【摘要】 目的探讨不同实验设备对非连续等温热分析(DITA)法测定药物共晶三元相图的适用性,总结DITA法对不同部件的精度、灵敏度、稳定性的要求。方法设计可用于DITA法操作的实验装置,并使用自制DITA装置绘制布洛芬-烟酰胺在40℃下的共晶三元相图。结果与结论自制装置可满足DITA法操作要求。DITA法测定三元相图时存在方法学误差,即实验过程中的搅拌效率变化不可避免,其对温度/温差-时间曲线数据的影响难以消除。DITA法在原理及操作方面仍待进一步改进。更多还原

【Abstract】 Objective To investigate the applicability of different types of experimental equipment for the determination of ternary phase diagram of drug co-crystal by discontinuous isothermal thermal analysis( DITA) method,and to summarize the requirements of DITA method for accuracy,sensitivity and stability of different components. Methods An experimental device for DITA method was designed and the co-crystal ternary phase diagram of ibuprofen-nicotinamide at 40 ℃ was plotted by the self-made device. Results and Conclusion The self-made device can meet the operation requirements of the DITA method. There are methodological errors in the determination of ternary phase diagram by the DITA method,because the change of stirring efficiency in the process of the experiment is inevitable,and its influence on the data of temperature-time curve is difficult to eliminate. It shows that the principle and operation of the DITA method need to be further improved.更多还原