摘要
本文从统计角度阐释精密度内涵,汇总国内外药典、指南中对精密度的具体操作和限度要求,并分析了影响方法精密度的一些因素。不同的分析目的,不同的测定原理和不同的样品含量,其分析方法精密度数据差异较大,在药物质量研究和质量控制中要遵从法规对精密度的要求并实现良好地控制和运用,保证检测结果的可行度。
This article clearly explaned the meaning of precision from the statistical point of view. Analytical procedures and RSD limitations which were recorded in the Chinese Pharmacopoeias and other foreign Pharmacopoeias were summarized. Some factors affecting the method precision were also analyzed. Great differences in the precision of analytical methods were shown among different aims, determination mechanism and sample contents. The regulatory compliance in pharmaceutical analysis should be fulfilled and applied flexibly to ensure data reliability.
作者
郝福
胡向青
张志伟
申琳
杨晓玲
侯金才
HAO Fu;HU Xiang-qing;ZHANG Zhi-wei;SHEN Lin;YANG Xiao-ling;HOU Jin-cai(Shineway Pharmaceutical Group Co.Ltd,Shijiazhuang 050035)
出处
《中南药学》
CAS
2019年第1期60-65,共6页
Central South Pharmacy
关键词
药物质量控制
分析方法
精密度
相对标准偏差
限度
pharmaceutical quality control
analytical method
precision
relative standard deviation
limitation
作者简介
郝福,男,高级工程师,硕士,主要从事药物质量研究与质量控制,Tel:(0316)5759866-8708,E-mail:haofu001@163.com;通讯作者:侯金才,男,研究员,博士,主要从事新药开发和技术管理,Tel:(0316)5759866-8657,E-mail:jincaihou@126.com.
