洛伐他汀原料药的萃取、纯化工艺研究

目的:建立洛伐他汀原料药的萃取、纯化工艺。方法:采用超临界CO2流体萃取,以萃取压力(A)、萃取温度(B)、夹带剂用量(C)、萃取时间(D)为考察因素,洛伐他汀萃取率为评价指标,设计L9(34)正交试验优化萃取工艺;采用超声洗涤法进行纯化,设计单因素试验考察洗涤溶剂、洗涤次数、洗涤剂用量对洛伐他汀纯度的影响,优化纯化工艺并进行验证试验。结果:优化萃取工艺为萃取压力25MPa、萃取温度55℃、夹带剂用量2.0mL·g-1、萃取时间100min;优化纯化工艺为95%乙醇为洗涤溶剂,洗涤4次,每次用量2mL·g-1,所得洛伐他汀纯度>98%。结论:该萃取、纯化工艺稳定、简便、可行。

Study on Isolation and Purification Technology of Lovastatin

OBJECTIVE:To establish the isolation and purification technology of lovastatin.METHODS:Supercritical CO2 fluid extraction was adopted.The extraction technology of lovastatin was optimized by L9(34) orthogonal design with extraction pressure(A),extraction temperature(B),the agent of entrainer(C) and extraction time(D) as factors and with the yield of the lovastatin as index.Ultrasonic elution was used for purification of samples.Single factor test was designed to investigate the effects of solvent,the washing times and amount of washing agent on the purity of lovastatin as factors to optimize the purification technology.Validation test was conducted.RESULTS:The optimum extraction conditions for lovastatin were as follows:the extraction pressure of 25 MPa,extraction temperature at 55 ℃,the agent of entrainer of 2.0 mL·g-1,extracting for 100 min.Purification condition was 95% ethanol as elution solution,washing for 4 times,2 mL·g-1 ethanol for each time.The purity of lovastatin achieved above 98%.CONCLUSION:This technology is stable,convenient and feasible.