摘要
目的比较2015版《中国药典》0941章中和《美国药典》905章(2011修订版)中的含量均匀度检测法的宽松度。方法在多个总体参数设置下通过随机模拟法分析国内外两种检测法的抽样特性曲线。结果两个抽样特性曲线展现了两个检测法通过概率与总体标准差的关系,及两个检测法之间的相对严格度。结论基于抽样特性曲线,现行的国内检测法与国外检测法宽松度近似。文章最后对如何展开进一步研究作了建议。
Objective This paper aims at comparing the strictness of the content uniformity test in Chinese and US pharmacopeia. Methods Monto carlo simulation approach is deployed to generate the operational characteristic（OC） curves of the content uniformity test under domestic and international regulation respectively. Results The two OC curves demonstrate the relationship between the passing probability and population standard deviation for the two content uniformity regulations. Conclusion Based on the two OC curves, the current domestic regulation is approximately as strict or as loose as the international regulation. At the end of the paper, some directions for further researches are suggested.
出处
《中国卫生标准管理》
2017年第8期65-67,共3页
China Health Standard Management
关键词
含量均匀度
中国药典
美国药典
content uniformity
Chinese pharmacopeia
US pharmacopeia
