药品中金黄色葡萄球菌能力验证样品的研制及应用  

Development and Application of the Proficiency Test Program for Staphylococcus Aureus Detection in Pharmaceuticals

作　　者：杨燕[1] 范一灵[1] 李芳[1] 秦峰[1] 杨美成[1] YANG Yan;FAN Yiling;LI Fang;QIN Feng;YANG Meicheng(NMPA Key Lab.for Testing Technology of Pharmaceutical Microbiology,Shanghai Institute for Food and Drug Control,Shanghai 201203)

机构地区：[1]上海市食品药品检验所国家药品监督管理局药品微生物检测技术重点实验室,上海201203

出　　处：《中国医药工业杂志》2020年第9期1184-1188,共5页Chinese Journal of Pharmaceuticals

摘　　要：依据中国合格评定国家认可委员会(CNAS)规定的程序,研制含有药品基质的金黄色葡萄球菌能力验证样品,并开展不同实验室的能力验证。采用单因素方差分析对制备的能力验证样品进行均匀性检验,以及采用t检验考察样品的运输稳定性和贮存稳定性,结果均符合要求。在实施考核应用中,通过增加干扰样及样品分组等方式防止数据串通。报告检测结果显示,参加检测的63家实验室中,有53家实验室合格,10家实验室不合格。本次能力验证考核制定了客观、合理的考核评价方案,为药品微生物检测能力验证提供了较有价值的借鉴和参考。According to the procedures prescribed by China National Accreditation Service for Conformity Assessment(CNAS),the proficiency test samples of Staphylococcus aureus containing drug substrates was produced in this study,and they were used to carry out proficiency test in different laboratories.Univariate analysis of variance was used to test the uniformity of the prepared proficiency test samples,and the t-test was used to investigate the transport stability and storage stability of the samples.The results showed that all the samples met the requirements.In the implementation of assessment application,the data collusion was prevented by adding interference samples and sample groups.The report test results showed that,in the 63 tested laboratories,53 laboratories were qualified and 10 were unqualified.This proficiency test has formulated an objective and reasonable evaluation plan,which provides a valuable reference for the ability verification of drug microbial detection.

关 键 词：药品检测 微生物 金黄色葡萄球菌 能力验证 

分 类 号：R927.1[医药卫生—药学]