吲哚拉辛HPMC骨架片药物释放因素研究

目的 考察影响吲哚拉辛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吲哚拉辛HPMC骨架片的体外释药的影响。结果 吲哚拉辛HPMC骨架片的体外释药均符合Higuchi方程。HPMC的用量，粒度和制法，片子大小对吲哚拉辛的释放速率随HPMC粒度和片子的减小而减慢。淀粉、PVP、MCC的加入（每片HPMC的含量不变）均加快吲哚拉辛释药速率，且加入量不同，其释药速率问具有显著性差异。随着EC加入量的增加（≥40mg。片^-1）．吲哚拉辛释放速率显著加快。结论 HPMC用量和粒度、制备方法、片子大小及其它辅料为影响吲哚拉辛骨架片释放速率主要因素。

The Factors Influencing Indolacin Release From Hydroxypropyl Methylcellulose Matrix Tablet

OBJECTIVE To study the factors influencing indoladn release rate from hydroxypropyl methylcellulose(HPMC)hydrophylic matrix tablets.METHODS The HPMC matrix tablet was compressed by wet and direct method with indolacin 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 indolacin release rate was decreased with decreasing the particle size of HPMC and the tablet size.Hydrophilic additives of starch,PVP,MCC could accelerate the indolacin release from the tablets and the changes of their amount in this test range significantly affected the drug release.The indolacin release rate increased sharply when EC content was 40mg per tablet.CONCLUSION The amount,and particle size of HPMC,preparation method,tablet size as well as the additives significantly influenced indolacin release from HPMC matrix tablet.