ASTRAGALUS - ASTRAGALUS MEMBRANACEUS

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

• Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
• The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant.

Date

February 25, 2019

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information

Proper name(s)	Common name(s)	Source information
		Source material(s)	Part(s)	Preparation(s)
Astragalus membranaceus	Astragalus Huangqi Huang qi Membranaceusmilk vetch Membranous milk-vetch Milk vetch root Mo jia huang qi	Astragalus membranaceus	Root	Dried

References: Proper name: USDA 2018; Common names: HKCMM 2008, McGuffin et al. 2000, PPRC 2000, Bensky and Gamble 1986; Source information: Hoffman 2003, PPRC 2000, Bensky and Gamble 1986.

Route of Administration

Oral

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

• Used in Traditional Chinese Medicine (TCM) to tonify the spleen and augment the qi (vital energy): for spleen deficiency presenting with the lack of appetite, fatigue, and diarrhea (PPRC 2000; Benksy and Gamble 1986).
• Used in Traditional Chinese Medicine (TCM) to tonify the lungs and is used for frequent colds (PPRC 1998; Benksy and Gamble 1986).
• Used in Traditional Chinese Medicine (TCM) to augment the protective qi and stabilize the exterior: for deficiency with spontaneous sweating (PPRC 2000; Benksy and Gamble 1986).
• Used in Herbal Medicine to help maintain a healthy immune system (Winston and Kuhn 2008; Mills and Bone 2005; Hoffman 2003; Upton 1999).
• Used in Herbal Medicine as an adaptogen to help increase energy and resistance to stress (e.g. in case of mental and physical fatigue related to stress) (Winston and Maimes 2007; Bone 2003).

Note
Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Traditional Chinese Medicine

Methods of preparation: Dry, Decoction

9 - 30 grams dried root per day (PPRC 2000; Benksy and Gamble 1986).

Maintenance of Healthy Immune System

Methods of preparation: Dry, Powder, Non-Standardised Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

2 - 4.8 grams dried root, per day (Mills and Bone 2005; Hoffman 2003).

Adaptogen

Methods of preparation: Dry, Powder, Non-Standardised Ethanolic Extracts (Dry extract, Tincture, Fluid extract)

2 - 4.8 grams dried root, per day (Bone 2003; Hoffman 2003)

Direction(s) for use

Traditional Chinese Medicine: For Dry Root

• Add water to 3-5 cm higher than the surface of the dried root, let sit for 60 minutes. Boil for 20-25 minutes, remove and drink.
• To make an additional preparation from the same dried root, add fresh water to 1-2 cm higher than surface of the dried root, boil for 15-20 minutes, remove and drink (Cao 1996).

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

All products

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant, breastfeeding or have an autoimmune disorder (Brinker 2010, Upton 1999).

Contraindication(s)

Traditional Chinese Medicine

According to Traditional Chinese Medicine, do not use this product in cases of exterior excess, qi stagnation, damp obstruction, food stagnation, yin deficiency with heat signs, or skin lesions in their early stages or where there is a heat toxin (Bensky and Gamble 1986).

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

No statement required.

Specifications

• The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
• The medicinal ingredient mustay comply with the requirements outlined in the NHPID

References Cited

• Bensky D, Gamble A. 1986. Chinese Herbal Medicine: Materia Medica. Seattle (WA): Eastland Press, Inc.
• Brinker F. 20010. Herb Contraindications and Drug Interactions, 4th Edition. Sandy (OR): Eclectic Medical Publications.
• Bone K. A clinical guide to blending liquid herbs: Herbal formulations for the individual patient. St. Louis (MI): Churchill Livingstone; 2003.
• Cao C. 1996. Chinese Drug Pharmaceutics: Chinese Collegiate Textbooks for Medical Institutions of Higher Learning. Beijing (China): Shanghai Science and Technology Publisher (in Chinese).
• HKCMM 2008: Hong Kong Chinese Materia Medica Standards, Volume 1. Wanchai (HK): Chinese Medicine Division, Government of the Hong Kong Special Administrative Region, the People's Republic of China.
• Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
• Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
• McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association.
• Peirce A. Practical Guide to Natural Medicines. 1999. New York (NY): The Stonesong Press, Inc.
• PPRC 2000: Pharmacopoeia of the People's Republic of China, Volume 1, English edition 2000. Beijing (CN): The State Pharmacopoeia Commission of the People's Republic of China.
• PPRC 1998: The People's Republic of China. Comprehensive Chinese Materia Medica, 1e version. Editorial board of Comprehensive Chinese Materia Medica of State Administration of Traditional Chinese Medicine of the People's Republic of China. Shanghai (China): Shanghai Science and Technology Publishing House; 1998 (in Chinese).
• Upton R, editor. 1999. American Herbal Pharmacopoeia and Therapeutic Compendium: Astragalus Root. Santa Cruz (CA): American Herbal Pharmacopoeia.
• USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Astragalus. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2018 November 27]. Available at: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
• Winston D, Kuhn MA. 2008. Winston and Kuhn's Herbal Therapy and Supplements: A Scientific and Traditional Approach, 2nd edition. Philadelphia (PA): Lippincott Williams and Wilkins.
• Winston D, Maimes S. Adaptogens: Herbs for strength, stamina and stress relief. Rochester (VT): Healing Arts Press; 2007.

References Reviewed

• Peirce A. Practical Guide to Natural Medicines. New York (NY): The Stonesong Press, Inc; 1999.