橡胶类药品包装材料灰分测定的能力验证研究  

Proficiency Testing for the Determination of Ash Content of Rubber Pharmaceutical Packaging Materials

作　　者：贾菲菲 程佳美 杨梦雨 赵霞[1] 杨会英[1] JIA Feifei;CHENG Jiamei;YANG Mengyu;ZHAO Xia;YANG Huiying(NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients·National Institutes for Food and Drug Control,Beijing,China 100050)

机构地区：[1]国家药品监督管理局药用辅料质量研究与评价重点实验室·中国食品药品检定研究院,北京100050

出　　处：《中国药业》2024年第23期82-85,共4页China Pharmaceuticals

基　　金：中国食品药品检定研究院中青年发展研究基金资助项目[2023C7]。

摘　　要：目的提升实验室对橡胶类药品包装材料的检测能力。方法按中国合格评定国家认可委员会(CNAS)相关文件要求,对能力验证样品进行均匀性和稳定性检验,分析各参加实验室的灰分测定结果,采用z比分数对参加实验室的能力验证结果满意度进行评价。结果能力验证样品均匀、稳定;参加能力验证的59家实验室中,收回58家实验室的能力证验结果,结果评定均为满意,满意率为98.31%。结论参加能力证验的实验室对橡胶类药品包装材料灰分的检测能力总体良好。Objective To improve the the capabilities of laboratories in the determination of rubber pharmaceutical packaging materials.Methods According to the relevant documents of the China National Accreditation Service for Conformity Assessment(CNAS),the uniformity and stability tests were conducted on the proficiency testing samples,and the ash content determination results from each participating laboratory were analyzed.The robust z-scores were used to evaluate the satisfaction of the proficiency testing results of the participating laboratories.Results The proficiency testing samples were uniform and stable.Among the 59 laboratories that participated in the proficiency testing,58 laboratories retrieved their proficiency test results,and the results were evaluated as satisfactory,with a satisfaction rate of 98.31%.Conclusion The laboratories participating in the proficiency testing have an overall good ability to detect the ash content of rubber pharmaceutical packaging materials.

关 键 词：能力验证 橡胶 药品包装材料 灰分 

分 类 号：R917[医药卫生—药物分析学] R979.9[医药卫生—药学]