论文部分内容阅读
目的建立抗抑郁药A613晶型的定量测定方法,并考察其原料药晶型稳定性。方法采用差示扫描量热法,氮气气氛下,升温速率20℃·min-1,升温范围:40～120℃,参比物:铝坩埚,对抗抑郁药A613的不同晶型进行定量测定。结果测得熔点温度、熔化焓等热力学参数,样品用量在0.1～4.0 mg范围内质量与熔化焓呈线性,线性方程为Y=-108.870 0X-4.275 8,r=0.999 6。结论所建立的方法可为生产工艺研究和判断产品质量提供快速、有效的测试方法。
Objective To establish a method for the quantitative determination of anti-depressant A613 and investigate the stability of its crystalline form. Methods Differential scanning calorimetry (DSC) was used to determine the different crystalline forms of antidepressant A613 in a nitrogen atmosphere with a heating rate of 20 ℃ · min-1, temperature range of 40 ~ 120 ℃ and aluminum crucible. Results The thermodynamic parameters such as melting temperature and enthalpy of fusion were obtained. The mass and enthalpy of fusion were linear in the range of 0.1-4.0 mg. The linear equation was Y = -108.870 0X-4.275 8, r = 0.999 6. Conclusion The established method provides a fast and effective test method for researching and judging product quality in production process.