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机构地区:[1]溧阳市中医院,溧阳213300
出 处:《中国药科大学学报》2014年第6期684-688,共5页Journal of China Pharmaceutical University
基 金:江苏省中医药管理局科技资助项目(No.LZ 11144)~~
摘 要:考察养肾排毒缓释片的制备工艺,并阐明缓释片中多种活性成分的体外释药规律。采用单因素试验法优选制剂处方与成型工艺参数,优选的制剂处方为:70%中药提取物,25%HPMC,4%乳糖和1%硬脂酸镁,采用湿颗粒压片法。采用体外释放度测定法,以相似因子比较法、释放模型拟合法以及Peppas方程研究肾排毒缓释片中4种代表性成分的释放规律与机制,结果表明养肾排毒缓释片中的丹酚酸B、丹参酮ⅡA、黄芪甲苷和大黄总蒽醌等4种成分的体外释放曲线高度相似。提示优选的制备工艺合理可行,体外释放具有明显的缓释特征和多成分均衡特性。To study the preparation process of the Yangshen-paidu sustained-release tablet, the preparation parameters were investigated by the single factor design method. The formulation was optimized to be 70% of extraction,25% of HPMC,4% of lactose,and 1% of magnesium stearate. The release rate of salvianolic acid B,tanshinone IIA, the total Anthraquinone of Radix et Rhizoma Rhei, Astragaloside A from the sustained-release tablet in vitro were measured according to Chinese Pharmacopeia( CP) 2010 using Dissolution Testing Apparatus 1( basket method). The similarity factor was used to compare cumulative release curves. The cumulative curve of drug release data were fitted to zero order,first-order and Higuchi models to ascertain the kinetic modeling of drug release. The release mechanism was ascertained using Peppas equation. The similarity factors of the cumulative release curve of four ingredients mutually compared were all over 80,indicating that the release of four ingredients was similar. The cumulative release rate of four ingredients all fitted Higuchi models. The value of slopes of Peppas models of four ingredients was all more than 0. 45,indicating that the drug released by concurrent action of diffusion and matrix erode( non-fickian diffusion). This preparation technology of Yangshen-paidu sustainedrelease tablet is rational and practicable.
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