中国药业2025，Vol.34Issue(21)：51-57,7.DOI:10.3969/j.issn.1006-4931.2025.21.011
右旋丹参素-右旋冰片酯制备过程中引入杂质分析与结构鉴定
Impurities Introduced During the Preparation of Tanshinol(D-Form)-Borneol(D-Form)Ester and Its Structural Identification
摘要
Abstract
Objective To analyze the impurities introduced during the preparation of tanshinol(D-form)-borneol(D-form)ester(DD-DBZ),and to identify their structures.Methods Reverse-phase high-performance liquid chromatography(RP-HPLC)was used to separate DD-DBZ and impurities,and ultraviolet spectroscopy,infrared spectroscopy,HPLC-mass spectrometry,and nuclear magnetic resonance were adopted to identify the structures of the impurities.Results Four impurities were identified,namely acetyl α-hydroxy DD-DBZ(impurity A),salvianic acid ethyl ester(impurity B),salvianolic acid borneol ester(D-form)(impurity C),and salvianolic acid(D-form)-borneol(L-form)(impurity D).Impurity A and impurity B were generated through the ester exchange reaction in the purification process,while impurity C and impurity D were generated during the reaction process.Conclusion It is necessary to strictly control the production process and raw materials in the DD-DBZ production process in order to effectively control the impurity content.关键词
右旋丹参素右旋冰片酯/杂质/反相高效液相色谱法/紫外光谱法/红外光谱法/核磁共振法/结构鉴定Key words
tanshinol(D-form)-borneol(D-form)ester/impurity/RP-HPLC/UV spectroscopy method/infrared spectroscopy method/nuclear magnetic resonance method/structural identification分类
医药卫生引用本文复制引用
夏丽,彭莉蓉,孙颖,贾璞,白亚军,郑晓晖..右旋丹参素-右旋冰片酯制备过程中引入杂质分析与结构鉴定[J].中国药业,2025,34(21):51-57,7.基金项目
国家中医药管理局科技项目[GZY-KJS-2023-035] （）
陕西省创新药物研究中心项目[2022YWZX-01] （）
陕西省中医药管理局秦创原中药创新研发项目[2022-QCYZH-023]. （）
