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机构地区:[1]河北科技大学化学与制药工程学院,河北石家庄050018 [2]石家庄市第23中学,河北石家庄050000 [3]河北省药用分子化学重点实验室-省部共建国家重点实验室培育基地,河北石家庄050018
出 处:《河北工业科技》2017年第6期434-439,共6页Hebei Journal of Industrial Science and Technology
基 金:河北省人力资源和社会保障厅择优资助项目(C201400317)
摘 要:为了控制奥贝胆酸药品的质量,从奥贝胆酸原料药中分离并鉴定了3种有关物质:3α-羟基-6-乙基-7-酮-5β-胆烷-24-酸(A),3α,7α-二羟基-6-亚乙基-5β-胆烷-24-酸(B)和3α(3α,7α-二羟基-6α-乙基-5β-胆烷-24-酰基氧基)-7α-羟基-6α-乙基-5β-胆烷-24-酸(C)。分析了这些物质产生的原因并进行了设计合成,其结构经过核磁共振氢谱得以确认。研究表明,3个有关物质与奥贝胆酸粗品中的主要有关物质的相对保留时间完全一致,合成的有关物质与分离得到的有关物质的核磁共振氢谱图相符合,可以判定奥贝胆酸产品中的主要有关物质就是合成得到的有关物质A、有关物质B、有关物质C。解决了有关物质研究所需对照品的问题,提高了原料药的质量,为奥贝胆酸的质量研究和有关物质的控制提供了一定的帮助。In order to control the quality of obeticholic acid,three related substances are separated from the obeticholic acid,as3α-hydroxy-6-ethyl-7-keto-5β-cholene-24-acid(A),3α,7α-dihydroxy-6-ethylidene-5β-cholene-24-acid(B)and 3α(3α,7α-dihydroxy-6α-ethyl-5β-cholyl-24-acyloxy)-7α-hydroxy-6α-ethyl-5β-cholene-24-acid(C).The cause of the substances existence is analyzed and the route for preparing the substances is designed,and the structure of the substances are determined by 1 H NMR.The study shows that the relative retention time of the three related substances is consistent with that of the main related substances in obeticholic acid crude products,and the nuclear magnetic resonance hydrogen spectra of the synthesized related substances is consistent with that of the separated related substances,so it is determined that the main related substances in obeticholic acid products are the related substance A,related substance B and related substance C.The study solves the problem of the reference substances needed for the study of the relative substances,improves the quality of the obeticholic acid,and provides some help for the quality research of obeticholic acid and control of the related substances.
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