A traditional Chinese medicine compound for treating hyperuricemia and a preparation method and application thereof

Abstract

This invention discloses a traditional Chinese medicine compound for treating hyperuricemia, its preparation method, and its application. The compound uses Alisma plantago-aquatica and Smilax glabra as the principal herbs, stir-fried Phellodendron chinense and stir-fried Atractylodes lancea as the assistant herbs, corn silk and Chaenomeles speciosa as adjuvant herbs, and Achyranthes bidentata as the guiding herb. The entire formula primarily addresses dampness, combining methods of resolving dampness, drying dampness, and promoting urination, thus addressing both the root cause and the symptoms. An optimized water extraction process is used to prepare the compound, making it convenient for patients to take and ensuring medication safety. This invention has advantages such as scientific formulation, definite efficacy, high safety, controllable quality, and reasonable process, providing a new option for the treatment of hyperuricemia and related diseases, with significant clinical advantages and broad application prospects.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine compound, and more particularly to a traditional Chinese medicine compound for treating hyperuricemia, its preparation method, and its application. Background Technology

[0002] Hyperuricemia is a metabolic disease caused by disordered purine metabolism, leading to excessive uric acid production or reduced excretion. With improved living standards and changes in dietary structure, its incidence is increasing year by year and showing a trend towards affecting younger people. Long-term elevated blood uric acid can not only induce gouty arthritis, leading to joint deformities and kidney damage, but is also an independent risk factor for hypertension, coronary heart disease, diabetes, and metabolic syndrome. A prospective cohort study in 2025 based on 4082 participants showed that those with elevated blood uric acid had a significantly higher incidence of cardiovascular events: coronary heart disease 8.4% vs 3.3%, stroke 2.6% vs 1.2%, and heart failure 3.4% vs 0.9%. Hyperuricemia was also independently associated with hyperlipidemia (OR 1.102).

[0003] Currently, commonly used Western medicines for the clinical treatment of hyperuricemia are mainly divided into two categories: one is xanthine oxidase inhibitors, represented by allopurinol and febuxostat, which work by inhibiting uric acid production; the other is uricosuric drugs, represented by benzbromarone and probenecid. However, the clinical application of these drugs has significant limitations: allopurinol can induce severe skin hypersensitivity reactions (including Stevens-Johnson syndrome / toxic epidermal necrolysis, DRESS syndrome). In 2024, the FDA Adverse Event Reporting System analysis confirmed allopurinol as a classic sensitizing drug causing severe skin adverse reactions. Genetic studies show that HLA-B*58:01 carriers have a significantly increased risk of severe skin adverse reactions caused by allopurinol (OR 28). Febuxostat poses cardiovascular safety risks. Based on the results of the CARES trial, the US FDA added a boxed warning regarding an increased risk of cardiovascular death. Studies have shown that this risk may be related to the drug's chemical structure itself, rather than the target effect of xanthine oxidase inhibition. Benzbromarone not only poses a risk of liver damage, but its association with cardiovascular and cerebrovascular events is also controversial. Studies show that the incidence of stroke may be lower in benzbromarone users than in non-users; however, other studies suggest a slightly higher incidence of ischemic cerebrovascular disease (HR 1.05), which did not reach statistical significance. Furthermore, long-term use of these drugs often involves side effects such as gastrointestinal irritation and kidney damage, and uric acid levels tend to rebound after discontinuation, leading to low patient compliance.

[0004] In recent years, traditional Chinese medicine (TCM) has demonstrated unique advantages in the prevention and treatment of hyperuricemia. A systematic review and network meta-analysis of asymptomatic hyperuricemia in 2025 showed that TCM compound formulas can significantly reduce serum uric acid levels, with an effect size ranging from -197.48 to -14.6, and no serious adverse events were reported. Studies have shown that the classic formula Simiao San can reduce serum uric acid through mechanisms such as regulating uric acid transport proteins (URAT1, GLUT9, OAT1), inhibiting xanthine oxidase, and regulating gut microbiota. However, existing research on traditional Chinese medicine compound prescriptions still has the following shortcomings: First, the sample size of clinical studies is small, lacking support from large-scale multi-center data; second, the synergistic or antagonistic effects between different mechanisms of action need to be explored in depth; third, the preparation process is relatively crude, failing to extract the effective components of the medicinal materials to the maximum extent, resulting in low utilization and bioavailability of the medicinal materials, and difficulty in fully exerting the efficacy; fourth, existing compound prescriptions mostly focus on a single TCM etiology and pathogenesis (such as damp-heat or blood stasis), failing to fully take into account the complex pathogenesis of hyperuricemia characterized by the confluence of "dampness, turbidity, phlegm, blood stasis, and deficiency," thus resulting in unstable efficacy, slow onset of action, and insignificant improvement of accompanying symptoms such as fatigue and epigastric fullness.

[0005] In summary, current drugs for treating hyperuricemia have certain toxic side effects, incomplete coverage of TCM pathogenesis, unstable efficacy, and crude preparation processes. Summary of the Invention

[0006] Objectives of this invention: The first objective is to provide a traditional Chinese medicine (TCM) compound for treating hyperuricemia. This compound is based on the principle of "resolving dampness and reducing turbidity," and through scientific formulation, comprehensively addresses the complex pathogenesis of hyperuricemia involving "dampness, turbidity, phlegm, blood stasis, and deficiency," avoiding the toxic side effects of existing Western medicines while overcoming the shortcomings of existing TCM compound formulas, such as incomplete coverage of pathogenesis and unstable efficacy. The second objective is to provide a preparation method for the above-mentioned TCM compound, employing an optimized water extraction process to solve the problems of crude existing TCM preparation processes and low extraction rates of effective components. The process is simple and suitable for industrial production. The third objective is to provide a quality control method for the above-mentioned TCM compound, ensuring product stability and quality controllability through thin-layer chromatography identification and content determination. The fourth objective is to provide the application of the above-mentioned TCM compound in the preparation of drugs for treating hyperuricemia.

[0007] Technical solution: The traditional Chinese medicine compound for treating hyperuricemia described in this invention comprises, by weight, 20-30 parts of Smilax glabra, 9-12 parts of Alisma plantago-aquatica, 9-15 parts of stir-fried Phellodendron chinense, 6-12 parts of stir-fried Atractylodes lancea, 12-18 parts of corn silk, 6-12 parts of Chaenomeles speciosa, and 9-12 parts of Achyranthes bidentata.

[0008] This formula uses "resolving dampness and reducing turbidity" as its main treatment principle, targeting the core pathogenesis of "internal accumulation of dampness and turbidity" in hyperuricemia. Its compatibility, medicinal materials, and chemical components are as follows.

[0009] (1) Chief herbs: Smilax glabra and Alisma plantago-aquatica.

[0010] Smilax glabra Roxb. is the dried rhizome of the plant Smilax glabra Roxb., belonging to the Liliaceae family. It is harvested in summer and autumn, the fibrous roots are removed, it is washed, and then dried; or it can be sliced ​​thinly while fresh and then dried. Its chemical composition is rich and diverse, with flavonoids and flavonoid glycosides as the core active ingredients. Dihydroflavonoids (such as astilbene, neoastilbene, isoflavone, and scutellarin) account for the largest proportion of total flavonoids and play a key role in antioxidation and anti-inflammation. It also contains organic acids, phenolic acids (such as succinic acid, palmitic acid, and ferulic acid), phenylpropanoids, steroids, volatile oils, and polysaccharides. These components work synergistically to endow Smilax glabra with anti-inflammatory, immunomodulatory, and anti-gout pharmacological activities. This formula uses Smilax glabra as the principal ingredient, taking advantage of its detoxifying and dampness-removing effects to directly target the affected area and clear accumulated dampness and toxins from the body.

[0011] Alisma plantago-aquatica is the dried tuber of *Alisma orientale* (Sam.) Juzep. or *Alisma plantago-aquatica* Linn., belonging to the Alismataceae family. It is harvested in winter when the stems and leaves begin to wither, washed, dried, and the fibrous roots and rough outer skin are removed. Its chemical composition is dominated by terpenoids, accounting for approximately 65%, mainly including triterpenoids (such as alisrol A, alisrol B, 23-acetylalisrol B, and 23-acetylalisrol C, which are the core active ingredients, accounting for more than 50% of the total extract), sesquiterpenoids, and diterpenoids. It also contains volatile oils, alkaloids, flavonoids, proteins, starch, and sugars. Alisma plantago-aquatica has diuretic and heat-clearing functions, allowing dampness and turbidity to be excreted through urination.

[0012] (2) Assistant herbs: Phellodendron bark and stir-fried Atractylodes lancea.

[0013] Phellodendron bark is the dried bark of the Phellodendron chinense Schneid., a plant in the Rutaceae family. Commonly known as "Sichuan Phellodendron," it is obtained by peeling the bark, removing the outer bark, and then sun-drying it. Its chemical composition is primarily composed of alkaloids, with berberine hydrochloride being the most abundant (not less than 3.0% on a dried basis). Other components include palmatine, purslane, magnoflorine, and berberine; flavonoids include berberine glycoside, isoberberine glycoside, quercetin, hyperoside, and berberine ketone; sterols include β-sitosterol and 7-dehydrostigmasterol; and it also contains volatile oils and various trace elements. Fried Phellodendron bark has the functions of clearing heat and drying dampness, purging fire and detoxifying, especially effective in clearing damp-heat in the lower burner, targeting the pathogenesis of dampness and turbidity transforming into heat over time.

[0014] Atractylodes lancea (Thunb.) DC. or Atractylodes chinensis (DC.) Koidz., belonging to the Asteraceae family, is a dried rhizome. It is harvested in spring and autumn, cleaned of mud and sand, sun-dried, and the fibrous roots removed. Its chemical components mainly include two categories: volatile oil and non-volatile oil. The volatile oil is primarily composed of sesquiterpenes (such as β-cineole, atractylodes lactone I-III), polyacetylenes (such as atractylodesin), and aromatic compounds. The non-volatile oil includes flavonoids (such as vitexin), organic acids (such as chlorogenic acid, citric acid), amino acids, and polysaccharides. Stir-fried Atractylodes lancea has the effects of drying dampness, strengthening the spleen, dispelling wind and cold. It can assist the principal herb in drying dampness and resolving turbidity, while also protecting the middle jiao (middle burner) and preventing the regeneration of dampness and turbidity.

[0015] Both herbs dry dampness and strengthen the spleen; one is cold and the other is warm, and they are both used as assistant herbs.

[0016] (3) Adjuvants: corn silk, papaya.

[0017] Corn silk is the dried filaments and stigmas of the female flowers of the grass Zea mays L. It is rich in chemical components, mainly including polysaccharides (composed of seven monosaccharides including mannose, rhamnose, glucose, galactose, arabinose, xylose, and glucuronic acid, with glucose being the most abundant), flavonoids (29 species have been isolated and identified, including flavonols and isoflavones, with chlorogenic acid content reaching 2.015-2.508 mg / g), saponins, organic acids (containing short-chain and long-chain acids, with linoleic acid being the most abundant), sterols, amino acids, and terpenes. Corn silk has the functions of promoting diuresis and reducing swelling, and relieving jaundice, assisting the main and auxiliary herbs in enhancing the diuretic and turbidity-eliminating effects.

[0018] Papaya is the dried, nearly mature fruit of *Chaenomeles speciosa* (Sweet) Nakai, a plant in the Rosaceae family. It is harvested in summer and autumn when the fruit is greenish-yellow, blanched in boiling water until the outer skin turns grayish-white, longitudinally split in half, and then sun-dried. Its chemical components include polysaccharides (24.45-27.60 mg / g in wrinkled-skin papaya), phenols, flavonoids (1080.68±73.57 μg / g in smooth-skin papaya), organic acids (4.91 g / 100 g of total organic acids in fresh juice of wrinkled-skin papaya), and terpenes (high content of triterpenes, with total oleanolic acid and ursolic acid content not less than 0.50% on a dried basis). Papaya has the functions of relaxing muscles and tendons, resolving dampness, and harmonizing the stomach. It can relieve joint discomfort caused by dampness obstructing the meridians and also help *Atractylodes lancea* strengthen the spleen and resolve dampness.

[0019] Both are used as adjuvant medicines to promote diuresis and eliminate dampness.

[0020] (4) Guiding herb: Achyranthes bidentata. This product is the dried root of Cyathula officinalis Kuan, a plant of the Amaranthaceae family. It is harvested in autumn and winter, and the rhizome, fibrous roots and mud are removed. It is then baked or sun-dried until semi-dry, piled up to rehydrate, and then baked or sun-dried again. Its chemical components mainly include four categories: triterpenoid saponins (25 kinds have been isolated and identified, with oleanolic acid and ivy saponin as the main aglycones), steroids (covering 19 kinds of ecdysterone compounds, including caliciferone, which shall not be less than 0.030% on a dried basis), phenolic glycosides and phenylpropanoids, as well as flavonoids, polysaccharides, etc. Achyranthes bidentata has the functions of removing blood stasis and promoting menstruation, promoting diuresis and relieving strangury, and guiding blood downward. It can also tonify the liver and kidneys and strengthen tendons and bones. This formula takes advantage of its function of guiding the medicine downward, so that the medicines can directly reach the diseased area of ​​the lower jiao. At the same time, it also promotes diuresis and relieves strangury to help expel dampness and turbidity, so it is the guiding herb.

[0021] The formula is meticulously formulated, with clear distinctions between the principal, assistant, and adjuvant herbs, working together to eliminate dampness and turbidity. It can both promote uric acid excretion to lower blood uric acid levels and improve systemic symptoms caused by internal dampness and turbidity, reflecting the characteristics of traditional Chinese medicine in holistic regulation and treating both the root cause and symptoms.

[0022] Quality standards for raw materials: The Smilax glabra, Alisma plantago-aquatica, stir-fried Phellodendron chinense, stir-fried Atractylodes lancea, Chaenomeles speciosa, and Achyranthes bidentata used in this invention are all listed in Part I of the 2020 edition of the Pharmacopoeia of the People's Republic of China. Before pilot-scale production, all the herbs in the formula were tested according to the Pharmacopoeia of the People's Republic of China to ensure that their quality met the legal standards before production began.

[0023] Preferably, by weight, the traditional Chinese medicine compound includes 25 parts of Smilax glabra, 10 parts of Alisma plantago-aquatica, 12 parts of stir-fried Phellodendron chinense, 9 parts of stir-fried Atractylodes lancea, 15 parts of corn silk, 9 parts of papaya, and 10 parts of Achyranthes bidentata.

[0024] The present invention also provides a method for preparing the concentrated liquid of the Chinese herbal compound, comprising the following steps: (1) weighing seven medicinal materials, namely, Smilax glabra, Alisma plantago-aquatica, stir-fried Phellodendron chinense, stir-fried Atractylodes lancea, corn silk, papaya, and Achyranthes bidentata, and cleaning them; (2) mixing the medicinal materials, extracting with water, filtering, and obtaining an extract; (3) concentrating the extract to obtain a concentrated liquid.

[0025] Preferably, in step (2), add 10-15 times the total weight of the medicinal materials in water, soak for 20-40 minutes, then heat to boiling, and decoct 1-3 times for 60-150 minutes each time. Filter, combine the filtrates, and obtain the extract. The optimal extraction process parameters were determined by orthogonal experimental design: add 12.5 times the amount of water, decoct for 120 minutes, and decoct twice. This extraction process is stable and feasible, with high extract yield and astilbin content, and good reproducibility.

[0026] Preferably, in step (3), vacuum concentration is used, the concentration temperature is 60~80℃, the vacuum degree is -0.06~-0.09MPa, and the concentration is concentrated to a specified volume or relative density to obtain a concentrated solution.

[0027] Preferably, the concentrated solution from step (3) is allowed to stand, the supernatant is filtered, and the filtrate is sealed and sterilized to obtain the traditional Chinese medicine compound preparation for treating hyperuricemia. Specifically, after standing for an appropriate time to allow insoluble impurities to precipitate, the solution is filtered to obtain a clear filtrate; the filtrate is then filled into a suitable container, sealed, and sterilized.

[0028] Depending on the dosage form requirements, the concentrate described in step (3) can be further concentrated and dried to prepare a solid oral dosage form. The specific method for processing into a solid oral dosage form is as follows: the filtrate is concentrated under reduced pressure to a thick paste with a relative density of 1.25 to 1.30 (measured at 60°C), and then vacuum dried (70-80°C, vacuum degree -0.08 to -0.10 MPa) or spray dried to obtain a dry extract. The extract is then pulverized, passed through an 80-mesh sieve, and pharmaceutically acceptable excipients are added. The extract is then prepared into granules, capsules, tablets, pills, powders, or oral liquids according to conventional pharmaceutical processes.

[0029] The present invention also provides a quality control method for the aforementioned traditional Chinese medicine compound, the quality control method including properties, identification, content determination and inspection items, wherein the identification is thin-layer chromatography to identify Phellodendron bark and Smilax glabra, the content determination is liquid chromatography to determine astilbin, and the inspection items include relative density and pH value.

[0030] To ensure the quality stability and clinical efficacy reliability of the traditional Chinese medicine compound of this invention, the invention also provides a quality control method for the traditional Chinese medicine compound, including quality standards for raw medicinal materials, qualitative identification of finished preparations, and content determination. According to the relevant provisions under the section on compound preparations in the 2020 edition of the Chinese Pharmacopoeia, three batches of pilot-scale samples of the traditional Chinese medicine compound preparation for treating hyperuricemia were tested for properties, identification, and other items. The results all met the requirements, indicating that the quality control method of this invention is feasible and can effectively control product quality.

[0031] The quality standards for raw medicinal materials are based on the Pharmacopoeia of the People's Republic of China, and the key quality control indicators are as follows.

[0032] (1) Smilax glabra. Origin: The dried rhizome of Smilax glabra Roxb., a plant of the Liliaceae family. Content determination: Determined by high performance liquid chromatography, based on dried product, it contains astilbin (C 21 H 22 O 11 () shall not be less than 0.45%.

[0033] (2) Alisma plantago-aquatica. Origin: The dried tubers of Alisma orientale (Sam.) Juzep. or Alisma plantago-aquatica Linn., belonging to the Alismataceae family. Content determination: Determined by high performance liquid chromatography, based on dried product, it contains 2,3-acetylalisenoside B (C 32 H 50 O5) and 23-acetylalisin C (C 32 H 48 The total amount of O6 must not be less than 0.10%.

[0034] (3) Stir-fried Phellodendron bark. Origin: The dried bark of Phellodendron chinense Schneid., a plant of the Rutaceae family, commonly known as "Sichuan Phellodendron bark," is stir-fried using the salt-roasting method until the surface turns deep yellow. Content determination: Determined by high performance liquid chromatography, based on the dried product, it contains berberine as berberine hydrochloride (C... 20 H 17 The content of NO4·HCl shall not be less than 3.0%.

[0035] (4) Stir-fried Atractylodes lancea. Origin: The dried rhizome of Atractylodes lancea (Thunb.) DC. or Atractylodes chinensis (DC.) Koidz., belonging to the Asteraceae family, stir-fried until the surface turns deep yellow using the wheat bran stir-frying method. Content determination: Determined by high performance liquid chromatography, based on the dried product, it contains atractylodesin (C... 13 H 10 O) shall not be less than 0.30%.

[0036] (5) Papaya. Origin: The dried, nearly mature fruit of Chaenomeles speciosa (Sweet) Nakai, a plant of the Rosaceae family. Content determination: Determined by high performance liquid chromatography, based on dried product, it contains oleanolic acid (C... 30 H 48 O3) and ursolic acid (C 30 H 48 The total amount of O3 must not be less than 0.50%.

[0037] (6) Achyranthes bidentata. Origin: The dried root of Cyathula officinalis Kuan, a plant of the Amaranthaceae family. Content determination: Determined by high performance liquid chromatography, based on dried product, it contains cylindricalone (C... 29 H 44 O8) shall not be less than 0.030%.

[0038] (7) Corn silk. Origin: Dried filaments and stigmas of the female flowers of Zea mays L., a plant of the Poaceae family. Quality control: The properties, identification, and inspection are carried out in accordance with the relevant provisions of the Chinese Pharmacopoeia to ensure that the quality meets the requirements.

[0039] The finished preparation is a traditional Chinese medicine compound for treating hyperuricemia. Product specifications: each 1 mL is equivalent to 1.51 g of raw herb, pH value 4.0-6.0, and relative density not less than 1.05 (20℃). Specific quality control methods are as follows.

[0040] 1. Appearance: Brownish-brown liquid; slightly fragrant odor, slightly bitter taste; a small amount of easily shaken precipitate forms after standing.

[0041] 2. Identification: Thin-layer chromatography is used to distinguish between Phellodendron bark and Smilax glabra.

[0042] ① Thin-layer identification of Phellodendron bark.

[0043] Solution preparation: (1) Preparation of test solution: Take 10 mL of this product, evaporate to near dryness in a water bath, add 20 mL of methanol, sonicate (power 250 W, frequency 40 kHz) for 10 minutes, filter, concentrate the filtrate to 2 mL in a water bath, and use it as the test solution. (2) Preparation of reference medicinal material solution: Take 0.5 g of Phellodendron bark reference medicinal material, add 20 mL of methanol, sonicate for 10 minutes, filter, and use the filtrate as the reference medicinal material solution. (3) Preparation of negative control solution: Prepare a negative control preparation lacking Phellodendron bark according to the prescription of the traditional Chinese medicine compound preparation for treating hyperuricemia, and prepare it in the same way as the test solution.

[0044] Assay: Perform the test according to the thin-layer chromatography method (Chinese Pharmacopoeia 2020 Edition, Part IV, General Chapter 0502). Take 3 μL of each of the above three solutions and spot them separately on the same silica gel G thin-layer plate. Use toluene-isopropanol-ethyl acetate-methanol-concentrated ammonia solution (12:3:6:3:2) as the developing solvent. Develop in a developing tank pre-saturated with ammonia vapor. Remove, air dry, and examine under a 365 nm ultraviolet lamp.

[0045] Result interpretation: In the chromatogram of the test sample, fluorescent spots of the same color appear at the corresponding positions as in the chromatogram of the reference medicinal material, while the negative control sample lacking Phellodendron bark does not have corresponding spots.

[0046] ② Thin-layer chromatography identification of Smilax glabra.

[0047] Solution preparation: (1) Preparation of test solution: Take 10 mL of this product, extract twice with ethyl acetate, 20 mL each time, combine the ethyl acetate solutions, evaporate to dryness, add 2 mL of methanol to dissolve the residue, filter through a 0.22 μm organic filter membrane, and take the filtrate as the test solution. (2) Preparation of reference medicinal material solution: Take 1.0 g of Smilax glabra reference medicinal material, add 20 mL of methanol, sonicate for 30 minutes, filter, evaporate the filtrate to dryness, add 2 mL of methanol to dissolve the residue as the reference medicinal material solution. (3) Preparation of reference standard solution: Take an appropriate amount of astilbene reference standard, add methanol to prepare a solution containing 1 mg per 1 mL as the reference standard solution. (4) Preparation of negative control solution: Prepare a negative preparation lacking Smilax glabra according to the prescription of the traditional Chinese medicine compound for treating hyperuricemia, and prepare it in the same way as the test solution.

[0048] Assay: Perform thin-layer chromatography (Chinese Pharmacopoeia 2020 Edition, Part IV, General Chapter 0502). Take 3 μL of each of the above four solutions and spot them separately on the same silica gel G thin-layer plate. Use toluene-ethyl acetate-formic acid (13:32:9) as the developing solvent, pre-saturate for 20 minutes, develop, remove, air dry, spray with 3% aluminum trichloride ethanol solution, heat at 105℃ for 5 minutes, and examine under sunlight.

[0049] Result interpretation: In the chromatogram of the test sample, spots of the same color appear at the corresponding positions as in the chromatograms of the reference medicinal material and the reference standard, while the negative control sample lacking Smilax glabra does not have corresponding spots.

[0050] 3. Content determination: Astilbin was determined by high performance liquid chromatography (General Chapter 0512, Part IV, Chinese Pharmacopoeia 2020 Edition).

[0051] Chromatographic conditions and system suitability test: Octadecylsilane-bonded silica gel was used as the stationary phase, and methanol-0.1% acetic acid aqueous solution was used as the mobile phase. Gradient elution mobile phase: methanol-0.1% acetic acid aqueous solution as the mobile phase, gradient elution, 0~5 min, 38%~42%; 5~10 min, 42%~47% A; 10~20 min, 47%~49% A; 15~20 min, 50%~55%; injection volume 5 μL; flow rate 1.0 mL / min; column temperature 25℃; UV detection wavelength 291 nm.

[0052] Solution preparation: (1) Preparation of reference solution: Accurately weigh 16.7 mg of astilbene reference standard and place it in a 10 mL volumetric flask. Add 60% methanol to prepare a solution containing 1.67 mg per mL. (2) Preparation of test solution: Take an appropriate amount of traditional Chinese medicine compound preparation for treating hyperuricemia, accurately measure it, add methanol to make the methanol concentration 60%, mix well, centrifuge at 12000 r / min for 10 minutes, and take the supernatant as the test solution.

[0053] Assay: Accurately pipette 5 μL each of the reference solution and the test solution into the liquid chromatograph, determine the content, and record the chromatogram. Calculate the content of astilbin based on peak area using the external standard method.

[0054] 4. Inspection items: including relative density and pH value.

[0055] ① Relative density: According to the General Chapter 0601 of Part IV of the 2020 edition of the Chinese Pharmacopoeia, the relative density of this product should not be less than 1.05 (20℃).

[0056] ② pH value: According to the General Chapter 0631 of Part IV of the 2020 edition of the Chinese Pharmacopoeia, the pH value of this product should be 4.0-6.0.

[0057] ③ Other: It should comply with all relevant provisions under the compound preparation section (General Chapter 0181, Part IV, Chinese Pharmacopoeia 2020 Edition).

[0058] The present invention also provides a pharmaceutical composition comprising the traditional Chinese medicine compound and a pharmaceutically acceptable carrier, wherein the dosage form of the pharmaceutical composition includes a mixture, granules, capsules, pills, powders or oral liquids.

[0059] The present invention also provides the use of the traditional Chinese medicine compound or the pharmaceutical composition in the preparation of a medicament for treating hyperuricemia and related diseases.

[0060] This invention relates to a traditional Chinese medicine compound that has the effects of resolving dampness and eliminating turbidity, and is suitable for hyperuricemia and related diseases caused by spleen deficiency and internal dampness. Clinically, it can be used to treat the following conditions:

[0061] (1) Asymptomatic hyperuricemia: manifested as elevated blood uric acid levels (male > 420 μmol / L, female > 360 μmol / L), without the presence of gouty arthritis symptoms, but may be accompanied by symptoms of dampness and turbidity such as fatigue, abdominal distension, obesity, and loose stools.

[0062] (2) Hyperuricemia complicated with chronic heart failure: Hyperuricemia is a common complication of chronic heart failure and is closely related to poor prognosis of heart failure. The traditional Chinese medicine compound of this invention can effectively reduce the blood uric acid level in such patients and help improve cardiac function.

[0063] (3) Hyperuricemia with renal impairment: Long-term hyperuricemia can lead to the deposition of urate crystals in the kidney tissue, causing renal tubular damage and interstitial inflammation. The traditional Chinese medicine compound of this invention has a certain kidney-protective effect and can improve renal function.

[0064] (4) Prevention of gouty arthritis: Hyperuricemia is the pathological basis of gouty arthritis. The traditional Chinese medicine compound of this invention can prevent gout attacks and the formation of uric acid nephropathy to a certain extent by lowering blood uric acid levels.

[0065] Preferably, the drug is a drug that lowers blood uric acid, improves cardiac and renal function, protects the myocardium, and reduces inflammatory response.

[0066] Clinical studies have confirmed that the traditional Chinese medicine compound of this invention is safe and effective; animal experiments have shown that the traditional Chinese medicine compound can reduce blood uric acid, improve cardiac function and protect the myocardium by regulating the expression of miR-27a-5p and miR-139-3p, inhibiting the AMPK-mTOR signaling pathway and reducing excessive autophagy of cardiomyocytes.

[0067] The mechanism of action of the traditional Chinese medicine compound in this invention can be summarized as follows:

[0068] (1) Inhibit uric acid production: Reduce endogenous uric acid production by inhibiting the activity of xanthine oxidase in the liver.

[0069] (2) Promote uric acid excretion: By upregulating the expression of uric acid excretion-related transporters in the kidneys, uric acid is excreted through the kidneys.

[0070] (3) Regulation of miRNA expression: downregulate miR-27a-5p expression and upregulate miR-139-3p expression, exerting a multi-target regulatory effect.

[0071] (4) Inhibit the AMPK-mTOR signaling pathway: Inhibit the activation of the myocardial AMPK-mTOR signaling pathway and reduce excessive autophagy of cardiomyocytes.

[0072] (5) Protect target organs: improve kidney function, reduce myocardial fibrosis and apoptosis, and delay myocardial remodeling.

[0073] (6) Anti-inflammatory effect: Reduces the levels of inflammatory factors such as IL-6 and hs-CRP, and alleviates the inflammatory response.

[0074] Beneficial Effects: Compared with existing technologies, this invention has the following significant advantages: This invention provides a scientifically formulated, effective, safe, quality-controllable, and rationally processed traditional Chinese medicine compound, offering a new option for the treatment of hyperuricemia and related diseases. Compared with existing Western medicines, this invention has no serious toxic side effects or adverse reactions; compared with existing traditional Chinese medicine compound formulas, this invention has comprehensive pathogenesis coverage, stable efficacy, and a clear mechanism of action, exhibiting significant clinical advantages and broad application prospects.

[0075] Specifically, the advantages of the traditional Chinese medicine compound of this invention are as follows.

[0076] (I) Scientific formulation, comprehensively covering complex TCM pathogenesis

[0077] This invention is based on the academic viewpoints and clinical experience of Professor Gu Ning, a renowned TCM doctor in Jiangsu Province and a successor of the academic master Zhou Zhongying, on "treating hyperuricemia from the perspective of dampness and turbidity." Targeting the complex TCM pathogenesis of hyperuricemia involving the convergence of "dampness, turbidity, phlegm, blood stasis, and deficiency," this invention, based on long-term clinical practice, selects effective prescriptions and scientifically combines seven herbs: Smilax glabra, Alisma plantago-aquatica, stir-fried Phellodendron chinense, stir-fried Atractylodes lancea, corn silk, Chaenomeles speciosa, and Achyranthes bidentata. The entire formula uses Alisma plantago-aquatica and Smilax glabra as the principal herbs, working together to resolve dampness, eliminate turbidity, and promote diuresis; stir-fried Phellodendron chinense and stir-fried Atractylodes lancea are the assistant herbs, drying dampness and strengthening the spleen, one cold and one warm; corn silk and Chaenomeles speciosa are the adjuvant herbs, promoting diuresis and resolving dampness; and Achyranthes bidentata is the guiding herb, directing the medicine downwards. This formula clearly distinguishes between the principal, assistant, and adjuvant herbs, focusing on treating dampness while combining methods of resolving, drying, and draining. It addresses both the symptoms and the root cause, emphasizing both the superficial manifestation of dampness and the underlying condition of the spleen and kidneys. It promotes uric acid excretion to treat the symptoms while regulating spleen and stomach function to address the root cause, reflecting the holistic and multi-target characteristics of traditional Chinese medicine. Compared to existing technologies that often focus on a single etiology and pathogenesis, this invention comprehensively addresses the complex pathogenesis of hyperuricemia, overcoming the shortcomings of existing compound Chinese medicine formulas such as unstable efficacy and limited improvement of accompanying symptoms.

[0078] (ii) It has a significant effect on lowering uric acid and has a dual mechanism of action.

[0079] The traditional Chinese medicine compound of this invention exerts a significant uric acid-lowering effect through multiple pathways, possessing the dual efficacy of inhibiting uric acid production and promoting uric acid excretion:

[0080] Firstly, it inhibits uric acid production. Animal experiments have shown that the traditional Chinese medicine compound of this invention can significantly inhibit the activity of xanthine oxidase in the liver of rats with hyperuricemia. The activity of xanthine oxidase in the liver of rats in the model group was significantly higher than that in the control group, while the activity of xanthine oxidase in the liver of rats in the traditional Chinese medicine compound group was significantly lower than that in the model group, with an effect comparable to that in the allopurinol group. Xanthine oxidase is a key rate-limiting enzyme in uric acid production; inhibiting its activity can effectively reduce the production of endogenous uric acid.

[0081] Secondly, it promotes uric acid excretion. Animal experiments showed that the urinary uric acid level in the model group rats was significantly lower than that in the control group, while the urinary uric acid level in the rats in the compound herbal formula group of this invention was significantly higher than that in the model group, indicating that this formula has the effect of promoting uric acid excretion through the kidneys.

[0082] Thirdly, the dual mechanism synergistically enhances the effect. The traditional Chinese medicine compound of this invention can simultaneously reduce serum xanthine oxidase activity and promote urinary uric acid excretion in model rats, achieving a dual regulatory effect of inhibiting uric acid production and promoting uric acid excretion. Compared with the currently used Western medicine benzbromarone group, the traditional Chinese medicine compound of this invention has a more significant effect in reducing serum xanthine oxidase activity in model rats, demonstrating the advantage of the multi-target action of this formula.

[0083] Fourth, it significantly reduces serum uric acid levels. In animal experiments, the serum uric acid level in the model group rats was significantly higher than that in the control group, while the serum uric acid level in the rats in the herbal compound group of this invention was significantly lower than that in the model group. Multiple batches of experiments have confirmed that the herbal compound preparation of this invention has a stable and significant uric acid-lowering effect.

[0084] (III) The mechanism of action is explored in depth, revealing the regulatory targets at the molecular level.

[0085] This invention is the first to discover the molecular mechanism by which this traditional Chinese medicine compound can intervene in hyperuricemia and its complications through the regulation of miRNA expression and the AMPK-mTOR signaling pathway:

[0086] Firstly, it regulates differentially expressed miRNAs. Clinical studies using high-throughput sequencing have revealed multiple differentially expressed miRNAs in the serum exosomes of patients with chronic heart failure complicated by hyperuricemia (dampness-turbidity syndrome), with miR-27a-5p significantly upregulated and miR-139-3p significantly downregulated. RT-PCR validation results were consistent with sequencing, showing increased miR-27a-5p expression and decreased miR-139-3p expression in the observation group. ROC curve analysis showed that the combined expression of miR-27a-5p and miR-139-3p has high predictive value for chronic heart failure complicated by hyperuricemia, suggesting that differential expression of miR-27a-5p and miR-139-3p in serum exosomes can serve as novel molecular markers for diagnosing complications of hyperuricemia. The traditional Chinese medicine compound of this invention has a certain regulatory effect in this study.

[0087] Secondly, it regulates the AMPK-mTOR signaling pathway. GO and KEGG enrichment analyses showed that autophagy was the most enriched target, and activation of the AMPK-mTOR signaling pathway may be one of the targets of differentially expressed miRNAs. Animal experiments confirmed that the traditional Chinese medicine compound of this invention can significantly downregulate the expression level of miR-27a-5p in the blood of model rats and significantly upregulate the expression level of miR-139-3p; at the same time, it reduces myocardial AMPK protein expression, increases mTOR protein expression, and inhibits the activation of the AMPK-mTOR signaling pathway. The addition of an AMPK agonist can partially reverse the intervention effect of the traditional Chinese medicine compound of this invention, further verifying the mechanism by which the traditional Chinese medicine compound of this invention exerts its therapeutic effect by regulating the AMPK-mTOR signaling pathway.

[0088] Third, it inhibits excessive autophagy in cardiomyocytes. The traditional Chinese medicine compound of this invention can significantly reduce the expression of autophagy-related proteins Beclin1 and LC3-II in the myocardial tissue of model rats, increase the expression of p62, and inhibit excessive autophagy in cardiomyocytes. Transmission electron microscopy observation shows that the traditional Chinese medicine compound of this invention reduces mitochondrial swelling, decreases the formation of autophagosomes, and improves the ultrastructure of the myocardium in model rats.

[0089] Fourth, it improves the pathological structure of the myocardium. HE staining showed that the traditional Chinese medicine compound of this invention can improve the disordered arrangement of cardiomyocytes, reduce vacuolar degeneration and inflammatory cell infiltration in model rats; Masson staining showed that the traditional Chinese medicine compound of this invention reduces myocardial collagen fiber deposition and alleviates myocardial fibrosis; TUNEL staining showed that the traditional Chinese medicine compound of this invention reduces the apoptosis rate of cardiomyocytes. The above results indicate that the traditional Chinese medicine compound of this invention exerts a comprehensive regulatory effect at multiple levels, including molecular, cellular, and tissue levels.

[0090] (iv) Multi-target protection of target organs and improvement of cardiac and renal function

[0091] The traditional Chinese medicine compound of this invention, while lowering uric acid, also has a significant protective effect on target organs such as the heart and kidneys:

[0092] Firstly, it improves cardiac function. Clinical observations show that the traditional Chinese medicine compound of this invention, when used to treat patients with chronic heart failure and hyperuricemia, has a similar effect on lowering serum uric acid as the benzbromarone control group, with fewer observed side effects. This helps improve cardiac function, suggesting that the traditional Chinese medicine compound of this invention may be more suitable for clinical application in patients with heart failure and hyperuricemia. In animal experiments, the traditional Chinese medicine compound of this invention can significantly reduce serum BNP levels in rats with chronic heart failure and hyperuricemia, increase LVEF, and effectively improve cardiac function.

[0093] Secondly, it protects kidney function. Animal experiments showed that the serum creatinine and blood urea nitrogen levels in the hyperuricemia model group were significantly higher than those in the control group. The traditional Chinese medicine compound of this invention can significantly reduce the serum creatinine and blood urea nitrogen levels in the model rats. Compared with the benzbromarone group, the traditional Chinese medicine compound of this invention has a more significant effect in reducing serum creatinine, demonstrating the advantage of the traditional Chinese medicine compound of this invention in protecting the kidneys while lowering uric acid.

[0094] Thirdly, anti-inflammatory effects. Clinical observations show that the traditional Chinese medicine compound of this invention can reduce serum hs-CRP levels in patients with chronic heart failure and hyperuricemia, with better improvement than the benzbromarone control group, indicating that the traditional Chinese medicine compound of this invention has the effect of reducing inflammatory response.

[0095] (v) High safety and few toxic side effects

[0096] The medicinal materials selected in this invention are all commonly used Chinese medicinal materials listed in the Chinese Pharmacopoeia. They are mild in nature and there are no contraindications such as the "Eighteen Incompatibilities" or "Nineteen Antagonisms" in the entire formula.

[0097] Compared with existing Western medicines for treating hyperuricemia, the traditional Chinese medicine compound of this invention has significant safety advantages: it avoids the severe skin hypersensitivity reaction of allopurinol, the cardiovascular risks of febuxostat, and the liver damage risk of benzbromarone. In clinical observation, patients in the benzbromarone control group experienced mild adverse reactions, while patients in the traditional Chinese medicine compound treatment group of this invention did not experience significant adverse reactions, indicating that the traditional Chinese medicine compound of this invention has good safety in clinical application.

[0098] (vi) Quality is controllable and stability is good

[0099] This invention establishes a comprehensive quality control method to ensure stable and controllable product quality:

[0100] Thin-layer chromatography (TLC) identification: Specific TLC identification methods for Phellodendron bark and Smilax glabra were established. For Phellodendron bark identification, toluene-isopropanol-ethyl acetate-methanol-concentrated ammonia solution was used as the developing solvent. Under 365 nm UV light, the test sample and the reference herb showed fluorescent spots of the same color at corresponding positions. For Smilax glabra identification, toluene-ethyl acetate-formic acid was used as the developing solvent. After spraying with aluminum trichloride ethanol solution, the sample was examined under sunlight. The test sample and the astilbin reference standard showed spots of the same color at corresponding positions. This method is highly specific, has good separation, and is highly reproducible.

[0101] Content determination: A high-performance liquid chromatography (HPLC) method was established to determine the content of astilbin using astilbin as the indicator. Gradient elution was employed, the detection wavelength was 291 nm, and the theoretical plate number calculated based on the astilbin peak met the requirements. Method validation showed that the method exhibited good linearity, and its precision, repeatability, and stability all met the requirements, enabling accurate control of product quality.

[0102] Formulation inspection: The pH value and relative density of this product meet the requirements under the compound preparation section. Accelerated stability test and long-term stability test show that there are no significant changes in the properties, identification, and content determination of this product during the storage period, and the quality is stable.

[0103] (vii) The preparation process is scientific and suitable for industrial production.

[0104] This invention utilizes orthogonal experimental design, with astilbene content and extract yield as comprehensive evaluation indicators, to determine the optimal extraction process parameters. Verification experiments show that under these process conditions, the extract yield and astilbene content remain stable, indicating a stable and feasible process with good reproducibility.

[0105] The preparation method of this invention employs a water extraction process, which is simple to operate, requires minimal equipment, and is suitable for large-scale industrial production. The extraction process parameters are clearly defined, and the concentration and sterilization conditions are specific, ensuring process repeatability and batch-to-batch consistency of the product. Compared with some complex extraction processes in existing technologies, this invention is simpler, consumes less energy, and saves costs, demonstrating good economic efficiency and practicality.

[0106] (viii) Various dosage forms, convenient to take

[0107] This invention relates to a traditional Chinese medicine compound that can be formulated into various oral dosage forms, such as compound preparations, granules, capsules, and tablets, to meet the medication needs of different patients. Compound preparations are convenient to take and rapidly absorbed; solid dosage forms are easy to carry and store. Product specifications are clearly defined, dosages are accurate, and patient compliance is good. Attached Figure Description

[0108] Figure 1 This is a flowchart illustrating the preparation process of the traditional Chinese medicine compound preparation for treating hyperuricemia according to the present invention.

[0109] Figure 2 High-performance liquid chromatograms for the determination of astilbene content (A is the high-performance liquid chromatogram of the traditional Chinese medicine compound test sample of this invention, and B is the high-performance liquid chromatogram of the astilbene standard).

[0110] Figure 3 Standard curve for the determination of astilbin content;

[0111] Figure 4 The images are thin-layer chromatographic identification diagrams (A is the thin-layer chromatographic identification diagram of Phellodendron bark, and B is the thin-layer chromatographic identification diagram of Smilax glabra).

[0112] Figure 5 The following are experimental results of the effect of the traditional Chinese medicine compound of this invention on the uric acid-lowering effect in rats with hyperuricemia (A is a bar chart comparing serum uric acid levels in each group of rats, B is a bar chart comparing liver xanthine oxidase (XOD) activity in each group of rats, C is a bar chart comparing urinary uric acid levels in each group of rats, and D is a bar chart comparing serum creatinine levels in each group of rats).

[0113] Figure 6 The experimental results of the effects of the traditional Chinese medicine compound of the present invention on cardiac function in rats with chronic heart failure and hyperuricemia are shown in the figure [AD are echocardiograms of rats in the control group, model group, traditional Chinese medicine compound + AMPK agonist group and traditional Chinese medicine compound group, respectively; E is a bar chart comparing the left ventricular ejection fraction (LVEF) of rats in each group; F is a bar chart comparing the blood brain natriuretic peptide (BNP) levels of rats in each group];

[0114] Figure 7 The figure shows the experimental results of the effect of the traditional Chinese medicine compound of the present invention on miRNA expression in rats with chronic heart failure and hyperuricemia (A is a bar chart comparing the relative expression levels of miR-27a-5p in the blood of rats in each group, and B is a bar chart comparing the relative expression levels of miR-139-3p in the blood of rats in each group).

[0115] Figure 8This is a Western blot result showing the effect of the traditional Chinese medicine compound of the present invention on the expression levels of AMPK-mTOR pathway and autophagy-related proteins in the myocardial tissue of rats with chronic heart failure and hyperuricemia.

[0116] Figure 9 The images show the effects of the traditional Chinese medicine compound of the present invention on the myocardial tissue pathology of rats with chronic heart failure and hyperuricemia [(1)-(4) are HE staining images (×40), Masson staining images (×100), TUNEL staining images (×40) and transmission electron microscopy images (×7000) of the myocardial tissue of each group of rats, respectively. AD are the control group, the model group, the traditional Chinese medicine compound + AMPK agonist group and the compound group, respectively]. Detailed Implementation

[0117] The technical solution of the present invention will be further described below with reference to the accompanying drawings.

[0118] Example 1

[0119] This embodiment provides a traditional Chinese medicine compound for treating hyperuricemia and its preparation method.

[0120] 1. Raw material ratio: see Table 1.

[0121] Table 1. Raw materials of traditional Chinese medicine compound for treating hyperuricemia

[0122] Name of medicinal materials Dosage (g) Smilax glabra 25 Alisma plantago-aquatica 10 Stir-fried Phellodendron bark 12 Stir-fried Atractylodes lancea 9 Corn silk 15 pawpaw 9 Sichuan Achyranthes 10 Total 90

[0123] 2. Preparation method

[0124] (1) Raw material processing: Weigh out the seven medicinal materials, namely Smilax glabra, Alisma plantago-aquatica, stir-fried Phellodendron chinense, stir-fried Atractylodes lancea, corn silk, papaya, and Achyranthes bidentata, according to the above proportions. Clean them, remove impurities, and test them in accordance with the provisions of each medicinal material item in Part I of the 2020 edition of the Chinese Pharmacopoeia to ensure that the quality meets the legal standards.

[0125] (2) Extraction: Mix the processed medicinal materials, add water in a volume of 12.5 times the total weight of the medicinal materials, soak for 30 minutes, heat to boiling, decoct and extract twice, each time for 2 hours, filter with a 300-mesh sieve, combine the two filtrates to obtain the extract.

[0126] (3) Concentration: The extract is concentrated under reduced pressure at a temperature of 60-80℃ and a vacuum of -0.06 to -0.09 MPa until the relative density is above 1.05 (measured at 20℃) to obtain the concentrate.

[0127] (4) Settling and filtration: Let the concentrated liquid stand for 12 hours to allow insoluble impurities to precipitate. Take the supernatant and filter it through a 300-mesh sieve to obtain a clear filtrate.

[0128] (5) Filling and sterilization: Fill the filtrate into a suitable container, seal it, and place it in a sterilizer. Sterilize at 100°C for 30 minutes to obtain the traditional Chinese medicine compound preparation for treating hyperuricemia.

[0129] 3. Product Specifications: This product is a brownish-brown liquid; it has a slightly fragrant odor and a slightly bitter taste; after standing, a small amount of easily shaken precipitate will form. Each 1 mL is equivalent to 1.51 g of the raw herb. The pH value should be 4.0-6.0, and the relative density should not be less than 1.05 (20℃).

[0130] Example 2

[0131] This embodiment is an optimization of the preparation process of the traditional Chinese medicine compound for treating hyperuricemia in Example 1.

[0132] 1. Experimental Design

[0133] Using astilbin content as the evaluation index, the factors investigated were the water addition ratio (A), decoction time (B), and number of decoctions (C). Each factor had three levels, and the experiment was conducted using an L9(34) orthogonal array. The factor levels are shown in Table 2.

[0134] Table 2 Orthogonal Factor Level Table

[0135] level Water addition (times) Simmering time (min) Number of times to boil (times) 1 7.5 60 1 2 10 90 2 3 12.5 120 3

[0136] 2. Experimental Methods

[0137] Nine samples were weighed according to the prescription amount and extracted according to the experimental conditions of the L9(34) orthogonal array. The astilbin content was determined. At the same time, the extract yield was determined: 20 ml of each of the nine orthogonal experimental sample solutions was accurately measured, transferred to an evaporating dish dried to constant weight, weighed, evaporated to dryness in a water bath, dried at 105℃ for 3 h, removed and cooled in a desiccator for 30 min, weighed quickly, and the extract yield was calculated. Extract yield (%) = (W×V) / (20×Wt)×100%; W is the weight of the extract, V is the fixed volume, and Wt is the weight of the medicinal slices.

[0138] The extract yield and astilbin content were comprehensively scored, with weights of 0.3 and 0.7 respectively. The comprehensive score was calculated as follows: Comprehensive score (%) = (Extract yield / highest value within the group × 0.3 + Astilbin content / highest value within the group × 0.7) × 100%.

[0139] 3. Experimental Results

[0140] Orthogonal experimental results show that the optimal extraction process is: add 12.5 times the amount of water, decoct for 120 minutes, and decoct twice.

[0141] 4. Verification Experiment

[0142] Three batches of validation experiments were conducted according to the optimized process, and the results are shown in Table 3. The results indicate that the extraction process is stable and feasible, with high extract yield and astilbin content, and good reproducibility.

[0143] Table 3 Validation Experiment Results

[0144] Experiment No. Extract yield (%) Astilbene content (mg / mL) 1 23.96 0.632 2 23.91 0.624 3 24.13 0.627

[0145] Based on the results of the orthogonal experiment and considering production energy consumption, the preferred preparation method of the traditional Chinese medicine compound of this invention is determined as follows:

[0146] ① Raw material processing: Weigh out 25 g of Smilax glabra, 10 g of Alisma plantago-aquatica, 12 g of stir-fried Phellodendron chinense, 9 g of stir-fried Atractylodes lancea, 15 g of corn silk, 9 g of Chaenomeles speciosa, and 10 g of Achyranthes bidentata according to the prescription ratio, clean them, remove impurities, and set aside.

[0147] ② Extraction: Mix the above-mentioned medicinal materials, add water in an amount of 12.5 times the total weight of the medicinal materials (about 1137.5 mL), soak for 30 minutes, heat to boiling, decoct and extract twice, 120 minutes each time, filter through a 300-mesh sieve, combine the two filtrates to obtain the extract.

[0148] ③ Concentration: Concentrate the extract under reduced pressure at a temperature of 60-80℃ and a vacuum degree of -0.06 to -0.09 MPa until approximately 60 mL is obtained.

[0149] ④ Settling and filtration: Let the concentrated liquid stand for 12 hours to allow insoluble impurities to precipitate. Take the supernatant and filter it through a 300-mesh sieve to obtain a clear filtrate.

[0150] ⑤ Filling and sterilization: Fill the filtrate into 250mL glass bottles, seal them, and place them in a sterilizer at 100℃ for 30 minutes to obtain the traditional Chinese medicine compound preparation for treating hyperuricemia.

[0151] Example 3

[0152] This embodiment provides a quality control method for the traditional Chinese medicine compound preparation for treating hyperuricemia in Example 1, including thin-layer chromatography for the identification of Phellodendron bark and Smilax glabra, and the determination and testing of astilbin content.

[0153] 1. Thin-layer chromatography identification

[0154] (1) Thin-layer identification of Phellodendron bark

[0155] Preparation of test solution: Take 10 mL of the traditional Chinese medicine compound preparation for treating hyperuricemia prepared in Example 1, evaporate it to near dryness in a water bath, add 20 mL of methanol, sonicate for 10 minutes, filter, and concentrate the filtrate to 2 mL in a water bath to obtain the test solution.

[0156] Preparation of reference herb solution: Take 0.5 g of Phellodendron bark reference herb, add 20 mL of methanol, sonicate for 10 minutes, filter, and use the filtrate as the reference herb solution.

[0157] Preparation of negative control solution: Prepare a negative control solution lacking Phellodendron bark according to the prescription of the traditional Chinese medicine compound for treating hyperuricemia, and prepare it in the same way as the test solution.

[0158] Assay: Refer to the TLC method under General Chapter 0502 of Part IV of the 2020 Chinese Pharmacopoeia. Take 3 μL of each of the above three solutions and spot them separately on the same silica gel G thin-layer plate. Use toluene-isopropanol-ethyl acetate-methanol-concentrated ammonia solution (12:3:6:3:2) as the developing solvent. Develop in a developing tank pre-saturated with ammonia vapor. Remove, air dry, and examine under a 365 nm ultraviolet lamp.

[0159] Result: As Figure 4 As shown in Figure A, 1, 2, and 3 are the test sample (a traditional Chinese medicine compound for treating hyperuricemia), 4 is the reference herb *Phellodendron amurense*, and 5 is the negative control sample lacking *Phellodendron amurense*. In the chromatogram of the test sample, fluorescent spots of the same color appear at the corresponding positions as in the chromatogram of the reference herb, while the negative control sample lacking *Phellodendron amurense* does not have corresponding spots.

[0160] (2) Thin-layer chromatography identification of Smilax glabra

[0161] Preparation of test solution: Take 10 mL of the traditional Chinese medicine compound preparation for treating hyperuricemia prepared in Example 1, extract it twice with ethyl acetate, 20 mL each time, combine the ethyl acetate solutions, evaporate to dryness, dissolve the residue in 2 mL of methanol, filter through a 0.22 μm organic filter membrane, and take the filtrate as the test solution.

[0162] Preparation of the reference herb solution: Take 1.0 g of Smilax glabra reference herb, add 20 mL of methanol, sonicate for 30 minutes, filter, evaporate the filtrate to dryness, add 2 mL of methanol to dissolve the residue, and use it as the reference herb solution.

[0163] Preparation of reference solution: Take an appropriate amount of astilbene reference standard, add methanol to prepare a solution containing 1 mg per 1 mL, and use it as the reference solution.

[0164] Preparation of negative control solution: Prepare a negative control solution lacking Smilax glabra according to the prescription of the traditional Chinese medicine compound for treating hyperuricemia, and prepare it in the same way as the test solution.

[0165] Determination method: According to the thin layer chromatography method, take 3 μL of each of the above four solutions and spot them separately on the same silica gel G thin layer plate. Use toluene-ethyl acetate-formic acid (13:32:9) as the developing solvent, pre-saturate for 20 minutes, develop, remove, air dry, spray with 3% aluminum trichloride ethanol solution, heat at 105℃ for 5 minutes, and examine under sunlight.

[0166] Result: As Figure 4 As shown in Figure B, 1, 2, and 3 are the test sample (a traditional Chinese medicine compound for treating hyperuricemia), 4 is the Smilax glabra reference material, 5 is astilbene reference standard, and 6 is the negative control sample lacking Smilax glabra. In the chromatogram of the test sample, spots of the same color appear at the corresponding positions as in the chromatograms of the reference material and the reference standard, while the negative control sample lacking Smilax glabra does not show corresponding spots.

[0167] 2. Content determination: Astilbin was determined by liquid chromatography.

[0168] Determined by high performance liquid chromatography (General Chapter 0512, Part IV, Chinese Pharmacopoeia 2020 Edition).

[0169] (1) Chromatographic conditions and system suitability test. Column: Octadecylsilane-bonded silica gel as packing material; Mobile phase: Methanol as mobile phase A, 0.1% acetic acid solution as mobile phase B, gradient elution; Detection wavelength: 291 nm; Flow rate: 1.0 mL / min; Column temperature: 25℃; Injection volume: 5 μL. The theoretical plate number, calculated based on the astilbin peak, should not be less than 5000.

[0170] (2) Preparation of reference solution. Take an appropriate amount of astilbene reference standard, accurately weigh it, and add 60% methanol to prepare a solution containing 0.1-0.2 mg per 1 mL.

[0171] (3) Preparation of test solution. Take an appropriate amount of the traditional Chinese medicine compound preparation prepared in Example 1, measure it accurately, add methanol to make the methanol concentration 60%, mix well, centrifuge, and take the supernatant as the test solution.

[0172] (4) Determination method. Accurately pipette 5-10 μL each of the reference solution and the test solution into the liquid chromatograph and determine the result. See the chromatogram below. Figure 2 The figure shows that the astilbin peak is well separated from other peaks and has a consistent retention time. The astilbin content was calculated based on peak area using the external standard method.

[0173] (5) Content Limit. Each mL of this product contains astilbene (C10) glyphosate. 21 H 22 O 11 The dosage shall not be less than 0.1 mg.

[0174] 3. Inspection Items

[0175] Relative density: According to the General Chapter 0601 of Part IV of the 2020 edition of the Chinese Pharmacopoeia, it should not be less than 1.05 (20℃).

[0176] pH value: According to the General Chapter 0631 of Part IV of the 2020 edition of the Chinese Pharmacopoeia, the pH value should be 4.0-6.0.

[0177] Other: It should comply with all relevant provisions under the compound preparation section (General Chapter 0181, Part IV, Chinese Pharmacopoeia 2020 Edition).

[0178] Example 4

[0179] To demonstrate the reliability of the astilbin content determination method in Example 3, the following methodological verification was performed in this example.

[0180] (1) Specificity test

[0181] The reference solution and the test solution were precisely pipetted separately and analyzed under chromatographic conditions. The results showed that the astilbin peak was well separated from other peaks, and the test sample chromatogram showed a single peak at the corresponding position as the reference solution chromatogram. There was no interference from the negative control, indicating that the method has good specificity.

[0182] (2) Examination of linear relationships

[0183] A 1.67 mg / mL astilbin reference solution was diluted with 60% methanol to prepare reference solutions of 0.835, 0.4175, 0.2087, 0.1043, and 0.0521 mg / mL. These solutions were then injected and the peak areas were recorded. A linear regression was performed with the mass concentration (X, mg / mL) of the reference solution on the x-axis and the peak area (Y) on the y-axis. The regression equation for astilbin was Y = 9323X, with a correlation coefficient (r) > 0.9999. The results indicate that the astilbin sample concentration has a good linear relationship with the peak area in the range of 0.0521–1.67 mg / mL (see...). Figure 3 ).

[0184] (3) Precision test

[0185] Accurately pipette 5 μL of the 1.67 mg / mL standard solution for analysis, repeat the injection 6 times, and record the peak area. The calculated RSD of the astilbin peak area is 0.10%, indicating good instrument precision.

[0186] (4) Repeatability test

[0187] Six samples were prepared according to the test solution preparation method, and the peak area of ​​astilbin was determined by injection. The calculated RSD of the peak area was 1.26%, indicating that the method has good repeatability.

[0188] (5) Stability test

[0189] The same test solution was placed at room temperature and injected at 0, 2, 4, 24, 48, and 72 h. The peak area of ​​astilbene was measured, and the calculated RSD of the astilbene peak area was 0.46%, indicating that the test solution was stable within 72 h.

[0190] (6) Recovery test

[0191] Six portions of the test sample with known content were accurately weighed and added to a reference solution of the same concentration at a 1:1 ratio. The average recovery rate of astilbin was measured and calculated to be 96.38%, with an RSD of 0.92% (n=6), which meets the requirement of a recovery rate of 95% to 105%, indicating that the method has a good recovery rate.

[0192] Example 5

[0193] This embodiment studies the stability of the traditional Chinese medicine compound preparation for treating hyperuricemia in Example 1.

[0194] 1. Accelerated stability test

[0195] Three batches of samples prepared in Example 1 were taken, packaged appropriately, and placed at 40℃±2℃ and 75%±5% relative humidity for 6 months. During the test, samples were taken once at the end of the 1st, 2nd, 3rd and 6th months respectively, and tested according to the key stability test items (appearance, identification, pH value, relative density, minimum fill weight and microbial limit).

[0196] Results: All three batches of samples met the requirements during the accelerated stability test, and there was no significant change compared with October.

[0197] 2. Long-term stability test

[0198] Three batches of samples prepared in Example 1 were taken, packaged appropriately, and placed at 25℃±2℃ and 60%±10% relative humidity for 12 months. Samples were taken at 0, 3, 6, 9, and 12 months respectively, and tested according to the key stability test items.

[0199] Results: All three batches of samples met the requirements during the long-term stability test, and there was no significant change compared with 0 months, indicating that the product quality is stable.

[0200] Example 6

[0201] This example is a pharmacodynamic experiment of the traditional Chinese medicine compound preparation for treating hyperuricemia in Example 1—the uric acid-lowering effect (inhibition of uric acid production mechanism) on a rat model of hyperuricemia.

[0202] 1. Experimental Materials

[0203] (1) Drugs:

[0204] The traditional Chinese medicine compound of this invention is a mixture prepared according to the method in Example 1, which is then concentrated to a suitable concentration.

[0205] Positive control drug: Allopurinol tablets, commercially available, dissolved in distilled water.

[0206] (2) Animals:

[0207] SPF grade SD rats, male, weighing 180-220 g. Husbandry conditions: temperature 22±2℃, relative humidity 50-60%, free access to food and water.

[0208] (3) Reagents:

[0209] Inosine, potassium oxonate, uric acid assay kit, xanthine oxidase assay kit, creatinine assay kit, blood urea nitrogen assay kit, alanine aminotransferase assay kit, aspartate aminotransferase assay kit.

[0210] 2. Experimental Methods

[0211] (1) Model establishment: The rat model of hyperuricemia was replicated by gavage of hypoxanthine combined with intraperitoneal injection of potassium oxonate.

[0212] (2) Grouping and administration: SD rats were randomly divided into a blank control group, a model control group, a positive drug control group, and the compound traditional Chinese medicine of this invention group. Except for the blank control group, the rats in the other groups were used to establish a hyperuricemia model. The drug administration group was used to establish the model in the morning and administer the drug in the afternoon for 7 consecutive days.

[0213] (3) Sample collection and testing: After the last administration, fasting for 12 hours was required. Blood was collected after anesthesia to test serum uric acid, ALT, AST, Scr, and BUN levels. Liver tissue homogenate was collected to test liver xanthine oxidase activity.

[0214] 3. Experimental Results

[0215] like Figure 5 As shown in the figure, serum uric acid and liver XOD activity in the model group rats were significantly higher than those in the blank group (P<0.01), indicating that the hyperuricemia model was successfully established. Serum uric acid levels in the herbal compound group of this invention were significantly lower than those in the model group (P<0.01), and liver XOD activity was also significantly lower than that in the model group (P<0.01), comparable to that in the allopurinol group. AST activity, Scr, and BUN levels in the herbal compound group of this invention were significantly lower than those in the model group (P<0.05 or P<0.01). There was no significant difference in ALT activity among the groups (P>0.05).

[0216] 4. Experimental Conclusions

[0217] The traditional Chinese medicine compound of this invention has a significant effect in lowering uric acid. Its mechanism of action is related to the inhibition of hepatic xanthine oxidase activity, and it also has the effects of improving kidney function and protecting the liver.

[0218] Example 7

[0219] This embodiment is a pharmacodynamic experiment of the traditional Chinese medicine compound preparation for treating hyperuricemia in Example 1—the uric acid-lowering effect (mechanism of promoting uric acid excretion) on a rat model of hyperuricemia.

[0220] 1. Experimental Materials

[0221] (1) Drugs:

[0222] The traditional Chinese medicine compound of this invention is a mixture prepared according to the method in Example 1, which is then concentrated to a suitable concentration.

[0223] Positive control drug: Benzbromarone tablets, commercially available, prepared as a suspension with distilled water.

[0224] (2) Animals: Same as in Example 6.

[0225] 2. Experimental Methods

[0226] (1) Model establishment: Same as Example 6.

[0227] (2) Grouping and administration: SD rats were randomly divided into blank control group, model control group, positive drug control group, and the compound Chinese medicine of this invention group. Starting from the 7th day of modeling, the drug group was modeled in the morning and administered the drug by gavage in the afternoon for 7 consecutive days.

[0228] (3) Sample collection and testing: 24-hour urine was collected on the 14th day after administration to test uric acid. Blood was collected after urine collection to test serum uric acid, serum XOD, Scr, and BUN levels.

[0229] 3. Experimental Results

[0230] like Figure 5 As shown in the figure, serum uric acid and XOD activity in the model group rats were significantly increased (P<0.01), while urinary uric acid was significantly decreased (P<0.01). The herbal compound group of this invention significantly reduced serum uric acid levels (P<0.01) and significantly increased urinary uric acid levels (P<0.01), indicating that the formula promotes uric acid excretion. Serum XOD activity in the herbal compound group of this invention was significantly lower than that in the model group (P<0.01) and significantly lower than that in the benzbromarone group (P<0.01), indicating that the formula's inhibitory effect on XOD activity is superior to that of benzbromarone, exhibiting a dual uric acid-lowering mechanism. Scr levels in the herbal compound group of this invention were significantly lower than those in the model group (P<0.01) and significantly lower than those in the benzbromarone group (P<0.01), indicating that the formula's effect on improving renal function is superior to that of benzbromarone.

[0231] 4. Experimental Conclusions

[0232] The traditional Chinese medicine compound of this invention has a dual mechanism for lowering uric acid: on the one hand, it inhibits xanthine oxidase activity, reducing uric acid production; on the other hand, it promotes uric acid excretion through the kidneys. Simultaneously, this formula has a protective effect against renal function damage caused by hyperuricemia.

[0233] Example 8

[0234] This embodiment is a pharmacodynamic experiment of the traditional Chinese medicine compound preparation for treating hyperuricemia in Example 1—the effect on a rat model of chronic heart failure complicated with hyperuricemia.

[0235] 1. Experimental Materials

[0236] (1) Drugs:

[0237] The traditional Chinese medicine compound of this invention is a mixture prepared according to the method in Example 1, which is then concentrated to a suitable concentration.

[0238] AMPK agonist: Acadesine.

[0239] (2) Animals:

[0240] SPF grade male SD rats, weighing 200-250 g.

[0241] (3) Reagents:

[0242] Doxorubicin hydrochloride, ethambutol, potassium oxonate, serum uric acid ELISA kit, serum BNP ELISA kit, serum creatinine ELISA kit, serum urea nitrogen ELISA kit, miRNA extraction kit, AMPK antibody, mTOR antibody, Beclin1 antibody, LC3-II antibody, p62 antibody.

[0243] 2. Experimental Methods

[0244] (1) Model establishment: A rat model of chronic heart failure was established by intraperitoneal injection of doxorubicin. After successful model establishment, a pathological model of chronic heart failure complicated with hyperuricemia was established by gavage with ethambutol combined with subcutaneous injection of potassium oxonate.

[0245] (2) Grouping and administration: Rats that successfully established the model were randomly divided into a model group, the compound traditional Chinese medicine of this invention group, and the compound traditional Chinese medicine of this invention + AMPK agonist group. A blank control group was also set up. Rats in each group were given drug intervention for 4 consecutive weeks.

[0246] (3) Observation indicators: Observe the general vital status of rats in each group; measure LVEF after the last administration; measure SUA, BNP, Scr and BUN in blood; measure the relative expression of miR-27a-5p and miR-139-3p in blood by RT-PCR; detect the expression of AMPK, mTOR, Beclin1, LC3-II and p62 proteins in myocardial tissue by Western blot; perform HE staining, Masson staining, TUNEL staining and transmission electron microscopy.

[0247] 3. Experimental Results

[0248] (1) General vital condition: The rats in the model group were listless, less active, and had dry and dull hair; the rats in the compound Chinese medicine group of this invention were more active, more responsive, and had softer hair than the rats in the model group.

[0249] (2) Effect on serum uric acid: The SUA level in the model group rats was significantly higher than that in the blank group (P<0.01); the SUA level in the traditional Chinese medicine compound group of the present invention was significantly lower than that in the model group (P<0.01), and the effect was better than that in the traditional Chinese medicine compound + AMPK agonist group of the present invention (P<0.05), suggesting that the uric acid lowering effect of the present invention may be related to the inhibition of the AMPK signaling pathway.

[0250] (3) Effects on cardiac function: such as Figure 6 As shown, the LVEF of rats in the model group was significantly lower than that in the blank group (P<0.01), and the BNP was significantly higher than that in the blank group (P<0.01); the LVEF of rats in the traditional Chinese medicine compound group of this invention was significantly higher than that in the model group (P<0.01), and the BNP was significantly lower than that in the model group (P<0.01), and the improvement effect was better than that in the traditional Chinese medicine compound + AMPK agonist group of this invention (P<0.05).

[0251] (4) Effects on renal function: The Scr level in the model group rats was significantly higher than that in the blank group (P<0.01); the Scr level in the traditional Chinese medicine compound group of the present invention was significantly lower than that in the model group (P<0.01), and was better than that in the traditional Chinese medicine compound + AMPK agonist group of the present invention (P<0.05).

[0252] (5) Effects on miRNA expression: such as Figure 7 As shown, the expression levels of miR-27a-5p in the blood of rats in the model group were significantly increased and the expression levels of miR-139-3p were significantly decreased (P<0.01); the expression levels of miR-27a-5p in the blood of rats in the traditional Chinese medicine compound group of this invention were significantly decreased (P<0.01) and the expression levels of miR-139-3p were significantly increased (P<0.05).

[0253] (6) Effects on the AMPK-mTOR signaling pathway: such as Figure 8As shown, in the model group, the expression of AMPK protein in the myocardium of rats was significantly increased and the expression of mTOR protein was significantly decreased (P<0.01); in the group treated with the traditional Chinese medicine compound of this invention, the expression of AMPK protein was significantly decreased and the expression of mTOR protein was significantly increased (P<0.01).

[0254] (7) Effects on autophagy-related proteins: such as Figure 8 As shown, in the model group, the expression of Beclin1 and LC3-II proteins in the myocardium of rats was significantly increased, while the expression of p62 protein was significantly decreased (P<0.01); in the compound herbal formula of this invention, the expression of Beclin1 and LC3-II proteins in rats was significantly decreased, while the expression of p62 protein was significantly increased (P<0.01).

[0255] (8) Pathological observation of myocardial tissue: such as Figure 9 As shown in the figure. HE staining showed that the cardiomyocytes of rats in the herbal compound group of the present invention were relatively tightly arranged with less widening of the intercellular matrix. The herbal compound of the present invention can improve the disordered arrangement of cardiomyocytes in the model rats, reduce vacuolar degeneration and inflammatory cell infiltration. Masson staining showed that the myocardial fibers of rats in the herbal compound group of the present invention were neatly and tightly arranged. This formula can reduce the deposition of collagen fibers in the myocardium of the model rats to a certain extent and alleviate myocardial fibrosis. TUNEL staining showed that the apoptosis rate of cardiomyocytes of rats in the herbal compound group of the present invention was significantly reduced. Transmission electron microscopy showed that the collagen fibers in the cardiomyocytes of rats in the herbal compound group of the present invention were tightly arranged with clear striations and no autophagosomes were observed. This formula can reduce mitochondrial swelling and reduce the formation of autophagosomes in the model rats to a certain extent.

[0256] 4. Experimental Conclusions

[0257] The traditional Chinese medicine compound of this invention can reduce blood uric acid, improve cardiac function and protect the myocardium by regulating the expression of miR-27a-5p and miR-139-3p in model rats, inhibiting the AMPK-mTOR signaling pathway, and reducing excessive autophagy of cardiomyocytes.

[0258] Example 9

[0259] This embodiment is a study on the safety and efficacy of the traditional Chinese medicine compound for treating hyperuricemia in Example 1—interventional effect on patients with chronic heart failure complicated with hyperuricemia.

[0260] Study Subjects and Methods: Sixty-two patients with chronic heart failure complicated by hyperuricemia (dampness and turbidity retention syndrome) were randomly divided into a treatment group and a control group, with 31 patients in each group. Both groups received standard drug treatment for chronic heart failure. The control group was additionally given benzbromarone, while the treatment group was additionally given the traditional Chinese medicine compound of this invention. The treatment course was 2 weeks.

[0261] Results: The total effective rate was 80.6% in the treatment group and 83.9% in the control group, with comparable efficacy between the two groups (P>0.05). Serum uric acid levels decreased from (519.4±79.8) μmol / L before treatment to (423.1±119.3) μmol / L (P<0.01) in the treatment group and from (508.7±81.2) μmol / L to (417.9±106.01) μmol / L in the control group (P<0.01), showing no significant difference in uric acid-lowering effects between the two groups. Regarding safety, two cases of mild nausea and vomiting and one case of mild liver damage occurred in the control group, while no significant adverse reactions occurred in the treatment group, indicating that the herbal compound of this invention has higher safety while ensuring efficacy.

[0262] Clinical observation of patients with chronic heart failure complicated with hyperuricemia, diagnosed as having internal dampness and turbidity, showed that the traditional Chinese medicine compound of this invention has significant effects in lowering uric acid and improving cardiac function.

[0263] Example 10

[0264] This example is a clinical observation of the traditional Chinese medicine compound for treating hyperuricemia in Example 1—a typical case study of a renowned doctor intervening in patients with chronic heart failure complicated by hyperuricemia.

[0265] 1. Typical Case 1

[0266] Ms. Feng, 81 years old. She presented with recurrent chest tightness and shortness of breath, recurring with bilateral lower extremity edema for over half a month. Current symptoms included: chest tightness and shortness of breath, inability to lie flat, fatigue, lower extremity edema, abdominal distension, poor appetite, scanty and yellow urine, loose stools, pale and swollen tongue with a white and greasy coating, and an irregular pulse. She had a history of hypertension, chronic kidney disease, and hyperuricemia. Test results showed elevated serum uric acid, serum creatinine, and blood urea nitrogen. Western medicine diagnosis: acute exacerbation of chronic heart failure, NYHA class IV, hyperuricemia, stage 4 chronic kidney disease, and hypertension. Traditional Chinese medicine diagnosis: Heart-water syndrome (deficiency of heart and lung qi, and excessive dampness). She was treated with a modified traditional Chinese medicine formula based on this invention. Two weeks later, at the follow-up visit, her chest tightness and shortness of breath had improved, and the lower extremity edema had subsided. Repeat tests showed significant decreases in serum uric acid, serum creatinine, and blood urea nitrogen, and proteinuria had turned negative. Subsequent follow-up showed stable symptoms and normalized serum uric acid levels.

[0267] 2. Typical Case 2

[0268] Mr. Zhu, male, 71 years old. History of coronary heart disease and heart failure. Six months ago, elevated blood uric acid levels led to a diagnosis of hyperuricemia. Current symptoms: occasional chest tightness and shortness of breath after exertion, lower extremity edema accompanied by fatigue, abdominal distension, obesity, poor appetite, loose stools, pale and dark tongue with a white, greasy coating, and a wiry, slippery pulse. Examination results: elevated blood uric acid, serum creatinine, and blood urea nitrogen. Western medicine diagnosis: coronary heart disease, NYHA class III heart failure, hyperuricemia. Traditional Chinese medicine diagnosis: Heart edema (dampness and turbidity retention syndrome). Treatment with this invention's modified traditional Chinese medicine formula was prescribed. Two weeks later, at the follow-up visit, appetite had improved, lower extremity edema had subsided, and a repeat blood uric acid test showed a decrease. After continuing medication, blood uric acid returned to normal, and the symptoms of chest tightness and shortness of breath became less pronounced.

Claims

1. A traditional Chinese medicine compound for treating hyperuricemia, characterized in that, By weight, it includes 20-30 parts of Smilax glabra, 9-12 parts of Alisma plantago-aquatica, 9-15 parts of stir-fried Phellodendron chinense, 6-12 parts of stir-fried Atractylodes lancea, 12-18 parts of corn silk, 6-12 parts of Chaenomeles speciosa, and 9-12 parts of Achyranthes bidentata.

2. The traditional Chinese medicine compound according to claim 1, characterized in that, By weight, it includes 25 parts of Smilax glabra, 10 parts of Alisma plantago-aquatica, 12 parts of stir-fried Phellodendron chinense, 9 parts of stir-fried Atractylodes lancea, 15 parts of corn silk, 9 parts of papaya, and 10 parts of Achyranthes bidentata.

3. A method for preparing a concentrated solution of the traditional Chinese medicine compound according to claim 1, characterized in that, Includes the following steps: (1) Weigh out seven medicinal materials: Smilax glabra, Alisma plantago-aquatica, stir-fried Phellodendron chinense, stir-fried Atractylodes lancea, corn silk, papaya, and Achyranthes bidentata, and clean them; (2) Mix the medicinal materials, extract with water, filter, and obtain an extract; (3) Concentrate the extract to obtain a concentrate.

4. The preparation method according to claim 3, characterized in that, In step (2), add 10 to 15 times the total weight of the medicinal materials in water, soak for 20 to 40 minutes, then heat to boiling, decoct and extract 1 to 3 times, each time for 60 to 150 minutes, filter, combine the filtrates, and obtain the extract.

5. The preparation method according to claim 3, characterized in that, In step (3), vacuum concentration is used, with a concentration temperature of 60~80℃ and a vacuum degree of -0.06~-0.09 MPa to obtain concentrated solution.

6. The preparation method according to claim 3, characterized in that, After the concentrated liquid in step (3) is left to stand, the supernatant is filtered, and the filtrate is sealed and sterilized to obtain a traditional Chinese medicine compound preparation for treating hyperuricemia; or the concentrated liquid in step (3) is further concentrated and dried to prepare a solid oral dosage form.

7. A quality control method for the traditional Chinese medicine compound according to claim 1, characterized in that, The quality control method includes properties, identification, content determination and inspection items. The identification is thin-layer chromatography to identify Phellodendron bark and Smilax glabra. The content determination is liquid chromatography to determine astilbin. The inspection items include relative density and pH value.

8. A pharmaceutical composition, characterized in that, The pharmaceutical composition comprises the traditional Chinese medicine compound of claim 1 and a pharmaceutically acceptable carrier, wherein the dosage form of the pharmaceutical composition includes a mixture, granules, capsules, pills, powders or oral liquids.

9. The use of the traditional Chinese medicine compound of claim 1 or the pharmaceutical composition of claim 8 in the preparation of a medicament for treating hyperuricemia and related diseases.

10. The application according to claim 9, characterized in that, The drug is used to lower blood uric acid, improve cardiac and renal function, protect the myocardium, and reduce inflammatory responses.

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