【摘要】 目的:对格列吡嗪缓释微丸胶囊的处方和工艺进行考察,并考察其体外释放行为。方法:以微丸成球性和释放度作为考察指标,采用正交设计试验优化处方和工艺。结果:格列吡嗪缓释微丸胶囊的最优处方为格列吡嗪5 g,微晶纤维素(MCC)4.5 g,乙基纤维素(EC)5 g,羟丙甲纤维素K4M 7 g,最佳工艺以50%乙醇溶液作为黏合剂,采用挤出滚圆法制备微丸,35 r/min滚圆10 min,200 r/min高速剪切5 min;所制微丸圆整度好,平面临界角12.4°,收率93.8%;释药行为符合一级释药方程,具有明显的缓释特征。结论:格列吡嗪缓释微丸胶囊具有良好的体外缓释效果。更多还原

【Abstract】 Aim:To study the formulation and processing of glipizide sustained-release pellet capsules,and to perform in vitro dissolution tesing.Methods:The pellets were prepared by extrusion/spheronization.Orthogonal design was used to screen the formulation of glipizide sustained-release pellet capsules and to optimize the manufacturing process.Results: The optimized formulation of glipizide sustained-release pellet and processing followed as:5 g of glipizide,4.5 g of MCC,5 g of EC,7 g of HPMC(K4M),and 50% alcohol as adhesive.In the extrusion/spheronization,speed of extrusion of 200 r/min,time of extrusion of 5 min,speed of spheronization of 35 r/min,and time of spheronization of 10 min were selected as the processing conditions.The prepared pellets had good spheronization.The critical angle of plan was 12.4°,and the recovery was 93.8%.Moreover,in vitro release of glipizide sustained-release pellet capsules properly described by first-order kinetics and the sustainedrelease of the pellets was evident.Conclusion: The sustained-release glipizide pellets with in vitro sustained release characteristics were successfully prepared.更多还原