呋塞米多晶型研究

目的：研究呋塞米的多晶型特征。方法：采用X射线粉末衍射法、傅里叶变换红外光谱法、近红外光谱法、拉曼光谱法，对呋塞米多晶型、呋塞米晶型的变化和结晶条件及现有呋塞米固体制剂中存在的药用晶型进行研究；采用便携式薄层色谱-拉曼光谱联用仪对呋塞米多晶型进行快速检测。结果：用不同有机溶剂重结晶制备了呋塞米的3种晶型。X射线粉末衍射法、傅里叶变换红外光谱法、近红外光谱法、拉曼光谱法均能有效鉴别呋塞米的多晶型样品，目前呋塞米片剂的药用晶型为晶型Ⅰ。便携式薄层色谱-拉曼光谱联用仪能快速鉴别呋塞米多晶型，完善了便携式分析终端设备（μTrait）及无线远程网络数据中心的呋塞米晶型拉曼图谱库。结论：本实验为呋塞米晶型标准的制定及优势晶型的选取提供一定的依据。

Objective:To study the polymorphism of furosemide.Methods:By the analysis of X-ray powder diffraction,Fourier transform infrared spectroscopy,near infrared spectroscopy and Raman spectroscopy,the polymorphism of furosemide was discussed;and the modifications of the furosemide crystallization were analyzed;and the effective pharmacological form of the existing furosemide solid preparation was determined.The rapid detection of furosemide polymorphism was carried out by portable thin layer chromatography - Raman spectroscopy.Results:The three polymorphic forms of furosemide were prepared by recrystallization from different organic solvents.X-ray powder diffraction,Fourier transform infrared spectroscopy,near infrared spectroscopy and Raman spectroscopy were used to identify the polymorphic samples of furosemide effectively.The current crystalline form in the furosemide tablet was form Ⅰ.The three polymorphic forms of furosemide can be quickly identified by the portable thin layer chromatography - Raman spectroscopy.The furosemide crystal Raman map library of the portable analysis of terminal equipment(μTrait)and wireless remote network data center was improved.Conclusion:This experiment provides references for the formulation of the standard of furosemide and the selection of dominant crystal.