《中华人民共和国药典》与美、英、日3国《药典》含量均匀度检查法的比较

目的比较《中华人民共和国药典》与美、英、日3国《药典》含量均匀度检查法的异同,尝试建立新的含量均匀度检查法。方法采用计算机模拟随机抽样方法,绘制《中华人民共和国药典》含量均匀度检查法和ICH方法的抽样特性曲线,计算统计特性参数。通过比较2种方法的特征曲线与抽样特性参数,分析2种方法的优点和产生原因,提出ICH改进方法并计算ICH改进方法的抽样特性参数。结果《中华人民共和国药典》含量均匀度检查方法I、CH方法及ICH改进方法的批允许废品率、复试率、平均样本容量和争议区分别为9.4%、27.4%、15.5和15.0%;5.5%、69.6%、23.9和11.0%;5.5%、40.5%、18.1和11.0%。结论ICH改进方法优于ICH方法。

Comparison of content uniformity test among ChP and USP,BP and JP

Objective To compare the differences on content uniformity test among ChP and USP,BP and JP(ICH method)and try to establish a new content uniformity test method.Methods By means of computer simulation,the operating characteristic curves for Chp and ICH method were drawn respectively,and the statistical characteristics were calculated.With the comparison of the two methods,the advantages of the two methods were assessed.At the same time,advanced ICH method was promoted and the statistical characteristics of the method were calculated.Results The lot tolerance percent defective,retest possibility,average sample number and disputable zone in ChP,ICH method and the advanced ICH method are 9.4%,27.4%,15.5 and 15.0%;5.5%,69.6%,23.9 and 11.0%;5.5%,40.5%,18.1 and 11.0%,respectively.Conclusions Advance ICH method is better than ICH method.