Gurley B J, Wang P, Gardner S F
Department of Pharmaceutics, College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock 72205, USA.
J Pharm Sci. 1998 Dec;87(12):1547-53. doi: 10.1021/js9801844.
Nutritional supplements containing Ephedra sinica (ma-huang), a botanical source of ephedrine-type alkaloids, have been linked to numerous episodes of ephedrine (EPH) toxicity. With passage of the 1994 Dietary Supplement Health and Education Act, nutritional supplements are no longer subject to the same FDA preapproval requirements as food additives, prescription, or nonprescription medications. As a consequence, EPH content is not a label requirement for Ephedra-containing supplements. Less stringent labeling requirements, therefore, may contribute to toxicity associated with these products. A validated HPLC method for the determination of ephedrine-type alkaloids, commonly found in Ephedra supplements, is presented. Nine commercially available supplements exhibited considerable variability in alkaloid content (EPH range: 1.08-13.54 mg). Only three products listed EPH content on the label while one exhibited lot to lot variations in EPH of 137%.
含有麻黄碱类生物碱植物来源的麻黄（麻黄）的营养补充剂与众多麻黄碱（EPH）中毒事件有关。随着1994年《膳食补充剂健康与教育法》的通过，营养补充剂不再像食品添加剂、处方药或非处方药那样受到美国食品药品监督管理局（FDA）相同的预先批准要求。因此，EPH含量不是含麻黄补充剂的标签要求。因此，不太严格的标签要求可能会导致与这些产品相关的毒性。本文介绍了一种经过验证的高效液相色谱法（HPLC），用于测定麻黄补充剂中常见的麻黄碱类生物碱。九种市售补充剂的生物碱含量存在显著差异（EPH范围：1.08-13.54毫克）。只有三种产品在标签上列出了EPH含量，而有一种产品的EPH批次间差异为137%。
