摘要
目的通过能力验证提升实验室药品无菌检查能力和实验室管理能力,增加社会公众对实验室检验检测能力的信任程度。方法样品前处理按照四川省食品药品检验检测院提供的SOP(薄膜过滤法)进行,结合《中国药典2015版》四部通则无菌检查法、VITEK 2 COMPACT全自动细菌鉴定及药敏分析系统等对样品中的菌株及环境中分离的菌株进行鉴定。结果样品ST-O17检出阴沟肠杆菌;样品ST-047检出枯草芽孢杆菌;样品ST-114未检出,环境菌株为托尔豪特链球菌。结论本实验室参加四川省食品药品检验检测院组织的药品无菌能力验证取得了满意的实验结果。
OBJECTIVE To improve the ability of laboratory drug sterility inspection and laboratory management through proficiency testing,and increase the level of public trust in laboratory testing capabilities.METHODS Sample pretreatment was performed in accordance with the SOP provided by the Sichuan Food and Drug Inspection and Testing Institute,and the Chinese Pharmacopoeia 2015 Edition,VITEK 2 COMPACT automatic bacterial identification and drug sensitivity analysis system were used to identify strains in the sample and isolates from the environment.RESULTS Enterobacter cloacae was detected in ST-O17;Bacillus subtilis was detected in ST-047;ST-114 was not detected;the environmental strain was Streptococcus thoraltensis.CONCLUSION The laboratory participated in the drug sterility test organized by Sichuan Food and Drug Inspection and Testing Institute and achieved satisfactory experimental results.
作者
雷郭富
吴任之
范维强
余永贵
更晓婷
梁恩艳
LEI Guo-fu;WU Ren-zhi;FAN Wei-qiang;YU Yong-gui;GENG Xiao-ting;LIANG En-yan(Aba Tibetan and Qiang Autonomous Prefecture Food and Drug Inspection and Research Center,Aba Tibetan 624000,China;College of Food Science,Sichuan Agricultural University,Ya′an 625014,China)
出处
《海峡药学》
2021年第2期61-64,共4页
Strait Pharmaceutical Journal
基金
阿坝州藏羌药质量评价创新研究实验室(2019JDPT0019)。
关键词
药品
无菌检测
菌株鉴定
Drug
Sterility test
Strain identification
