中美药典委员会植物药标准制定修订管理的比较分析

Comparative Analysis of Development,Revision and Management for Plant Medicines Standards between Chinese Pharmacopeia Commission and United States Pharmacopeia Commission

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。

To investigate difference between Chinese pharmacopeia commission（ChP） and United States Pharmacopeia commission（USP） at enacting and revising plant medicines standards,and suggest reasonable proposals to revision of standards for Chinese medicine in China.By analyze the current situation of standards revision in USA and China,basic research of standards in ＂Chinese Pharmacopeia＂ should be improved;Focus on coordination and harmonization of series of varieties and wholeness of analysis methods;Difficulty of analysis consistency and chromatography normalization could be solved by applying control extract of botanicals or the control preparation;Pay high attention to the overall safety of drugs and choice of detection methods;We recommended to learn from USP,such as experience of drafting revised standards with low-cost,management model and philosophy of varieties of responsible person system.Found out insufficient in ChP by analyzing difference between ChP and USP,these advanced experience in USP should be mirrored and shifted to ChP,in order to provide a reference for development of our botanical drugs.