论文部分内容阅读
采用挤出-滚圆法制备吗替麦考酚酯微丸,以单因素试验优化了挤出-滚圆工艺参数及黏合剂、崩解剂和微晶纤维素用量等处方因素。所得优化工艺为:吗替麦考酚酯75%,微晶纤维素15%,崩解剂羧甲淀粉钠10%,并以含1.5%羧甲纤维素钠的25%乙醇为黏合剂,挤出和滚圆速度为928 r/min,滚圆5 min。制品表面光滑,坚硬,圆整度良好,能用于后续的流化床包衣,并且在含0.5%十二烷基磺酸钠的p H 6.8磷酸钠缓冲液中2 h累积释放率达80%以上。
The extrusion-spheronization method was used to prepare mycophenolate mofetil. One-factor experiments were used to optimize the extrusion-spheronization parameters and prescription factors such as binders, disintegrants and microcrystalline cellulose content. The optimized process is as follows: mycophenolate mofetil 75%, microcrystalline cellulose 15%, disintegrating agent sodium carboxymethyl starch 10%, and with 1.5% sodium carboxymethyl cellulose 25% ethanol as a binder, squeeze Out and roll speed of 928 r / min, round 5 min. The product surface is smooth, hard, good roundness and can be used in subsequent fluidized bed coatings and has a cumulative release rate of 2 h in p H 6.8 sodium phosphate buffer containing 0.5% sodium dodecyl sulfate up to 80% %the above.