摘要
为了解决维格列汀原料药在压片过程中对湿热不稳定的问题,实验采用粉末直压法制备维格列汀片剂。制备的维格列汀片,在外观、有关物质、含量均匀度等方面符合药品进口注册标准。片重差异、脆碎度、水分等方面符合2015版药典标准。与原研制剂相比,四条溶出曲线的相似因子均可达到50以上。自制片放置6个月,在含量、溶出度、有关物质均无明显变化,与原研相当。
Vildagliptin tablets were prepared by direct powders compression in order to solve the problem of vildagliptin API＇s damp heat instability problems during the tablet process.The prepared Vildagliptin tablets reached the drug import registration standards in appearance,related substances,content uniformity,etc,also reached the provisions of the ChP 2015 edition in weight difference,crisp,moisture and other provisions.Compared with the reference preparation,the similar factors of four dissolution curves can reach more than 50.There was no significant change in the content,dissolution and related substances of the self-made tablets for 6 months,almost the same to the reference preparation.
出处
《广州化工》
CAS
2017年第13期74-76,共3页
GuangZhou Chemical Industry
关键词
维格列汀片
粉末直压
溶出曲线
相似因子
稳定性
Vildagliptin tablets
direct powders compression
dissolution curves
similarity factor
stability
