摘要
目的:本研究结合无菌药品受微生物污染的案例,通过多种技术手段分析药品微生物污染情况,保证药品无菌检验结果判断的准确性,对药品微生物污染追踪溯源提供技术支持。方法:对从无菌检查阳性样品和实验环境中分离得到14株革兰氏阳性球菌进行鉴定和分型,采用VITEK2 Compact、16S rRNA基因测序技术、RiboPrinter系统以及DiversiLab系统等手段对微生物进行同源性分析。结果:无菌阳性样品中分离出的微生物经鉴定为3株溶血葡萄球菌、4株沃氏葡萄球菌和5株表皮葡萄球菌,从环境中得到2株表皮葡萄球菌。由同源性分析可知,来源于不同产地的样品中分离出来的同种微生物亲缘关系较远,来源不同,与环境中收集到的微生物不相关。若仅考虑现有收集到的环境监控菌,污染源是样品在加工或运输过程中引入的,与无菌检查环境无关。结论:通过对14株葡萄球菌的鉴定和溯源分析,综合评价多种技术手段的分型效果,以完善药品无菌检查过程控制,为药品微生物污染的溯源调查提供解决方案。
Objective：To analyze a case of drug contamination by several microbiological and biochemical methods to reassure the result of sterility test and give technical supports for inspectors to trace the microorganism.Method：Fourteen gram-positive cocci,isolated from sterilized drug samples and inspection environment,were identified and characterized by VITEK 2 Compact system,16S rRNA gene sequencing technique,RiboPrinter system and DiversiLab system.Result：Three strains of Staphylococcus haemolyticus,four strains of Staphylococcus warneri and five strains of Staphylococcus epidermidis were identified from drug samples,and two strains from environment were identified as Staphylococcus epidermidis.Strains in the same species but not isolated from same pharmaceutical product were characterized into different types by the analysis of phylogenetic relationships.If the strains islated from environment were representativeness,the source of drug contamination would be introduced from process and transportation steps,and it was not related to the inspection environment.Conclusion：The methods for bacteria characterization was evaluated to supplement for the process control of drug sterility test and to give a support for investigation of drug contamination.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2011年第6期1067-1072,共6页
Chinese Journal of Pharmaceutical Analysis
关键词
药品
污染
微生物
溶血葡萄球菌
沃氏葡萄球菌
表皮葡萄球菌
基因测序
鉴定
溯源
drug
contaminate pollute
microorganism
Staphylococcus haemolyticus
Staphylococcus warneri
Staphylococcus epidermidis
identification
characterization
