《中国药典》污染微生物鉴定相关标准体系建立的回顾及展望  

Retrospect and prospect of the establishment of relevantstandard system for microbial identification in the Chinese pharmacopoeia

作　　者：张文燕 解慧 曹晓云 ZHANG Wenyan;XIE Hui;CAO Xiaoyun(Tianjin Institute of Drug Inspection,Tianjin 300070,China)

机构地区：[1]天津市药品检验研究院,天津300070

出　　处：《中国药品标准》2023年第6期567-572,共6页Drug Standards of China

摘　　要：微生物污染在制剂、原辅料以及生产环境中具有分布不均匀、控制难度大等特点,控制不当会严重影响产品的质量和用药安全。对污染微生物的鉴定在微生物的检验和控制工作中尤为重要,只有对污染微生物进行了适宜的鉴定,才能满足药品质量控制、偏差调查和溯源分析的需要,进而实现对药品的全生命周期质量控制。本综述全面回顾了《中国药典》收载的与微生物鉴定相关的标准和检验方法,对比国外药典与微生物鉴定相关的要求,对《中国药典》未来的微生物鉴定发展方向进行了展望,旨在为药品污染微生物检验工作者提供信息,同时也为今后药典相关通则及指导原则的增修订提供借鉴和参考。Microbial contamination is frequent and difficult to control in the preparation,raw materials and production environment,and improper control seriously affects product quality and drug safety.Microbial identification is particularly important in the inspection and control of microorganisms.Only by accurate identification of microorganisms can we meet the needs of drug quality control,deviation investigation and traceability analysis,so as to achieve the quality control of the whole life cycle of drugs.This review comprehensively reviewed the content and test methods of microbiological identification standards contained in the Chinese pharmacopoeia,compared the requirements of some standards related to microbiological identification in foreign pharmacopoeia,and looked forward to the future development direction related to microbiological identification in the Chinese pharmacopoeia,aiming to provide information for the work of drug-related microbiological testing.In addition,it also provides reference for the future revision of pharmacopoeia related general rules and guiding principles.

关 键 词：《中国药典》 微生物鉴定 标准体系建立 

分 类 号：R921.2[医药卫生—药学]