分子生物学技术在药品微生物鉴定溯源中的应用  

Application of molecular biology technology in the drug microbial identification and traceability

作　　者：王淑娟 朱冉 蒋波 杨燕 宋明辉 张宁 范一灵 杨美成 WANG Shujuan;ZHU Ran;JIANG Bo;YANG Yan;SONG Minghui;ZHANG Ning;FAN Yiling;YANG Meicheng(Shanghai Institute for Food and Drug Control,NMPA Key Laboratory for Testing Technology of Pharmaceutical Microbiology,Shanghai 201203,China;Shanghai Quality Inspection and Testing Center for Innovative Biological Products,Shanghai 201203,China;National Institutes for Food and Drug Control,Beijing 100050,China;Shanghai Food and Drug Packaging Materials Testing Institute,Shanghai 201203,China)

机构地区：[1]国家药品监督管理局药品微生物检测技术重点实验室,上海市食品药品检验研究院,上海201203 [2]上海市创新生物制品质量检验检测中心,上海201203 [3]国家药典委员会,北京100050 [4]上海市食品药品包装材料测试所,上海201203

出　　处：《中国药品标准》2023年第6期579-584,共6页Drug Standards of China

基　　金：上海市市场监督管理局科技项目(2023-70)。

摘　　要：目的:为满足基于风险评估的微生物控制体系及药品质量全过程控制的要求,建立更加完善的药品微生物鉴定溯源标准化分子生物学技术体系。方法:总结各国药典中分子生物学标准体系的构成,并分析《中国药典》中收载的分子生物学技术及该技术在药品微生物鉴定溯源中的应用。结果与结论:分子生物学技术是进行药品微生物鉴定溯源的重要标准,不同的分子生物学鉴定方法都有其优势和局限性,需要根据需求选择最合适的方法,以期达到最佳效果。Objective:To establish a more comprehensive standardized molecular biology technology system for the pharmaceutical microbiological identification and traceability in order to meet the requirements of the microbial control system and entire process control of drug quality based on the risk assessment.Methods:The review summarizes the composition of molecular biology standard systems in pharmacopoeias of various countries and analyzes the molecular biology techniques included in the Chinese Pharmacopoeia and their applications in the drug microbiological identification and traceability.Results and Conclusion:Molecular biology technology is a significant standard for the drug microbiological identification and traceability.Different identification methods of molecular biology have their advantages and limitations,and the most suitable method needs to be selected according to the requirements to achieve the best results.

关 键 词：分子生物学技术 核酸扩增技术 16S rRNA 全基因组测序 MALDI-TOF MS 药品微生物 鉴定溯源 

分 类 号：R921.2[医药卫生—药学]