盐酸安非他酮凝胶骨架缓释片的制备  

Preparation of hydrogel matrix sustained release tablets containing bupropion hydrochloride

作　　者：王震红[1] 潘卫三[1] 杨星钢[1] 孙天慧[1] 

机构地区：[1]沈阳药科大学药学院

出　　处：《中国药剂学杂志（网络版）》2008年第3期77-83,共7页Chinese Journal of Pharmaceutics：Online Edition

摘　　要：目的制备盐酸安非他酮凝胶骨架缓释片,对影响药物释放的处方因素和工艺因素进行考察,为制备盐酸安非他酮缓释片提供一种简便方法。方法以羟丙甲基纤维素(HPMC)为骨架材料,以枸橼酸为致孔剂,通过正交设计确定最优处方;采用粉末直接压片法制备盐酸安非他酮缓释片;用单因素考察及正交实验等方法考察HPMC种类、用量、粒度及制片压力等工艺因素对释药速率的影响。结果成功制备了盐酸安非他酮缓释片剂;选择HPMC-K100M为盐酸安非他酮缓释片的骨架材料;骨架材料HPMC K100M与主药质量比为1:1;HPMC粒径为125μm。结论可应用粉末直接压片法制备盐酸安非他酮缓释片;HPMC种类、用量,致孔剂用量对释药速率有显著影响;其他工艺因素对片剂的释放影响较小。Objective To prepare bupropion hydrochloride sustained-release tablets and investigate the formulation and process factors influencing in vitro drug release characteristics.Methods Orthogonal experiment was carried out to optimize the formulation which contained HPMC as matrix material and citric acid as poreforming agent.The direct compression was applied to prepare the sustained release tablets.The effects of the viscosities, the amounts and the particle size of hydroxypropylmethylcellulose(HPMC) and the preparation technique on the release of bupropion hydrochloride were studied by single factor experiments and orthogonal test.Results The bupropion hydrochloride sustained release tablets was prepared successfully.Selecting HPMC K100M with particle size of 125 μm as matrix material, the rate of HPMC K100M to bupropion hydrochloride was 1:1(mass proportion) .Conclusions The direct compression is used to prepare the sustained release tablets.The viscosity and amounts of HPMC, amount of citric acid have more significant effects on drug release from the tablets comparing with other factors.

关 键 词：药剂学 缓释片 盐酸安非他酮 羟丙基甲基纤维素 

分 类 号：R944[医药卫生—药剂学]