摘要
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.
出处
《中国药房》
CAS
CSCD
2013年第9期835-837,共3页
China Pharmacy
关键词
富马酸喹硫平缓释片
释放曲线
相似因子
篮法
紫外分光光度法
Quetiapine fumarate sustained-release tablets
Release curve
Similarity factor
Basket method
UV spectrophotometry