片剂含量均匀度计量检验新方案的研究

本文通过大量测试工作,查明10批国产小剂量片剂的含量分布,在此基础上提出了计量检验新方案。采用计算机模拟随机抽样的方法,通过计算绘制了USP XX,BP,JP和新方案在正态分布和10批实际分布下的OC曲线。结果表明,当用于测定生产规模的片剂批时,与国外片剂含量均匀度计数检验方案中统计特性最优的USP XX方案相比,新方案NEW能在化验工作量相近的前提下,作出更准确的判断;新方案SMA能在不降低判断准确性的前提下,减少化验工作虽约三分之一。新方案还可减免分析方法误差对判定结果的影响。

STUDIES ON A NEW SAMPLING SCHEME BY VARIABLES FOR THE CONTENT UNIFORMITY OF TABLETS

In order to work out a new criterion for the content uniformity of tablets that leads to more accurate results or requires less analytical work than those of USP XX, BP, and JP, we have advanced a new sampling inspection scheme by variables. The scheme consists of two subschemes, NEW and SMA, which are different only in the sample size required. By assaying of tablets made in our country which contain very small amount of active ingredients, 10 content distribution curves of tablet lots were obtained. The OC curves of USP XX, BP, JP, NEW, and SMA criteria under the normal and 10 real distributions were plotted through computing by means of computer simulation. Comprehensive comparisons of different criteria with regard to decision accuracy, adaptability to real distributions, effect of errors of analytical method and average sample size were made.