摘要
目的建立维生素D2软胶囊溶出度曲线测定的方法,评价国内维生素D2软胶囊与原研之间的体外溶出行为。方法采用桨法(沉降篮),转速100r/min,以高效液相法测定维生素D2软胶囊在不同溶出介质中的溶出度并绘制溶出曲线。结果在0.5mol/L NaOH-10%曲拉通X-100介质中国产维生素D2软胶囊与原研在90min溶出度均可达到80%以上。结论该方法可用于维生素D2软胶囊的溶出度测定。
Objective To establish a method for the dissolution curve determination of vitamin D2 soft capsules and evaluate the in vitro dissolution behavior between domestic vitamin D2 soft capsules and the original preparation.Methods Using the paddle method with a sinker,the rotate speed was set at 100r/min,and the dissolution curves testing in different media were performed by using HPLC.Results The dissolution of domestic vitamin D2 soft capsules and the original preparation were all above 80%at 90min in 0.5mol/L NaOH-10%triton X-100 medium.Conclusion The method is suitable for the dissolution determination of vitamin D2 soft capsules.
作者
林斌
陈秀明
周璟明
陈有钟
郑孝贤
王海龙
徐兰
方东升
Lin Bin;Chen Xiu-ming;Zhou Jing-ming;Chen You-zhong;Zheng Xiao-xian;Wang Hai-long;Xu Lan;Fang Dong-sheng(Fujian Institute of Microbiology,Fujian Key Laboratory of Screening for Novel Microbial Products,Fuzhou 350007)
出处
《中国抗生素杂志》
CAS
CSCD
2020年第10期1044-1048,共5页
Chinese Journal of Antibiotics
基金
福建省属公益类科研院所基本科研专项(No.2018R1009-13)。
关键词
维生素D2软胶囊
溶出曲线
溶出方法
Vitamin D2 soft capsule
Dissolution curve
Dissolution method
