论文部分内容阅读
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、外盐酸普罗帕酮片剂间存在显著性差异
OBJECTIVE: To comprehensively investigate the quality of propafenone hydrochloride tablets by dissolution test. Methods: First, establish a dissolution method that is water as the dissolution medium, the detection wavelength of 248nm. At the same time, the dissolution of three kinds of domestic tablets and German tablets were compared, and the dissolution parameters and variance analysis were extracted. Results: The dissolution of each tablet at 30min was more than 75%. Weibull parameters T50, Td and m values, in addition to C and D tablets between the P> 0.05, the other two were P <0.01. Conclusion: The method of determination of dissolution shows that there is a significant difference between domestic and foreign propafenone hydrochloride tablets