布洛芬HPMC骨架片药物释放因素研究

The Factors Influencing Ibuprofen Release from Hydroxypropyl Methyl Cellulose Matrix Tablet

目的 考察影响布洛芬亲水性骨架片体外释药的各种因素。 方法 以羟丙基甲基纤维素 (HPMC)为骨架材料 ,用湿法制粒和粉末直接压片法制备缓释骨架片 ,并考察 HPMC用量 ,粒度 ,制备方法 ,片子大小及其它辅料对布洛芬 HPMC骨架片的体外释药的影响。 结果 布洛芬HPMC骨架片的体外释药均符合 Higuchi方程。HPMC的用量 ,粒度和制法 ,片子大小对布洛芬的释放速率均有显著性影响。湿法制片的释药速率比干法慢。布洛芬的释药速率随 HPMC粒度的减小和片子的增大而减慢。淀粉 ,PVP、MCC、EC的加入 (每片 HPMC的含量不变 )均减慢布洛芬释药速率。 结论 HPMC用量、粒度、制备方法。

OBJECTIVE To study the factors influencing ibuprofen release rate from hydroxypropyl methylcellulose(HPMC)hydrophylic matrix tablets.METHODS The HPMC matrix tablet was compressed by wet and direct method with ibuprofen as a model drug.The effects of the amount,particle size of HPMC,preparation method,tablet size and additives on the drug release from the matrix tablets were observed.RESULTS To all cases,the plot of drug released against time produced a straight line,which represented a favorable compliance with Higuchi equation.The drug release from the tablet prepared by dry method was faster than that by wet method.The ibuprofen release rate was decreased with decreasing the particle size of HPMC and the tablet size.Hydrophilic additives of starch,PVP,MCC could slow the ibuprofen release from the tablets and the changes of their amount in this test range significantly affected the drug release.The ibuprofen release rate increased sharply when EC content was 40 mg pertablet.CONCLUSION The amount,and particle size of HPMC,preparation method,tablet size as well as the additives significantly influenced ibuprofen release from HPMCmatrix tablet.