摘要
通过大容量样本实验，考察了复方炔诺酮片重和炔诺酮含量的分布类型以及片重与含量的相关性；借助计算机模拟随机抽样方法，绘制出ＵＳＰ（ＸＶＩＩ～ＸＸ），ＢＰ（１９８８）、新方案、中国药典（ｌ９９０，限度为±１５％和±２０％）等含量均匀度检查法的抽样特性曲线，并进行了统计特性分析，表明计量型的含量均匀度检查法优于计数型的。
Test for nonnormality of the weight and content of the single dosage units of a Composite Norethisterone Tablets lot and analysis of their correlation have been made by experiment with a large sample size of 100.OC curves for the NEW Scheme and the content uniformity test of USP BP 1988. ChP(1990) [±15%]. ChP (1990) [±20%] have been drawn by computer simulation and analyses of their statistical characteristics. The results showed that the content uniformity tests by variables are better than those by attributes.
出处
《药物分析杂志》
CAS
CSCD
北大核心
1994年第4期23-26,共4页
Chinese Journal of Pharmaceutical Analysis
基金
国家自然科学基金
关键词
含量均匀度
抽样特性曲线
炔诺酮片
content uniformity test
operating characteristics curves
composite norethisterone tablets
