无菌检查中污染微生物多样性分析及数据偏差调查  

Microbial Diversity Analysis and Data Deviation Investigation of Contaminated Microorganisms in Sterility Test

作　　者：王璐 向东 张艳 刘勤 徐帆 WANG Lu;XIANG Dong;ZHANG Yan;LIU Qin;XU Fan(Yunnan Institute for Food and Drug Control·Ministry of Industry and Information Technology Industrial Technology Basic Public Service Platform,Kunming,Yunnan,China 650106;The 920th Hospital of the Joint Logistic Support Force of the Chinese PLA,Kunming,Yunnan,China 650032)

机构地区：[1]云南省食品药品监督检验研究院·工业和信息化部产业技术基础公共服务平台,云南昆明650106 [2]中国人民解放军联勤保障部队第九二〇医院,云南昆明650032

出　　处：《中国药业》2024年第8期67-70,共4页China Pharmaceuticals

基　　金：云南省中青年学术和技术带头人后备人才培养项目[2017HB052];云南省科技厅科技计划项目[202101AY070001-293]。

摘　　要：目的对无菌检查中污染微生物进行多样性分析及数据偏差调查。方法以曲安奈德注射液为例,按2020年版《中国药典》方法进行无菌检查,对污染微生物分离纯化后进行生化鉴定及基于16SrRNA的微生物多样性分析,与实验环境中的环境菌库进行比较并溯源,同时进行微生物数据检查偏差数据调查(MDD)。结果样品中检出表皮葡萄球菌、克式柠檬酸杆菌、唾液链球菌,且均在试验环境菌库39株环境菌中。MDD结果表明,样品中污染的微生物是由操作人员未完全按无菌隔离器使用的标准操作规程进行规范操作而导致的。即样品中污染的微生物来源于环境,而非样品本身,试验结果无效,应重试。结论对无菌检查中污染微生物进行溯源及数据偏差调查,可确认其阳性结果的准确性。Objective To carry out microbial diversity analysis and data deviation investigation on contaminated microorganisms in sterility test.Methods Triamcinolone Acetonide Injection was taken as an example for sterility test according to the Chinese Pharmacopoeia(2020 Edition).Biochemical identification and microbial diversity analysis based on 16S rRNA were performed on contaminated microorganisms after separation and purification;the above results were compared and traced to the experimental environment bacterial bank;the microbial data deviation(MDD)investigation was carried out at the same time.Results Staphylococcus epidermidis,Citrobacter koseri and Streptococcus salivarius were detected in the samples,all of which were found in the 39 strains of environmental bacteria in the experimental environment bacterial bank.The MDD investigation showed that the microbial contamination of samples were caused by the operator′s failure to fully follow the operation standards for the use of sterile isolators,that was,the contaminated microorganisms in the samples were from the environment rather than the samples,the test were invalid and should be retried.Conclusion Traceability and MDD investigation of contaminated microorganisms in sterility test can confirm the accuracy of positive results.

关 键 词：无菌检查 曲安奈德注射液 细菌 生化鉴定 微生物多样性 溯源 偏差数据调查 

分 类 号：R927.1[医药卫生—药学]