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米非司酮中杂质的分离和鉴定
SEPARATION AND IDENTIFICATION OF IMPURITIES IN MIFEPRISTONE
【摘要】 <正> 米非司酮(mifepristone,RU486),是八十年代初法国Roussel-Uclaf公司首次合成的甾体化合物,“七·五”期间我国亦成功地合成了,它具有抗孕激素和抗肾上腺皮质激素的作用,在靶细胞上竞争性地抑制孕激素、黄体期和妊娠期的激素,目前主要作为避孕药物进行研究。 近来报告早孕时如以米非司酮与前列腺素类似物联合使用,可使流产成功率达90%以上,且作用专一、使用方便、副作用小,该药的研制成功是抗生育药物研究领域的显著进展之一。
【Abstract】 In this paper we presented details of metnods for the TLC and HPLC separation ofmifepristone and its impurities. The results showed that Chinese mifepristone contained five impurities.The major one was isolated by sillca gel column chromatography and thin layer chromatography. Onbasis of its UV, IR, EIMS and ~1HNMR spectral analysis and by comparison with reference substance,it was identified as (11β, 17β)-11-[(4-methylamino) phenyl]-17-hydroxy-17-(1-propyny)-estra-4,9-dien-3-one.Meanwhile, TLC analysis indicated that French mifepristone contained the sameimpurity.
- 【文献出处】 药学学报 ,Acta Pharmaceutica Sinica , 编辑部邮箱 ,1992年10期
- 【被引频次】3
- 【下载频次】120