Composition with hypoglycemic effect and application thereof

Abstract

The invention relates to the technical field of health care product development, in particular to a composition with a hypoglycemic effect and application thereof. The composition disclosed by the invention comprises the following components in parts by mass: 35-40 parts of tartary buckwheat flavone and 23-27 parts of a black fungus polysaccharide-vitamin compound, the auricularia auricula polysaccharide-vitamin compound comprises the following components: vitamin B1, vitamin B2, nicotinamide and auricularia auricula polysaccharide in a mass ratio of (4-6): (4-6): (45-55): (800-900). According to the invention, dosage optimization of the components is realized, and the composition can be developed into functional food or adjuvant therapy preparations or medicines, and provides a basis for treatment and prevention of diabetes mellitus, especially treatment and prevention of type 2 diabetes mellitus.

Description

Technical Field

[0001] This invention relates to the field of health product development technology, and in particular to a composition with hypoglycemic effect and its application. Background Technology

[0002] Diabetes mellitus is a disease characterized by an absolute or relative deficiency of insulin production in the body, leading to disordered glucose metabolism, elevated blood sugar, and accompanying abnormalities in the metabolism of fats and proteins. It mainly includes type 1 diabetes and type 2 diabetes. In recent years, with changes in lifestyle and dietary structure, the incidence of diabetes has shown a gradual upward trend.

[0003] Currently, traditional hypoglycemic drugs (such as metformin and acarbose) pose risks of gastrointestinal side effects and drug resistance with long-term use in the treatment of diabetes. Single natural ingredients (such as flavonoids or polysaccharides) have limited hypoglycemic effects, and research on multi-target synergistic effects is lacking. Furthermore, existing compound preparations often lack a clear understanding of the type of synergistic effect (independent / synergistic / additive) and specific dosage design methods.

[0004] Based on this, the present invention is proposed. Summary of the Invention

[0005] The purpose of this invention is to provide a composition with hypoglycemic effect and its application.

[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0007] This invention provides a composition with hypoglycemic effect, comprising the following components in parts by weight:

[0008] 35-40 parts of buckwheat flavonoids and 23-27 parts of black fungus polysaccharide-vitamin complex;

[0009] The black fungus polysaccharide-vitamin complex comprises components in the following mass ratio: vitamin B1: vitamin B2: nicotinamide: black fungus polysaccharide in a ratio of 4-6: 4-6: 45-55: 800-900.

[0010] Preferably, the components include the following parts by mass:

[0011] 36-38 parts of buckwheat flavonoids and 24-26 parts of black fungus polysaccharide-vitamin complex;

[0012] The black fungus polysaccharide-vitamin complex comprises components in the following mass ratio: vitamin B1: vitamin B2: nicotinamide: black fungus polysaccharide = 4.5-5.5: 4.5-5.5: 48-52: 820-880.

[0013] Preferably, the components include the following parts by mass:

[0014] 37 parts of buckwheat flavonoids and 25 parts of black fungus polysaccharide-vitamin complex;

[0015] The black fungus polysaccharide-vitamin complex comprises components in the following mass ratio: vitamin B1: vitamin B2: nicotinamide: black fungus polysaccharide = 5:5:50:850.

[0016] Preferably, the components of the composition have a combined additive effect, and the K value of the combined additive effect is 0.4 to 2.7.

[0017] The present invention also provides the use of the composition in the preparation of foods or medicines that inhibit α-glucosidase activity and upregulate glucokinase activity.

[0018] This invention also provides the use of the described composition in the preparation of food or medicine with hypoglycemic effects, and the ED of the composition's hypoglycemic rate. 50 The concentration is 407 mg / kg·bw. The components of the composition have a combined additive effect, and the K value of the combined additive effect is 0.4 to 2.7.

[0019] The present invention also provides the use of the composition in the preparation of food or medicine with improved glucose tolerance, wherein the components of the composition have a synergistic additive effect, and the K value of the synergistic additive effect is 0.4 to 2.7.

[0020] The present invention also provides the use of the composition in the preparation of food or medicine with reduced insulin resistance index, wherein the components of the composition have a synergistic additive effect, and the K value of the synergistic additive effect is 0.4 to 2.7.

[0021] The present invention also provides the use of the described composition in the preparation of foods or medicines for the treatment and / or prevention of diabetes, and the ED of the composition in terms of blood glucose lowering rate. 50 The concentration is 407 mg / kg·bw. The components of the composition have a combined additive effect, and the K value of the combined additive effect is 0.4 to 2.7.

[0022] This invention provides a composition with hypoglycemic effects and its application. The composition comprises buckwheat flavonoids and a black fungus polysaccharide-vitamin complex; the black fungus polysaccharide-vitamin complex includes vitamin B1, vitamin B2, nicotinamide, and black fungus polysaccharide. In this composition, buckwheat flavonoids can inhibit α-glucosidase activity and delay glucose absorption. Black fungus polysaccharide, in combination with vitamin B1, vitamin B2, and nicotinamide, improves glucokinase activity, promotes glycogen synthesis, and inhibits gluconeogenesis. When these components are combined to prepare a composition, the components, through multi-target synergistic effects (K-value of synergistic additive effect 0.4–2.7), significantly improve the hypoglycemic effect, with an ED50% reduction in hypoglycemic rate. 50With a dose of 407 mg / kg bw, the dosage has been optimized and can be developed into a functional food, adjuvant therapy preparation, or drug, providing a basis for the treatment and prevention of diabetes, especially type 2 diabetes. Attached Figure Description

[0023] Figure 1 The dose-response curve for the hypoglycemic rate of buckwheat flavonoids;

[0024] Figure 2 The dose-response curve of the blood sugar lowering rate of black fungus polysaccharide-vitamin complex;

[0025] Figure 3 The dose-response curve for the hypoglycemic rate of the composition;

[0026] Figure 4 The effect of different doses of the test substance on α-glucosidase activity;

[0027] Figure 5 The effect of different doses of the test substance on glucokinase (GK) activity;

[0028] Figure 6 The effects of different oral doses of buckwheat flavonoids on fasting blood glucose levels in mice;

[0029] Figure 7 The effects of different oral doses of black fungus polysaccharide-vitamin complex on fasting blood glucose levels in mice;

[0030] Figure 8 The effects of different oral doses of the composition on fasting blood glucose levels in mice;

[0031] Figure 9 The results show the effects of different oral doses of buckwheat flavonoids on oral glucose tolerance test (OGTT) curves and area under the curve (AUC) in mice.

[0032] Figure 10 The results of the effects of different oral doses of black fungus polysaccharide-vitamin complex on the oral glucose tolerance test (OGTT) curves and the area under the curve (AUC) in mice;

[0033] Figure 11 The results show the effects of different oral doses of the composition on oral glucose tolerance test (OGTT) curves and area under the curve (AUC) in mice;

[0034] Figure 12 The effect of different oral doses of tartary buckwheat flavonoids on fasting serum insulin levels in mice;

[0035] Figure 13 The effect of different oral doses of black fungus polysaccharide-vitamin complex on fasting serum insulin levels in mice;

[0036] Figure 14 The effect of different oral doses of the composition on fasting serum insulin levels in mice;

[0037] Figure 15 The effect of different oral doses of tartary buckwheat flavonoids on the insulin resistance index in mice;

[0038] Figure 16 The effect of different oral doses of black fungus polysaccharide-vitamin complex on insulin resistance index in mice;

[0039] Figure 17 The effect of different oral doses of the composition on the insulin resistance index in mice. Detailed Implementation

[0040] This invention provides a composition with hypoglycemic effect, comprising the following components in parts by weight:

[0041] 35-40 parts of buckwheat flavonoids, preferably 36-38 parts, and more preferably 37 parts;

[0042] The black fungus polysaccharide-vitamin complex contains 23-27 parts, preferably 24-26 parts, and more preferably 25 parts;

[0043] The black fungus polysaccharide-vitamin complex comprises components in the following mass ratio: vitamin B1: vitamin B2: nicotinamide: black fungus polysaccharide in a ratio of 4-6: 4-6: 45-55: 800-900, preferably 4.5-5.5: 4.5-5.5: 48-52: 820-880, and more preferably 5: 5: 50: 850.

[0044] In this invention, the components of the composition have a combined additive effect, and the K value of the combined additive effect is 0.4 to 2.7.

[0045] The present invention also provides the use of the composition in the preparation of foods or medicines that inhibit α-glucosidase activity and upregulate glucokinase activity.

[0046] This invention also provides the use of the described composition in the preparation of food or medicine with hypoglycemic effects, and the ED of the composition's hypoglycemic rate. 50 The concentration is 407 mg / kg·bw. The components of the composition have a combined additive effect, and the K value of the combined additive effect is 0.4 to 2.7.

[0047] The present invention also provides the use of the composition in the preparation of food or medicine with improved glucose tolerance, wherein the components of the composition have a synergistic additive effect, and the K value of the synergistic additive effect is 0.4 to 2.7.

[0048] The present invention also provides the use of the described composition in the preparation of a food or drug having a reduced insulin resistance index, and there is a combined additive effect among the components of the composition, and the K value of the combined additive effect is 0.4 to 2.7.

[0049] The present invention also provides the use of the described composition in the preparation of a food or drug for treating and / or preventing diabetes. The ED 50 of the composition for reducing blood sugar rate is 407 mg / kg·bw, and there is a combined additive effect among the components of the composition, and the K value of the combined additive effect is 0.4 to 2.7.

[0050] The technical solutions provided by the present invention will be described in detail below in conjunction with the examples, but they should not be construed as limiting the protection scope of the present invention.

[0051] Sources of raw materials in the examples of the present invention:

[0052] SPF-grade male ICR mice, 4 weeks old, with a body weight of 20.5 ± 1.5 g, were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd., and the certificate number is: SCXK(Jing)2021-0006.

[0053] The maintenance feed and the high-sugar and high-fat feed were purchased from Keao Xieli (Tianjin) Feed Co., Ltd.

[0054] Instruments and equipment

[0055] The Roche blood glucose meter and blood glucose test strips, model Zhihang, were purchased from Roche Pharmaceutical International Group Co., USA; the WFYZ-BJ-005 high-speed refrigerated centrifuge was from Sigma Co., USA;; the Mindray automatic biochemical analyzer, model BS-420, was purchased from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.; the Huawei Weidelang microplate reader, model DR-200BS, was purchased from Wuxi Huawei Weidelang Instrument Co., Ltd.

[0056] Example 1

[0057] 1 Preparation of the test substance

[0058] Buckwheat flavonoids, auricularia auricula polysaccharide, vitamin B1, vitamin B2, and nicotinamide were uniformly dispersed in the sodium carboxymethyl cellulose solution according to the required dosage requirements to prepare a suspension.

[0059] 2 Establishment of the animal model

[0060] Male ICR mice were randomly divided into groups according to body weight. The model group was fed a high-sugar, high-fat diet and fasted for 12 hours. Then, they were injected intraperitoneally with nicotinamide solution (at a dose of 110 mg / kg body weight). Fifteen minutes later, they were injected intravenously with streptozotocin solution (STZ solution) (at a dose of 60 mg / kg body weight). A total of four injections were administered. Seven days later, the blood glucose levels of the mice were measured. Mice with blood glucose levels greater than 11 mmol / L but less than 30 mmol / L were selected as the type 2 diabetes model.

[0061] 3. Grouping and Dosing

[0062] Mice that successfully developed the model were randomly divided into five dosage groups based on their fasting blood glucose levels: a model control group (MOD), a positive drug-metformin hydrochloride control group (MET), a tartary buckwheat flavonoids (TBF) group, an auricularia auricular polysaccharide (AAP)-B vitamin complex group (AAP+B), and a tartary buckwheat flavonoids-auricularia polysaccharide-vitamin complex group (TBF+AAP+B). The model control group and the blank control group (CON) were administered an equal volume of distilled water by gavage daily, while the positive drug-metformin control group received 200 mg / kg bw for 28 days.

[0063] 3.1 Dosage design of buckwheat flavonoids

[0064] Using 1000 mg / kg as the highest dose and 200 mg / kg as the lowest dose, the group interval i was calculated using Formula 1. The doses were grouped from lowest to highest: 1. 200 mg / kg·bw; 2. 299 mg / kg·bw; 3. 447 mg / kg·bw; 4. 669 mg / kg·bw; and 5. 1000 mg / kg·bw. Tartary buckwheat flavonoid powder was prepared into solutions of 20 mg / mL, 29.9 mg / mL, 44.7 mg / mL, 66.9 mg / mL, and 100 mg / mL using sodium carboxymethyl cellulose as a solvent. These solutions were administered to mice via gavage at a concentration of 0.1 mL / 10 g·bw. The hypoglycemic rate was calculated using Formula 2. A standard curve was plotted with the logarithm of the tartary buckwheat flavonoid concentration on the x-axis and the hypoglycemic rate on the y-axis. Figure 1 ), calculate the ED of buckwheat flavonoids 50 Value (ED) 50 This refers to the dosage that elicits a 50% response. The efficacy (ED) of a test substance is defined as the dose at which it causes a 50% reduction in fasting blood glucose levels in mice. 50 ).

[0065] Formula (1):

[0066]

[0067] In the formula:

[0068] i represents the group interval;

[0069] HD indicates the highest dose value;

[0070] LD represents the minimum effective dose.

[0071] n represents the number of groups (each test substance is divided into 5 groups).

[0072] Formula (2):

[0073]

[0074] D represents the blood sugar reduction rate, in percentage.

[0075] FBG MOD This represents the fasting blood glucose level in the MOD group on day 28, in mmol / L.

[0076] FBG CON This indicates the fasting blood glucose level (mmol / L) in group CON on day 28.

[0077] FBG represents the fasting blood glucose level in the experimental group on day 28, in mmol / L.

[0078] The ED (eructose retardation rate) of buckwheat flavonoids was calculated based on the standard curve. 50 The value is 1259 mg / kg·bw.

[0079] 3.2 Dosage design of black fungus polysaccharide-vitamin complex

[0080] A black fungus polysaccharide-vitamin complex was obtained by mixing vitamin B1, vitamin B2, nicotinamide, and black fungus polysaccharide in a ratio of 5:5:50:850. The group interval i was calculated using Formula 1, and the mice were grouped by dose from low to high. The doses of the black fungus polysaccharide-vitamin complex, from low to high, were: dose 1: 162 mg / kg·bw, dose 2: 288 mg / kg·bw, dose 3: 513 mg / kg·bw, dose 4: 912 mg / kg·bw, and dose 5: 1622 mg / kg·bw. Solutions of these concentrations (16.2 mg / mL, 28.8 mg / mL, 51.3 mg / mL, 91.2 mg / mL, and 162.2 mg / mL) were prepared using sodium carboxymethyl cellulose as a solvent and administered by gavage at a dose of 0.1 mL / 10 g·bw per mouse. The hypoglycemic rate was calculated using Formula 2. A standard curve was plotted with the logarithm of the concentration of black fungus polysaccharide-vitamin complex on the x-axis and the blood sugar reduction rate on the y-axis. Figure 2), calculate the ED of black fungus polysaccharide-vitamin complex. 50 value.

[0081] The ED of the black fungus polysaccharide-vitamin complex was calculated. 50 The value was 851 mg / kg·bw.

[0082] 3.3 Dosage Design of Composition Groups

[0083] The ED ratio of the glycemic index of the buckwheat flavonoid and black fungus polysaccharide-vitamin complex obtained from 3.1 and 3.2 was calculated. 50 The concentrations were 1259 mg / kg bw and 851 mg / kg bw, respectively, with a ratio of approximately 37:25. This ratio was used as the sample for the combined effect. The combined effect coefficient method was employed, i.e., the ED of each group was obtained first. 50 Based on the Finney toxicity additive formula, and assuming that the combined effect of each group is additive, the expected ED of the composition is calculated according to formula (3). 50 The value is 1055 mg / kg·bw.

[0084] Expected ED of the composition 50 The calculation formula is as shown in formula (3):

[0085] Formula (3):

[0086]

[0087] In the formula:

[0088] (A+B+…+N)ED 50 Indicates the expected ED of the composition 50 mg / kg·bw;

[0089] (A)ED 50 Indicates the expected value of A, ED. 50 mg / kg·bw;

[0090] (B)ED 50 Indicates the expected value of B, ED. 50 mg / kg·bw;

[0091] (N)ED 50 Indicates the expected value of N, ED 50 mg / kg·bw;

[0092] a represents the weight percentage of A in the composition;

[0093] b represents the weight percentage of B in the composition.

[0094] In the formula, A and B represent buckwheat flavonoids and black fungus polysaccharide-vitamin complex, respectively, and a+b=1.

[0095] According to the expected ED of the composition 50 With a target concentration of 1055 mg / kg body weight (bw), the designed dosages of the composition system, from lowest to highest, were 106 mg / kg bw, 228 mg / kg bw, 491 mg / kg bw, 1055 mg / kg bw, and 2270 mg / kg bw. The hypoglycemic rate was calculated using Formula 2. A standard curve was plotted with the logarithm of the composition concentration on the x-axis and the hypoglycemic rate on the y-axis. Figure 3 ), calculate the actual ED of the composition 50 value.

[0096] according to Figure 3 As shown, within the designed dosage range, the glycemic rate in mice showed a good linear relationship with the logarithm of the composition intake, consistent with the biological principle that the dose-effect curve is S-shaped and the dose-logarithm-effect curve is linear. The actual efficacy of the composition was calculated based on the standard curve. 50 The value is 407 mg / kg·bw.

[0097] The Smyth method was used to evaluate the K-value criterion (expected ED) for combined effects. 50 With actual ED 50 The ratio is shown in Table 1. Calculations show a combined effect coefficient K = 2.59, indicating that the hypoglycemic effects of buckwheat flavonoids and black fungus polysaccharide-vitamin complex on mice are additive, and their combined use can exert effects through different targets or pathways.

[0098] Table 1. K values ​​for evaluating the combined effects using the Smyth method.

[0099]

[0100]

[0101] 4. Determination of indicators

[0102] 4.1 Fasting blood glucose and oral glucose tolerance test

[0103] On day 28, the oral glucose tolerance test (OGTT) was conducted. Mice were fasted for 12 hours but allowed free access to water. They were then administered glucose solution by gavage at a dose of 2 g / kg. Blood glucose levels were measured at 0, 30, 60, 90, and 120 minutes after gavage.

[0104] 4.2 Determination and Calculation of Biochemical Indicators

[0105] The specific procedures for serum insulin, α-glucosidase, and glucokinase should be performed according to the kit instructions.

[0106] The inhibition rate of α-glucosidase activity results are as follows: Figure 4 As shown; glucokinase activity results are as follows Figure 5 As shown.

[0107] The Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR) is an indicator used to assess an individual's level of insulin resistance. The formula for calculating the HOMA-IR is shown in Equation 4.

[0108] Formula (4):

[0109]

[0110] In the formula:

[0111] HOMAIR represents the insulin resistance index, μIU / mL×mmol / L;

[0112] INS represents fasting serum insulin, μIU / mL;

[0113] FBG represents fasting blood glucose, mmol / L. The changes in oral glucose tolerance test (OGTT) curves and area under the curve (AUC) for different test substances are shown below. Figures 6-11 As shown.

[0114] Glucose tolerance is the dynamic change in blood glucose levels within 2 hours after a meal, reflecting insulin secretion capacity and somatic cellular sensitivity to insulin. For example... Figure 6 , 7 As shown, in the MOD group, blood glucose levels had not returned to normal by the end of 120 minutes; in normal mice, blood glucose levels peaked at 15 minutes, and returned to normal between 90 and 120 minutes; in the TBF dosage groups, peak values ​​appeared around 30-40 minutes. Figure 4This indicates that after ingestion, buckwheat flavonoids inhibit the activity of α-glucosidase, hindering carbohydrate hydrolysis and thus preventing the rapid entry of glucose into the bloodstream, thereby slowing the rate of blood glucose rise. The AAP+B group showed a blood glucose peak at 20-30 minutes, indicating that AAP+B can delay glucose diffusion. Based on the chemical structure and properties of AAP, it is known that AAP can form a gel barrier in the intestine through physical adsorption, inhibiting glucose absorption in the small intestine, but its effect is weaker than TBF. Around 60 minutes, the AAP+B group showed a more obvious inflection point in the blood glucose decrease process, with a faster blood glucose decrease rate compared to the TBF group. Furthermore, the peak value decreased with increasing dosage of the test substance, and the blood glucose decrease rate was faster. Because vitamin B1, vitamin B2, and nicotinamide, as coenzyme factors of decarboxylase systems, promote efficient glucose metabolism in pyruvate decarboxylation and the tricarboxylic acid cycle, and bind... Figure 5 The combination of AAP and B can significantly enhance GK activity, enabling the liver to rapidly clear excess glucose from the blood, which is beneficial for reducing postprandial blood glucose spikes. Figure 8 As shown, the TBF+AAP+B dosage groups showed peak values ​​around 30 minutes and inflection points around 60 minutes, indicating that the combined use of the three drugs can both inhibit the rapid entry of glucose into the blood and slow down the rate of blood glucose rise, and accelerate the rate of blood glucose fall, thus fully exerting their effects in improving glucose tolerance; and as the dosage increases, the peak value decreases and the rate of blood glucose fall becomes faster.

[0115] The area under the glucose tolerance curve (AUC) reflects the overall level of blood glucose change over time in an oral glucose tolerance test (OGTT). A smaller AUC indicates a stronger ability to metabolize glucose and better glucose tolerance. Figure 9 , 10 As shown, both buckwheat flavonoids and black fungus polysaccharides combined with B vitamins can reduce AUC (P < 0.05). Compared with the MOD group, the AUC of the MET group, TBF group, and AAP+B group decreased by 35.64%, 41.76%, and 45.27%, respectively, indicating that after intervention with buckwheat flavonoids and black fungus polysaccharides combined with B vitamins, the AUC of OGTT was significantly reduced, and postprandial blood glucose fluctuations were decreased. Figure 11 As shown, the combined use of the three drugs can reduce AUC (P<0.05). Compared with the MOD group, the AUC of the MET group and the TBF+AAP+B-5 group was reduced by 40.45% and 54.17%, respectively, and the reduction rate of AUC was higher than that of the single use.

[0116] The effects of different test substances on fasting serum insulin levels are as follows: Figures 12-14 As shown.

[0117] Serum insulin levels reflect the secretory capacity of pancreatic β-cells. Normal mice have low fasting insulin levels, with a rapid increase in secretion after meals. Fasting insulin levels reflect the combined effects of basal insulin secretion and insulin resistance. Figure 12 , 13 As shown, the fasting insulin level in the MOD group mice reached 37.67 μIU·mL. -1 This indicates that although pancreatic β-cells were damaged by STZ during the modeling process, prolonged high glucose levels led to decreased insulin sensitivity in tissues such as muscle and fat, forcing β-cells to compensate by secreting more insulin, resulting in fasting blood glucose levels higher than normal. Buckwheat flavonoids and black fungus polysaccharides combined with B vitamins all had the effect of reducing fasting insulin levels (P < 0.05). The insulin reduction rates in the MET group, TBF-5 group, and AAP+B-5 group were 90.51%, 80.94%, and 94.12%, respectively, approaching normal levels. In the TBF group, due to the protective effect of buckwheat flavonoids on pancreatic β-cells, the blood glucose levels in mice gradually approached normal levels during the experiment, thus affecting fasting insulin. There was no significant difference among the AAP+B groups, possibly due to the influence of multiple factors. Nicotinamide, on the one hand, reduces β-cell apoptosis caused by DNA damage and enhances insulin secretion; on the other hand, it enhances mitochondrial function through the SIRT1 / PGC-1α pathway, reduces insulin resistance, and improves insulin sensitivity. In addition, black fungus polysaccharides can enhance the response of peripheral tissues to insulin through the AMPK pathway, thereby reducing fasting insulin requirements.

[0118] according to Figure 14 As shown, the fasting serum insulin levels of the three combined groups were all lower than those of the MOD group (P<0.05). Compared with the MOD group, the insulin reduction rates of the MET group and the TBF+AAP+B-5 group were 94.96% and 93.70%, respectively. This indicates that the combined use of buckwheat flavonoids, black fungus polysaccharides, and B vitamins is close to the efficacy of MET in reducing fasting serum insulin. Moreover, compared with the use of buckwheat flavonoids alone, the combined use of the three groups can balance the high fasting insulin levels caused by the use of buckwheat flavonoids alone. The additive combined action mechanism offsets the limitations of the use of buckwheat flavonoids alone, achieving a combined effect of protecting pancreatic β cells and improving insulin sensitivity.

[0119] The effects of different test substances on the insulin resistance index, such as Figures 15-17 As shown.

[0120] A higher HOMA-IR value indicates more severe insulin resistance. According to... Figure 15 , 16As shown, both buckwheat flavonoids and black fungus polysaccharides combined with B vitamins have the effect of reducing insulin resistance index (P<0.05). The HOMA-IR reduction rates of the MET group, TBF-5 group, and AAP+B-5 group were 82.66%, 78.65%, and 87.21%, respectively. The AAP+B-5 group was significantly better than the TBF-5 group and also better than the MET group in reducing insulin resistance index. This indicates that the combined effect of black fungus polysaccharides and B vitamins may exert a stronger anti-insulin resistance effect through mechanisms such as enhancing peripheral tissue insulin sensitivity (e.g., activating the AMPK signaling pathway) or improving mitochondrial function.

[0121] according to Figure 17 As shown, compared with the MOD group, the combined use of the three drugs reduced the insulin resistance index (P<0.05). Specifically, the HOMA-IR reduction rates in the MET group and the TBF+AAP+B-5 group were 85.12% and 86.67%, respectively. The combined use of buckwheat flavonoids, black fungus polysaccharides, and B vitamins achieved therapeutic effects comparable to or even superior to the traditional drug metformin. Figure 16 The reduction rate in the AAP+B-5 group was 87.21%. Figure 17 Although the value decreased slightly after the addition of TBF (86.67%), it may reflect the dynamic balance between different components. The addition of buckwheat flavonoids may enhance the antioxidant effect while bidirectionally regulating certain metabolic pathways, reflecting that the improved efficacy of the TBF+AAP+B group is not a simple dose-addition effect.

[0122] 5. Data Statistical Analysis

[0123] Experimental data were analyzed using SPSS 26.0 software. One-way ANOVA was used for data processing, and Duncans' multiple comparison test was used to analyze the significance of the results. All experimental results are expressed as mean ± standard deviation (Mean ± SD). P < 0.05 was considered statistically significant.

[0124] As can be seen from the above embodiments, the present invention provides a composition with hypoglycemic effect and its application. The composition of the present invention for treating diabetes includes buckwheat flavonoids and a black fungus polysaccharide-vitamin complex; the black fungus polysaccharide-vitamin complex includes vitamin B1, vitamin B2, nicotinamide, and black fungus polysaccharide. In the composition of the present invention, buckwheat flavonoids can inhibit α-glucosidase activity and delay glucose absorption. Black fungus polysaccharide, in combination with vitamin B1, vitamin B2, and nicotinamide, improves glucokinase activity, promotes glycogen synthesis, and inhibits gluconeogenesis. When these components are combined to prepare a composition, the components significantly improve the hypoglycemic effect through multi-target synergy (combined additive effect, with a K value of 0.4-2.7 for the combined additive effect), and the ED ratio of the hypoglycemic rate is significantly improved. 50With a dose of 395 mg / kg bw, the dosage has been optimized and can be developed into a functional food, adjunctive therapy preparation, or drug, providing a basis for the treatment of diabetes, especially type 2 diabetes.

[0125] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A composition with hypoglycemic effect, characterized in that: The composition includes the following components in parts by weight: 35-40 parts of tartary buckwheat flavonoids, 23-27 parts of black fungus polysaccharide-vitamin complex; The black fungus polysaccharide-vitamin complex comprises the following components in a mass ratio: vitamin B1: vitamin B2: nicotinamide: black fungus polysaccharide is 4-6: 4-6: 45-55: 800-900.

2. The composition according to claim 1, characterized in that The composition includes the following components in parts by weight: 36-38 parts of tartary buckwheat flavonoids and 24-26 parts of black fungus polysaccharide-vitamin complex; The black fungus polysaccharide-vitamin complex comprises the following components in a mass ratio: vitamin B1: vitamin B2: nicotinamide: black fungus polysaccharide is 4.5-5.5: 4.5-5.5: 48-52: 820-880.

3. The composition according to claim 2, characterized in that The composition includes the following components in parts by weight: 37 parts of tartary buckwheat flavonoids and 25 parts of black fungus polysaccharide-vitamin complex; The black fungus polysaccharide-vitamin complex comprises components in the following mass ratios: vitamin B1: vitamin B2: nicotinamide: black fungus polysaccharide in a ratio of 5:5:50:

850.

4. The composition according to any one of claims 1 to 3, characterized in that The components of the composition have a combined additive effect, and the K value of the combined additive effect is 0.4-2.

7.

5. Use of the composition according to any one of claims 1 to 4 in the preparation of food or medicine for inhibiting α-glucosidase activity and upregulating glucokinase activity.

6. Use of the composition according to any one of claims 1 to 4 in the preparation of food or medicine having a blood sugar lowering effect, characterized in that: Composition of glucose-lowering rate of ED 50 The total amount of the drug was 407 mg / kg·bw. The components of the composition had a combined additive effect, and the K value of the combined additive effect was 0.4-2.

7.

7. Use of the composition according to any one of claims 1 to 4 in the preparation of food or medicine for improving glucose tolerance, characterized in that: The components of the composition have a combined additive effect, and the K value of the combined additive effect is 0.4-2.

7.

8. Use of the composition according to any one of claims 1 to 4 in the preparation of food or medicine for reducing insulin resistance index, characterized in that: The components of the composition have a combined additive effect, and the K value of the combined additive effect is 0.4-2.

7.

9. The composition according to any one of claims 1 to 4 for preparing a method for treating and / or preventing diabetes Application in food or medicine, characterized in that Composition of glucose-lowering rate of ED 50 407mg / kg·bw, The components of the composition have a combined additive effect, and the K value of the combined additive effect is 0.4-2.7.

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