尼莫地平胶囊溶出度测定的不确定度评定  

Evaluation of Uncertainty for Determination of Dissolution of NimodipineCapsules

作　　者：陈文 刘斌 邢征宇 Chen Wen;Liu Bin;Xing Zhengyu(Hainan Provincial Institute For Food and Drug Control Haikou Branch,Haikou 570100,China)

机构地区：[1]海南省食品药品检验所海口分所,海南海口570100

出　　处：《广东化工》2020年第7期209-210,203,共3页Guangdong Chemical Industry

摘　　要：为建立尼莫地平胶囊溶出度试验过程不确定度的评定方法,本文根据《中国药典》2015年版收载的方法和《测量不确定度要求的实施指南》,对尼莫地平胶囊溶出度进行测定,并对不确定度影响因素进行分析。本次试验尼莫地平胶囊溶出度测定结果平均值为98%,扩展不确定度为6.4%。To establish an uncertainty evaluation method for the dissolution of Nimodipine Capsules,dissolution rate of Nimodipine capsules were tested according to the dissolution method of Ch.P 2015 and the factors affecting the uncertainty were analysized according to the Guidance on the Application of the Requirements for Measurement Uncertainty in this paper.The average result of dissolution rate of Nimodipine capsules is 98%with the expanded uncertainty rate is 6.4%(k=2).

关 键 词：紫外-可见分光光度法 尼莫地平胶囊 不确定度 溶出度 

分 类 号：R917[医药卫生—药物分析学]