《中华人民共和国药典》药用辅料标准与ICH Q3C协调实施策略研究  

Research on the Coordinated Implementation Strategy Between the Chinese Pharmacopoeia Pharmaceutical Excipient Standards and ICH Q3C

作　　者：陈旻[1] 伍伟聪[1] 宋郁 王彩媚[1] 郭雅娟 陈英[1] 陈蕾[3] CHEN Min;WU Weicong;SONG Yu;WANG Caimei;GUO Yajuan;CHEN Ying;CHEN Lei(Guangdong Institute for Drug Control,National Medical Products Administration Key Laboratory of Quality Control and Evaluation of Pharmaceutical Excipients,Guangzhou 510663,China;Merck Chemicals(Shanghai)Co.,Ltd,Shanghai 200126,China;Chinese Pharmacopoeia Commission,Beijing 100061,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]默克化工(上海)有限公司,上海200126 [3]国家药典委员会,北京100061

出　　处：《医药导报》2025年第2期208-212,共5页Herald of Medicine

基　　金：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：目的探讨《中华人民共和国药典》(简称《中国药典》)药用辅料标准中残留溶剂控制与ICH Q3C协调实施的思路。方法梳理《中国药典》现行药用辅料标准残留溶剂控制的相关情况,结合国际人用药品注册技术协调会残留溶剂指导原则(ICH Q3C)和国外主流药典的协调进展,进行对比和分析研究。结果提出了基于关联审评机制下《中国药典》药用辅料标准与ICH Q3C的协调和实施策略。结论提出的协调实施方案有助于完善我国药用辅料标准体系的国际接轨,提升监管部门和制药工业对药用辅料残留溶剂控制执行的科学性和有效性,全面推进ICH Q3C指导原则在我国药用辅料标准的转化实施。Objective Exploring the ideas for coordinating the implementation of residual solvent control and ICH Q3C in the Chinese Pharmacopoeia standards for pharmaceutical excipients.Methods The relevant situation of residual solvent control in the current pharmaceutical excipient standards in Chinese pharmacopoeia was analyzed,and the progress of the International Conference on Harmonistion of Human Drug Registration Technology's Guidelines for Residual Solvents(ICH Q3C)and the coordination of foreign pharmacopoeias were compared and were analyzed.Results Proposed a coordination and implementation strategy between the Chinese Pharmacopoeia pharmaceutical excipient standards and ICH Q3C based on the association review mechanism.Conclusions The proposed coordinated implementation plan helps to improve the international integration of Chinese pharmaceutical excipient standard system,enhance the scientific and effective control of residual solvents in pharmaceutical excipients by regulatory authorities and the pharmaceutical industry,and comprehensively promote the translation and implementation of ICH Q3C guiding principles in Chinese pharmaceutical excipient standards.

关 键 词：中华人民共和国药典 ICH Q3C 残留溶剂 药用辅料标准 

分 类 号：R927[医药卫生—药学]