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作 者:申建伟 赵金红 吴晶 柴雨柱 徐丹 SHEN Jian-wei;ZHAO Jin-hong;WU Jing(Nanjing Chia-Tai Tianqing Pharmaceutical Company,Nanjing 210000,China)
出 处:《中国处方药》2022年第3期33-35,共3页Journal of China Prescription Drug
摘 要:目的研究替格瑞洛晶型Ⅱ和晶型Ⅲ之间的热力学稳定性关系。方法制备了替格瑞洛晶型Ⅱ和晶型Ⅲ,并对两种晶型进行了X射线衍射和差示扫描量热表征,同时通过两种晶型的混悬竞争实验进行研究。结果发现单独通过差示扫描量热数据很难对两者的热力学稳定性关系进行判断,需结合实验研究的方法进行确认。结论研究确定了替格瑞洛晶型Ⅱ和晶型Ⅲ之间为热力学互变的关系。为该产品在重结晶过程中制备单一晶型奠定了基础。Objective To study the thermodynamic stability relationship between Ticagrelor Form Ⅱ and Form Ⅲ.Methods Ticagrelor Form Ⅱ and Form Ⅲ were prepared and characterized by X-ray diffraction and differential scanning calorimetry.The two form were also studied by suspension competition test.Results The results show that it is difficult to judge the thermodynamic stability relationship between two forms by calorimetric data alone,so it needs to be confirmed by experimental study.Conclusion The relationship between Ticagrelor Form Ⅱ and Form Ⅲ is determined as enantiotropic relationship.It lays a foundation for the preparation of pure crystal form in the crystallization process.
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