摘要
Abstract
OBJECTIVE:To prepare Lamotrigine dispersible tablets,and to evaluate the quality of it.METHODS:Lamotrigine dispersible tablets were prepared with wet granulation.The formulation was optimized by orthogonal design using disintegration time as index with the amount of calcium carbonate (A),L-HPC (B),sodium starch glycolate (C) and mass fraction of povidone K30 (D) as factors.The disintegration time of 3 batches of tablets in optimized formulation was investigated,and in vitro dissolution of the tablets within 45 min was determined and compared with that of medicine on the market (Beidelin).The influencing factors (high temperature,high light and high moisture) were investigated as well.RESULTS:A,B and C were 25.75,8.75,3.5 mg,respectively; D was 1.0％.Mean disintegration time of 3 batches of samples were 23.8,22.5,22.2 s.The dissolution of the tablets was over 90％ within 45 min in vitro.The dissolution behavior of the tablets was similar to that of Beidelin (f2＞50).In high temperature test,related substance was increased slightly,but other index were stable 5 d and 10 d later.CONCLUSIONS:The technology is reliable,the tablets were stable.关键词
拉莫三嗪/分散片/正交试验/制备/质量研究Key words
Lamotrigine/ Dispersible tablets/ Orthogonal test/ Preparation/ Quality study分类
医药卫生
