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无菌检查中污染微生物多样性分析及数据偏差调查

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原文链接
  • 国家科技期刊平台
  • NETL
  • NSTL
  • 万方数据
  • 维普
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 16S rRNA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。
Microbial Diversity Analysis and Data Deviation Investigation of Contaminated Microorganisms in Sterility Test
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.

sterility testTriamcinolone Acetonide Injectionbacteriabiochemical identificationmicrobial diversitytraceabilityinvestigation of data deviation

王璐、向东、张艳、刘勤、徐帆

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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

中国人民解放军联勤保障部队第九二〇医院,云南 昆明 650032

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

云南省中青年学术和技术带头人后备人才培养项目云南省科技厅科技项目

2017HB052202101AY070001-293

2024

10.3969/j.issn.1006-4931.2024.08.016

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子：1.369
ISSN：1006-4931
年,卷(期)：2024.33(8)
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