藤甲酰苷缓释片的处方优化及释药机制研究

目的：制备藤甲酰苷缓释片并探讨其药物释放机理。方法：以羟丙基甲基纤维素（HPMC）为缓释材料、乙基纤维素（EC）为凝胶骨架材料，以及乳糖等为填充剂制备藤甲酰苷缓释片，采用正交设计法进行处方优化。使用DDslover软件拟合释放曲线。结果：采用压片法制得的骨架型藤甲酰苷缓释片具有良好的缓释效果。藤甲酰苷缓释片的体外释药行为符合 Higuchi 模型，是扩散和溶蚀协同作用的结果，其释药过程用 Higuchi 平面扩散模式方程，相关系数 r = 0.9993（1～12小时）。结论：制备出体外释放度符合要求的藤甲酰苷缓释片。

Formulation Optimization and the Release Mechanism of Garcinia Glycosides Sustained-release Tablets

OBJECTIVE To prepare the garcinia glycosides sustained-release tablets and study drug release mechanism in vitro. METHODS Garcinia glycosides sustained-release tablets were prepared using hydroxypropylmethyl cellulose(HPMC) as gel matrix material, ethyl cellulose (EC) as skeleton material, lactose as filler and so on. The formulation was optimized using orthogonal experimental design. DDslover software was used to fitting drug release curve. RESULTS Garcinia glycosides sustained-release tablets had good sustained-release profile. The release behavior of the tablets in vitro followed Higuchi equation. It was the synergies of diffusion and dissolution and the main mechanism of drug release was diffusion for fitting well with Higuchi equation, r=0.999 3(1-12 h). CONCLUSION The garcinia glycosides sustained-release tablets prepared meet the release requirement in vitro.