《中国药典》《美国药典》及《欧洲药典》中药用辅料微生物控制标准的比较分析  

Analysis and Comparison of Microbial Control Criteria Among Chinese Pharmacopeia,United States Pharmacopeia and European Pharmacopeia

作　　者：王静 范一灵 杨美成 WANG Jing;FAN Yiling;YANG Meicheng(Shanghai Food and Drug Packaging Material Control Center,Shanghai 201203,China;Shanghai Institute for Food and Drug Control,Shanghai 201203,China;Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China)

机构地区：[1]上海市食品药品包装材料测试所,上海201203 [2]上海市食品药品检验研究院,上海201203 [3]上海药品审评核查中心,上海201203

出　　处：《中国药学杂志》2025年第6期658-662,共5页Chinese Pharmaceutical Journal

基　　金：国家药典委《中国药典》药用辅料微生物控制相关标准研究项目资助(2024Y27-1)。

摘　　要：目的 探讨药用辅料微生物控制关键要素及药用辅料微生物控制标准体系建设方向。方法 通过比较《中国药典》《美国药典》及《欧洲药典》中药用辅料通则、各论标准,结合行业现状与发展,分析现行标准体系,展开未来标准体系建设方向的讨论。结果 《中国药典》《美国药典》及《欧洲药典》在药用辅料品种、微生物控制要求等方面具有较多差异;针对药用辅料微生物控制均缺乏科学系统且具有指导性的标准,在检测方法、标准规范性与指导性等方面无法满足行业需求。结论 应重视药用辅料的方法学研究及微生物控制风险管理研究,以制剂为核心综合药用辅料自身因素及预期用途形成药用辅料微生物控制指导标准,完善药用辅料质量标准体系,确保药品安全。OBJECTIVE To investigate the key factors and directions for construction of a standard system for microbial control of pharmaceutical excipients.METHODS The contents related to pharmaceutical excipient microbial control including general requirements and monographs of standards in Chinese Pharmacopeia,United States Pharmacopeia and European Pharmacopeia were extracted and analyzed in combination with the current industrial status.RESULTS The included pharmacopoeias exhibit considerable differences in the coverage of pharmaceutical excipients and requirement for microbial control and there is still a lack of scientific and systematic guiding standards.The industrial requirements are yet to be met in terms of testing methodology,standardization,and instruction.CONCLUSION Attention should be paid to the methodological research and risk management of microbial control of pharmaceutical excipients.Instructive standards for microbial control of pharmaceutical excipients should be developed based on comprehensive consideration of excipient features and intended use with formulation as a core,to improve the quality standard system of pharmaceutical excipients and ensure drug safety.

关 键 词：药用辅料 微生物控制 药典标准 药品安全 关联审评审批 风险管理 

分 类 号：R95[医药卫生—药学]