克拉霉素缓释胶囊的制备与体外释放度研究

目的:制备克拉霉素缓释胶囊,考察不同包衣增质量对其体外释放特性的影响。方法:采用流化床包衣工艺,以3%羟丙基甲基纤维素为黏合剂,乙基纤维素水分散体(Surelease?)为缓释包衣材料,制备克拉霉素缓释胶囊。采用高效液相色谱法测定不同包衣增质量胶囊的体外释放度,并与进口缓释片的释放度进行比较。结果:成功制备克拉霉素缓释胶囊,包衣增质量为5%、8%、11%的自制缓释胶囊与进口缓释片比较,体外释放曲线相似因子f2分别为40.3、66.8、53.3。结论:该制剂制备工艺可行,包衣增质量为8%的克拉霉素缓释胶囊体外释放与进口缓释片基本一致。

Preparation and Release Rate in vitro of Clarithromycin Sustained-release Capsules

OBJECTIVE： To prepare Clarithromycin sustained-release capsules, and to investigate the effects of different coating weight gain on release behavior in vitro. METHODS： Clarithromycin sustained-release capsules were developed by fluid bed coating technique by using 3 % HPMC as adhesive and ethyl cellulose dispersion as sustained-release coating material. HPLC method was used to determine the release rate in vitro of the capsules with different coating weight gain, which was compared with the release rate of imported sustained-release tablets. RESULTS： The Clarithromycin sustained-release capsules were prepared successfully. The similarity factor fi between dissolution curves in vitro of self-made sustained-release capsules with coating weight of 5 %, 8% and 11% and imported sustained-release tablet were 40.3, 66.8 and 53.3, respectively. CONCLUSIONS： The preparation procedure for the capsules is feasible, and Clarithromycin sustained-release capsules with coating weight gain of 8 % have similar sustained-release property to imported sustained-release tablet.