Aim In this study, compound metformin/glipizide bilayer extended release tablets were formulated with hydroxypropyl methylcellulose (HPMC) by wet granulation technique in order to tackle the problems associated with the multidrug therapy of non-insulin dependent diabetes mellitus. Methods High-dose metformin is difficult to formulate into a tablet dosage form due to its poor compressibility and compactibility. In this study, the way to overcome the difficulty was to utilize stearic alcohol to prepare the tablet formulation. The influences of viscosity, amount of HPMC, and weight of fillers were investigated. The optimal formulation had acceptable physicochemical properties and released metformin and glipizide over 10 h. Results The data of metformin obtained from in vitro release fitted Higuchi kinetics best, while the release of glipizide in vitro was found to follow zero kinetics. Conclusion Compound metformin/glipizide bilayer extended release tablets have been successfully developed.%目的本文为了解决2型糖尿病中的多药治疗问题,用HPMC进行湿法制粒制备了复方二甲双胍/格列吡嗪双层缓释片.方法由于二甲双胍的压缩成型性较差,高剂量的二甲双胍很难压制成片.在实验中,采用十八醇克服了这一问题.研究了HPMC的黏度、用量和填充剂的用量对药物释放的影响.优化的处方具有较好的物理化学性质,其中二甲双胍和格列吡嗪缓释时间为10小时.结果二甲双胍的体外释放符合Higuchi方程, 而格列吡嗪的体外释放符合零级方程.结论本文成功地设计了一种新型的复方二甲双胍/格列吡嗪双层缓释片.
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