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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。
Objective: To establish the extraction and purification of lovastatin drug substance. Methods: Using supercritical CO2 fluid extraction, taking extraction pressure (A), extraction temperature (B), entrainer dosage (C), extraction time (D) as the investigation factors and lovastatin extraction rate as the evaluation index, 34) orthogonal test optimization of the extraction process; ultrasonic cleaning method was used to purify the design single-factor test to investigate the influence of washing solvent, washing times, detergent dosage on lovastatin purity, purification process optimization and validation test. Results: The optimal extraction conditions were as follows: extraction pressure 25MPa, extraction temperature 55 ℃, entrainer 2.0mL · g-1, extraction time 100min; optimized purification process as 95% ethanol as washing solvent, washing 4 times, each dosage 2mL · g -1, the resulting lovastatin purity> 98%. Conclusion: The extraction and purification process is stable, simple and feasible.