【摘要】 伏环孢素是一种新型钙调神经磷酸酶抑制剂，已被列入第三批鼓励仿制药品目录。该研究开发了基于大孔树脂的伏环孢素分离和纯化工艺，并优化了大孔树脂种类和纯化工艺参数。优化得到的分离和纯化条件为：采用树脂3号，用50%乙醇溶液配制为0.1 g/mL的伏环孢素样品溶液，设置上样流速为20 mL/h，上样体积为30 mL，洗脱剂为50%～70%乙醇溶液，结晶溶剂则选用体积比为3∶3的丙酮-水混合溶液。结果显示，该工艺高效、稳定、可重复，精制得到的伏环孢素纯度>99.2%，纯化收率60%，为伏环孢素的工业化生产提供了一种可行且高效的纯化策略。更多还原

【Abstract】 Voclosporin is a novel calcineurin inhibitor that has been included in the third batch of the encouraged generic drug list.This study developed a separation and purification process for voclosporin based on macroporous resins,and optimized the type of macroporous resins and purification process parameters.The optimal conditions were as follows:using Resin No.3,preparing voclosporin sample solution(0.1 g/mL) with 50% ethanol aqueous solution,maintaining an sampling flow rate of 20 mL/h,a loading volume of 30 mL,employing 50%-70% ethanol as eluent,and utilizing the acetone-water mixture in a volume ratio of 3∶3 as crystallization solvent.This optimized process consistently yielded voclosporin with purity over 99.2 % and purification recovery of 60 %. These results demonstrated the high efficiency, stability, and reproducibility of the developed method, providing a viable and effective purification strategy for industrial production of voclosporin.更多还原