| ObjectiveMany people's life and health were threatened by Diabetes seriously,so researching and developing high quality auxiliary hypoglycemic health foods has vital significance to improve patients' quality of life.Under the guidance of TCM theory,the features of traditional Chinese medicine which are used to treat diabetes in ancient and modern times,and the formulation characteristics of modern auxiliary hypoglycemic health foods were sorted out and analyzed in this study.Combined the main pathological characteristics of type 2 diabetes patients which are Yin scorching,Gas Yin deficiency,blood stasis with the modern Chinese medicine pharmacology study,Radix astragali,radix puerariae,rehmannia,rhubarb,etc were selected from the raw materials which the national ministry of health released can be used in health food,to form a formula which has the efficacy of clearing heat purging fire,yang Qi and Yin,promoting blood circulation to remove blood stasis.And research the preparation process and quality standards to provide research foundation for a new type auxiliary hypoglycemic health food.Methods1.Through the ancient books of traditional Chinese medicine and modern literatures,the characteristics and treatment principle of traditional Chinese medicine of diabetes in ancient and modern times were analyzed.Using the network database to statistical analysis the features of Chinese patent drug and health food.Combined statistical analysis results with the raw material released from the state ministry of health of the items which can be used in health food formula,Select the dosage form and name it.2.Using single factor experiment method,to compare the transfer rate of puerarin in Radix Puerariae with alcohol extraction technology and water extraction technology.3.The orthogonal test was employed with the index of the content of puerarin,total anthraquinones,calycosin-7-O-?-D-glucoside,total polysaccharide and the rate of extraction,optimizing the extraction process of Sanhuangtaoge capsule by multi-index comprehensive evaluation method.4.Using single factor experiment method,with the index of the content of puerarin,total anthraquinones,calycosin-7-O-?-D-glucoside to select the best concentrate process and dry process.5.In the study of granulating conditions,the bulk density,angle of repose of the granular and critical relative humidity were investigated.6.Quality standard was studied for the preparation,using thin layer chromatography(TLC)for preparation of radix et rhizoma rhei,radix puerariae and peach kernel for qualitative identification,using high performance liquid chromatography(HPLC)of puerarin,calycosin separately glycosides and rhubarb five kinds of free anthraquinone content determination.7.High performance liquid chromatography(HPLC)was adopted to construct feature picture of Sanhuangtaoge capsuleResults1.Through system literature research,summed up the ancient and modern traditional Chinese medicine doctor dialectical treatment of common methods for collateral for oneself clear heat purging fire,Yin,and modern physicians in Yin heat at the same time,pay more attention to treatment of replenishing qi and promoting blood circulation to remove blood stasis.(1)That ancient physicians commonly used drugs are ophiopogon root,radix trichosanthis,ginseng,rhizoma coptidis,poria cocos,rehmannia root,rhizoma anemarrhenae,radix astragali,radix puerariae,rehmannia glutinosa,fructus schisandrae,etc.,that modern physicians commonly used drugs are astragalus membranaceus,yam,rehmannia root,salvia miltiorrhiza and radix puerariae,rhizoma coptidis,radix scrophulariae,fructus lycii,rhizoma anemarrhenae,radix glycyrrhizae,atractylodes,radix paeoniae alba,radix trichosanthis,poria cocos,etc.(2)Sold more than 40 hypoglycemic Chinese patent drug formulations,the use frequency in the top ten Chinese medicine are radix astragali,radix trichosanthis,radix rehmanniae,radix ophiopogonis,yam,fructus schisandrae,radix puerariae,rhizoma anemarrhenae,ginseng,medlar(3)Commercially available fall blood sugar health food's formula contains varieties of formula of traditional Chinese medicine(84.36%),the top 11 of which in turn are astragalus,mulberry leaf,puerariae,yam,wolfberry,ginseng,American ginseng,polygonatum,ginkgo biloba,ophiopogon root,radix rehmanniae.Released by the combination of the above statistical analysis,from the ministry of health can be used in health food raw materials,radix astragali,radix puerariae,peach seed,rhubarb,etc a few taste traditional Chinese medicine(TCM),form a kind of has clear heat purging fire,qi Yin,promoting blood circulation to remove blood stasis formula,made into capsule,named three yellow peach ge capsule.2.With 70%ethanol and water as solvent,reflux extraction of radix puerariae,extracting 3 times,the first 2.0 h,the second and third time 1.0 h,puerarin metastasis rate were 87.04%and 71.62%respectively.Alcohol has a better effect than water,but considering the effective formula of other drugs fall blood sugar composition mainly polysaccharides and saponins,easily dissolved in hot water,and better is extracted by water,and water extraction of the puerarin consociation sibeline transfer rate can achieve above 70%,so using water extraction,cost savings,more conducive to industrial mass production.3.By orthogonal test method on the water extraction process optimization,to determine the optimal extraction process is six times the amount of water,heating reflux extracting 3 times,1.0 h each time,the process is simple and reasonable,stable and feasible.4.Using single factor experiment method to determine the best enrichment process to extract by 70 ? stress concentration to the concentration of 1.351.38 thick paste;The best drying technology for the thick paste after 75 ?dry paste made from vacuum drying.5.Granulating conditions,in order to prevent damp agglomerate particles,liquidity is poor,to join the right amount of medicine in the dry extract powder,dextrin,adopting the wet legal system grain.Determination of Angle of repose is 32.75,which indicates that particle mobility is good.Determination of bulk density of 0.70 g·mL-1,determine the powder particles with 0 capsule shell fills,adjust the weight as 0.5 g per grain,determination of the critical relative humidity of 57.0%.6.Set up the quality standard of Sanhuangtoage capsule,using thin layer chromatography(TLC)to identify radix et rhizoma rhei,radix pueraria.e and peach kernel,the picture is clear,and the negative control without interference;Puerarin,calycosin separately the five kinds of the content of free anthraquinone glycosides and rheum determination method by HPLC method,is simple,accurate and reliable with good reproducibility,which can be used as a quality control method of Sanhuangtaoge capsule.7.By high performance liquid chromatography(HPLC),three groups of Sanhuangtaoge capsules' feature picture was set up,with total 20 common peaks,determine seven components as gallic acid,puerarin,calycosin-7-O-?-D-glucoside,aloe-emodin,rhein,emodin,chrysophanol respectively.ConclusionThe results show that the formulation of Sanhuangtaoge capsule is scientific and reasonable,and it makes up the lack of auxiliary hypoglycemic health food.The preparation process is simple and feasible,the quality of the product is stable,controllable,which meets the requirements of the modern health food of traditional Chinese medicine.The results of the study can provide effective experimental basis for clinical research and and provides an experimental basis for effective production. |
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