伏格列波糖片处方工艺研究

Study on formulation of voglibose tablets

目的设计并制备出溶出与原研一致且符合产业化生产的伏格列波糖片。方法进行原辅料相容性实验筛选辅料,并通过筛选考察不同处方工艺对产品成型性、外观、溶出影响,确定最佳处方工艺,成品与市售原研制剂伏格列波糖片在4种溶出介质中进行累积-溶出曲线对比研究。结果开发出最优处方,产品与原研伏格列波糖片在4种溶出介质中溶出曲线相似,产品质量与原研产品一致。结论该处方设计合理、制备工艺可靠,具有实际应用可行性。

Objective Voglibose tablets which met the industrial production criterion are designed and manufactured.Methods The compatibility of raw materials was first screened,then different prescription technologies were also investigated their effect on product shape,appearance and dissolution so as to confirm the best one. The cumulative dissolution curves of screened product were compared with that of originator product in four kinds of dissolutionmedium. Results The four different dissolution curve of screened product and originator product were similar,as well as the quality. Conclusion The prescription design is reasonable and the preparation process is reliable with practical application feasibility.