复方盐酸二甲双胍缓释胶囊的制备及体外释放度考察  

Preparation and in vitro release test of compound metformin hydrochloride sustained-release capsules

作　　者：白靖[1] 张倩[1] 李立[1] 方瑜[1] 曹德英[1] 

机构地区：[1]河北医科大学药学院,石家庄050017

出　　处：《中国新药杂志》2011年第7期651-655,660,共6页Chinese Journal of New Drugs

摘　　要：目的:研制复方盐酸二甲双胍缓释胶囊,并对盐酸二甲双胍(MH)和格列美脲进行释放度研究。方法:采用挤出滚圆法制备MH微丸,以乙基纤维素水分散体进行包衣,得到MH缓释微丸;采用混合物研磨法,结合湿法制粒技术得到格列美脲速释颗粒。将MH缓释微丸与格列美脲颗粒混合灌装成胶囊。结果:释放度测定结果表明,制得胶囊满足格列美脲在45 min内迅速释放,MH可在12 h内持续缓慢释放。结论:优选工艺稳定,复方盐酸二甲双胍缓释胶囊具有较好的速释、缓释效果。Objective： To prepare compound metformin hydrochloride sustained-release capsules,and investigate the release behavior of metformin hydrochloride（MH） and glimepiride.Methods： The MH pellets were prepared by extrusion-spheronization,and used as the core to prepare the sustained-release pellets by coating with ethylcellulose dispersion.Granules of the immediate-release granules containing glimepiride were prepared by grinding mixture and using aqueous wet granulation technology.The final sustained-release capsules were obtained by mixing the MH sustained-release pellets and granules of glimepiride.Results： The release behavior indicated the successful preparation of compound sustained-release capsules.MH enabled desired drug release for up to 12 h,whereas glimepiride showed an immediate-release in 45 min.Conclusion： The optimal technique for the preparation of compound metformin hydrochloride sustained-release capsules is stable.The capsules have a good behavior of immediate-and sustained-release.

关 键 词：盐酸二甲双胍 格列美脲 复方 挤出滚圆 缓释胶囊 

分 类 号：R943.41[医药卫生—药剂学] R977.15[医药卫生—药学]