复方盐酸伪麻黄碱/马来酸溴苯那敏单层渗透泵控释片的制备  

Preparation and optimization of compound pseudoephedrine hydrochloride/brompheniramine maleate monolithic osmotic pump tablets

作　　者：韩晓[1] 王东凯[1] 张晓君[1] 王玉[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）》2010年第4期95-102,共8页Chinese Journal of Pharmaceutics：Online Edition

摘　　要：目的对复方盐酸伪麻黄碱/马来酸溴苯那敏单层渗透泵控释片的处方进行考察。方法采用HPLC法对渗透泵的体外释放度进行测定,采用单因素优化渗透泵的处方。结果优化后处方为:含药层中羟丙基甲基纤维素K15M(hydroxypropyl methyl cellulose,HPMCK15M)150mg、衣膜中含聚乙二醇1500(polyethylene glycol,PEG1500)质量浓度为1.5g·L-1、衣膜增量为7%。本渗透泵片恒速释药,12h累积释药率达85%以上。结论本渗透泵片制备简便,能在12h内良好的控制盐酸伪麻黄碱及马来酸溴苯那敏的零级释放。Objective To optimize the formulation of pseudoephedrine hydrochloride/brompheniramine maleate osmotic pump controlled release tablets.Methods in vitro release of the model drugs was determined by HPLC method, and the optimal formulation was selected by investigating the influence of each single factor.Results The optimal formulation was as follows:hydroxypropyl methyl cellulose (HPMC) K15M 150 mg in the drug containing layer, PEG1500 1.5 g·L-1 in the film coating solution and film weight gain 7%.PPH and BPM were released from the osmotic pump tablets according to zero order kinetics for 12 h, and the accumulative release was 85%.Conclusions The osmotic pump tablets of PPH/BPM were prepared by using a simple method, and PPH/BPM could be released constantly for 12 h.

关 键 词：药剂学 盐酸伪麻黄碱 马来酸溴苯那敏 单层渗透泵 体外释放 

分 类 号：R94[医药卫生—药剂学]