盐酸倍他司汀缓释骨架片的制备及体外释药特性研究  

Preparation and in vitro Drug Release of Betahistine Dihydrochloride Sustained-release Matrix Tablets

作　　者：李凯[1,2] 陈鹰[1] 柴俊[1,2] 熊运[2] 熊姣[2] 

机构地区：[1]广州军区武汉总医院药剂科,武汉430070 [2]湖北中医药大学药学院

出　　处：《中国药师》2014年第10期1665-1669,共5页China Pharmacist

摘　　要：目的:制备盐酸倍他司汀缓释骨架片。方法:采用亲水性高分子材料HPMC为骨架,制备盐酸倍他司汀缓释片,并用单因素试验考察其释药特征。正交试验优化处方工艺。结果:以60% HPMC K15M为骨架材料,磷酸氢钙为填充剂,用10% PVP的90%乙醇溶液为黏合剂,湿法制粒压片为最佳工艺,片重为500 mg。药物体外释放接近Higuchi模型,能实现药物12 h内缓慢释放。结论:本品制备工艺简便,具有缓解特性。Objective： To prepare betahistine dihydrochloride sustained-release matrix tablets. Methods： The tablets were pre- pared with water soluble HPMC matrix, and the release behaviors were investigated by single factor study. The formula and preparation procedures were optimized by orthogonal design. Results： The optimal technology was as follows： using 60% HPMC K15M as the ma- trix material, calcium hydrogen phosphate as the filler, 10% PVP in 90% alcohol as the bonding agent; wet granulation compression technique was used to prepare the tablets with the tablet weight of 500mg. The in vitro drug release fits a Higuchi equation and the drug can be sustained-released within 12 h. Conclusion： The preparation technology is simple and the tablets have sustainol release behav-

关 键 词：盐酸倍他司汀 缓释骨架片 制备 体外释药 

分 类 号：R944.9[医药卫生—药剂学]