美伐他汀结晶纯化工艺研究  

Study on the Crystallization and Purification Process of Mevastatin

作　　者：吴勇良 王平 WU Yongliang;WANG Ping(Zhejiang Haizheng Pharmaceutical Co.,Ltd.,Taizhou 318000,China;Yaseli(Taizhou)Pharmaceutical Co.,Ltd.,Taizhou 318000,China)

机构地区：[1]浙江海正药业股份有限公司,浙江台州318000 [2]雅塞利(台州)制药有限公司,浙江台州318000

出　　处：《生物化工》2022年第1期138-139,152,共3页Biological Chemical Engineering

摘　　要：目的:分析并总结优化美伐他汀提取工艺。方法:以相同质量美伐他汀粗品为原料,采用丙酮、乙酸乙酯、乙醇和异丙醇4种溶剂结晶。结果:脱水美伐杂质去除效果顺序为乙酸乙酯>丙酮>乙醇>异丙醇;双氢美伐杂质去除效果顺序为异丙醇>乙醇>乙酸乙酯>丙酮;低温浸泡(≤5℃)去除蛋白效果较好。结论:综合考虑应选择异丙醇溶剂作为结晶溶剂;在5℃进行蛋白除杂效果较好,可满足生产和节能需求。Objective:To analyze and summarize the optimized mervastatin extraction process.Methods:the same quality mervastatin crude as raw material,and four kinds of solvents,acetone,ethyl acetate,ethanol and isopropanol,were used for crystallization.Results:The order of dehydration meval impurity removal effect was ethyl acetate>acetone>ethanol>isopropanol;the order of dihydromeval impurity removal effect was isopropanol>ethanol>ethyl acetate>acetone;low temperature soaking(≤5℃)has better protein removal effect.Conclusion:Isopropanol solvent should be selected as the crystallization solvent and the protein removal effect is better at 5℃,which can meet the needs of production and energy saving.

关 键 词：美伐他汀 结晶 溶剂 工艺优化 

分 类 号：R972.6[医药卫生—药品]