Composition, health food or medicine for reducing serum uric acid level

Abstract

The present invention provides a composition, health food or medicine for reducing serum uric acid levels, belonging to the field of life and health technology. The present invention provides a composition for reducing serum uric acid levels, including extracts of Chinese medicine for both medicinal and edible purposes, curcumin, euglena and probiotics. Based on the theory of traditional Chinese medicine and the action pathways of modern pharmacology, the present invention organically combines extracts of Chinese medicine for both medicinal and edible purposes and new resource food raw materials, thereby producing multiple protective effects, such as inhibiting XOD activity, thereby reducing uric acid production; resisting free radical oxidation, protecting the liver and kidneys; while promoting urination, improving intestinal flora, promoting intestinal purine and uric acid metabolism, reducing endotoxin levels and reducing inflammation and relieving pain, which helps to reduce serum uric acid content in a healthy and stable manner.

Description

Technical Field

[0001] The present invention belongs to the field of life and health technology, and specifically relates to a composition, health food or medicine for reducing serum uric acid level. Background Art

[0002] Hyperuricemia is a common disease caused by disordered purine metabolism or insufficient uric acid excretion in the body, and the incidence rate has been on the rise in recent years. Uric acid is the end product of purine metabolism in the human body and is widely distributed in plasma, extracellular fluid, and synovial fluid. Its sources mainly come from two aspects, namely, endogenous uric acid produced by the metabolism of endogenous purines synthesized / metabolized in the body and exogenous uric acid produced by the degradation of purines in the ingested food. Since purines from food sources are rarely used by the body, excessive intake of foods with high purine content, such as animal offal, seafood, seafood or beef soup, etc., adenine and guanine are hydrolyzed in the body by various deaminases, and finally oxidized to xanthine under the action of xanthine oxidase (XOD), and then finally hydrolyzed to uric acid under the action of the enzyme, thereby producing symptoms of hyperuricemia. Another major cause of hyperuricemia is uric acid excretion disorder, such as the lack of certain enzymes that affect the excretion of uric acid during purine metabolism.

[0003] High concentrations of uric acid in plasma accumulate in tissues in the form of urate, which in turn causes gout, kidney stones and other diseases, seriously endangering human health. At present, the treatment of hyperuricemia mainly uses the inhibition of uric acid synthesis in pharmacological screening, which reduces uric acid formation by inhibiting XOD activity, such as allopurinol and febuxostat; and inhibits the reabsorption of uric acid by the renal tubules, increases uric acid excretion, and thus reduces blood uric acid levels, such as benzbromarone and probenecid. However, these drugs generally have more serious toxic side effects, which to a certain extent limit their clinical application. Therefore, it is of great practical significance to study and develop new low-toxic and efficient drugs for the treatment of hyperuricemia. Summary of the invention

[0004] The invention provides a composition, health food or medicine for reducing serum urea level, which has the functions of improving purine metabolism disorder and reducing blood uric acid, has almost no toxic side effects and can be taken for a long time.

[0005] The present invention provides a composition for reducing serum uric acid level, comprising an extract of a Chinese medicine for both medicinal and edible use, curcumin, euglena and probiotics;

[0006] The Chinese medicine for both medicinal and edible purposes includes mulberry, cornus officinalis, chicory, astragalus, tuckahoe, polygonatum and mint.

[0007] In a specific embodiment of the present invention, the mass percentage of total flavonoids in the mulberry extract is not less than 2.5%; the mass percentage of chicoric acid in the chicory extract is not less than 2.5%; the mass percentage of astragaloside IV in the astragalus extract is not less than 5%;

[0008] The extraction solvents of Cornus officinalis extract, Poria cocos extract, Polygonatum sibiricum extract and Peppermint extract are all polar solutions.

[0009] In a specific embodiment of the present invention, the following components are included in weight parts based on effective ingredients: 49.5 to 159 weight parts of extracts of Chinese medicine for both medicinal and edible purposes, 1.5 to 8 weight parts of curcumin, 1.5 to 7 weight parts of euglena and 1 to 4 weight parts of probiotics.

[0010] In a specific embodiment of the present invention, the extracts of the medicinal and edible Chinese medicine are included in the following weight parts, calculated as the effective ingredients: 3 to 15 weight parts of mulberry extract, 10 to 35 weight parts of cornus extract, 20 to 50 weight parts of chicory extract, 10 to 30 weight parts of astragalus extract, 2.5 to 11 weight parts of poria extract, 2.5 to 11 weight parts of polygonatum and 1.5 to 7 weight parts of peppermint extract.

[0011] In a specific embodiment of the present invention, the following components are included in weight proportion, based on effective ingredients: 81 to 120 weight parts of extracts of Chinese medicine for both medicinal and edible purposes, 3.5 to 5.5 weight parts of curcumin, 2 to 4 weight parts of euglena and 1.5 to 2.5 weight parts of probiotics.

[0012] In a specific embodiment of the present invention, the extracts of the medicinal and edible Chinese medicine are included in the following weight parts, calculated as the effective ingredients: 6-10 weight parts of mulberry extract, 15-25 weight parts of Cornus officinalis extract, 35-42 weight parts of chicory extract, 15-25 weight parts of Astragalus extract, 4-7 weight parts of Poria extract, 4-7 weight parts of Polygonatum sibiricum and 2-4 weight parts of peppermint extract.

[0013] In a specific embodiment of the present invention, the probiotics include bifidobacteria and lactobacilli.

[0014] In one embodiment of the present invention, the viable count of probiotics in the composition is 6×10 9 ~10×10 9 cfu / g.

[0015] The present invention also provides health food or medicine comprising the above composition, and also comprises auxiliary materials.

[0016] In a specific embodiment of the present invention, the mass parts of the auxiliary material is 0 to 20 mass parts.

[0017] Beneficial effects: The present invention provides a composition for reducing serum uric acid levels, comprising extracts of Chinese medicine for both medicinal and edible purposes, curcumin, euglena and probiotics. Based on the theory of traditional Chinese medicine and the action pathways of modern pharmacology, the present invention selects components with relatively strong xanthine oxidase inhibitory activity, components with strong anti-free radical oxidation activity and multiple effects of improving liver and kidney function and anti-inflammatory, components with dampness-removing, diuretic and kidney-protecting effects, and probiotics with strong relevance to metabolic diseases for organic combination.

[0018] The main components of the composition of the present invention are Chinese medicinal and edible dual-purpose extracts and new resource food raw materials, which are almost non-toxic and side-effect-free, can be taken for a long time, and have the effects of reducing serum uric acid content and improving gout symptoms caused by hyperuricemia while improving liver and kidney function. Specifically, the examples show that the composition of the present invention has multiple protective effects, such as inhibiting XOD activity, thereby reducing uric acid production; resisting free radical oxidation, protecting the liver and kidneys; promoting urination while improving intestinal flora, reducing endotoxin levels, reducing inflammation and relieving pain. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is a graph showing the changes in body weight growth rate of rats in each group after administration of excipients or test samples;

[0020] Figure 2 The graph shows the serum uric acid levels in hyperuric acid model rats after 1 and 2 weeks of test sample intervention. DETAILED DESCRIPTION

[0021] The present invention provides a composition for reducing serum uric acid level, comprising an extract of a Chinese medicine for both medicinal and edible use, curcumin, euglena and probiotics;

[0022] The Chinese medicine for both medicinal and edible purposes includes mulberry, cornus officinalis, chicory, astragalus, tuckahoe, polygonatum and mint.

[0023] In a specific embodiment of the present invention, seven Chinese medicinal extracts with the same origin as medicine and food are selected. When used for the extraction of the Chinese medicinal extracts, the raw medicinal pieces used must comply with the provisions of the pharmacopoeia. The quality of mulberry, chicory and astragalus, calculated by the content of active ingredients, requires total flavonoids ≥ 2.5% (m / m) in mulberry extract, chicory acid ≥ 2.5% (m / m) in chicory extract, and astragaloside ≥ 5% (m / m) in astragalus extract. Others, such as cornus officinalis, tuckahoe, polygonatum and mint, are extracted using a dosage form solvent, such as water extraction or alcohol extraction.

[0024] In a specific embodiment of the present invention, the extract of the medicinal and edible Chinese medicine can be 49.5-159 parts by weight, or 81-120 parts by weight, calculated as the effective ingredients. The extract of the medicinal and edible Chinese medicine includes the following components in parts by weight: 3-15 parts by weight of mulberry extract, 10-35 parts by weight of cornus extract, 20-50 parts by weight of chicory extract, 10-30 parts by weight of astragalus extract, 2.5-11 parts by weight of Poria extract, 2.5-11 parts by weight of polygonatum and 1.5-7 parts by weight of mint extract; it can also be 6-10 parts by weight of mulberry extract, 15-25 parts by weight of cornus extract, 35-42 parts by weight of chicory extract, 15-25 parts by weight of astragalus extract, 4-7 parts by weight of Poria extract, 4-7 parts by weight of polygonatum and 2-4 parts by weight of mint extract.

[0025] The mass parts of the mulberry extract of the present invention are 3 to 15 parts, such as 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts or 15 parts. The mulberry extract of the present invention is rich in flavonoids, non-anthocyanidin polyphenol compounds and resveratrol, and has strong free radical elimination and antioxidant capabilities. The mulberry extract of the present invention has the effects of nourishing the liver and kidneys, nourishing yin and blood, and at the same time, because it contains polyphenol compounds, the ORAC value can reach more than 2500 μmolTE / g, and at the same time, it shows a strong XOD activity inhibition effect.

[0026] The weight percentage of the cornus extract of the present invention is 10 to 35 parts, such as 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 19.5 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts, 30 parts, 31 parts, 32 parts, 33 parts, 34 parts and 35 parts. The cornus extract of the present invention has the effects of enhancing immune function and improving renal function, and also has anti-inflammatory effect, can reduce the expression of reactive oxygen species (ROS) in renal tissue, increase the content of glutathione (GSH) in tissue, and reverse renal inflammation and fibrosis.

[0027] The mass parts of the chicory extract of the present invention are 20 to 50 parts, such as 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts, 30 parts, 31 parts, 32 parts, 33 parts, 34 parts, 35 parts, 35.5 parts, 36 parts, 37 parts, 38 parts, 39 parts, 40 parts, 41 parts, 41.5 parts, 42 parts, 43 parts, 44 parts, 45 parts, 46 parts, 47 parts, 48 ​​parts, 49 parts and 50 parts. The chicory extract described in the present invention has the effects of diuresis and detumescence, gallbladder clearing and liver benefiting, and has the effect of inhibiting XOD activity; the chicory extract also has the effect of inhibiting the expression of sugar transporter Glut9 in the kidney, thereby reducing the effect of uric acid reabsorption, that is, significantly reducing the production of uric acid and promoting uric acid excretion, so it can reduce uric acid metabolism enzymes and key reaction enzymes, such as reducing the activity of xanthine oxidase, thereby achieving the reduction of uric acid, and can also promote uric acid excretion, inhibit reabsorption and regulate the intestinal environment, and achieve the balance of uric acid metabolism. In addition, chicory can also significantly reduce uric acid in hyperuricemia rats by improving the intestinal tissue morphology of experimental animals and regulating the macroscopic structure of intestinal flora (reducing harmful bacteria and increasing the abundance of probiotics such as bifidobacteria).

[0028] The mass parts of the astragalus extract of the present invention can be 10 to 30 parts, such as 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts and 30 parts. The astragalus extract of the present invention contains active substances such as terpenoid saponin derivatives, polysaccharide compounds and flavonoid compounds, and has the effects of enhancing body immunity, diuresis and protecting kidneys. The astragalus extract of the present invention has strong antioxidant activity, and the ORAC value of the extract oxygen free radical absorption capacity can reach more than 3000 μmolTE / g.

[0029] The mass parts of the Poria extract of the present invention can be 2.5 to 11 parts, such as 2.5 parts, 3 parts, 4 parts, 5 parts, 5.5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts and 11 parts. The Poria extract of the present invention contains Poria triterpenes, which can effectively remove superoxide anion free radicals and hydroxyl free radicals, and the clearance rate and concentration are dose-dependent, and have a good removal effect on malondialdehyde (MDA) produced by tissue peroxidation. The Poria extract of the present invention has diuretic, anti-inflammatory, antioxidant and immune-enhancing effects; at the same time, it also has a strong inhibitory effect on XOD activity, and can relieve kidney damage and promote the excretion of uric acid in the body by regulating the probiotics in the intestine, thereby achieving the effect of lowering uric acid.

[0030] The mass proportion of the polygonatum extract of the present invention can be 2.5 to 11 parts, such as 2.5 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts and 11 parts. The polygonatum extract of the present invention is rich in physiologically active steroidal saponins and polysaccharide oligosaccharides, which have a significant effect of improving superoxide dismutase (SOD), and thus has strong antioxidant activity. The polygonatum extract of the present invention can also inhibit XOD activity and improve the pathological damage of liver and kidney tissues caused by high uric acid.

[0031] The mass proportion of the peppermint extract of the present invention can be 1.5 to 7 parts, such as 1.5 parts, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts and 7 parts. The peppermint extract of the present invention has a strong XOD activity inhibition effect and a high free radical resistance ability, and the ORAC value of the extract can reach more than 2000 μmolTE / g.

[0032] The composition of the present invention also includes curcumin, which is a food resource. In the composition, the mass parts of curcumin are 1.5 to 8 parts, such as 1.5 parts, 2 parts, 3 parts, 3.5 parts, 4 parts, 5 parts, 5.5 parts, 6 parts, 7 parts and 8 parts. The main active ingredient of the curcumin of the present invention is curcumin, which has anti-inflammatory, choleretic and liver-protecting effects, and has a strong inhibitory effect on xanthine oxidase activity; it can reduce uric acid production and promote uric acid excretion in urine; curcumin has stronger antioxidant effect and free radical scavenging activity than vitamin C; curcumin can also improve the intestinal flora of patients with uric acid nephropathy and synergize with probiotics.

[0033] The composition of the present invention also includes euglena, such as euglena powder, which is a new resource food, and its weight portion is 1.5 to 7 parts, such as 1.5 parts, 2 parts, 3 parts, 4 parts, 5 parts, 5.5 parts, 6 parts and 7 parts. The euglena powder of the present invention is rich in polyunsaturated fatty acids, vitamins, minerals and polysaccharide active ingredients. Its polysaccharides will not be metabolized and absorbed by the human body, and can absorb excessive purines during the degradation process to be excreted from the body, thereby reducing uric acid production, preventing and improving gout symptoms. At the same time, euglena powder has a strong antioxidant and free radical scavenging effect, as well as a liver protection effect. At the same time, the euglena powder of the present invention also has the function of regulating intestinal flora and promoting the decomposition and metabolism of purine and uric acid in the intestine, wherein the regulation of intestinal flora is mainly reflected in promoting the growth of probiotic flora in the intestine and inhibiting the growth of harmful flora in the intestine.

[0034] The composition of the present invention also includes probiotics, and the weight portion of the probiotics is 1 to 4 parts, such as 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts and 4 parts. The probiotics of the present invention include bifidobacteria and lactobacilli that can be used in food. There is no special limitation on the specific strains. As long as the number of viable probiotics in the composition reaches 6×109 ~10×10 9 cfu / g. The lactobacillus of the present invention can regulate the composition of intestinal flora, increase the abundance of short-chain fatty acids (SCFAs) producing flora in the intestine, promote the improvement of SCFAs (especially acetic acid and valeric acid) levels in the large intestine, and uric acid levels, XOD activity, etc. have a strong correlation with beneficial flora and the production of SCFAs, thereby inhibiting XOD activity and ultimately alleviating hyperuricemia. The probiotics of the present invention can balance the uric acid level in serum, such as enriching the abundance of intestinal flora, reducing the level of endotoxin in the blood circulation, and can also reduce the inflammatory response when tissue damage occurs, and inhibit the increase of XOD activity.

[0035] The composition of the present invention comprises components with multiple functions, such as XOD activity inhibition components, which block the pathway of purine synthesis of uric acid and reduce the uric acid content in serum; components for resisting free radical oxidation and protecting liver and kidneys, which have the effects of resisting oxidation, eliminating free radicals, protecting or improving liver and kidney functions while reducing uric acid generation; components for promoting urination, which can act on multiple transport proteins, improve the uric acid metabolism process in the body, inhibit uric acid reabsorption, stimulate uric acid secretion, and ultimately achieve the effects of promoting uric acid excretion and reducing blood uric acid (SUA) levels; components for anti-inflammatory and pain relief, which inhibit inflammation caused by kidney damage, such as urate crystal (MSU) deposition, causing abnormal inflammatory response of surrounding tissues; as is known, hyperuricemia, diabetes and obesity are all metabolic disorders, which are all related to intestinal microbial imbalance, and hyperuricemia is caused by purine metabolic disorder. Moreover, intestinal microbial imbalance is not only related to metabolic disorders, but also can increase the level of endotoxin in the blood circulation, thereby inducing chronic inflammation, aggravating the deposition of urate crystals in joints, kidneys and other tissues of patients with hyperuricemia, causing inflammatory reactions and tissue damage, and is accompanied by increased xanthine oxidase activity, which in turn accelerates uric acid synthesis and may form a vicious circle. Therefore, the composition described in the present application also includes a probiotic component for improving intestinal flora.

[0036] In one embodiment of the present invention, when preparing the composition, the four materials with index requirements, namely, mulberry extract (total flavonoids ≥ 2.5%), chicory extract (chicoric acid ≥ 2.5%), astragalus extract (astragaloside ≥ 5%), and curcumin (curcumin ≥ 50%), are all fed as extracts. Other extracts, such as cornus extract, tuckahoe extract, polygonatum extract, and mint extract, can be extracted separately or mixed, and extracted three times with 10 times, 8 times, and 6 times the amount of deionized water respectively at 95-100° C. reflux, the extracts are combined, concentrated, and spray-dried to obtain extracts for feeding.

[0037] The present invention also provides health food or medicine comprising the above composition, and also comprises auxiliary materials.

[0038] The health food or medicine of the present invention may also contain 0 to 20 parts by weight of auxiliary materials, and the auxiliary materials may be preparation auxiliary materials and flavoring agents, etc. At the same time, various dosage forms such as tablets, capsules, solid beverages, granules, and even soft capsules can be prepared according to different proportions of the extract, preparation auxiliary materials and flavoring agents.

[0039] When the composition is prepared into a corresponding dosage form according to the present invention, the preparation can be carried out according to the following method:

[0040] (1) Weighing and mixing:

[0041] Weigh the extracts and flavoring agents of each component according to the proportion of the preparation (flavoring agents and auxiliary materials are not required for swallowable tablets and hard capsules). Mix the extracts of each component, flavoring agents and preparation auxiliary materials (except probiotics, lubricants, flavors and fragrances, etc.) in a three-dimensional mixer;

[0042] (2) Granulation and drying

[0043] The mixed powder is granulated in a fluidized bed or wet granulated with a 50-85% ethanol solution, dried by hot air circulation at 45-65°C to a moisture content of 2-5%, and granulated by a 14-mesh sieve swing granulator;

[0044] (3) Total mixing:

[0045] Weigh the probiotics, tableting lubricant or flavors and spices according to the proportion, and mix them evenly with other particles using appropriate methods;

[0046] (4) Tableting or filling

[0047] Tablet pressing: Select appropriate punches, adjust appropriate tablet weight and pressure, and perform tablet pressing. The tablet hardness is required to be greater than 5kg, and the disintegration time is within 60 minutes. After the tablet is formed, it can be film-coated if necessary, and the amount of coating powder is 1-3% of the amount of the plain tablet.

[0048] Filling capsules, solid beverages or granules: Select capsule shells of appropriate size, solid beverage or granule packaging bags. And determine the appropriate filling volume, use capsule filling machines to fill into capsule products, or use solid beverage or granule packaging machines to pack into bags.

[0049] In the embodiment of the present invention, the composition was used to conduct animal function tests, and the dosage of mice when there was a significant difference in the uric acid lowering effect was used as the benchmark, and the effective dose was converted to the adult dosage according to 30 times the dosage on this benchmark. The present invention has been proved by animal experiments: the dosage of mice is 3 grams / kg, and the daily consumption of 6g or more of the extract according to 30 times the dosage of adults has a more significant effect on lowering uric acid.

[0050] The present invention discloses a completely medicinal and edible Chinese medicine, a new resource food and a probiotic that can be used for food, and a functional food or medicine that can be taken for a long time and has the functions of improving purine metabolism disorders and reducing blood uric acid is prepared. The functional food or medicine of the present invention has various components that are organically coordinated to play a synergistic role, and has the functions of reducing the activity inhibition of xanthine oxidase (XOD), a key enzyme for uric acid production, anti-free radical oxidation, protecting the liver and kidneys, promoting urination, anti-inflammatory and pain relief, and improving intestinal flora to reduce endotoxin levels, reduce inflammation and XOD activity.

[0051] To further illustrate the present invention, a composition, health food or medicine for reducing serum uric acid levels provided by the present invention is described in detail below in conjunction with examples, but they should not be construed as limiting the scope of protection of the present invention.

[0052] Embodiment 1 (solid beverage)

[0053] Taking the total amount of solid beverage as 100%, the raw material combination (m / m) is: mulberry extract (water extract, total flavonoids content ≥2.5%) 6.3%, cornus extract (water extract) 16.2%, chicory extract (chicoric acid ≥2.5%) 30.15%, astragalus extract (astragaloside ≥5%) 18%, curcumin (curcumin ≥50%) 3.6%, Poria extract (water extract) 4.95%, polygonatum extract (water extract) 4.5%, euglena powder 2.7%, peppermint extract (water extract) 1.8%, probiotics (including bifidobacteria and lactobacilli) 1.8% and excipients (flavoring agents, fragrances and lubricants) 10%.

[0054] 1. Extract raw materials and ingredients

[0055] 1. According to the formula, weigh four raw materials: mulberry extract (total flavonoids ≥ 2.5%), chicory extract (chicoric acid ≥ 2.5%), astragalus extract (astragaloside ≥ 5%) and curcumin (curcumin ≥ 50%), which meet the index component requirements, food hygiene indicators and harmful substance limits.

[0056] 2. Extract cornus officinalis, Poria cocos, Polygonatum sibiricum and mint separately or in combination according to the following method. Extract with 10 times, 8 times and 6 times of deionized water at 95-100℃ for three times, filter respectively, combine the extracts, concentrate and spray dry to obtain cornus officinalis extract, Poria cocos extract, Polygonatum sibiricum extract and mint extract respectively. Weigh these four extracts according to the formula.

[0057] 3. Weigh the euglena powder and probiotics according to the formula.

[0058] 4. Weigh appropriate amounts of flavoring agents, essences and lubricants as needed, accounting for 10% of the total amount.

[0059] 2. Preparation

[0060] 1. Mixing:

[0061] The mulberry extract, chicory extract, astragalus extract, curcumin, cornus officinalis extract, Poria cocos extract, polygonatum sibiricum extract, mint extract and euglena powder are mixed evenly in a three-dimensional mixer.

[0062] 2. Granulation and drying

[0063] The mixed powder is granulated in a fluidized bed or wet granulated with a 50-85% ethanol solution, dried by hot air circulation at 45-65° C. to a moisture content of 2-5%, and granulated by a 14-mesh sieve swing granulator.

[0064] 3. Total mixing

[0065] The weighed probiotics and excipients are mixed evenly with the granulated particles in equal increments.

[0066] 4. Filling

[0067] Select appropriate aluminum foil packaging material. Adjust the filling machine to 2 grams per tube. Fill and seal.

[0068] 5. Dosage regimen: According to subsequent animal experiment results, the solid beverage of the present invention has a significant effect on lowering uric acid. The dosage of the solid beverage of the present invention is 6.67 g / day / person or more, i.e., about 4 bottles / day / person.

[0069] 3. Testing of some important active ingredients in the product

[0070] 1) Oxygen Radical Absorption Capacity (ORAC) analysis test results show that the ORAC value of this product is 650 (μmol TE / g).

[0071] 2) Product probiotics live bacteria content detection: 7.0×10 9 (cfu / g), about 14 billion per tube. That’s 55 billion probiotics per day.

[0072] Example 2 (Tablet)

[0073] Taking the mass of the tablet as 100%, the raw material combination (m / m) is: mulberry extract (water extract, total flavonoids content ≥2.5%) 6.8%, cornus extract (water extract) 8.5%, chicory extract (chicoric acid ≥2.5%) 35.3%, astragalus extract (astragaloside ≥5%) 12.8%, curcumin (curcumin ≥50%) 4.6%, Poria extract (water extract) 3.4%, polygonatum extract (water extract) 6%, euglena powder 3.4%, peppermint extract (water extract) 2.5%, probiotics (including bifidobacteria and lactobacilli) 1.7% and excipients (binders, disintegrants and lubricants) 15%.

[0074] 1. Extract raw materials and ingredients

[0075] 1. According to the formula, weigh four raw materials: mulberry extract (total flavonoids ≥ 2.5%), chicory extract (chicoric acid ≥ 2.5%), astragalus extract (astragaloside ≥ 5%) and curcumin (curcumin ≥ 50%), which meet the index component requirements, food hygiene indicators and harmful substance limits.

[0076] 2. Extract cornus officinalis, tuckahoe, polygonatum sibiricum and mint separately or in combination according to the following methods. Extract with 10 times, 8 times and 6 times the amount of deionized water at 95-100℃ for three times, filter separately, combine the extracts, concentrate, spray dry, and obtain cornus officinalis extract, tuckahoe extract, polygonatum sibiricum extract and mint extract respectively. Weigh these four extracts according to the formula.

[0077] 3. Weigh the euglena powder and probiotics according to the formula.

[0078] 4. Weigh appropriate amounts of tablet forming excipients (binders, disintegrants) and lubricants as needed, accounting for 15% of the total amount.

[0079] 2. Preparation

[0080] 1. Mixing:

[0081] The mulberry extract, chicory extract, astragalus extract, curcumin, cornus officinalis extract, Poria cocos extract, polygonatum sibiricum extract, mint extract, euglena powder and molding auxiliary materials are mixed evenly in a three-dimensional mixer.

[0082] 2. Granulation and drying

[0083] The mixed powder is granulated in a fluidized bed or wet granulated with a 50-85% ethanol solution, dried by hot air circulation at 45-65° C. to a moisture content of 2-5%, and granulated by a 14-mesh sieve swing granulator.

[0084] 3. Total mixing

[0085] The weighed probiotic lactobacillus and tableting lubricant are mixed evenly with the granulated particles by an equal and incremental method.

[0086] 4. Tablet compression: Select appropriate punches, adjust the tablet weight to 0.71 g / tablet, and compress the tablets. The tablet hardness is required to be greater than 5 kg, and the disintegration time is within 60 minutes. After tablet compression, film coating is performed, and the amount of coating powder is 3% of the amount of the plain tablets.

[0087] 5. Dosage regimen: According to the results of subsequent animal experiments, the tablets of the present invention have a significant effect on lowering uric acid. The daily dosage of the tablets of the present invention is ≥7.06 g, i.e., about 10 tablets / day / person.

[0088] 3. Testing of some important active ingredients in the product

[0089] 1) Oxygen Radical Absorption Capacity (ORAC) analysis test results, the ORAC value of this product is 600 (μmol TE / g);

[0090] 2) Product probiotics live bacteria content test: 6.8.0×10 9 (cfu / g), about 4.8 billion per tablet. That’s 48 billion probiotics per day.

[0091] Embodiment 3 (granule)

[0092] Taking the mass of the granules as 100%, the raw material composition (m / m) is: mulberry extract (water extract, total flavonoids content ≥2.5%) 9%, cornus extract (water extract) 17.5%, chicory extract (chicoric acid ≥2.5%) 30.6%, astragalus extract (astragaloside ≥5%) 22.5%, curcumin (curcumin ≥50%) 1.8%, Poria extract (water extract) 2.3%, polygonatum extract (water extract) 2.2%, euglena powder 1.3%, peppermint extract (water extract) 1.4%, probiotics (including bifidobacteria and lactobacilli) 1.4% and excipients (flavoring agents, fragrances and lubricants) 10%.

[0093] 1. Extract raw materials and ingredients

[0094] 1. According to the formula, weigh four raw materials: mulberry extract (total flavonoids ≥ 2.5%), chicory extract (chicoric acid ≥ 2.5%), astragalus extract (astragaloside ≥ 5%) and curcumin (curcumin ≥ 50%), which meet the index component requirements, food hygiene indicators and harmful substance limits.

[0095] 2. Extract cornus officinalis, Poria cocos, Polygonatum sibiricum and mint separately or in combination according to the following methods. Extract with 10 times, 8 times and 6 times the amount of deionized water at 95-100℃ for three times, filter respectively, combine the extracts, concentrate and spray dry to obtain cornus officinalis extract, Poria cocos extract, Polygonatum sibiricum extract and mint extract respectively. Weigh these four extracts according to the formula.

[0096] 3. Weigh the Euglena powder and probiotic Bifidobacterium according to the formula.

[0097] 4. Weigh appropriate amounts of flavoring agents, fragrances and lubricants as needed, accounting for 10% of the total amount.

[0098] 2. Preparation

[0099] 1. Mixing:

[0100] The mulberry extract, chicory extract, astragalus extract, curcumin, cornus officinalis extract, Poria cocos extract, polygonatum sibiricum extract, mint extract and euglena powder are mixed evenly in a three-dimensional mixer.

[0101] 2. Granulation and drying

[0102] The mixed powder is granulated in a fluidized bed or wet granulated with a 50-85% ethanol solution, dried by hot air circulation at 45-65° C. to a moisture content of 2-5%, and granulated by a 14-mesh sieve swing granulator.

[0103] 3. Total mixing

[0104] The weighed probiotics Bifidobacterium, flavoring agents, essences, lubricants, etc. are mixed evenly with the granulated particles in equal and increasing amounts.

[0105] 4. Filling

[0106] Select appropriate aluminum foil packaging material. Adjust the filling machine to 3.5g / bag. Fill and seal.

[0107] 5. Dosage: According to the results of subsequent animal experiments, the granules have a significant effect on lowering uric acid, and the daily dosage is ≥6.67g, i.e., about 2 packs / day / person.

[0108] 3. Testing of some important active ingredients in the product

[0109] 1) Oxygen Radical Absorption Capacity (ORAC) analysis test results, the ORAC value of this product is 650 (μmol TE / g);

[0110] 2) Product probiotic live bacteria content detection: 5.4×10 9 (cfu / g), about 18 billion per package. That’s 36 billion probiotics per day.

[0111] Embodiment 4 (capsule)

[0112] Taking the total amount of capsules as 100%, the raw material combination (m / m) is: mulberry extract (water extract, total flavonoids content ≥2.5%) 3%, cornus extract (water extract) 21.8%, chicory extract (chicoric acid ≥2.5%) 41.6%, astragalus extract (astragaloside ≥5%) 9.9%, curcumin (curcumin ≥50%) 3.5%, Poria extract (water extract) 6.9%, polygonatum extract (water extract) 3.9%, euglena powder 2%, peppermint extract (water extract) 4%, probiotics (including bifidobacteria and lactobacilli) 2.4% and excipients (lubricant) 1%.

[0113] 1. Extract raw materials and ingredients

[0114] 1. According to the formula, weigh four raw materials: mulberry extract (total flavonoids ≥ 2.5%), chicory extract (chicoric acid ≥ 2.5%), astragalus extract (astragaloside ≥ 5%) and curcumin (curcumin ≥ 50%), which meet the index component requirements, food hygiene indicators and harmful substance limits.

[0115] 2. Extract cornus officinalis, Poria cocos, Polygonatum sibiricum and mint separately or in combination according to the following methods. Extract with 95-100℃ reflux deionized water 10 times, 8 times and 6 times respectively for three times, filter respectively, combine the extracts, concentrate and spray dry to obtain cornus officinalis extract, Poria cocos extract, Polygonatum sibiricum extract and mint extract respectively. Weigh these four extracts according to the formula.

[0116] 3. Weigh the Euglena powder and probiotic Bifidobacterium according to the formula.

[0117] 4. Weigh an appropriate amount of lubricant as needed to account for 1% of the total amount.

[0118] 2. Preparation

[0119] 1. Mixing:

[0120] The mulberry extract, chicory extract, astragalus extract, curcumin, cornus officinalis extract, Poria cocos extract, polygonatum sibiricum extract, mint extract and euglena powder are mixed evenly in a three-dimensional mixer.

[0121] 2. Granulation and drying

[0122] The mixed powder is granulated in a fluidized bed or wet granulated with a 50-85% ethanol solution, dried by hot air circulation at 45-65° C. to a moisture content of 2-5%, and granulated by a 14-mesh sieve swing granulator.

[0123] 3. Total mixing

[0124] The weighed probiotics Bifidobacterium and lubricant are mixed evenly with the granulated particles by an equal and incremental method.

[0125] 4. Filling: Select 0# hard capsule shell. Adjust the filling volume to 0.52g / capsule. Fill the capsule.

[0126] 5. Dosage regimen: According to subsequent animal experimental results, the capsules of the present invention have a significant effect on lowering uric acid, and the daily dosage is ≥6.06 g, i.e., about 12 capsules / day / person.

[0127] 3. Testing of some important active ingredients in the product

[0128] 1) Oxygen Radical Absorption Capacity (ORAC) analysis test results, the ORAC value of this product is 650 (μmol TE / g);

[0129] 2) Product probiotics live bacteria content test: 9.9.0×10 9 (cfu / g), about 5.1 billion per capsule. That’s a total of 61.5 billion probiotics per day.

[0130] The dosage regimens in Examples 1 to 4 of the present invention are determined according to the following experimental examples:

[0131] Test example: Experiment on improving the function of uric acid formula (animal test)

[0132] The test sample has a statistically significant and effective measurement effect on improving uric acid in hyperuricemia model rats. Comparison and verification of the rationality of the recommended dosage of the sample for human consumption. The Shanghai Institute of Pharmaceutical Industry was specially commissioned to complete this experiment.

[0133] 1.1. Test drug: solid beverage prepared in Example 1, properties: brown-yellow granular powder.

[0134] 1.2. Animal source: Wistar rats, SPF male, weight 160-180 g, source: Shanghai Slake Laboratory Animal Co., Ltd., production license: SCXK (Shanghai) 2022-0004, quality certificate number: 202200457099.

[0135] 1.3. Instruments and reagents

[0136] Balance: YP-0001, Shanghai Precision Instrument Co., Ltd. Biochemical detector: HITACHI7080. Sodium carboxymethyl cellulose: 20190303 Sinopharm Chemical Reagent Company. Potassium oxonate: HWYS30381, batch number, HW24A2305-2, specification, 25g, Huawei Raycus.

[0137] 1.4 Dosage and route

[0138] The recommended dosage of the sample for human body is 6g / day, and the dosage of the sample to be tested is 30 times of the human dosage. It is planned to use 3g / kg.

[0139] Route and volume of administration: Oral (PO), 10ml / kg, concentration 0.3g / ml, once a day (qd).

[0140] 1.5 Experimental methods: After adaptive feeding, the rats were randomly divided into 3 groups, model group and test group. They were given 250 mg / kg potassium oxonate (intraperitoneal injection, 10 ml / kg) daily. The test group was also given 3 g / kg of the test product (10 ml / kg, PO) for two consecutive weeks. Body weight and serum uric acid were measured (once a week). One hour after the test product intervention, intraocular blood was drawn to measure serum uric acid.

[0141] 1.6 Preparation of drug solution:

[0142] 0.5% sodium carboxymethylcellulose (CMCNa): weigh 5g sodium carboxymethylcellulose into 1000ml pure water and stir overnight;

[0143] 3g / kg sample: accurately weigh 30g of the solid beverage of Example 1 into 100ml of 0.5% CMCNa, shake at 150rpm to form a uniform brown suspension, store at 4℃, and prepare once a week;

[0144] 250mg.kg potassium oxonate (10ml / kg dosing volume): concentration 25mg / ml.

[0145] Table 1 Grouping and drug administration design

[0146] Group Number of animals Dosage and administration Normal group 5 - Model Group 5 Excipient, PO×qd Test group 5 3g / kg, PO×qd

[0147] 1.7 For data analysis, data were expressed as Mean ± SD, group examination was performed using ANOVA test, pairwise comparison was performed using Uncorrected Fisher's LSD test, and component comparison was performed with the model group. A P value of < 0.05 was considered statistically significant.

[0148] 1.8 Weight changes of rats

[0149] After the rats were adapted to feeding, they were randomly divided into 3 groups, with 5 animals in each group. The body weights of the rats were measured before administration of the test article, one week after administration of the test article, and two weeks after administration of the test article. Figure 1 As shown in Table 2, there was no statistically significant difference in weight gain among the normal control group, model control group and 3 g / kg test product group (P>0.05).

[0150] Table 2 Body weight changes of rats after intervention with the test article (Mean±SD)

[0151]

[0152] 1.9 Effects of the test article on hyperuricemia induced by potassium oxonate in rats

[0153] The serum uric acid of rats in each group was measured 1 week and 2 weeks after intervention. The results are shown in Table 3 and Figure 2 As shown in the figure, compared with the normal group, the serum uric acid level in the model group was significantly increased, while the serum uric acid level in the test group was lower than that in the model group (P < 0.05), which proved that the test product had the effect of lowering uric acid.

[0154] Table 3 Effects of the test samples on serum uric acid content

[0155]

[0156]

[0157] Although the above embodiment describes the present invention in detail, it is only a part of the embodiments of the present invention, not all of the embodiments. People can also obtain other embodiments based on this embodiment without creativity, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A composition for reducing serum uric acid levels, characterized in that Including extracts of Chinese medicines for both medicinal and edible purposes, curcumin, euglena and probiotics; The Chinese medicine for both medicinal and edible purposes includes mulberry, cornus officinalis, chicory, astragalus, tuckahoe, polygonatum and mint.

2. The composition according to claim 1, characterized in that The mass percentage of total flavonoids in mulberry extract is not less than 2.5%; the mass percentage of chicoric acid in chicory extract is not less than 2.5%; the mass percentage of astragaloside IV in astragalus extract is not less than 5%; The extraction solvents of Cornus officinalis extract, Poria cocos extract, Polygonatum sibiricum extract and Peppermint extract are all polar solutions.

3. The composition according to claim 1, characterized in that Calculated by effective ingredients, the invention comprises the following components in parts by weight: 49.5 to 159 parts by weight of extracts of Chinese medicine for both medicinal and edible purposes, 1.5 to 8 parts by weight of curcumin, 1.5 to 7 parts by weight of euglena and 1 to 4 parts by weight of probiotics.

4. The composition according to claim 3, characterized in that Calculated on the basis of effective ingredients, the extracts of the Chinese medicinal and edible herbs are included in the following weight parts: 3-15 weight parts of mulberry extract, 10-35 weight parts of cornus extract, 20-50 weight parts of chicory extract, 10-30 weight parts of astragalus extract, 2.5-11 weight parts of poria extract, 2.5-11 weight parts of polygonatum and 1.5-7 weight parts of peppermint extract.

5. The composition according to claim 1, characterized in that Calculated by effective ingredients, the invention comprises the following components in parts by weight: 81 to 120 parts by weight of extracts of Chinese medicine for both medicinal and edible purposes, 3.5 to 5.5 parts by weight of curcumin, 2 to 4 parts by weight of euglena and 1.5 to 2.5 parts by weight of probiotics.

6. The composition according to claim 5, characterized in that Calculated on the basis of effective ingredients, the extracts of the Chinese medicinal and edible herbs are included in the following weight parts: 6-10 weight parts of mulberry extract, 15-25 weight parts of cornus extract, 35-42 weight parts of chicory extract, 15-25 weight parts of astragalus extract, 4-7 weight parts of poria extract, 4-7 weight parts of polygonatum and 2-4 weight parts of peppermint extract.

7. The composition according to claim 1, characterized in that The probiotics include bifidobacteria and lactobacilli.

8. The composition according to claim 1 or 7, characterized in that The number of viable probiotics in the composition is 6×10 9 ~10×10 9 cfu / g.

9. A health food or medicine comprising the composition according to any one of claims 1 to 8, characterized in that: Also includes auxiliary materials.

10. The health food or medicine according to claim 9, characterized in that: The mass parts of the auxiliary material are 0 to 20 mass parts.

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