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作 者:刘春芳[1] 牟肖男 唐顺之[1] 王国财 李继荣[1] 关伟键 许文东[1] Liu Chunfang;Mu Xiaonan;Tang Shunzhi;Wang Guocai;Li Jirong;Guan Weijian;Xu Wendong(National Engineering Research Center for Modernization of Extraction and Separation Process of TCM/Guangzhou Hanfang Pharmaceutical Co.,Ltd.,Guangzhou 510240,China)
机构地区:[1]中药提取分离过程现代化国家工程研究中心/广州白云山汉方现代药业有限公司
出 处:《广东化工》2020年第1期37-38,32,共3页Guangdong Chemical Industry
基 金:广州市科技计划项目产学研协同创新专题(201802030002);国家重大新药创制(2018ZX09721002-003)
摘 要:目的:研究胆固醇工艺中精制工序前后甾醇类杂质的变化,采用GC-MS方法对甾醇类杂质进行分析鉴定,同时获得符合欧洲药典标准的供注射用胆固醇。结论:从精制前胆固醇粗品中分析出10种甾醇类成分,分别是芥酸酰胺、胆固醇、24-脱氢胆固醇、5α-Cholest-8(14)-en-3-one、3β,4α,5α-4-methyl-8(14)-cholest-en-3-ol、3β-Ergosta-5,24-dien-3-ol、Δ5-菜油甾醇、4β-methyl-Cholesta-8,24-dien-3β-ol、α-环氧胆固醇、γ-谷甾醇。对制备出的胆固醇样品进行检测,产品质量符合欧洲药典要求。Objective: The change of sterol impurities before and after cholesterol refining was studied, and the sterol impurities were analyzed and identified by GC-MS method. Conclusion: Ten sterols were analyzed from cholesterol crude product, and identified as erucamide, cholesterol, 24-dehydrocholesterol, 5α-Cholest-8(14)-en-3-one, 3β, 4α.,5α-4-methyl-8(14)-cholest-en-3-ol, 3β-Ergosta-5,24-dien-3-ol, Δ5-citronol sterol, 4β-methyl-Cholesta-8,24-dien-3β-ol, α-epoxycholesterol, γ-sitosterol. The cholesterol product was tested and the quality of the product met the requirements of the European pharmacopoeia.
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