药物质量控制对分析方法精密度的要求  

Precision requirement of analytical methods in pharmaceutical quality study and quality control

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)

机构地区：[1]神威药业集团有限公司,石家庄050035

出　　处：《中南药学》2019年第1期60-65,共6页Central South Pharmacy

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.

关 键 词：药物质量控制 分析方法 精密度 相对标准偏差 限度 

分 类 号：R921.2[医药卫生—药学]