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探讨中美药典植物药标准制修订的差异,对我国中药标准的修订提出合理建议。通过分析比较中美两国植物药标准修订的现状,提出《中国药典》标准提高应加强基础研究;注重分析方法整体性和系列品种的协调和统一;应用植物药对照提取物(或对照制剂),解决色谱鉴别规范化和分析一致性的难点;重视整体药物的安全性,注重检测方法的选择;建议借鉴美国低成本高效率的起草修订标准经验及品种负责人负责制的管理模式和理念。中药标准制修订可借鉴美国植物药制修订管理中先进经验,为我国植物药发展提供参考。
Discussing the differences between the revision of the standard prescriptions of Chinese and American Pharmacopoeia and putting forward reasonable suggestions on the revision of the standards of Chinese traditional medicine. By analyzing and comparing the status quo of revision of plant medicine standards between China and the United States, it is suggested that the standard of “Chinese Pharmacopoeia” should be strengthened and basic research should be strengthened. Attention should be paid to the analysis of the integrity of the method and the coordination and harmonization of series of varieties. , To solve the difficulty of standardization and analysis of chromatographic identification and consistency; emphasis on overall drug safety, pay attention to the choice of detection methods; recommended the United States to learn from the low cost and high efficiency of the drafting revision of the standard experience and varieties responsible person management system and philosophy. Standard revision of Chinese medicine can learn from the advanced experience in the revision of the management of the United States plant medicine for the development of plant medicine in China to provide a reference.