富马酸喹硫平缓释片在不同释放介质中的体外释放研究

Drug Release of Quetiapine Fumarate Sustained-release Tablets in Different Release Mediums in vitro

目的:考察自制富马酸喹硫平缓释片的体外释放情况及其释放机制。方法:以国外上市制剂为参比,采用篮法进行2种制剂分别在3种释放介质(水、0.1mol/L盐酸溶液、pH6.8磷酸盐缓冲液)中体外释放行为的相似性比较;采用紫外分光光度法测定释放度,以相似因子(f2)进行相似度评价;并对自制制剂进行释放行为模型的拟合。结果:在3种释放介质中,2种制剂比较,f2值均大于50;自制制剂在水和pH6.8磷酸盐缓冲液中体外释放拟合模型更接近Higuchi方程和Peppas方程,在0.1mol/L盐酸溶液中更接近一级方程和Peppas方程。结论:自制制剂与参比制剂在不同释放介质中的体外释放行为一致,释放机制以扩散为主。

OBJECTIVE：To investigate release behavior of Quetiapine fumarate sustained-release tablets in vitro and its mechanism.METHODS：Taking foreign preparations in the market as control,the similarity of release behavior of 2 preparations in 3 medium（water,0.1 mol/L hydrochloric acid,pH 6.8 phosphate buffer solution）were analyzed with basket method.The release rates of them were determined by UV spectrophotometry,and similarity factor f 2 was used to evaluate the similarity of release curves.Release behavior model was fitted for self-made preparation.RESULTS：In 3 kinds of mediums,similarity factor f 2 of 2 preparations was more than 50;in vitro drug release of self-made preparation was consistent with Higuchi equation and Peppas equation in water and pH 6.8 phosphate buffer,and more consistent with first-order equation and Peppas equation in 0.1 mol/L hydrochloric acid.CONCLUSIONS：The release behavior of self-made preparation and reference preparation are similar in different release mediums,and the release mechanism is mainly diffusion mode.