摘要
目的对《美国药典》(USP)29版含量均匀度检查方法进行统计特性分析,并与《中国药典》等相应检查法比较,得到一系列定量评价结果。方法采用计算机模拟随机抽样方法,求算评价抽样检查方法判断准确性的抽样特性(OC)曲线。结果USP 29版采用了计量型二次抽样检查法,具有判断准确性高、高效实用的优点。结论进一步肯定计量型含量均匀度检查方法是国际药学界寻求统一的先进方法。
OBJECTIVE To investigate the content uniformity test published in USP29 and compare its statistical characteristics with several content uniformity sampling tests in other pharmacopoeia, METHODS Their operating characteristic curves drawn by means of computer simulation were evaluated, RESULTS The result of the content uniformity sampling test in USP29 was most accurate;its percent of double sampling is the largest. CONCLUSION A consensus on the content uniformity test by variable will be reached over the world.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2007年第12期932-934,共3页
Chinese Pharmaceutical Journal
