Ginseng panax – Monographie Santé Canada

SOURCE- SANTÉ CANADA :

Nomenclature du compendium des ingrédients médicinaux;

Médicaments et produits de santé naturels

Monographie: Ginseng Panax

La présente monographie vise à servir de guide à l’industrie pour la préparation de demandes de licence et d’étiquettes dans le but d’obtenir une autorisation de mise en marché d’un produit de santé naturel. Elle ne vise pas à être une étude approfondie de l’ingrédient médicinal. La présente monographie est un document, avec références à l’appui, à utiliser en tant que norme d’étiquetage. Nota : (i) Les parenthèses contiennent des éléments d’information facultatifs — il n’est pas nécessaire de les inclure dans la demande de licence de mise en marché (DLMM) ou sur l’étiquette du produit. La barre oblique (/) indique que les termes sont synonymes. Le demandeur peut utiliser n’importe lequel des termes indiqués. (ii) Les allégations relatives à l’utilisation traditionnelle doivent inclure les termes « en phytothérapie/herboristerie », sauf dans le cas de la MTC.

Date: 2009-11-04

Nom de la BDIPSN

Panax ginseng (USDA, 2008) 

Nom(s) propre(s)

Panax ginseng C.A. Meyer (Araliaceae) (USDA 2008)

Nom(s) commun(s)

• Ginseng asiatique
• Ginseng chinois
• Ginseng coréen
• Ginseng coréen rouge
• Ginseng de Corée
• Ginseng rouge
• Panax ginseng
• Renshen

Matière d’origine

Racine

Orale

Forme posologique(s)

• Les aliments ou les formes posologiques semblables aux aliments telles que les barres, les gommes à mâcher ou les breuvages, sont exclus de cette monographie.
• Les formes posologiques pharmaceutiques acceptables comprennent, notamment les bandelettes, les capsules, les comprimés, les formes posologiques à croquer (p. ex. les comprimés, les gélifiées), les liquides ou les poudres.

Usage(s) ou fin(s) recommandé(s)

Enoncé(s) précisant ce qui suit:

• (Utilisé en phytothérapie comme) thérapie de soutien pour aider au contrôle du taux de glucose
• Utilisé en médecine traditionnelle chinoise (MTC) pour renforcer le Qi, aider la Rate et le Poumon, soulager les symptômes de la soif associés au manque de Liquides organiques et à la chaleur interne
• (Utilisé en phytothérapie pour) aide(r) au maintien des fonctions cognitives et/ou à la réduction de fatigue mentale (dans les cas de tension mentale)  (
• Utilisé en phytothérapie pour aider à accroître les capacités physiques/la performance physique (dans les cas de stress physique)

Dose(s)

Adultes:

MTC
Préparation: Décoction 

Dose(s): 3 – 9 Grammes par jour, racines séchées

Préparation: Poudre 

Dose(s): 2 Grammes 2 fois par jour, racines séchées

Préparation: Préparation séchée 

Dose(s): 3 – 9 Grammes par jour, racines cuites à la vapeur et séchées
Taux de glucose; Tension mentale; Stress physique
Préparation: Sec, décoction, poudre et infusion + tousles extraits non nrmalisés 

Dose(s): 0.5 – 9 Grammes par jour, racines et/ou radicelles séchées

Préparation: Tous les extraits normalisés  

Dose(s): 0.5 – 9 Grammes par jour, racines et/ou radicelles séchées 0.008-0.27 Grammes ginsénocides au total par jour

Consulter l’annexe 1 pour des exemples pertinents de préparations de doses et de fréquences d’emploi, selon les références citées. L’annexe 1 a pour objet de guider l’industrie.

Consulter un praticien de soins de santé si l’utilisation se prolonge au-delà de 3 mois
Mention de risques

Enoncé(s) précisant ce qui suit:

Précaution(s) et mise(s) en garde:

• Consulter un praticien de soins de santé avant d’en faire l’usage si vous êtes enceinte ou si vous allaitez
• Consulter un praticien de soins de santé avant d’en faire l’usage si vous prenez des anticoagulants ou de la digoxine
• Consulter un praticien de soins de santé avant d’en faire l’usage si vous prenez des antidépresseurs
• Consulter un praticien de soins de santé avant d’en faire l’usage si vous souffrez de diabète

MTC:
Selon la MTC, ne pas utiliser en cas de déficience du Yin accompagnée de symptômes de chaleur, de chaleur excessive, ou en l’absence d’une déficience importante du Qi

Réaction(s) indésirable(s) connue(s):
Certaines personnes pourraient souffrir d’insomnie, d’anxiété, ou de maux de tête. Si tel est le cas, cesser l’utilisation

Ingrédients non médicinaux

Doivent être choisis de la Base de données d’ingrédients de produits de santé naturels actuelle et doivent respecter les restrictions définies dans la base de données.
Spécifications

• Les spécifications du produit fini doivent être établies conformément aux exigences décrites dans le Guide de référence sur la qualité des produits de santé naturels de la DPSN.
• L’ingrédient médicinal doit être conforme aux exigences mentionnées dans la Base de données d’ingrédients de produits de santé naturels (BDIPSN).
• L’ingrédient médicinal peut être conforme aux spécifications énoncées dans les monographies officinales suivantes: ‘Ginseng’ de la pharmacopée britannique (BP), ‘Ginseng’ de la pharmacopée européenne (Ph. Eur.), de même que ‘Asian Ginseng’, ‘Powdered Asian Ginseng’, ‘Powdered Asian Ginseng Extract’ ou ‘Asian Ginseng Tablets’ de la pharmacopée américaine (USP).

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Annexe 1: Exemples de préparations posologiques, de fréquences et de modes d’emploi

Racine et/ou radicelle:

• 9 g de racines séchées, par jour (Heo et collab 2008)
• 4,5 g de racines séchées, par jour (Lee et collab 2008b)
• 2 g de radicelles séchées, 3 fois par jour (Vuksan et collab 2008)
• 2 à 6 g de radicelles séchées, par jour (Sievenpiper et collab 2006)
• 1,8 à 9 g de racines séchées, par jour (Mills et Bone 2005)
• 2 g de racines séchées, 2 fois par jour (PPRC 2005)
• 3 à 9 g de racines séchées(PPRC 2005)
• 0,5 à 2 g de racines séchées, par jour (ESCOP 2003)
• 1 à 2 g de racines séchées, par jour (Blumenthal et collab 2000)
• 0,6 à 2 g de racines séchées, par jour ((Bradley 1992)
• 1 à 2 g de racines séchées, 3 fois par jour (BHP 1983)

Décoction:

• 1,8 à 9 g de racines séchées, par jour (Mills et Bone 2005)
• 3 à 9 g de racines séchées, par jour (PPRC 2005)
• 1 à 2 g de racines séchées, par jour (Blumenthal et collab 2000)
• 0,5 à 2 g de racines séchées, par jour (WHO 1999)
• 0,6 à 2 g de racines séchées, par jour (Bradley 1992)
• 1 à 2 g de racines séchées, 3 fois par jour (BHP 1983)

Extrait fluide:

équivalent sec de 1 à 2 g, par jour (1:1, 1 à 2 ml) (Blumenthal et collab 2000)

Teinture:

• équivalent sec de 0,75 à 3 g, par jour (1:2, 1.5 à 6 ml) (Mills et Bone 2005)
• équivalent sec de 0,2 à 0,4 g, 3 fois par jour (1:5, alcool à 60%, 1 à 2 ml) (Hoffmann 2003)
• équivalent sec de 1 à 2 g, par jour (1:5, 5 à 10 ml) (Blumenthal et collab 2000)

Extraits normalisés à 4 à 7 % de ginsénosides au total:

• 100 mg, 2 fois par jour (3 à 7:1, éthanol à 40%) (Blumenthal et collab 2000; Scaglione et collab 2001; Scaglione et collab 1994; Scaglione et collab 1990; Gross et collab 1995; D’Angelo et collab 1986)
• 200 mg, par jour (3 à 7:1, éthanol à 40%) (Reay et collab 2006; Reay et collab 2005; Kennedy et collab 2004; Kennedy et collab 2001; Allen et collab 1998; Scaglione et collab 1996; Forgo 1983)
• 200 mg, par jour (5:1) (Engels et Wirth 1997; Engels et collab 1996)
• 400 mg, par jour (5:1) (Sünram-Lea et collab 2005; Reay et collab 2005; Engels et collab 2003; Kenney et collab 2002; Scholey et Kennedy 2002; Engels et collab 2001; Kennedy et collab 2001; Engels et Wirth 1997)
• 600 mg, par jour (3-7:1, éthanol à 40%) (Kennedy et collab 2001)