普伐他汀粗品结晶母液回收工艺研究

Study on the recovery process of pravastatin API from mother liquor of crude crystalline

目的建立一种普伐他汀粗品结晶母液中有效成份的回收工艺方法。方法根据普伐他汀的特性,将普伐他汀内酯转为开环的可溶于水的盐,采用大孔离子交换树脂作吸附剂,吸附流速1/50(BV/min),采用80%的乙醇(含2%氢氧化钠)作解吸剂,解吸流速1/100(BV/min)。结果普伐他汀总收率提高了10%以上,产品质量符合标准。结论大孔树脂法在普伐他汀提高收率和降低生产成本上工艺操作可行,值得在工业生产上推广。

Objective To establish a method to extract pravastatin active ingredient from crude crystal liquor. Methods Firstly, pravastatin lactone was transformed into the form of open-loop water-soluble salt. Then pravastatin active ingredient was extrcted through chromatography. Macroporous ion-exchange resin was used as adsorbent. The adsorption flow rate was 1/50 （BV/min）. 80% ethanol （containing 2% sodium hydroxide） were used as desorption agent, desorption flow rate was 1/100 （BV/min）. Results The overall yield ofpravastatin was increased by 10%, and product quality meet the standards. Conclusion This process has the advantages of high yield and low cost, so it is suitable for industrial manufacture.