盐酸吡格列酮缓释片处方筛选及工艺研究

目的:对盐酸吡格列酮缓释片进行处方筛选及工艺研究。方法:通过测定不同时间吡格列酮在pH6.8磷酸盐缓冲液中的累积释药率,对缓释骨架材料、填充剂、黏合剂的种类或规格、用量及工艺等进行考察,确立片芯处方及制备工艺。结果:片芯处方以羟丙基甲基纤维素(HPMC)(K15M)为骨架材料,微晶纤维素为填充剂,2%HPMC(E5)的70%乙醇溶液为黏合剂;制备工艺采用薄膜包衣法,以欧巴代的70%乙醇溶液作为薄膜包衣材料;所制3批样品12h的累积释药率均在90%以上。结论:本制剂工艺简单,符合缓释制剂要求。

Study on the Formulation Optimization and Preparation Technology of Pioglitazone Hydrocloride Sustained-release Tablets

OBJECTIVE:To screen the formulation of Pioglitazone hydrocloride sustained-release tablets,and to optimize the preparation technology of it.METHODS:The type,amount and preparation technology of matrix material,bulking agent,and adhesive were investigated by determining accumulative rate of pioglitazone at different time in PBS to determine the formulation and preparation technology of tablet core.RESULTS:The tablet core was prepared with HPMC(K15M) as matrix material,microcrystaline celulose as the bulking agent and 70% ethanol solution of 2% HPMC(E5) as adhesive material for Pioglitazone hydrocloride sustained-release tablets.The tablet was prepared by film coating method using 70% ethanol solution of Opadry as film coating material.Accumulative drug release rate of prepared 3 batches of samples were all more than 90% in 12 h.CONCLUSION:The preparation method is simple and the tablet is up to the requirements of sustained-release preparation.