配位滴定法测定枸橼酸铋钾胶囊含量各类实验室能力验证的结果与分析  

Results and discussion on various laboratories proficiency-testing for assays of bismuth potassium citrate capsules by complexometric titration

作　　者：杨仪雪 黄丹 王叶茹 吴凤如 刘逸韬 贝琦华[1] 严全鸿[1] 项新华[2] YANG Yixue;HUANG Dan;WANG Yeru;WU Fengru;LIU Yitao;BEI Qihua;YAN Quanhong;XIANG Xinhua(Guangdong Institute for Drug Control,Guangzhou 510663,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]广东省药品检验所,广州510163 [2]中国食品药品检定研究院,北京100050

出　　处：《中国药品标准》2024年第1期30-34,共5页Drug Standards of China

基　　金：国家药品监督管理局2019年药品检验能力验证计划(NIFDC-PT-183)。

摘　　要：目的:设计组织枸橼酸铋钾胶囊含量测定的能力验证项目(编号为NIFDC-PT-183),评价参加能力验证实验室配位滴定法的检测能力和水平,并提供技术分析与建议。方法:制备2组浓度不同的能力验证样品;采用单因子方差分析进行均匀度检验,采用t检验考察稳定性,均符合要求;样品分3种组合方式随机发放给279家实验室,参考《中国药典》2015年版二部枸橼酸铋钾胶囊的含量测定项方法测定样品含量,对结果回收后采用中位值和标准化四分位距法的稳健统计分析,用Z比分数评价各参加实验室的测试结果。结果:279家实验室中240家结果满意,23家结果可疑,16家结果不满意,满意率为86.0%。结论:国内实验室枸橼酸铋钾胶囊含量测定检测能力总体较好,但部分实验室仍有待提高。Objective:To design the proficiency testing(PT)project(No.NIFDC-PT-183)for assays of bismuth potassium citrate capsules and organize to assess the proficiency of complexometric titration in laboratories,and provide some technical analyses and advices.Methods:Two groups of samples with different concentration were prepared.The uniformity was evaluated with one-way analysis of variance and the stability was confirmed with t-test,whose results all conformed the requirements.The samples with three combinations were randomly distributed to 279 laboratories.The determination was performed according to the assays of bismuth potassium citrate capsules in VolumeⅡof the Chinese Pharmacopoeia 2015.The median value and normalized interquartile range(NIQR)of robust statistical analysis was adopted and Z-scores were used to evaluate the results from each of laboratories.Results:Among 279 laboratories,240 laboratories results were satisfactory,23 were questionable,and the other 16 were unsatisfied.The satisfaction rate was 86.0%.Conclusion:The overall capacity of national laboratories for assays of bismuth potassium citrate capsules is good while a portion of participants require further improvement.

关 键 词：能力验证 配位滴定法 枸橼酸铋钾胶囊 含量测定 稳健统计 Z比分数 

分 类 号：R921.2[医药卫生—药学]