抗癌药Imatinib Mesylate的多晶型结构与稳定性

Study on Polymorphism and Stability of Anticancer Drug Imatinib Mesylate

本文对抗癌药物甲磺酸伊马替尼的多晶型与稳定性进行了分析与研究.通过X射线粉末衍射仪(XRD)测定了伊马替尼的晶型,并测定了在不同湿度下的稳定性,用X射线衍射原位高温附件(in situ high temperature)测定了伊马替尼的热稳定性.结果表明,该批次伊马替尼为α晶型,在从室温至200℃的加热过程中晶体结构稳定,在RH 75%的湿度条件下,结构也比较稳定,但在RH 92.5%的高湿度时,晶体结构逐渐向无定形转化.

This article studies the stability and the crystal structure of an anticancer drug imatinib mesylate. The crystal form of the imatinib mesylate was determined by means of X-ray powder diffraction. The stability under different humidity was determined and the thermostability of imatinib mesylate was analyzed by X-ray diffraction（ XRD） with in situ high temperature accessories. The results showed that the sample is the α crystalline form and its crystal form was stable during the heating process from room temperature to 200℃. The crystal form was stable under low humidity,but unstable under high humidity and finally turned to amorphous.