A medicinal and edible composition for improving hyperuricemia and application thereof

Abstract

This invention belongs to the technical field of food-medicine homology compositions, specifically relating to a food-medicine homology composition for assisting in the improvement of hyperuricemia and its application. By weight, the food-medicine homology composition is made from the following raw materials: 3-15 parts kudzu root, 2-4 parts honeysuckle, 5-10 parts codonopsis, 2-4 parts astragalus, 6-8 parts coix seed, 3-5 parts red adzuki bean, and 2-4 parts licorice. The formulation of the food-medicine homology composition of this invention is based on the core principles of strengthening the spleen and kidneys, clearing heat and removing dampness, and resolving phlegm and removing blood stasis. All raw materials used in the food-medicine homology composition are food-medicine homology materials, and compared with chemical drugs, they cause less liver damage in the treatment of hyperuricemia. This invention mainly addresses the problem of high liver damage caused by chemical drugs used in the treatment of hyperuricemia.

Description

Technical Field

[0001] This invention belongs to the field of food and medicine homology composition technology, specifically relating to a food and medicine homology composition that can help improve hyperuricemia and its application. Background Technology

[0002] Hyperuricemia is a metabolic disease caused by purine metabolism disorder or uric acid excretion disorder. Traditional Chinese medicine classifies it under the categories of "gout," "dampness and turbidity," and "phlegm and blood stasis," believing that its core pathogenesis is spleen and kidney deficiency as the root cause, and damp-heat accumulation and phlegm and blood stasis as the manifestations.

[0003] Currently, commonly used clinical chemical drugs such as allopurinol and febuxostat mainly reduce serum uric acid levels by inhibiting xanthine oxidase to reduce endogenous uric acid production, or by increasing the kidney's excretion of uric acid. However, the use of these drugs carries a high risk of liver damage. Summary of the Invention

[0004] The purpose of this invention is to address the problem of significant liver damage caused by the use of chemical drugs in the treatment of hyperuricemia in the prior art, and to provide a food-derived composition that can help improve hyperuricemia and its application.

[0005] The technical solution adopted in this invention is: A medicinal and edible composition for assisting in the improvement of hyperuricemia, wherein the medicinal and edible composition is made from the following raw materials in parts by weight: 3 to 15 parts of kudzu root, 2 to 4 parts of honeysuckle, 5 to 10 parts of codonopsis, 2 to 4 parts of astragalus, 6 to 8 parts of coix seed, 3 to 5 parts of red adzuki bean and 2 to 4 parts of licorice.

[0006] Furthermore, the medicinal and edible composition is made from the following raw materials in parts by weight: 3.75 parts of kudzu root, 2.5 parts of honeysuckle, 7.5 parts of codonopsis, 2.5 parts of astragalus, 7.5 parts of coix seed, 3.75 parts of red adzuki bean, and 2.5 parts of licorice.

[0007] Furthermore, the Job's tears mentioned are processed Job's tears.

[0008] Furthermore, the kudzu root mentioned is simmered kudzu root.

[0009] Application of food-medicine homologous compositions in the preparation of foods suitable for people with high blood uric acid and in the preparation of drugs for the treatment and / or prevention of hyperuricemia.

[0010] Furthermore, the dosage form of the drug includes oral decoction, powder, granules, ointment, pills, or tablets.

[0011] Furthermore, the preparation method of the oral decoction includes the following steps: Weigh the raw materials according to the weight proportions; Soak Codonopsis pilosula, Pueraria lobata, Glycyrrhiza uralensis, Vigna angularis, Astragalus membranaceus and Coix lacryma-jobi in the first decoction. After boiling the first decoction over high heat, simmer it over low heat for 15 to 25 minutes. Then add Lonicera japonica and simmer for another 15 minutes. Filter out the decoction to obtain the first decoction. After adding water for the second decoction, bring it to a boil over high heat, then simmer over low heat for 30 to 40 minutes. Filter out the liquid to obtain the second decoction. The first and second decoctions are mixed, filtered, and concentrated to obtain an oral decoction. The mass ratio of the raw materials to the first decoction is 1:10~20; the mass ratio of the raw materials to the water added in the second decoction is 1:5~10. The oral decoction contains 0.10g to 0.5g of a food-medicine homology composition per milliliter.

[0012] Furthermore, the soaking time is 15 min to 30 min.

[0013] The preparation method of the powder or granules includes the following steps: The raw materials are pulverized to obtain raw material powders of 30 to 80 mesh. The raw material powders are mixed according to the mass fraction of the raw materials to obtain a drug for treating and / or preventing hyperuricemia.

[0014] The inventive concept of this invention is as follows: The medicinal and edible composition of the present invention uses kudzu root and honeysuckle in combination, which are the core of the whole formula and the principal medicine, targeting the damp-heat pathogenesis of hyperuricemia and clearing away heat toxins in the body.

[0015] Honeysuckle is cold in nature and sweet in taste, and enters the lung, heart, and stomach meridians. It has the effects of clearing heat and detoxifying, and dispersing wind-heat. Honeysuckle can regulate the body's immune function, inhibit inflammatory responses, and promote uric acid excretion. Kudzu root is cool in nature and sweet and pungent in taste, and enters the spleen and stomach meridians. It relieves muscle tension and reduces fever, promotes body fluid production and quenches thirst, and raises yang to stop diarrhea. Kudzu root contains puerarin, which can relieve the symptoms of acute gouty arthritis, help reduce joint swelling, and lower the body's uric acid levels.

[0016] The combination of kudzu root and honeysuckle creates a synergistic effect of "clearing heat and removing dampness, lowering uric acid and detoxifying." Kudzu root focuses on multi-target effects of "inhibiting uric acid production, promoting excretion, and regulating gut microbiota," while honeysuckle enhances the effects of "clearing heat and detoxifying, anti-inflammatory and diuretic." The combined use of the two can inhibit uric acid production at its source, enhance kidney and intestinal excretion functions, and simultaneously achieve multi-dimensional regulation of uric acid metabolism through regulating gut microbiota and anti-inflammatory effects.

[0017] Codonopsis pilosula and Astragalus membranaceus are used together as assistant herbs. Codonopsis pilosula is neutral in nature and sweet in taste, and enters the spleen and lung meridians. It tonifies the middle energizer and benefits qi, strengthens the spleen and lungs, enhances the body's resistance, lowers blood pressure, and nourishes blood while tonifying qi. Astragalus membranaceus is slightly warm in nature and sweet in taste, and enters the spleen and lung meridians. It tonifies qi and raises yang, consolidates the exterior and stops sweating, and promotes diuresis and reduces swelling. It can promote the metabolism of water in the body and improve poor urine excretion.

[0018] When combined with Astragalus, Codonopsis pilosula creates a synergistic effect of "tonifying qi and strengthening the spleen, promoting diuresis and eliminating dampness." Codonopsis pilosula focuses on "tonifying the middle jiao and replenishing qi, strengthening the spleen and generating fluids," while Astragalus membranaceus focuses on "tonifying qi and raising yang, promoting diuresis and reducing swelling." When used together, Codonopsis pilosula helps the spleen and stomach convert food into energy, while Astragalus membranaceus transports the energy throughout the body and promotes the metabolism of water and dampness, which aligns with the traditional Chinese medicine theory that "the spleen governs the transformation and transportation of water and dampness."

[0019] The combination of Job's tears and red adzuki beans is used as adjuvant herbs. Job's tears are cool in nature and sweet and bland in taste, and enter the spleen, stomach, and lung meridians. They strengthen the spleen, eliminate dampness, promote diuresis and reduce swelling, and clear heat and drain pus. Their active ingredients can regulate intestinal flora, promote uric acid excretion, and alleviate symptoms of high uric acid. Red adzuki beans are neutral in nature and sweet and sour in taste, and enter the heart and small intestine meridians. They promote diuresis and reduce swelling, and detoxify and drain pus. Rich in potassium, they can promote sodium metabolism and have the effects of promoting diuresis and eliminating dampness, and assisting in regulating uric acid. Job's tears focus on "strengthening the spleen and eliminating dampness," while red adzuki beans focus on "promoting diuresis and reducing swelling." The combination of the two can enhance the spleen's digestive function and promote water metabolism, thus jointly promoting uric acid excretion. This combination assists the principal herbs, kudzu root and honeysuckle, in clearing heat and eliminating dampness, reflecting the traditional Chinese medicine principle of "treating dampness by first treating the spleen."

[0020] Licorice is used as the guiding herb. Licorice tonifies the spleen and replenishes qi, clears heat and detoxifies, relieves spasms and pain, and harmonizes the effects of other herbs. It can enhance the spleen-strengthening and qi-replenishing effects, and also harmonize the cold and cooling properties of other herbs, making the whole formula mild and avoiding excessive coldness that could damage the spleen and stomach.

[0021] All seven ingredients in this formula are food-grade medicinal materials, ensuring high safety and suitability for long-term use. Furthermore, the formula employs a clear hierarchy of herbs: Kudzu root and honeysuckle are the principal herbs, clearing heat, removing dampness, lowering uric acid, and detoxifying to treat the symptoms; Codonopsis and Astragalus are the assistant herbs, strengthening the spleen, replenishing qi, and promoting the transformation and transportation of fluids; Coix seed and red adzuki bean are the adjuvant herbs, promoting diuresis, eliminating turbidity, and facilitating excretion; and licorice is the guiding herb, harmonizing the effects of all the herbs. This formula embodies the TCM principle of "clearing heat and removing dampness, strengthening the spleen and eliminating turbidity," working synergistically through multiple pathways such as clearing heat and removing dampness, strengthening the spleen and kidneys, and promoting diuresis to both promote uric acid excretion and improve spleen and kidney function, thus regulating uric acid metabolism at its root. Honeysuckle, kudzu root, and coix seed are slightly cooling in nature, while Codonopsis and Astragalus are slightly warming, and licorice is neutral. The overall balance of cooling and warming properties prevents excessive cooling from damaging the spleen and stomach's yang qi.

[0022] Compared with the prior art, the beneficial effects of the present invention are: (1) This invention provides a medicinal and edible homologous composition for assisting in the improvement of hyperuricemia. By weight, the composition is made from the following raw materials: 3-15 parts kudzu root, 2-4 parts honeysuckle, 5-10 parts codonopsis, 2-4 parts astragalus, 6-8 parts coix seed, 3-5 parts red adzuki bean, and 2-4 parts licorice. All raw materials used in the composition are safe medicinal and edible homologous materials, with low liver damage from long-term consumption, and thus have the effect of assisting in the improvement of hyperuricemia. Compared with chemical drugs, the raw materials used in the composition are all medicinal and edible homologous materials, and have lower liver damage in the treatment of hyperuricemia.

[0023] (2) The food-medicine homology composition provided by the present invention is characterized by its multi-target, holistic regulation and high safety, and shows unique advantages in the treatment of hyperuricemia. The food-medicine homology material originates from the traditional food culture, and is both food and Chinese medicine. Its safety has been verified by long-term practice.

[0024] (3) The food-medicine homology composition provided by this invention can synergistically regulate uric acid metabolism through multiple pathways, including inhibiting xanthine oxidase activity, promoting uric acid excretion, and regulating intestinal flora. It also possesses the traditional Chinese medicine conditioning effects of strengthening the spleen and removing dampness, clearing heat and detoxifying, and promoting blood circulation. Compared to chemical drugs, the food-medicine homology composition has fewer side effects, is less likely to induce drug resistance, and is suitable for long-term use. It alleviates symptoms while simultaneously conditioning the body's constitution, aligning with the concept of "prevention of disease."

[0025] (4) The food-medicine composition provided by the present invention not only meets market demand, but also provides a safer and more sustainable health management solution for the prevention and treatment of hyperuricemia. Attached Figure Description

[0026] Figure 1 A graph showing the serum uric acid level in mice after 21 days of intervention.

[0027] Figure 2 In the diagram, A represents the serum urea nitrogen level of mice after 21 days of intervention; B represents the serum creatinine level of mice after 21 days of intervention.

[0028] Figure 3 In the diagram, A represents the serum ALT level of mice after 21 days of intervention; B represents the serum AST level of mice after 21 days of intervention.

[0029] Figure 4 In the diagram, A represents the serum TNF-α level of mice after 21 days of intervention; B represents the serum IL-1β level of mice after 21 days of intervention; and C represents the serum IL-6 level of mice after 21 days of intervention.

[0030] Figure 5 Results of xanthine oxidase (XOD) activity assay in the liver of mice after 21 days of intervention.

[0031] Figure 6 To analyze the diversity and species richness of the gut microbiota in mice after 21 days of intervention, the following methods were used: A) Simpson index analysis; B) Shannon index analysis; C) Chao1 index analysis; and D) Ace index analysis.

[0032] Figure 7 Serum uric acid levels in mice after 21 days of intervention with oral decoction C, powder D, granules E, ointment F, pills G, tablets H, decoction I, and decoction J. Detailed Implementation

[0033] Those skilled in the art will understand that the techniques disclosed in the following embodiments represent those discovered by the inventors that function well in the practice of this invention. However, many changes can be made to the specific embodiments disclosed, still obtaining the same or similar results without departing from the spirit and scope of this invention. The following explanations are necessary: CMC-Na represents sodium carboxymethyl cellulose; PO represents potassium oxonate; HX represents hypoxanthine; Benzbromarone tablets, hereinafter referred to as benzbromarone, are from Hermann Pharmaceuticals in Germany, and are repackaged by Kunshan Longdeng Ruide Pharmaceutical Co., Ltd. Approval number: National Drug Approval Number J20180056, Production batch number: 2309291, solvent is 0.5% CMC-Na; ALT represents alanine aminotransferase; AST represents aspartate aminotransferase.

[0034] Example 1 An oral decoction of a medicinal and edible homologous composition that can help improve hyperuricemia is prepared as follows: S1. Weigh out 37.5g of stewed kudzu root, 25g of honeysuckle, 75g of codonopsis, 25g of astragalus, 75g of prepared coix seed, 37.5g of red adzuki bean and 25g of licorice, for a total of 300g of raw materials.

[0035] S2. For the first decoction, soak all raw materials except honeysuckle in water for 15 minutes. The mass ratio of water to raw materials is 20:1, i.e., 6 kg of water is used for soaking. After soaking, pour the water and herbs into a decoction pot. Bring the first decoction to a boil over high heat, then simmer over low heat for 15 minutes. Add honeysuckle and simmer for another 15 minutes. Filter out the liquid. For the second decoction, add water. The mass ratio of water to raw materials is 10:1, i.e., 3 kg of water. Bring the second decoction to a boil over high heat, then simmer over low heat for 30 minutes. Filter out the liquid. Mix the first decoction liquid with the first decoction liquid, filter, and finally concentrate under reduced pressure to 0.15 g / mL to obtain an oral decoction A of 0.15 g / mL equivalent of the medicinal and edible homologous composition.

[0036] Example 2 Based on Example 1, the final concentration under reduced pressure to 0.15 g / mL was changed to 0.3 g / mL, while other parameters remained unchanged; thus, an oral decoction of the food-medicine homology composition with an equivalent of 0.3 g / mL was obtained.

[0037] Example 3 An oral decoction of a medicinal and edible homologous composition that can help improve hyperuricemia is prepared as follows: S1. Weigh out 100g of stewed kudzu root, 40g of honeysuckle, 50g of codonopsis, 40g of astragalus, 60g of prepared coix seed, 50g of red adzuki bean, and 30g of licorice, for a total of 370g of raw materials.

[0038] S2. For the first decoction, soak all raw materials except honeysuckle in 7.4 kg of water for 30 minutes. After soaking, pour the water and herbs into a decoction pot. Bring the first decoction to a boil over high heat, then simmer over low heat for 25 minutes. Add honeysuckle and simmer for another 15 minutes. Filter the liquid. For the second decoction, add 3.7 kg of water, bring to a boil over high heat, then simmer over low heat for 40 minutes. Filter the liquid. Mix the first decoction liquid with the second decoction liquid, filter, and finally concentrate the liquid under reduced pressure to 0.3 g / mL to obtain the oral decoction C, a combination of food and medicine.

[0039] Example 4 A powder made from a medicinal and edible homologous composition, used to help improve hyperuricemia, is prepared as follows: S1. Weigh out 37.5g of kudzu root, 25g of honeysuckle, 75g of codonopsis, 25g of astragalus, 75g of coix seed, 37.5g of red adzuki bean and 25g of licorice, for a total of 300g of raw materials.

[0040] S2. Crush each raw material to obtain raw material powder of 30-80 mesh, mix them to obtain the medicinal and edible homologous composition powder D.

[0041] Example 5 A granule formulation of a food-derived medicinal composition for assisting in the improvement of hyperuricemia, the preparation steps of which are as follows: S1. Weigh out 37.5g of kudzu root, 25g of honeysuckle, 75g of codonopsis, 25g of astragalus, 75g of coix seed, 37.5g of red adzuki bean and 25g of licorice, for a total of 300g of raw materials.

[0042] S2. Add 3.8 kg of water to the raw materials and soak for 2 hours. First, bring to a boil over high heat, then simmer over low heat for 2 hours. Filter out the liquid. For the second decoction, add 2.8 kg of water to the dregs, bring to a boil over high heat, then simmer over low heat for 1.5 hours. Filter out the liquid. Combine the two decoctions and concentrate under reduced pressure to a thick paste with a relative density of 1.05~1.10 at 60℃. Mix evenly with soluble starch and mannitol in a mass ratio of 1.5-1.8:0.3 to prepare a soft mass. Granulate and size the granules to obtain the granules of the food-medicine homology composition E.

[0043] Example 6 A medicinal and edible homologous composition ointment for assisting in the improvement of hyperuricemia, the preparation steps are as follows: S1. Weigh out 37.5g of kudzu root, 25g of honeysuckle, 75g of codonopsis, 25g of astragalus, 75g of coix seed, 37.5g of red adzuki bean and 25g of licorice, for a total of 300g of raw materials.

[0044] S2. Soak the raw materials in 3.0 kg of water for 2 hours. For the first decoction, bring to a boil over high heat, then simmer over low heat for 2 hours and filter out the liquid. For the second decoction, add 2.8 kg of water to the dregs, bring to a boil over high heat, then simmer over low heat for 1.5 hours and filter out the liquid. Combine the two decoctions, reduce the pressure and concentrate to 1 / 3 of the original volume of the filtrate, let stand at 8°C for 24 hours, filter out the liquid, and concentrate to a clear paste with a relative density of 1.40 at 60°C to obtain the medicinal and edible homologous composition paste F.

[0045] Example 7 A medicinal and edible homologous composition pill for assisting in the improvement of hyperuricemia, the preparation steps are as follows: S1. Weigh out 37.5g of kudzu root, 25g of honeysuckle, 75g of codonopsis, 25g of astragalus, 75g of coix seed, 37.5g of red adzuki bean and 25g of licorice, for a total of 300g of raw materials.

[0046] S2. Crush all raw materials to obtain 100-120 mesh powder, mix them evenly; use 10%-15% of the powder with an appropriate amount of cold boiled water as a binder to form fine particles, and prepare pill molds; use the panning method to continuously add powder and spray binder to gradually increase the size of the pill molds to form water pills; use No. 3 and No. 4 sieves as screening standards to remove water pills that are too large or too small; dry the screened water pills at 60℃ for 4 hours until the moisture content is below 5%, to obtain the medicinal and edible homologous composition pill G; the water pill diameter is 6mm and the unit pill weight is 0.18g.

[0047] Example 8 A tablet made from a food-derived medicinal composition that helps improve hyperuricemia, prepared by the following steps: S1. Weigh out 37.5g of kudzu root, 25g of honeysuckle, 75g of codonopsis, 25g of astragalus, 75g of coix seed, 37.5g of red adzuki bean and 25g of licorice, for a total of 300g of raw materials.

[0048] S2. Directly pulverize all raw materials to obtain raw material powder that passes through a 100-120 mesh sieve, and mix them evenly; mix the mixed raw material powder with microcrystalline cellulose, lactose and starch filler at a ratio of 10:1-1.5, add 50% ethanol and wet granulate to obtain wet granules; place the wet granules at 50℃ and dry for 3 hours until the moisture content is 6%; add 2% croscarmellose sodium as a disintegrant and 0.5% magnesium stearate as a lubricant, mix thoroughly, and directly compress into tablets. The resulting tablets have a diameter of 12 mm and a unit tablet weight of 0.5 g; thus, the food-medicine homology composition tablet H is obtained.

[0049] Example 9 Weigh out 30g of kudzu root, 20g of honeysuckle, 60g of codonopsis, 20g of astragalus, 60g of coix seed, 30g of red adzuki bean, and 20g of licorice, totaling 240g of raw materials. Following the method in Example 2, simmer over low heat until the concentration reaches 0.5g / mL to obtain decoction K.

[0050] Example 10 An oral decoction of a medicinal and edible homologous composition that can help improve hyperuricemia is prepared as follows: S1. Weigh out 30g of roasted kudzu root, 20g of honeysuckle, 50g of codonopsis, 20g of astragalus, 60g of prepared coix seed, 30g of red adzuki bean and 20g of licorice, for a total of 230g of raw materials.

[0051] S2. For the first decoction, soak all raw materials except honeysuckle in water for 30 minutes, with a water-to-raw material mass ratio of 10:1. After soaking, pour the water and herbs into a decoction pot, bring to a boil over high heat, then simmer over low heat for 15 minutes. Add honeysuckle and simmer for another 15 minutes. Filter out the liquid. For the second decoction, add water, with a water-to-raw material mass ratio of 5:1. Bring to a boil over high heat, then simmer over low heat for 30 minutes. Filter out the liquid. Mix the first decoction liquid with the first decoction liquid, filter, and finally concentrate under reduced pressure to 0.1 g / mL to obtain an oral decoction of 0.1 g / mL equivalent of the food-medicine homology composition.

[0052] Example 11 An oral decoction of a medicinal and edible homologous composition that can help improve hyperuricemia is prepared as follows: S1. Weigh out 150g of stewed kudzu root, 40g of honeysuckle, 100g of codonopsis, 40g of astragalus, 80g of prepared coix seed, 50g of red adzuki bean and 40g of licorice, for a total of 500g of raw materials.

[0053] S2. For the first decoction, soak all raw materials except honeysuckle in water for 30 minutes, with a water-to-raw material mass ratio of 10:1. After soaking, pour the water and herbs into a decoction pot, bring to a boil over high heat, then simmer over low heat for 15 minutes. Add honeysuckle and simmer for another 15 minutes. Filter out the liquid. For the second decoction, add water, with a water-to-raw material mass ratio of 5:1. Bring to a boil over high heat, then simmer over low heat for 30 minutes. Filter out the liquid. Mix the first decoction liquid with the first decoction liquid, filter, and finally concentrate under reduced pressure to 0.5 g / mL to obtain an oral decoction of the medicinal and edible homologous composition at a concentration of 0.5 g / mL.

[0054] Example 12 A food product containing both medicinal and edible ingredients is prepared using the following steps: S1. Weigh out 7.5kg of stewed kudzu root, 5kg of honeysuckle, 15kg of codonopsis, 5kg of astragalus, 15kg of prepared coix seed, 7.5kg of red adzuki bean and 5kg of licorice, for a total of 60kg of raw materials.

[0055] S2. For the first decoction, soak all raw materials except honeysuckle in water for 15 minutes. The mass ratio of water to raw materials is 20:1, i.e., 1200 kg of water is used for soaking. After soaking, pour the water and raw materials into a decoction tank, heat with a steam jacket, and control the heat by adjusting the steam valve. Open the steam valve to quickly raise the temperature to boiling, then close the steam valve to maintain a gentle boil. The steam pressure is 0.05 MPa. After decocting for 15 minutes, add honeysuckle and decoct for another 15 minutes. Filter out the decoction. Add water again, with a mass ratio of water to raw materials of 10:1, i.e., 600 kg of water. Quickly boil and then simmer for 30 minutes. Filter out the decoction. Mix the two decoctions and filter through a 100-micron filter bag. The soluble solids are 3°Brix. After flavoring with acidulants and sweeteners, sterilize, and bottle, a medicinal and edible homologous beverage is obtained.

[0056] Example 13 A food product containing both medicinal and edible ingredients is prepared using the following steps: S1. Weigh out 1.5kg of stewed kudzu root, 1kg of honeysuckle, 3kg of codonopsis, 1kg of astragalus, 3kg of prepared coix seed, 1.5kg of red adzuki bean and 1kg of licorice, for a total of 12kg of raw materials.

[0057] S2. For the first decoction, soak all raw materials except honeysuckle in water for 15 minutes. The mass ratio of water to raw materials is 20:1, i.e., 240 kg of water is used for soaking. After soaking, pour the water and raw materials into a decoction tank, heat with a steam jacket, and control the heat by adjusting the steam valve. Open the steam valve to quickly raise the temperature to boiling, then reduce the steam valve to maintain a gentle boil. The steam pressure is 0.1 MPa. After decocting for 15 minutes, add honeysuckle and decoct for another 15 minutes. Filter out the decoction. Add water again, with a mass ratio of water to raw materials of 10:1, i.e., 120 kg of water. Quickly boil and then simmer for 30 minutes. Filter out the decoction. Mix the two decoctions and filter through a 100-micron filter bag. Concentrate under reduced pressure at a vacuum degree of -0.05 MPa and a temperature of 60°C until a concentrated extract with a soluble solids content of 20°Brix and a density of 1.08 g / mL is obtained.

[0058] S3. Maltodextrin and β-cyclodextrin are slowly added to the above concentrated extract while stirring, and stirred until completely dissolved to form a homogeneous liquid. The prepared liquid is spray-dried to make a fine powder, which is then passed through an 80-mesh sieve, sterilized, and packaged to obtain a medicinal and edible homologous composition powder.

[0059] Comparative Example 1 Weigh out 37.5g of kudzu root, 2.5g of honeysuckle, 75g of codonopsis, 25g of astragalus, 75g of coix seed, 37.5g of red adzuki bean, and 25g of licorice, totaling 300g of raw materials. Concentrate under reduced pressure to 0.3g / mL according to the method in Example 2 to obtain Comparative Decoction I.

[0060] Comparative Example 2 Weigh out 7.5g of kudzu root, 25g of honeysuckle, 75g of codonopsis, 25g of astragalus, 75g of coix seed, 37.5g of red adzuki bean, and 25g of licorice, totaling 300g of raw materials. Concentrate under reduced pressure to 0.3g / mL according to the method in Example 1 to obtain comparative decoction J.

[0061] Experiment 1: The oral decoctions A and B prepared in Examples 1 and 2 were used to verify their effects on improving hyperuricemia induced by potassium oxonate and hypoxanthine in mice.

[0062] Four-week-old healthy male Kunming mice, SPF grade, weighing 18g-20g, were used. The mice were fed at the Animal Experiment Center of Jiangxi University of Traditional Chinese Medicine and acclimatized for one week in an environment with a temperature of 24℃-26℃ and a relative humidity of 50%-60%. The mice had free access to standard feed and sterile filtered water, and their bedding and feed were changed daily.

[0063] After being fed for one week, male Kunming mice were randomly divided into three groups according to their body weight: a blank control group, a model group, a positive drug group, the oral decoction group (Example 1), and the oral decoction group (Example 2), with six mice in each group. Body weight was recorded daily. The dosage for mice was calculated based on the dosage of the traditional Chinese medicine formula for an adult weight of 60 kg.

[0064] After the first week of acclimatization, the positive control group received a dose of 10 mg / kg, while the oral decoction A group (Example 1) and oral decoction B group (Example 2) received 4.55 g / kg. Benzbromarone, oral decoction A (Example 1), and oral decoction B (Example 2) were administered first, respectively. During this period, the control group and model group were administered the same volume of 0.5% CMC-Na solution by gavage. This was done once daily for 7 consecutive days. After the prophylactic administration phase, modeling was initiated. Except for the control group, the model group, oral decoction A group (Example 1), oral decoction B group (Example 2), and positive control group were all administered a combined oral decoction of 300 mg / kg PO and 300 mg / kg HX by gavage at 9:00 AM daily. One hour after modeling, the mice were treated with the oral decoction of Example 1. The normal control group received an equal volume of 0.5% CMC-Na solution by gavage during this period, with a dosage of 10 mL / kg of oral decoction. Mice had free access to food and water during the experiment, and their weight and general condition were recorded. The modeling process lasted for 21 consecutive days.

[0065] On day 21 of the experiment, one hour after drug administration, blood was collected from the eyes of mice in 1.5 mL centrifuge tubes. After the blood samples were allowed to stand at room temperature for 2 hours, they were centrifuged at 4°C for 15 minutes using a pre-cooled centrifuge with the following settings: temperature 4°C, speed 4000 rpm. The supernatant serum was aliquoted into new centrifuge tubes and stored at -80°C for later testing, avoiding repeated freeze-thaw cycles.

[0066] After blood collection, the mouse kidneys, liver, small intestine, spleen, cecal contents, and colon were quickly separated on an ice box. The tissues were gently washed in physiological saline, and the surface water was gently blotted with absorbent paper. The weight of the kidneys and liver was weighed and recorded. After weighing, small pieces of liver and kidney tissue were quickly fixed in 4% paraformaldehyde fixative.

[0067] Serum uric acid levels were measured using the uricase assay kit, serum creatinine levels were measured using the sarcosine oxidase assay kit, serum urea nitrogen levels were measured using the urease assay kit, serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels were measured using the microplate assay kit, and serum TNF-α, IL-1β, and IL-6 levels were measured using the ELISA kit, as per the kit instructions.

[0068] GraphPad Prism 10 software was used for plotting, and the data are expressed as mean ± standard deviation. One-way ANOVA was used to process the data, and the results are expressed as Mean ± SD. A p-value less than 0.05 indicates statistical significance, where '#' indicates a significant difference compared to the control group, and '*' indicates a significant difference compared to the model group.

[0069] The results are as follows: 1. Serum uric acid levels such as Figure 1 As shown, 21 days after modeling, the uric acid level in the blank group was 72.3 μmol / L, while the uric acid level in the model group significantly increased to 187.7 μmol / L, indicating successful establishment of the hyperuricemia model. Compared to the model group, the uric acid level significantly decreased after intervention with the positive control drug benzbromarone tablets, indicating that the positive control drug has a uric acid-lowering effect. The average uric acid level in the oral decoction A group of Example 1 was 94.4 μmol / L, comparable to that of the positive control group, suggesting that oral decoction A of Example 1 has an effect in improving hyperuricemia. The average uric acid level in the oral decoction B group of Example 2 was 79.6 μmol / L, significantly lower than that of the model group, but with no significant difference from the blank group, indicating that oral decoction B of Example 2 has a better effect in improving hyperuricemia, and after 21 days of intervention, the serum uric acid level was close to that of the blank group.

[0070] Serum blood urea nitrogen (BUN) and creatinine are core indicators reflecting renal function. Hyperuricemia is often accompanied by kidney damage, and elevated levels of both suggest impaired renal function. Serum BUN concentration and creatinine levels on day 21 of modeling are as follows: Figure 2As shown, serum urea nitrogen and creatinine levels in the model group were significantly higher than those in the control group, indicating that renal function was impaired in hyperuricemic mice. Urea nitrogen and creatinine levels in the positive control group, oral decoction A group, and oral decoction B group were significantly lower than those in the model group, with urea nitrogen and creatinine levels in decoction B group being closer to those in the control group. This indicates that both oral decoction A in Example 1 and oral decoction B in Example 2 have significant effects in improving hyperuricemia with renal damage.

[0071] 3. Hyperuricemia is often accompanied by liver damage. Elevated ALT and AST levels, as core indicators of liver function, suggest hepatocellular damage. Serum ALT concentration and AST levels on day 21 of modeling are as follows: Figure 3 As shown in the figure, compared with the control group, the serum ALT and AST levels of the model group mice were significantly increased, indicating that the liver function of the hyperuricemic mice was impaired. The levels of these two indicators were significantly reduced in the groups treated with oral decoction A and oral decoction B, and the ALT and AST levels in the oral decoction B group were comparable to those in the control group. This indicates that both oral decoction A in Example 1 and oral decoction B in Example 2 have significant effects in improving hyperuricemia with liver damage.

[0072] 4. Hyperuricemia is often accompanied by a chronic inflammatory state. On day 21 of modeling, serum levels of inflammatory factors TNF-α, IL-1β, and IL-6 were as follows: Figure 4 As shown, these three factors, as core inflammation-related factors, can be used to assess inflammatory damage and the effects of drug intervention in a hyperuricemia model. Compared with the control group, the serum levels of inflammatory factors TNF-α, IL-1β, and IL-6 in the model group mice were significantly increased, suggesting that hyperuricemia can induce inflammatory damage in the body; while the levels of the above three inflammatory factors were significantly reduced in the groups given oral decoction A and oral decoction B, indicating that both oral decoction A in Example 1 and oral decoction B in Example 2 can significantly inhibit the inflammatory response associated with hyperuricemia.

[0073] In addition, such as Figure 5 The results show that the food-medicine homology composition provided by this invention can inhibit xanthine oxidase activity; the food-medicine homology composition can regulate intestinal flora, such as... Figure 6 As shown.

[0074] The oral decoction A in Example 1 and the oral decoction B in Example 2 of this invention can effectively reduce serum uric acid levels in a mouse model of hyperuricemia, improve liver and kidney function, and inhibit the body's inflammatory response. Compared with the positive control group, this composition exhibits superior safety while exerting its uric acid-lowering effect.

[0075] Experiment 2: Oral decoctions C, powders D, granules E, ointments F, pills G, tablets H, decoctions I and J, prepared using the same methods as in Experiment 1, were used to verify their effects in improving potassium oxonate and hypoxanthine-induced hyperuricemia in mice. Serum uric acid levels were measured using a uricase assay kit. The results are as follows: Figure 7 As shown: All formulations showed significant improvement in hyperuricemia. Among them, decoction C, powder D, granules E, ointment F, and tablets H showed the most significant intervention effects, with serum uric acid levels significantly lower than the model group, comparable to or similar to the uric acid-lowering ability of the positive control drug. Pill G showed the second most significant effect, also significantly different from the model group, indicating it also significantly improved hyperuricemia. These results suggest that different dosage forms of this food-medicine homology composition can easily achieve similar effects. However, the effects of Comparative Example 1 (decoction I) and Comparative Example 2 (decoction J) were relatively weaker; their serum uric acid levels did not differ significantly from the model group, but showed a certain decreasing trend, indicating that when the dosage of kudzu root or honeysuckle in the composition is low, the composition's effect in improving hyperuricemia is limited.

[0076] Clinical Study: This study included 64 patients with hyperuricemia of the damp-heat retention type treated at the outpatient clinic of Jiangxi Provincial Hospital of Traditional Chinese Medicine, affiliated with Jiangxi University of Traditional Chinese Medicine, from September 2021 to September 2023. Patients were randomly divided into an experimental group (n=32, mean age 42.7±10.1 years, mean disease duration 3.9±1.3 years) and a control group (n=32, mean age 43.3±8.5 years, mean disease duration 3.6±1.4 years). Inclusion criteria: Patients met the diagnostic criteria for "damp-heat retention syndrome" of gout in the "Multidisciplinary Expert Consensus on the Diagnosis and Treatment of Hyperuricemia-Related Diseases in China (2017)" and the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases". Diagnosis criteria: (1) Fasting serum uric acid levels exceeding 420 μmol / L on two separate occasions; (2) Age 20-60 years; (3) Normal liver and kidney function. Exclusion criteria: Secondary gout caused by kidney disease, blood disorders, medication use, or chemotherapy / radiotherapy for tumors; acute gouty arthritis attack; severe pulmonary, cardiovascular, hematologic, hematopoietic, central nervous system, or other systemic diseases; malignant tumors; pregnant or lactating women or those planning to become pregnant; allergic to the investigational drug or those with weak constitution or allergic constitution. There were no statistically significant differences in gender, age, body mass index, or serum uric acid levels between the two groups (P>0.05), indicating comparability. This study was approved by the hospital's ethics committee, and informed consent was obtained from all patients and their families.

[0077] Treatment methods: General treatment: Both the experimental group and the control group received gout education and were advised to maintain a light diet, avoiding high-purine foods such as seafood and animal organs, and to consume low-purine foods such as fresh vegetables and fruits. Patients were also advised to drink more than 2000 mL of water daily to increase urine output, and to abstain from smoking and alcohol. During the treatment period, patients were prohibited from taking other medications that could affect uric acid concentration.

[0078] Control group: In addition to routine treatment, patients in the control group received oral febuxostat tablets once daily after breakfast, 40 mg each time, for 2 weeks as one course of treatment, for a total of 4 weeks. The drug specification is 40 mg, manufactured by Hangzhou Zhuyangxin Pharmaceutical Co., Ltd., with the national drug approval number: H20130009.

[0079] Experimental group: In addition to general treatment, the experimental group was treated with Decoction K of Example 9. The Chinese herbs in the formula were obtained from the outpatient pharmacy of the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine and decocted at the hospital. One dose was 300mL, taken warm at one time. One course of treatment was 2 weeks, and a total of 4 weeks were taken.

[0080] Observation indicators and efficacy evaluation criteria: Peripheral venous blood samples were collected before and after treatment to measure serum uric acid levels 12 weeks prior to treatment. Adverse reactions, including nausea, abdominal discomfort, rash, and abnormal liver and kidney function, were recorded in both groups.

[0081] The clinical efficacy of the two groups of patients was compared according to the "Guidelines for the Diagnosis and Treatment of Primary Gout". A markedly effective diagnosis was defined as significant improvement in clinical symptoms and signs with a serum uric acid level below 360 μmol / L; an effective diagnosis was defined as some improvement in clinical symptoms and signs with a serum uric acid level between 360 μmol / L and 420 μmol / L; and an ineffective diagnosis was defined as no improvement in clinical symptoms and signs with a serum uric acid level above 420 μmol / L. The overall effective rate was calculated as (number of markedly effective cases + number of effective cases) / total number of cases × 100%. The attack rate was calculated as (number of gout attacks during the period / total number of cases) × 100%. The adverse reaction rate was calculated as (number of adverse reactions / total number of cases) × 100%.

[0082] Statistical analysis was performed using SPSS 26.0 software. Normally distributed measurement data were expressed as mean ± standard deviation (x ± s). Independent samples t-tests were used to compare two groups, and P < 0.05 was considered statistically significant.

[0083] The results are shown in Table 1: the overall effective rates of the experimental group and the control group after 4 weeks of treatment were 83.34% and 93.55%, respectively. Before treatment, the baseline uric acid levels of the two groups were similar, and after treatment, the uric acid levels of both groups showed a decreasing trend. At 4 weeks after treatment, the uric acid level of the experimental group was close to that of the control group, reaching a significant effective level. This indicates that the decoction K in Example 9 has a significant effect in improving hyperuricemia. Regarding the incidence of gout attacks during treatment, the experimental group had a rate of 33.33%, slightly lower than the 38.71% in the control group, but there was no significant difference between the two groups, indicating that there was little difference in the prevention of acute attacks between the two groups. In terms of safety, the adverse reaction rate in the experimental group was 1 case (3.33%), lower than the 2 cases (6.67%) in the control group, suggesting that the experimental group may be more tolerable.

[0084] Table 1 Clinical trial results

[0085] Note: Adverse reactions refer to the following during the treatment period: 2 patients in the control group experienced mild epigastric pain, which was relieved after rest without treatment; 1 patient in the experimental group experienced mild diarrhea, which resolved spontaneously without treatment. During this period, 2 patients dropped out of the experimental group and 1 patient dropped out of the control group.

[0086] In summary, decoction K has a significant effect on improving hyperuricemia. It is comparable to febuxostat tablets in terms of reducing uric acid levels and clinical efficacy, but it shows certain advantages in terms of safety and tolerability.

[0087] The above descriptions are merely embodiments of the present invention, and common knowledge such as specific technical solutions and / or characteristics are not described in detail here. It should be noted that those skilled in the art can make various modifications and improvements without departing from the technical solutions of the present invention, and these should also be considered within the scope of protection of the present invention. These modifications and improvements will not affect the effectiveness of the implementation of the present invention or the practicality of the patent. The scope of protection claimed in this application should be determined by the content of its claims, and the specific embodiments described in the specification can be used to interpret the content of the claims.

Claims

1. A medicinal and edible composition for assisting in the improvement of hyperuricemia, characterized in that, The medicinal and edible composition is made from the following raw materials in parts by weight: 3 to 15 parts of kudzu root, 2 to 4 parts of honeysuckle, 5 to 10 parts of codonopsis, 2 to 4 parts of astragalus, 6 to 8 parts of coix seed, 3 to 5 parts of red adzuki bean and 2 to 4 parts of licorice.

2. The medicinal and edible composition for assisting in the improvement of hyperuricemia according to claim 1, characterized in that, The medicinal and edible composition is made from the following raw materials in parts by weight: 3.75 parts of kudzu root, 2.5 parts of honeysuckle, 7.5 parts of codonopsis, 2.5 parts of astragalus, 7.5 parts of coix seed, 3.75 parts of red adzuki bean, and 2.5 parts of licorice.

3. The medicinal and edible composition for assisting in the improvement of hyperuricemia according to claim 1, characterized in that, The Job's tears mentioned are processed Job's tears.

4. The medicinal and edible composition for assisting in the improvement of hyperuricemia according to claim 1, characterized in that, The kudzu root mentioned is stewed kudzu root.

5. The use of the food-derived medicinal composition according to claim 1, which helps improve hyperuricemia, in the preparation of a medicament for treating and / or preventing hyperuricemia.

6. The application according to claim 5, characterized in that, The dosage forms of the drug include oral decoctions, powders, granules, ointments, pills, or tablets.

7. The application according to claim 6, characterized in that, The method for preparing the oral decoction includes the following steps: Weigh the raw materials according to the weight proportions; Soak Codonopsis pilosula, Pueraria lobata, Glycyrrhiza uralensis, Vigna angularis, Astragalus membranaceus and Coix lacryma-jobi in the first decoction. After boiling the first decoction over high heat, simmer it over low heat for 15 to 25 minutes. Then add Lonicera japonica and simmer for another 15 minutes. Filter out the decoction to obtain the first decoction. After adding water for the second decoction, bring it to a boil over high heat, then simmer over low heat for 30 to 40 minutes. Filter out the liquid to obtain the second decoction. The first and second decoctions are mixed, filtered, and concentrated to obtain an oral decoction. The mass ratio of the raw materials to the first decoction is 1:10~20; the mass ratio of the raw materials to the second decoction with added water is 1:5~10. The oral decoction contains 0.10g to 0.5g of a food-medicine homology composition per milliliter.

8. The application according to claim 7, characterized in that, The soaking time is 15 min to 30 min.

9. The application according to claim 6, characterized in that, The preparation method of the powder includes the following steps: The raw materials are pulverized to obtain raw material powders of 30 to 80 mesh. The raw material powders are mixed according to the mass fraction of the raw materials to obtain a drug for treating and / or preventing hyperuricemia.

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