| Dispersible tablets is a notale new preparation which developed in recent years.It is easy to prepare and easy for the patients to take,and it can decrease the side effects and increase the bioavailability of the drugs. Total flavonoids is Euphorbiae humifusae's chief active ingredient.It has effects:antioxygen,antibiosis, stopping bleeding and so on.Total flavonoids has the nature:poor dissolvability,poor dissolution and low biological availability.So the Euphorbiae humifusae dispersible tablets was developed and it can accelerate the rate of absorption and improve biological availability.The determination method of the active component was established.Spectrophotometric method was established to determine the content of total flavonoids and HPLC method to determine the content of quercetin.Solution stability,instrument precision,reproducibility,recovery rate of total flavonoids were investigated.The result was that these methods have high sensitivity and reproducibility.So these can used to determine the content of total flavonoids and quercetin.The extraction technology contained water extraction, alcohol extraction and super sound extraction methods.According to the calculation results of the mon-factor and orthogonal design,the best extracting condition was:75%ethanol,ratio of ethanol to materials was 15, extract 2 times and 2 hour of each times.Tn the course of purified technology:the best resin was picked out from 8 types of macroporous resins and 1 type polyamide which were tested by stational absorbtion and disorbtion experiment as index.XAD-1 and XAD-8 macroporous resins were picked out.Isothermal adsorption and adsorption dynamics experiments were applied to test these two resins.In the last,XAD-8 was picked out to test further.On the basis of uni-factor test,the best purified project was obtained:XAD-8 macroporous resin,the color saturation was 1.49mg/ml,the application of sample of speed was 2BV/h,pH5.7,60%alcohol to elute,the speed of elution was 3BV/h.25%total flavonoids can be obtained.In the course of preliminary screening preparation,uni-factor was applied to pick out the best adjuvants from these adjuvants,such as disintegrating agent:L-HPC,PVPP,super CMS-Na,CMS-Na;bulking agent:brittle micas,galactosylglucose,MCC;swelling adjuvant:amylum pregelatinisatum,hydroxypropyl cellulose by the index being disaggregation velocity.Orthogonal experiment was applied to determine the amount of these adjuvants.The best recipe was:44%Euphorbiae humifusae powdered extract,28%Mcc, 12.8%HPC,5%L-HPC,10%PVPP,1%magnesium stearate.The best precipitated artwork was:wet granulating and tabletting,grain passing 20 screen mesh,pressure controling in 4～6Kg,disintegrant applied endo-addition method.Lamellar appreciation method was established to detect the content of quercetin, HPLC method to determine the amout of quercetin in Euphorbiae humifusae dispersible tablets.The quality control was safety and feasible.The dissolution time of the dispersible tablets was determined.As a result,it can dissolve 90%in 9 minutes and performed better dissolution than common tablets.In the last,the stability of Euphorbiae humifusae dispersible tablets was determined.The result was that Euphorbiae humifusae dispersible tablets should protect from light and keep in desiccated place. |
