本试验使用混合溶剂对罗米地辛进行结晶,分别对罗米地辛添加量、结晶温度及混合溶剂比例进行优化。结果显示,低温环境对罗米地辛纯度影响较大,建议温度控制在25℃。使用丙酮与甲醇作为罗米地辛结晶的混合溶剂,能够有效提升罗米地辛纯度,由结晶前的96.5%提高至98.81%,罗米地辛的收率为83.07%;而使用乙醇与甲醇作为混合溶剂,在保证罗米地辛HPLC纯度的同时能有效提升收率至86.59%。所制备的罗米地辛为L晶型,罗米地辛晶核在乙醇与甲醇混合溶剂中形成速度较快,并且晶体颗粒较大。本研究为罗米地辛的动态结晶控制提供一个优化方向;首次对罗米地辛结晶前后杂质进行分析,观察到结晶后杂质Rl、R2、R3含量显著降低;首次对混合溶剂在罗米地辛结晶过程中的工艺参数进行研究与优化,使用乙醇与甲醇进行结晶,可大幅提高罗米地辛收率。同时,本研究所提供的罗米地辛结晶工艺不需要任何专业仪器设备即可实现。 In this experiment, the mixed solvent was used for the crystallization of romidepsin. The amount of romidepsin, the crystallization temperature and the proportion of the mixed solvent were optimized. The results show that the low temperature environment of greater impact on the purity of romidepsin, the proposed temperature control at 25 ℃. Using acetone and methanol as the mixed solvent of romidepsin crystals, the purity of romidepsin can be effectively increased from 96.5% before crystallization to 98.81%, and the yield of romidepsin is 83.07%; while ethanol and methanol As a mixed solvent, while maintaining the HPLC purity of romidepsin can effectively improve the yield to 86.59%. The prepared romidepsin is in the L crystal form, and the nucleus of the romidecid is formed faster in the mixed solvent of ethanol and methanol, and the crystal grains are larger. This study provides an optimization direction for the dynamic crystallization control of romidepsin. The impurities before and after the crystallization of romidepsin are analyzed for the first time, and the content of impurities Rl, R2 and R3 after crystallization is significantly reduced. For the first time, Xin crystallization process parameters in the process of research and optimization, the use of ethanol and methanol for crystallization, can significantly increase the yield of romidepsin. At the same time, the romidepsin crystallization process provided by this research does not need any professional equipment to achieve.