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目的对氟康唑4种晶型的热稳定性进行分析与研究。方法通过X-射线粉末衍射仪(XRD)、差示扫描量热仪(DSC)和热重分析仪(TGA)分析氟康唑4种晶型的热稳定性,并采用X-射线粉末衍射仪及其原位高温附件测定氟康唑的多晶型结构及相转变。结果氟康唑Ⅰ、Ⅱ型结晶具有较好的热稳定性,Ⅲ型结晶在40℃左右晶型开始发生变化,一水合晶在70℃时转化为Ⅱ型结晶。结论氟康唑不同晶型谱学特征显著,根据晶型的热稳定性,可对氟康唑晶型进行质量控制,也为优势晶型的确定提供基础数据。
Objective To analyze and study the thermal stability of four fluconazole formulations. Methods The thermal stability of four fluconazole formulations was analyzed by X-ray powder diffraction (XRD), differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA). The X-ray powder diffraction And its in situ high temperature attachment determination of fluconazole polymorphic structure and phase transition. Results Fluconazole Ⅰ and Ⅱ crystals had good thermal stability. The type Ⅲ crystal began to change at about 40 ℃, and the crystal of the first crystal changed to type Ⅱ crystal at 70 ℃. CONCLUSION Fluconazole has different crystal types with significant spectral characteristics. According to the thermostability of fluconazole, the quality of fluconazole crystal can be controlled, and the basic data can also be provided for the determination of the dominant crystal form.