对乙酰氨基酚片含量测定能力验证的结果与分析

目的 开展对乙酰氨基酚片含量测定能力验证活动研究,了解和评价药品检测实验室的技术状况,提高药品检测实验室质控能力。方法 按国际标准ISO/IEC17043《合格评定能力验证的通用要求》进行,委托药品生产企业制备样品,经均匀性和稳定性试验合格后作为能力验证样品,随机分发给参加者,回收结果,采用Z比分数评价实验室能力。结果 全国共339家实验室参加本次能力验证,其中302家实验室结果评定为满意,满意率为89.1%;20家实验室结果评定为可疑,占比为5.9%;17家实验室结果评定为不满意,不满意率为5.0%。结论 绝大部分实验室具备紫外分光光度法(UV)分析对乙酰氨基酚片含量的能力;基本了解我国药品检测实验室的技术状况,药监系统实验室与药品企业质量控制实验室(QC)和第三方实验室相比,药监系统实验室能力较高。

Results of the Proficiency Test of Content Determination of Acetaminophen Tablets and Related Analysis

OBJECTIVE To conduct a proficiency test of content determination of acetaminophen tablets,thus to understand and evaluate the technical status of drug testing laboratories, and improve their quality control capabilities.METHODS According to the General requirements for proficiency testing in the international standard ISO/IEC 17043 conformity assessment, the samples were prepared by commissioned drug manufacturers. After passing the homogeneity and stability test, they were randomly distributed to the participants. Then the results were collected, and the laboratory′s testing capabilities were evaluated by Z-score.RESULTS A total of 339 laboratories in this proficiency testing program,of which 302(89.1%) laboratories obtained satisfactory results,20(5.9%)laboratories obtained suspicious results,17(5.0%) laboratories gave unsatisfactory results.CONCLUSION China′s drug regulatory inspection and testing system participate in the proficiency test actively, and most laboratories have the ability to analyze the content of acetaminophen tablets by UV.The technical status of the drug testing laboratories in China were basically found out through this study. Compared with the quality control laboratories of pharmaceutical enterprises(QC) and third-party laboratories, the laboratories of drug regulatory inspection and testing system have higher ability of content determination of acetaminophen tablets.