均匀设计法优化格列本脲片的处方工艺

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目的:制备格列本脲片,筛选出最佳处方工艺.方法:采用均匀设计法,以硬度,溶出度为指标,优化处方.结果:格列本脲片优化处方为微晶纤维素65mg,甘露醇12mg,低取代羟丙纤维素4mg,硬脂酸镁0.3mg,硬度约4Kgf,溶出度95%以上.结论:该处方合理,工艺简单,质量稳定.“,”Objective:To prepare Glibenclamide Tablets,and to optimize the formula technology. Methods:The formula was optimized by uniform design using dissolution and hardness as index,Results:The optimal formula of Glibenclamide tablets was as folowed:microcrystaline celulose,mannitol,L-HPC,magnesium Stearate were 65mg,12mg,4mg,0.3mg.The values of dissolution 3 batches of samples were more than 95%,and hardness was about 4Kgf.Conclusion: The formula of glibenclamide tablets is reasonable, technology is simple, quality is stable.
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