基于曼德尔h/k统计法评价16家实验室盲样考核结果  

Evaluation of blind sample examination results of 16 laboratories based on Mandel’s h/k statistical method

作　　者：何虹 朱荣 丁建东 卢日刚 He Hong;Zhu Rong;Ding Jiandong;Lu Rigang(Guangxi Zhuang Autonomous Region Institute for Food and Drug Control,Nanning 530021,China)

机构地区：[1]广西壮族自治区食品药品检验所,南宁530021

出　　处：《化学分析计量》2021年第9期68-72,共5页Chemical Analysis And Meterage

基　　金：广西科技计划(重点研发计划)项目(桂科AB18221125)。

摘　　要：基于曼德尔h/k统计方法,对广西壮族自治区内药品检验和药品生产企业等16家实验室进行盲样考核,评价检验技术水平及实验室用高效液相色谱法进行含量测定的能力,识别实验室中的问题以及实验室间的差异。16家实验室采用相同的测定方法,对1个相同固定样本和2个随机的干扰样进行测定,分别采用安德森-达林检验和曼德尔h/k检验对各参加实验室的测试结果进行统计分析。制备样品采用单因素方差分析进行均匀性、稳定性检验。16家实验室盲样考核结果均为满意。该考核结果准确反映数据的统计特征,有效识别检验人员检验质量控制问题,是药企监控实验室的持续检测能力、识别实验室问题并采取纠正措施和提高质量管理水平的重要举措。Based on Mandel’s h/k statistical method,blind sample examination was carried out in 16 laboratories such as drug inspection and drug production enterprises in Guangxi Zhuang Autonomous Region.Evaluate the level of testing technology and the ability of the laboratory to determine the content by high performance liquid chromatography,and identify the problems in the laboratory and the differences between laboratories.16 laboratories used the same determination method to determine one same fixed sample and two random interference samples.The test results of participating laboratories were statistically analyzed by Anderson-Darling test and Mandel’s h/k test.The samples were tested for uniformity and stability by one-way analysis of variance.Results all of the 16 laboratories that participated in the blind sample examination were satisfactory.The assessment results accurately reflect the statistical characteristics of data and effectively identify the inspection quality control problems of inspectors.It is an important measure for pharmaceutical enterprises to monitor the continuous detection ability of laboratories,identify laboratory problems,take corrective measures and improve the quality management level.

关 键 词：曼德尔h/k检验 安德森-达林检验 盲样考核 诺氟沙星 

分 类 号：O657.7[理学—分析化学]