复方缬沙坦双层片的处方筛选及优化  

Formulation screening and optimization of compound valsartan double-layer tablets

作　　者：张志东[1] 林少珠[1] 金伟军[1] 卓羽波[1] 

机构地区：[1]暨南大学附属第一医院,广东广州510630

出　　处：《中国医院药学杂志》2012年第10期779-782,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:优选由硝苯地平缓释层与缬沙坦速释层组成的双层片处方。方法:先制备硝苯地平固体分散体,以丙烯酸树脂Eudragit NE30D为缓释骨架材料,采用正交试验设计优选处方;然后以缬沙坦在30 min的释放度为评价指标优化速释层的处方。结果:硝苯地平缓释层的最佳处方为Eudragit NE30D(以聚合物干重计)3.0%,乳糖为40%,磷酸氢钙为35%;缬沙坦速释层的最佳处方为乳糖18%、微晶纤维素40%、羧甲基淀粉钠6%、十二烷基硫酸钠10%。结论:正交试验优化的双层片处方良好,达到了设计要求。OBJECTIVE To optimize the formulation of the double-layer tablets of valsartan rapid-release layer and nifedipine sustained-release layer. METHODS The solid dispersion of nifedipine was prepared firstly, based on acrylic resin Eudragit NE 30D as a sustained release matrix material, the formulation was optimized through orthogonal experimental design; the formulation of rapid-release layer was optimized with the index of release in 30 min of valsartan. RESULTS The optimized formulation of nifedipine sustained-release layer was as follows： Eudragit NE30D （The dry weight of polymer）, lactose and calcium hydrogen phosphate were 3. 0% ,40% and 35% respectively. The optimized formulation of valsartan rapid-release layer was as follows： lactose, microcrystalline cellulose, sodium carboxymethyl starch and sodium dodecyl sulfate were 18%, 40%, 6% and 10% respectively. CONCLUSION The formulation of the optimized double-layer tablet is satisfactory and up to the standard of the design.

关 键 词：硝苯地平 缬沙坦 双层片 正交设计 

分 类 号：R944[医药卫生—药剂学]