药品中污染微生物的鉴定和溯源能力验证结果与分析  

Results and analysis of proficiency testing for microbiological identification and traceability in pharmaceuticals

作　　者：徐晓洁 冯丹阳 任丽宏 孟晓丽 沈振 邢晟 丁勃 XU Xiao-jie;FENG Dan-yang;REN Li-hong;MENG Xiao-li;SHEN Zhen;XING Sheng;DING Bo(Shandong Institute for Food and Drug Control,Jinan 250101,China;Shandong Research Center of Engineering and Technology for Safety Inspection of Food and Drug,Jinan 250101,China;Industrial Technology Foundation Public Service Platform,Jinan 250101,China;School of Pharmaceutical Sciences Shandong University,Jinan 250012,China)

机构地区：[1]山东省食品药品检验研究院,济南250101 [2]山东省食品药品安全检测工程技术研究中心,济南250101 [3]产业技术基础公共服务平台,济南250101 [4]山东大学药学院,济南250012

出　　处：《药物分析杂志》2024年第3期427-433,共7页Chinese Journal of Pharmaceutical Analysis

基　　金：山东省重点研发计划重大科技创新工程项目(2021CXGC010511)。

摘　　要：目的:通过药品中污染微生物鉴定和溯源分析能力验证,考察山东省药品生产企业对污染微生物的鉴定、溯源以及对微生物异常检测结果的处理分析能力。方法:本次能力验证模拟一起药品微生物污染事件,设计产品污染组(共5个样品,模拟5个产品,其中1个加入2种目标菌混合物,其余4个为阴性)和生产环节污染组(共5个样品,模拟5个生产环节,其中4个分别加入了单一目标菌或干扰菌,其余1个为阴性)的能力验证样品,264家药品生产企业参与了能力验证活动,从样品检验,微生物种属鉴定,微生物系统进化分析,污染溯源等方面,评价参加单位的微生物鉴定分析的综合能力。结果:259家参与企业报告了结果。3.5%的企业未能正确判断阴性或阳性样品,判为不合格;49.8%的企业虽正确检测了样品,但未能正确鉴定出微生物种属或未进行微生物鉴定操作,判为合格;46.7%的企业正确鉴定出微生物种属,但未能进行有效的溯源分析,判为良好;仅有4家企业基于16S rRNA基因构建了系统发育树,但未能在菌株水平上进行近缘关系比对和溯源。结论:多数参与企业基本具备检出污染微生物的能力。但是,污染微生物的鉴定、溯源分析能力以及处理异常检测结果的能力还需要进一步加强。Objective:To evaluate the processing ability of identification,tracing and abnormal occurs in drug manufactures by the proficiency testing for microbiological identification and traceability in Shandong Province.Methods:The proficiency test was derived from an event of drug microbial contamination,and samples including contaminated products group and production group were designed to evaluate the testing and tracing competence of 264 participants from those aspects of drug control,identification,genetic comparison and traceability.The contaminated products group was composed of five simulated samples including one positive sample which includedEnterobacter cloacae and Staphylococcus aureus,and four negative samples which were sterile.The production group was composed of five simulated samples including four positive samples and one negative sample,but each of the four positive sample included only one strain of Enterobacter cloacae,Staphylococcus aureus,Staphylococous epidemidis and Pseudomons aeruginosa,respectively.Results:259 participants reported their results.The rate of unqualified,qualified,good and excellent results were 3.5%,49.8%,46.7%and 0,respectively.But four results reported phylogenetic tree based on 16S rRNA gene without genetic comparison at the strain level.The unqualified result indicated inaccurate inspection of positive and negative sample.The qualified result indicated accurate inspection but inaccurate species identification or not.The good result showed accurate species identification without effective tracing analysis.Conclusion:The ability of most drug manufactures to contaminant microorganisms testing are acceptable.But the ability of microbiological identification and traceability,the precise judgement and the effective measures to an emergency of microbial contamination in drugs remain to be strengthened.

关 键 词：能力验证 微生物鉴定 微生物污染 溯源 亲缘关系比对 微生物检验 

分 类 号：R917[医药卫生—药物分析学]