复方硫酸庆大霉素胃内滞留漂浮型缓释片的研究

Studies on Compound Gentamicin Sulfate Floating Tablets

根据流体动力学平衡控释系统（HBS）原理研制了复方硫酸庆大霉素胃内滞留漂浮型缓释片,用正交设计原理进行了处方筛选,并考察了处方及工艺因素对复方硫酸庆大霉素释放度的影响及援释片在胃内的滞留时间。结果表明,优选处方片于释放介质中漂浮达12h,硫酸庆大霉素的释放在0～10h符合一级动力学过程,葡萄糖酸锌的释放在1～sh符合零级动力学过程。同位素γ-闪烁照相技术表明缓释片在胃内的滞留时间长达4～6h,空腹和饱腹时滞留情况基本相似,明显长于普通片1～Zh。

Compound gentamccin sulfate floating tablets were developed based on the hydrodynamically balanced drug delivery system（HBS）, which could prolong the residence time of drug in the stomach and improve the bioavailability.The release in vitro of gentamicin-HBS was determined by rotary basket method（100 r／min, 37±0.5℃, 0.1mol／L HCl）.The release characteristics of gentamicin sulfate showed the first-ordor kinltics, Whill Zinc gluconate showed good zero-order kinetics.The γ-scintiphoto technique was used to examine the gastric residence time of gentamicin-HBS and conventional gentamicin sulfate tablets.It showed that the gastric residence time of all subjects taking gentamicin-HBS under fed and fasted condition were over 4 h,in contrasr with conventional gentamicin tablets of only 1～2 h.