洛伐他汀原料药的制备工艺及质量研究
World Journal of Integrated Traditional and Western Medicine（2013）
Abstract
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。
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Key words
HPLC,Supercritical CO2 Fluid Extraction,Ultrasonic Washing
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