Preparation And Evaluation Of Dange Dispersible Tablet

Objective: To research and develop a new solid quick effectivity preparation of acompound traditional Chinese medicine, Dange dispersible tablet, whichcan be used to treatstroke and stroke sequelae caused by blood stasis congestion.Methods: Establishing theextracting and refining processes and parameters of active parts of five drugs in Dangedispersible tablet through literature research and orthogonal design method; Usingorthogonaltest,we optimized the Supercritical CO2extraction process of the DalbergiaOdorifera and the clathration process of volatile oil; Using ultrafine grinding technology tosmashthe Hirudo; Conducted a study on the forming process of Dange dispersible tablet;Establishing the determination of content method of TanshinoneⅡA；Puerarin,which canbe usedfor content of Dange dispersible tablet;To determine the dissolution of Dangedispersible tablet forvalidation the quanlity of this preparation; Investigating thepreliminary stability of the preparation and carried out the preliminary study of the acutetoxicity test and main pharmacodynamics. Result: The extraction and refining process：Using8times the volume of70%ethanol refluxing extraction for2times, each time2hours；Using beta cyclodextrin to include the volatile oil （oil: cyclodextrins: water=1:4:2times the volume of water, grinding1hours）；Using ultrafine grinding technology tosmash the Hirudo for twenty minutes; Formulation: Adding28%of the disintegratingagent(PVPP: L-HPC=3:1)to the alcohol extract powder, volatile oil inclusion compoundand leech ultrafine powder, mixed evenly, with50%ethanol as wetting agent,granulation,drying in50℃,adding2%silica gel and0.2%aspartame, uniform mixing,squashing; Methodical study showed: the Ident ification method for thin layerchromatograph and the determination of content method actue and credible can control thequanlity; The dissolution showed the qanlity of the Dange dispersible tablet is good; Thestudies of the pharmacodynamics indicated that it can obviously lower blood viscosity and improve cerebral cirulation Conclusion: Dange dispersible tablet is a new drugwithsteadily practical preparing, and its quality is stable and controllable, which can be used totreat stroke and stroke sequelae caused by blood stasis congestion.