不同晶型那格列奈的稳定性研究

Study on Stability of Nateglinide Polymorphism

对那格列奈的不同晶型特别是对新发现的S晶型的稳定性进行了测定和研究 ,并将其与专利报道的H晶型进行对比 .用X射线多晶粉末衍射法对S晶型的稳定性试验 ,包括在不同温度下的热处理以及在光照、高湿度、机械球磨后的晶态变化进行了测定和研究 .结果发现S晶型那格列奈热稳定性最好 ,在室温到 170℃的温度区间能保持原有的晶型不变 ,H晶型可稳定到 138℃ ,而B晶型最差 ,其晶型随着温度的变化而变化 .像H晶型一样 ,S晶型也具有良好的耐光照性。

A study has been made on the stability of three forms of nateglinide treated in different conditions, such as temperature, humidity, irradiation and so on. Analysis of the crystal structure was performed by X-ray powder diffraction. Their particle shapes were observed in scan electron microscope. The results show that the stability of S-form of nateglinide is the best among the three forms.