盐酸美西律多晶型研究

Study on the polymorphism of mexiletine hydrochloride

目的:研究盐酸美西律的多晶型特征。方法:采用差示扫描量热法、红外光谱分析法和 X-ray 法,对盐酸美西律多晶型进行了初步研究。结果:盐酸美西律原料有多晶型现象,样品经过溶剂处理和热处理后均可获得稳定晶型。结论:获得了盐酸美西律多晶型相关的热力学数据、红外光谱和 X-ray 特征,为盐酸美西律对照品及其原料和制剂的质量标准提供了依据。

Objective：To study the polymorphism of raw material of mexiletine hydrochloride. Methods：By the analysis of differential scanning calorimeter（DSC）, fourier transform infrared spectroscopy（FTIR） and X -ray powder diffraction, the polymorphism of raw material of mexiletine hydrochloride were discussed. Results ： Mexiletine hydrochloride is a polymorphous material;and one single and stable type of crystal can be obtained by means of agent recrystallization or thermal analysis for the polymorphous material. Conclusion：The thermal, IR and X - ray characters of mexiletine hydrochloride obtained results give references for its preparation study, and help to provide the proof for the corresponding criterion of mexiletine hydrochloride.