盐酸二甲双胍缓释颗粒的制备

Preparation of metformin hydrochloride sustained-release granules

目的研究盐酸二甲双胍缓释颗粒的制备方法,并考察其体外释放特性。方法以盐酸二甲双胍的释放度为考察指标,采用正交实验法考察羟丙甲纤维素(HPMC)、聚维酮k30和微晶纤维素的用量,确定最佳的制备工艺。结果以HPMC用量为4 g,聚维酮k30用量为0.5 g,微晶纤维素用量为1 g制备盐酸二甲双胍缓释颗粒,该制剂2 h释放约33%,6 h释放约60%,12 h释放约90%,符合缓释制剂的要求。结论本方法制备的盐酸二甲双胍缓释颗粒外观较好,具有良好的释放性能,且工艺简单易行,生产成本低。

Objective To study the method of preparing metformin hydrochloride sustained-release tablets and inves- tigate its release characteristics in vitro. Methods The release of Metformin Hydrochloride was used as indicators to evaluate and optimize the formulation. The effects of hydroxypropyl methyl cellulose( HPMC) amount,povidone( k30) amount,microcrystalline cellulose amount on release behavior in vitro were observed in orthogonal design testing meth- od to determine the best preparation technological conditions. Results The optimal prescription were prepared with HPMC 4 g,povidone( K30) 0. 5 g and microcrystalline cellulose 1 g. The granules released 33% in 2 h,60% in 6 h, and exceeding 90% in 12 h,meeting the requirements for sustained-release. Conclusion Metformin Hydrochloride Sustained-Release Granules prepared in this method has good behavior of release characteristics. The preparative tech- nology is also simple with low producing cost.