中药灭菌方法及典型问题分析  

Analysis of Sterilization Methods and Typical Problems of Traditional Chinese Medicine

作　　者：刘向萍 袁建龙 Liu Xiangping;Yuan Jianlong(Center for Food and Drug Inspection of Yunnan Province,Kunming 650000,China;Fujian Center for Drug Evaluation and Monitoring,Fuzhou 350003,China)

机构地区：[1]云南省食品药品审核查验中心,昆明650000 [2]福建省药品审评与监测评价中心,福州350003

出　　处：《中国药事》2024年第11期1282-1286,共5页Chinese Pharmaceutical Affairs

基　　金：福建省药品监督管理局2023年度药品安全监管科研项目(编号2023023)。

摘　　要：目的:为中药生产企业开展中药灭菌研究提出建议,为药监部门实施相关监管提供参考。方法:梳理中药灭菌的法规要求和常规中药灭菌工艺,并基于中药审评检查案例归纳、分析典型问题。结果:中药灭菌工艺研究存在灭菌条件选择不合理、研究验证不充分、研究管理不当、过程控制不足等典型问题。结论:建议企业加强物料管理,强化生产过程控制,基于药品特性确定中药灭菌方法,做好变更研究管理工作,确保变更的合理性和合规性。Objective:In order to provide suggestions for Chinese medicine manufacturers to carry out research on sterilization of traditional Chinese medicine,and to provide reference for the implementation of relevant supervision by the pharmaceutical supervision department.Methods:The regulatory requirements of traditional Chinese medicine sterilization and the conventional sterilization process of traditional Chinese medicine were sorted out,and typical problems were summarized and analyzed based on the cases of traditional Chinese medicine review and inspection.Results:There were some typical problems in the research of sterilization process of traditional Chinese medicine,such as unreasonable selection of sterilization conditions,insufficient research verification,improper research management and insufficient process control.Conclusion:It is suggested that enterprises should strengthen material management,strengthen production process control,determine the sterilization method of traditional Chinese medicine based on drug characteristics,and do a good job in change research and management to ensure the rationality and compliance of changes.

关 键 词：中药 灭菌 典型问题 审评 检查 变更 

分 类 号：R95[医药卫生—药学]