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发明公开
CN108069925A 沃替西汀氢溴酸盐无水晶型I及其制备方法和应用 无效 - 驳回

沃替西汀氢溴酸盐无水晶型I及其制备方法和应用
摘要：
本发明提供一种沃替西汀氢溴酸盐无水晶型I及其制备方法和应用。所述沃替西汀氢溴酸盐无水晶型I的X-射线粉末衍射图谱以衍射角2θ±0.20°表示，具有处于3.76°、5.98°、11.96°、12.92°、18.37°、18.68°、24.62°的特征峰，TGA分析显示其结构中不含溶剂，DSC分析显示其在127.27℃处有一小的相变吸热峰，在227.41℃处有一大的相变吸热峰，熔点(峰顶值)为约233.73℃，分解温度为约260℃。本发明还提供包含所述沃替西汀氢溴酸盐无水晶型I的药物组合物，以及所述沃替西汀氢溴酸盐无水晶型I和包含所述沃替西汀氢溴酸盐无水晶型I的药物组合物在制备治疗严重抑郁症药物中的应用。
摘要（英）：

The invention provides a vortioxetine hydrobromide anhydrous crystal form I as well as a preparation method and application thereof. The vortioxetine hydrobromide anhydrous crystal form I has an X-raypowder diffraction pattern represented by a diffraction angle of 2theta plus or minus 0.20 degrees, having characteristic peaks at angles of 3.76 degrees, 5.98 degrees, 11.96 degrees, 12.92 degrees,18.37 degrees, 18.68 degrees, and 24.62 degrees. The TGA analysis (Thermogravimetric analysis) shows that no solvent is included in the structure, and the DSC (Dynamic Stability Control) analysis shows that a small phase transition endothermic peak is positioned at a temperature of 127.27 DEG C, a large phase transition endothermic peak is positioned at a temperature of 227.41 DEG C, the melting point (peak value) is about 233.73 DEG C and a decomposition temperature is about 260 DEG C. The invention also provides a pharmaceutical composition comprising the vortioxetine hydrobromide anhydrouscrystal form I, and the vortioxetine hydrobromide anhydrous crystal form I and the application of the pharmaceutical composition comprising the vortioxetine hydrobromide anhydrous crystal I in the preparation of a medicine for treating severe depression.

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