各国药典标准残留溶剂控制与ICH Q3C协调策略分析  

Analysis of Coordination Strategies with ICH Q3C for Residual Solvent Control in Pharmacopoeia of Various Countries

作　　者：陈旻[1] 伍伟聪[1] 徐昕怡 王粟明 凌霄 张启明[5] 陈英[1] 陈蕾[2] CHEN Min;WU Weicong;XU Xinyi;WANG Suming;LIN Xiao;ZHANG Qiming;CHEN Ying;CHEN Lei(Guangdong Institute for Drug Control,Key Laboratory of Quality Control and Evaluation of Pharmaceutical Excipients,National Medical Products Administration,Guangzhou 510663,China;Chinese Pharmacopoeia Commission,Beijing 100061,China;Ashland(China)Holdings Co.,Ltd,Shanghai 200233,China;United States Pharmacopoeia-China,Shanghai 200137,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]广东省药品检验所,国家药品监督管理局药用辅料质量控制与评价重点实验室,广州510663 [2]国家药典委员会,北京100061 [3]亚什兰(中国)投资有限公司,上海200233 [4]美国药典委员会上海代表处,上海200137 [5]中国食品药品检定研究院,北京102629

出　　处：《医药导报》2025年第2期227-235,共9页Herald of Medicine

基　　金：2020年度国家药品标准制修订研究课题(2020Y12);2022年度国家药品标准制修订研究课题(2022Y28);2023年度国家药品标准制修订研究课题(2023Y43);2023年广东省药品监督管理局科技创新项目(2023YDZ06)。

摘　　要：目的分析各国药典残留溶剂控制与国际人用药品注册技术协调会残留溶剂指导原则(ICH Q3C)的协调策略,为《中华人民共和国药典》(简称《中国药典》)残留溶剂与ICH Q3C协调提供思路和方案。方法通过文献调研和梳理,对比各国药典残留溶剂控制与ICH Q3C的协调进程,分析国外主流药典残留溶剂控制与ICH Q3C协调实施策略,梳理《中国药典》与国外药典残留溶剂控制的差异。结果《中国药典》残留溶剂的相关控制有必要与ICH Q3C进行协调。结论建议在结合中国国情的基础上,借鉴国外药典与ICH Q3C协调的经验,稳步推进我国药典残留溶剂控制与ICH的整体协调。Objective To analyze the coordination strategies of residual solvent control in various pharmacopoeias with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for residual solvents(ICH Q3C),aiming to provide ideas and solutions for coordinating residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Methods Through literature research and review,compare the coordination process between residual solvent control in various pharmacopoeias and ICH Q3C,analyze the implementation strategies of mainstream pharmacopoeia residual solvent control and ICH Q3C coordination in foreign countries,and clarify the differences in residual solvent control between the Chinese Pharmacopoeia and foreign pharmacopoeias.Results It is necessary to coordinate the control of residual solvents in the Chinese Pharmacopoeia with ICH Q3C.Conclusion It is recommended to steadily promote the overall coordination of residual solvent control in Chinese pharmacopoeia and ICH by drawing on the experience of coordination between foreign pharmacopoeias and ICH Q3C,based on the national conditions of China.

关 键 词：国际人用药品注册技术协调会残留溶剂指导原则 残留溶剂 药典 协调策略 

分 类 号：R921[医药卫生—药学]