient, nausea and
thrombocytopeniea have been reported. The following adverse reactions were also reported for
Passiflora incarnata as single active ingredient, however, concomitant drug uses were noted:
tachycardia, vomiting, abnormal nausea, left ventricular failure, ventricular fibrillation, hepatic function
abnormal, arrhythmia, tremor, agitation and withdrawal syndrome. A causality of these reported
serious adverse events and Passiflora intake has not been established. (Ireland).
No adverse events appear to have been reported for registered products in the EU. According to recent
decisions and scope of the revision, the MLWP agreed not to include references to single cases in the
revised version of the Community monograph.
5.4. Laboratory findings
No data available.
5.5. Safety in special populations and situations
Drug interactions
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One case of a possible interaction of Valeriana officinalis and Passiflora incarnata in a patient treated
with lorazepam was reported. The patient reported hand tremor, dizziness, throbbing and muscular
fatigue within 32 h before clinical diagnosis. The symptoms disappeared after stopping consuming
valerian and passionflower (lorazepam medication continued). An additive or synergistic effect is
suspected to have produced these symptoms (Carrasco et al., 2009).
Although no clinical data are available on Passiflora incarnata as a single active ingredient concerning
interactions with synthetic sedatives (such as benzodiazepines), concomitant use is not recommended.
Use in pregnancy and lactation, influence on fertility
Safety during pregnancy and lactation has not been established. No adverse effects have been
reported from the use of Passiflora incarnata during pregnancy and lactation. In the absence of
sufficient data, the use during pregnancy and lactation is not recommended.
Fertility data are not available.
Contraindications
Hypersensitivity to the active substance.
Effects on ability to drive or operate machinery
Theoretically, products containing Passiflora incarnata L., herba may cause drowsiness. The ability to
drive a car or to operate machinery may be reduced. If affected, patients should not drive nor operate
machinery (ESCOP, 2003). Excessive doses may cause sedation (Barnes et al., 1996).
5.6. Overall conclusions on clinical safety
Conventional clinical safety data are virtually absent. However, longstanding medicinal use and
experience of Passiflora incarnata L., herba has been documented within the Community. During this
time, no clear clinical signals that Passiflora incarnata L., herba is harmful under normal conditions of
use have been identified. As no data on use in children are available, products containing Passiflora
incarnata L., herba cannot be recommended for use in children below the age of 12 years. No data to
recommend a specific limit of duration of use of Passiflora products is available, but as a general
precaution the patient is recommended to consult a doctor or a qualified health care practitioner if the
symptoms persist longer than 2 weeks during the use of the product.
6. Overall conclusions
The information available is still insufficient to establish that Passiflora incarnata L., herba has a
recognised efficacy and a ´well-established´medicinal use as defined in article 10a of Directive
2001/83/EC.
However, traditional medicinal use of Passiflora incarnata L., herba for the relief of mild symptoms of
mental stress and to aid sleep is well documented in a number of recognised handbooks. The
pharmacodynamic studies in animals and the clinical studies may be seen as supportive to the
plausibility of the traditional use of Passiflora incarnata L, herba.
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Products containing Passiflora incarnata L., herba have been registered as THMPs in many Member
States. A lot of the products commercially available are combination products with other herbal
substances/preparations.
The requirement of medicinal use for at least 30 years (15 years within the Community) according to
Directive 2004/24/EC as amended is considered fulfilled for the following herbal preparations:
a) Comminuted herbal substance
b) Powdered herbal substance
c) Liquid extract (DER 1:8) extraction solvent ethanol 25% V/V
d) Liquid extract (DER 1:8) extraction solvent ethanol 45% V/V
e) Liquid extract (DER 1:3.6) extraction solvent ethanol 60% V/V
f) Liquid extract (DER 1:1) extraction solvent ethanol 25% V/V
g) Liquid extract (DER 1:1) extraction solvent ethanol 70% V/V
h) Liquid extract (DER 1:3.8-4.3) extraction solvent ethanol 54% m/m, glycerine 4% m/m, water
60%
Dried extracts corresponding to the tea and liquid extracts above.
There is very little information on toxicity. Information on genotoxicity, carcinogenicity, reproductive
and developmental toxicity is lacking. Use during pregnancy and lactation thus can not be
recommended.
Conventional clinical safety data are virtually absent, however, longstanding medicinal use and
experience of Passiflora incarnata L., herba have been documented within the Community. No clinical
signals that Passiflora incarnata L., herba is harmful under normal conditions of use have been
identified.
Insufficient data on use in children are available therefore products containing Passiflora incarnata L.,
herba are not recommended for use in children below the age of 12 years.
In view of the empirically acknowledged sedative properties of Passiflora incarnata L., herba a warning
for use in connection with driving of cars and operation of machinery is advisable.
Sufficient data for a Community herbal monograph on the traditional use of Passiflora incarnata L.,
herba are available. As the minimum required data on mutagenicity (Ames test) are still not available,
an inclusion to the Community list of traditional herbal substances, preparations and combinations
thereof for use in traditional herbal medicinal products is not recommended.
Annex
List of references

Learn more about Passiflora incarnata
Sleep
George M. Kapalka, in Nutritional and Herbal Therapies for Children and Adolescents, 2010

Passion Flower
Passion flower (Passiflora incarnata) is an herb that is approved by Commission E to treat nervousness and insomnia, but its hypnotic effects are not widely supported. As discussed in Chapter 8, passion flower may offer some limited benefits as an anxiolytic, but the use of the herb as a sleep aid needs further investigation. Currently, its use as a hypnotic falls into the category of ‘unproven uses' (Medical Economics, 2007, p. 634). Indeed, another review of literature concluded that passion flower is not effective as a sleep aid (Morin et al., 2007). While no significant dangers are associated with the use of passion flower and the herb is usually well tolerated, its use as a sleep aid is not likely to produce any beneficial effects and parents and clinicians are encouraged to try more effective alternatives.

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Valerian and Other CAM Botanicals in Treatment of Sleep Disturbances
Diana M. Taibi, Carol A. Landis, in Complementary and Alternative Therapies and the Aging Population, 2009

Passion Flower
Passion flower (Passiflora incarnata) is recommended by the German Commission E for nervous restlessness, but not specifically for sleep [37]. It is commonly used in sedative herb combinations and is rarely used alone. Biologically active constituents include flavonoids (e.g., apigenin, quercetin) and alkaloids, among numerous other constituents [52, 95]. Little evidence exists about the sedative effects or safety of the herb and no controlled trials have been conducted on the effects of passion flower on sleep in older adults. Animal studies have shown sedative effects [74, 95-97] that are blocked by a benzodiazepine receptor antagonist[98]. Equivalent sedating effects of passion flower extracts and benzodiazepines have been shown in two human studies of anxiety [99-101]. One open-labeled study of a valerian-hops-passion flower combination reported improvement in self-reported sleep latency and overall sleep quality in a general adult population. In this study, over 90% of the 190 participants rated the tolerability of the product "good" or "very good" and no side effects occurred [102]. Reported potential side effects of passion flower include cardiac dysrhythmia, headache, allergic reactions, and asthma. Overdoses may cause CNS depression, nausea, and vomiting[95, 101, 103].

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Anxiety Disorders
George M. Kapalka, in Nutritional and Herbal Therapies for Children and Adolescents, 2010

Passion Flower
Passion flower (Passiflora incarnata) is indigenous to many parts of the world, except Europe and Africa, although various species of passion flower have now been naturalized in those regions. Various species of passion flower are native to the US, especially the middle and southeastern regions of the country. Only a few species have psychotropic properties, including Passiflora incarnata, and perhaps P. coerulea and P. edulis (Spinella, 2001). Passion flower has long been used by Native American Indians for its sedative and anxiolytic effects (Kowalchick & Hylon, 1987). It is also recognized in other parts of the world for these properties. Passion flower is approved by Germany's Commission E to treat nervousness and insomnia but, as discussed in Chapter 9, its hypnotic effects are not widely supported. As a supplement, passion flower is available in liquid and capsules.

Passion flower has many constituents, including flavonoids, maltol, and indole alkaloids. Active ingredients include chrysin, vitexin, coumerin, and umbelliferone (Spinella, 2001). Chrysin is the most studied component. Along with other flavonoids, chrysin has been shown to bind to benzodiazepine receptors sites and acts as an agonist for GABA activity, especially at A type GABA receptors. This has an inhibitory effect on the brain, accounting for passion flower's anxiolytic properties. In animal studies, psychoactive effects of passion flower were reversed by benzodiazepine antagonists, and the overall effect in the brain has been compared to that of diazepam (Valium) (Wolfman et al., 1994).

Some studies began to confirm passion flower's effectiveness as an anxiolytic in humans. Bourin et al. (1997) found that the herb was effective in reducing symptoms in patients with adjustment disorder with anxiety. Akhondzadeh et al. (2001) performed a small, double-blind, randomized study in which the effects of passion flower were compared with anxiolytic properties of oxazepam (a benzodiazepine). Results revealed similar efficacy and less adverse effects with the use of passion flower. Larzelere and Wiseman (2002) found similar efficacy when they reviewed a number of small studies, and a recent review in the Cochrane system revealed that studies are beginning to emerge that support its efficacy (Miyasaka et al., 2007). Although no studies have thus far been performed with children or adolescents, supplementation with passion flower is regarded as safe and adverse effects are quite rare. Consequently, clinicians and parents may want to consider a cautious trial of passion flower to treat symptoms of anxiety.

Little is known about passion flower's pharmacokinetics, but its half-life may be short because the supplement is generally taken two to three times per day. When brewed as tea, about 150 ml (1 cup) of boiling water is poured over about 1 teaspoon. of dried herb are brewed for about 10 minutes, and drunk two to three times per day (Medical Economics, 2007). When used in capsules, children and adolescents should start with a low dose (200 mg capsules seem to be the lowest available) and used twice to three times per day. Dosage may slowly be adjusted upward while monitoring response and adverse effects.

Passion flower is usually well tolerated and side effects are rare. When initiated, treatment with passion flower may exert sedative effects, so monitoring of response is necessary. Passion flower may contribute to blood thinning, so those who take anticoagulant medications should avoid using passion flower. This may include over-the-counter medications, such as aspirin and ibuprofen. Use of passion flower is contraindicated during pregnancy. Female adolescents who take passion flower and are suspected of being sexually active must be advised of this risk, and should use contraception to prevent pregnancy.

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Infectious diseases of the ear, nose, throat, and bronchus
Kamyar M. Hedayat, Jean-Claude Lapraz, in The Theory of Endobiogeny, 2019

Summary of approach to dry bronchitis
1.
Reduce alpha

2.
Bronchospasm

3.
Emollients

4.
Support global adrenal function

5.
Reduce cortisol

6.
Reduce global thyrotropic activity

Sample treatment of dry bronchitis
Neuroendocrine-infectious: Passiflora incarnata MT 40 mL, Vibernum lantanum GM 40 mL, Cornus sanguinea GM 40 mL, Lavandula angustafolia EO 1.5 mL, Cinnamomum zeylanicum EO 1 mL, Dose: 3 mL three times per day for 10-14 days.

Emollient-drainage-infectious: Agrimonia eupatora MT 60 mL, Malva sylvestris MT 60 mL, Eucalyptus smithii or globulus EO 1 mL, Cupressus sempervirans EO 1 mL, Dose: 3 mL three times per day for 10-14 days.

A recipe for spasmodic cough in adults
Regardless of the wet or dry nature, when the cough is spasmodic, the endocrine-infectious treatment can be modified to address the spasm:

Neuroendocrine-infectious: Ribes nigrum GM 60 mL, Populus niger GM 60 mL, Satureja montana EO 0.5 mL, Cinnamomum zeylanicum EO 0.5 mL, dose: 2 mL three times per day.

A recipe for spasmodic cough in children
Children are more taste sensitive. Remove the essential oils from the tincture and utilize a topical blend of antispasmodic essential oils.

Antispasmodic topical essential oil blend
Eucalyptus ssp. EO 8 drops, Lavandula angustafolia EO 4 drops, Cupressus sempervirans EO 3 drops in 1 tbsp (15 mL) carrier oil: mix in a glass bowl, apply with friction rub in circular and cephalad/caudal motions for 3-4 min, then cover chest with a shirt or blanket, then a heated pad or towel. Repeat up to every hour as needed. May also diffuse in an aromatherapy diffuser placed within 0.6 m from the child.

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Botanicals and Nutrition in the Treatment of Epilepsy
Siegward-M. Elsas, in Complementary and Alternative Therapies and the Aging Population, 2009

Passionflower
The medicinal use of Passiflora incarnata originated with native Americans [25], and its most popular uses are for insomnia [26], anxiety [27], and epilepsy [25]. While its active ingredients have not yet been conclusively defined [27], available data suggests flavonoids as most likely active ingredients [28-30]. Studies in animal models show efficacy of Passiflora extracts and flavonoid fractions against pentylenetetrazole-induced seizures[29, 31], which can be inhibited by the benzodiazepine antagonist Ro 15-1788[32]. Purified flavonoids have been shown to have anxiolytic properties in mice similar to benzodiazepines[33, 34].

Passionflower extract is a popular botanical currently sold over the counter in many different preparations in many countries. In light of the common use, very few reports on undesirable effects have been reported. One patient with hypersensitivity developed cutaneous vasculitis and urticaria following ingestion of tablets including passionflower extract [35]. One patient developed nausea, vomiting, prolonged QT-interval in the EKG and reversible nonsustained ventricular arrythmias after ingestion of a total of 3.5 grams of Passiflora incarnata extract [36]. A clinical pilot trial has been published, which shows similar efficacy of Passiflora incarnata extract with oxazepam for treatment of anxiety [37]. While this trial did not include a placebo, a trial of 182 patients with anxiety found a reduced Ham-A score in 43% of patients treated with a combination botanical extract which included Passiflora compared to 25% in the placebo group (p = 0.012) [38].

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Phenols and phenolic glycosides
William Charles Evans BPharm BSc PhD DSc FIBiol FLS FRPharmS, ... Daphne Evans BA MA, in Trease and Evans' Pharmacognosy (Sixteenth Edition), 2009

PASSIFLORA
Passiflora (Passion Flower) consists of the dried aerial parts of Passiflora incarnata L. collected during the flowering and fruiting period. The drug is described in the BP, EP, BHP, the British Herbal Compendium, Vol. 1 and in an ESCOP monograph; it is also official in the French, German and Swiss pharmacopoeias. The genus is native to South America and species are widely cultivated as ornamentals. P. incarnata is imported from the USA, India and to some extent from the West Indies.

By the nature of its definition, the macroscopical and microscopical characteristics of the drug are numerous and for these the reader should consult one of the sources mentioned above.


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Constituents of the genus include flavonoids, mainly C-glycosides of apigenin and luteolin such as vitexin, isovitexin, orientin, iso-orientin and their 2′′-β-d-glucosides. The BP drug is required to contain not less than 1.5% total flavonoids calculated as vitexin (measurement at 401 nm) after treatment of a dry extract with methanol in glacial acetic acid followed by boric acid and oxalic acid in anhydrous formic acid. Other constituents include traces of volatile oil, cyanogenetic glycosides and possibly traces of alkaloids of the harman type. Species other than D. incarnata (P. coerulea, P. edulis) are eliminated by thin-layer chromatography.

Passiflora has sedative actions; it is a popular ingredient of herbal preparations designed to counteract sleeplessness, restlessness and irritability.

For a review update covering all aspects of the drug (over 200 refs). see K. Dhawan et al., J. Ethnopharmacol., 2004, 94, 1-23.

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Insomnia
Jane Buckle PhD, RN, in Clinical Aromatherapy (Third Edition), 2015

Passionflower and Lime Blossom
Buchbauer et al (1992) found that essential oils of passionflower (Passiflora incarnata) and lime blossom (Tilia cordata) had sedative effects. Lime blossom and its major component, benzyl alcohol, decreased the motility of animals in both normal and induced-agitation states. Interestingly, passionflower and its main components, maltol and 2-phenylethanol, only reduced motility when the animals were in an agitated state. A recent review of herbal preparations used for anxiety, depression, and insomnia in humans (Sarris et al 2011) found that although human studies indicated that passionflower had a measurable anxiolytic effect, more studies were required. Passionflower appears to work by modulating the GABA system (Appel et al 2011). In these studies, passionflower was taken internally.

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Nutraceuticals as Adaptogens
Kavita Gulati, ... Arunabha Ray, in Nutraceuticals, 2016

Herbal Agents (Adaptogens)
Many medicinal plants are used as sources of antistress agents or adaptogens, for example, Bacopa monnieri, Centella asiatica, , Valeriana officinalis, W. somnifera, Humulus lupulus, Matricaria chamomilla, Galphimia glauca, Melissa officinalis, Piper methysticum, Scutellaria lateriflora, and Ziziphus jujuba. They act by complex mechanisms and by neutralizing one or another or a combination of stress mechanisms. The net outcome is benefit in stress and stress-related disorders, which is of great relevance in today's changing lifestyle. Some of these herbal agents are briefly discussed.

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Dosage and dosage forms in herbal medicine
In Principles and Practice of Phytotherapy (Second Edition), 2013

Marker compounds or constituents
Marker compounds are characteristic phytochemicals found in a plant that are chosen to represent the standard for a standardised extract. Hence, in the case of say passionflower (Passiflora incarnata), the marker compound is often chosen to be the flavonoid isovitexin and the standardised extract of passionflower is fixed to contain a consistent level of this compound (usually a few per cent). Marker compounds are not necessarily active compounds (see below). However, if well chosen they do serve a useful function in terms of quality, such as the purposes of identification and ensuring appropriate drying, handling and extraction of the herbal starting material.

Usually to achieve a consistent level of a marker compound (or compounds) in a standardised extract, the starting herbal raw material will need to contain a minimum acceptable level. This implies consistent quality practices in terms of harvesting, drying and storage of the herb. Also, the way in which the herb is processed such as extraction conditions and choice of solvent will need to be carefully controlled. Because of this, it is likely that fixing an extract to a consistent level of marker compound(s) will also render the extract more or less consistent in terms of other phytochemical components, at least for that particular manufacturer. This aspect underpins much of the utility of standardised extracts as consistent products.

However, the difficulty arises when another manufacturer then attempts to produce the same standardised extract. Although this ‘imitation' extract will obviously be made to contain the same level of marker compound(s), it is not necessarily true that it will be an identical extract to that produced by the original manufacturer (see the concept of phytoequivalence below).

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Herbal approaches to pathological states
In Principles and Practice of Phytotherapy (Second Edition), 2013

Others
Ginkgo biloba, Salvia miltiorrhiza and Zanthoxylum (prickly ash) can improve blood flow. Ginkgo decreases erythrocyte fragility and improves blood rheology and short-term memory. Valeriana (valerian), Passiflora incarnata (passionflower), Piper methysticum (kava) and other such herbs will help the disordered sleep pattern and sympathetic dominance. Crataegus (hawthorn) may help any cardiac and circulatory abnormalities and the sympathetic dominance. Butcher's broom (Ruscus aculeatus) and horsechestnut (Aesculus hippocastanum), being venous toning, should be considered for orthostatic symptoms (see monographs). EFA therapy with evening primrose oil and fish oil is also recommended.

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PASSIONFLOWER
OTHER NAME(S): Apricot Vine, Burucuya, Corona de Cristo, Fleischfarbige, Fleur de la Passion, Fleur de Passiflore, Flor de Passion... Show More
Read Reviews (69)
Overview
Uses
Side Effects
Interactions
Dosing
Overview Information
Passion flower is a climbing vine that is native to the southeastern United States, and Central and South America. The above ground parts are used to make medicine.

Some people take passion flower by mouth for sleep problems (insomnia), anxiety, adjustment disorder, attention deficit-hyperactivity disorder (ADHD), pain, fibromyalgia, relieving opioid withdrawal symptoms, reducing anxiety and nervousness before surgery, and heart failure.

Some people apply passion flower directly to the skin for hemorrhoids, burns, and swelling (inflammation).

In foods and beverages, passion flower extract is used as a flavoring.

Passion flower was formerly approved as an over-the-counter sedative and sleep aid in the U.S., but this approval was withdrawn in 1978 when the U.S. Food and Drug Administration (FDA) reviewed the class and manufacturers did not submit evidence of safety and effectiveness.

How does it work?
The chemicals in passionflower have calming, sleep inducing, and muscle spasm relieving effects.

Next: Uses
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CONDITIONS OF USE AND IMPORTANT INFORMATION: This information is meant to supplement, not replace advice from your doctor or healthcare provider and is not meant to cover all possible uses, precautions, interactions or adverse effects. This information may not fit your specific health circumstances. Never delay or disregard seeking professional medical advice from your doctor or other qualified health care provider because of something you have read on WebMD. You should always speak with your doctor or health care professional before you start, stop, or change any prescribed part of your health care plan or treatment and to determine what course of therapy is right for you.

This copyrighted material is provided by Natural Medicines Comprehensive Database Consumer Version. Information from this source is evidence-based and objective, and without commercial influence. For professional medical information on natural medicines, see Natural Medicines Comprehensive Database Professional Version.
© Therapeutic Research Faculty 2018.

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Passiflora Incarnata Seed Oil
Passiflora incarnata, commonly known as Maypop, Purple passionflower, True passionflower, Wild apricot, and Wild passion vine, is a fast growing perennial vine with climbing or trailing stems. A member of the passionflower genus Passiflora, the Maypop has large, intricate flowers with prominent styles and stamens. One of the hardiest species of passionflower, it is a common wildflower in the southern United States. The Cherokee in the Tennessee area called it ocoee; the Ocoee River and valley are named after this plant, which is the Tennessee State Wildflower.

The dried, ground herb is frequently used in Europe by drinking a teaspoon of it in tea. A sedative chewing gum has even been produced. In cooking, the fruit of this variety is sometimes used for jam and jellies or as a substitute for its commercially grown South American brother.

Properties of the herb. Best used to help with sleep. If the fresh flowers are available, float them on water next to the bed for a wonderful sleep. A depressant to the motor side of the spinal cord. Slightly reduces arterial pressure while it increases the rate of respiration. Used to treat diarrhea, dysentery, neuralgia, sleeplessness and dysmenorrhea. (from Global Herb)

Also known as Maracuja Oil - the Passion Flower Seed Oil provides a light blast of hydration for young skin. Harvested from seeds of the passion flower, selected from both South Africa, cold pressed, fully filtered and refined. The passion flower, or passiflora incarnate, was originally used by the Aztecs to calm anxiety and relieve insomnia; but we love it for its light hydration & balancing properties that help make skin glow.


BENEFITS

Passion flower seed oil (also known as Maracuja oil' ) is one of the best known sourced of omega 6 fatty acids, containing nearly 80% linoleic acid.
Linoleic acid helps restore the barrier function and reduce scaling on the skin.
Light and thin in consistency, protecting and nourishing without being too heavy - perfect for oily skin types, and non-clogging.
Skin with acne has been found to have less linoleic acid than ‘normal' skin types.
The high level of essential fatty acids are known to recharge and replenish the skin.
Vitamin C brightens skin.
Anti-inflammatory - calming for problematic skin
Vitamin A slows the breakdown of collagen, and normalises oil production - great for balancing oily skin.
Vitamin A normalises the appearance of pigmentation & help prevent breakouts. It also promotes natural moisturising - leaving skin radiant and glowing.
Passion Flower seed oil helps to treat dry hair and scalp - lighter than other hair oils, anti-inflammatory and great for an irritated scalp.
Not available (from DeWolf) in the following state(s):
BASF Personal Care not available from DeWolf in Montana, Wyoming, Alabama, Florida, Georgia, North Carolina, South Carolina, Virginia, Illinois, Minnesota, North Dakota, South Dakota, and Wisconsin. For the West Coast States: Arizona, California, Colorado, Idaho, Nevada, New Mexico, Oregon, Utah, Washington Please contact our sister company Ross organic at http://rossorg.com/ or 562-236-5700.
Description
Cegesoft PFO is a Passionflower Oil from the regions of South America, Africa, and Madagascar. The oil is produced from the seeds which are sun dried prior to pressing. Contains a high content of linoleic fatty acid, approx. 70 % omega-6, an essential fatty acid known to reduce transepidermal water loss of the skin. Provides a pleasant & silky skin feel comparable to evening primrose oil that is long lasting due to low spreading behavior.
BASF offers one of the most comprehensive ingredients portfolios in the personal care industry. We provide the resources of a global industry leader along with the consumer insights and innovative drive our customers expect. Our high-quality product range includes surfactants, emulsifiers, polymers, emollients, cosmetic active ingredients, UV filters, thickeners, protein products and lipid layer enhancers. With production and development sites as well as sales and marketing offices all over the world, we offer our customers the winning combination of global reach, technological excellence and formulation expertise. Our focus on consumer trends, specific industry requirements and ability to innovate and bring new products rapidly to the market contribute strongly to the success of our customers - and make BASF a valued partner for the personal care industry.

Company Documents
BASF Personal Care Raw Material Guide
The information presented here was acquired by UL from the producer of the product or material or original information provider. However, UL assumes no responsibility or liability for the accuracy of the information contained on this website and strongly encourages that upon final product or material selection information is validated with the manufacturer. This website provides links to other websites owned by third parties. The content of such third
What is passionflower?
There are about 500 known species of passionflower. This family of plants is also known as Passiflora. Some studies suggest that certain species may have medicinal benefits. For example, Passiflora incarnata may help treat anxiety and insomnia.

Native Americans have used passionflower to treat a variety of conditions. These include boils, wounds, earaches, and liver problems.

Spanish explorers learned about passionflower from native Peruvians. They named these plants for their resemblance to a crucifix. In Christian traditions, "the Passion" is a term used to describe the final period of Jesus Christ's life, including his crucifixion.

In Europe, people have used P. incarnata to treat restlessness and agitation. And some people use it to treat anxiety. The fruit is also used to flavor certain beverages.

What are the potential benefits of passionflower?
According to the National Center for Complementary and Integrative Health (NCCIH)Trusted Source, more research is needed to assess the potential uses of P. incarnata. Some studies suggest it may help relieve anxiety and insomnia. Other species of passionflower have shown promise for treating stomach problems.


It may calm your mind
P. incarnata has many common names, including purple passionflower and maypop. Early studies suggest it might help relieve insomnia and anxiety. It appears to boost the level of gamma-aminobutyric acid (GABA) in your brain. This compound lowers brain activity, which may help you relax and sleep better.

In a trial published in Phytotherapy ResearchTrusted Source, participants drank a daily dose of herbal tea with purple passionflower. After seven days, they reported improvements in the quality of their sleep. The researchers suggest that purple passionflower may help adults manage mild sleep irregularities.

Some trials suggest that purple passionflowermay also relieve anxiety. A study reported in the journal Anesthesia and AnalgesiaTrusted Source examined its effects on patients scheduled for surgery. Patients who consumed it reported less anxiety than those who received a placebo.

It might soothe your stomach
Other members of the Passiflora family might help treat stomach problems. Passiflora foetida is more commonly known as stinking passionflower. In a study reported in the Indian Journal of PharmacologyTrusted Source, researchers examined its potential for treating stomach ulcers. They found it helped alleviate ulcers in rats.It also showed antioxidant potential.

In another study reported in BioMed Research InternationalTrusted Source, scientists examined Passiflora serratodigitata. They created an extract from itsleaves and stems. This extract also showed promise for treating ulcers in rats. But more research is needed on humans.


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What are the potential risks?
According to the NCCIHTrusted Source, passionflower is generally considered safe. But it may cause some side effects, such as:

sleepiness
dizziness
confusion
Because of this, it should not be taken with sedative medications. Also, it's not safe for pregnant women or breast-feeding women. It may induce contractions if you're pregnant.


How can you take passionflower?
You can add dried passionflower to boiling water to create an herbal tea. You can find dried passionflower or prepackaged tea at many health food stores. You can also find liquid extracts, capsules, and tablets.

Always talk to your doctor before trying passionflower as an alternative treatment. They can help you assess the potential benefits and risks.

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Passiflora incarnata L. (Passionflower) extracts elicit GABA currents in hippocampal neurons in vitro, and show anxiogenic and anticonvulsant effects in vivo, varying with extraction method
S.-M. Elsas,a,* D. J. Rossi,b J. Raber,a,b,c G. White,a C.-A. Seeley,a W. L. Gregory,d C. Mohr,b T. Pfankuch,b and A. Soumyanatha
Author information Copyright and License information Disclaimer
The publisher's final edited version of this article is available at Phytomedicine
See other articles in PMC that cite the published article.
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Abstract
Potential mechanisms of Passiflora incarnata extracts and the effect of extraction methods on ingredients and biological effects were explored. Using the same batch of plant material, total flavonoid yields as measured by high performance liquid chromatography coupled to diode array detection (HPLC-DAD) increased substantially with hot vs. cold extraction methods.

Whole Passiflora extract induced prominent, dose-dependent direct GABAA currents in hippocampal slices, but the expected modulation of synaptic GABAA currents was not seen. GABA was found to be a prominent ingredient of Passiflora extract, and GABA currents were absent when amino acids were removed from the extract.

Five different extracts, prepared from a single batch of Passiflora incarnata, were administered to CF-1 mice for one week in their drinking water prior to evaluation of their behavioral effects. Anticonvulsant effects against PTZ induced seizures were seen in mice that received two of the five Passiflora extracts. Instead of the anxiolytic effects described by others, anxiogenic effects in the elevated plus maze were seen in mice receiving any of the five Passiflora extracts.

Keywords: Flavonoid, GABAA receptor, Epileptic seizure, Elevated plus maze, Rotarod, Pentylenetetrazol
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Introduction
Passiflora incarnata (Purple Passionflower) is an indigenous American vine with white and blue or purple flowers and an edible fruit (Dhawan et al. 2001a). Its medicinal use originated with native Americans (Spinella 2001), and its most popular uses are for insomnia and anxiety (Carlini 2003) as well as epilepsy (Spinella 2001). Passiflora incarnata is listed in the pharmacopoeias of Great Britain, United States, India, France, Germany, Switzerland and others (Dhawan et al. 2001b). The active ingredients have not been conclusively defined (Carlini 2003). Most available data suggests flavonoids as possible active ingredients (Speroni and Minghetti 1988; Dhawan et al. 2001b; Dhawan et al. 2003).

Studies in animal models show efficacy of Passiflora extracts and flavonoid fractions against pentylenetetrazol (PTZ) induced seizures (Speroni and Minghetti 1988; Speroni and Billi 1996; Nassiri-Asl et al. 2007; Nassiri-Asl et al. 2008). This effect of Passiflora can be inhibited by the benzodiazepine site antagonist Ro 15-1788, suggesting the involvement of GABAA receptors (Medina et al. 1990). Flavonoids bind with high affinity to the benzodiazepine site of the GABAA receptor (Medina et al. 1997; Marder and Paladini 2002), but appear to modulate GABAA and also GABAC receptor currents by a different mechanism than benzodiazepines (Goutman et al. 2003; Kavvadias et al. 2004).

In 3 clinical trials, Passiflora extracts showed anxiolytic efficacy. One of the trials compared Passiflora to placebo (Movafegh et al. 2008), and two others showed Passiflora to have anxiolytic efficacy similar to benzodiazepines (Mori et al. 1993; Akhondzadeh et al. 2001b). In addition, Passiflora extract showed sedative effects in 2 clinical trials (Akhondzadeh et al. 2001a; Movafegh et al. 2008).

In preparation for a clinical trial in epilepsy patients, potential mechanisms of Passiflora extracts and the effect of extraction method on ingredients and biological effects were explored. An initial extract was tested with full and with reduced amino acid content in a hippocampal slice preparation. Using several extraction methods, another 5 extracts were prepared from the same original plant material. All 5 extracts were analyzed for flavonoid and amino acid content, and tested for neurological effects in mice using the elevated plus maze, the rotarod, and the subcutaneous PTZ model of epileptic seizures after application in the drinking water for one week.

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Methods
Passiflora extracts for in vitro testing in hippocampal slices
Whole extract
An extract of passionflower (Lot# PAS 02034C) was obtained from a local dietary supplement manufacturer, Oregon's Wild Harvest (OWH), Sandy, OR. Fresh passionflower, collected from the wild, was steeped in 44% ethanol for 35 days. The extract was distilled to remove ethanol, and freeze dried to a dry powder (1 g equivalent to 25.78 g of fresh Passionflower herb or 5.6 g of dried plant material).

Amino acid-reduced extract
The freeze dried powder from above (3 g) was dissolved in a minimum amount of water and applied to a column containing EMD C-18 silica gel 60 (Sigma; 100 g), previously conditioned with methanol and water. Amino acids were eluted with water (1 l), and flavonoids by elution with 80% aqueous methanol containing 1% ammonia (400 ml), methanol:chloroform; water (48:30:12; 150 ml), chloroform (100 ml) and finally dichloromethane; methanol; ammonia (200:75:5; 175 ml). The water elution containing amino acids was freeze dried (extracted amino acids, 2.4 g). The combined organic elutions were dried on a centrifugal evaporator (amino-acid reduced extract, 0.8 g).

Thin layer chromatography (TLC) of amino acids in Passiflora extracts
Amino acids in the various Passiflora extracts (50 mg/ml; 10 μl) were compared by TLC on silica gel with n-butanol-acetone-glacial acetic acid-water 35:35:10:20 as mobile phase. Standards applied (1 mg/ml; 10 μl) were alanine, aspartic acid, cystine, GABA, glutamine, glycine, methionine, serine, tryptophan, and tyrosine (Sigma-Aldrich). Amino acids were visualized by spraying with 0.3% ninhydrin in n-butanol containing 3% acetic acid and heated for 10 minutes. Amino acids, including GABA were prominent in the total extract and amino acid extract, and virtually absent in the amino acid reduced extract. Using NIH ImageJ for simple densitometry, GABA content was semi-quantified as compared to a 1 mg/ml (10 μl) GABA standard.

Passiflora extracts for in vivo testing in CF1 mice
Passiflora herb source
Fresh Passiflora herb (flower, fruit, leaf, and stem) was collected from the wild in Salisbury, North Carolina, USA by Botanical Supply, Inc. and obtained from OWH (Lot# PAS035FWBO). A voucher specimen was deposited with the herbarium at Portland State University and confirmed to be Passiflora incarnata L.. A portion of the batch was air-dried in a drying room at OWH. Moisture content of the fresh and dried herb was determined as 75% and 5 % respectively, using an A&D MF-50 moisture analyzer.

Extraction methods
Five different extracts were prepared from fresh or dried Passiflora herb as described in Table 1. Extract PAS 1 was prepared at OWH, whereas extracts PAS 4, 5, 7 and 8 were prepared at OHSU. Ethanol was removed from extracts using a rotary evaporator, and residual water by freeze drying. The weight of the freezedried residue was calculated as percent of the weight of fresh or dried herb extracted, and corrected for moisture content to enable comparison of the extracts (Table 1).

Table 1
Extraction methods of the five extracts from P. incarnata
Extraction methods of the five extracts from P. incarnata whole herb, and the relative yields of each extraction method are shown.

Extract Condition of herb Extraction Temperature Solvent Duration of extraction Extract weight as % w/w of plant material extracted Extract weight as % w/w of dry plant material*
PAS 1 Fresh 25°C 65% Ethanol 14 days 2.12 8.5
PAS 4 Fresh 100°C
then 4°C Water
Water 75 min
21 h 6.00 24.0
PAS 5 Dried 4°C 65% Ethanol 14 days 7.30 7.7
PAS 7 Dried 100°C
then 4°C 65% Ethanol
65% Ethanol 65 min
19 h 9.34 9.8
PAS 8 Dried 100°C
then 4°C Water
Water 60 min
20 h 8.40 8.8
*Corrected for moisture content i.e.75% of fresh herb and 5% of dry herb.
HPLC
A chemical fingerprint of the freeze-dried Passiflora extracts was obtained using an Agilent HPLC-DAD apparatus with an Econosil 5 micron C18 column. A stepwise, binary gradient of acetonitrile and water, each containing 0.1% acetic acid, was applied. The percentage of acetonitrile was 5, 25, 50 and 70 at 0, 20, 35 and 40 min respectively, with a return to starting conditions from 45 to 48 min. UV absorbance was monitored at 205 nm, 254 nm, 290 nm, 330 nm, and 350 nm. For LC-MS, full scan electrospray ionization mass spectra of the eluent were obtained using a ThermoElectron LCQ Advantage 3D Ion trap tandem mass spectrometer (San Jose, CA). The ionization source was operated in the negative mode with spray voltage 4500 V, sheath gas 35, auxiliary gas 15, capillary temperature 275°C and tube lens 40 V. Total and individual flavonoids were estimated against vitexin as a standard, using peak areas obtained at 330 nm.

Hippocampal slice physiology
Male Sprague Dawley albino rats were obtained from and housed in the OHSU NSI vivarium. Care and use of the animals was approved by the OHSU Animal Research Committee and performed according to its policies and guidelines.

Hippocampal slices were prepared from young (2-3 week old) rats and kept viable by perfusion with O2-saturated artificial CSF as described (Rossi et al. 2000). Electrical currents induced in the cell membrane by Passiflora total extract and amino acid reduced extract were measured under whole-cell voltage clamp conditions (Rossi et al. 2000). All current traces and the mean values are from CA1 pyramidal cells voltage-clamped at -30 mV with ECl- set to -60 mV, so GABAA mediated chloride currents were outward currents. Blocking a GABAA mediated current resulted in an inward current. All experiments were performed in the presence of the glutamate receptor antagonist kynurenic acid (1mM).

In vivo studies in CF-1 mice
Male CF-1 mice were obtained from and housed in the OHSU vivarium. Care and use of the animals was approved by the OHSU Animal Research Committee and performed according to its policies and guidelines. Each of the 5 different passionflower extracts was tested on a group of CF-1 mice after continuous administration in the drinking water (1000 mg freeze dried extract/kg/day; equivalent to between 4.2 and 13 g of dry herb/kg/day depending on preparation method) for one week and compared to a group of control mice which received normal drinking water.

PTZ-induced seizure model
Effects of passionflower on seizure activity induced by subcutaneous injection of 85 mg/kg pentylenetetrazol (PTZ) (Swinyard et al. 1989) were determined in groups of 8 CF-1 mice for each of the 5 passionflower extracts and compared to a group of 28 control mice. At this dose of the proconvulsant, 97% of unprotected mice typically experience clonic seizures for at least 5 minutes (Swinyard et al. 1989). Over an observation time of one hour after PTZ injection, the number of stage 2 seizures (face and forelimb clonus), and of stage 4 seizures (tonic hindlimb extension) was counted for each mouse simultaneously by 2 or 3 trained observers blinded to the animals' treatment status.

Measures of Anxiety in the Elevated Plus maze and Sensorimotor Function on the Rotarod
Groups of 8 CF-1 mice for each of the 5 passionflower extracts and 8 control mice were tested for sensorimotor function using a rotarod (Kinder Scientific, Poway, CA), as described (Acevedo et al. 2006). In the same mice, measures of anxiety were assessed using the elevated plus maze (Kinder Scientific, Poway, CA), as described (Acevedo et al. 2006).

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Results
Chemical analysis of Passiflora extract ingredients
1. Passionflower extract analysis by high-performance liquid chromatography (HPLC)
To determine the effect of different extraction methods on flavonoid content, chemical fingerprints of the five Passiflora extracts prepared by different methods (Table 1) were obtained using HPLC-DAD and LC-MS. A typical Passiflora flavonoid profile with 11 peaks was detected; Fig. 1 shows the profile of PAS1 as an example. The identity of the major peaks (Table 2) was derived by obtaining molecular weights from LC-MS (Fig. 2) and comparison of their elution order to published reports (Raffaelli et al. 1997; Bilia et al. 2002). Peaks seen by LC-MS beyond 39 minutes elution time (Fig. 2) do not appear when using UV detection at wavelengths above 250nm, suggesting that these relatively lipophilic components are not flavonoids, lack aromatic rings and may represent terpenoids.
A comparison of flavonoid content obtained with each of the 5 different extraction methods (Table 3) showed that there were large differences in total flavonoid yields with different extraction methods. Highest flavonoid yields were obtained using a hot (100°C) solvent (PAS 4, PAS 7, PAS 8, Table 1). Using only cold (4°C) extraction (PAS 1, PAS 5) resulted in about 10-fold lower total flavonoid yield. This was independent of solvent composition (ethanol or water), and independent of the use of fresh or dry herb. Similar results were also seen with additional, different extraction methods (data not shown). In contrast, the general flavonoid profile was not substantially affected by different extraction methods. All extracts appear to follow a similar pattern, with isoschaftoside, schaftoside, isovitexin and isovitexin glucoside forming the major components. The relative proportions of these components varied somewhat.

Table 3
LC-MS flavonoid analysis of the 5 different Passiflora extracts
Summary LC-MS flavonoid analysis of the 5 different Passiflora extracts using UV detection at 330 nm. The total flavonoid content, obtained as the sum of peak areas relative to vitexin, of each of the 5 different extracts is shown, along with the relative percent distribution of those flavonoids that could be identified with some certainty by comparison to the mass spectrometric analysis (Fig. 2, Table 2).

Extract Total Flavonoid content (% w/w of freeze-dried extract) Relative content of individual flavonoids (% of total flavonoid)
Isoorientin-2″-O-β-glucopyran-oside Vicenin-2 Isoschafto-side Schaftoside Isoorientin Isovitexin-2″-O-β-glucopyrano-side Isovitexin
PAS 1 3.0% 1.8% 3.6% 14.5% 19.1% 13.2% 20.1% 18.9%
PAS 4 30.6% 0.5% 2.8% 13.3% 18.3% 7.6% 24.2% 14.5%
PAS 5 2.8% 1.6% 3.9% 15.4% 19.7% 16.1% 15.9% 20.0%
PAS 7 46.4% 0.9% 5.3% 20.7% 13.9% 10.3% 17.4% 19.3%
PAS 8 20.3% 1.1% 7.1% 23.4% 14.9% 8.0% 17.6% 12.2%
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2. Passionflower extract amino acids by thin-layer chromatography (TLC)
To determine the effect of different extraction methods on amino acid content, a simple analysis was done using TLC-densitometry. Fig. 3 shows a TLC chemical fingerprint analysis for amino acids in the five different Passiflora extracts.
GABA was the dominant amino acid in all extracts (Fig. 3A). The highest amino acid and GABA content was seen in extract PAS 1 (Fig. 3B), prepared from fresh herb by cold extraction (Table 1). This suggests that using either dried herb or hot extraction may reduce the proportion of amino acids in the extract.

In vivo and in vitro biological assays of extract properties
3. Direct GABA agonist effect of Passiflora extract on hippocampal pyramidal cells
Experiments were conducted to test potential effects of whole Passiflora extract in CA1 pyramidal cells in hippocampal slices. Bath application of Passiflora extract to voltage-clamped pyramidal cells did not affect the rise time, amplitude or decay time of electrically-evoked synaptic currents mediated by pharmacologically identified GABAA receptors (data not shown). However, the extract did evoke a direct current with a dose-dependent amplitude (Figs. 4A and C). This was mediated by GABAA receptors, as evidenced by its complete but reversible block by the GABAA receptor antagonist GABAzine (10 μM, Fig. 4A). The GABAA receptor current was likely elicited by GABA present in the extract, because no current was induced by extracts from which GABA and other amino-acids had been largely removed (Figs. 4B, C and D).

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Fig. 4
Hippocampal pyramidal cell responses to Passiflora extract. Each specimen trace is from a different cell. The scale bar is the same for all traces. A, Traces of inhibitory currents elicited by Passiflora extract. Inhibition by GABAzine was tested in 2 cells at 0.128 mg/ml, 3 cells at 0.256 mg/ml and 2 cells at 0.512 mg/ml Passiflora extract. In all 7 cases, the block by GABAzine (10 μM) was 100%. B, No currents were seen with amino acid reduced Passiflora extract. C, Dose response curve with points representing 0 mg/ml, 0.128 mg/ml (n=6), 0.256 mg/ml (n=5) and 0.512 mg/ml (n=4). The amino acid reduced extract (red dot) was tested at 0.138 mg/ml (n=8). D, TLC comparison of whole Passiflora extract (Whole PAS), amino acid-reduced PAS extract (AA-reduced PAS), and amino acids removed from PAS extract (Extracted AA) with standard amino acids including GABA.

4. Effects of Passiflora incarnata extracts on PTZ-induced seizures, anxiety and sensorimotor function
To determine potential effects of extraction method on biological effects, the five different Passiflora extracts were tested in established animal models of epilepsy (PTZ-induced seizures, Fig. 5), anxiety (elevated plus maze, Fig. 6) and sensorimotor function (rotarod, Fig. 7) in mice.

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Fig. 5
Effects of Passiflora extracts on pentylenetetrazol (PTZ) induced seizures in CF-1 mice. A, the average number of stage 2 seizures (face and forelimb clonus). B, the average number of stage 4 seizures (fatal tonic hindlimb extension). Means and standard errors are shown, and statistically significant differences versus control (**) as well as trends toward significance (*) are noted (**p < 0.05, *p < 0.08, one-way ANOVA followed by Tukey's LSD, two-tailed).

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Fig. 6
Effect of Passiflora extracts on CF-1 mice in the elevated plus maze. A, percent time spent in the open arms (time spent in open arms/(time spent in open + closed arms). B, Extending over edges of the open arms. C, ratio of entries into open arms over entries into open + closed arms. D, distance moved in the open arms. Means and standard errors are shown, *p < 0.05 versus control, **p < 0.01 versus control, ***p < 0.001 versus control, one-way ANOVA followed by Dunnet's posthoc test, two-tailed. All extracts show anxiogenic effects in one or more measures of anxiety.

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Fig. 7
Effect of 5 extracts on sensorimotor activity in the rotarod (A, average of 3 trials) and total distance moved in the plus maze (B). None of the extracts resulted in a reduction of locomotor activity.

Two of the extracts, PAS4 and PAS5, reduced the frequency and severity of PTZ-induced seizures (Fig. 5). Surprisingly, all of the Passiflora extracts increased anxiety levels when compared to control, as evidenced by significantly reduced time in the open arms of the elevated plus maze and other measures of anxiety (Fig. 6). These anxiogenic effects were most prominent in mice treated with extracts PAS 5 and PAS 8. None of the extracts had an effect on sensorimotor function, assessed as fall latency on the rotarod (Fig. 7A) or the total distance moved in the elevated plus maze (Fig. 7B). These data confirm that potential sedative effects of Passiflora extracts did not contribute to their observed behavioral effects in the plus maze.

5. Comparison of extract properties following 5 different extraction methods
A summary of all extract properties is shown in Table 4. Comparing ingredient and biological activity from all extracts, there was no correlation between total flavonoid or GABA content with anxiogenic or anticonvulsant effects. The two extracts with the highest GABA content (PAS 1 and PAS 8) did not show anticonvulsant effects, and the two extracts with anticonvulsant effects differed widely in their total flavonoid content (PAS 4 and PAS 5). Similarly, there was no correlation between GABA content and anxiogenic effects.

In the present study of 5 extracts prepared from a single batch of Passiflora incarnata, we found that different extraction methods influenced the extract yield and total flavonoid and GABA content. Extraction method also affected the anticonvulsant potential. In contrast, the relative proportions of specific flavonoids, and the surprising anxiogenic effects seen in all tested extracts were not much affected by the extraction method. There was no correlation between measured flavonoid and GABA content with anticonvulsant effects of the extracts.
GABA and anticonvulsant effects
While many plant extracts contain amino acids, Passiflora extracts were found to have the highest GABA content of 21 examined plants (Carratù et al. 2008). Our studies show that Passiflora extracts not only contain a high amount of GABA, but are also able to induce direct GABAA currents in CA1 hippocampal pyramidal neurons. Since the extract with reduced amino acid levels induced no current, it is likely that the GABA content of the extract is sufficient to explain the observed GABA currents in vitro. As the main endogenous inhibitory neurotransmitter, GABA might be expected to act as a natural anticonvulsant. However, we did not find a correlation between an extract's GABA content and its anticonvulsant activity in vivo. Since orally administered GABA is subject to active transport across membranes both in the intestinal tract as well as across the blood-brain barrier (Takanaga et al. 2001), the pharmacological significance of GABA-content in Passiflora extract is still unclear.
Anxiogenic effects
Our study is the first to administer Passiflora incarnata extracts in the drinking water for 1 week prior to behavioral testing in CF1 mice, thus closely mimicking regular intake using the oral route in humans. Strikingly, our data showed an increase in anxiety measures. Importantly, the activity of the mice was not affected, excluding the possibility that potential alterations in activity contributed to the increase in anxiety measures. Consistent with this, we also found that intraperitoneal (i.p.) injections of C57Bl6/J wild-type mice or mice deficient in apolipoprotein E once 1 hour prior to behavioral testing increased measures of anxiety (data not shown). In contrast to our findings, other studies have reported anxiety-reducing effects of Passiflora extracts following single i.p. injections or oral (p.o.) administration (Table 5). Differences between Passiflora botanical species tested, geographical source of plants, extraction methods, dose, method and duration of administration, vehicle used, test animal species and strain, baseline anxiety levels and potential effects of the extracts on activity levels might all have contributed to the divergent findings. In our studies, the baseline anxiety levels in the vehicle-treated animals were such that we could easily detect both increases and decreases in measures of anxiety. However, for all previous animal studies on effects of P. incarnata on anxiety (Table 5), baseline anxiety levels were very high, with animals spending 5% or less time spent in open arms of the plus maze. Clearly, it is difficult if not impossible to detect a potential anxiogenic effect under these experimental conditions. In addition, potential effects on activity levels could contribute to group differences in performance in anxiety mazes. There, it is key to assess activity levels to exclude these potential confounds but not in all studies is this actually done. This is particularly important for anxiety-modulating compounds that often affect activity levels at higher doses. Clearly, future studies are warranted to determine the mechanisms underlying these differential effects. However, together these data support the concept that the effects of Passiflora incarnata extracts on measures of anxiety probably depend on the baseline anxiety state of the animals. In turn, this suggests that the extracts might function as modulators of one or several neurotransmitter systems, similar to positive and negative allosteric modulators whose action critically depends on the presence or absence of endogenous neurotransmitters whose levels would vary with baseline anxiety states. The anxiogenic results observed here, in vivo, also contradict reported clinical anxiolytic effects of Passiflora incarnata. However, the clinical results are specific to the Passiflora product tested. Plant extracts containing so many different constituents can exhibit a variety of effects, sometimes contradictory, depending on the chemical composition, route of administration and dosage of the individual extracts used. Furthermore in vitro and in vivo effects of pharmacological agents do not always correlate directly to clinical studies, due to issues of bioavailability, metabolism, and species differences. Additionally, the clinical data (Table 5) is not without limitations. Two of the published clinical studies of Passiflora extracts did not have a placebo control (Mori et al. 1993; Akhondzadeh et al. 2001b), and the third (Movafegh et al. 2008) measured anxiety by an unusual, possibly not standardized scale. Large, well-designed clinical studies, possibly comparing a variety of Passiflora extracts, are needed for a more complete understanding of the range of clinical actions of Passionflower.
Species
tested and
strain Plant
species Source of
plant
material Effective
extraction
method Type of
effect Vehicle:
% time
in open
arms Motility
change? Effective
dose Vehicle
used Reference
10 Swiss albino mice/group P. incarnata Collected in Bari, Italy Hydroethanolic Anxiolytic (staircase test) N/A increased 100-800 mg/kg i.p. 0.9% saline (Soulimani al. 1997)
5 Swiss mice/group P. incarnata Cultivated in Saharanpur, India Methanol, petroleum ether, chloroform, or water Anxiolytic (plus maze) 0 % not measured 75-300 mg/kg p.o. 1% carboxymethyl cellulose, 66% sucrose (Dhawan et al. 2001b)
5 Swiss albino mice/group P. incarnata Cultivated in Saharanpur, India Fractions from methanolic extract Anxiolytic (plus maze) 0 % not measured 20-100 mg/kg p.o. 1% carboxymethyl cellulose, 66% sucrose (Dhawan et al. 2001c)
5 Swiss albino mice/group P. incarnata German and Indian Suppliers Multiple methods Anxiolytic (plus maze) 0 % not measured 100-400 mg/kg p.o. 1% carboxymethyl cellulose, 66% sucrose (Dhawan et al. 2002)
9-10 Wistar rats/group P. alat
P. edulis Collected in Rio Grande, Brazil Hydroethanolic Anxiolytic (plus maze) 35% no change/increased 50-150 mg/kg i.p. Propylene glycol and saline (Petry et al. 2001)
12 Wistar rats/group P. alata
P. edulis Collected in Rio Grande, Brazil Hot water extraction Anxiolytic (plus maze) 35% no change/increased 400-800 mg/kg p.o. Propylene glycol and saline (Reginatto al. 2006)
10 BL6/C57 mice/group P. incarnata Pascoe Pharmaceutic al Co. Germany Hydroethanolic Anxiolytic (plus maze) 5 % No change 150-600 mg/kg p.o. 0.5% propylene glycol (Grundmann et al. 2008)
7-10 Swiss mice/group P. edulis Collected in Antonio Carlos, Brazil Hot water extraction of pericarp Anxiolytic (light/dark box) N/A No change 100-300 mg/kg p.o. 0.9% saline (Sena et al. 2009)
RCT in 79-83 patients/group P. incarnata Maruho Co. Japan Hydroethanolic Anxiolytic (clinical scoring) 90-180 mg/day p.o. (Mori et al. 1993)
RCT in 18 patients/group P. incarnata Iran Darouk Co. Hydroethanolic Anxiolytic (HAM-A) 45 drops/day p.o. (Akhondzadeh et al. 2001b)
RCT in 30 patients/group P. incarnata Iran Darouk Co. Hydroethanolic Anxiolytic (NRS) 500 mg p.o. x1 (Movafegh al. 2008)
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Role of flavonoids
Are flavonoids the active ingredient of Passiflora? In the more recent literature, flavonoids are considered the most likely active ingredient (Speroni and Minghetti 1988; Dhawan et al. 2001b; Dhawan et al. 2004), because some flavonoids have anxiolytic properties in mice similar to benzodiazepines (Zanoli et al. 2000), and modulate (Kavvadias et al. 2004) or inhibit (Goutman et al. 2003) GABAA and GABAC receptor currents. However, while benzodiazepines typically show anticonvulsant, anxiolytic and sedative effects, Passiflora extracts in our study showed only anticonvulsant effects, no sedation and anxiogenic instead of the expected anxiolytic effects. Recent studies have shown that specific benzodiazepine-induced pharmacological effects are mediated by specific GABAA receptor subtypes; agonists acting on the α1 subunit show predominantly sedative effects and partially anticonvulsant effects, while agonists acting on the α2 subunit show predominantly anxiolytic effects (Rudolph and Möhler 2006; Fradley et al. 2007). Since the natural flavonoids tested to date (hispidulin, apigenin, and quercetin) all seem to modulate α1GABA receptors, they may be more effective as anticonvulsants than as anxiolytics. It is also conceivable that the unexpected anxiogenic activity of Passiflora extracts under some conditions, such as dosage changes, may result from flavonoids which change from weak agonists to weak antagonists at specific GABAA receptor subtypes (Rudolph and Möhler 2006). The reported narrow dose range of anxiolytic effects of Passiflora (Dhawan et al. 2001b; Grundmann et al. 2008) may also suggest the presence of both anxiolytic and anxiogenic components with different dose/response profiles, possibly with increased anxiogenic effect at higher doses.

Our studies in CA1 pyramidal cells in hippocampal slices are the first to examine whole Passiflora extract rather than isolated flavonoids, and, contrary to expectation, did not show benzodiazepine-like modulation of synaptic GABAA currents. One reason for this may be the low concentration of individual flavonoids in whole Passiflora extract, as pointed out by other authors (Speroni et al. 1996). At the concentrations of whole extract used in our experiments (0.128-0.512 mg/ml), according to our HPLC analysis individual flavonoids are likely to have ranged up to 2 μg/ml; e.g. quercetin can be estimated at about 0.34 pM, which is well below its reported ED50 of 30 μM to inhibit α1β1γ2s GABAA and ρ1 GABAC receptors.

Another reason for the absence of GABAA receptor modulation by whole Passiflora extract could be that the receptor characteristics of the hippocampal CA1 pyramidal cells tested were different from the receptor types shown to be modulated by flavonoids (inhibition by apigenin and quercetin, and modulation by hispidulin in α1β1γ2sGABAA, α1γ2γ2sGABAA and ρ 1GABAC receptors, but no modulation in α1β2GABAA receptors (Kavvadias et al. 2004)).

It is also possible that we missed a phenomenon described as "second order positive modulation" of GABAA receptors (Campbell et al. 2004). This has been described in flavonoids such as apigenin (present in Passiflora incarnata), and means that GABA responses are only enhanced in the presence of a first order positive modulator such as diazepam. Endogenous first order GABAA modulators such as steroids and other hormones would not have been present in our slice experiments.

There are several reports suggesting that a poorly defined, tri-substituted benzoflavone compound termed BZF is the active ingredient of Passiflora incarnata (Dhawan et al. 2003; Dhawan et al. 2004). No matching compound was detected in our studies after careful examination by TLC or LC-MS following the published descriptions (Dhawan et al. 2003; Dhawan et al. 2004). Since our studies showed little variation in relative abundance of specific flavonoids with extraction methods, if present but not detected, the benzoflavone compound would have been expected to co-vary with total flavonoid content, which was not correlated with anticonvulsant or anxiogenic effects in our study.

In summary, the true active ingredients of Passiflora incarnata extract remain elusive. They might comprise one or more specific flavonoids that we were unable to individually detect and characterize, or they might be compounds of altogether different chemical characteristics such as the unidentified lipophilic compounds seen in our LC-MS study. Passiflora bioactivity may also result from synergistic actions of several compounds, such as a combination of GABA with additional compounds which may facilitate its membrane permeation, and possibly along with second order positive modulation of GABAA receptors by flavonoids (Campbell et al. 2004). The recent literature, e.g. on interactions between multiple sedative ingredients of Valeriana officinalis (Marder et al. 2003; Fernández et al. 2004; Granger et al. 2005), suggests that such synergistic interactions between several active constituents within the same extract may be a common finding in natural products (Johnston et al. 2006). Future efforts are clearly warranted to determine the active ingredients of Passiflora and the mechanisms underlying their behavioral effects.

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Acknowledgments
This study was supported by NCCAM K23 grant AT01993-01 to S.M.E., NINDS R01 NS051561 to D.J.R, NIMH R01 MH77647 to J.R., NCCAM grant AT002656 (W.G.) and a career development award from NIH P50 AT00066 to A.S. The authors wish to thank Randy Buresh, Nate Couture, Joanne Roberts and Matthew Cresswell of Oregon's Wild Harvest for providing Passiflora incarnata fresh herb and preparing some of the extracts for these studies. HPLC-DAD and LC-MS were performed at the Bioanalytical Shared Resource Pharmacokinetic Core laboratories at OHSU.

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Footnotes
Disclosure of Conflict of Interest

A. S. is a part-time employee of Oregon's Wild Harvest, a company which manufactures botanical extracts and has provided Passiflora incarnata fresh herb and some of the extracts for these studies.

Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Product description
Passion flower is rich in Omega 6 and other essential fatty acids . It has relaxing properties and is often used in massage preparations for aiding a goods nights sleep. Oils4life Passion Flower oil originates from South Africa and is cold pressed and refined. Passion flower is also known as apricot vine, granadilla, maypop, passiflora or passion vine and is so called because the stigma, stamens and sepals are likened to the instruments associated with Christs passion and crucifixion. This oil is used in the food and cosmetic industries. It is the macerated oil which is of particular importance in aromatherapy. Passion flower oil is obtained from the seeds by expression, the seed hulls and kernals releasing the crude oil, which is then refined to remove sediment and impurities
Commons-logo.svg Wikimedia Commons'ta Passiflora incarnata ile ilgili çoklu ortam belgeleri bulunur.
Wikispecies-logo.svg Wikispecies'te Passiflora incarnata ile ilgili detaylı taksonomi bilgileri bulunur.
Passiflora incarnata, commonly known as maypop, purple passionflower, true passionflower, wild apricot, and wild passion vine, is a fast-growing perennial vine with climbing or trailing stems. A member of the passionflower genus Passiflora, the maypop has large, intricate flowers with prominent styles and stamens. One of the hardiest species of passionflower, it is both found as a wildflower in the southern United States and in cultivation for its fruit and striking bluish purple blooms.
The stems can be smooth or pubescent; they are long and trailing, possessing many tendrils. Leaves are alternate and palmately 3-lobed and occasionally 5-lobed, measuring 6-15 centimetres (2.4-5.9 in). They have two characteristic glands at the base of the blade on the petiole. Flowers have five bluish-white petals. They exhibit a white and purple corona, a structure of fine appendages between the petals and stamens. The large flower is typically arranged in a ring above the petals and sepals. They are pollinated by insects such as bumblebees and carpenter bees, and are self-sterile. The flower normally begins to bloom in July.[1]
The fleshy fruit, also referred to as a maypop, is an oval yellowish berry about the size of a hen egg; it is green at first, but then becomes yellow as it matures. As with other passifloras, it is the larval food of a number of lepidoptera species, including the zebra longwing, the Gulf fritillary, the crimson-patched longwing, the Julia, the Plebeian sphinx, and the variegated fritillary.[2] In many cases its fruit is very popular with wildlife. The egg-shaped green fruits 'may pop' when stepped on. This phenomenon gives the P. incarnata its common name, as well as the fact that its roots can remain dormant for most of the winter underground and then the rest of the plant "pops" out of the ground by May, unharmed by the snow.
The maypop occurs in thickets, disturbed areas, near riverbanks, and near unmowed pastures, roadsides, and railroads. It thrives in areas with lots of available sunlight. It is not found in shady areas beneath a forest canopy.[citation needed] The Cherokee in the Tennessee area called it ocoee; the Ocoee River and valley are named after this plant, which is the Tennessee state wildflower.[3] For thousands of years the maypop was a staple food and medicinal plant for the Cherokee and to this day it is a revered piece of their heritage. This, and other passionflowers are the exclusive larval host plants for the Gulf fritillary and non-exclusive for the variegated fritillary butterflies.[4]
Cultivation
Passiflora incarnata is easily cultivated and in its native range and homeland is a common low maintenance garden plant that can be trained to adorn fences and arbors. The wild maypop is an aggressive vine native to the southeastern United States extending into the central US reaching Illinois, Indiana, and Ohio.[5] The vines can carpet the floor of thickets within days in favorable weather. The plants grow in full sun and need direct sunlight for at least half of the day. The best soils for P. incarnata are well-drained [6] but the plants tolerate occasionally wet and acidic soils. The plants have a high drought tolerance. P. incarnata can be planted all the year in zone 7-11 (hardiness zone). The space between two plants is 36-60 inches (91.44 - 152.4 cm).[5] One to two years are necessary before they begin bearing. Each flower has a very short life (about one day). Then the fruit develops in two to three months.[6] The harvest depends on vine size and age of the plant but one reported 10-20 fruits per vine. Seeds can be collected in the fall after the fruit has begun to shrivel. There are some problems with nematodes and caterpillars in the culture of P. incarnata.[5]
The flowers appear suitable for bumblebee pollination and may attract ruby-throated hummingbirds.[citation needed] As both bees and hummingbirds look for nectar, the pollen filled flower anthers brush the back of the bee or the face of the hummingbird, enabling pollen to be readily transferred to the central sticky stigma.[citation needed] Passiflora incarnata can potentially become an agricultural weed. The genus Passiflora introduced for agricultural purpose has been reported as an important weed in certain regions of the world.[7] The United States Department of Agriculture notes that P. incarnata is referred to as a weed by these publications:[8] Weeds of Kentucky and adjacent states: a field guide[9] and Weeds of the United States and Canada.[10] Mechanical control as removing the suckers regularly is advised to prevent the spreading of maypop. It is also recommended to train the vines onto trellis and fences to limit propagation.[7]
Medicinal use
Historical uses and folk medicine
Historically, the plant has been used as an herbal medicine in the belief it may treat anxiety, insomnia, or hypertension.[11][12][non-primary source needed] Passionflower is included in pharmacopeias, such as the European and British Pharmacopoeias in which the dried aerial parts of the plant are mentioned.[12] In North America and South America, tea made from the roots is used as a tonic.[12]
Safety
In traditional medicine, passionflower is reputed to have sedative effects as used historically in Europe,[12][13] but in 1978, the U.S. Food and Drug Administration (FDA) prohibited its use in over-the-counter sedative preparations because it had not been proven safe and effective. When used in food manufacturing as a flavor, passionflower is included among substances approved by the FDA.[14]
Passionflower is classified as generally recognized as safe (GRAS) for use as a flavor in foods in the United States,[14] and possibly "can be used for the relief of mild symptoms of mental stress and to aid sleep."[13] There is no evidence that P. incarnata has anti-disease activity.[13][15] Interactions
Possible interactions with following medications Sedatives Anticoagulants Monoamine oxidase inhibitors
P. incarnata may increase main effects or side effects of medications listed above.[16]
For oral consumption, pregnant or breastfeeding women should use caution and seek medical advice before orally consuming P. incarnata. The effects of oral ingestion of the plant compounds on reproduction or on unborn child have not been tested. The oral consumption of this plant may prejudice the ability to drive and use machinery.[13][14]
Phytochemistry P. incarnata contains flavonoids and alkaloids,[13][15][16] with leaves containing the greatest concentration of flavonoids. Other flavonoids present in P. incarnata include chrysin, apigenin, luteolin, quercetin, kaempferol, and isovitexin.[17]
Culinary use
In cooking, the fruit of passionflower may be used for jams, jellies, desserts, and the juice is a favorite in drinks. It can be used as a fresh substitute for its commercially grown South American relative, Passiflora edulis; both belong to the same subgenus within their species and have similar sized fruit. The fruit can be eaten by hand, as indicated by its common name, given to it by Cajuns: liane de grenade or "pomegranate vine". It has a slightly sweet-tart taste and a pleasant scent when fully ripe.
References
"Maypop-Passion Flower - Passiflora incarnata". Root Buyer. Retrieved 18 October 2018.
The Xerces Society (2016), Gardening for Butterflies: How You Can Attract and Protect Beautiful, Beneficial Insects, Timber Press.
"State Symbols". Tennessee Government. Retrieved October 24, 2011.
Horn, compiled and edited by Dennis Horn and Tavia Cathcart ; technical editor: Thomas E. Hemmerly ; photo editors: David Duhl and Dennis (2005). Wildflowers of Tennessee, the Ohio Valley, and the Southern Appalachians : the official field guide of the Tennessee Native Plant Society. [Edmonton]: Lone Pine Pub. p. 105. ISBN 978-1-55105-428-5.
Gilman EF (2015). "Passiflora incarnata (Wild Passion Flower, Maypop)". Institute of Food and Agricultural Sciences, University of Florida. Retrieved 23 January 2018.
"Purple passionflower" (PDF). US Department of Agriculture. 15 August 2008.
Mc Guire, C. M. (1999). "Passiflora incarnata (Passifloraceae): A new fruit crop". Economic Botany. 53 (2): 161-176. doi:10.1007/bf02866495.
PLANTS Database. "Purple Passionflower". United States Department of Agriculture. Retrieved 22 November 2015.
Haragan, P. D. (1991). Weeds of Kentucky and Adjacent States: A Field Guide. Lexington, KY: The University Press of Kentucky. ISBN 978-0-8131-3369-0.
Southern Weed Science Society (1998). Southern Weed Science Society's weeds of the United States and Canada [electronic resource]. Champaign, Ill: Southern Weed Science Society.
Plants For A Future: Passiflora incarnata
Miroddi,, M (2013). "Passiflora incarnata L.: Ethnopharmacology, clinical application, safety and evaluation of clinical trials". Journal of Ethnopharmacology. 150 (3): 791-804. doi:10.1016/j.jep.2013.09.047. PMID 24140586.
"Passiflora". European Medicines Agency. Retrieved 22 November 2015.
"Food Additive Status List". US Food and Drug Administration. 4 January 2018. Retrieved 23 January 2018.
Miroddi, M.; Calapai, G.; Navarra, M.; Minciullo, P.L.; Gangemi, S. (2013). "Passiflora incarnata L.: Ethnopharmacology, clinical application, safety and evaluation of clinical trials". Journal of Ethnopharmacology. 150 (3): 791-804. doi:10.1016/j.jep.2013.09.047. ISSN 0378-8741. PMID 24140586.
Ehrlich, Steven D. "Passionflower". University of Maryland. A.D.A.M. Retrieved 22 November 2015.
Dhawan K., Dhawan S., Sharma A. (2004). "Passiflora: a review update". Journal of Ethnopharmacology. 94 (1): 1-23. doi:10.1016/j.jep.2004.02.023. PMID 15261959.
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Passiflora incarnata State flowers of the United States

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