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目的:研究一种非洋地黄强心苷、非儿茶酚胺类的正性肌力药物米力农(millrinone)的熔点、吸附水、结晶水的含量,确定其结构和晶型变化。方法:用差示扫描量热分析(DSC)和热重分析(TGA)法研究其热变化,利用核磁共振(NMR)实验确定其结构,并结合X-射线衍射实验确定其晶型变化。结果:米力农试样不含结晶水,熔点为314.7℃,试样从201.04℃开始失重,在293.06℃发生微小的晶相转变,从亚稳态晶型转变为稳态晶型;试样发生熔融变化后随即发生完全分解反应,试样最终残留量为23.5%。结论:热分析用于药物晶型研究以及熔点、结晶水含量等的测量具有用量少、快速、灵敏高、检测方便等优点。
OBJECTIVE: To study the melting point, adsorption water and crystallization water content of a positive inotropic drug non-digitalis, non-catecholamines millrinone to determine its structure and crystal type changes. Methods: Differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) were used to investigate the thermal changes. The structure of the samples was confirmed by nuclear magnetic resonance (NMR) and the crystal form was determined by X - ray diffraction. Results: Milrinone sample did not contain water of crystallization and the melting point was 314.7 ℃. The sample started to lose weight from 201.04 ℃, and the microstructure changed from metastable to steady state at 293.06 ℃. Melt changes occur immediately after the complete decomposition reaction, the final sample was 23.5% residual. Conclusion: The thermal analysis is used to study the drug crystal form and to measure the melting point and the crystal water content. It has the advantages of less dosage, quickness, high sensitivity and convenient testing.