盐酸氨溴索缓释胶囊的研制  

Preparation of Sustained Release Ambroxol Hydrochloride Capsules

作　　者：胡晋红[1] 张立超[1] 李珍[1] 朱全刚[1] 孙华君[1] 

机构地区：[1]第二军医大学长海医院药学部,上海200433

出　　处：《中国医药工业杂志》2001年第11期500-502,517,共4页Chinese Journal of Pharmaceuticals

摘　　要：采用薄膜试验法进行包衣处方优化 ,筛选出适合丙烯酸树脂 (Eudragit) RS10 0包衣的较理想增塑剂邻苯二甲酸二丁酯 ,流化床底喷装置中混悬液法上药制备载药小丸后包衣 ,以 4种不同释药包衣小丸配比 ,制得日服 1次的盐酸氨溴索缓释胶囊。8名健康志愿者单剂量口服自制缓释胶囊与进口同剂型缓释胶囊后 ,体内吸收和峰浓度以及经对数转化均无显著性差异 (P>0 .0 5 ) ,具有生物等效性 ,自制胶囊的相对生物利用度为 (10 8.2 7± 15 .5 7) %,并具有显著的体内外相关性 (P<0 .0 1)。Dibutyl phthalate is a suitable plasticizer to Eudrag it RS100 films by testing mechanical properties of dry and wet polymeric films. Drug-containi ng beads were prepared by drug layering onto nonpareils using the fluid-bed and then coated by the pan coating process. The ambroxol capsules prepared consists of four kinds of pellets with different releasing properties. Pharmacokinetics and relative bioavailability study were carried out in 8 healthy volunteers afte r a single oral dose of the prepared ambroxol capsules and Lanbroxol respectivel y. The relative bioavailability of the prepared sustained release capsule was (108.27± 15.57%).

关 键 词：增塑剂 力学性能 盐酸氨溴索 缓释小丸 生理利用度 体内外相关性 祛痰药 

分 类 号：R974.1[医药卫生—药品] R944.9[医药卫生—药学]