Study On Prearation Technology And Preliminary Pharmacodynamic Of Huaige Jiangtang Orally Disintegrating Tablets

Based on the folkremedy treatment of diabetes,compatibility of Puerariae Lobamle Radixe and Sophorae Flos(the original prescription for the decoction,the main active ingredient of rutin and puerarin),combined with modern pharmaceutical technology in this study.The extract of rutin and puerarin combination is prepared for the hypoglycemic Huaige Jiangtang Orally Disintegrating Tablets,which is used to treat diabetes with rutin and puerarin,established the quality standards and preliminary analysis in the view of pharmacodynamics.The proportion of material and dosage was investigated using the orthogonal experiment method with powder flowability and disintegration time as indexes.The recipe is listed as follows: disintegrating agent(45%,MCC:L-HPC=8:1),filler(42%,lactose:mannitol = 3:2),foamer(2.4%,citric acid:NaHCO3 :citric acid=0.8:1),flavoring agent(0.3%,cyclamate),lubricant(0.3%,magnesium stearate).The produced Huaige Jiangtang Orally Disintegrating Tablets can be disintegrated in 25 s and have good taste.Qualitative identification is taken on rutin and puerarin in Huaige Jiangtang Orally Disintegrating Tablets based on the thin layer chromatogram.The content measurement method for the rutin and puerarin in Huaige Jiangtang Orally Disintegrating Tablets is built based on High performance liquid chromatogram.Methodological study is taken and the recovery rate is 98.70%and 99.13%,meanwhile the RSD is 1.66% and 1.37% respectively,which turns out that this method is exact and reliable.The content for rutin and puerarin in Huaige Jiangtang Orally Disintegrating Tablets should be no less than 30mg/g and 60mg/g respectively.Review on moisture,disintegrating rate,friability,weight variance,microbe tolerance for the tablet is established,whose result indicates that the tablet meets the requirements of The Rules of Preparation of Chinese Pharmacopoeia,2015.At room temperature,we found that the three batches of the samples were in accordance with the provisions in the 6 months in the preliminary study on the stability of Huaige Jiangtang orally disintegrating tablets.Type II diabetic mice were built by continuously injected with low dose(75mg/kg?day)streptozotocin.The treatment effect of the Huaige Jiangtang Orally Disintegrating Tablets is verified taking the content of fasting blood glucose,serum total cholesterol(TC),triglyceride(TG),high density lipoprotein cholesterol(HDL-C),low density lipoprotein cholesterol(LDL-C),malondialdehyde(MDA),protein carbonyl(PCO),nitric oxide(NO),glutathione(GSH),superoxide dismutase(SOD)and catalase(CAT)to explore the mechanism.The result indicates that the produced Huaige Jiangtang Orally Disintegrating Tablets could decrease the model's blood sugar definitely,defend the weight decreasing trend,decrease the content of TC,TG and LDL-C in serum(P<0.05 respectively),activate SOD,CAT and GSH(P<0.05)and decrease the content of MDA,PCO and NO(P<0.05).The Huaige Jiangtang Orally Disintegrating Tablets could affect the glycometabolism and lipid metabolism of diabetic mice and modify oxidative stress,leading to an effective protection to the diabetic mice.The preparation technology of the Huaige Jiangtang Orally Disintegrating Tablets introduced in this thesis is reasonable and feasible.The quality of the product is controllable.The effect for anti diabetes is remarkable.