Composition for lowering uric acid and treating gout

Abstract

The present invention relates to a composition for reducing uric acid and treating gout and a preparation method thereof, wherein the raw materials for preparing the composition include: 100-150 parts of royal jelly, 100-150 parts of acai berries, 90-140 parts of bao le, 90-140 parts of green coffee beans, 90-140 parts of pomegranates, 90-140 parts of red beetroots and 60-90 parts of lupines. The composition of the present invention combines seven components, significantly exerts a synergistic effect, has a significant effect of reducing uric acid and treating gout compared to existing commercial products or similar compositions, and the composition of the present invention will not produce drug resistance after continuous consumption, has a significant effect of reducing uric acid after taking it for 1 month, and after adjusting to a normal uric acid level, the uric acid value is still stable and will not rebound after being discontinued for a period of time.

Description

Technical Field

[0001] The present invention relates to the technical field of health food and pharmaceutical compositions, and in particular to a composition for lowering uric acid and treating gout. Background Art

[0002] Gout is a group of metabolic diseases caused by purine metabolism disorder, excessive uric acid and / or reduced uric acid excretion, continuous increase in blood uric acid concentration, and deposition of urate crystals in soft tissues. Hyperuricemia is the most important biochemical basis of gout. With the continuous improvement of people's living standards and changes in dietary structure, the prevalence of gout and hyperuricemia has been increasing year by year worldwide. The overall prevalence of hyperuricemia in my country is 13.3%, and the number of patients is about 177 million. Existing drugs for the treatment of gout have many side effects. For example, allopurinol and febuxostat, which are more commonly used in clinical practice, have adverse reactions such as fever, allergies, gastrointestinal reactions, urticaria, headache, renal function damage, and liver necrosis. Moreover, chemical drugs have strong drug resistance, and uric acid is easy to rebound after discontinuation of the drug. Therefore, people prefer to use products that can be used as both medicine and food to continuously reduce uric acid. It is very necessary to create a formula that can melt uric acid stones and reduce uric acid to minimize the harm of gout. Summary of the invention

[0003] Based on the defects of the prior art, the purpose of the present invention is to provide a composition for lowering uric acid and treating gout. The components of this product include royal jelly, acai berry, boluo fruit, green coffee beans, pomegranate, red beetroot and lupine. The seven components can achieve significant effects of lowering uric acid and treating gout through synergistic effect.

[0004] In order to achieve the above purpose, the technical solution adopted by the present invention is:

[0005] A composition for lowering uric acid and treating gout, wherein the raw materials for preparing the composition include, by weight, 100-150 parts of royal jelly, 100-150 parts of acai berries, 90-140 parts of boluo fruit, 90-140 parts of green coffee beans, 90-140 parts of pomegranates, 90-140 parts of red beetroots and 60-90 parts of lupine beans.

[0006] The preparation of the composition comprises the following steps:

[0007] (1) Thaw the royal jelly with water and freeze-dry it into powder;

[0008] (2) washing and crushing acai berries, bao le, pomegranates and red beetroots, extracting with ethanol aqueous solution and filtering to obtain a mixed extract 1, and freeze-drying the mixed extract 1 to obtain a mixed freeze-dried powder 1;

[0009] (3) Grinding green coffee beans and lupin beans, pressing and removing oil to obtain bean dregs, extracting with water and filtering to obtain a mixed extract 2, and freeze-drying the mixed extract 2 to obtain a mixed freeze-dried powder 2;

[0010] (4) The mixed freeze-dried powder 1 and the mixed freeze-dried powder 2 obtained by the above treatment are mixed to obtain the composition.

[0011] Preferably, the raw materials for preparing the composition include, by weight: 120-140 parts of royal jelly, 120-140 parts of acai berries, 100-130 parts of bolus fruit, 110-130 parts of green coffee beans, 110-130 parts of pomegranates, 100-130 parts of red beetroots and 70-80 parts of lupine beans.

[0012] Preferably, the raw materials for preparing the composition include, by weight: 100-130 parts of royal jelly, 130-150 parts of acai berries, 90-130 parts of bolus fruit, 110-140 parts of green coffee beans, 110-140 parts of pomegranates, 90-130 parts of red beetroots and 60-80 parts of lupine beans.

[0013] Preferably, the raw materials for preparing the composition include, by weight: 130-150 parts of royal jelly, 100-130 parts of acai berries, 120-140 parts of bolus fruit, 90-130 parts of green coffee beans, 90-130 parts of pomegranates, 100-140 parts of red beetroots and 80-90 parts of lupine beans.

[0014] The effects of the above raw materials are:

[0015] Royal jelly: Royal jelly is rich in the active ingredient royal jelly protein. On the one hand, royal jelly protein can inhibit the conversion of purine into uric acid by inhibiting the activity of xanthine oxidase, thereby reducing the generation of uric acid from the source; on the other hand, royal jelly protein can inhibit the reabsorption of uric acid by the kidneys, helping the human body to accelerate the excretion of uric acid from the kidneys, thereby reducing the uric acid level in the body. In addition, royal jelly is also rich in the active ingredient decenoic acid, which has a strong anti-inflammatory effect, improves glomerular inflammation, improves the normal filtration barrier function of the glomeruli, and plays a role in normal uric acid excretion.

[0016] Acai berry: Acai berry is the fruit of the Acai palm tree that grows in the Amazon basin. It is rich in polyphenols, flavonoids and other substances, which have the functions of protecting cells and reducing endogenous uric acid production. The polyphenols and flavonoids represented by catechins contained in acai berry have the effect of lowering uric acid, inhibiting the activity of xanthine oxidase and adenosine deaminase, thereby reducing the production of uric acid, and can significantly reduce the levels of urea nitrogen and creatinine in serum. The effect is better than allopurinol, and it has a protective effect on the kidneys. It can achieve the overall function of lowering uric acid, repairing the liver and kidneys, and restoring the balance of uric acid metabolism. In addition, the rich Omega-3 (α-linolenic acid) in acai berry can prevent gout and reduce the frequency and severity of gout attacks by reducing uric acid synthesis, making it less likely to precipitate in joints, and preventing inflammation.

[0017] Buds: Fresh buds are rich in B vitamins, with vitamin B2 far higher than most fruits, and niacin content higher than other tropical fruits. Excessive intake of purine or excessive endogenous purine production will cause a large amount of uric acid to be produced. Purine is decomposed into hypoxanthine by nucleosidase, which is metabolized into xanthine by xanthine oxidase, and further metabolized to form a large amount of uric acid. B vitamins such as folic acid can inhibit the activity of xanthine oxidase by reducing the ability of xanthine oxidase to produce oxygen free radicals and peroxides, thereby reducing serum uric acid production at the same time. In addition, adenosine deaminase is also an important enzyme in purine nucleoside metabolism, and its metabolic end product is uric acid. Vitamin B2 can reduce the activity of adenosine deaminase to reduce the production of uric acid in the blood.

[0018] Green coffee beans: Green coffee beans are a type of coffee beans, which refer to unroasted coffee beans picked from coffee trees. Compared with roasted coffee beans, green coffee beans retain a large amount of nutrients. Chlorogenic acid is the main active ingredient in green coffee bean extracts. It is produced during the aerobic respiration process in plants and is a phenylpropanoid secondary metabolite produced through the shikimic acid pathway. Chlorogenic acid has a wide range of biological activities. Research results show that green coffee bean water extract can play a role in lowering uric acid through the uric acid homeostasis pathway. At the same time, the purine content in every 100g of green coffee is about 19mg, which is a low-purine food and can play an auxiliary therapeutic role for patients with hyperuricemia or gout.

[0019] Red beetroot: Red beetroot belongs to the root vegetable family. This root vegetable is rich in trace elements and vitamin C. Vitamin C can promote the dissolution of urate, facilitate the excretion of uric acid, and prevent the formation of urinary stones. It is worth mentioning that hyperuricemia is associated with renal tubular damage, macrophage infiltration, and increased expression of inflammatory mediators. The components such as rutin contained in red beetroot can inhibit lipid peroxidation, stabilize cell membranes and calcium ion levels, improve renal effective plasma flow, and increase glomerular filtration rate, thereby improving renal function, preventing and treating renal damage. In addition, red beetroot contains a high concentration of betalain. Moreover, betalain is an excellent antioxidant that can help the renal excretion of uric acid and also protect the kidneys. Traditional Chinese medicine believes that one of the causes of acute gout attacks is blood stasis, and "blood circulation will eliminate wind by itself". Betalain can also improve blood circulation. Therefore, in the acute attack of gout, betalain can play a certain analgesic role.

[0020] Pomegranate: Pomegranate belongs to the genus Punica of the Punica family. It is native to Iran and its surrounding areas and is cultivated throughout my country. Pomegranate is rich in phytochemicals such as ellagitannins and ellagic acid. Although the gastrointestinal tract cannot directly absorb the ellagitannins present in pomegranates, they will spontaneously participate in hydrolysis to produce ellagic acid and its derivatives. Studies have shown that ellagic acid isolated from pomegranate extracts has better bioavailability and biological activity than other fruits. Ellagic acid is a natural small molecule phenolic compound and natural flavonoid. It is an effective xanthine oxidase inhibitor and superoxide anion scavenger. Ellagic acid can reduce serum uric acid levels by inhibiting the activity and protein expression of xanthine oxidase and increasing uric acid excretion. At the same time, ellagic acid can reduce hyperuricemia-induced liver and kidney acid damage and gouty edema symptoms, such as foot swelling, by regulating the NLRP3 inflammasome pathway.

[0021] Lupin: Lupin is rich in the active ingredient lupeine, which is an active alkaloid with a weak alkaline characteristic. It increases the solubility of uric acid in body fluids, protects kidney function, promotes excretion, and thus effectively inhibits the increase of blood uric acid levels in the body.

[0022] Preferably, the volume fraction of the ethanol aqueous solution in step (2) is 50% to 80%.

[0023] Preferably, in step (2), the extraction solid-liquid ratio is 1:5-1:10, the extraction temperature is 50-80°C, and the extraction time is 1-4h.

[0024] Preferably, in step (3), the extraction material-liquid ratio is 1:8-1:20, the extraction temperature is 60-90°C, and the extraction time is 2-6h. The present invention also provides the use of the composition in the preparation of food or medicine for lowering uric acid or treating gout. Preferably, the dosage form of the food is tablets, powders, capsules, pills, oral liquids, beverages or soft candies. Preferably, the food is made of the composition and acceptable excipients in the food. Preferably, the food is a health food.

[0025] Compared with the prior art, the present invention has the following beneficial effects:

[0026] The present invention provides a composition for lowering uric acid and treating gout. The product is a composite combination of seven components, namely royal jelly, acai berry, baole fruit, green coffee beans, pomegranate, red beetroot and lupine, which significantly exerts a synergistic effect. Compared with existing commercial products or similar compositions, it has significant effects of lowering uric acid and treating gout. The efficacy of the product can be confirmed by animal model experiments and human food trials. The present invention will not produce drug resistance after continuous consumption. It has a significant uric acid lowering effect after taking it for 1 month. After adjusting to the normal uric acid level, the uric acid value remains stable and will not rebound after stopping for a period of time. DETAILED DESCRIPTION

[0027] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. Example 1

[0028] A composition for lowering uric acid and treating gout, wherein the raw materials for its preparation include, by weight:

[0029] Royal Jelly 120 parts, Acai Berry 140 parts, Polvera 130 parts, Green Coffee Bean 110 parts, Pomegranate 140 parts, Red Beetroot 90 parts and Lupine 70 parts.

[0030] The preparation of the composition comprises the following steps:

[0031] (1) Thaw the royal jelly with water and freeze-dry it into powder;

[0032] (2) washing and crushing acai berries, bao le, pomegranates and red beetroots, extracting them with a 50% volume fraction ethanol aqueous solution at a solid-liquid ratio of 1:10 at 70° C. for 2 h, and filtering to obtain a mixed extract 1, and freeze-drying the mixed extract 1 to obtain a mixed freeze-dried powder 1;

[0033] (3) Grinding green coffee beans and lupin beans, pressing and removing oil to obtain bean dregs, extracting with water at a solid-liquid ratio of 1:10 at 80° C. for 6 h, and filtering to obtain a mixed extract 2, and freeze-drying the mixed extract 2 to obtain a mixed freeze-dried powder 2;

[0034] (4) The mixed freeze-dried powder 1 and the mixed freeze-dried powder 2 obtained by the above treatment are mixed to obtain the composition. Example 2

[0035] A composition for lowering uric acid and treating gout, wherein the raw materials for its preparation include, by weight:

[0036] 100 parts Royal Jelly, 150 parts Acai Berry, 100 parts Polva Fruit, 140 parts Green Coffee Bean, 110 parts Pomegranate, 130 parts Red Beetroot and 60 parts Lupine Bean.

[0037] The preparation of the composition comprises the following steps:

[0038] (1) Thaw the royal jelly with water and freeze-dry it into powder;

[0039] (2) washing and crushing acai berries, baole fruits, pomegranates and red beetroots, extracting them with a 60% volume fraction ethanol aqueous solution at a solid-liquid ratio of 1:8 at 80° C. for 1 h, and filtering to obtain a mixed extract 1, and freeze-drying the mixed extract 1 to obtain a mixed freeze-dried powder 1;

[0040] (3) Grinding green coffee beans and lupin beans, pressing and removing oil to obtain bean dregs, extracting with water at a solid-liquid ratio of 1:15 at 70° C. for 4 h, and filtering to obtain a mixed extract 2, and freeze-drying the mixed extract 2 to obtain a mixed freeze-dried powder 2;

[0041] (4) The mixed freeze-dried powder 1 and the mixed freeze-dried powder 2 obtained by the above treatment are mixed to obtain the composition. Example 3

[0042] A composition for lowering uric acid and treating gout, wherein the raw materials for its preparation include, by weight:

[0043] 150 parts Royal Jelly, 100 parts Acai Berry, 140 parts Polva Fruit, 90 parts Green Coffee Bean, 120 parts Pomegranate, 120 parts Red Beetroot and 90 parts Lupine Bean.

[0044] The preparation of the composition comprises the following steps:

[0045] (1) Thaw the royal jelly with water and freeze-dry it into powder;

[0046] (2) washing and crushing acai berries, bao le, pomegranates and red beetroots, extracting them with 70% by volume ethanol aqueous solution at a solid-liquid ratio of 1:6 at 50° C. for 2 h, and filtering to obtain a mixed extract 1, and freeze-drying the mixed extract 1 to obtain a mixed freeze-dried powder 1;

[0047] (3) Grinding green coffee beans and lupin beans, pressing and removing oil to obtain bean dregs, extracting with water at a solid-liquid ratio of 1:8 at 90° C. for 5 h, and filtering to obtain a mixed extract 2, and freeze-drying the mixed extract 2 to obtain a mixed freeze-dried powder 2;

[0048] (4) The mixed freeze-dried powder 1 and the mixed freeze-dried powder 2 obtained by the above treatment are mixed to obtain the composition. Example 4

[0049] A composition for lowering uric acid and treating gout, wherein the raw materials for its preparation include, by weight:

[0050] Royal Jelly 140 parts, Acai Berry 120 parts, Polana Fruit 120 parts, Green Coffee Bean 130 parts, Pomegranate 90 parts, Red Beetroot 140 parts and Lupine 80 parts.

[0051] The preparation of the composition comprises the following steps:

[0052] (1) Thaw the royal jelly with water and freeze-dry it into powder;

[0053] (2) washing and crushing acai berries, baole fruits, pomegranates and red beetroots, extracting them with 80% by volume ethanol aqueous solution at a solid-liquid ratio of 1:7 at 60° C. for 3 h, and filtering to obtain a mixed extract 1, and freeze-drying the mixed extract 1 to obtain a mixed freeze-dried powder 1;

[0054] (3) Grinding green coffee beans and lupin beans, pressing and removing oil to obtain bean dregs, extracting with water at a solid-liquid ratio of 1:20 at 60° C. for 2 h, and filtering to obtain a mixed extract 2, and freeze-drying the mixed extract 2 to obtain a mixed freeze-dried powder 2;

[0055] (4) The mixed freeze-dried powder 1 and the mixed freeze-dried powder 2 obtained by the above treatment are mixed to obtain the composition. Example 5

[0056] A composition for lowering uric acid and treating gout, wherein the raw materials for its preparation include, by weight:

[0057] 130 parts Royal Jelly, 130 parts Acai Berry, 90 parts Polva Fruit, 120 parts Green Coffee Bean, 130 parts Pomegranate, 100 parts Red Beetroot and 80 parts Lupine Bean.

[0058] The preparation of the composition comprises the following steps:

[0059] (1) Thaw the royal jelly with water and freeze-dry it into powder;

[0060] (2) washing and crushing acai berries, baole fruits, pomegranates and red beetroots, extracting them with 75% by volume ethanol aqueous solution at a solid-liquid ratio of 1:5 at 60° C. for 4 h, and filtering to obtain a mixed extract 1, and freeze-drying the mixed extract 1 to obtain a mixed freeze-dried powder 1;

[0061] (3) Grinding green coffee beans and lupin beans, pressing and removing oil to obtain bean dregs, extracting with water at a solid-liquid ratio of 1:18 at 70° C. for 3 h, and filtering to obtain a mixed extract 2, and freeze-drying the mixed extract 2 to obtain a mixed freeze-dried powder 2;

[0062] (4) The mixed freeze-dried powder 1 and the mixed freeze-dried powder 2 obtained by the above treatment are mixed to obtain the composition.

[0063] Comparative Example 1

[0064] The difference between this comparative example and Example 1 is that an equal amount of celery seed extract is used to replace royal jelly.

[0065] Comparative Example 2

[0066] The difference between this comparative example and Example 1 is that an equal amount of sour cherries are used to replace acai berries.

[0067] Comparative Example 3

[0068] The difference between this comparative example and Example 1 is that an equal amount of gardenia by weight is used to replace green coffee beans.

[0069] Comparative Example 4

[0070] The difference between this comparative example and Example 1 is that an equal amount of chicory is used to replace boluo fruit.

[0071] Comparative Example 5

[0072] The difference between this comparative example and Example 1 is that turmeric is used in equal parts by weight to replace lupine.

[0073] Comparative Example 6

[0074] The difference between this comparative example and Example 1 is that: equal parts by weight of celery seed extract are used instead of royal jelly, equal parts by weight of sour cherry are used instead of acai berry, equal parts by weight of gardenia are used instead of green coffee beans, equal parts by weight of chicory are used instead of bao le, and equal parts by weight of turmeric are used instead of lupin.

[0075] 1. Experimental study on the inhibition rate of the composition of the present invention on xanthine oxidase

[0076] 1. Solution preparation

[0077] (1) 0.2 mol / L (pH 7.5) phosphate buffer (PBS): Accurately weigh 30.0838 g Na2HPO4·12H2O and 2.4962 g NaH2PO4·2H2O, dissolve them in deionized water, and make up to 500 mL.

[0078] (2) Xanthine solution: Accurately weigh 6.4 mg of xanthine and dissolve it in 1 mL of 1 M NaOH. Then add 100 mL of PBS and adjust the pH to 7.5 with 1 M HCl.

[0079] (3) Xanthine oxidase: Take 120 μl of enzyme solution and dilute to 8 mL with PBS.

[0080] (4) Uric acid standard curve solution: Accurately weigh 10 mg of uric acid, add 10 mL of water, and then dilute to 0.1, 0.3, 0.5, 0.7 and 0.9 mg / mL uric acid solution. After ultrasonic centrifugation, perform high performance liquid chromatography analysis.

[0081] (5) Ammonium acetate-glacial acetic acid solution: Accurately weigh 3.85 g of ammonium acetate and add water to make up to 1000 mL. Then add 4 mL of glacial acetic acid.

[0082] 2. Sample pretreatment:

[0083] The composition samples prepared in Examples 1-5 and Comparative Examples 1-6 were diluted with PBS to 40 mg / mL to obtain sample liquids. In the experimental group, 50 μL of sample liquid and 50 μL of xanthine solution were added to a 96-well ELISA plate in sequence. Each sample was subjected to 3 parallels. After 10 min of incubation at 37°C, 150 μL of xanthine oxidase was added. After 20 min of incubation at 37°C, 80 μL of 1M HCl was added to terminate the reaction, and the reaction was passed through a 0.25 μm aqueous membrane for testing. In the control group, 50 μL of PBS and 50 μL of xanthine solution were added to a 96-well ELISA plate in sequence, and the rest of the operations were the same as those of the experimental group.

[0084] 3. High performance liquid chromatography test:

[0085] The experimental group and the control group were sampled after the sample pretreatment, and after the ultrasonic centrifugation treatment, the high performance liquid chromatography test analysis was performed respectively under the following conditions:

[0086] Chromatographic column: Zorbax Eclipse XDB-C18 column (5 μm, 4.6×250 mm, Agilent).

[0087] Liquid phase conditions: the eluent was 10% methanol + 90% ammonium acetate-glacial acetic acid solution, the injection volume was 20 μL, the flow rate was 1 mL / min, the detection wavelength was 290 nm, and the running time was 10 min.

[0088] 4. Calculation formula

[0089] Xanthine oxidase inhibition rate = .

[0090] Where:

[0091] A0——peak area of ​​uric acid peak in HPLC analysis of the control group;

[0092] A——Peak area of ​​uric acid peak in HPLC analysis of the experimental group.

[0093] Table 1

[0094]

[0095] As can be seen from the results in Table 1, the inhibition rate of xanthine oxidase in each example group is good, all reaching more than 30%, indicating that the composition of the present invention has significant potential for lowering uric acid. Compared with Example 1, after the preparation raw materials in the composition of Comparative Examples 1-6 were changed respectively, the inhibition rate of xanthine oxidase was generally less than 30%, indicating that changing any component of the composition of the present invention will affect the inhibition rate of xanthine oxidase in the composition.

[0096] II. Evaluation of the uric acid-lowering effect of the composition of the present invention

[0097] 1. Test methods

[0098] The hyperuricemia mouse model was established by inducing the uricase inhibitor potassium oxonate. Kunming male mice were first randomly divided into 14 groups, namely: blank group, model group, example group (administered with the composition of examples 1-5) for a total of 5 groups (200 mg / kg•bw), comparative group (administered with the composition of comparative examples 1-6) for a total of 6 groups (200 mg / kg•bw), and allopurinol positive control group (5 mg / kg•bw), with 10 mice in each group. Under the condition of ensuring normal diet and drinking water, the blank group was intraperitoneally injected with an equal volume of normal saline, and the other groups were intraperitoneally injected with 250 mg / kg•bw potassium oxonate (suspended in a 0.5% CMC-Na solution) for 7 consecutive days. At the same time, the corresponding doses for the embodiment group and the comparative group were 200 mg / kg•bw of the composition (dissolved in 0.9% by mass saline), the dose for the positive group mice was 5 mg / kg•bw of allopurinol (dissolved in 0.9% by mass saline), and the blank group and the model group were gavaged with the same dose of 0.9% saline solution as in the embodiment, and the gavage was continued for 7 days. After the gavage on the 7th day, the mice were fasted for 12 hours so that the test samples could be extracted after the gavage on the 7th day.

[0099] 2. Determination of organ index

[0100] All mice were deprived of food 12 hours before gavage on the 7th day. The mice were weighed, and after gavage on the 7th day, the eyeballs were removed to collect blood, and the mice were killed by cervical dislocation. The liver and kidney tissues were removed, rinsed in 4°C precooled saline, weighed, and the organ index was calculated. The results are shown in Table 2.

[0101] 3. Determination of serum uric acid (UA), urea nitrogen (BUN) and creatinine (Cr) levels in mice

[0102] After 7 days of continuous gavage, the eyeballs were removed to collect blood, and the mice were killed by dislocation of the neck. The blood was naturally coagulated for 1 hour at room temperature and then centrifuged at 3500rpm for 10 minutes at 4°C. The supernatant was taken to obtain serum, which was packaged and stored in a -20°C freezer for later use. The uric acid test kit, urea nitrogen test kit and creatinine test kit were used to determine the levels of uric acid, urea nitrogen and creatinine in mouse serum. The results are shown in Table 3.

[0103] Table 2

[0104]

[0105]

[0106] As can be seen from the results in Table 2, the liver / kidney coefficients of the mice in the model group were significantly increased compared with those in the blank group (P < 0.01), indicating that intraperitoneal injection of potassium oxonate can cause liver and kidney enlargement in mice, and the hyperuricemia mouse model was successfully established. The liver / kidney coefficients of each embodiment group were significantly reduced compared with the model group (P < 0.01), indicating that the composition of the present invention can alleviate hyperuricemia liver and kidney damage induced by potassium oxonate. The liver / kidney coefficients of the comparative examples 1-6 groups were significantly reduced compared with the model group (P < 0.05, P < 0.01), but the reduction effect was significantly lower than that of Example 1 (P < 0.05, P < 0.01), indicating that changing any component of the composition of the present invention has a significant difference in the effect of reducing the liver / kidney coefficient of mice.

[0107] Table 3

[0108]

[0109]

[0110] As shown in Table 3, the serum uric acid value, urea nitrogen and creatinine of the model group mice were significantly increased compared with the blank group (P < 0.01), further indicating that the hyperuricemia mouse model was successfully established after intraperitoneal injection of potassium oxonate. The serum uric acid value, urea nitrogen and creatinine of each embodiment group were significantly reduced compared with the model group (P < 0.05, P < 0.01), indicating that the composition of the present invention has a significant effect of lowering uric acid. The serum uric acid value, urea nitrogen and creatinine of each comparative example group were significantly reduced compared with the embodiment 1 group (P < 0.05, P < 0.01), indicating that changing any component of the composition of the present invention has a significant effect on the uric acid lowering effect of mice.

[0111] III. Evaluation of the Gout Improvement Effect of the Composition of the Present Invention

[0112] 1. Inclusion criteria for human trials: ① Meet the 2015 ACR / EULAR gout classification criteria. ② Serum uric acid level ≥ 480 μmol / L.

[0113] Those who meet the above two conditions and are between 18 and 65 years old.

[0114] 2. Test method: The above 120 people were divided into 12 groups, 10 people in each group, half of them were male and half were female, and they were respectively Example 1-5 group, Comparative Example 1-6 group, and positive control allopurinol tablet group. The study lasted for 1 month, and each person in the Example and Comparative Example consumed 1g of the composition once a day, and the positive control group consumed 0.1g of allopurinol tablets once a day. Conventional dietary intervention was as follows:

[0115] ①Diet: No tobacco, alcohol, or soft drinks; low-purine diet with purine content <75mg / 100g;

[0116] ② Basic treatment: Sodium bicarbonate, 100 mg each time, 3 times a day, used when pH <6.0, maintain pH at 6.5-6.8, urine volume >2000 mL per day, when the patient's acute gout attack cannot be controlled, etoricoxib tablets, 60 mg, once a day should be given;

[0117] ③Maintain a regular life.

[0118] (3) Safety and effectiveness evaluation

[0119] Safety indicators examined weight changes before and after consumption, adverse reactions (gastrointestinal discomfort, liver and kidney function damage, rash, etc.), and effectiveness evaluation examined changes in fasting blood uric acid levels and changes in gout TCM syndrome scores. The results are shown in Table 4.

[0120] Table 4

[0121]

[0122]

[0123] As shown in Table 4, after taking the products of each embodiment group for 1 month, the weight change was not significant (P>0.05), and there was no adverse reaction, indicating that the product of the present invention is safe to eat. After treatment, the uric acid of each embodiment group was significantly reduced (P<0.01), and the TCM syndrome score of gout was significantly reduced (P<0.01). Moreover, compared with before 15 days after stopping treatment, the uric acid value was not much different from that 30 days after treatment (P>0.05), and the value was still within the safe value range. There was no significant difference in the TCM syndrome score of gout (P>0.05), indicating that the composition of the present invention has a stable effect on lowering uric acid and treating gout, and will not rebound after stopping treatment.

[0124] The effects of each comparative example after treatment were average compared with those of the embodiments. Among them, the differences in uric acid values ​​and TCM syndrome scores of gout before and after treatment in comparative example 6 (replacing royal jelly, acai berries, coffee beans, baole fruit, and lupine beans of the present invention) were not significant (P>0.05), indicating that changing the components of the composition of the present invention will not be able to exert the synergistic effect between the compositions, and will have a significant impact on the effect of lowering uric acid and treating gout in the human body. Moreover, compared with before 15 days after stopping treatment, the difference in uric acid values ​​was significant (P<0.05) 30 days after treatment, which further illustrates that there is a synergistic effect between the components of the composition of the present invention, and changing any component of the present invention will affect the effect of lowering uric acid and the efficacy of treating gout.

[0125] Finally, it should be noted that the above is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art can still modify the technical solutions described in the aforementioned embodiments or replace some of the technical features therein by equivalents. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A composition for lowering uric acid and treating gout, characterized in that: The raw materials for preparing the composition are, by weight, 100-150 parts of royal jelly, 100-150 parts of acai berries, 90-140 parts of boluo fruit, 90-140 parts of green coffee beans, 90-140 parts of pomegranates, 90-140 parts of red beetroots and 60-90 parts of lupine beans.

2. The composition for lowering uric acid and treating gout according to claim 1, characterized in that: The raw materials for preparing the composition are, by weight, 120-140 parts of royal jelly, 120-140 parts of acai berries, 100-130 parts of boluo fruit, 110-130 parts of green coffee beans, 110-130 parts of pomegranates, 100-130 parts of red beetroots and 70-80 parts of lupine beans.

3. The composition for lowering uric acid and treating gout according to claim 1, characterized in that: The raw materials for preparing the composition are, by weight, 100-130 parts of royal jelly, 130-150 parts of acai berries, 90-130 parts of boluo fruit, 110-140 parts of green coffee beans, 110-140 parts of pomegranates, 90-130 parts of red beetroots and 60-80 parts of lupine beans.

4. The composition for lowering uric acid and treating gout according to claim 1, characterized in that: The raw materials for preparing the composition are, by weight, 130-150 parts of royal jelly, 100-130 parts of acai berries, 120-140 parts of boluo fruit, 90-130 parts of green coffee beans, 90-130 parts of pomegranates, 100-140 parts of red beetroots and 80-90 parts of lupine beans.

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