Preparation Process of Xuangui Zhitong Dispersible Tablets / 中国药房

ABSTRACT

OBJECTIVE:To prepare Xuangui zhitong dispersible tablets and optimize its formulation technology. METHODS:Using disintegration time as index,single factor test was conducted for filler,disintegrating agent,the types and amount of adhe-sives and compression pressure. The amount of mixed disintegrating agent,avicel and gum arabic were optimized by orthogonal test. The tablet quality by optimized formulation was detected,and disintegration time,the content and dissolution rate of tetrahy-dropalmatine were determined;the similarity of in vitro dissolution rate of dispersible tablets and dropping pills were evaluated by similarity factor test. RESULTS:The optimized formulation was composed of 25% MCC as fillers,9% PVPP and 9% L-HPC as mixed disintegrants,85% ethanol solution as adhesives,micro-silica gel 2%,compression pressure of 3.0 kg/cm2. The average dis-integration time was 1.22 min,and the content of tetrahydropalmatine was 1.097 mg/g. The accumulative dissolution rate was more than 80% at 10 min and more than 90% at 15 min. The similarity factor f2 of dissolution curve was 62,using dropping pills as ref-erence preparation. CONCLUSIONS:Xuangui zhitong dispersible tablet had a rapid disintegration and the behavior of dissolution is similar to Xuangui zhitong dropping pills.