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目的 :研究格列齐特缓释片的制备方法 ,筛选最佳制备工艺条件。方法 :采用正交试验设计 ,以处方工艺中羟丙基甲基纤维素、微晶纤维素的用量及缓释片的硬度为试验因素 ,每个因素取三个水平 ,按正交试验表的安排进行实验 ,并确定其最佳制备工艺条件 ,按优化后的结果选择实验条件 ,进行重复实验 ,用体外溶出实验考察其缓释释放效果。结果 :制备的缓释片在 2、6、12h的累积释放率分别为 2 9.91%± 1.3 8%、61.77%± 1.13 %和 95 .89%± 0 .81%。结论 :按优化结果选择的制备工艺所制备的格列齐特缓释片其缓释效果与预测值基本吻合 ,工艺的重复性较好 ,体外累积释放率符合要求
Objective: To study the preparation of gliclazide sustained-release tablets, screening the best preparation conditions. Methods: Using orthogonal experimental design, the dosage of hydroxypropyl methylcellulose and microcrystalline cellulose in formulation process and the hardness of sustained-release tablets were taken as the experimental factors. Each factor was taken as three levels. According to the orthogonal test table Arrange the experiment, and determine the optimal preparation process conditions, select the experimental conditions according to the optimized results, repeat the experiment, in vitro dissolution test to investigate the sustained release effect. Results: The cumulative release rates of prepared sustained-release tablets at 2, 6 and 12 h were 29.91% ± 1.3 8%, 61.77% ± 1.13% and 95.89% ± 0.81%, respectively. Conclusion: Gliclazide sustained-release tablets prepared according to the optimized preparation process basically consistent with the predicted value, the process repeatability is good, the cumulative cumulative release rate in vitro meet the requirements