细菌DNA特征序列鉴定法在常见种属中的鉴定水平研究  

Study on the identification level of bacterial DNA signature sequence identification in common bacterial species

作　　者：冯震[1] 蒋波[1] 李芳[1] 张宁[1] 杨燕[1] 秦峰[1] 杨美成[1] FENG Zhen;JIANG Bo;LI Fang;ZHANG Ning;YANG Yan;QIN Feng;YANG Mei-cheng(Shanghai Institute for Food and Drug Control,NMPA Key Laboratory for Testing Technology of Pharmaceutical Microbiology,Shanghai 201203,China)

机构地区：[1]上海市食品药品检验所国家药品监督管理局药品微生物检测技术重点实验室

出　　处：《药物分析杂志》2019年第11期1924-1932,共9页Chinese Journal of Pharmaceutical Analysis

基　　金：2016年上海市科委技术标准专项：《药品中微生物鉴定通用DNA条形码国家标准的建立》(16DZ0500202);2017年国家药典委员会标准提高研究项目：《标准核酸测序数据库的建立》(2017-6)、《致病菌鉴定与溯源用标准核酸序列的建立》(2017-17)

摘　　要：目的:开展细菌DNA特征序列鉴定法在药品质量控制中常见种属的鉴定水平研究,为药品全生命周期质量控制中的菌株鉴定与污染风险识别提供方法依据。方法:针对性地选择芽孢杆菌、库克氏菌、微球菌、柠檬酸杆菌、肠杆菌、肠球菌、假单胞菌、不动杆菌、鞘氨醇单胞菌和罗尔斯通氏菌共10个常见属中41个种72株的典型菌株,依据细菌DNA特征序列鉴定法,建立菌株鉴定的DNA特征序列,分析属内种间的菌株聚类关系,评价菌株DNA特征序列的鉴定水平。结果:10个属41个种典型菌株的DNA特征序列均具有特异性。结论:细菌DNA特征序列可满足"种"水平的鉴定,为药品质量控制中常见细菌的鉴定、分类与溯源提供研究思路和方法依据。Objective:To study on the identification level of common bacteria in the drug quality control by DNA signature sequence,and to provide reference for the identification of bacterial strains and contamination risk investigation of the whole life cycle quality control of drugs. Methods:72 strains in 41 species in 10 common genus were selected for study,including Bacillus,Kocuria,Micrococcus,Citrobacter,Enterobacter,Enterococcus,Pseudomonas,Acinetobacter,Sphingomonas and Rolstonia. According to the bacterial DNA signature sequence identification method,the bacterial DNA signature sequences were established,the cluster relationship between the species within the genus were analyzed, and the strain identification level was evaluated. Results:The DNA signature sequences which identified by 72 strains of 14 species in 10 genus were respectively specificity in the level of species. Conclusion:The bacterial DNA signature sequence can identify bacterial in the level of species. The results may provide research ideas and methodological basis for the identification,classification and traceability of common bacteria in drug quality control.

关 键 词：菌种鉴定 DNA特征序列 系统进化分析 药品质量控制 风险识别 

分 类 号：R917[医药卫生—药物分析学]