摘要
目的:制备硝苯地平胃漂浮型延迟缓释微丸并考察其体外漂浮行为。方法:挤出滚圆法制备漂浮型空白丸芯,空白丸芯上药法制备载药丸芯,分别以Surelease(水分散体和Eudragit L30D-55为包衣材料,进行流化床包衣。采用正交试验设计对处方进行优化。结果:模拟人体胃肠道条件下溶出,自制漂浮型微丸在人工胃液中6 h累计释放小于10%,换人工肠液后12 h释放完全,体外漂浮10 h以上。结论:自制微丸达到了漂浮和延迟缓释的效果。
Objective： To prepare nifedipine （NF） intragastric floating delayed-onset sustained-release pellets and study their floating behavior in vitro. Methods： The intra-gastric floating blank-pellets were prepared by extrusion-spheronization. Nifedipine pellets were prepared and then subsequently coated with Surelease aqueous dispersion and Eudragit L30D-55 in a fluidized bed coating system. Results： During the in vitro release studies, the pellets released less than 10% in simulated gastric fluid for 6 h, then released all their drug contents in another 12 h in simulated intestinal fluid. The prepared pellets remained floating over 10 h in vitro. Conclusion： NF pellets exhibited excellent release profiles in vitro and can float well in simulated gastric fluid.
出处
《药学与临床研究》
2009年第4期279-282,共4页
Pharmaceutical and Clinical Research
关键词
硝苯地平
挤出滚圆法
胃漂浮
延迟缓释
Nifedipine
Extrusion-spheronization
Intragastric floating
Delayed-onset sustained -release
