盐酸普拉克索缓释微丸的制备及体外释放度考察  

Preparation of pramipexole dihydrochloride sustained-release pellets and its released behavior in vitro

作　　者：袁中文[1] 周郁斌[1] 关世侠[1] 张怡[1] 胡波[1] 何枫敏[1] 

机构地区：[1]广州中医药大学中药学院,广州510006

出　　处：《中国新药杂志》2013年第1期107-110,共4页Chinese Journal of New Drugs

摘　　要：目的:制备盐酸普拉克索缓释微丸。方法:采用挤出-滚圆法制备盐酸普拉克索微丸,再用EudragitRL30D和EudragitRS30D进行包衣,最终制成盐酸普拉克索缓释微丸,并用高效液相色谱法测定药物含量。结果:体外释放度实验显示,制备的盐酸普拉克索缓释微丸在24 h内平稳释放且释药完全。结论:用本方法制备的盐酸普拉克索缓释微丸体外释药平稳,释药规律符合一级释放模型。Objective： To prepare and evaluate sustained-release pellets of pramipexole dihydrochloride.Methods： Extrusion-spheronization technique was used to prepare sustained-release pellets with Eudragit RL30D and Eudragit RS 30D as coating materials.HPLC method was adopted to determine pramipexole dihydrochloride content and to explore the released behavior.Results： The in vitro release data proved that the drug release from formulation was steady and complete during 24 h.Conclusion： The release of pramipexole dihydrochloride from sustained-release pellets is slow and steady,and easy to operate.The in vitro drug release profile fits first order kinetics model.

关 键 词：盐酸普拉克索 挤出-滚圆法 微丸 丙烯酸树脂 体外释放度 

分 类 号：R943.41[医药卫生—药剂学] R971.4[医药卫生—药学]