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目的:比较4种国产替米沙坦商品制剂与进口Micardis片的体外溶出曲线。方法:采用RCZ-8A智能溶出仪,以0.1mol.L-1盐酸和磷酸缓冲液(PBS,pH7.5)为溶出介质,测定5种替米沙坦制剂在不同时间的累计释放量,并绘制溶出曲线。通过差异因子(f1)和溶出效率法(DE)比较各溶出曲线的差异。结果:3种国产制剂的溶出性质呈明显pH依赖性,在PBS(pH7.5)介质中溶出不完全。国产制剂与进口Micardis片的溶出曲线存在显著差异。
OBJECTIVE: To compare in vitro dissolution profiles of four domestic formulations of telmisartan with imported Micardis tablets. Methods: The cumulative release of five kinds of telmisartan in different time was determined by using RCZ-8A intelligent dissolution apparatus with 0.1mol.L-1 hydrochloric acid and phosphate buffer (PBS, pH7.5) as dissolution medium Draw the dissolution curve. The difference of each dissolution curve was compared by the difference factor (f1) and the dissolution efficiency method (DE). Results: The dissolution profiles of the three domestic preparations showed obvious pH dependence, and the dissolution was incomplete in PBS (pH7.5) medium. Dissolution curves of domestic preparations and imported Micardis tablets were significantly different.