2025年版《中国药典》微生物标准的变化与发展趋势  

Changes and Trends in the microbiological-related standards in the Chinese Pharmacopoeia 2025 Edition

作　　者：范一灵 朱冉 杨燕 蒋波 宋明辉 王静 李琼琼 厉高慜 王淑娟 邵泓 马仕洪[5] 曹晓云 胡昌勤[5] 马双成 杨美成 张军[3] FAN Yiling;ZHU Ran;YANG Yan;JIANG Bo;SONG Minghui;WANG Jing;LI Qiongqiong;LI Gaomin;WANG Shujuan;SHAO Hong;MA Shihong;CAO Xiaoyun;HU Changqin;MA Shuangcheng;YANG Meicheng;ZHANG Jun(NMPA Key Laboratory for Testing Technology of Pharmaceutical Microbiology,Shanghai Quality Inspection and Testing Center for Innovative Biological Products,Shanghai Institute for Food and Drug Control,Shanghai 201203,China;China State Institute of Pharmaceutical Industry,Shanghai 201203,China;Chinese Pharmacopoeia Commission,State Key Laboratory of Drug Regulatory Science,Beijing 100061,China;Shanghai Food and Drug Packaging Materials Testing Institute,Shanghai 201203,China;National Institutes for Food and Drug Control,Beijing 100050,China;Tianjin Institute for Drug Control,Tianjin 300070,China;Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China)

机构地区：[1]国家药监局药品微生物检测技术重点实验室,上海市创新生物制品质量检验检测中心,上海市食品药品检验研究院,上海201203 [2]中国医药工业研究总院,上海201203 [3]国家药典委员会,药品监管科学全国重点实验室,北京100061 [4]上海市食品药品包装材料测试所,上海201203 [5]中国食品药品检定研究院,北京100050 [6]天津市药品检验研究院,天津300070 [7]上海药品审评核查中心,上海201203

出　　处：《中国药品标准》2025年第1期93-98,共6页Drug Standards of China

基　　金：国家药品标准提高课题(2023Y36、2024Y22、2024Y24和2024Y27)。

摘　　要：目的:系统分析2025年版《中国药典》微生物相关标准的制修订内容及发展趋势,探讨药典在药品全生命周期质量风险管理中的新要求。方法:全面梳理2025年版《中国药典》中微生物相关的26项标准,从标准的修订概况、微生物标准的国际协调、基于风险的质量管理与标准体系和具有中国特色的新工具和新方法等角度,总结标准制修订的方向和科学内涵。结果:2025年版《中国药典》在微生物标准方面呈现三大特点,即强化了国际协调与接轨,引入了以分子生物学检测为主的新兴技术,构建了基于风险评估的微生物质量控制体系。结论:2025年版《中国药典》系统性构建了微生物标准体系,充分体现了国家药品标准的科学化、国际化和现代化,为我国药品微生物质量控制水平的提升提供了重要的支撑。Objective:To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia(ChP)2025 Edition,and explore its novel requirements in risk-based pharmaceutical product lifecycle management.Methods:A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview,international harmonization of microbiological standards,risk-based quality management system,and novel tools and methods with Chinese characteristics.Results:The ChP 2025 edition demonstrates three prominent features in microbiological-related standards:enhanced international harmonization,introduced emerging molecular biological technologies,and established a risk-based microbiological quality control system.Conclusion:The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system,which significantly improves the scientificity,standardization and applicability of the standards,providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

关 键 词：中国药典 微生物 药品 全生命周期 过程控制 

分 类 号：R921.2[医药卫生—药学]