2025年版《中国药典》(四部)通用技术要求和指导原则增修订概况  

Overview of the amendments and revisions to the General Technical Requirements adopted by the VolumeⅣof the Chinese Pharmacopoeia 2025 Edition

作　　者：张军[1] 宁保明[2] 韦石凤 沈昊禹 尚悦[1] 朱冉 徐昕怡 陈蕾[1] 刘婷婷 马双成 ZHANG Jun;NING Baoming;WEI Shifeng;SHEN Haoyu;SHANG Yue;ZHU Ran;XU Xinyi;CHEN Lei;LIU Tingting;MA Shuangcheng(Chinese Pharmacopoeia Commission,State Key Laboratory of Drug Regulatory Science,Beijing 100061,China;National Institutes for Food and Drug Control,Beijing 102629,China;Capital Medical University,Beijing 100069,China)

机构地区：[1]国家药典委员会,北京100061 [2]中国食品药品检定研究院,北京102629 [3]首都医科大学,北京100069

出　　处：《中国药品标准》2025年第1期34-44,共11页Drug Standards of China

基　　金：国家药品标准制修订研究课题(2023Y01、2023Y07、2023Y21、2023Y22、2023Y34、2023Y37)。

摘　　要：介绍编制2025年版《中国药典》(四部)通用技术要求和指导原则的总体思路、工作目标和编制过程,总结分析其主要特点以及制剂、理化分析、微生物和生物检定、药用辅料和药包材、标准物质、指导原则等增修订内容。新修订药典通则充分发挥《中国药典》标准规范性和导向性作用,跟踪国际药品监管科学和药品标准制修订前沿动态、扩大先进检测技术的应用、稳步推进与国际人用药品注册技术协调会(ICH)指导原则的协调统一;重点加强药品安全性控制要求,进一步提升中药质量控制的总体能力、积极开展动物实验的替代研究;践行绿色环保理念,制修订有毒有害试剂的替代方法。为全面、正确理解和准确执行2025年版《中国药典》四部通用技术要求提供参考。To introduce the general thinking,guidelines,work objectives and elaboration process of the general technical requirements adopted by volumeⅣof the Chinese Pharmacopoeia 2025 Edition,and to summarize and figure out the main characteristics on dosage forms,physico-chemical testing,microbial and biological testing,reference standards and guidelines.The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard,track the frontier dynamics of international drug regulatory science and the elaboration of monographs,expand the application of state-of-the-art technologies,and steadily promote the harmonization and unification with the ICH guidelines;further enhance the overall capacity of TCM quality control,actively implement the 3 R principles on animal experiments,and practice the concept of environmental-friendly;replace and/or reduce the use of toxic and hazardous reagents,strengthen the requirements of drug safety control.This paper aims to provide a full-view perspective for the comprehensive,correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.

关 键 词：2025年版《中国药典》(四部) 通用技术要求 增修订 

分 类 号：R921.2[医药卫生—药学]