Pharmaceutical Study Of Pulian Kangru Perfusion Agent

Objective: To study the preparation of process parameters for the treatment of dairy cows' hidden mastitis,and to study the quality standard,preliminary stability,safety test and clinical trial of the finished product.Methods: Combined with single factor test and orthogonal test,multi-index optimization of the drug taste process parameters;and study of the filling agent molding process.The content of arctiin in Forsythia suspensa and Arctium lappa in Forsythia suspensa was determined by high performance liquid chromatography(HPLC).The content of arctiin in Forsythia suspensa was determined by high performance liquid chromatography(HPLC).And the initial stability of the finished product was investigated by experiments,light acceleration test and heating acceleration experiment.Results: Pulian Kangru perfusion agent preferred preparation process route:Will horseradish,dandelion,violet to the ground,fried king does not stay line,Motherwort,Forsythia,Polygonum cuspidatum,Arctium,honeysuckle,rhubarb,salvia boiling water twice,each time for 1.5 hours,the first time plus 10 times the amount of water,the second plus 8 times the amount of water,boiling water filtration(200 mesh screen),combined filtrate concentrated to contain crude drug 1.5g / ml,to the concentrate Add 5% of the 5% gelatin solution,put 12 h,filter,and add 95% ethanol to 85% alcohol,standing for 24 h,high-speed centrifuge centrifuge,the filtrate and sediment,the filtrate by Pressure recovery of ethanol,concentrated to the non-alcoholic flavor,concentrated solution by adding 1.5% of granular activated carbon,at 60 ? constant temperature oscillation decolorization 120 min,the hot filter,add water to the drug containing 1.5g / ml,with NAOH solution Ph to 6.8 ~ 7.0,0.22?m microporous filter fine filter,aseptic potting,at 115 ? hot sterilization 30 min,leak detection,that was perfusion.Dandelion,honeysuckle,violet,danshen for the test sample in the corresponding position with the control substance was the same color spots;through quantitative analysis,to determine the content of forsythia should not be less than 0.23 mg / ml,arctiin glycosides may not Less than 8.44 mg / ml.12 months stability study of the indicators are in line with the requirements.Conclusion: The preparation process of Pu Liankang infusion preparation is stable.The quality control method is accurate,the stability is good and the safety is effective.It is an effective preparation for the treatment of latent mastitis in dairy cows.