Aristolochic Acid Evaluation Program: Standards of Identity for the Responsible Trade of Chinese Medicinal Herbs
The American Herbal Pharmacopoeia (AHP), in collaboration with the American Herbal Products Association, the Therapeutic Goods Agency of Australia, and the State Drug Administration of China, is establishing international standards for the identification of those plants known to contain aristolochic acid (AA) and those that may become adulterated with AA-containing plants.
In recent years, Chinese herbal formulas containing AA have been associated with numerous case reports of kidney failure and kidney cancer. Many of these adulterations are quite common and have led to import alerts and trade restrictions in several countries.
The aristolochic acid project is designed to protect and promote the responsible trade of Chinese medicinal herbs, specifically many of those cited by the U.S. Food and Drug Administration (FDA) as those that contain, or may be adulterated with AA-containing plants. These herbs include:
¥ stephania (Stephania tetrandra S. Moore, Menispermaceae),
¥ aristolochia (Aristolochia fangchi Y.C. Wu ex L.D. Chou & S.M. Hwang, Aristolochiaceae),
¥ costus (Saussurea costus (Falc.) Lipsch, Asteraceae, syn. S. lappa (Decne.) C.B. Clarke),
¥ Chinese wild ginger (Asarum heterotropoides F. Schmidt var. mandshuricum (Maxim.) Kitag, and A. sieboldii Miq., Aristolochiaceae),
¥ akebia (Akebia quinata (Houtt.) Decne., and A. trifoliata (Thunb.) Koidz., Lardizabalaceae)
¥ Armand's clematis (Clematis armandii Franch., Ranunculaceae)
¥ Chinese clematis (C. chinensis Retz., Ranunculaceae).
The primary goal of the Aristolochic Acid Evaluation Program is to develop standards from botanically verified samples that have already been obtained, to develop multiple validated methods of identification (macroscopic, microscopic, and thin-layer chromatography fingerprinting), and to combine this with analytical work currently underway by FDA in validating analytical methods for the analysis of AA. This will then be formally presented to herbal products manufacturers and regulatory agencies worldwide as the definitive body of information needed to identify these botanicals, thereby taking the self-regulatory steps needed to protect public health. The program will also provide recommendations for the appropriate trade or restriction of these botanicals.
Seed money to help offset the cost of obtaining authenticated botanical voucher samples was provided by the Chinese Herbal Products Committee of the American Herbal Products Association through contributions from Golden Flower, Health Concerns, Chuanheng Management, KPC Products, Inc., K'an Herb Co., and Crane Herb Co. Contributors will receive a complimentary copy upon completion.
Further funding is needed. To support the Aristolochic Acid Program and receive the future publication of the Aristolochic Acid Evaluation Program: Standards of Identity Document, contact the AHP.
For more information, contact: AHP's executive director, Roy Upton at P.O. Box 66809, Scotts Valley, CA 95067, USA, Tel: 831/461-6317, Fax: 831/475-6219, or email: <firstname.lastname@example.org>.
[American Herbal Pharmacopoeia. Aristolochic Acid Evaluation Program: Standards of Identity for the Responsible Trade of Chinese Medicinal Herbs (press release). 2001 June 13.]