| The number of people with diabetes worldwide will reach 330 million by 2025,and90%-95% are non-insulin-dependent diabetes.A large number of hypoglycemic drugs are in clinical use,but with high side effects,inconvenient use and unstable efficacy,no effective therapeutic drug has been found yet.In this paper,we developed a health food with auxiliary hypoglycemic function by combining Amaranthus,bitter melon,Astragalus and Atractylodes and adding chromium pyridinecarboxylate,and studied the preparation process,quality standard and auxiliary hypoglycemic function.The details are as follows.1、Prescription screeningWith the purpose of screening the best formula to assist in lowering blood glucose,this study was analyzed and researched based on the research of the group in the past years and discussions with the group members.The results showed that amaranth is a "medicinal food source" health food raw material,lowering blood sugar,anti-inflammatory and thirst,bitter melon clearing fire,brightening eyes and benefiting qi,according to the principle of Chinese medicine,astragalus with atractylodes,which has a significant effect on diabetic nephropathy,and chromium picolinate enhances insulin activity and improves human glucose metabolism.Therefore,the formula was finally determined to be composed of Astragalus membranaceus,bitter melon,Astragalus membranaceus,Atractylodes macrocephala and chromium pyridinecarboxylate.2.Formulation process studyThe best extraction process was selected by response surface test,and the best extraction process was determined as follows: ultrasonic power 200 W,liquid to material ratio 22:1(m L/g),extraction temperature 65℃,extraction time 2h.3 times of extraction,filtration to remove the filter residue,filtrate with equal amount of 95% ethanol,alcohol precipitation overnight,precipitation dried to obtain Amaranthus crude polysaccharide.According to the Chinese Pharmacopoeia and GB16740 National Standard for Food Safety-Health Food,the selection and dosage of excipients for the tablets were studied based on the evaluation indexes of particle fluidity,tablet appearance,fragility,disintegration time,hardness and so on.The best preparation process was screened as follows: 25.1% of the main ingredients composed of crude polysaccharide of Amaranthus,bitter melon,astragalus and atractylodes,0.1% of chromium pyridinecarboxylate,35% of disintegrant,38.8% of filler and 1%of lubricant.Wet granulation with 10% polyvinylpyrrolidone PVP alcohol solution,dried at 55℃,whole granule,passed 14 mesh sieve,added 0.3% magnesium stearate,and pressed into tablets,that is,the Portulaca oleracea compound hypoglycemic tablets.3.Quality standard studyWith reference to GB 16740 and the relevant requirements in Chinese Pharmacopoeia 2020 edition,the appearance,physicochemical index,microbial limit,weight difference and disintegration time limit of this product were studied;the crude polysaccharide content of this product was determined by spectrophotometric method,and the content of chromium pyridinecarboxylate in this product was determined by high performance liquid chromatography,and the methodological investigation was conducted respectively.Based on the above studies,the quality standards of Portulaca oleracea compound hypoglycemic tablets were formulated.4、Functional study of auxiliary hypoglycemiaAccording to the "Evaluation Method of Adjuvant Hypoglycemic Function" of No.107 of State Food and Drug Administration,the functional evaluation of Portulaca oleracea compound hypoglycemic tablets was conducted.Fasting blood glucose index: After giving the test samples,the fasting blood glucose value of each dose group was lower than that of the control group in the hyperglycemic model mice,but the difference was not significant(P>0.05),and the decrease rate of blood glucose in each dose group was higher,and the difference was significant(P<0.05)in the high dose group.Glucose tolerance index: before the administration of glucose,the blood glucose values at 0 hours were lower in each dose group than in the model control group,and compared with the control group,but none of the differences were significant(P>0.05).After glucose was given to each group,the blood glucose values at 0.5 and 2 hours and the area under the blood glucose curve of each dose group were lower than those of the control group,and compared with the control group,among which the blood glucose values at 2 hours of the high dose group,the difference was significant(P<0.05).The experimental results showed that the fasting blood glucose index and glucose tolerance of the hyperglycemic model animals were positive,and there was no effect on the fasting blood glucose of normal mice,so it can be judged that "Portulaca oleracea compound hypoglycemic tablets" has the function of auxiliary hypoglycemia. |
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