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阿德福韦酯片的制备研究
  

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f2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). f2 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.



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