Traditional Chinese medicine composition for relieving gout pain and regulating uric acid metabolism as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for relieving gout pain and regulating uric acid metabolism as well as a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from tea leaves, lophatherum gracile, lalang grass rhizome, celery seeds, folium cortex eucommiae, endothelium corneum gigeriae galli, radix angelicae, sophora flower bud and momordica grosvenori, all the components are reasonably matched, and the traditional Chinese medicine composition has the effects of clearing heat, promoting diuresis, invigorating the spleen, tonifying the kidney, treating stranguria, relieving pain and obviously preventing and treating gout. The effects of reducing uric acid and treating gouty arthritis of the traditional Chinese medicine composition are verified through a hyperuricemia animal model and a gouty arthritis animal model, the test result shows that the traditional Chinese medicine composition has the remarkable effects of reducing uric acid and relieving gouty arthritis pain, and the traditional Chinese medicine composition is simple in preparation process, high in prescription safety and low in cost. The traditional Chinese medicine composition is suitable for long-term administration, and has a good application prospect in the aspects of uric acid metabolism regulation, hyperuricemia treatment and gouty arthritis pain relief.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine and health care products, and specifically relates to a traditional Chinese medicine composition for relieving gout pain and regulating uric acid metabolism, as well as a preparation method and application thereof. Background Art

[0002] Hyperuricemia (HUA) is a metabolic disease caused by impaired purine metabolism or decreased uric acid excretion. Long-term high uric acid levels can lead to the deposition of sodium urate crystals in joints and surrounding tissues, triggering acute gouty arthritis, characterized by joint redness, swelling, and severe pain, most commonly in the big toe and ankle joints. If high uric acid levels are not promptly controlled, it can easily develop into chronic tophi, leading to joint deformity and dysfunction, and even irreversible damage. Hyperuricemia, on the other hand, is a metabolic disease often closely associated with renal, cardiovascular, and other metabolic diseases. When uric acid concentrations are too high, urate crystals can easily deposit in the kidneys, forming kidney stones, which can affect renal function and cause kidney damage.

[0003] Currently, clinical treatment for uric acid reduction relies primarily on chemical medications. These include xanthine oxidase inhibitors like allopurinol and febuxostat, which can cause hepatotoxicity and Stevens-Johnson syndrome with long-term use. Benzbromarone-based uricosuric drugs carry the risk of kidney stones and are contraindicated in patients with renal insufficiency. Uricase preparations, primarily based on pegolase, are expensive and prone to allergic reactions. The side effects and contraindications of these drugs limit their long-term use, resulting in poor patient compliance. Traditional Chinese medicine, which combines food and medicine with both food safety and pharmacological activity, is suitable for long-term conditioning.

[0004] Traditional Chinese Medicine (TCM) classifies hyperuricemia and gout as "gout," "arthritis," "turbid stasis and arthritis," "phlegm and dampness," and "damp-heat," believing their causes to be related to dietary irregularities, spleen and kidney dysfunction, and damp-heat and blood stasis. Common TCM classifications of hyperuricemia include damp-heat accumulation, phlegm and blood stasis blocking the collaterals, spleen deficiency and dampness accumulation, liver and kidney yin deficiency, and yang deficiency and cold stagnation. Different types of hyperuricemia are treated differently. Treatment for damp-heat accumulation focuses on clearing heat and dampness, unblocking the collaterals, and alleviating pain. Treatment for phlegm and blood stasis blocking the collaterals focuses on resolving phlegm and blood stasis, unblocking the collaterals, and alleviating pain. Treatment for spleen deficiency and dampness accumulation focuses on strengthening the spleen and eliminating dampness, promoting diuresis, and clearing turbidity. Treatment for liver and kidney yin deficiency focuses on nourishing the liver and kidneys, clearing turbidity, and unblocking the collaterals. Treatment for yang deficiency and cold stagnation focuses on warming yang, dispersing cold, and resolving blood stasis. Clinically, a combination of damp-heat accumulation, spleen deficiency and dampness accumulation, and liver and kidney yin deficiency is common, and the treatment principles are based on clearing heat and dampness, promoting diuresis, and clearing turbidity, nourishing the liver and kidneys, and relieving stranguria and pain.

[0005] Chinese invention patent application CN119258182A discloses a traditional Chinese medicine for treating gout and hyperuricemia, a medicinal and edible herb. The herb is comprised of the following ingredients in parts by weight: 40-60 g of Smilax glabra (Rhizoma Smilacis Glabrae), 3-7 g of turmeric, 10-20 g of dandelion, 5-15 g of plantain, 10-20 g of knotweed, 10-20 g of umbellatus, 3-7 g of rhubarb, and 5-15 g of wax gourd peel. The turmeric in this formula may cause side effects such as stomach discomfort, nausea, dizziness, or diarrhea in some people. Rhubarb is not a medicinal and edible herb and should not be taken long-term or in excess, as it can easily cause poisoning. The rhubarb added after the meal is particularly toxic and can cause adverse reactions such as nausea, vomiting, dizziness, abdominal cramps, and jaundice.

[0006] Based on the above, in order to solve the problems of long-term medication effectiveness and safety for people with hyperuricemia and gout, the present invention aims to provide a medicine-food composite composed of a combination of medicine-food ingredients and medicinal materials. According to the Chinese medicine syndrome differentiation and treatment of hyperuricemia, gouty arthritis and the application of Chinese medicine compatibility, the materials are selected mainly to clear away heat and dampness, strengthen the spleen and kidney, and relieve stranguria and pain, help nourish the spleen and kidney, enhance the spleen and stomach transportation and transformation, promote qi and eliminate dampness, eliminate damp heat in the body, and strengthen water metabolism function. On the one hand, it promotes uric acid excretion, increases uric acid metabolism and reduces uric acid levels to achieve the purpose of relieving pain. On the other hand, it is supplemented with analgesic and anti-inflammatory drugs to enhance the pain relief effect. Summary of the Invention

[0007] In order to solve the above technical problems, the object of the present invention is to provide a kind of medicinal material with medicinal and edible homologous medicinal materials, food raw materials and other ingredients as raw materials, according to Chinese medicine differentiation and treatment, uric acid metabolism is regulated to carry out material selection, compatibility and drug efficacy research and verification, raw material selection is based on the effects such as clearing away heat and dampness, diuresis and turbidity, relieving stranguria and relieving pain, invigorating the spleen and kidney, and compatibility application can help invigorating the spleen and kidney, enhance spleen and stomach transportation and transformation, with qi circulation and dampness removal, remove damp heat evil in the body, strengthen water metabolism function, reduce uric acid levels, and relieve gout pain. The composition preparation process is simple, production cost is low, safety is high, can be widely used in food, health products and medicines, and has strong market competitiveness and clinical value.

[0008] In order to achieve the above object, the technical solution adopted by the present invention is as follows: The present invention provides a Chinese medicinal and edible medicinal composition for relieving gout pain and regulating uric acid metabolism. The Chinese medicinal and edible medicinal composition comprises main functional ingredients and auxiliary ingredients.

[0009] A traditional Chinese medicine composition for relieving gout pain and regulating uric acid metabolism, the traditional Chinese medicine composition comprising the following functional ingredients in parts by weight: 3-10 parts of tea leaves, 3-10 parts of bamboo leaves, 3-9 parts of Imperata rhizome, 3-8 parts of celery seeds, 2-6 parts of Eucommia ulmoides leaves, 2-6 parts of chicken gizzard lining, 2-6 parts of Angelica dahurica, 2-6 parts of Sophora japonica seeds, and 0.2-2 parts of Momordica grosvenori.

[0010] Furthermore, the tea leaves may be green tea, white tea, black tea, or oolong tea, preferably white tea.

[0011] Further preferably, the traditional Chinese medicine composition is composed of the following functional ingredients in parts by weight: 3-8 parts of tea leaves, 3-6 parts of light bamboo leaves, 3-9 parts of Imperata rhizome, 3-5 parts of celery seeds, 2-6 parts of Eucommia ulmoides leaves, 2-6 parts of chicken gizzard lining, 2-6 parts of Angelica dahurica, 2.5-5 parts of Sophora japonica seeds and 0.3-2 parts of Momordica grosvenori.

[0012] Further preferably, the chicken's gizzard lining is preferably processed chicken's gizzard lining powder, and the specific steps include: taking the chicken's gizzard lining powder into coarse powder, adding 5%-15% sodium bicarbonate or sodium carbonate solution to immerse it, treating it in a high-pressure steam sterilizer at 100-121°C for 10-30 min, filtering, washing, dehydrating, and setting aside.

[0013] Further preferably, the chicken gizzard powder is 80-100 mesh.

[0014] Furthermore, each functional ingredient is directly crushed and used or subjected to solvent extraction to form an extract, and the extract is prepared into various suitable preparations in one step, including tea substitutes, solid beverages, oral solutions, granules, capsules, and tablets.

[0015] The present invention also provides a method for preparing the Chinese medicine composition, comprising the following steps: S1. Grind chicken gizzard lining into coarse powder, add 5%-15% sodium bicarbonate or sodium carbonate solution to immerse, sterilize in a high-pressure steam sterilizer at 100-121°C for 10-30 min, filter, wash, remove moisture, and set aside; S2 Grind tea leaves, Imperata root, Angelica dahurica, Lophatherum gracile, Eucommia ulmoides leaf and Momordica grosvenori into coarse powder, mix evenly with celery seeds, Sophora japonica seeds and chicken gizzard lining powder of S1, and divide into packages to obtain a tea substitute.

[0016] The present invention further provides a method for preparing the Chinese medicine composition, comprising the following steps: Grind chicken gizzard powder into coarse powder, add 5%-15% sodium bicarbonate or sodium carbonate solution to immerse it, sterilize it in a high-pressure steam sterilizer at 100-121°C for 10-30 minutes, filter, wash, remove moisture, and set aside; Tea leaves, Imperata rhizome, Angelica dahurica, celery seeds, Glehnia littoralis leaf, Eucommia ulmoides leaf, processed chicken gizzard lining, Sophora japonica seed and Momordica grosvenori are added with water or 30-60% ethanol, heated at 60-90°C for reflux extraction, with a material-liquid ratio of 1:6-12, W / V; the number of extractions is 1-3; each extraction time is 30-90 minutes; the extracts are filtered, combined and concentrated, and concentrated under reduced pressure to produce extract A, or further dried to produce dry extract B for later use.

[0017] Furthermore, extract A is further added with water to a relative density of 1.03-1.05 (22-28°C) and precipitated in water for 24-72 hours, or 90%-95% alcohol is added to a concentration of 40%-70% alcohol and precipitated for 24-72 hours, and then concentrated under reduced pressure to obtain extract C, or dried to obtain dry extract D.

[0018] Furthermore, the obtained extract / dry paste is added with one or more pharmaceuticals, food-acceptable adjuvants and / or excipients, and food additives to prepare a finished preparation.

[0019] Furthermore, the auxiliary materials and / or excipients of the finished preparation refer to one or more of cherry powder, turmeric extract, lemon, licorice, anserine, citric acid, sodium citrate, and sodium bicarbonate.

[0020] The present invention also provides the use of the uric acid metabolism regulating traditional Chinese medicine composition, or the composition prepared by the method, for preparing functional foods, health products, and medicines for reducing hyperuricemia and relieving gouty arthritis pain.

[0021] Furthermore, the hyperuricemia includes hyperuricemia, uric acid arthritis, gout and hyperuricemia-related diseases.

[0022] The present invention is based on clinical experience and combines the cause of hyperuricemia and the analysis of disease symptoms. The invention uses bamboo leaf, Imperata root, tea leaf and Sophora japonica to collaboratively clear the damp-heat of the three burners and has a strong diuretic and fire-purging effect. Celery seed is added to diuresis and expel turbidity and Momordica grosvenori is added to regulate water metabolism. In order to strengthen the function of promoting qi and removing dampness, chicken's gizzard lining is added to invigorate the spleen and stomach, remove dampness, guide the medicine to return to the meridians, and Eucommia leaf is added to nourish the liver and kidney to help the metabolism of uric acid. Finally, Angelica dahurica is added to dry dampness and relieve pain, and Celery seed is added to relieve inflammation and analgesia to jointly treat the red, swollen, hot and painful joints caused by hyperuricemia. The whole prescription plays the role of clearing heat and dampness, tonifying the spleen and kidney, and relieving stranguria and pain. It can be used for short and dark urine, swollen and painful joints, and heaviness of limbs caused by damp-heat accumulation. Hyperuricemia is seen in those with the above-mentioned symptoms.

[0023] The prescription further demonstrates that the medicinal and edible ingredients tea and monk fruit not only improve the taste but also exhibit synergistic diuretic, antioxidant, and anti-inflammatory effects, synergizing uric acid excretion. Tea can be green tea, white tea, black tea, or oolong tea. Comparing the properties, ingredients, and efficacy of teas produced by different origins and preparation processes, Fujian-produced green tea has a strong diuretic effect but a strong cooling effect, making it unsuitable for people with cold stomachs. Fermentation weakens the effects of black tea and oolong tea, necessitating increased dosages. Slightly fermented white tea is preferred, as it has a mild flavor, moderate activity, and is less likely to upset the stomach, especially aged white tea over three years. White tea has a sweet, slightly bitter flavor and a slightly cooling nature. It enters the heart, liver, and stomach meridians. This slightly fermented tea possesses heat-clearing and detoxifying properties, protects the liver, and relieves summer heat and promotes diuresis. It is used to treat summer heat damage to body fluids, dry mouth and throat, and poor urination. Rich in tea polyphenols, caffeine, amino acids, vitamins, and other nutrients, it possesses antioxidant, anti-inflammatory, and uric acid-lowering properties, promoting metabolism and accelerating uric acid excretion.

[0024] Compared with the prior art, the present invention has the following beneficial effects: (1) The Chinese medicinal composition of food and medicine for regulating uric acid metabolism prepared by the present invention is prepared under the guidance of traditional Chinese medicine theory through syndrome differentiation and treatment, and compatibility, and plays the role of strengthening the spleen and kidney, clearing away heat and dampness, and relieving stranguria and pain. From the perspective of traditional Chinese medicine, it is necessary to treat both the symptoms and the root cause of uric acid reduction. High uric acid is the symptom of various evils lurking in the body, while the root cause is the deficiency of the body's vital energy and dysfunction of the spleen, kidney and other internal organs. As the saying goes, "When the vital energy is inside, the evil cannot enter; where the evil gathers, the vital energy must be weak." High uric acid is the symptom, and deficiency is the essence of high uric acid. Therefore, the treatment principle should be to nourish the vital energy and eliminate the latent evils. At the same time, drugs that clear away heat and dampness, strengthen the spleen and kidney, promote diuresis and reduce swelling, and relieve stranguria and pain should be used. Only by treating both the symptoms and the root cause can the disease be prevented from being prolonged and recurring.

[0025] (2) The present invention adopts a reasonable combination of raw materials of medicinal and edible origin, namely tea, Imperata root, Angelica dahurica, celery seed, bamboo leaf, Eucommia leaf, chicken gizzard lining, Sophora japonica seed, liquorice and Momordica grosvenori, which have obvious pharmacological effects on hyperuricemia model mice, can effectively reduce blood creatinine level and xanthine oxidase activity, and significantly reduce blood uric acid level and urine creatinine level, indicating that the Chinese medicine composition of medicinal and edible origin of the present invention has a significant improvement effect on hyperuricemia.

[0026] (3) The present invention also takes into account the need for anti-inflammatory and analgesic measures during gout attacks. In addition to being able to quickly reduce uric acid levels, it is also combined with Angelica dahurica, which has strong analgesic properties, celery seeds, which are anti-inflammatory, and Sophora japonica seeds, which are good at cooling blood and purging fire. Together, they play a role in reducing swelling and relieving pain, thereby synergistically solving the problem of gout attacks.

[0027] (4) The materials and medicines used in the present invention are all Chinese medicines with medicinal and edible properties and can be used as functional foods for regulating uric acid. The preparation process of the present invention is simple, safe, low-cost, quality-controlled, tastes good, and has high patient compliance. It is suitable for long-term use to control uric acid levels, has high application value, and is suitable for promotion and application.

[0028] The detailed structure of the present invention is further described below in conjunction with the accompanying drawings and specific embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 This is a diagram showing the experimental results of the screening study on the efficacy of the prescriptions in Example 1, and a comparison of the results of the in vitro enzyme activity test on the effects of three prescriptions on XOD enzyme activity. DETAILED DESCRIPTION

[0030] The present invention is illustrated below by way of examples to facilitate understanding and grasp of the technical solutions of the present invention, but the present invention is not limited thereto. The experimental methods described in the following examples are conventional methods unless otherwise specified; the medicinal materials and reagents described are commercially available unless otherwise specified; and the performance of products from different sources does not significantly affect each other.

[0031] When numerical ranges are given in the examples, it should be understood that, unless otherwise specified herein, both endpoints of each numerical range and any value between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the invention belongs. Example 1 Preparation and in vitro screening of prescription active ingredients

[0032] This invention aims to develop a uric acid metabolism-regulating drug or functional food for the treatment of gout. Combining fundamental Traditional Chinese Medicine theories with the inventors' years of R&D experience, the inventors conducted repeated research and preliminary testing, ultimately formulating three formulations for active ingredient screening. Samples were prepared, and the inhibitory effects of the three formulations on xanthine oxidase (XOD) activity were evaluated through in vitro enzyme activity assays. The formulations with the highest uric acid-lowering activity were rapidly screened, and in vivo efficacy validation tests were then conducted. The following formulations serve as representative formulations and serve as the foundation for this invention's early research.

[0033]

[0034] Preparation method: Take the above 10 herbs, add 10 times the amount of water, soak for half an hour, heat and reflux to extract twice, 30 min each time, filter, combine the filtrate, and concentrate at 70℃ to a relative density of 1.15-1.25 (50℃).

[0035]

[0036] Preparation method: Take the above 9 herbs, add 10 times the amount of water, soak for half an hour, heat and reflux to extract twice, 30 min each time, filter, combine the filtrate, and concentrate at 70℃ to a relative density of 1.15-1.25 (50℃).

[0037]

[0038] Preparation method: Take the above 9 herbs, add 10 times the amount of water, soak for half an hour, heat and reflux to extract twice, 30 min each time, filter, combine the filtrate, and concentrate at 70℃ to a relative density of 1.15-1.25 (50℃).

[0039]

[0040] Comparison of the results of in vitro enzyme activity test on the effects of three prescriptions on XOD enzyme activity 1. Sample pretreatment: Dilute the concentrate to 1 g of crude drug per ml. Centrifuge (4000 r, 15 min) to remove insoluble matter. Pass through a 0.22 μm filter. Gradual dilutions were performed using PBS buffer to different concentrations (1-100 μg / ml).

[0041] 2. Grouping: Set up a blank group, a negative control group, a positive control group, and a test substance group. The blank group is used to measure background values ​​and does not contain XOD enzyme. The negative control group does not contain the concentrate. The positive control group contains allopurinol.

[0042]

[0043] 3. Reaction system: Mix the buffer, xanthine and concentrate and pre-incubate at 37℃ for 5 min. Add XOD enzyme to start the reaction. Incubate at 37°C for 30 min and immediately measure the absorbance at 293 nm.

[0044] 4. Detection method: Measure the absorbance at 293 nm (A293) every 5 minutes and calculate ΔA / min.

[0045]

[0046] IC50 was calculated and dose-effect curves were fitted using GraphPad Prism.

[0047] The test results are attached. Figure 1Under the conditions of this experiment, test substance 1 (prescription 1) and test substance 3 (prescription 3) showed significant inhibition of XOD enzyme activity. The 100 μg / mL extract showed an inhibition rate of 80% on XOD enzyme, suggesting that it may be used as a natural XOD inhibitor to lower uric acid levels or treat hyperuricemia. Comprehensive analysis showed that under the conditions of this experiment, prescription 1 (test substance 1) had the most obvious dose-related effect, with the strongest activity at 200 μg / mL, but the intensity was weaker than prescription 3 at concentrations below 150 μg / mL. Prescription 3 (test substance 3) had a light, slightly bitter taste and a relatively good taste. It had a significant inhibitory effect on XOD enzyme at low doses, and the half-maximal inhibitory concentration IC of test substance 3 was 2. 50 28.42 μg / mL (less than the IC 50 ), with the best inhibitory effect. Although Formulation 2 contains chicory, which has a clear uric acid-lowering effect, and coix seed, which has a strong diuretic effect, its XOD inhibition rate is not as good as that of Formulations 1 and 2. This shows that the compatibility of the formulation is crucial. Therefore, the present invention will further conduct in vivo follow-up studies based on Formulation 3 to improve its activity and feasibility. Example 2 Optimization Study Example of Prescription and Preparation Method

[0048] Based on Example 1, further optimization studies were conducted to obtain a more specific and active medicinal and edible Chinese medicine composition, and the processing methods of key ingredients were studied. Based on Recipe 3 of Example 1, a Chinese medicine composition for treating hyperuricemia was further formulated, comprising the following ingredients by weight: 3-10 parts tea leaves, 3-10 parts bamboo leaves, 3-9 parts Imperata cylindrica root, 3-8 parts celery seeds, 2-6 parts Eucommia ulmoides leaves, 2-6 parts chicken's gizzard lining, 2-6 parts Angelica dahurica, 2-6 parts Sophora japonica seeds, and 0.2-2 parts Momordica grosvenori. Optimized Recipe 1, based on Recipe 3, replaced Eucommia ulmoides leaves with Eucommia ulmoides leaves and Astragalus membranaceus with chicken's gizzard lining, to compare the pharmacodynamic effects before and after optimization. Optimized Recipes 2 and 3 had the same composition as Optimized Recipe 1, but with different dosages. Comparative Example 1, based on Optimized Recipe 1, omitted the high-temperature heating of the chicken's gizzard lining, to compare the effect of high-temperature heating and alkali treatment on its efficacy. Comparative Example 2, based on Optimized Recipe 1, omitted the chicken's gizzard lining to examine its efficacy in the formulation. The raw materials and dosages of the Chinese medicine compositions of Prescription 3, the optimized prescription and the comparative example are shown in Table 3.

[0049] The preparation method of the Chinese medicine composition of the optimized formula 1-3 is as follows:

[0050] Weigh the prescribed amount of chicken's gizzard lining, immerse in 10% sodium bicarbonate solution, and heat in an autoclave at 105°C for 20 minutes. Filter, rinse, and drain. Weigh the prescribed amount of the entire formula and processed chicken's gizzard lining, add 10 times the prescribed amount of water and 8 times the prescribed amount of water, respectively, and soak for half an hour. Heat and reflux extraction twice, each for half an hour. Filter, combine the filtrates, and concentrate under reduced pressure below 70°C to an extract with a relative density of 1.20-1.25 (at 50°C). This yields the traditional Chinese medicine composition. The preparation method of the Chinese medicine composition of Comparative Example 1-2 is as follows:

[0051] Weigh the prescribed amount of all the medicinal raw materials, add 10 times and 8 times the amount of water respectively, soak for half an hour, heat and reflux extraction twice, each time for half an hour, filter, combine the filtrate, and concentrate under reduced pressure below 70°C to an extract with a relative density of 1.20-1.25 (50°C) to obtain a Chinese medicine composition. Pharmacodynamic test of each prescription sample on mouse hyperuricemia model

[0052] 1. Animals: 80 SPF-grade ICR mice, male, 6-7 weeks old, weighing 22-30 g, were purchased from Guangdong Weitonglihua Laboratory Animal Technology Co., Ltd. (Laboratory Animal Production License No.: SCXK (Yue) 2022-0063) and quarantined for 3 days.

[0053] 2. Grouping and Dosing: ICR mice were randomly divided into nine groups, each consisting of eight mice (half male and half female), namely, the model control group (pure water), the normal control group (pure water), the positive control group (febuxostat), and test substance groups 1-6. Grouping and dosing are shown in Table 4. The recommended initial dose of febuxostat is 20 mg once daily. The dose can be gradually increased by 20 mg each time after the start of treatment, based on the serum uric acid level, to a maximum daily dose of 80 mg. The minimum effective dose should be maintained after the serum uric acid level reaches the target (<6 mg / dL or <360 μmol / L). The doses of febuxostat and the test substance for mice were 15 mg / kg and 12 g / kg, respectively.

[0054]

[0055] Approximately 1 hour before administration of the modeling drug, animals in each group were gavage-administered 10 ml / kg body weight of the drug as described in Table 4. The day of first administration was designated as D1, the day before as D0, and so on. Administration was performed once daily for 4 consecutive days.

[0056] 3. Modeling and Testing Methods: Mice in the modeling group were gavaged with 500 mg / kg hypoxanthine and 300 mg / kg potassium oxonate at a volume of 5 ml / kg, twice daily for 4 consecutive days. The normal control group received an equal volume of vehicle. On the fourth day of modeling, the uric acid concentration in each animal was measured using a uric acid test kit. If modeling was unsuccessful, the modeling period was extended until successful. During the medication period, mice in all groups except the normal control group were gavaged with 1 g / kg hypoxanthine and 600 mg / kg potassium oxonate at a volume of 5 ml / kg. The normal control group received an equal volume of vehicle once daily.

[0057] Observation indicators: Blood uric acid level was measured before administration and on the third day after administration; xanthine oxidase activity was measured after the end of administration.

[0058] 4. Data Processing and Statistical Methods The measurement data were summarized in Excel and expressed as mean ± standard deviation. SPSS 28.0 was used for analysis. One-way analysis of variance was used for statistical analysis. The LSD test was used for comparison between groups when the variances were equal, and the Dunnett's T3 test was used for comparison between groups when the variances were unequal. P < 0.05 was considered statistically significant.

[0059] 5. Test results 5.1 Effects on blood uric acid in hyperuricemia model mice As shown in Table 5, before administration, the blood uric acid level of the model group animals was significantly increased compared with the normal control group ( P <0.01); compared with the model control group, there was no significant difference in the blood uric acid levels of the animals in each drug-treated group. After drug administration on D3, compared with the normal control group, the blood uric acid level of the model control group was significantly increased ( P <0.01); compared with the model control group, the blood uric acid levels of the animals in the positive control group and test substance 2-5 groups were significantly decreased ( P <0.01 or P <0.05), with a downward trend in test substance 1 and 6 groups, but no statistically significant difference. The order of the intensity of the effect of lowering blood uric acid levels was test substance 4 > test substance 2 > test substance 3 > test substance 5 > test substance 1 > test substance 6.

[0060]

[0061] 5.2 Effects on xanthine oxidase activity in hyperuricemia model mice As shown in Table 6, after administration of D4, the xanthine oxidase activity in the model control group was significantly increased compared with the normal control group, with statistically significant differences ( P<0.01); compared with the model control group, the xanthine oxidase activity of the positive control group and test group 2-4 animals decreased significantly, with statistically significant differences ( P <0.05 or P<0.01), and the xanthine oxidase activity of animals in the other groups showed a downward trend, but there was no statistical difference ( P >0.05). The order of the degree of reduction of xanthine oxidase activity from high to low was positive control group > test substance 4 > test substance 3 > test substance 2 > test substance 5 > test substance 1 > test substance 6.

[0062] By analyzing the test substance prescription and process, it can be seen that adding chicken's gizzard lining to the prescription has a significant synergistic promoting effect on xanthine oxidase activity. The results of Comparative Examples 1 and 2 show that the addition of chicken's gizzard lining and the high-temperature heating alkali solution treatment method in the present invention have a significant enhancing effect on the activity of the traditional Chinese medicine composition.

[0063]

[0064] 6. Conclusion The above results show that, based on Prescription 3, Astragalus is adjusted to Gallus gallus domesticus and Eucommia ulmoides is adjusted to Eucommia ulmoides leaves, which are both medicinal and edible, to optimize Prescription 1, and the uric acid metabolism effect is significantly enhanced. Prescription 3 has a certain effect on the inhibition of xanthine oxidase and the reduction of blood uric acid, but the intensity is significantly less than that of Optimized Prescription 1, and the intensity of the effect is highly correlated with the dosage of Gallus gallus domesticus and celery seeds. Among them, the pre-treatment method of Gallus gallus domesticus and high-temperature heating plays a key role in reducing blood uric acid content. Comprehensive observation of the uric acid-lowering effect is Optimized Prescription>Comparative Example 1>Prescription 3>Comparative Example 2. The above results show that the components and proportions of the medicinal and edible Chinese medicine composition of the present invention are very critical, and different components and proportions have a greater impact on the efficacy. Example 3 Tea substitute of the Chinese medicine composition of the present invention

[0065] Take chicken gizzard lining and immerse it in 5% sodium carbonate solution, treat it in a high-pressure steam sterilizer at 105℃ for 20 minutes, filter, wash, drain the water, and dry it in an oven at 60℃ for later use; Take 300 g of white tea, 300 g of light bamboo leaves, 300 g of white imperata roots, 200 g of angelica dahurica, 200 g of celery seeds, 200 g of sophora japonica seeds, 200 g of eucommia leaves, 100 g of momordica grosvenori, 200 g of processed chicken gizzard powder, and add 60 g of licorice for seasoning, mix well, crush, pass through a 24-mesh sieve, mix well, put into tea bags (20 g per package), and brew with boiling water. Example 4 Granules of the Chinese medicine composition of the present invention

[0066] Take 600 g of chicken gizzard lining and immerse it in 10% sodium bicarbonate solution. Treat it in a high-pressure steam sterilizer at 120°C for 10 minutes. Filter, wash, drain the water and mix it with other medicinal materials.

[0067] Separately, 450 g of oolong tea, 900 g of bamboo leaves, 600 g of Imperata root, 350 g of celery seed, 250 g of Eucommia ulmoides leaf, 500 g of Angelica dahurica, 300 g of Sophora japonica seed, and 150 g of Momordica grosvenori (Siraitia grosvenori), totaling 3500 g, were added to a 12-fold volume of 30% ethanol and subjected to two extractions under reflux, the first for 60 minutes and the second for 30 minutes. The two extracts were combined and concentrated to a relative density of 1.05-1.08 (at 50°C). The extracts were then allowed to cool to room temperature for 12 hours. The supernatant was filtered and further concentrated to a thick paste, which was then microwave-dried to yield 572 g of dry paste.

[0068] The dry paste was taken and crushed to obtain dry paste powder, 820 g of dextrin, 328 g of mannitol, and 12 g of steviol glycoside were added, and 50% ethanol was added to prepare a soft material. The soft material was squeezed and passed through a 24-mesh sieve to obtain wet granules. The wet granules were dried at 60°C, and after drying, they were granulated through a 16-mesh sieve and bagged (5 g per bag, equivalent to 10 g of crude drug), thereby obtaining the edible and medicinal Chinese medicine composition granules of the present invention. Example 5 Solid beverage of the Chinese medicinal composition of the present invention

[0069] Take 500 g of chicken gizzard powder, add 15% sodium bicarbonate solution to immerse it, treat it in a high-pressure steam sterilizer at 110℃ for 30 minutes, filter, wash, drain the water and mix it with other medicinal materials.

[0070] Separately, 900 g of white tea, 450 g of bamboo leaves, 450 g of Imperata root, 600 g of celery seed, 300 g of Eucommia ulmoides leaf, 300 g of Angelica dahurica, 600 g of Sophora japonica seed, 300 g of Momordica grosvenori, and 500 g of processed chicken gizzard lining were added to the mixture, adding 12 times the amount of water. The mixture was heated at 80-90°C and extracted twice, the first time for 60 minutes and the second for 45 minutes. The two extracts were combined and concentrated to a relative density of 1.05-1.08 at 50°C. The extracts were then cooled to room temperature for 12 hours. The supernatant was filtered and further concentrated to a thick paste, which was then microwave-dried to yield 851 g of dry paste.

[0071] Take 10 parts of the dry paste, add 10 parts of anserine powder, 5 parts of maltitol, 5 parts of erythritol, 3.5 parts of cherry powder, 1.2 parts of citric acid, 0.5 parts of sodium citrate, 0.3 parts of stevioside, 0.2 parts of licorice extract, and 0.3 parts of silicon dioxide, mix, put into a blender and stir for 30 minutes, use water to mix the materials evenly, and bag (6 g per bag) to obtain the medicine and food Chinese medicine composition solid beverage of the present invention. Example 6 Capsules or tablets of the Chinese medicinal composition of the present invention

[0072] Take 600 g of green tea, 450 g of light bamboo leaves, 300 g of Imperata root, 300 g of celery seeds, 450 g of chicken gizzard lining, 450 g of Eucommia ulmoides leaves, 450 g of Angelica dahurica, 300 g of Sophora japonica seeds, and 200 g of Momordica grosvenori, totaling 3500 g; mix into coarse powder.

[0073] Extract twice with 70% ethanol, adding 8 times the amount of alcohol for the first time and 6 times the amount for the second time, heat at 60-70℃ and extract twice, the first time for 60 minutes and the second time for 30 minutes; combine the two extracts, filter, and concentrate under reduced pressure to recover ethanol, further concentrate into a thick paste, and dry under reduced pressure at no more than 70℃ to obtain 536 g of dry paste, with each gram of dry paste equivalent to 6.53 g of crude drug.

[0074] Take the dry paste, pulverize it, and pass it through an 80-mesh sieve. Take 100 parts of the dry paste powder, take microcrystalline cellulose and pregelatinized starch and pass it through an 80-mesh sieve. Take 120 parts of microcrystalline cellulose, 60 parts of pregelatinized starch, and mix them evenly with the extract powder. Use 60% ethanol to granulate using a wet granulator, dry it, and pass it through a 20-mesh sieve to granulate it. Then add 10 parts of silicon dioxide and 3 parts of magnesium stearate. Mix for 30 minutes (at a speed of 20-30 rpm). Fill it into capsules or compress it into tablets. Each granule or tablet weighs 0.45 g. This is to obtain the Chinese medicine composition capsules or tablets of the present invention. Example 7 Observation of the pharmacological effects of the granules of Example 4 and the solid beverage of Example 5 on gouty arthritis models

[0075] Test materials 1.1 Animals: 60 male Sprague-Dawley rats (SPF grade, weighing 200–240 g) were purchased from Guangdong Weitonglihua Laboratory Animal Technology Co., Ltd. (Laboratory Animal Production License No. SCXK (Yue) 2022-0063) and were quarantined for 3 days.

[0076] 1.2 Main reagents: Microcrystalline sodium urate (C12205925), hypoxanthine (C12198099), potassium oxonate (C12747023), all provided by Shanghai MacLean Biochemical Technology Co., Ltd.

[0077] 2. Test methods Sixty SD rats that had passed quarantine were enrolled in the experiment. On days 1 and 3 of the experiment, all rats, except for the eight in the blank control group, were gavage-administered 500 mg / kg hypoxanthine and subcutaneously injected with 300 mg / kg potassium oxalate at a volume of 10 and 5 mL / kg, respectively, to establish the model. Blood was collected on day 3 for uric acid analysis. The first 40 rats to successfully establish the model were randomly divided into groups based on uric acid levels: a blank control group, a model control group, a tongfengding group (0.48 g / kg), the sample group from Experimental Example 4, and the sample group from Experimental Example 5 (12 g crude drug / kg, excluding excipients and heavy drugs). Each group consisted of eight rats, for a total of five groups.

[0078] On the fourth day of the experiment, after model establishment, gavage administration began at a volume of 10 mL / kg, once daily for five consecutive days. On the fifth day of the experiment, rats were fasted for 12 hours. All rats, except for eight in the blank control group, were gavaged with 500 mg / kg hypoxanthine and subcutaneously injected with 300 mg / kg potassium oxonate at a volume of 10 and 5 mL / kg, respectively, to establish the model. One hour after model establishment, gavage administration was repeated. One hour after drug administration, the volume of the right hind limb at 0.5 mm below the ankle joint was measured using a toe volume meter. Two measurements were repeated, and the average value was calculated. The joint cavity between the ankle joint and the tibia and fibula on the dorsal side of the right hind limb was opened. The ankle joint was positioned at a right angle to fully expose the gap between the ankle joint and the tibia and fibula. A 4.5-gauge needle was inserted into the joint cavity at a 45-degree angle, and 0.05 mL of 5% sodium urate crystal solution was injected per rat. The volume at 0.5 mm below the ankle joint of the right hind limb was measured using a toe volume meter 6 and 20 hours after injection. The measurement was repeated twice and the average value was taken. The increase in ankle joint volume and joint swelling index within 24 hours of modeling were calculated. The joint swelling index (%) = 100% × (joint volume at the measurement time point - initial volume) / initial volume. 24 hours after modeling, blood was collected from the ophthalmic venous plexus, and serum IL-1β, TNF-α, and uric acid levels were measured according to the instructions. 3. Test results 3.1 Effects on serum uric acid, IL-1β, and TNF-α in rats with acute gouty arthritis The results in Table 7 show that compared with the blank control group, the model control group showed significantly increased serum uric acid, IL-1β, and TNF-α levels (P < 0.05 or P < 0.01). This indicates that the model rats had elevated levels of uric acid and inflammatory mediators, indicating the success of the model. Compared with the model control group, the tongfengding group and the test substance of the present invention group significantly reduced serum aciduria in rats (P < 0.05 or P < 0.01). The tongfengding group and the sample group of Example 5 significantly reduced IL-1β (P < 0.05), and all treatment groups also had a lowering effect on TNF-α. These results indicate that Examples 4 and 5 of the present invention have significant uric acid-lowering effects and also exhibit strong anti-inflammatory effects, with Example 5 showing a stronger uric acid-lowering effect. This suggests that the combination of the medicinal and edible composition with cherry powder, citric acid, sodium citrate, and the like synergistically enhances the uric acid-lowering and anti-inflammatory effects.

[0079]

[0080] 3.2 Effect on the swelling of the toes of rats with acute gouty arthritis As shown in Table 8, rats in each group developed paw swelling to varying degrees within 20 hours after modeling.

[0081] As shown in Table 9, compared with the blank control group, the increase in joint volume 6 and 20 hours after modeling was significantly increased (P < 0.01). Compared with the model control group, the tongfengding group and the sample groups of Examples 4 and 5 significantly reduced or lowered the increase in joint volume of rats 6 and 20 hours after modeling (P < 0.01 or P < 0.05). Both the removal and retention of the samples in Examples 4 and 5 reduced the increase in joint volume of rats 6 and 20 hours after modeling. Overall, the effect of Example 5 was more significant. These results suggest that the present invention has a significant effect on the acute phase of this rat model.

[0082]

[0083]

[0084] The above is a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any technician familiar with the technical field, within the technical scope disclosed by the present invention, who makes equivalent replacements or changes based on the technical solutions and concepts of the present invention, should be covered by the scope of protection of the claims of the present invention.

Claims

1. A Chinese medicine composition for relieving gout pain and regulating uric acid metabolism, characterized in that: The traditional Chinese medicine composition is composed of the following functional ingredients in parts by weight: 3-10 parts of tea leaves, 3-10 parts of bamboo leaves, 3-9 parts of Imperata rhizome, 3-8 parts of celery seeds, 2-6 parts of Eucommia ulmoides leaves, 2-6 parts of chicken gizzard lining, 2-6 parts of Angelica dahurica, 2-6 parts of Sophora japonica seeds and 0.2-2 parts of Momordica grosvenori.

2. The Chinese medicine composition according to claim 1, characterized in that The tea leaves are selected from green tea, white tea, black tea and oolong tea.

3. The Chinese medicine composition according to claim 1, characterized in that The chicken's gizzard lining is preferably processed chicken's gizzard lining powder, and the specific steps include: obtaining the chicken's gizzard lining powder into coarse powder, adding 5%-15% sodium bicarbonate or sodium carbonate solution to immerse the medicinal material, treating it in a high-pressure steam sterilizer at 100-121° C. for 10-30 min, filtering, washing, removing moisture, and setting aside.

4. The Chinese medicine composition according to claim 1, characterized in that Each functional ingredient is directly crushed and used or subjected to solvent extraction to form an extract, and the extract is prepared into various suitable preparations in one step. The dosage forms include tea substitute, solid beverage, oral solution, granule, capsule and tablet.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The following steps are involved: S1. Grind chicken gizzard lining into coarse powder, add 5%-15% sodium bicarbonate or sodium carbonate solution to immerse, sterilize in a high-pressure steam sterilizer at 100-121°C for 10-30 min, filter, wash, remove moisture, and set aside; S2. Grind tea leaves, Imperata root, Angelica dahurica, Bambusa longifolia, Eucommia ulmoides leaf and Momordica grosvenori into coarse powder, mix evenly with celery seeds, Sophora japonica seeds and chicken gizzard lining powder in S1, and divide into portions to obtain a tea substitute.

6. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The following steps are involved: Grind chicken gizzard powder into coarse powder, add 5%-15% sodium bicarbonate or sodium carbonate solution to immerse it, sterilize it in a high-pressure steam sterilizer at 100-121°C for 10-30 minutes, filter, wash, remove moisture, and set aside; Tea leaves, Imperata rhizome, Angelica dahurica, celery seeds, Glehnia littoralis leaf, Eucommia ulmoides leaf, processed chicken gizzard lining, Sophora japonica seed and Momordica grosvenori are added with water or 30-60% ethanol, heated at 60-90°C for reflux extraction, with a material-liquid ratio of 1:6-12, W / V; the number of extractions is 1-3; each extraction time is 30-90 minutes; the extracts are filtered, combined and concentrated, and concentrated under reduced pressure to obtain extract A, or further dried to obtain dry extract B for later use.

7. The method for preparing the Chinese medicine composition according to claim 6, characterized in that: The extract A is further added with water to a relative density of 1.03-1.05 (22-28° C.) and precipitated in water for 24-72 hours, or 90%-95% alcohol is added to a solution containing 40%-70% alcohol and precipitated for 24-72 hours, and then concentrated under reduced pressure to form extract C, or dried to form dry paste D.

8. The method for preparing the Chinese medicine composition according to claim 6 or 7, characterized in that: The extract / dry paste obtained in claim 6 or claim 7 is added with one or more pharmaceuticals, food-acceptable adjuvants and / or excipients, and food additives to prepare a finished preparation.

9. The method for preparing the Chinese medicine composition according to claim 7, wherein: The auxiliary materials and / or excipients of the finished preparation are one or more of cherry powder, turmeric extract, lemon, licorice, anserine, citric acid, sodium citrate, and sodium bicarbonate.

10. Use of the uric acid metabolism regulating Chinese medicine composition according to any one of claims 1 to 4, or the composition prepared by the method according to any one of claims 5 to 9, characterized in that: It can be used in the preparation of functional foods, health foods and medicines for reducing high uric acid and relieving the pain of gouty arthritis.

11. The use according to claim 10, characterized in that The hyperuricemia includes hyperuricemia, uric acid arthritis, gout and hyperuricemia-related diseases.

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