Study On Hypoglycemic Granules

Diabetes mellitus(DM)is high blood sugar caused by defective insulin secretion,impaired insulin action,or both.According to DIF data,the number of patients with diabetes is increasing year by year,and DM is also prone to many complications.There are many people who lose their lives due to diabetes and its complications every year in the world,and the cost of treating DM is staggering.Traditional Chinese medicine can have multi-level,multi-step,multi-target synergistic effect,with few adverse reactions,small toxic and side effects,and no dependence.Therefore,it is very necessary and meaningful to develop a traditional Chinese medicine health food to assist in lowering blood sugar.Based on the existing hypoglycemic health foods,Chinese patent medicines and literature research,this topic has developed extracts of Pueraria lobata,Astragalus,and mulberry leaves as the main medicine,mixed with suitable auxiliary materials,and then granulated by wet method.The obtained blood sugar reducing granules and the effective ingredients of the three-flavor traditional Chinese medicine can not only lower blood sugar,but also effectively control the complications caused by diabetes.After clarifying the research content of this subject,first consult the relevant literature,determine the use of water extraction method to extract the three traditional Chinese medicines;then design a single factor experiment.Choose three independent variables(extraction times,material-to-liquid ratio,extraction time);two inspection indicators(dry paste yield,puerarin content),use single factor test to clarify the possible range of extraction process conditions,and then conduct response surface methodology.Experimental design and optimization to obtain the best extraction process: After the three Chinese medicines are mixed in a certain proportion,10 times the amount of water is added,and the extraction is performed twice for 1.5 hours each time.The obtained water decoction is combined and concentrated under reduced pressure.Dried in vacuum to obtain a dry paste of three-flavored traditional Chinese medicine.When optimizing the preparation process,the dry paste is crushed,sieved to obtain the Chinese medicine extract powder,and then the powder is mixed with various diluents in equal amounts,and the appropriate amount of the mixture is placed in a weighing bottle of constant weight,and accurately weighed Determine the total weight of the mixture and the weighing bottle,place it in a drug stabilization instrument(temperature 25°C,relative humidity 75%),accurately weigh it at different times,calculate the moisture absorption rate,and make a moisture absorption curve to screen out suitable The type and amount of excipients for this topic.Since the extracts of traditional Chinese medicine are bitter and astringent,the taste of the granules is improved by adding different proportions of correctives.Volunteers with different tastes will taste the taste and evaluate the taste to determine the amount of correctives.According to the molding rate test,the best adhesive is selected.In the end,the optimal preparation process for this topic was obtained: 29.3g Chinese medicine extract,29.3g dextrin,0.3g sodium cyclamate,0.15 g sodium saccharin.After mixing the dry paste powder of traditional Chinese medicine extract and auxiliary materials,add 3% PVPK30 in 85% ethanol solution,continue to rub and loosen to make soft material,and gently squeeze it in a 14-mesh sieve to obtain wet granules.Dried in an oven at 60℃,and granulated through a 14-mesh sieve to obtain hypoglycemic granules.Establish quality standards for Jiangxue Granules,and conduct routine inspections for Jiangxue Granules in accordance with the pharmacopoeia and national standards,and the results all meet the standards.The thin-layer identification method was used to qualitatively analyze the iconic components(puerarin,verbasil glucoside,and rutin)in the three medicinal materials.The test results showed that all three components were detected;the HPLC method was used to determine puerarin,verbasil glucoside,The content of rutin,and formulate the content standards for three iconic components,namely: puerarin ≥1.42g/100 g,verbascum glucoside ≥27.2mg/100 g,and rutin ≥16.8mg/100 g.The safety and toxicological evaluation of the developed blood sugar granules is carried out to indicate the clinical safety of this product and prove that the product has no toxic effect on the body.Acute oral toxicity test proved that this product is non-toxic;the results of Ames test,mouse bone marrow polychromatic erythrocyte micronucleus test and mouse sperm abnormality test are all negative;rats are fed with food,water and size during 30 feeding period The stools were all normal,the growth and development and general performance were good,no obvious behavior changes and poisoning were observed,and the important indexes of physiological and biochemical functions were normal.The safety evaluation test results show that the blood sugar reducing granules are non-toxic products,meet the health food safety standards,and can be eaten with confidence.Finally,the stability of Jiangxue Granules was tested,including accelerated tests at the end of 0,1,2,3,and 6 and long-term tests at the end of 0,3,6,9 and 12.The results prove that the inspection results are within the range required by the pharmacopoeia,indicating that the product has good stability and will not be affected by external environmental factors.It provides a certain scientific basis for the formulation of future large-scale industrial production,storage,transportation conditions and shelf life.