盐酸二甲双胍肠溶微丸胶囊的制备及其释放度测定

 目的 制备盐酸二甲双胍肠溶微丸胶囊,并测定其释放度.方法 采用丸芯喷雾上药法,筛选微丸处方,并通过溶出度试验考察其释放度.结果 以空白丸芯(600～700 μm)400 g;盐酸二甲双胍800 g;HPMC(6 cps)40 g;水2 500 ml为优选处方,所制备的微丸在规定的酸性介质中几乎不释放,而在磷酸盐缓冲液中则释放80%以上.结论 该片剂制备工艺简单易行,能达到肠溶的目的,可降低或消除盐酸二甲双胍在临床上使用的不良反应.

Preparation and release rate determination of metformin hydrochloride enteric coated micropill capsules

Objective To prepare metformin hydrochlofide enteric coated micropill capsules and determine the release rate of the drug.Methods The drug substance was microencapsulated into aqueous dispersed coating materials to prepare enteric coated micropill capsules by a centrifugal spraying granulator.The formulation and process of encapsulation were optimized.The drug release rate of finished preparation was determined by testing its solubility.Results The coating formulation has a good release behaviour.The release rate of the pellets was less than 10% in specified acid medium and more than 80% in phosphate buffer.Conclusions The formulation and preparation of metformin hydrochlofide enteric wated miozopill capsules are practical and reasonable,and the side effects of metformin are reduced or eliminated.