Phytonutrient Blog

Panax Ginseng – Health Canada Product Monograph

SOURCE- HEALTH CANADA:

Nomenclature of the Compendium of Medicinal Ingredients;

Drugs and natural health products

Product Monograph: Panax Ginseng

The purpose of this monograph is to serve as a guide for industry in the preparation of licence applications and labels for the purpose of obtaining a product market authorization. It is not intended to be an in-depth study of the medicinal ingredient. This monograph is a document, with supporting references, to be used as a labelling standard. Note: (i) Parentheses contain optional pieces of information — they do not need to be included in the Product Licence Application (MDL) or on the product label. The forward slash (/) indicates that the terms are synonymous. The applicant may use any of the terms indicated. (ii) Traditional use claims must include the words « in herbal medicine/herbalism », except in the case of TCM.

Date: 2009-11-04

Name of NHPID

Panax ginseng (USDA, 2008)

Proper name(s)

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

Common name(s)

  • Asian ginseng
  • Chinese ginseng
  • Korean ginseng
  • Korean red ginseng
  • Korean ginseng
  • Red ginseng
  • Panax ginseng
  • Renshen

Material of origin

Root

Oral

Dosage form(s)

  • Foods or food-like dosage forms such as bars, chewing gum or beverages are excluded from this monograph.
  • Acceptable dosage forms include, but are not limited to, strips, capsules, tablets, chewable dosage forms (e.g., tablets, gummies), liquids or powders.

Recommended use(s) or purpose(s)

Statement(s) specifying the following:

  • (Used in herbal medicine as) supportive therapy to help control glucose levels
  • Used in Traditional Chinese Medicine (TCM) to strengthen Qi, help the Spleen and Lung, relieve thirst symptoms associated with lack of body fluids and internal heat
  • (Used in herbal medicine for) helps maintain cognitive function and/or reduce mental fatigue (in cases of mental tension) (
  • Used in herbal medicine to help increase physical abilities/physical performance (in cases of physical stress)

Dose(s)

Adults:

MTC
Preparation: Decoction

Dose(s): 3 – 9 Grams per day, dried roots

Preparation: Powder

Dose(s): 2 Grams 2 times a day, dried roots

Preparation: Dried preparation

Serving(s): 3 – 9 Grams per day, steamed and dried roots
Glucose levels; Mental tension; Physical stress
Preparation: Dry, decoction, powder and infusion + allunmalized extracts

Dose(s): 0.5 – 9 Grams per day, dried roots and/or rootlets

Preparation: All standardized extracts

Dose(s): 0.5 – 9 Grams per day, dried roots and/or rootlets 0.008-0.27 Grams ginsenocides in total per day

Refer to Appendix 1 for relevant examples of dose and frequency preparations for use, as referenced above. The purpose of Annex 1 is to provide guidance to industry.

Consult a health care practitioner if use extends beyond 3 months
Mention of risks

Statement(s) specifying the following:

Precaution(s) and warning(s):

  • Consult a health care practitioner prior to use if you are pregnant or breastfeeding
  • Consult a health care practitioner prior to use if you are taking blood thinners or digoxin
  • Consult a health care practitioner prior to use if you are taking antidepressants
  • Consult a health care practitioner prior to use if you have diabetes

TCM:
According to TCM, do not use in case of Yin deficiency accompanied by symptoms of heat, excessive heat, or in the absence of a significant qi deficiency

Known adverse reaction(s):
Some people might suffer from insomnia, anxiety, or headaches. If this is the case, discontinue use

Non-medicinal ingredients

Must be selected from the current Natural Health Products Ingredient Database and must meet the restrictions defined in the database.
Specifications

  • Finished product specifications must be established in accordance with the requirements outlined in the NHPD’s Natural Health Product Quality Reference Guide.
  • The medicinal ingredient must comply with the requirements set out in the Natural Health Products Ingredients Database(NHPID).
  • The medicinal ingredient may comply with the specifications set out in the following compendial monographs: ‘Ginseng’ of the British Pharmacopoeia (BP), ‘Ginseng’ of the European Pharmacopoeia (Ph. Eur.), as well as ‘Asian Ginseng’, ‘Powdered Asian Ginseng’, ‘Powdered Asian Ginseng Extract’ or ‘Asian Ginseng Tablets’ of the American Pharmacopoeia (USP).

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Appendix 1: Examples of Dosage Preparations, Frequencies and Directions for Use

Root and/or rootlet:

  • 9 g of dried roots, per day (Heo et al. 2008)
  • 4.5 g dried roots, per day (Lee et al. 2008b)
  • 2 g dried rootlets, 3 times daily (Vuksan et al. 2008)
  • 2 to 6 g of dried rootlets, per day (Sievenpiper et al. 2006)
  • 1.8 to 9 g of dried roots, per day (Mills and Bone 2005)
  • 2 g dried roots, 2 times a day (PPRC 2005)
  • 3 to 9 g of dried roots (PPRC 2005)
  • 0.5 to 2 g of dried roots, per day (ESCOP 2003)
  • 1 to 2 g of dried roots, per day (Blumenthal et al. 2000)
  • 0.6 to 2 g of dried roots, per day ((Bradley 1992)
  • 1 to 2 g of dried roots, 3 times a day (BHP 1983)

Decoction:

  • 1.8 to 9 g of dried roots, per day (Mills and Bone 2005)
  • 3 to 9 g of dried roots, per day (PPRC 2005)
  • 1 to 2 g of dried roots, per day (Blumenthal et al. 2000)
  • 0.5 to 2 g of dried roots, per day (WHO 1999)
  • 0.6 to 2 g of dried roots, per day (Bradley 1992)
  • 1 to 2 g of dried roots, 3 times a day (BHP 1983)

Fluid extract:

dry equivalent of 1 to 2 g, per day (1:1, 1 to 2 ml) (Blumenthal et al. 2000)

Dye:

  • dry equivalent of 0.75 to 3 g, per day (1:2, 1.5 to 6 ml) (Mills and Bone 2005)
  • dry equivalent from 0.2 to 0.4 g, 3 times a day (1:5, 60% alcohol, 1 to 2 ml) (Hoffmann 2003)
  • dry equivalent of 1 to 2 g, per day (1:5, 5 to 10 ml) (Blumenthal et al. 2000)

Extracts normalised to 4 to 7 % ginsenosides in total:

  • 100 mg, 2 times daily (3 to 7:1, 40% ethanol) (Blumenthal et al. 2000; Scaglione et alab 2001; Scaglione et al. 1994; Scaglione et al. 1990; Gross et alab 1995; D’Angelo et al. 1986)
  • 200 mg, daily (3 to 7:1, 40% ethanol) (Reay et al. 2006; Reay et alab 2005; Kennedy et al. 2004; Kennedy et al. 2001; Allen et al. 1998; Scaglione et al. 1996; Forgo 1983)
  • 200 mg, daily (5:1) (Engels and Wirth 1997; Engels et al. 1996)
  • 400 mg, daily (5:1) (Sünram-Lea et al. 2005; Reay et alab 2005; Engels et al. 2003; Kenney et al. 2002; Scholey and Kennedy 2002; Engels et alab 2001; Kennedy et al. 2001; Engels and Wirth 1997)
  • 600 mg, daily (3-7:1, 40% ethanol) (Kennedy et al. 2001)

 

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