【摘要】 目的制备复方布洛芬(ibuprofen)和盐酸伪麻黄碱(pseudoephedrine hydrochloride)缓释微丸,建立体外含量测定方法并对体外释药行为进行研究。方法采用流化床技术,以surelease为骨架材料制备布洛芬缓释微丸,以eudragit RS为骨架和包衣材料制备盐酸伪麻黄碱缓释微丸,并运用统计软件SPSS进行处方和工艺的正交设计优化。采用HPLC对缓释微丸进行含量测定和体外释放度测定。结果建立了准确快捷的含量测定方法和释放度测定方法,释放度试验结果表明,在优化的处方和工艺条件下,可获得在12 h内释药符合Higuchi动力学过程的复方缓释微丸。结论制得的复方布洛伪麻缓释微丸具有较为理想的缓释效果,有进一步开发价值。更多还原

【Abstract】 Objective To prepare the compound ibuprofen and pseudoephedrine hydrochloride sustained-release pellets, establish the content assay method and evaluate the in vitro release behavior of sustained-release pellets. Methods surelease and eudragit RS were respectively used to prepare the ibuprofen pellets and the pseudoephedrine hydrochloride pellets by fluidized-bed technology. Statistical soft ware SPSS was employed to deal with the results of orthogonal design for formulation and preparation procedure optimization. HPLC was used to assay the content of ibuprofen and psedoephedrine hydrochloride in the sustained-release pellets and measure the release behavior of the drags from the pellets.Results Developed a new content assay method of ibuprofen and pseudoephedrine hydrochloride, and in vitro drug release of from the sustained pellets. The release profiles of the sustained-release pellets followed the Higuchi model within 12 h. Conclusions The compound-release pellets exhibite ideal sustained-release characteristics.更多还原