目的 通过对NIFDC-PT-139《药品的比旋度测定能力验证计划》和NIFDC-PT-182《药品的相对密度测定能力验证计划》能力结果的分析研究,评价全国范围内参加实验室的药品理化检验水平,使监管机构掌握药品检验实验室的能力状况,提高实验室能力水平。方法 从结果满意率、发现问题和技术要点对结果进行了分析;从实验室类型、实验室数量、能力情况对实验室能力进行了分析。结果 省级药品检验机构结果满意率为100.0%(NIFDC-PT-139)和93.5%(NIFDC-PT-182),地市级药品检验机构结果满意率为71.3%(NIFDC-PT-139)和81.9%(NIFDC-PT-182),企业实验室结果满意率为75.0%(NIFDC-PT-139)和79.3%(NIFDC-PT-182),其他类型实验室结果满意率为55.6%(NIFDC-PT-139)和58.3%(NIFDC-PT-182)。结论 两项能力验证项目的成功开展,为实验室提供了有效的外部质量控制手段,也为监管机构掌握全国药品实验室能力状况提供了一手资料,药品检验实验室检测能力基本较好,尚有部分实验室的管理和技术能力有待提高。

OBJECTIVE To evaluate the ability level of drug detection in laboratories nationwide, so that the regulatory agencies can get the proficiency status of drug inspection laboratories and the laboratories can improve the detection ability level through the analysis and study on the capability results of NIFDC-PT-139 and NIFDC-PT-182. METHODS Statistical analysis and summary were made on the satisfaction rate of results, problems found,key technical points, the laboratory types and capability results of the two proficiency testing projects. RESULTS The result satisfaction rates of provincial drug control institutions were 100.0% (NIFDC-PT-139) and 93.5% (NIFDC-PT-182), the rates of municipal drug control institutions were 71.3% (NIFDC-PT-139) and 81.9% (NIFDC-PT-182), the rates of enterprise laboratories were 75.0% (NIFDC-PT-139) and 79.3% (NIFDC-PT-182), the rates of other laboratories were 55.6% (NIFDC-PT-139) and 58.3% (NIFDC-PT-182). CONCLUSION The successful implementation of the two plans has provided the laboratories with effective external quality control means, as well as the first-hand reference for regulatory authorities on the capacity of nationwide drug laboratories. The detection abilities of drug testing laboratories are basically good, and the management and technical capacity of some laboratories need to be improved.