布洛芬片剂的溶出度研究

Dissolution Test on Ibuprofen Tablets

本文对国内外10个厂家的布洛芬片剂进行了体外溶出度测定。各厂布洛芬片在30分钟的溶出度均大于50%,符合美国药典21版规定。但其体外平均溶解时间(MDT)有明显区别。三种国外布洛芬片的MDT分别为5.9,6.2和14.2。国内除山东某厂布洛芬片的MDT为3.5属最低外,多数比国外产品长。本文并对改善布洛芬片溶出度的方法作了初步探讨。

The dissolution of ten brands Ibuprofen tablets from ten pharmaceutical labo-ratories were de termined. It was shown that the dissolution results of all tabletsmet the standard of USP XXI (30min, >50%), but the MDTs had significant dif-ference. The MDTs of three imported products were 5.9, 6.2, 14.2min respectively.The MDT of a product from shan Dong Province was the lowest. only about 3.5minThe MDTs of most domestic products were higher than those of imported products.The dissolution could be improved by useing excipients such as CMS-Na andL-HPC.