论文部分内容阅读
采用聚乙二醇6000为载体制备伊拉地平固体分散体,考察了固体分散体中药物-载体质量比对药物溶出速度的影响。进一步制备了基于药物-载体比1∶4的固体分散体的亲水凝胶骨架型缓释片。再以自制缓释片与参比制剂(Dyna Circ CR)在0.2%十二烷基二甲基氧化胺溶液中释放曲线的相似因子(f2)为评价指标优化处方。评价了优化缓释片与参比制剂在0.1 mol/L盐酸、p H 4.5和6.8磷酸盐缓冲液、水中释放曲线的相似性,并计算f2值,结果均大于50,说明两种制剂在4种介质中的释放行为相似。并且,3批优化缓释片的体外释放度重现性良好。
The preparation of isradipine solid dispersion with polyethylene glycol 6000 as carrier was used to investigate the effect of drug-carrier mass ratio on drug dissolution rate in solid dispersion. Further, a hydrophilic gel matrix sustained release tablet based on a solid dispersion of drug-carrier ratio 1: 4 was prepared. Then the similarity factor (f2) of the release profile of homemade sustained-release tablets and reference preparation (Dyna Circ CR) in 0.2% dodecyldimethylamine oxide solution was optimized for the evaluation index. The similarity of the release profiles of the optimized and the reference formulations in 0.1 mol / L hydrochloric acid, pH 4.5 and 6.8 phosphate buffer and water was evaluated and the f2 values were calculated and the results were greater than 50, indicating that the two formulations were stable at 4 The release behavior in the media is similar. Moreover, the in vitro release of 3 batches of optimized sustained-release tablets was reproducible.