中药源植物的天然变异性以及其活性成分以混合物形式存在导致其质量一致性与化学合成或高度纯化的产品相比更为复杂。美国食品药品监督管理局(FDA)和欧盟药物管理局(EMA)在其多个行业指南中反复强调将对植物原料药和植物制剂的控制延伸到对植物药材的控制是保证药品质量一致性的重要手段。尝试从另一个角度,即结合中国、欧盟和世界卫生组织对药材生产质量管理规范的要求以及FDA至今批准的唯一一个植物处方药Veregen^?的植物学审评案例探讨中药材质量控制手段。

Because of natural variability and complex effective components in source plants of Chinese materia medica, quality consistency is a more complicated issue compared with that of chemical synthesis or high purity compounds. Both the FDA and EMA have emphasized in several guidelines that it is a key method to extend the quality control method of botanical drug substance and product to that of botanical raw material for quality consistency. This paper is trying to discuss the quality control method for Chinese medicinal materials from another aspect, that is combination of GAP guidelines in China, EU, and WHO with the botanical review case of Veregen^?, which is the only botanical prescription drug appoved by the FDA.

国家“十一五”重大新药创制专项:“现代中药国际化产学研联盟建设”(2010ZX09401-06)