盐酸二甲双胍缓释骨架微丸的研制

摘要

采用挤出滚圆造粒机制备盐酸二甲双胍缓释骨架微丸,通过单因素考察和正交设计筛选最优化处方及工艺条件,评价了微丸的粉体学性质和体外释放度.本工艺中微晶纤维素(MCC)的质量分数为10％,乙基纤维素(EC)和硬脂酸物质的量比为1∶1,黏合剂采用质量分数为2％的羟丙基甲基纤维素(HPMC K4M),在此条件下经烘干制得的盐酸二甲双胍缓释骨架微丸具有较好的缓释效果,释药动力学符合Higuchi方程,且圆整度好.本方法制备盐酸二甲双胍缓释骨架微丸工艺可靠,质量可控.%Metformin hydrochloride sustained-release matrix pellets are prepared by extrusion-spheronization method.The optimal operating conditions and formulation are obtained by single-factor and orthogonal experimental design.The micromeritic characteristics and the release in vitro of these pellets are evaluated.In the process,micro-crystal cellulose (MCC) is 10％,ethyl cellulose (EC) ∶ stearic acid=l∶ 1,and 2％ hypromellose(HPMC K4M) is used.The profiles of the prepared sustainedrelease pellets follow Higuchi equation,and have good sphericity.The developed process is reliable and the quality of the pellets is controllable.