心达康片溶出度测定方法研究及体外溶出度考察

Study on dissolution determination method and dissolution rate of Xindakang Sugar-coated Tablets in vitro

目的 :建立心达康片溶出度测定方法 ,评价和提高产品质量。并对三个厂家的心达康片进行体外溶出度考察。方法 :以 90 0mL 0 .5 %吐温 80 水为溶出介质 ,采用转篮法 ,1 0 0r·min- 1 。以紫外分光光度法测定累积溶出百分率 ,提取威布尔分布溶出参数并进行统计学处理。结果 :统计结果显示 ,三个厂家心达康片的溶出参数Td,T50 ,m均存在显著性差异 (P <0 .0 1 ) ,溶出速度明显不同。结论 :建立了适用可行的心达康糖衣片的溶出度测定方法。通过对三个厂家心达康片的考察 ,认为有必要将溶出度测定纳入其质量标准中 。

Objective: To establish the method of dissolution determination for evaluating and improving the quality of Xindakang sugar coated Tablets. Xindakang Sugar coated Tablets from three enterprises were investigated. Methods: To adopt 900mL0.5% Tween80 H 2O as dissolvent and rotating basket method at 100r·min -1 , the cumulative dissolution percentage was determined by UV. The dissolution parameters was obtained by Weibull distribution model and dealed with one way ANOVA. Results: The significant differences in dissolution parameters(T d, T 50 ,m)( P <0.01)of the three samples Xindakang Sugar coated Tablets were discovered by statistical analysis. Conclusion: The method established is suitable and feasible for the dissolution determination of Xindakang sugar coated tablets. It will be necessary to bring the dissolution determination method into the quality control standard for improving the quality and preparation technology of Xindakang Sugar coated Tablets.