洛伐他汀原料药的制备工艺及质量研究  

Preparation and Quality Study of Lovastatin Bulk Drug

作　　者：王一婕[1] 徐捷 周慧[3] 曾品涛 

机构地区：[1]山西中医学院,山西太原030024 [2]山西省中西医结合医院,山西太原030001 [3]山西医科大学,山西太原030001 [4]宜宾市南溪区科技局,四川宜宾644100

出　　处：《世界中西医结合杂志》2013年第5期461-463,共3页World Journal of Integrated Traditional and Western Medicine

摘　　要：目的研究洛伐他汀原料药的制备工艺及质量控制方法。方法采用超临界CO2流体萃取,95%乙醇超声洗涤进行分离纯化,HPLC进行含量测定。结果超临界CO2萃取洛伐他汀的萃取率达97.17%,超声洗涤后洛伐他汀的纯度达98%以上。HPLC检测洛伐他汀的检测限为0.248～1.24μg(r=0.999 7);平均回收率为98.32%,RSD=1.98%。结论该制备工艺稳定、可行,检测方法准确、可靠,可用于洛伐他汀的质量控制。Objective To study the preparation and quality control method of lovastatin bulk drug. Methods The supercritical CO2 fluid extraction was adopted. 95% ethanol ultrasonic washing was used for separation and purification. HPLC was applied for the content determination. Results With the supercritical CO2 fluid extraction,the extraction rate of lovastatin was 97.17%. The purification of lovastatin with ultrasonic washing was up to over 98%. The detection limit of HPLC was 0. 248 - 1.24 μg（r = 0. 999 7 ） , the average recovery was 98.32% and RSD = 1.98%. Conclusion This preparation is stable and feasible. The detection method is accurate and reliable and can be used for the quality control of lovastatin.

关 键 词：超临界CO2流体 超声洗涤 HPLC 

分 类 号：R927[医药卫生—药学]