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。 OBJECTIVE To compare the similarities and differences between the Pharmacopoeia of the People’s Republic of China and the Uniformity Test of Pharmacopoeia of the United States, Britain and Japan, and try to establish a new content uniformity test. Methods The computer simulation of random sampling method was used to draw the sampling curve of the content uniformity of the Pharmacopoeia of the People’s Republic of China and the ICH method to calculate the statistical characteristic parameters. By comparing the characteristic curves and sampling characteristic parameters of the two methods, the advantages and causes of the two methods are analyzed, and the improved ICH method is proposed and the sampling characteristic parameters of ICH improved method are calculated. Results The allowable rejection rate, retest rate, average sample size and disputed area of ​​the method of checking the content uniformity of the People’s Republic of China Pharmacopoeia I, CH method and ICH method were 9.4%, 27.4%, 15.5 and 15.0% respectively; 5.5% , 69.6%, 23.9 and 11.0%; 5.5%, 40.5%, 18.1 and 11.0% respectively. Conclusion ICH improvement is superior to ICH.