摘要
目的:应用Box-Behnken效应面法优化替硝唑胃漂浮片处方。方法:采用Box-Behnken设计试验,考察羟丙基甲基纤维素(HPMC)、卡波姆及海藻酸钠三者在处方中的用量对缓释片的漂浮性能和释药性能的影响,通过二项式方程拟合因素与响应值之间的数学关系以优化处方,对体外释药数据进行方程拟合,探讨其释药机制。结果:优化处方为HPMC30%、卡波姆14%、海藻酸钠18%,优化处方的实测值与预测值之间比较接近;药物的释放模型符合Higuchi方程(r=0.9879),释药机制为骨架溶蚀与药物扩散双重作用。结论:通过Box-Behnken效应面法建立的模型可用于替硝唑胃漂浮片处方的优化。
OBJECTIVE： To optimize Tinidazole gastric floating tablet by Box-Behnken response surface methodology. METH- ODS： Box-Behnken response surface methodology was used for the design. The effects of the amount of HPMC, carbopol and sodi- um alginate on floating performance and drug release capacity were investigated, and mathematic relationship of factors and re- sponse value was fitted and established by binomial equation to optimize the formulation. The in vitro drug release data equations were fitted to discuss drug release mechanism of it. RESULTS： Optimized formulation was as follows： HPMC 30%, carbopol 14%, sodium alginate 18%. Bias between the observed and predicted values was little. Drug release model was up to Higuchi equa- tion （r=0.987 9）, drug release mechanism was associated with the effects of bulk erosion and drug diffusion. CONCLUSION： The model developed by Box-Behnken response surface methodology could be used to optimize the formulations of Tinidazole gastric floating tablet.
出处
《中国药房》
CAS
CSCD
2012年第13期1197-1200,共4页
China Pharmacy
关键词
替硝唑胃漂浮片
BOX-BEHNKEN效应面法
处方优化
Tinidazole gastric floating tablet
Box-Behnken response surface methodology
Formulation optimization
