盐酸普拉克索缓释骨架片的制备

Preparation of the pramipexole hydrochloride sustained release matrix tablets

目的研制盐酸普拉克索缓释骨架片,并对其体外释药行为进行考察。方法以高分子材料羟丙甲纤维素(HPMC)为骨架,制备盐酸普拉克索缓释片,单因素实验考察其释药特征,正交实验筛选最佳处方。结果以HPMC K100M为骨架材料,磷酸氢钙为填充剂,缓释片直径为9 mm,湿法制粒为最佳工艺。结论所制备的盐酸普拉克索缓释骨架片能缓释24 h,体外释放接近Higuchi模型,重现性好。

Objective To prepare pramipexole hydrochloride sustained release matrix tablets, and investigate their in vitro drug release behaviors. Methods The tablets were prepared with polymer materials of hydroxypropyl methyl cellulose（HPMC） as the matrix, and the release behaviors were investigated with single factor study. The best prescription was optimized by orthogonal design. Results The optimal technology was as follows： HPMC K100 M used as the matrix material, calcium hydrogen phosphate as the filler, and 9 mm as the diameter of sustained release tablets. Wet granule compression technique was used to prepare pramipexole hydrochloride sustained release matrix tablets. Conclusion Pramipexole hydrochloride sustained release matrix tablets can release for 24 h, and the in vitro release is close to the Higuchi model with good repeatability.