《欧洲药典》凡例的主要内容介绍  

Introduction of the Main Content of the General Notices in the European Pharmacopoeia

作　　者：耿晓婷 楼永军 郑金琪 唐登峰 王绯[2] 潘芳芳 郑成 朱价 陶巧凤 GENG Xiaoting;LOU Yongjun;ZHENG Jinqi;TANG Dengfeng;WANG Fei;PAN Fangfang;ZHENG Cheng;ZHU Jia;TAO Qiaofeng(Zhejiang Institute for Food and Drug Control,Hangzhou 310052,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]浙江省食品药品检验研究院,杭州310052 [2]国家药典委员会,北京100061

出　　处：《中国现代应用药学》2024年第23期3392-3398,共7页Chinese Journal of Modern Applied Pharmacy

基　　金：国家药典委员会药品标准制修订研究课题(2023Y18)。

摘　　要：目的对《欧洲药典》11.0版凡例的主要内容及相较10.0版的变化内容进行介绍,并对其中具有借鉴意义的部分进行分析。方法比较《欧洲药典》11.0版与10.0版凡例的编排结构与内容,对变化和重点内容进行评述。结果与《欧洲药典》10.0版比较,11.0版凡例的编排结构和内容均有明显变化,增加了各论适用性说明、总论和制剂总论、草药各论和化学药品各论的相关要求等内容,并对部分定义进行规范化修订。结论《欧洲药典》11.0版凡例的编排结构更为清晰,内容更为严谨全面,对《欧洲药典》的实施具有重要的指导意义,可供中国药典凡例的修订参考。OBJECTIVE To introduce the main and changing content of the General Notices in the 11.0 edition of European Pharmacopoeia compared with the 10.0 edition,and to compare and analyze the content with reference significance.METHODS To compare the layout structure and main content of the General Notices in the 11.0 edition of European Pharmacopoeia with the 10.0 edition,and to comment on changes and key content of the 11.0 edition of General Notices.RESULTS Compared with the 10.0 edition,the layout structure and content of the 11.0 edition of General Notices had changed significantly.And it supplemented the contents of demonstration of suitability of monographs,general monographs and general monographs on dosage forms,monographs on herbal drugs,monographs on medicinal active substance,etc.Furthermore,it normalized some definitions.CONCLUSION The layout structure of the new version of the General Notices is more clear,the content is more rigorous and comprehensive,and it has guiding significance for the implementation of European Pharmacopoeia,and can be used as reference for the revision of the General Notices in the Chinese Pharmacopoeia.

关 键 词：欧洲药典 凡例 修订 质量标准 

分 类 号：R951[医药卫生—药学]