诺氟沙星胃漂浮片处方及体外释放研究

Formula and in Vitro Release Study of Norfloxacin Intra-gastric Floating Sustained Release Tablets

摘要: 目的通过对诺氟沙星胃漂浮片的制备处方研究，考察其漂浮性和体外释放性。方法对处方中辅料的因素水平进行逐一考察，并采用相似因子法比较药物释放曲线的差异。结果HPMC规格对胃漂浮片的释药和持漂时间有明显影响，HPMC K100M用量为120 mg·片-1、碳酸氢钠用量为200 mg·片-1和羧甲基淀粉钠用量为100 mg·片-1时漂浮性能和释放度最佳。结论该处方研制的诺氟沙星胃漂浮片具有良好的漂浮特性和缓释特性。

Abstract: OBJECTIVE Norfloxacin intra-gastric floating sustained-release tablets were formulated and the in vitro release was studied. METHODS The in vitro release was determined and the effects of formulation factors were investigated. The data were analyzed by the statistical method-similar factor method. RESULTS The specification of HPMC affected significantly the sustained-release and continual floating property. The tablets showed a good sustained-release and continual floating property with HPMC K100M 120 mg tablet-1, sodium bicarbonate 200 mg·tablet-1, CMS-Na 100 mg·tablet-1. CONCLUSION The tablets showed a good sustained-release and continual floating property with the formula.