盐酸多巴酚丁胺合成工艺优化及杂质控制研究  

Study on Optimization of Synthesis Process and Impurity Control of Dobutamine Hydrochloride Drug Substance

作　　者：王飞龙 刘存领 王玲玉 沈红宾 赵海桥 Wang Feilong;Liu Cunling;Wang Lingyu;Shen Hongbin;Zhao Haiqiao(Shandong Fangming Pharmaceutical Group Co.,Ltd.,Heze 274500,China;Heze Institute of Food and Drug Inspection and Testing,Heze 274500,China)

机构地区：[1]山东方明药业集团股份有限公司,山东菏泽274500 [2]菏泽市食品药品检验检测研究院,山东菏泽274500

出　　处：《山东化工》2023年第9期27-29,共3页Shandong Chemical Industry

摘　　要：以3,4-二甲氧基苯乙胺和4-(4-甲氧苯基)-2-丁酮为起始物料合成盐酸多巴酚丁胺,经过缩合、还原、脱甲基和盐酸置换及精制过程,同时,对缩合反应催化剂种类和反应溶剂种类,氢溴酸与中间体1配比,盐酸置换的反应温度及精制溶剂的筛选,得到了本次研究的工艺,本研究工艺反应条件温和,收率相对较高,未知杂质可以有效地控制在≤0.05%。Dobutamine hydrochloride was synthesized with 3,4-dimethoxyphenylethylamine and 4-(4-methoxyphenyl)-2-butanone as starting materials.The process of this study was obtained through condensation,reduction,demethylation,hydrochloric acid replacement and refining.At the same time,the type of condensation reaction catalyst and reaction solvent,the ratio of hydrobromic acid to intermediate 1,the reaction temperature of hydrochloric acid replacement and the screening of refining solvent.The process of this study has mild reaction conditions.The yield is relatively high,and the unknown impurities can be effectively controlled at≤0.05%.

关 键 词：盐酸多巴酚丁胺 合成工艺 杂质控制 

分 类 号：TQ463[化学工程—制药化工]