盐酸氯米帕明缓释片的制备及其体外释放度考察

目的:制备盐酸氯米帕明缓释片并考察其体外释放度。方法:以辅料羟丙基甲基纤维素(HPMC)、乳糖、可压性淀粉在处方中的含量为因素,体外释放度为指标,用正交试验优化处方并制备制剂,同时考察其体外释放度。结果:筛选最优处方为HPMC45mg、乳糖35mg、可压性淀粉40mg。所制制剂可持续24h释药,释药行为符合零级释放模型。结论:所制缓释片的处方合理,具有良好的缓释效果。

Preparation and Release Rate in Vitro of Clomipramine Hydrochloride Sustained - release Tablets

OBJECTIVE： To prepare clomipramine hydrochloride sustained release tablet and study its in vitro release rate. METHODS： Orthogonal experiment was carried out to optimize the formulation and the preparation was prepared taking by the formula dosage of HPMC, lactose and amylum pregelatinisatum as factors and the in vitro release rate as index. The in vitro drug release rate was investigated as well. RESULTS： The optimal formulation was as follows： HPMC 45 mg, lactose 35 mg, and amylum pregelatinisatum 40 mg. The preparation prepared in the optimal formulation had a sustained release of 24 h and the release behavior of the tablets followed the zero order equation. CONCLUSION： The formula of the sustained release tablets is reasonable and which had satisfactory sustained release efficacy.