重复性测定结果可接受性检查方法在滴定液标定中的应用  

Application of Acceptable Assessment Method of Test Results under Repeatability Conditions in Standard Volumetric Solution Standardization

作　　者：王林波[1] 刘蔚[1] 李苗 石蓓佳[3] 马蓓 彭兴盛[1] 陈桂良[1] 

机构地区：[1]上海市食品药品检验所,上海200131 [2]武汉市药品检验所,武汉430012 [3]江苏省食品药品检验所,南京210008 [4]美国药典会,罗克韦尔20852

出　　处：《中国药品标准》2015年第3期172-175,共4页Drug Standards of China

摘　　要：目的:总结分析我国国家标准和《中国药典》滴定液标定结果可接受性检查方法,对食品药品检验系统滴定液标定的管理提供建议。方法:查阅国内相关标准、规定以及文献,总结现状,分析问题,提出相应对策。结果与结论:应建立食品、保健食品和化妆品滴定液标定方法的技术指导文件,积累标定数据,计算检验机构内部的标定重复性标准差,建立动态更新的数据库,进一步加强应用于国标方法滴定液的管理办法。Objective：To summarize and analyze the standardization method in Chinese Pharmacopoeia and National Standards, in order to provide advices for further improvement in the management of standard volumetric solution.Methods： By searching the standards, the domestic regulations and literatures, the current situation was summarized, the problems were analyzed, and corresponding countermeasures were proposed.Results and Conclusion：The SOPs, management practices and technical guidance documents of the standard volumetric solution standardization should be established in the foods,the health foods,and the cosmetics testing fields; the standardization results should be accumulated in order to calculate the repeatable testing standard deviation（σr ）;and the continuously updated database should be build, so as to further strengthen the management of standard volumetric solutions.

关 键 词：重复性测定结果 可接受性检查 滴定液标定 

分 类 号：R921.2[医药卫生—药学]