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Monograph: Astragalus

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicant's discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.

Date: 2010-07-07

NHPID Name

Astragalus membranaceus (USDA 2008)

Proper Name(s)

Astragalus membranaceus (Fisch. ex Link) Bunge ( Fabaceae /Leguminosae) ( USDA 2008 )

Common Name(s)

Source Material

Root ( Hoffmann 2003 , PPRC 2000 , Bensky and Gamble 1993 )

Route Of Administration

Oral

Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Dose(s)

Adults:

Maintainance of healthy immune system
Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 2 - 4.8 Grams per day, dried root

TCM for spleen; TCM for lungs; TCM for stabilizing the exterior
Preparation: Dry and decoction

Dose(s): 9 - 30 Grams per day, dried cut root
Directions For Use: 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)


See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(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 have an auto-immune disorder  (Brinker 2001, Upton 1999)

Contraindication(s):
TCM for spleen; TCM for lungs; TCM for stabilizing the exterior:
Do not use 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 1993)

Known Adverse Reaction(s):
No statement is required

Non-medicinal ingredients

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

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient may comply with the specifications outlined in the British Pharmacopoeia (BP) monographs Astragalus root for use in THM and Processed Astragalus Root for use in THMP.

References cited

  • Bensky D, Gamble A. Chinese Herbal Medicine: Materia Medica. Revised Edition. Seattle (WA): Eastland Press, Incorporated; 1993.
  • BP 2009: British Pharmacopoeia Commission. 2008. British Pharmacopoeia 2009, Volume II. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA).
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Cao C. Chinese Drug Pharmaceutics: Chinese Collegiate Textbooks for Medical Institutions of Higher Learning. Beijing (China): Shanghai Science and Technology Publisher; 1996 (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.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone
  • PPRC 2000: Pharmacopoeia of the People's Republic of China. English Edition, Volume 1. Compiled by The State Pharmacopoeia of the People's Republic of China. Beijing (China): Chemical Industry Press; 2000.
  • PRC 1998: The People's Republic of China. Comprehensive Chinese Materia Medica, 1st 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. American Herbal Pharmacopoeia and Therapeutic Compendium: Astragalus Root. Santa Cruz (CA): American Herbal Pharmacopoeia; 1999.
  • USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. 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.

References reviewed

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

Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for maintenance of healthy immune system use

Dried root:

Liquid extract:

2.25-4.25 g dried equivalent, per day (1:2, 4.5-8.5 ml) (Mills and Bone 2005)

Tincture:

0.8-1.6 g dried equivalent, 3 times per day (1:5, 40% alcohol, 4-8 ml) (Hoffman 2003)