磷酸西格列汀片处方工艺研究

Study on formulation process of Sitagliptin Phosphate Tablets

目的筛选磷酸西格列汀片的最佳处方工艺。方法设计不同处方工艺,通过检测溶出曲线及粉体学数据,确定最佳处方工艺。结果自制片的4个处方中,粉体学数据及压片流畅性均较好,其中湿法制粒工艺两个处方溶出比参比制剂慢,粉末直压工艺中当交联羧甲基纤维素钠为16 mg时溶出曲线与参比制剂拟合较好。结论通过对磷酸西格列汀片的处方工艺研究,最终确定了磷酸西格列汀片的工艺和崩解剂用量。

Objective To screen the best prescription process of Sitagliptin Phosphate Tablets.Methods Designingdifferent prescription processes to determine the best prescription process by detecting dissolution profiles and powder data.Results In the four prescriptions of the self-made tablets,the powder data and the fluency of the tablets were all good.Among them,the two prescriptions in the wet granulation process elute slower than the reference preparations,and the cross-linked carboxymethyl cellulose in the powder direct compression process.The dissolution curve was better with the referenceformulation when the sodium sodium was 16 mg.Conclusion Through the study on the formulation process of SitagliptinPhosphate Tablets,the process and disintegrant dosage of Sitagliptin Phosphate Tablets were finally determined.