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目的:观察黄体酮药物的热特性,并测定其纯度。方法:利用差示扫描量热法(DSC)和导数热重法(DTG)测定黄体酮的熔点、纯度及挥发性物质,在氮气氛下升温速率分别为1.5,10,20℃·min~(-1)。结果:用差示扫描量热法,升温速率为1.5℃·min~(-1),测定黄体酮的熔点为130℃,在程序控温下对其吸热峰进行分析,其纯度为99.8%,与高效液相色谱测定的结果(99.9%)一致。用导数热重法可准确测定其挥发性物质包括水分在内的变化,以及推测其降解历程。结论:该分析法简便、快捷,可测定黄体酮的晶型、水分及纯度,并为研究降解机理及开发新剂型提供参考。
Objective: To observe the thermal characteristics of progesterone drugs and determine its purity. Methods: The melting point, purity and volatile substances of progesterone were determined by differential scanning calorimetry (DSC) and differential thermal gravimetric method (DTG). The heating rates were 1.5, 10, 20 ℃ · min ~ (-1) -1). Results: The temperature rise rate was 1.5 ℃ · min ~ (-1), the melting point of progesterone was 130 ℃, and the endothermic peak was analyzed under programmed temperature. The purity was 99.8% , Consistent with the results of HPLC (99.9%). Derivative thermogravimetric method can accurately measure the change of its volatile matter, including moisture, and speculate its degradation process. Conclusion: This method is simple and rapid, and can determine the crystal form, water content and purity of progesterone, and provide a reference for studying the mechanism of degradation and developing new dosage forms.