The Study On Quality Control And Stability Of The Extract Of Fanbaicao And Its Preparation

Potentilla discolor Bunge,recored first in the "Herbal for Relief of Famines",was the whole plant with roots of Potentilla discolor Bunge form Potentilla of Rosaceae.Potentilla discolor Bunge has the effect heat-clearing,detoxifying,cooling blood and bleeding.The main chemical ingredients terpenoids,steroids,flavonoids and polyphenols,etc.Recent studies have reported that it has a hypoglycemic effect.And the study of preliminary course showed that the Potentilla flavonoids has significant hypoglycemic effects.Therefore,on the basis of the previous result,study on extraction,purification and preparation process of total flavonoids from Potentilla.In the guidance of "Chinese Pharmacopoeia" and national relevant technical regulations on quality control of drugs,a systemic study on quality standard and stability of Potentilla extracts and its preparation was conducted,the quality standard(draft)of Potentilla extracts and its preparation was established.1 Study on extraction,purification and preparation process of total flavonoids from PotentillaThis study used the ethyl alcohol reflux extraction total flavonoids of Potentilla.Based on single factor experiment,we used response surface methodology to optimize the process of extraction total flavonoids from Potentilla.The conclusion are:ethanol concentration is 70%,liquid material proportion is 8:1,extracting time is 2h,extracting order is 2Through study on extraction,macroporous resin purification,alcohol extracting-water precipitating,flocculating setting,water extracting-alcohol precipitation and acid-alkaline precipatation process for purification of total flavonoids from Potentilla,we choosed acid-alkaline precipatation process for purification of total flavonoids from Potentilla,this process is simple,apply.By comparing absorption rate and angle of rest for different auxiliary material and excipients and total flavonoids,we selected aerosil as the auxiliary materials preparation Potentilla flavonoids capsule.2 The study on quality standard and stability of Potentilla flavonoids extractIn this part of the thesis,the quality standard of Potentilla flavonoids extract was investigated according to the China Pharmacopoeia of 2015 and relevant technical regulations on quality control of drugs.The items of soulubility,identification,moisture,a rsenic salt et al.By uv spectrophotometry,we used rutin as the reference subatance to determine the assay of Potentilla flavonoids extract.By HPLC method,we used rutin quercetin and kaempferol as the reference subatance to determine the assay of three representative flavonoid.According to the experimental results,the quality standards of Potentilla flavonoids extract has been drafted.In addition,the stability of Potentilla flavonoids extract was investigated according to the guiding principles of drug stability test.Impact factors test,accelerated test and long-term test were carried out respectively.The results show that all indicators come up to the standards in the study period.3 The study on quality standard and stability of Potentilla capsulesAccording to the China Pharmacopoeia of 2015 edition,the study of the Potentilla flavonoids capsules quality standard contains:appearances,dissolutionand,weight differences et al.The test results all met the requirements.Besides,the study on identification and assay was conducted.According to the experimental results,the quality standards of Potentilla capsules has been drafted first.In addition,the stability of Potentilla capsules was investigated according to the guiding principles of drug stability test.Impact factors test,accelerated test and long-term test were carried out respectively.After the accelerated test at 25℃,humidity of 90%,a slight agglomeration occurred,the content of three three representative flavonoid dissolutionand were below about 4%.After the long-term test at 25℃,humidity of 60%±5%,there is no change in sanple characteristics,and the content of three three representative flavonoid were not below the limits.According to the current situation,Potentilla capsules can be stored under this condition.