褪黑素缓释片的研制及释药特性的研究

目的：研制凝胶骨架型褪黑素缓释片，考察其体外释药特性。方法：以羟丙基甲基纤维素(HPMCK4M)为骨架材料，根据设计的体外释药速率，筛选处方。结果：药物释放是骨架溶蚀和药物扩散的综合效应，释药速率不受pH环境的影响，受压片压力的影响，受机械搅动影响较小。结论：本文研制的褪黑素缓释片成型性好，具有工艺重现性，体外释放符合拟定的释药速率。

Development of Melatonin Sustained-Release Tablets and Exploration of Release Character

AIM:Melatonin sustained-release tablets were developed as a gel matrix and evaluated in vitro release characteristics. METHOD:The formulations were screened according to the designed in vitro release rate by the use of HPMC as the gel matrix to modify the release. RESULT:The release was properly characterized by the diffusion mechanism, influenced by the pressure exerted during the tabletting procedure, and slightly affected by the basket rotating speed, without the influences from the pH of the media. CONCLUTION:The selected formulation of melatonin sustained-release tablets could ensure the desired in vitro release rate. In addition, it is proved to have a good manufacturing reproducibility.