阿德福韦酯片的制备研究

Study on Preparation of Adefovir Dipivoxil Tablets

目的:优化阿德福韦酯片的处方。方法:采用均匀设计法,以填充剂比为因素A,崩解剂为因素B,润滑剂为因素C,以溶出度相似因子作为考察指标。结果:最优化的条件为填充剂比(乳糖、预胶化淀粉比为2.6),崩解剂(5.2%交联聚维酮),润滑剂(0.5%硬脂酸钙),3批验证试验的f_(2)均大于50,与参比制剂溶出行为相似,平均累积溶出度90%以上。结论:该处方设计合理,易于操作,体外溶出度良好。

Objective:To optimize the formulation of adefovir dipivoxil tablets.Methods:The uniform design method was adopted,with the proportion of filler as factor A,disintegrant as factor B,lubricant as factor C,and dissolution similarity factor as the index.Results:The optimal conditions were the ratio of fillers(lactose and pregelatinized starch was 2.6),disintegrators(5.2%crosslinked povidone)and lubricants(0.5%calcium stearate).f_(2) of the 3 batches of verification tests were all greater than 50,similar to the dissolution behavior of the reference preparation,and the average cumulative dissolution rate was more than 90%.Conclusion:The prescription was reasonable in design,easy to operate and had good dissolution in vitro.