Preparation method of auxiliary blood sugar reducing composition for diabetes mellitus based on shiny-leaved yellowhorn leaves

Abstract

The invention relates to the field of functional foods, and discloses a preparation method of a composition for assisting in reducing blood sugar of diabetes based on shiny-leaved yellowhorn leaves. The composition comprises the following components in percentage by mass: 2.00% of rutin, 1.00% of ursolic acid, 3.00% of charantin, 0.05% of chromium picolinate, 2.00% of a mulberry leaf extract, 2.00% of puerarin, 8.00% of an astragalus membranaceus extract, 10.00% of Chinese yam powder, 2.00% of a ginseng extract, 20.00% of oligosaccharide, 48.45% of soluble dietary fibers, 1.00% of erythritol and 0.50% of microcrystalline cellulose. The Xanthoceras sorbifolia leaf double-component extraction is adopted, multiple natural functional factors and a low-GI matrix are matched, and the effect of assisting in reducing blood sugar is achieved through multi-channel synergy of regulating intestinal flora, delaying sugar absorption, enhancing insulin sensitivity and the like. The composition has the advantages of high safety and natural components, can be industrially granulated and produced, and is suitable for auxiliary conditioning of prediabetic people and patients with type 2 diabetes mellitus. The invention also discloses a preparation method and action verification data of the composition.

Description

Technical Field

[0001] This invention relates to the field of functional foods, and more specifically to a method for preparing a diabetes adjuvant hypoglycemic composition based on *Sapindus mukorossi* leaves. Background Technology

[0002] Currently, the incidence of diabetes, especially type 2 diabetes, continues to rise, becoming a global public health challenge. Its etiology is complex, closely related to multiple factors such as insulin resistance, impaired insulin secretion, gut microbiota imbalance, and oxidative stress. While commonly used hypoglycemic drugs such as metformin, glibenclamide, and acarbose can effectively control blood sugar, long-term use often brings side effects such as gastrointestinal discomfort, liver and kidney damage, and the risk of hypoglycemia.

[0003] In recent years, active ingredients derived from natural plants that aid in lowering blood sugar have received widespread attention. These include bitter melon extract, mulberry leaf extract, puerarin, and ginsenosides, which possess multiple functions such as improving insulin sensitivity, inhibiting glucose absorption, and regulating metabolic pathways. Meanwhile, intestinal regulatory factors such as dietary fiber and oligosaccharides have been shown to slow glucose absorption, promote GLP-1 secretion, and optimize gut microbiota, thus playing an important auxiliary role in diabetes management.

[0004] However, most existing products lack systematic formulation design, simply adding 1-2 extracts without forming a scientific synergistic mechanism; at the same time, some products use high glycemic excipients (such as maltodextrin), which actually increases the glucose load; in addition, potential high-value plant resources such as Xanthoceras sorbifolium leaves have not been effectively developed for glucose metabolism intervention, and there is a lot of room for research and application. Therefore, we propose a method for preparing a diabetes adjuvant hypoglycemic composition based on Xanthoceras sorbifolium leaves. Summary of the Invention

[0005] To address the shortcomings of existing technologies, this invention provides a method for preparing a diabetes adjuvant hypoglycemic composition based on Xanthoceras sorbifolium leaves, thereby solving the technical problems existing in the prior art.

[0006] The above-mentioned technical objective of the present invention is achieved through the following technical solution: A hypoglycemic adjunctive composition based on *Sapindus mukorossi* leaves, comprising the following ingredients by weight percentage: Rutin 2%, ursolic acid 1%, bitter melon extract 3%, chromium picolinate 0.05%, mulberry leaf extract 2%, puerarin 2%, astragalus extract 8%, yam powder 10%, ginseng extract 2%, oligosaccharides 20%, soluble dietary fiber 48.45%, erythritol 1%, microcrystalline cellulose 0.5%; The rutin and ursolic acid are both derived from the leaves of *Sapindus mukorossi*, the oligosaccharides are one or more of fructooligosaccharides, galactooligosaccharides, and isomaltooligosaccharides, and the soluble dietary fiber is one or a combination of inulin, pectin, konjac flour, or oat β-glucan.

[0007] A method for preparing a diabetes adjuvant hypoglycemic composition based on *Sapindus mukorossi* leaves, wherein the extraction of rutin and ursolic acid includes the following steps: S1: Soak the leaves of *Xanthoceras sorbifolium* in enough clean water for 15-20 minutes, and gently stir the leaves during the soaking process to remove dust and impurities. Then rinse them repeatedly with clean water 3-5 times until the washing liquid is clear. The water flow rate should be controlled to a level that does not cause physical damage to the leaves. S2: Spread the washed Xanthoceras sorbifolium leaves evenly in a well-ventilated, dry environment away from direct sunlight. The thickness of the spread should not exceed 5 cm. Turn the leaves over every 2 to 3 hours until they are completely dry and the moisture content is less than 10%. S3: Crush the dried leaves of *Sapindus mukorossi* to a particle size of 0.5–2 mm, and introduce inert gas during the crushing process to create an anaerobic environment; S4: Add the crushed Xanthoceras sorbifolium leaves to 70% ethanol at a material-to-liquid ratio of 1:10. Set the temperature to 75°C and reflux for 2 hours. Filter and retain the filtrate. Repeat the extraction once. Combine the filtrates and concentrate them under reduced pressure at 50–55°C to one-third of the original volume to obtain the concentrated extract. S5: Cool the obtained concentrate to room temperature, add an equal volume of ethyl acetate, mix and stir for 10 minutes, let stand and separate into layers, take the upper ethyl acetate phase, repeat the extraction three times, combine the ethyl acetate phases, and rotary evaporate to 1 / 10 of the original volume at 50°C and 0.08MPa under reduced pressure to obtain crude ursolic acid extract. S6: Dissolve the crude ursolic acid extract in 4-5 times its volume of 95% ethanol, add 0.1 mol / L NaOH to adjust the pH to 8.0-8.5, stir and saponify for 10 minutes, wash with deionized water until neutral, and filter out the residue to obtain the clear ursolic acid extract. S6.1: Dissolve the clear extract in 95% ethanol (weight-volume ratio 1:10), stir at room temperature to dissolve, refrigerate at 4°C for 24-48 hours to precipitate and crystallize, filter to obtain ursolic acid crystals, wash with cold ethanol, dry at 50°C and vacuum –0.08MPa for 8-10 hours, pulverize and sieve to obtain ursolic acid powder; adjust the pH of the aqueous phase after ethyl acetate extraction to 5.5-6.0, and send the liquid into a chromatography column packed with AB-8 or HPD-100 macroporous resin at a flow rate of 1 BV / h using a peristaltic pump, and let stand for 15 minutes after injection; S7: First, elute with 1-2 BV of deionized water, collect and test the eluent; S7.1: Elute with 1-2 BV of 50% ethanol, collect and group the rutin content per liter, and end elution when the rutin content decreases to the baseline level; S7.2: Combine the eluents containing rutin, concentrate under reduced pressure at 45-50°C to 1 / 5 of the original volume, dry under light-proof and airtight conditions for 8-12 hours, and pulverize and sieve to obtain rutin powder.

[0008] Preferably, the soaking water temperature is room temperature, and the stirring tool is a glass rod or a clean hand; The inert gas introduced during the pulverization process is nitrogen or argon. The extraction process involved two extractions, each lasting 2 hours, with an ethanol concentration of 70% used in both extractions. During the ursolic acid extraction process, the volume ratio of ethyl acetate to extract was 1:1, with each extraction lasting 10 minutes and followed by 15 minutes of standing. The extraction was repeated a total of 3 times.

[0009] Preferably, the ursolic acid extract obtained after the saponification reaction is dissolved in 95% ethanol and then precipitated at 4°C for 24–48 hours to form ursolic acid crystals. The ursolic acid powder was dried at 50°C and under vacuum of -0.08MPa for 8 to 10 hours, and finally pulverized through a 60-mesh sieve. The rutin separation process uses AB-8 or HPD-100 macroporous resin, with a resin filling volume of 10L wet volume, a column height of 60-80cm, and an inner diameter of 10-15cm. During the rutin elution process, the ethanol concentration was 50%, and the eluent was analyzed by UV or HPLC in groups of one liter. Rutin powder was dried at 50°C and under vacuum (<–0.08 MPa) for 8–12 hours, and finally pulverized through a 60-mesh sieve to obtain a light yellow powder.

[0010] A method for preparing a diabetes adjuvant hypoglycemic composition based on *Xanthoceras sorbifolium* leaves, the method comprising the following steps: (A) Weigh each component according to the proportion, wherein oligosaccharides and soluble dietary fiber are premixed, and chromium pyridinecarboxylate is dissolved in water and then mixed with erythritol and microcrystalline cellulose; (B) Add all raw materials into a V-type mixer and premix for 15–20 minutes; (C) Add 1% gelatin solution and moisten until it can be formed into a ball and is not sticky to the touch; (D) Granulation is performed using a swing granulator with a sieve aperture of 0.8–1.2 mm; (E) Dry in a hot air circulating oven at 60–70°C until moisture content ≤5%; (F) After drying, the grains are sieved, sized, and packaged for storage.

[0011] Preferably, the composition is suitable for preparing dosage forms such as granules, powders, chewable tablets, compressed tablets, and oral liquids, wherein the tablet disintegration time is less than 10 minutes and the granule moisture content is ≤5%.

[0012] Preferably, the daily dose of the composition is 5–9 grams, suitable for individuals with fasting blood glucose levels of 5.6–7.0 mmol / L, or for adjunctive management of patients diagnosed with type 2 diabetes.

[0013] Preferably, the composition enhances AMPK pathway activity, upregulates GLUT4 expression, and inhibits α-glucosidase activity, thereby helping to lower fasting blood glucose and postprandial blood glucose.

[0014] Preferably, the composition is used to prepare a health food for assisting in lowering blood sugar and regulating insulin sensitivity.

[0015] In summary, the present invention has the following main beneficial effects: This application utilizes mulberry leaf extract rich in 1-deoxynojirimycin (DNJ), which can inhibit the activity of α-glucosidase in the small intestine, slow down the rate of starch breakdown into glucose, and thus reduce the postprandial blood glucose peak. Puerarin can enhance insulin sensitivity and promote glucose uptake and utilization in muscle and liver tissues by activating the PI3K / Akt and AMPK signaling pathways; momordicin has an insulin-like structure and participates in glucose metabolism regulation; rutin can resist oxidation, scavenge free radicals, and upregulate GLUT4 transporter expression to improve glucose uptake efficiency; ursolic acid can enhance AMPK activity, improve insulin resistance, and inhibit gluconeogenesis; chromium picolinate, as a trace element, participates in the formation of insulin signal transduction complexes and promotes insulin function; ginseng and astragalus extracts have anti-inflammatory, immunomodulatory, and anti-stress functions, which can stabilize the internal environment and indirectly assist in blood glucose regulation.

[0016] The composition contains 48.45% soluble dietary fiber and 20% oligosaccharides, forming a slow-release glucose-controlling base. Soluble dietary fiber forms a viscous gel in the gastrointestinal tract, slowing down chyme emptying and carbohydrate absorption, and reducing insulin requirements. Oligosaccharides, as prebiotics, improve the gut microbiota structure, increase short-chain fatty acid-producing bacteria, and promote GLP-1 secretion, indirectly improving glucose metabolism. This design meets the recommendations of the "Dietary Guidelines for Diabetes" for high-fiber foods and helps control postprandial blood glucose fluctuations.

[0017] This invention represents the first systematic extraction of rutin and ursolic acid from *Xanthoceras sorbifolium* leaves. Highly efficient purification methods, including phase-separation extraction, macroporous resin separation, and low-temperature crystallization, were employed to obtain ≥60% rutin powder and ≥50% ursolic acid crystalline powder, respectively, improving activity utilization and product consistency. This method overcomes the traditional limitations of *Xanthoceras sorbifolium* applications, which are confined to oils and saponins, and represents the first systematic development of its application in the field of blood sugar lowering adjuvant therapy. Attached Figure Description

[0018] Figure 1 This is a diagram illustrating the synergistic effects of the components in this invention. Detailed Implementation

[0019] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0020] Example 1 refer to Figure 1 A diabetes adjunct hypoglycemic composition based on *Sapindus mukorossi* leaves, comprising the following ingredients by weight percentage: Rutin 2%, ursolic acid 1%, bitter melon extract 3%, chromium picolinate 0.05%, mulberry leaf extract 2%, puerarin 2%, astragalus extract 8%, yam powder 10%, ginseng extract 2%, oligosaccharides 20%, soluble dietary fiber 48.45%, erythritol 1%, microcrystalline cellulose 0.5%; The rutin and ursolic acid are both derived from the leaves of *Sapindus mukorossi*, the oligosaccharides are one or more of fructooligosaccharides, galactooligosaccharides, and isomaltooligosaccharides, and the soluble dietary fiber is one or a combination of inulin, pectin, konjac flour, or oat β-glucan.

[0021]

[0022] Example 2 refer to Figure 1 A method for preparing a diabetes adjuvant hypoglycemic composition based on *Sapindus mukorossi* leaves, wherein the extraction of rutin and ursolic acid includes the following steps: S1: Soak the leaves of *Xanthoceras sorbifolium* in enough clean water for 15-20 minutes, and gently stir the leaves during the soaking process to remove dust and impurities. Then rinse them repeatedly with clean water 3-5 times until the washing liquid is clear. The water flow rate should be controlled to a level that does not cause physical damage to the leaves. S2: Spread the washed Xanthoceras sorbifolium leaves evenly in a well-ventilated, dry environment away from direct sunlight. The thickness of the spread should not exceed 5 cm. Turn the leaves over every 2 to 3 hours until they are completely dry and the moisture content is less than 10%. S3: Crush the dried leaves of *Sapindus mukorossi* to a particle size of 0.5–2 mm, and introduce inert gas during the crushing process to create an anaerobic environment; S4: Add the crushed Xanthoceras sorbifolium leaves to 70% ethanol at a material-to-liquid ratio of 1:10. Set the temperature to 75°C and reflux for 2 hours. Filter and retain the filtrate. Repeat the extraction once. Combine the filtrates and concentrate them under reduced pressure at 50–55°C to one-third of the original volume to obtain the concentrated extract. S5: Cool the obtained concentrate to room temperature, add an equal volume of ethyl acetate, mix and stir for 10 minutes, let stand and separate into layers, take the upper ethyl acetate phase, repeat the extraction three times, combine the ethyl acetate phases, and rotary evaporate to 1 / 10 of the original volume at 50°C and 0.08MPa under reduced pressure to obtain crude ursolic acid extract. S6: Dissolve the crude ursolic acid extract in 4-5 times its volume of 95% ethanol, add 0.1 mol / L NaOH to adjust the pH to 8.0-8.5, stir and saponify for 10 minutes, wash with deionized water until neutral, and filter out the residue to obtain the clear ursolic acid extract. S6.1: Dissolve the clear extract in 95% ethanol (weight-volume ratio 1:10), stir at room temperature to dissolve, refrigerate at 4°C for 24-48 hours to precipitate and crystallize, filter to obtain ursolic acid crystals, wash with cold ethanol, dry at 50°C and vacuum –0.08MPa for 8-10 hours, pulverize and sieve to obtain ursolic acid powder; adjust the pH of the aqueous phase after ethyl acetate extraction to 5.5-6.0, and send the liquid into a chromatography column packed with AB-8 or HPD-100 macroporous resin at a flow rate of 1 BV / h using a peristaltic pump, and let stand for 15 minutes after injection; S7: First, elute with 1-2 BV of deionized water, collect and test the eluent; S7.1: Elute with 1-2 BV of 50% ethanol, collect and group the rutin content per liter, and end elution when the rutin content decreases to the baseline level; S7.2: Combine the eluents containing rutin, concentrate under reduced pressure at 45-50°C to 1 / 5 of the original volume, dry under light-proof and airtight conditions for 8-12 hours, pulverize and sieve to obtain rutin powder; The soaking water temperature is room temperature, and the stirring tool is a glass rod or a clean hand; The inert gas introduced during the pulverization process is nitrogen or argon. The extraction process involved two extractions, each lasting 2 hours, with an ethanol concentration of 70% used in both extractions. During the ursolic acid extraction process, the volume ratio of ethyl acetate to extract was 1:1, the extraction time was 10 minutes each time, followed by 15 minutes of standing, and the extraction was repeated 3 times in total. After the saponification reaction, the ursolic acid extract obtained was dissolved in 95% ethanol and then precipitated at 4°C for 24–48 hours to form ursolic acid crystals. The ursolic acid powder was dried at 50°C and under vacuum of -0.08MPa for 8 to 10 hours, and finally pulverized through a 60-mesh sieve. The rutin separation process uses AB-8 or HPD-100 macroporous resin, with a resin filling volume of 10L wet volume, a column height of 60-80cm, and an inner diameter of 10-15cm. During the rutin elution process, the ethanol concentration was 50%, and the eluent was analyzed by UV or HPLC in groups of one liter. Rutin powder was dried at 50°C and under vacuum (<–0.08 MPa) for 8–12 hours, and finally pulverized through a 60-mesh sieve to obtain a light yellow powder.

[0023] Example 3 A method for preparing a diabetes adjuvant hypoglycemic composition based on *Xanthoceras sorbifolium* leaves, the method comprising the following steps: (A) Weigh each component according to the proportion, wherein oligosaccharides and soluble dietary fiber are premixed, and chromium pyridinecarboxylate is dissolved in water and then mixed with erythritol and microcrystalline cellulose; (B) Add all raw materials into a V-type mixer and premix for 15–20 minutes; (C) Add 1% gelatin solution and moisten until it can be formed into a ball and is not sticky to the touch; (D) Granulation is performed using a swing granulator with a sieve aperture of 0.8–1.2 mm; (E) Dry in a hot air circulating oven at 60–70°C until moisture content ≤5%; (F) After drying, the grains are sieved, sized, and packaged for storage.

[0024] The composition is suitable for preparing dosage forms such as granules, powders, chewable tablets, compressed tablets, and oral liquids, wherein the tablet disintegration time is less than 10 minutes and the granule moisture content is ≤5%; the daily dosage of the composition is 5–9 grams, suitable for people with fasting blood glucose levels of 5.6–7.0 mmol / L, or for adjunctive management of patients diagnosed with type 2 diabetes; the composition enhances AMPK pathway activity, upregulates GLUT4 expression, and inhibits α-glucosidase activity, thereby helping to lower fasting blood glucose and postprandial blood glucose. The composition is used to prepare health food products for assisting in lowering blood glucose and regulating insulin sensitivity.

[0025] Example 4 Male Kunming mice (weighing 18–22 g) were used to establish a type 2 diabetes model via a high-fat diet combined with intraperitoneal injection of streptozotocin (STZ). The mice were divided into 5 groups (n=10): Normal control group (NC group) Diabetes model group (DM group) Drug control group (administered metformin 200 mg / kg) The low-dose group of the composition of the present invention (200 mg / kg·d) High-dose group of the composition of the present invention (400 mg / kg·d) Administered via gavage for 28 consecutive days, with monitoring during this period: Fasting blood glucose (days 0, 7, 14, 21, and 28) Oral glucose tolerance test (OGTT) Serum insulin (ELISA method) Expression of GLUT4 and AMPK genes in liver tissue (RT-PCR) The high-dose group showed an average decrease of 32.6% in fasting blood glucose, a significant decrease in AUC in the OGTT, recovery of insulin levels, and upregulation of GLUT4 and AMPK, suggesting that the composition of the present invention has a good auxiliary hypoglycemic effect.

[0026] Example 5 Thirty subjects with prediabetes (fasting blood glucose 5.6–6.9 mmol / L), half male and half female, with an average age of 53 years, were selected and randomly placed into a single group for observation. They took 6g of the granules of the composition of this invention twice a day, morning and evening, for 30 consecutive days.

[0027] Testing indicators: Fasting blood glucose (FBG) 2-hour postprandial blood glucose (2hPG) Glycated hemoglobin (HbA1c) Safety indicators (weight, gastrointestinal reactions, etc.) result: FBG decreased from 6.4 to 5.9 mmol / L, a decrease of approximately 7.8%; 2hPG decreased from 9.6 to 8.4 mmol / L, a decrease of 12.5%; HbA1c decreased from 6.2% to 5.8%; No adverse reactions occurred, and some participants reported gastrointestinal comfort and no drowsiness after eating.

[0028] Conclusion: The composition of the present invention has significant potential for assisting blood sugar control in people with prediabetes and has good safety.

[0029] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A diabetes mellitus adjunct blood sugar lowering composition based on Xanthoceras sorbifolia Bunge leaves characterized in that, By mass percentage, the following components are included: Rutin 2%, Ursolic acid 1%, Momordicin 3%, Chromium picolinate 0.05%, Mulberry leaf extract 2%, Puerarin 2%, Astragalus extract 8%, Yam powder 10%, Ginseng extract 2%, Oligosaccharide 20%, Soluble dietary fiber 48.45%, Erythritol 1%, Microcrystalline cellulose 0.5%; The rutin and ursolic acid are derived from Xanthoceras leaves, the oligosaccharide is one or several of fructooligosaccharide, galactooligosaccharide, or isomaltooligosaccharide, and the soluble dietary fiber is one or several combinations of inulin, pectin, konjac powder, or oat beta-glucan.

2. A process for the preparation of a diabetes mellitus adjunct blood sugar lowering composition based on Xanthoceras sorbifolia Bunge leaves as claimed in claim 1, wherein, The extraction of the rutin and ursolic acid includes the following steps: S1: Soak the Xanthoceras leaves in sufficient clean water for 15-20 minutes, and gently stir the leaves during the soaking process to remove dust and impurities, then rinse repeatedly with clean water for 3-5 times until the washing liquid is clear, and the water flow speed is controlled to a degree that does not cause physical damage to the leaves; S2: Uniformly spread the washed Xanthoceras leaves in a well-ventilated, dry, and sunlight-free environment, with a thickness of no more than 5 centimeters, and turn them over every 2-3 hours until they are completely dry, with a water content of less than 10%; S3: Crush the dried Xanthoceras leaves to a particle size of 0.5-2 millimeters, and introduce inert gas during the crushing process to create an oxygen-free environment; S4: Add 70% ethanol to the crushed Xanthoceras leaves at a solid-liquid ratio of 1:10, set the temperature to 75°C, and extract for 2 hours, then filter the filtrate and repeat the extraction once, combine the filtrates, and concentrate under reduced pressure at 50-55°C to one-third of the original volume to obtain a concentrated extract; S5: Cool the obtained concentrated extract to room temperature, add an equal volume of ethyl acetate, mix and stir for 10 minutes, separate the layers after standing, and take the upper ethyl acetate phase, repeat the extraction three times, combine the ethyl acetate phases, and rotary evaporate under reduced pressure at 50°C and 0.08 MPa to 1 / 10 of the original volume to obtain a ursolic acid crude extract paste; S6: Dissolve the ursolic acid crude extract paste in 4-5 times the volume of 95% ethanol, add 0.1 mol / L NaOH to adjust the pH to 8.0-8.5, stir for 10 minutes for saponification reaction, wash with deionized water until neutral, filter out the residue to obtain a ursolic acid clear paste; S6.1: Dissolve the clear paste in 95% ethanol (1:10 by weight and volume), stir to dissolve at room temperature, store in a 4°C refrigerator for 24-48 hours to precipitate crystals, filter to obtain ursolic acid crystals, rinse with cold ethanol, and dry at 50°C under vacuum at -0.08 MPa for 8-10 hours, crush and sieve to obtain ursolic acid powder; adjust the pH of the water phase after ethyl acetate extraction to 5.5-6.0, and use a peristaltic pump to feed the liquid into a chromatographic column filled with AB-8 or HPD-100 macroporous resin at a flow rate of 1 BV / h, stand for 15 minutes after feeding; S7: First, elute with 1-2 BV of deionized water, collect and detect the eluate; S7.1: Then elute with 1-2 BV of 50% ethanol, collect and measure the rutin content per liter, and stop elution when the rutin content decreases to the base level; S7.2: combine the rutin-containing eluate, concentrate under reduced pressure at 45-50°C to 1 / 5 of the original volume, dry under dark and airtight conditions for 8-12 hours, and pulverize and sieve to obtain rutin powder.

3. A process for the preparation of a diabetes mellitus adjunctive hypoglycemic composition based on Xanthoceras sorbifolia Bunge leaves as claimed in claim 2, wherein, The soaking water temperature is normal temperature, and the stirring tool is a glass rod or a clean hand; The inert gas introduced during the pulverization process is nitrogen or argon; The time for each of the two extractions in the ethanol extraction step is 2 hours, and the ethanol concentration used is 70%; In the ursolic acid extraction process, the volume ratio of ethyl acetate to the extraction liquid is 1:1, each extraction is performed for 10 minutes, and the liquid is allowed to stand for 15 minutes, and the extraction is performed for 3 times.

4. A process for the preparation of a diabetes mellitus adjunct blood sugar lowering composition based on Xanthoceras sorbifolia Bunge leaves as claimed in claim 3, wherein, After the saponification reaction, the ursolic acid clear paste obtained is dissolved in 95% ethanol, and then the ursolic acid crystal is formed by refrigeration at 4°C for 24-48 hours; The ursolic acid powder is dried at 50°C under a vacuum of -0.08 MPa for 8-10 hours, and finally pulverized through a 60-mesh sieve; The rutin separation uses AB-8 or HPD-100 type macroporous resin, the resin filling amount is 10 L of wet volume, the column height is 60-80 cm, and the inner diameter is 10-15 cm; During the rutin elution, the ethanol concentration is 50%, and the eluate is detected by UV or HPLC at a rate of one set per liter; The rutin powder is dried at 50°C under a vacuum of < -0.08 MPa for 8-12 hours, and finally pulverized through a 60-mesh sieve to obtain a light yellow powder.

5. A process for the preparation of a diabetes mellitus adjunct blood sugar lowering composition based on Xanthoceras sorbifolia Bunge leaves as claimed in any one of claims 1 to 4, wherein, The preparation method of the composition comprises the following steps: (A) weigh each component according to the proportion, wherein the oligosaccharides are premixed with the soluble dietary fiber, and the chromium picolinate is dissolved in water and then mixed with erythritol and microcrystalline cellulose; (B) put all the raw materials into a V-type mixer and premix for 15-20 minutes; (C) add 1% gelatin water to adjust the humidity until the mixture can be shaped into a ball without sticking to the hand; (D) use a swing granulator to granulate, and the sieve aperture is 0.8-1.2 mm; (E) dry in a hot air circulation oven at 60-70°C until the moisture content is ≤5%; (F) sieve and granulate after drying, and then store and package.

6. The method of preparation of a diabetes mellitus adjunctive blood glucose lowering composition based on Xanthoceras sorbifolia Bunge leaves as claimed in claim 4, wherein, The composition is suitable for preparing granules, powders, chewable tablets, compressed tablets, oral solutions and other dosage forms, wherein the tablet disintegration time is less than 10 minutes, and the water content of the granules is ≤5%.

7. A method of preparing a diabetes mellitus adjunctive blood glucose lowering composition based on Xanthoceras sorbifolia Bunge leaves as claimed in claim 6, wherein, The daily dosage of the composition is 5-9 grams, and it is suitable for people with fasting blood glucose values of 5.6-7.0 mmol / L or for the auxiliary regulation of patients with diagnosed type 2 diabetes.

8. A process for the preparation of a diabetes mellitus adjunct blood sugar lowering composition based on Xanthoceras sorbifolia Bunge leaves as claimed in claim 7, wherein, The composition can help reduce fasting blood glucose and postprandial blood glucose by enhancing the activity of the AMPK pathway, up-regulating the expression of GLUT4, and inhibiting the activity of α-glucosidase.

9. A method of preparing a diabetes mellitus adjunctive blood glucose lowering composition based on Xanthoceras sorbifolia Bunge leaves as claimed in claim 8, wherein, The composition is used for preparing a health food for auxiliary reduction of blood glucose and regulation of insulin sensitivity.

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