不同药典指导原则下X射线衍射法检测结果对药物晶型判定的影响

发布时间：2018-05-31 12:20

本文选题：X射线衍射法 + 晶型　；参考：《中国药学杂志》2017年05期

【摘要】：目的考察X射线衍射法(PXRD)检测不同粒度药用晶体时的衍射峰峰强度、峰个数及其强弱顺序变化,评价在不同药典指导原则下该检测结果对药物晶型判定的影响。方法以无机和有机药用晶体作为研究对象,筛分或研磨获得同一晶型的不同粒径样品用以PXRD检测,对比不同样品的衍射峰数量、峰强、峰位置以及峰强弱顺序的变化情况。结果由于晶粒在检测时的择优取向,同一晶型的不同粒径的样品在PXRD检测中会表现为PXRD衍射谱图中衍射峰数量、衍射峰相对强度以及衍射峰强弱顺序的变化。结论同一检测结果,根据2015年版《中国药典》和美国等国家药典的相关指导原则来鉴别晶型,会得出不同的结论。现将其提出讨论,以期进一步完善晶型鉴定的标准,提高晶型鉴定的水平,从而进一步确保晶型鉴定方法的准确性,为建立专业的晶型鉴定方法提供参考意见和依据。
[Abstract]:Objective to investigate the changes of peak intensity, number of peaks and their order of intensity in the detection of pharmaceutical crystals with different particle sizes by X-ray diffraction (PXRD), and to evaluate the effect of the results on the determination of drug crystal type under the guidance of different pharmacopoeia. Methods Inorganic and organic medicinal crystals were used to screen or grind the samples of the same crystal form for PXRD detection. The number of diffraction peaks, peak strength, peak position and order of peak intensity of different samples were compared. Results because of the preferred orientation of the grain, the sample with different particle size of the same crystal type will show the change of the number of diffraction peaks, the relative intensity of diffraction peak and the order of diffraction peak intensity in PXRD diffraction pattern in PXRD detection. Conclusion according to the relevant guidelines of Chinese Pharmacopoeia and American Pharmacopoeia, different conclusions can be drawn. It is discussed in this paper in order to further improve the standard of crystal type identification and improve the level of crystal type identification, so as to further ensure the accuracy of crystal type identification method, and provide reference and basis for the establishment of professional crystal type identification method.
【作者单位】：杭州领业医药科技有限公司;浙江省药品化妆品审评中心;
【分类号】：R927

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