Box-Behnken效应面法优化尼群地平凝胶骨架缓释片处方  

Formulation optimization of nitrendipine gel matrix extended-release tablets by Box-behnken response surface method

作　　者：王露[1] 权利娜[1] 陈珊珊[1] 

机构地区：[1]陕西中医学院药学院陕西秦岭中草药开发应用工程技术中心,陕西咸阳712046

出　　处：《中南药学》2013年第7期513-516,共4页Central South Pharmacy

摘　　要：目的对尼群地平凝胶骨架缓释片的处方进行筛选和研究。方法以凝胶骨架基质HPMC K4M和HPMC100LV的用量为考察因素,药物在1、2、4、6、10h的累积释放度Y1h、Y2h、Y4h、Y6h、Y10h为考察指标,利用2因素3水平中Box-Behnken效应面法优化处方。结果联合使用HPMC K14M及HPMC 100LV作为尼群地平缓释片的基本骨架材料,乳糖作为填充剂,硬脂富马酸钠为润滑剂,85%乙醇溶液适量作为黏合剂制成尼群地平缓释骨架片在各时间点释放度符合标准。结论通过Box-Behnken效应面法优化法建立的模型可以用于尼群地平凝胶骨架缓释片处方的优化,所制得的缓释片释放度符合规定。Objective To optimize the formulation of nitrendipine extended-release tablets.Methods Nitrendipine extended-release tablets were prepared by the mixture of hydroxypropyl methylcellulose（HPMC） K4M and HPMC 100LV as the basic matrix materials.Box-Behnken design-response surface method was applied to optimize the formulation of the nitrendipine extended-release tablets.Results The optimal formulation and technology were as follows： HPMC as the matrix material,lactose as the filler,sodium stearyl fumarate as the lubricant,and 85% ethanol as adhensive material and the accumulative release percentages at 1,2,4,6 and 10 h were consistent with the criterion.Conclusion Box-Behnken design-response surface method is suitable for optimizing the formulation of nitrendipine gel matrix extended-release tablets,complying with requirements of the ChP.

关 键 词：尼群地平 缓释片 羟丙甲纤维素 BOX-BEHNKEN效应面法 

分 类 号：R94[医药卫生—药剂学]