【摘要】 目的 研究普卢利沙星的多晶型特征，为该药晶型杂质成分的质量控制提供科学依据。方法 制备了普卢利沙星的3种晶型（晶型Ⅰ、晶型Ⅱ和晶型Ⅲ），采用粉末X射线衍射法、红外光谱法、差示扫描量热分析、拉曼光谱法对普卢利沙星3种晶型进行了表征分析，并通过混悬实验探索3种晶型之间的转化规律及稳定性关系。结果 粉末X射线衍射法、红外光谱法、差示扫描量热分析、拉曼光谱法均能有效区分普卢利沙星的3种晶型，晶型间的稳定性关系为晶型Ⅰ>晶型Ⅱ>晶型Ⅲ。结论 本实验建立的分析方法为普卢利沙星晶型控制标准的制定提供依据。更多还原

【Abstract】 Objective To study the polymorphism of prulifloxacin and provide a scientific basis for the quality control of the polymorphic impurities in the drug. Methods Three forms of prulifloxacin(formⅠ, form Ⅱ and form Ⅲ) were prepared. The forms were characterized by using powder X-ray diffraction, infrared spectroscopy, differential scanning calorimetry and Raman spectroscopy, and the stability relationship and crystal transformation rules of the three forms were explored by suspension experiments. Results Powder X-ray diffraction, infrared spectroscopy, thermal analysis and Raman spectroscopy were used to identify the three polymorphs of prulifloxacin effectively. The stability relationship of forms is: form Ⅰ>form Ⅱ>form Ⅲ. Conclusion This study provides references for the formulation of the standard of prulifloxacin.更多还原