药用辅料二丁基羟基甲苯吸收系数测定的能力验证研究  

Proficiency test on the determination of absorption coefficient of pharmaceutical excipient dibutylhydroxytoluene

作　　者：王珏[1] 许凯 杨洋 杨锐[1] 肖新月[1] 杨会英[1] WANG Jue;XU Kai;YANG Yang;YANG Rui;XIAO Xin-yue;YANG Hui-ying(NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients,National Institutes for Food and Drug Control,Beijing 100050)

机构地区：[1]中国食品药品检定研究院,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,北京100050

出　　处：《中南药学》2023年第8期2224-2227,共4页Central South Pharmacy

摘　　要：目的设计和组织紫外分光光度计法测定药用辅料二丁基羟基甲苯的吸收系数的能力验证项目(编号NIFDC-PT-398),评价参加者吸收系数的测定能力。方法按照中国合格评定国家认可委员会(CNAS)规定的程序进行样品制备,在发样前完成均匀性和稳定性检验,结果均符合要求。采用基于z比分数的稳健统计方法对上报数据进行统计分析,将稳健均值作为能力验证指定值,将稳健标准差作为能力评定标准差。结果在提交的130个数据中,108家为“满意”,12家为“可疑”,10家为“不满意”,满意率为83.1%。结论本次能力验证项目检测结果主要受到样品溶液配制中溶液转移体积及器具、称样量、紫外分光光度计、溶剂等因素影响,建议未获得满意结果的实验室通过采用移液管、改正溶液配制时的转移体积、按要求满足称样量、规范紫外分光光度计的操作等措施以保证结果的准确。Objective To design and organize the proficiency test project(No.NIFDC-PT-398)to determine the absorption coefficient of the pharmaceutical excipient dibutylhydroxytoluene by ultraviolet spectrophotometer and evaluate participants’ability in determining the absorption coefficient.Methods The samples were prepared according to the procedures specified in the China National Accreditation Service for Conformity Assessment.The uniformity and stability were tested were completed before the sample was issued,and the results met the requirements.Robust statistical method based on the z score was used to analyze the reported data.The robust mean was used as the specified value in the ability verification,and the robust standard deviation was used as the standard deviation in the ability evaluation.Results Among the 130 data submitted,108 laboratory results were satisfactory,12 were suspicious,and 10 were not qualified.The satisfaction rate was 83.1%.Conclusion The proficiency test project is mainly affected by factors such as solution transfer volume and instrument,sample weight,ultraviolet spectrophotometer and solvent in the sample solution preparation.Correcting the transfer volume and instrument during solution preparation,proper sample weight,and standard operation of ultraviolet spectrophotometer will help ensure the accuracy of the results.

关 键 词：药用辅料 吸收系数 能力验证 

分 类 号：R95[医药卫生—药学] R927