半微量法测定氮含量能力验证及新评价方法的应用  

Application of A New Evaluation Method to the Proficiency Testing Project of Nitrogen Determination by Semimicro Method

作　　者：刘莉莎[1] 李京[1] 廖海明[1] 常艳[1] 张会亮[1] 刘雅丹[1] 项新华[1] 张佟 郭乘凤 范慧红[1] LIU Li-sha;LI Jing;LIAO Hai-ming;CHANG Yan;ZHANG Hui-liang;LIU Ya-dan;XIANG Xin-hua;ZHANG Tong;GUO Cheng-feng;FAN Hui-hong(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药学杂志》2023年第11期1026-1030,共5页Chinese Pharmaceutical Journal

摘　　要：目的实施氮含量测定能力验证计划,对参加者的结果采用新的统计方法。方法根据中国合格评定国家认可委员会(CNAS)规定的程序组织能力验证,借助JMP软件对制备样品进行均匀性和稳定性检验。对参加者的结果采用了新的统计方法,采用双z比分数的方式进行评价,在计算z比分数所需的能力评定标准差时,采用了合成标准差的方法。结果共有73家实验室报告了有效测定结果,实验室总满意率为93.2%,可疑率为1.4%,不满意率为5.5%。结论在本次能力验证中,使用了新评价方法对参加者测定结果进行评价,保证了能力评定标准差涵盖了所有可能产生误差的因素,使评价结果更加准确可靠。OBJECTIVE To conduct proficiency testing(PT)project for determination of nitrogen using a new evaluation method.METHODS According to the procedures of China National Accreditation Service for Conformity Assessment,the proficiency testing profect was organized.The homogeneity and stability of the prepared samples were tested with JMP software.A new evaluation method was applied.The double z-scores were calculated,and the synthetic standard deviation method was used for proficiency assessment.RESULTS A total of 73 laboratories reported valid test results,with a total satisfaction rate of 93.2%,suspicion rate of 1.4%,and dissatisfaction rate of 5.5%.CONCLUSION In the proficiency testing project,the new statistical evaluation method is used,which ensures that the standard deviation covered all the factors that might cause errors,and makes the evaluation results more accurate and reliable.

关 键 词：能力验证 氮含量测定 半微量法 双z比分数 合成标准差 

分 类 号：R917[医药卫生—药物分析学]