一个含量均匀度检查的新方案  

A New Proposal for the Content Uniformity Test

作　　者：韩鹏[1] 王玉[2] 李涛 蔡美明[2] 

机构地区：[1]国家药典委员会,北京100061 [2]江苏省食品药品检验所,南京210008 [3]河南省安阳药检所,安阳455000

出　　处：《中国药品标准》2013年第5期333-337,共5页Drug Standards of China

摘　　要：目的:评估含量均匀度现行检查法的风险,提出含量均匀度检查法新方案。方法:通过分析含量均匀度计算公式中的各参数物理意义,比较中美两国现行药典的含量均匀度检查法的差异,探究含量均匀度质量控制的实质。结果:分析过程简明清楚,逻辑性强,根据分析结果,提出了新方案。结论:含量均匀度检查法新方案的判断结果更为真实,标准更为严格,方法更为合理,新方案减少了复试工作量。Objective： To evaluate the risk of the results obtained by the test methods currently in effect, and suggest a new proposal for the content uniformity test in Pharmacopeia. Methods： By discussing the physical meaning of the parameters in the calculation for- mula for the content uniformity test, the differences of content uniformity tests between Chinese Pharmacopeia and US Pharmacopeia were compared, and the essence of the test in the drug quality control were investigated. Result： The analysis procedure was logical, clear and concise, and the new proposal for the content uniformity test was fully described. Conclusion： With the new proposal, the results obtained are more authentic and the criterion is more strictly. The new method is more scientific and reasonable, and the num- bers of the re-test are less than the test methods currently in effect.

关 键 词：含量均匀度 检查法 新方案 

分 类 号：R921.2[医药卫生—药学]