湖南省药检系统进行氨甲环酸含量测定实验室比对的结果分析

Comparative Analysis of Laboratory Determination Results of Tranexamic Acid Content by Drug Control System in Hunan Province

目的:为进一步规范药检人员的操作技能,组织湖南省26家药品检测实验室参加氨甲环酸含量测定的实验室比对。方法:对供试样采用均匀性检验,对26家实验室的检测结果进行正态性检验,采用稳健统计技术进行数据分析。结果:参加本次比对计划的26家实验室中,24家为满意结果,2家为有问题结果。结论:采用Minitab软件能够对数据进行快速分析处理;人员操作、对照品、色谱条件和仪器等因素,是产生问题结果的主要原因。

Objective： To perform the laboratory comparisons of tranexamic acid content determination among 26 medicine testing laboratories in Hunan Province so as to further standardize the operating skills of drug testing staff. Methods： Homogeneity examinations were performed on the standard testing specimens. Normality tests were executed among the results from the 26 laboratories and the result data were analyzed by means of robust statistical techniques. Results： The results from 24 laboratories were satisfactory and the results from the other 2 laboratories were doubtful. Conclusion： The software Minitab is capable of analyzing data. The process of operating, the reference substance, and the condition of chromatograph as well as instruments are main causes of doubtful results.