摘要
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.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2008年第9期1503-1505,共3页
Chinese Journal of Pharmaceutical Analysis