呋喃妥因多晶现象的探索

目的：对呋喃妥因的晶型进行初步研究。方法：采用红外光谱法（IR法）、X线粉末衍射法（XRPD法）、扫描电镜法（SEM法）对呋喃妥因USP对照品、ChP对照品及国内原料的晶型进行初步研究。结果：IR法测定对照品及原料药未见明显差异，XRPD法测定原料药为2种晶型的混晶，SEM法测定ChP对照品及原料为2种晶型的混晶。结论：呋喃妥因存在多晶现象，且USP对照品同ChP对照品的晶型不一致。

Objective: To preliminarily study on the crystal form of nitrofurantoin.Methods: The crystal forms of nitrofurantoin samples from ChP reference substance,USP reference substance and domestic raw material were studied by infrared spectroscopy(IR),X-ray powder diffraction(XRPD) and scanning electron microscope(SEM),respectively.Results: There was no significant difference in the content of the reference substance and the drug substance by IR.The 2 mixed crystals in raw material samples were identified by XRPD.The 2 mixed crystals in samples of ChP reference substance and raw material were identified by SEM.Conclusion: There is polycrystalline phenomenon in nitrofurantoin,and the crystal form of the USP reference substance is not consistent with that of ChP reference substance.

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