| The effective component compatibility of Chinese herbal is a new form of modern Chinese medicine research.Following the theory and principles of traditional Chinese medicine,it consists of compatibility of two or multiple active ingredients.The effective component compatibility can help to discuss the multi-component and multi-target integration mechanism of Chinese medicine.Fenugreek is the dried ripe seed of Trigonella foenum-graecum Linn.It is widely grown in India,Egypt,the Middle East and South Africa,and it is used in many areas,such as food,medicine health care products and so on.Fenugreek has curative effect on diabetes mellitus,and the three kind of the highest content of potential active components are polysaccharides,saponins and flavonoids.Moreover,mechanisms of these active components are not exactly the same.In this paper,the Fenugreek hypoglycemic active ingredients saponins,flavonoids and polysaccharide were mixed in different proportion firstly.The best compatibility proportion of components was confirmed through the study on pharmacodynamics and metabolomics.Then the synergistic effect and mechanism of various components were studied.In the end,the forming process and the quality standard of Fenugreek hypoglycemic capsules were established.The results are showed as follows:1.Pharmacokinetics of Fenugreek fractionsFirst,the three components of Fenugreek were extracted and purified,and then the STZ-induced diabetic rat is used to study the hypoglycemic activities of flavonoids,saponins and polysaccharides components.By observing the survival rate,blood glucose level,the changes of urinary protein,the organizational form of pancreas and kidney as well as the levels of urinary protein and serum triglyceride,total cholesterol,high density lipoprotein,low density lipoprotein and advancedglycation end products in rat urine,hypoglycemic effects of components compatibility of polysaccharides,saponins and flavonoids in Fenugreek on diabetic rats were investigated.The optimum compatibility ratio of three components was confirmed in at the same time.The results showed that the compatibility ratio of polysaccharide:saponin: flavonoid(3: 6: 1)could better lower the blood glucose,improve the lipid metabolism,inhibit the nonenzymatic glycosylation of protein and protect the function of pancreas and kidney.2.Study on metabolomics of component compatibility of Fenugreek in the treatment of diabetes mellitusThe method of metabolomics analysis and the mouses with diabetes mellitus were used,and a method based on the combination of UPLC-Q-TOF-MS,principal component analysis(PCA)and OPLS-DA had been established to investigate metabolomics of component compatibility of Fenugreek in the treatment of diabetes mellitus.A total of 28 biomarkers related to diabetes,such as D-glucuronic acid,cholic acid,uric acid,hippuric acid and citric acid,were identified.These biomarkers were mainly involved in tryptophan metabolism,phenylalanine metabolism,TCA cycle,liver sugar metabolic enzyme activity and diabetes complicated with renal injury and liver and gallbladder injury and other channels.The changes of these biomarkers showed that Fenugreek saponins,flavonoids and polysaccharides had regulating effects on these markers to some degree and had an effect on many metabolic pathways.3.Study on the Forming Technology of Fenugreek Hypoglycemic CapsulesIn the aspect of molding process,the best preparation process of capsules was established through the study of the minimum amount and type of excipients,the ratio of soluble starch and dextrin.The results were as follows: The Fenugreek polysaccharides,saponins and flavonoids were mixed in the ratio of 3: 6: 1 and then dissolved in appropriate amount of water to obtain extract whose density was in the range of 1.10 and 1.20.Subsequently,soft material was made with the ratio of extract:excipients(Starch: dextrin = 6.2: 1)1: 1.8 and were squeezed through 16 mesh sieve to give granules.Finally,the granules were filled into capsule after desiccation under65℃ for 2 h.4.Study on quality standard of Fenugreek hypoglycemic capsulesThrough the study of component determination and methodological research,the quality standard of Fenugreek hypoglycemic capsules was established.According to the relevant regulation of capsules in the "Chinese Pharmacopoeia" 2015 edition,the examination of water,loading differences,disintegration time and dissolution were checked.The results are in line with the provisions. |