注射剂微生物污染的RiboPrinter~?微生物基因指纹系统鉴定及同源性分析  

Identification and homology analysis of microbial contamination in injection with RiboPrinter~? system

作　　者：孙雪奇 秦力 陈婕 费国琴 袁军 SUN Xueqi;QIN Li;CHEN Jie;FEI Guoqin;YUAN Jun(Sichuan Institute for Food and Drug Control,Chengdu,Sichuan,611731 P.R. China;Shanghai NOD Biotech Co.,Ltd., Shanghai,201600 P.R. China)

机构地区：[1]四川省食品药品检验检测院,四川成都611731 [2]上海诺狄生物科技有限公司,上海201600

出　　处：《华西药学杂志》2019年第5期481-484,共4页West China Journal of Pharmaceutical Sciences

基　　金：四川省成都市科技局科技惠民技术研发项目(2016-HM01-00087-SF)

摘　　要：目的对注射剂的无菌检查阳性结果进行核糖体分型鉴定,并根据鉴定结果进行微生物污染的来源分析。方法采用RiboPrinter■微生物基因指纹系统对阳性菌A1和污染调查中采集菌株中的的16株葡萄球菌进行鉴定和同源性分析。结果 RiboPrinter■微生物基因指纹系统的鉴定结果与菌株的生化鉴定结果完全相同;A1的鉴定结果为科氏葡萄球菌,溯源自无菌检查实验的环境污染。结论基于核糖体分型原理的RiboPrinter■微生物基因指纹系统鉴定结果准确可靠,可用于鉴定及同源性分析污染的微生物。OBJECTIVE To identify the bacteria of positive result from injection sterility test with ribosomal typing analysis,and to track microbial contamination source according the results. METHODS Positive A1 and 16 Staphylococcus collected in pollution investigation were identified and homology analysised by RiboPrinter■ system. RESULTS The identification results of RiboPrinter■ microbial genetic fingerprint system and biochemical analysis are exactly the same;A1 was S. cohnii,and was from environmental contamination in sterility test. CONCLUSION The results from RiboPrinter■ microbial genetic fingerprint system which was based on the principle of the ribosome parting are accurate and reliable,and RiboPrinter■ system can be used to identify strains and trace the source of the microbial contamination.

关 键 词：微生物污染 鉴定 同源性分析 葡萄球菌 RiboPrinter■微生物基因指纹系统 生化鉴定 阳性结果 无菌检查 相似系数 

分 类 号：R915[医药卫生—微生物与生化药学]