布洛芬缓释片的制备及工艺研究

实验制备了布洛芬缓释片，并考察了压片力及高分子缓释材料的配比对缓释片体外释药速度的影响．实验结果表明，采用本文处方及工艺方法制备的缓释片对压力敏感，在一定压力范围内释药速度较恒定，可达到缓释效果．处方中乙基纤维素用量不变，调节肠溶型丙烯酸树酯（Ⅱ）与（Ⅲ）的配比可得不同释药速度的缓释片；（Ⅲ）用量增加时，释药速度减慢．缓释片体外释药速度符合一级动力学方程（相关系数r均大于0．98）．采用Higuchi方程对缓释片累积释药曲线拟合，相关系数均大于0．96，证明该工艺制备的布洛芬缓释片为混合型骨架片．

PREPARATION OF SUSTAINED-RELEASE TABLET OF IBUPROFEN AND ITS TECHNOLOGICAL INVESTIGATION

Sustained-release tablet of Ibuprofen was prepared and the effect of upper punch pressure (UPP) and polymer ratio on the sustained release of the drug was examined. It can be seen from the test result that the tablet is sensitive to UPP and hence the effect of extendedrelease of the drug can be obtained over a certain UPP range. When the content of Ethylcellulose is fixed in the tablet formulation,the release rate of Ibuprofen can be changed by adjusting the ratio of Eudragit (Ⅱ) to (Ⅲ). The effect of Eudragit (Ⅲ) on retarding Ibuprofen release is larger than that of Eudragit (Ⅱ). It can be well established that the in vitro drug release rate from sustained-release Ibuprofen tablet conforms to the first kinetic equation (r＞0. 98). Also, the Higuchi equation confirms the in vitro sustained drug release profile fromthe tablet (r＞0. 96). It is shown that the release mechanism of the tablet prepared by thepresent method is a combination of matrix erosion and duct release.