背景:为了定义植物膳食补充剂的适当质量,植物药,和草药,美国药典(USP)和草药汇编(HMC)包含基于科学的质量标准,其中包括多个相互关联的测试,以提供一个完整的质量特征为每篇文章的身份,纯度,和内容。
目的:提供上述药典中植物来源文章的药典测试和要求的全面描述。选择性色谱程序,如高效液相色谱(HPLC)和高效薄层色谱(HPTLC),在药典专著中用作鉴定测试,以检测物种替代或其他混杂因素。HPLC定量测试通常用于确定关键成分的含量,即,被认为是生物活性成分或分析标记化合物的植物次生代谢物的总量或单独量。纯度规格通常设置为限制污染物的含量,例如有毒元素,杀虫剂,和真菌毒素。附加要求突出了命名的重要性,定义,参考材料的使用,和包装/储存条件。
方法:用具体的例子说明了各篇专著的技术要求。使用药典参考标准对真实样品进行测试。对色谱分析程序进行了验证,以提供用于鉴定和/或准确确定质量标记物含量的特征曲线。
结果:每个专著中包含的多个测试相互补充,为用作草药和膳食补充剂的植物药提供适当的药典质量表征。专著提供了详细的身份规范,生物活性成分或质量标记的含量,和污染物的限制,掺假者,和潜在的有毒物质。标签和包装等附加要求进一步有助于保持这些产品的质量。
结论:应遵守药典规范,以确保用于医疗保健目的的植物制品的可靠性。
BACKGROUND: In order to define appropriate quality of botanical dietary supplements, botanical drugs, and herbal medicines, the United States Pharmacopeia (USP) and the Herbal Medicines Compendium (HMC) contain science-based quality standards that include multiple interrelated tests to provide a full quality characterization for each article in terms of its identity, purity, and content.
OBJECTIVE: To provide a comprehensive description of the pharmacopeial tests and requirements for articles of botanical origin in the aforementioned compendia. Selective chromatographic procedures, such as high-performance liquid chromatography (HPLC) and high-performance thin-layer chromatography (HPTLC), are used as Identification tests in pharmacopeial monographs to detect species substitution or other confounders. HPLC quantitative tests are typically used to determine the content of key constituents, i.e., the total or individual amount of plant secondary metabolites that are considered bioactive constituents or analytical marker compounds. Purity specifications are typically set to limit the content of contaminants such as toxic elements, pesticides, and fungal toxins. Additional requirements highlight the importance of naming, definition, use of reference materials, and packaging/storage conditions.
METHODS: Technical requirements for each section of the monographs were illustrated with specific examples. Tests were performed on authentic samples using pharmacopeial reference standards. The chromatographic analytical procedures were validated to provide characteristic profiles for the identity and/or accurate determination of the content of quality markers.
RESULTS: The multiple tests included in each monograph complement each other to provide an appropriate pharmacopeial quality characterization for the botanicals used as herbal medicines and dietary supplements. The monographs provide detailed specifications for identity, content of bioactive constituents or quality markers, and limits of contaminants, adulterants, and potentially toxic substances. Additional requirements such as labeling and packaging further contribute to preserve the quality of these products.
CONCLUSIONS: Compliance with pharmacopeial specifications should be required to ensure the reliability of botanical articles used for health care purposes.