摘要
目的:制备盐酸阿夫唑嗪缓释胶囊,观测体外释放度.方法:采用挤出-滚圆法制备载药丸芯,以Eudragit RS 30D作为主要包衣材料,制备盐酸阿夫唑嗪缓释微丸.采用紫外分光光度法建立含量测定方法,通过释放度试验评价缓释效果.结果:所制备的盐酸阿夫唑嗪缓释胶囊1,3,8h时的累积释放率分别为38.4%,70.0%,99.8%,其释药行为符合Higuchi方程(Q=0.3533t1/2+0.052,r=0.9915),缓释效果良好,3批样品与进口缓释片释放曲线基本一致.结论:研制的盐酸阿夫唑嗪缓释胶囊剂处方合理,制备工艺简单可行,释放度与进口缓释片无明显区别.
AIM： To prepare alfuzosin hydrochloride sustainedrelease capsule and to test its release profile in vitro. METHODS ： Extrusion-spheronisation method was introduced to prepare alfuzosin hydrochloride sustained-release pellets and Eudragit RS-30D dispersion was used as sustained-release layer. The content of alfuzosin hydrochloride was determined by UV speetrophotometry and the sustained-release profile of the capsule was evaluated by drug release test. RESULTS： The capsule demonstrated an excellent release profile and its accumulative release percentage was 38.4% ,70.0% and 99.8% at 1,3 and 8 h, respectively. The release of the drugs from pellets was in accordance with Higuchi equation （ Q = 0. 3533t^1/2 ＋ 0. 052, r = 0. 9915 ）. The release curves of three batches of samples were in general accordance with the imported alfuzosin hydroehloride sustained-release tablets. CONCLUSION： The characteristics of drug release from capsules have no difference with that of the imported tablets. The formula of alfuzosin hydroehloride sustained-release capsule is reasonable and its preparation technology is simple and feasible.
出处
《第四军医大学学报》
北大核心
2008年第21期1973-1976,共4页
Journal of the Fourth Military Medical University
关键词
盐酸阿夫唑嗪
缓释胶囊
微丸
释放度
alfuzosin hydrochloride
sustained-release capsules
pellets
drug release
