| Objective:Study on the Preparation and the Quality Standards of Compound Gouteng Tablets,thus provide experience basis of preparation technology and quality control for prostatitis.Methods:prescription analysis and retrieval line screening to determine the extraction process routes,by using single factor test and orthogonal test,the extraction technology was optimized with the extracting ratio and the content of rhynchophylline,ferulic acid and ruscogenin as index;through comparing experiment the process of purification and concentration drying was made with the content of rhynchophylline,ferulic acid as index;the combination of granulation process and compression parameters gifted Compound Gouteng Tablets best molding process conditions;done by TLC Identification;using High Performance Liquid Chromatography(HPLC)determination,and methods of inspection.Results:Water extraction.The optimum conditions:0.5hours soaking water,extrating two times,and the water was six times the medicine,four times,the extraction time of 2.0 hours,1.5 hours.0.5 hours soaking ethanol,extracting two times,and the ethanol was six times the medicine,four times,the extraction time of 2.0 hours,1.5 hours.Mention condensed water from liquid to a relative density of 1.25,alcohol precipitation,filtration,and filter liquor drying at 70.Process condition:drug powders:dextrin=5.3:4.7,ethanol solution+3%PVP for wetting agent.There was no negative interference with TLC of Uncaria,Radix ophiopogonis,Ligusticum wallichii.The determination method of rhynchophylline was feasible and repeatabe.Conclusion:The preparation technology is viable,and the quality standards are reliable.It can be used for industrial production. |