替米沙坦分散片的制备及质量控制

目的：制备替米沙坦分散片，建立替米沙坦分散片的溶出度测定法。方法：采用正交试验，以崩解时间为指标，以羧甲淀粉钠与微晶纤维素的用量、葡甲胺的用量为3个因素，分别设计3个水平优化分散片的处方，采用桨法对自制的分散片与进口普通片进行了溶出度测定，比较研究二者的溶出度Weibull分布参数。结果：替米沙坦分散片工艺简单，在1min内全部崩解，溶出速率明显优于进口普通片，符合分散片的各项质量指标。结论：用优化处方制备的替米沙坦分散片体外溶出特性明显优于普通片。

Preparation and quality control of telmisartan dispersible tablets

Objective:To prepare telmisartan dispersible tablets and to establish its dissolution method. Methods:The formulation of telmisartan dispersible tablets was optimized with regard to quantity of CMS-Na, microcrystallite fibrin and meglumine by orthogonal test. The dissolution and the Weibull distribution index of the dispersible tablets made by paddel way were compared to the imported regular tablets. Results:The dispersible tablets showed full disintegration within one minute. The dissolution rate of the dispersible tablets was superior over the imported regular tablets. Conclusion: The vitro dissolution property of the optimal telmisartan dispersible tablet was more achievable than that of regular tablet.