A composition with blood sugar lowering function and application thereof

Abstract

This invention provides a composition with hypoglycemic function and its application, belonging to the field of diabetes treatment technology. The composition comprises burdock root extract, *Ilex chinensis* extract, hypoglycemic decapeptide, trehalose, sodium benzoate, glycerin, vitamin C, and water. The composition of this invention exhibits multi-target synergistic effects, integrating natural plant extracts and functional peptides to regulate multiple diabetes-related targets, significantly reducing blood glucose levels and effectively improving cholesterol metabolism, oxidative damage, and inflammatory responses. This composition can be used to treat type 2 diabetes and has promising clinical application prospects.

Description

Technical Field

[0001] This invention relates to the field of diabetes treatment technology, and in particular to a composition having a hypoglycemic function and its application. Background Technology

[0002] Diabetes mellitus, a common chronic metabolic disease, is characterized by persistently high blood glucose levels, accompanied by metabolic abnormalities and oxidative damage. In recent years, the prevalence of diabetes has been rising continuously, becoming a global public health issue. Long-term hyperglycemia can lead to various complications, including cardiovascular disease, kidney disease, neuropathy, and retinopathy, severely impacting patients' quality of life and lifespan. Therefore, developing effective blood glucose-lowering treatments has become a research hotspot in the field of diabetes treatment.

[0003] Currently, hypoglycemic drugs mainly include insulin preparations and oral hypoglycemic agents (such as metformin, sulfonylureas, and DPP-4 inhibitors). Although these drugs have certain effects in lowering blood sugar, they also have many side effects. At present, natural extracts are gradually attracting researchers' attention due to their diversity and lower side effects. Some plant extracts have been found to have potential hypoglycemic mechanisms such as regulating insulin sensitivity, inhibiting glucose metabolism enzyme activity, and anti-oxidation, providing new directions for the development of hypoglycemic drugs. Against this backdrop, this invention provides a novel hypoglycemic composition that integrates natural extracts and functional peptides, aiming to achieve multi-target hypoglycemic effects. Summary of the Invention

[0004] The purpose of this invention is to provide a hypoglycemic composition that achieves synergistic treatment of type 2 diabetes by realizing a multi-target hypoglycemic effect.

[0005] To achieve the above objectives, the present invention provides a composition with hypoglycemic function, wherein the composition comprises, by weight percentage: 3%-5% burdock root extract, 1%-2% ivy extract, 0.1%-0.3% hypoglycemic decapeptide, 2%-3% trehalose, 0.2%-0.5% sodium benzoate, 0.5%-1% glycerin, 0.5%-0.75% vitamin C, and water to 100%; The amino acid sequence of the hypoglycemic decapeptide is LRSELAAWSR.

[0006] Preferably, the preparation method of the burdock root extract includes the following steps: (1) Remove impurities from dried burdock root, wash it clean, slice it and crush it into burdock root powder; (2) Mix burdock root powder with 50% ethanol at a mass-volume ratio of 1:10, and extract with ultrasound for 30 minutes at a temperature of 50°C and a power of 250W. (3) Use a filter screen to filter and collect extract a and filter residue; (4) Mix the filter residue with 70% ethanol at a mass-volume ratio of 1:10, and extract with ultrasound for 30 minutes at a temperature of 50°C and a power of 250W. (5) Filter the solution using a filter screen, collect extract b, and combine extract a and extract b to obtain a mixed extract; (6) Concentrate the mixed extract to 1 / 10 of its original volume to obtain a concentrated extract; (7) Freeze-dry the concentrated extract to obtain burdock root extract; The preparation method of the *Ilex cornuta* extract includes the following steps: (1) Remove impurities from dried evergreen leaves, wash them clean, and then pulverize them into evergreen powder; (2) Add the powder of Sijiqing to a 50% ethanol solution at a mass-volume ratio of 1:10 and extract at room temperature for 24 hours; (3) Use a filter screen to filter and collect extract a and filter residue; (4) Mix the filter residue with 70% ethanol at a mass-volume ratio of 1:8, and extract by ultrasonication at 40°C and 250W for 30 minutes. (5) Filter the solution using a filter screen, collect extract b, and combine extract a and extract b to obtain a mixed extract; (6) The mixed extract was concentrated to 1 / 10 of its original volume using a rotary evaporator to obtain a concentrated extract; (7) Freeze-dry the concentrated extract to obtain the Four Seasons Green Extract.

[0007] Preferably, the composition comprises, by weight percentage, the following ingredients: 3% burdock root extract, 2% ivy extract, 0.1% hypoglycemic decapeptide, 2% trehalose, 0.2% sodium benzoate, 1% glycerin, 0.75% vitamin C, and water to 100%.

[0008] Preferably, the composition is used to reduce blood glucose elevation caused by type 2 diabetes.

[0009] Meanwhile, the present invention provides an application of the composition in the preparation of a treatment drug for type 2 diabetes. The composition, by weight percentage, comprises the following components: 3%-5% burdock root extract, 1%-2% *Ilex chinensis* extract, 0.1%-0.3% hypoglycemic decapeptide, 2%-3% trehalose, 0.2%-0.5% sodium benzoate, 0.5%-1% glycerin, 0.5%-0.75% vitamin C, and water to 100%. The amino acid sequence of the hypoglycemic decapeptide is LRSELAAWSR; The burdock root extract was prepared according to the above-described method for preparing burdock root extract. The *Ilex cornuta* extract was prepared according to the above-described method for preparing *Ilex cornuta* extract.

[0010] Preferably, the type 2 diabetes treatment drug is used to reduce the increase in blood glucose caused by diabetes and to improve abnormal cholesterol metabolism, oxidative damage and inflammatory response caused by diabetes.

[0011] Preferably, the composition comprises, by weight percentage, the following ingredients: 3% burdock root extract, 2% ivy extract, 0.1% hypoglycemic decapeptide, 2% trehalose, 0.2% sodium benzoate, 1% glycerin, 0.75% vitamin C, and water to 100%.

[0012] Furthermore, the present invention provides a medicament for treating type 2 diabetes, said medicament being prepared by the following method: (1) Add 2%-3% trehalose, 0.2%-0.5% sodium benzoate and 0.5%-1% glycerol to water and stir well to obtain solution a; (2) Slowly add 3%-5% of burdock root extract and 1%-2% of woad extract, and stir continuously until completely dissolved to obtain solution b; (3) Dissolve 0.1%-0.3% of hypoglycemic decapeptide in water to obtain hypoglycemic decapeptide solution, and slowly add it to solution b, stirring until homogeneous; (4) Add 0.5%-0.75% vitamin C, stir well, and add water until the total mass percentage is 100% to obtain solution c; (5) Sterilize solution c by filtration through a 0.22 μm filter membrane to obtain a drug for treating type 2 diabetes.

[0013] Preferably, the amino acid sequence of the hypoglycemic decapeptide is LRSELAAWSR; The burdock root extract was prepared according to the above-described method for preparing burdock root extract. The *Ilex cornuta* extract was prepared according to the above-described method for preparing *Ilex cornuta* extract.

[0014] Preferably, by mass percentage, the amount of trehalose added is 2%, the amount of sodium benzoate added is 0.2%, the amount of glycerol added is 1%, the amount of burdock root extract added is 3%, the amount of evergreen extract added is 2%, the amount of hypoglycemic decapeptide added is 0.1%, and the amount of vitamin C added is 0.75%.

[0015] The beneficial effects of this invention are as follows: The hypoglycemic composition of this invention synergistically reduces blood glucose levels in treated mice by regulating multiple diabetes-related targets through burdock root extract, ivy extract, and hypoglycemic decapeptide. Simultaneously, through the multi-target synergistic effect of the three core components, it effectively improves cholesterol metabolism, oxidative damage, and inflammatory responses, thereby enhancing the overall therapeutic effect on patients with type 2 diabetes. Therefore, the hypoglycemic composition and therapeutic drug disclosed in this invention have significant clinical therapeutic potential. Attached Figure Description

[0016] Figure 1 A graph showing the differences in fasting blood glucose concentration in mice from different experimental groups; Figure 2 Figure showing the differences in serum total cholesterol levels in mice from different experimental groups; Figure 3 A graph showing the differences in serum SOD (superoxide dismutase) activity among mice in different experimental groups; Figure 4 This figure shows the differences in serum TNF-α (tumor necrosis factor-α) levels in mice from different experimental groups. Detailed Implementation

[0017] The present invention will now be further described in conjunction with the accompanying drawings and specific embodiments. It should be noted that, without conflict, the various embodiments or technical features described below can be arbitrarily combined to form new embodiments.

[0018] Example 1: Preparation of burdock root extract in this example Select dried burdock root, remove impurities, rinse with water, slice and grind into powder; Mix the powder with 50% ethanol at a mass-volume ratio of 1:10 (10g:100ml), place the mixture in a constant temperature ultrasonic extractor, and extract for 30 minutes at 50℃ and 250W. Filter through a 200-mesh filter to collect extract a and filter residue; Mix the filter residue with 70% ethanol at a mass-volume ratio of 1:10, place it in a constant temperature ultrasonic extractor, and extract for 30 minutes at 50℃ and 250W. Filter through a 200-mesh filter, collect extract b, and combine extract a and extract b to obtain a mixed extract; The mixed extract was concentrated to 1 / 10 of its original volume using a rotary evaporator to obtain a concentrated extract. The concentrated extract was freeze-dried to obtain burdock root extract powder.

[0019] Example 2: Preparation of Ilex chinensis extract in this example Remove impurities from dried evergreen leaves, rinse them with water, and then grind them into powder. Add the powder to a 50% ethanol solution at a mass-volume ratio of 1:10 and extract at room temperature for 24 hours. Filter through a 200-mesh filter to collect extract a and filter residue; Mix the filter residue with 70% ethanol at a mass-volume ratio of 1:8, and place it in a constant temperature ultrasonic extractor. Extract for 30 minutes at 40℃ and 250W. Filter through a 200-mesh filter, collect extract b, and combine extract a and extract b to obtain a mixed extract; The mixed extract was concentrated to 1 / 10 of its original volume using a rotary evaporator to obtain a concentrated extract. The concentrated extract was freeze-dried to obtain the powder of *Ilex cornuta* extract.

[0020] Example 3: This example describes the preparation of a composition and drug with hypoglycemic function. The composition consists of 3% burdock root extract, 2% ivy extract, 0.1% hypoglycemic decapeptide (amino acid sequence: LRSELAAWSR, synthesized by Nanjing Genscript Pharmaceutical Co., Ltd.), 2% trehalose, 0.2% sodium benzoate, 1% glycerol, 0.75% vitamin C, and water to make up to 100% of the total volume.

[0021] The steps for preparing the hypoglycemic drug using this composition are as follows: (1) Preparation of basic solution In a clean mixing container, add 60% water and keep stirring; Add trehalose (2%) and stir until completely transparent; Add sodium benzoate (0.2%) and continue stirring until homogeneous; Add 1% glycerin and stir until well combined; (2) Add plant extracts Slowly add burdock root extract (3%) to the stirred base solution, stirring constantly to ensure complete dissolution.

[0022] Next, add the 2% clover extract and keep stirring to ensure it is completely dissolved.

[0023] (3) Add hypoglycemic decapeptide Dissolve 0.2% of the hypoglycemic decapeptide powder in 5% water and mix thoroughly to form a homogeneous hypoglycemic decapeptide solution.

[0024] Slowly add the blood sugar-lowering decapeptide solution into the mixing container while stirring to ensure even distribution.

[0025] (4) Add antioxidants Dissolve 0.75% vitamin C powder in 5% water and add it to the mixed solution, then stir well.

[0026] (5) Replenish water volume Add the remaining water to adjust to the target formula total (100%), continue stirring for 10 minutes, and then sterilize using a 0.22 μm filter to obtain the hypoglycemic drug.

[0027] Example 4: This example describes the preparation of a composition and drug with hypoglycemic function. The composition consists of 5% burdock root extract, 1% ivy extract, 0.3% hypoglycemic decapeptide (amino acid sequence: LRSELAAWSR), 3% trehalose, 0.5% sodium benzoate, 0.5% glycerol, 0.5% vitamin C, and water to make up to 100% of the total volume.

[0028] The preparation method for the hypoglycemic drug is the same as in Example 3.

[0029] Example 5: This example describes the preparation of a composition and drug with hypoglycemic function. The composition consists of 4% burdock root extract, 2% ivy extract, 0.2% hypoglycemic decapeptide (amino acid sequence: LRSELAAWSR), 2% trehalose, 0.25% sodium benzoate, 1% glycerol, 1% vitamin C, and water to make up to 100% of the total.

[0030] The preparation method for the hypoglycemic drug is the same as in Example 3.

[0031] Comparative Example 1: The composition of this composition is 3% burdock root extract, 2% sage extract, 2% trehalose, 0.2% sodium benzoate, 1% glycerin, 0.75% vitamin C, and water to make up to 100% of the total amount.

[0032] The preparation method for the hypoglycemic drug is the same as in Example 3.

[0033] Comparative Example 2: The composition of this composition is 2% Ilex chinensis extract, 0.1% hypoglycemic decapeptide (amino acid sequence: LRSELAAWSR), 2% trehalose, 0.2% sodium benzoate, 1% glycerol, 0.75% vitamin C, and water to make up to 100% of the total.

[0034] The preparation method for the hypoglycemic drug is the same as in Example 3.

[0035] Comparative Example 3: The composition of this composition is 3% burdock root extract, 0.1% hypoglycemic decapeptide (amino acid sequence: LRSELAAWSR), 2% trehalose, 0.2% sodium benzoate, 1% glycerol, 0.75% vitamin C, and water to make up to 100% of the total.

[0036] Comparative Example 4: The composition of this composition is 3% burdock root decoction extract, 2% ivy decoction extract, 0.1% hypoglycemic decapeptide (amino acid sequence: LRSELAAWSR), 2% trehalose, 0.2% sodium benzoate, 1% glycerol, 0.75% vitamin C, and water to make up to 100% of the total.

[0037] The burdock root decoction extract and the four-leaf clover decoction extract are obtained by mixing burdock root or four-leaf clover powder with water at a mass-volume ratio of 1:10 and then decocting at 90℃ for 2 hours.

[0038] Comparative Example 5: The composition of this composition is 3% burdock root extract, 2% ivy extract, 0.1% hypoglycemic decapeptide (amino acid sequence: LRSELAAWSR), 2% trehalose, 0.2% sodium benzoate, 1% glycerol, 0.75% vitamin C, and water to make up to 100% of the total.

[0039] The single-use extract of burdock root was obtained by direct ultrasonic extraction with 70% ethanol at 40°C and 250W for 60 minutes. The single-use extract of *Ilex cornuta* was obtained by directly extracting with 70% ethanol at 40°C and 250W using ultrasound for 60 minutes.

[0040] Comparative Example 6: The composition of this composition is 3% kudzu root extract, 2% black goji berry extract, 0.1% hypoglycemic decapeptide (amino acid sequence: LRSELAAWSR), 2% trehalose, 0.2% sodium benzoate, 1% glycerol, 0.75% vitamin C, and water to make up to 100% of the total.

[0041] The kudzu root extract is obtained by soaking kudzu root tuber powder in a 70% ethanol solution at a ratio of 1:10 and extracting at room temperature for 24 hours. The black goji berry extract is obtained by soaking black goji berry fruit powder in 50% ethanol at a ratio of 1:10 and then ultrasonically extracting it at 40℃ and 250w for 60 minutes.

[0042] Example 6: Detection of the effects of feeding different compositions on diabetic mice Construction of a type 2 diabetes mouse model Healthy SPF-grade C57BL / 6J mice were selected and acclimatized for one week. The environmental control was as follows: temperature: 22±2℃, relative humidity: 50%-60%, and light cycle: 12 hours of light / 12 hours of darkness.

[0043] Six mice were randomly selected as the blank control group and fed a standard diet. The remaining mice were fed a high-sugar, high-fat diet with the following composition: 10.0% lard, 20.0% sucrose, 2.5% cholesterol, 1.0% bile salts, and 66.5% standard diet.

[0044] After feeding continuously for 3 weeks, fast for 12 hours and ensure free access to water.

[0045] The blank control group was given citrate buffer (pH=4.4) at a dose of 100 mg / kg via intraperitoneal injection; The model group was given STZ solution (100 mg / kg, dissolved in citrate buffer) via intraperitoneal injection.

[0046] After three consecutive days of injections, the mouse model of type 2 diabetes was successfully established.

[0047] 72 hours after modeling, blood was collected by tail clipping and blood glucose was measured. Mice with blood glucose levels exceeding 11.0 mmol / L were considered to have successfully modeled the mice and could be used for subsequent experiments.

[0048] Drug administration and fasting blood glucose testing Six mice fed with standard diet were selected as blank control group. Mice were given 0.1 mL of purified water (average weight about 20 g) by gavage daily. Mice that successfully modeled diabetes were selected as experimental group. The experimental group was divided into 10 groups (type 2 diabetes model group and treatment groups 1-9), with 6 mice in each group. Mice in type 2 diabetes model group were given 0.1 mL of purified water by gavage daily. Mice in treatment groups 1-9 were given different hypoglycemic drugs prepared in Examples 3-5 and Comparative Examples 1-6 by gavage daily, respectively.

[0049] After three weeks of continuous administration, all mice were fasted for 12 hours to avoid food intake affecting blood glucose levels.

[0050] Blood was collected by tail clipping to detect fasting blood glucose concentration in mice after different experimental treatments.

[0051] Table 1. Differences in fasting blood glucose concentration in mice

[0052] pass Figure 1 Based on the results in Table 1, the following conclusions can be drawn: The blood glucose concentration of the blank control group mice was 6.20 ± 0.22 mmol / L, indicating that the blood glucose level of normal mice was stable and within the normal physiological range. In contrast, the fasting blood glucose concentration of the type 2 diabetes model group mice was 19.46 ± 1.36 mmol / L, which was significantly higher than that of the blank control group, proving that the diabetes model was successfully established.

[0053] In the treatment groups, the blood glucose concentrations of mice in treatment groups 1, 2, and 3 were 8.30±0.63 mmol / L, 9.32±0.67 mmol / L, and 9.81±0.72 mmol / L, respectively, which were significantly lower than those in the model group and close to normal levels. Treatment group 1 showed the most significant blood glucose reduction effect and was statistically different from treatment groups 2 and 3, indicating that the hypoglycemic drug prepared in Example 3 had the best hypoglycemic effect. This may be attributed to the rational coordination of the proportions of the drug components and the complementary multi-target mechanism of action. For example, burdock root extract works by improving insulin sensitivity, the appropriate proportion of *Ilex chinensis* extract enhances the antioxidant effect, and the hypoglycemic decapeptide inhibits the activity of α-amylase and α-glucosidase. Through the synergistic therapeutic effect of multiple targets, the ideal hypoglycemic effect was ultimately achieved.

[0054] In contrast, while blood glucose levels decreased in treatment groups 4, 5, and 6, the effects were limited. This indicates that the synergistic effect of hypoglycemic drugs is affected when key components (burdock root extract, ivy extract, or hypoglycemic decapeptide) are lacking, thus failing to significantly lower blood glucose levels. Especially when the effective components are absent, the overall effect of the drugs falls far short of optimality.

[0055] Furthermore, the results of treatment groups 7 and 8 showed that the burdock root extract and *Ilex chinensis* extract obtained by decoction extraction or single extraction without ethanol concentration and temperature adjustment, while slightly better than the groups lacking core components, still failed to produce a synergistic effect with the hypoglycemic peptides. This may be because the decoction extraction method, under high-temperature conditions, may cause the degradation of some heat-sensitive active ingredients (such as polyphenols and flavonoids), resulting in insufficient activity of the extract. The single extraction method, on the other hand, does not completely extract complex components from the plant, also leading to a lack of synergistic hypoglycemic effect.

[0056] Finally, the results of treatment group 9 showed that although kudzu root extract and black goji berry extract also have certain hypoglycemic effects, when used in combination with hypoglycemic peptides, they failed to produce the significant synergistic effect seen in burdock root extract and holly extract. This indicates that when hypoglycemic peptides work together with the burdock root extract and holly extract prepared in this invention, they can form an effective synergistic effect, and none of them can be omitted, further demonstrating the important role of these components in the treatment of diabetes.

[0057] Example 7: Blood samples obtained from different experimental treatments in Example 6 were placed in centrifuge tubes, and centrifuged at a speed of 3500 rpm for 15 minutes. After centrifugation, the supernatant serum was collected, and the total cholesterol content in mouse serum was detected by radioimmunoassay. The results are shown in Table 2 and... Figure 2 As shown.

[0058] Table 2. Differences in total cholesterol content in mice

[0059] From Table 2 and Figure 2 The results showed that the total cholesterol in the diabetic model group mice was significantly elevated, reflecting the metabolic disorders and lipid metabolism abnormalities caused by diabetes.

[0060] In treatment groups 1-3, especially treatment group 1, a better cholesterol-lowering effect was observed, with a significant reduction in total cholesterol levels. This indicates that the hypoglycemic drugs prepared in Examples 3 to 5 can effectively improve total cholesterol metabolism abnormalities caused by diabetes. Furthermore, the effect of treatment group 1 was superior to that of treatment groups 2 and 3, similar to the results of blood glucose testing, further validating the advantages of the hypoglycemic drug prepared in Example 3, whose effect was significantly better than that of the drugs prepared in Examples 4 and 5. This demonstrates that the optimal synergistic effect was achieved at this combination ratio. The results of treatment groups 4 to 6 showed that, in the absence of the core active ingredient, the drug's effect on restoring abnormal total cholesterol metabolism was relatively limited, indicating that the synergistic effect of the drug could not be fully exerted when the key ingredient was missing, and the cholesterol-lowering effect was also affected.

[0061] The results of treatment groups 7 and 8 further demonstrated that the burdock root extract and *Ilex chinensis* extract obtained by decoction extraction or single extraction methods could not significantly restore cholesterol metabolism abnormalities in diabetic mice. This may be because the decoction and single extraction methods may result in insufficient activity of the extracted components, thus affecting the overall efficacy of the drug.

[0062] Finally, the results of treatment group 9 were consistent with the blood glucose test results. Although the drug prepared by replacing burdock root extract and holly extract showed a certain cholesterol-lowering effect, it could not produce a synergistic effect with the hypoglycemic peptide, indicating that the combination of burdock root extract and holly extract with hypoglycemic peptide is indispensable in cholesterol metabolism abnormalities caused by diabetes treatment.

[0063] Example 8: Testing the effects of the hypoglycemic drugs prepared in Examples 3-5 of this invention on oxidative damage and inflammatory response caused by diabetes. The blood samples from the blank control group, the type 2 diabetes model group, treatment group 1, treatment group 2, and treatment group 3 obtained in Example 6 were placed in centrifuge tubes, and the centrifuge speed was set to 3500 rpm and the time was set to 15 minutes for centrifugation. After centrifugation, the supernatant serum was collected, and the levels of SOD and IL-6 in the serum were detected using a superoxide dismutase (SOD) ELISA kit and a tumor necrosis factor-α (TNF-α) ELISA kit. The results are shown in Table 3. Figure 3 and Figure 4 As shown.

[0064] Table 3. Differences in SOD and TNF-α levels in mice

[0065] As shown in Table 3, the SOD (superoxide dismutase) content in the blank control group mice was 193.07±11.68 U / ml, indicating that the antioxidant enzyme activity in healthy mice was at a normal level, effectively scavenging free radicals and maintaining redox balance. However, in the type 2 diabetes model group, the SOD content decreased significantly to 99.26±4.96 U / ml, indicating a significant increase in oxidative stress and a significant decrease in antioxidant capacity in diabetic mice. This may be related to the hyperglycemic state caused by diabetes, leading to the accumulation of free radicals and exacerbated oxidative damage.

[0066] Under the intervention of the hypoglycemic drugs prepared in Examples 3-5, SOD activity was restored. Specifically, the SOD content in treatment group 1 was 174.28±9.86 U / ml, in treatment group 2 it was 139.05±9.91 U / ml, and in treatment group 3 it was 144.91±8.66 U / ml. Although the degree of SOD recovery varied among the groups, all groups demonstrated the positive effect of the hypoglycemic drugs in improving the antioxidant capacity of diabetic mice, indicating that these drugs can effectively reduce oxidative damage caused by diabetes.

[0067] Regarding TNF-α (tumor necrosis factor-α) levels, the TNF-α content in the blank control group was 23.90±2.78 pg / mL, which is within the normal physiological level. However, in the type 2 diabetes model group, the TNF-α content was significantly increased to 72.29±3.35 pg / mL, indicating a significant inflammatory response in the diabetic mice. A hyperglycemic environment typically promotes chronic low-grade inflammation, further exacerbating the pathological process of diabetes.

[0068] After treatment with hypoglycemic drugs, the TNF-α levels in treatment groups 1, 2, and 3 decreased to 31.04±3.99 pg / mL, 44.95±2.88 pg / mL, and 40.74±3.09 pg / mL, respectively, demonstrating that these drugs can effectively inhibit the inflammatory response in diabetic mice. Treatment group 1, in particular, showed the largest decrease in TNF-α levels, indicating that this group of drugs has a significant effect in reducing the inflammatory response induced by diabetes.

[0069] In treatment groups 1, 2, and 3, TNF-α levels were reduced to 31.04±3.99 pg / mL, 44.95±2.88 pg / mL, and 40.74±3.09 pg / mL, respectively. This indicates that the hypoglycemic drugs of Examples 3-5 can effectively inhibit the inflammatory response in diabetic mice. Further comparison of the drug effects in Examples 3, 4, and 5 reveals that the hypoglycemic drug prepared in Example 3 exhibits the best effect in improving SOD activity and inhibiting TNF-α levels. In contrast, while the drugs in Examples 4 and 5 also show some improvement, their effects are not as significant as those in Example 3. This indicates that the drug prepared in Example 3 has a stronger synergistic effect in reducing oxidative damage and inflammatory responses caused by diabetes, and the optimization and formulation of the drug components lead to better therapeutic effects. Therefore, the hypoglycemic drug prepared in Example 3 demonstrates significant clinical potential in the antioxidative and anti-inflammatory treatment of diabetes.

Claims

1. A composition that reduces blood glucose levels in patients with type 2 diabetes and improves cholesterol metabolism abnormalities, oxidative damage, and inflammatory responses caused by type 2 diabetes, characterized in that, The composition comprises, by weight percentage, the following ingredients: 3% burdock root extract, 2% ivy extract, 0.2% hypoglycemic decapeptide, 2% trehalose, 0.2% sodium benzoate, 1% glycerin, 0.75% vitamin C, and water to 100%. The method for preparing the composition includes the following steps: (1) Preparation of basic solution In a clean mixing container, add 60% water and keep stirring; Add 2% trehalose and stir until completely transparent; Add 0.2% sodium benzoate and continue stirring until homogeneous; Add 1% glycerin and stir until smooth; (2) Add plant extracts Slowly add 3% burdock root extract to the stirred base solution, keeping stirring to ensure complete dissolution; Next, add 2% of the evergreen extract, stirring constantly to ensure complete dissolution; (3) Add hypoglycemic decapeptide Dissolve 0.2% hypoglycemic decapeptide powder in 5% water and mix thoroughly to form a homogeneous hypoglycemic decapeptide solution. Slowly add the blood sugar-lowering decapeptide solution to the mixing container while stirring to ensure even distribution; (4) Add antioxidants Dissolve 0.75% vitamin C powder in 5% water and add it to the mixed solution, then stir well. (5) Replenish water volume Add the remaining water to adjust to 100% of the target formula, continue stirring for 10 minutes, and then sterilize by 0.22 μm filtration to obtain the hypoglycemic drug. The amino acid sequence of the hypoglycemic decapeptide is LRSELAAWSR; The preparation method of the burdock root extract includes the following steps: (1) Remove impurities from dried burdock root, wash it clean, slice it and crush it into burdock root powder; (2) Mix burdock root powder with 50% ethanol at a mass-volume ratio of 1:10, and extract with ultrasound for 30 minutes at a temperature of 50°C and a power of 250W. (3) Use a filter screen to filter and collect extract a and filter residue; (4) Mix the filter residue with 70% ethanol at a mass-volume ratio of 1:10, and extract with ultrasound for 30 minutes at a temperature of 50°C and a power of 250W. (5) Filter the solution using a filter screen, collect extract b, and combine extract a and extract b to obtain a mixed extract; (6) Concentrate the mixed extract to 1 / 10 of its original volume to obtain a concentrated extract; (7) Freeze-dry the concentrated extract to obtain burdock root extract; The preparation method of the *Ilex cornuta* extract includes the following steps: (1) Remove impurities from dried evergreen leaves, wash them clean, and then pulverize them into evergreen powder; (2) Add the powder of Sijiqing to a 50% ethanol solution at a mass-volume ratio of 1:10 and extract at room temperature for 24 hours; (3) Use a filter screen to filter and collect extract a and filter residue; (4) Mix the filter residue with 70% ethanol at a mass-volume ratio of 1:8, and extract by ultrasonication at 40°C and 250W for 30 minutes. (5) Filter the solution using a filter screen, collect extract b, and combine extract a and extract b to obtain a mixed extract; (6) The mixed extract was concentrated to 1 / 10 of its original volume using a rotary evaporator to obtain a concentrated extract; (7) Freeze-dry the concentrated extract to obtain the Four Seasons Green Extract.

2. The use of a composition in the preparation of a drug for treating hyperglycemia, abnormal cholesterol metabolism, oxidative damage, and inflammatory responses caused by type 2 diabetes, characterized in that, The composition comprises, by weight percentage, the following ingredients: 3% burdock root extract, 2% ivy extract, 0.1% hypoglycemic decapeptide, 2% trehalose, 0.2% sodium benzoate, 1% glycerin, 0.75% vitamin C, and water to 100%. The amino acid sequence of the hypoglycemic decapeptide is LRSELAAWSR; The burdock root extract is prepared according to the method described in claim 1; The *Ilex cornuta* extract is prepared according to the method for preparing *Ilex cornuta* extract as described in claim 1.

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