本文根据实测片剂批的含量分布曲线,采用计算机模拟随机抽样方法对USP ⅩⅪ版片剂含量均匀度检验方案诸统计特性进行了分析,并与USP ⅩⅩ版相应方案的统计特性比较,获得了一系列定量结果。结果表明,由于引入统计量RSD,属于计数—计量混合型的USP ⅩⅪ版方案,在判断可靠性上优于属于计数型的USP ⅩⅩ版方案。 Based on the content distribution curve of the measured tablet lot, we analyzed the statistical characteristics of the tablet USP ⅩXI tablet content uniformity test by computer simulation random sampling method and compared with the statistical characteristics of the corresponding USP XX version, Series of quantitative results. The results show that due to the introduction of statistical RSD, the USP ⅩΠ scheme, which belongs to the counter-measure mixed type, is superior to the USP ⅩⅩ scheme which belongs to the counting type in determining the reliability.