从源头探讨中药国际化之路-天津中草药杂志社.pdfVIP

·630 · 中草药 Chinese Traditional and Herbal Drugs 第 43 卷 第 4 期 2012 年 4 月 从源头探讨中药国际化之路 1, 2 2 2 2 2 1, 2* 何 毅 ，肖传学 ，朱永宏 ，郭治昕 ，叶正良 ，孙 鹤 1. 天津大学药物科学与技术学院，天津 300072 2. 天津天士力集团有限公司，天津 300410 摘 要：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。 关键词：中药材；中药国际化；药材生产质量管理规范；安全性；有效性；质量一致性 中图分类号：R282.2 ；R282.4 文献标志码：A 文章编号：0253 - 2670(2012)04 - 0630 - 06 Investigation on internationalization of Chinese materia medica from source plants 1, 2 2 2 2 2 1, 2 HE Yi , XIAO Chuan-xue , ZHU Yong-hong , GUO Zhi-xin , YE Zheng-liang , SUN He 1. School of Pharmaceutical Science and Technology, Tianjin University, Tianjin 300072, China 2. Tianjin Tasly Group Co., Ltd., Tianjin 300410, China Abstract: 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. Key words: Chinese medicinal materials; internationalization of Chinese materia medica; GACP; safety; efficacy; quality consistency 中药源植物的天然变异性以及活性成分以混合