保健食品中N-单去甲基西布曲明和N,N-双去甲基西布曲明含量检测的能力验证

Proficiency Testing on the Determination of N-Monodemethylsibutramine and N,N-Didemethylsibutramine in Supplements

目的:基于保健食品中N⁃单去甲基西布曲明和N,N⁃双去甲基西布曲明含量检测的能力验证,评价我国检测机构对保健食品中非法添加药物的检测能力和水平。方法:制备单一水平样品,样品均匀性和稳定性分别使用单因素方差分析和t检验进行分析。采用随机分配方式将样品发至各参加实验室。对回收的检测结果采用稳健统计分析法,以稳健Z比分数评价实验室检测能力。结果:在95%置信水平下,样品均匀性符合要求,样品稳定性在3个月内满足要求。共收回45家实验室检测结果,其中N⁃单去甲基西布曲明项目满意结果数为37个,满意率为82.2%,N,N⁃双去甲基西布曲明满意结果数为36个,满意率为80.0%。2项检测结果均满意的实验室有36个,满意率为80.0%。结论:大多数检测机构对保健食品中N⁃单去甲基西布曲明和N,N⁃双去甲基西布曲明的检测水平良好。结果离群的实验室应进行查找离群原因,分析关键控制点,加强内部质量控制等来提升自身能力。

Objective:To evaluate test capability and standard of detection institutions based on the proficiency testing on the determination of N-monodemethylsibutramine and N,N-didemethylsibutramine in supplements.Methods:Single content level control samples were prepared,and the uniformity and stability of samples were analyzed by one-way ANOVA and t test,respectively.The samples were randomly assigned to each participating laboratory.Robust statistical analysis was applied to testing feedback,and the testing ability of labs was evaluated by robust Z scores.Results:The homogeneity and stability in 3 month of the quality control sampls reached the standard at the confidence level of 95%.The total number of feedback was 45.The satisfaction number of results of N-monodemethylsibutramine was 37 with a satisfaction rate of 82.2%;and that of N,N-didemethylsibutramine was 36 with a satisfaction rate of 80.0%.The number of laboratories with satisfactory results of both parameters was 36,and the satisfaction rate was 80.0%.Conclusion:The majority of detection institutions have a fair capability of testing N-monodemethylsibutramine and N,N-didemethylsibutramine in supplements.However,labs with outliers should be improved by finding outlier causes,analyzing critical control points and strengthening internal quality control.