2020年云南省三七中3种皂苷含量测定能力验证结果评价

Evaluation on the Results of Proficiency Test for the Determination of Three Saponins in Panax Notoginseng in Yunnan Province in 2020

目的:通过组织三七中3种皂苷含量测定能力验证,了解和评价本省药品检验机构对三七中人参皂苷Rg_(1)、人参皂苷Rb_(1)、三七皂苷R_(1)含量测定的整体水平,识别和掌握本省药品检验机构间存在的差异,并通过对不满意结果的问题分析,提高相关机构的质量管理水平和检验检测能力。方法:根据CNAS相关文件要求,对制备的能力验证用三七样品A和B进行均匀性和稳定性检验,参加机构报告的检测结果采用稳健统计方法进行统计处理,以稳健平均值作为指定值,考虑指定值不确定度后,采用z′值对能力验证结果进行统计分析,|z′|≤2时评价结果为满意;2<|z′|<3时评价结果为有问题;|z′|≥3时评价结果为不满意。结果:参加本次能力验证的全省16家药品检验机构,样品A均取得满意结果,满意率为100%;样品B有13家机构取得满意结果,满意率为81.2%,不满意率为18.8%。结论:参加本次能力验证的药品检验机构的质量管理水平及检验检测能力总体较好,具有相应项目的检验检测能力,少数药品检验机构的质量管理水平及检测能力有待改进提高。

Objective:To perform a proficiency test for the determination ability of three saponins in Panax notoginseng in order to evaluate the overall level of the laboratories for the determination of ginsenoside Rg_(1),ginsenoside Rb_(1) and notoginsenoside R_(1) in Panax notoginseng,identify the differences among these inspection institutions in Yunnan province,and improve the quality management level and inspection and testing ability of relevant institutions through the analysis of unsatisfactory results.Methods:According to the requirements in the related documents of China National Accreditation Service for Conformity Assessment(CNAS),Panax notoginseng samples were divided into sample A and sample B for homogeneity and stability inspection.The test results reported by the participating laboratories were statistically processed by the robust statistical method.Taking the robust average value as the specified value,and considering the uncertainty of the specified value,z′value was used for the statistical analysis of the proficiency test results.When|z′|≤2,the evaluation result was satisfactory,when 2<|z′|<3,the evaluation result was questionable,and when|z′|≥3,the evaluation result was unsatisfactory.Results:Among the 16 drug inspection institutions in the province participating in the proficiency test,all the 16 institutions in sample A achieved satisfactory results with a satisfaction rate of 100%,and 13 institutions in sample B achieved satisfactory results with a satisfaction rate of 81.2%and a unsatisfactory rate of 18.8%.Conclusion:The quality management level and inspection and testing ability of drug inspection institutions participating in this proficiency test are generally good,and they have the inspection and detection ability of corresponding items.The quality management level and testing ability of a small number of drug inspection institutions need to be improved.