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[摘要]
目的 对甲泼尼龙的晶型进行分析研究。方法 参考文献方法制备甲泼尼龙的两种晶型(晶型I、II),分别采用粉末X射线衍射分析(PXRD)、差示扫描量热分析(DSC)、红外光谱分析(IR)和热重-差热分析(TG-DTA)等方法对甲泼尼龙晶型样品和微粉化样品进行表征。结果 文献报道的晶型II实为叔丁醇溶剂化物,可通过加热脱溶剂过程得到真正的晶型II,微粉化过程会导致晶型I发生部分转晶。结论 甲泼尼龙存在3种晶型:晶型I、II和叔丁醇溶剂化合物。
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[Abstract]
Objective To investigate the crystal form of methylprednisolone. Methods The two crystal forms (form I and form II) of methylprednisolone were prepared according to the reference method. The polymorphs and micronized methylprednisolone were characterized by powder X ray diffraction (PXRD), differential scanning calorimetry (DSC), infrared spectrometry (IR), and thermogravimetric analysis coupled with differential thermal analysis (TG-DTA). Results The form II said in the reference was tert-butanol solvate indeed which could transfer to the true form II by desolvation. In addition, the micronization could make the structure of form I change. Conclusion The methylprednisolone exsists in three crystal forms which are form I, form II and tert-butanol solvate.
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