吗替麦考酚酯胶囊的制备工艺研究  

Preparation Technique of Mycophenolate Mofetil Capsules

作　　者：李坚 葛楠 罗兴洪[2] LI Jian;GE Nan;LUO Xing-hong(Hainan Simcere Pharmaceutical Co.,Ltd.;Jiangsu Simcere Pharmaceutical Co.,Ltd.State Key Laboratory for Translational Medicine and Innovative Drug)

机构地区：[1]海南先声药业有限公司 [2]江苏先声药业有限公司,转化医学与创新药物国家重点实验室

出　　处：《中国食品药品监管》2023年第1期74-81,共8页China Food & Drug Administration Magazine

摘　　要：目的:探讨吗替麦考酚酯胶囊的制备工艺。方法:吗替麦考酚酯由瑞士罗氏(Roche)公司开发,商品名为骁悉(CellCept)。选用原研胶囊剂作为参比制剂,经文献调研,获得与参比制剂溶出相似的处方,成功开发出与参比制剂质量一致的仿制药。结果:自制吗替麦考酚酯胶囊溶出曲线与参比制剂相似,有关物质在制剂加速试验过程中稳定可控,且制备方法工艺简单,流化床干燥所得颗粒粒度均匀、流动性好。结论:自制吗替麦考酚酯胶囊与参比制剂质量一致。Objective:The purpose of this article is to investigate the preparation of Mycophenolate Mofetil capsules.Methods:After literature investigation and reverse engineering research of CellCept,reference listed drug from Roche,a similar prescription was obtained for dissolution of the reference preparation,and the generic drug with the same quality as the reference preparation was successfully developed.Results:The dissolution of self-made mycophenolate mofetil capsules is consistent with that of reference preparation,the related substances are stable and controllable in the preparation process of preparation acceleration,and the preparation method provided is simple.The size of particle obtained by fluidized bed drying is uniform and the fluidity is good.Conclusion:The quality of self-made Mycophenolate Mofetil capsules was consistent with that of reference preparation.

关 键 词：吗替麦考酚酯 工艺研究 溶出度 稳定性 

分 类 号：R979.5[医药卫生—药品]