盐酸普罗帕酮片的溶出度测定

Study on the dissolution of propafenone hydrochloride tablets

目的：通过溶出度检查来全面考察盐酸普罗帕酮片剂的质量。方法：首先建立溶出度测定方法即以水为溶出介质，检测波长为２４８ｎｍ。同时对国内３种来源的片剂与德国产片剂进行溶出度比较，提取溶出参数及方差分析。结果：各片剂在３０ｍｉｎ时的溶出量均大于７５％。威布尔参数Ｔ５０、Ｔｄ和ｍ值，除Ｃ片与Ｄ片间比较Ｐ＞０．０５外，其余两两间比较Ｐ均＜０．０１。结论：采用溶出度测定方法，表明国内。

OBJECTIVE:To evaluate the quality of propafenone hydrochloride tablets.METHODS:Study on the dissolution of the tablets was carried out using distilled water as solvent,detection wavelength was 248 nm.The dissolution of three kinds of domestic tablets was compared with german tablets.Parameters were collected and analysed by Anova.RESULTS:The dissolved amount of all the tablets was more than 75% at 30 minutes.P value of weibull parameters T 50 , T d, m of every two tablets were < 0.01 ,except C and D tablets( P > 0.05 ).CONCLUSIONS:It is suggested that there are apparent difference in dissolution tests,between imported and domestic propafenone hydrochloride tablets.