Traditional Chinese medicine composition with uric acid reducing effect as well as preparation method and application of traditional Chinese medicine composition

By developing a traditional Chinese medicine compound uric acid-lowering composition based on traditional Chinese medicine theory and modern pharmaceutical technology, the toxic side effects of existing uric acid-lowering drugs are solved, and the problems of unclear composition and backward process of traditional Chinese medicine products are achieved, which significantly reduces serum uric acid levels and improves safety and tolerance.

CN119656265APending Publication Date: 2025-03-21INSTITUTE OF CHINESE MATERIA MEDICA CHINA ACADEMY OF CHINESE MEDICAL SCIENCES
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Patent Information

Application Number
CN202510102762.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-01-22
Publication Date
2025-03-21

AI Technical Summary

Technical Problem

The existing uric acid-lowering drugs have problems such as great toxic side effects, poor long-term use safety, and low patient tolerance. The uric acid-lowering products based on traditional Chinese medicine on the market have problems such as unclear composition, backward process and lack of systematic verification.

Method used

Develop a traditional Chinese medicine compound uric acid-reducing composition based on traditional Chinese medicine theory, scientific compatibility and advanced technology. Through modern technologies such as water extraction, nanofiltration purification and spray drying, the purity and bioavailability of drugs are improved, and scientifically matched with traditional Chinese medicinal materials to exert synergistic effects.

Benefits of technology

It significantly reduces serum uric acid levels, regulates the expression of renal URAT1 protein, reduces uric acid reabsorption, reduces drug toxicity and side effects, and improves the safety and tolerance of long-term use. It is suitable for patients with hyperuricemia and susceptible people.

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Abstract

The invention relates to a traditional Chinese medicine composition with an effect of reducing uric acid as well as a preparation method and application of the traditional Chinese medicine composition, which can effectively solve the problems of large toxic and side effects, poor safety after long-term use and low patient tolerance of the existing uric acid reducing medicine. The compound traditional Chinese medicine is prepared from the following raw material medicines in parts by weight: 1 to 20 parts of flos chrysanthemi, 1 to 10 parts of radix puerariae, 1 to 8 parts of folium mori, 1 to 8 parts of herba taraxaci, 1 to 10 parts of herba cichorii, 1 to 5 parts of herba pogostemonis, 1 to 5 parts of bulbus lilii, 1 to 5 parts of orange peel, 0.1 to 2 parts of radix ginseng and 0.1 to 2 parts of cordyceps militaris peptide. The effects of remarkably reducing the serum uric acid level, regulating the URAT1 protein expression of the kidney and reducing uric acid reabsorption are achieved, so that the hyperuricemia and related complications thereof are effectively prevented and treated.
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Description

1. Technical Field

[0001] The present invention relates to the medical field, and in particular to a Chinese medicine composition having uric acid lowering effect, and a preparation method and application thereof. 2. Background Technology

[0002] Hyperuricemia is a metabolic disease caused by purine metabolism disorder or reduced uric acid excretion, which leads to elevated serum uric acid levels. It is an important cause of gout, uric acid nephropathy, uric acid stones, etc. In recent years, with the change of lifestyle and unreasonable diet structure, the incidence of hyperuricemia has shown a significant upward trend and has gradually become a global public health problem.

[0003] At present, the drugs used in clinical treatment of hyperuricemia mainly include the following two categories: (1) Xanthine oxidase inhibitors (such as allopurinol and febuxostat): they reduce the production of uric acid by inhibiting xanthine oxidase, thereby achieving the effect of lowering serum uric acid levels. However, these drugs may cause side effects such as liver and kidney damage and skin allergies during long-term use. (2) Uric acid excretion drugs (such as benzbromarone and probenecid): they lower serum uric acid levels by promoting renal uric acid excretion, but this type of drug has poor efficacy in patients with renal insufficiency and there is a risk of increasing urate deposition in the urinary system. Although the above drugs can control serum uric acid levels to a certain extent, long-term use has large side effects, and some patients have drug tolerance, which seriously affects the quality of life of patients. Therefore, it is particularly important to develop uric acid-lowering products with high safety, low toxicity and side effects, and long-term use.

[0004] Traditional Chinese medicine has a long history and rich clinical experience in preventing and treating hyperuricemia and related complications. Many Chinese medicinal materials have been proven to have the effects of clearing away heat and dampness, promoting blood circulation and removing blood stasis, regulating kidney function, inhibiting uric acid production, and promoting uric acid excretion. Due to its multi-component and multi-target characteristics, Chinese herbal compound prescriptions have unique advantages in the treatment of metabolic diseases, especially in reducing drug side effects and improving the overall metabolic status of patients. However, most of the uric acid-lowering products based on Chinese medicine on the market currently have the following problems: (1) Unclear ingredients: The active ingredients have not been fully separated and identified, and there is uncertainty about the efficacy. (2) Outdated technology: The extraction process and purification technology are relatively rough, resulting in the loss of active ingredients and unstable product quality. (3) Lack of systematic verification: There is a lack of systematic pharmacodynamic and safety evaluation, and clinical data are insufficient. With the development of modern pharmaceutical technology, the use of modern processes such as water extraction, nanofiltration technology, and spray drying can effectively retain the active ingredients in Chinese medicinal materials, remove ineffective or harmful ingredients, and significantly improve the purity and bioavailability of medicinal material extracts. At the same time, scientific combination of Chinese medicinal materials and giving full play to the synergistic effect among the medicinal materials can significantly improve the effect of lowering uric acid, reduce toxic side effects, and make the drug more suitable for long-term use.

[0005] In view of the shortcomings of existing drugs for the treatment of hyperuricemia and the problems existing in traditional Chinese medicine in the treatment of uric acid lowering, there is an urgent need to develop a traditional Chinese medicine compound uric acid lowering composition based on traditional Chinese medicine theory, scientific compatibility, advanced technology, high safety and long-term use to meet the dual needs of clinical treatment and prevention. III. Summary of the invention

[0006] In view of the above situation, in order to solve the defects of the prior art, the purpose of the present invention is to provide a Chinese medicine composition with uric acid lowering effect and its preparation method and application, which can effectively solve the problems of existing uric acid lowering drugs such as large toxic and side effects, poor safety for long-term use, and low patient tolerance.

[0007] In order to achieve the above object, one of the technical solutions of the present invention is:

[0008] A traditional Chinese medicine composition with uric acid lowering effect is composed of the following raw materials in parts by weight: 1-20 parts of chrysanthemum, 1-10 parts of kudzu root, 1-8 parts of mulberry leaf, 1-8 parts of dandelion, 1-10 parts of chicory, 1-5 parts of patchouli, 1-5 parts of lily, 1-5 parts of orange peel, 0.1-2 parts of ginseng, and 0.1-2 parts of cordyceps militaris peptide.

[0009] One of the technical solutions of the present invention is that the preparation method of the Chinese medicine composition can be prepared into powders, granules, tablets, capsules, pills, decoctions, ointments and other oral dosage forms according to specific needs.

[0010] One of the technical solutions of the present invention is: the preparation method of the Chinese medicine composition comprises the following steps:

[0011] 1) Pretreatment of medicinal materials: Select the compatible Chinese medicinal materials, wash and dry them, and use them directly or roughly grind them to a specific particle size;

[0012] 2) Extraction: Mix the Chinese medicinal materials evenly according to the proportion, and add water for extraction;

[0013] 3) Solid-liquid separation: separating the extract from the residue and collecting the extract;

[0014] 4) Nanofiltration purification: The extract is subjected to nanofiltration separation to remove macromolecular impurities and retain the effective ingredients;

[0015] 5) Spray drying: The extract after nanofiltration is subjected to spray drying treatment to obtain the product.

[0016] Furthermore, in step 1), the particle size is controlled at 10-20 mesh.

[0017] Furthermore, in step 2), the extraction conditions are to add 8-10 times the amount of deionized water as the raw material drug, and extract 1-3 times at 80-120° C., each time for 0.5-2 h.

[0018] Furthermore, in step 4), the molecular cutoff range is 100-1000 Daltons, and the operating conditions are pressure 0.4 MPa and temperature 25°C.

[0019] Furthermore, in step 5), the inlet air temperature of the spray drying is set to 160° C., the outlet air temperature is set to 90° C., and the spray drying rate is 10 mL / min.

[0020] One of the technical solutions of the present invention is: use of the traditional Chinese medicine composition in preparing a medicine having a uric acid-lowering effect.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] (1) It can significantly reduce serum uric acid levels and has a good dose-dependency.

[0023] (2) Effectively regulate the expression of renal URAT1 protein and reduce the reabsorption of uric acid in the renal tubules.

[0024] (3) Through scientific compatibility and modern extraction technology, the toxic and side effects of drugs are reduced, and long-term use is highly safe.

[0025] (4) Suitable for different populations, including patients with hyperuricemia and susceptible populations.

[0026] (5) Use modern technologies such as water extraction, nanofiltration purification, and spray drying to improve the purity and bioavailability of active ingredients in drugs.

[0027] (6) It can be prepared into various dosage forms such as powders, granules, tablets, capsules, pills, decoctions, ointments, etc. to meet the needs of different patients. IV. Description of the drawings

[0028] Figure 1 The present invention shows the effect of the composition on the serum uric acid level in hyperuricemia mice.

[0029] Figure 2 The present invention shows the effect of the composition of the present invention on the expression of URAT1 protein in mouse kidney.

[0030] Figure 3 The figure shows the effect of the composition of the present invention on the liver and kidney of mice.

[0031] Figure 4 These are the clinical trial results of the composition of the present invention. V. Specific implementation methods

[0032] The specific implementation of the present invention is further described in detail below in conjunction with the accompanying drawings and examples.

[0033] Example 1

[0034] A traditional Chinese medicine composition with uric acid lowering effect is composed of the following raw materials in parts by weight: 10 parts of chrysanthemum, 8 parts of kudzu root, 6 parts of mulberry leaf, 6 parts of dandelion, 8 parts of chicory, 4 parts of patchouli, 4 parts of lily, 3 parts of tangerine peel, 1 part of ginseng, and 0.5 part of cordyceps militaris peptide.

[0035] The preparation method is:

[0036] 1) Pretreatment of medicinal materials: After cleaning the Chinese medicinal materials in sequence, place them in a ventilated place to dry until constant weight, and roughly grind the dried medicinal materials to a particle size of 15 mesh for later use;

[0037] 2) Extraction: Mix the Chinese medicinal materials in proportion, add 10 times the amount of deionized water, extract at 100°C, extract for 1.5 hours for the first time, collect the extract after filtering; add 8 times the amount of deionized water for the second time, extract for 1 hour;

[0038] 3) Solid-liquid separation: after filtering, the extracts are combined, filtered through filter cloth, the drug residue is removed, and the filtrate is collected for later use;

[0039] 4) Nanofiltration purification: The extract is subjected to nanofiltration separation using a nanofiltration membrane with a molecular cutoff range of 800 Daltons, operating conditions are 0.4 MPa pressure and 25°C temperature, the effective ingredients are retained, macromolecular impurities are removed, and the nanofiltrate is collected for later use;

[0040] 5) Spray drying: The nanofiltrate was treated with a spray dryer, with the inlet air temperature set at 160° C., the outlet air temperature set at 90° C., and the spray drying rate set at 10 mL / min to obtain a powder of the Chinese medicine composition extract.

[0041] Example 2

[0042] A traditional Chinese medicine composition with uric acid lowering effect is composed of the following raw materials in parts by weight: 1 part of chrysanthemum, 1 part of kudzu root, 1 part of mulberry leaf, 1 part of dandelion, 1 part of chicory, 1 part of patchouli, 1 part of lily, 1 part of tangerine peel, 0.1 part of ginseng, and 0.1 part of cordyceps militaris peptide.

[0043] The preparation method is:

[0044] 1) Pretreatment of medicinal materials: After cleaning the Chinese medicinal materials in sequence, place them in a ventilated place to dry until constant weight, and roughly grind the dried medicinal materials to a particle size of 10 meshes for later use;

[0045] 2) Extraction: Mix the Chinese medicinal materials in proportion, add 10 times the amount of deionized water, extract at 80°C, extract for 1 hour for the first time, collect the extract after filtering; add 8 times the amount of deionized water for the second time, extract for 0.5 hour;

[0046] 3) Solid-liquid separation: after filtering, the extracts are combined, filtered through filter cloth, the drug residue is removed, and the filtrate is collected for later use;

[0047] 4) Nanofiltration purification: The extract is subjected to nanofiltration separation using a nanofiltration membrane with a molecular cutoff range of 500 Daltons, operating conditions are a pressure of 0.4 MPa and a temperature of 25°C, the effective ingredients are retained, macromolecular impurities are removed, and the nanofiltrate is collected for later use;

[0048] 5) Spray drying: The nanofiltrate was treated with a spray dryer, with the inlet air temperature set at 160° C., the outlet air temperature set at 90° C., and the spray drying rate set at 10 mL / min to obtain a powder of the Chinese medicine composition extract.

[0049] Example 3

[0050] A traditional Chinese medicine composition with uric acid lowering effect is composed of the following raw materials in parts by weight: 20 parts of chrysanthemum, 10 parts of kudzu root, 8 parts of mulberry leaf, 8 parts of dandelion, 10 parts of chicory, 5 parts of patchouli, 5 parts of lily, 5 parts of orange peel, 2 parts of ginseng, and 2 parts of cordyceps militaris peptide.

[0051] The preparation method is:

[0052] 1) Pretreatment of medicinal materials: After cleaning the Chinese medicinal materials in sequence, place them in a ventilated place to dry until constant weight, and roughly grind the dried medicinal materials to a particle size of 20 meshes for later use;

[0053] 2) Extraction: Mix the Chinese medicinal materials in proportion, add 10 times the amount of deionized water, and extract at 120°C. The first extraction is 2 hours, and the extract is collected after filtration; the second extraction is 8 times the amount of deionized water, and the extraction is 1.5 hours;

[0054] 3) Solid-liquid separation: after filtering, the extracts are combined, filtered through filter cloth, the drug residue is removed, and the filtrate is collected for later use;

[0055] 4) Nanofiltration purification: The extract is subjected to nanofiltration separation using a nanofiltration membrane with a molecular cutoff range of 1000 Daltons, operating conditions are a pressure of 0.4 MPa and a temperature of 25°C, the effective ingredients are retained, macromolecular impurities are removed, and the nanofiltrate is collected for later use;

[0056] 5) Spray drying: The nanofiltrate was treated with a spray dryer, with the inlet air temperature set at 160° C., the outlet air temperature set at 90° C., and the spray drying rate set at 10 mL / min to obtain a powder of the Chinese medicine composition extract.

[0057] The Chinese medicine composition of the present invention can significantly reduce serum uric acid levels, regulate the expression of kidney URAT1 protein, and reduce the reabsorption of uric acid in the renal tubules; it can significantly improve kidney tissue damage caused by hyperuricemia and enhance kidney excretion function; it is suitable for long-term use by patients with hyperuricemia and susceptible populations, and has good safety and tolerability. The relevant experimental data are as follows: 1. Component detection

[0058] Total phenolic acid content detection: The Folin-Ciocalteu method was used to detect the total phenolic acid content in the extract with gallic acid as the standard. Total flavonoid content detection: The aluminum salt colorimetric method was used to detect the total flavonoid content in the extract with rutin as the standard.

[0059] It was determined that the contents of total phenolic acid and total flavonoids in the Chinese medicine composition of the present invention were 13.55% and 22.53%, respectively, as shown in Table 1, indicating that the Chinese medicine composition extract prepared by scientific compatibility and standardized process has good process adaptability and stability.

[0060] Table 1 Content of components in extracts of Chinese medicine composition

[0061]

[0062] 2. Animal experiments (activity, mechanism, safety-pathological sections)

[0063] 1 Experimental Purpose

[0064] The purpose of this experiment is to explore the regulatory effect of the optimal Chinese medicine compound composition of the present invention on the serum uric acid level in hyperuricemia model mice, evaluate its uric acid-lowering effect and protective effect on liver and kidney tissues, and conduct comparative analysis using benzbromarone as a positive control drug.

[0065] 2 Experimental Grouping

[0066] The experimental mice were randomly divided into the following 6 groups, with 12 mice in each group:

[0067] Blank group: oral gavage and intraperitoneal injection of normal saline (blank solvent);

[0068] Model group: yeast + potassium oxonate modeling, no drug intervention;

[0069] Positive control group (benzbromarone group): yeast + potassium oxonate modeling, oral administration of benzbromarone 8.3 mg / kg;

[0070] Compound low-dose group: yeast + potassium oxonate modeling, intragastric administration of the Chinese medicine compound composition of the present invention 0.039 g / kg;

[0071] The compound medium dose group: yeast + potassium oxonate modeling, intragastric administration of the Chinese medicine compound composition of the present invention 0.078g / kg;

[0072] Compound high-dose group: yeast + potassium oxonate modeling, intragastric administration of the Chinese medicine compound composition of the present invention 0.156 g / kg.

[0073] 3 Animal modeling and drug administration

[0074] Adaptive feeding: All mice were adaptively fed with standard feed and free access to drinking water for 7 days before the start of the experiment.

[0075] Modeling stage (D1-D9): Except for the blank group, the mice in other groups were gavaged with yeast (9 g / kg, 0.2 mL / 10 g body weight) daily, followed by intraperitoneal injection of potassium oxonate (250 mg / kg, 0.1 mL / 10 g body weight).

[0076] Drug administration phase (D7-D14): The blank group was gavaged and intraperitoneally injected with an equal volume of saline every day. The mice in other groups were gavaged with corresponding drugs according to the group dose 1 hour after modeling, and the drugs were continuously administered for 7 days.

[0077] 4. Sample collection and indicator detection

[0078] On the 14th day of the experiment, 1 hour after administration, the mice were eyeballed and blood was collected, and then anesthetized and killed to separate liver and kidney tissues. The blood samples were placed in a 4°C refrigerator overnight, centrifuged at 3500r / min for 10 minutes, and the upper serum was collected for uric acid detection. The collected liver and kidney tissues were immediately fixed with 4% paraformaldehyde solution and pathological sections were prepared.

[0079] Detection indicators: serum uric acid level, liver and kidney pathological histological observation

[0080] 5 Experimental results and analysis

[0081] (1) Analysis of changes in serum uric acid levels

[0082] like Figure 1 As shown in the figure, the serum uric acid level of the blank group was stable in the normal range, about 200 μmol / L, indicating that the experimental environment did not interfere with normal mice. The serum uric acid level of the model group (green column) increased significantly to about 600 μmol / L, indicating that the yeast combined with potassium oxonate modeling successfully induced a hyperuricemia model. The serum uric acid level of the benzbromarone positive control group (BENZ.) decreased to about 300 μmol / L, which was significantly lower than that of the model group, indicating that the positive drug had a significant effect in lowering uric acid. Compound extract group: Low-dose group (Low density): The serum uric acid level dropped to about 400 μmol / L, which was statistically significant compared with the model group (* is P<0.05). Medium-dose group (Medium density): The serum uric acid level further dropped to about 350 μmol / L, and the effect was significantly better than that of the low-dose group (P<0.01). High-dose group: serum uric acid level decreased to nearly 200μmol / L, with no significant difference from the blank group (**P<0.0001), indicating that the high-dose compound extract has a significant uric acid-lowering effect. The compound extract showed significant uric acid-lowering effects in the high, medium and low-dose groups, and was dose-dependent. The effect of the medium-dose group was equivalent to that of benzbromarone.

[0083] (2) Analysis of changes in URAT1 protein expression

[0084] like Figure 2As shown, the URAT1 protein expression level in the blank group (blue column) was 1.00, which is the normal basal value. The URAT1 expression level in the model group (orange column) increased to 1.28, indicating that the expression of URAT1 in the kidney of the hyperuricemia model was significantly upregulated, further verifying the success of the model. Benzbromarone positive control group (gray column): The URAT1 expression level dropped to 0.98, close to the normal level, indicating that benzbromarone plays a role in lowering uric acid by inhibiting URAT1 expression. Compound extract group: Low-dose group (yellow column): The URAT1 expression level dropped to 1.06, which was lower than that in the model group, but the inhibitory effect was not significant enough. Medium-dose group (dark blue column): The URAT1 expression level dropped to 0.91, close to the normal level, and the effect was significantly better than the low-dose group. High-dose group (green column): The URAT1 expression level further dropped to 0.84, which was significantly lower than the model group, with the strongest inhibitory effect, close to or better than benzbromarone. The compound extract can significantly inhibit the expression of URAT1 protein in the kidney, thereby reducing uric acid reabsorption and achieving the effect of lowering uric acid.

[0085] (3) Pathological observation of liver tissue

[0086] like Figure 3 As shown in a, blank group: liver tissue structure is clear, hepatocytes are normal in size and arranged neatly, and no obvious pathological changes are observed;

[0087] Model group: Compared with the blank group, the hepatocytes around the central vein were edematous and the cytoplasm was translucent;

[0088] Benzbromarone group: Compared with the model group, the hepatocyte edema was improved, but there was inflammatory cell infiltration;

[0089] Allopurinol group: Compared with the model group, the hepatocyte edema was slightly improved. There was slight inflammatory cell infiltration, and some hepatocyte edema was still visible;

[0090] Compared with the model group, the hepatocyte edema in the compound group was significantly improved, and the liver tissue morphology was similar to that in the blank group, and no physiological lesions were observed.

[0091] (4) Pathological observation of renal tissue

[0092] like Figure 3 As shown in b, blank group: the mouse kidney structure is normal and clear, the cortex and medulla are clearly demarcated, the glomerulus is normal in size and clear in structure, the renal tubule structure is normal, and no obvious pathological changes such as inflammatory cell infiltration and edema are observed;

[0093] Model group: Compared with the blank group, the glomeruli were atrophied and the borders were unclear, and congestion was occasionally seen. The renal capsule partially disappeared, the renal tubular epithelial cells were edematous, the cytoplasm was transparent, and cells occasionally fell off;

[0094] Benzbromarone group: Compared with the model group, glomerular atrophy was improved, but congestion was present. The renal tubular lumen was edematous, with red-stained protein exudates, translucent cytoplasm, cell shedding, and obvious tissue lesions.

[0095] Allopurinol group: Compared with the model group, glomerular atrophy and disappearance of renal capsule were slightly improved, glomerular congestion and tubular epithelial cell edema were significantly improved, and protein leaching and cell shedding were occasionally observed;

[0096] Compared with the model group, the medium-dose compound group showed: improved tubular atrophy, significantly improved glomerular congestion, significantly improved tubular epithelial cell edema, and occasional disappearance of renal capsules.

[0097] Table 2 Effects of compound extract on blood uric acid content in HUA mice induced by yeast combined with potassium oxonate (x-±SD)

[0098]

[0099] Note: Compared with the blank group, ###p<0.001; compared with the model control group, *p<0.05, **p<0.01, ***p<0.001.

[0100] 3. Clinical Trials

[0101] In order to evaluate the actual effect and safety of the Chinese herbal compound composition of the present invention in the human body, a clinical trial was conducted to verify the regulatory effect of the composition on serum uric acid levels and to explore its short-term and medium-term use effects.

[0102] 40 adult subjects who voluntarily participated in the test were selected, all of whom were diagnosed with high blood uric acid levels but without acute gout symptoms (serum uric acid level ≥ 500 μmol / L). The subjects, regardless of gender and age, took 5 g / person of the composition of the present invention daily for 3 consecutive weeks.

[0103] During the trial, the subjects were required to maintain a normal diet and avoid high-purine foods and alcoholic beverages. Fasting blood samples were collected regularly every week to measure serum uric acid levels and record the changes in the uric acid reduction rate of each group.

[0104] The serum uric acid reduction rate was defined as:

[0105]

[0106] The statistical results were expressed as mean ± standard deviation.

[0107] The results show that the compound composition of the present invention exhibits a significant uric acid-lowering effect during a 3-week clinical trial.

[0108] Figure 4a shows the change of uric acid reduction rate with the trial time (weeks). In the first week of the trial, the uric acid reduction rate reached about 11%, showing a rapid onset of action (green dots). By the second week of the trial (blue dots), the uric acid reduction rate was further increased to about 15%, significantly higher than the first week (p<0.05). In the third week of the trial (red dots), the uric acid reduction rate reached more than 20%, showing dose-dependency and cumulative effects.

[0109] Figure 4 b provides a bar graph of the uric acid reduction rate at each time point from the first to the third week of the trial. The experimental results show that as the duration of administration increases, the uric acid reduction rate shows a trend of gradual increase, and the differences between the various time points are statistically significant (p<0.01).

[0110] The above experiments show that the Chinese medicine composition of the present invention can significantly reduce the serum uric acid level of the human body in a short period of time, and the effect gradually increases with the prolonged administration time. In particular, the effect of reducing uric acid by about 11% was achieved in the first week, and the reduction rate was further expanded to more than 20% in the third week, showing excellent uric acid regulation ability. In addition, no obvious adverse reactions were observed during the test, indicating that the composition has good safety and tolerability.

[0111] IV. Conclusion

[0112] The present invention is based on the theory of traditional Chinese medicine, and has developed a traditional Chinese medicine compound uric acid lowering composition through scientific compatibility and modern preparation technology. Modern extraction technology is used to ensure the full extraction and purification of the effective ingredients of the medicinal materials, maintain the stability of the efficacy and bioavailability, and give full play to the advantages of the traditional Chinese medicine compound with multiple components and multiple targets, so as to achieve the effects of significantly lowering serum uric acid levels, regulating the expression of renal URAT1 protein, and reducing uric acid reabsorption, thereby effectively preventing and treating hyperuricemia and its related complications.

[0113] The present invention has a wide range of application prospects. As a prescription component of medicine and food, the present invention can be used in functional foods or health foods to play an auxiliary role in lowering uric acid. In addition, the Chinese medicine compound of the present invention can also be applied to traditional pharmaceutical preparations (such as powders, granules, tablets, capsules, etc.), meet the needs of different groups of people, improve the feasibility and convenience of clinical application, and widely serve the long-term management and health prevention of patients.

[0114] The diversified applications of this traditional Chinese medicine composition provide a solid foundation for its market demand in different fields, and it has significant application value and commercial potential in both clinical and health care fields.

Claims

1. A Chinese medicine composition having a uric acid-lowering effect, characterized in that: The invention is composed of the following raw materials in parts by weight: 1-20 parts of chrysanthemum, 1-10 parts of kudzu root, 1-8 parts of mulberry leaf, 1-8 parts of dandelion, 1-10 parts of chicory, 1-5 parts of patchouli, 1-5 parts of lily, 1-5 parts of orange peel, 0.1-2 parts of ginseng and 0.1-2 parts of cordyceps militaris peptide.

2. The Chinese medicine composition having uric acid lowering effect according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 10 parts of chrysanthemum, 8 parts of kudzu root, 6 parts of mulberry leaf, 6 parts of dandelion, 8 parts of chicory, 4 parts of patchouli, 4 parts of lily, 3 parts of tangerine peel, 1 part of ginseng and 0.5 parts of cordyceps militaris peptide.

3. A method for preparing the Chinese medicine composition having uric acid lowering effect according to any one of claims 1 to 2, characterized in that: According to specific needs, it can be prepared into powders, granules, tablets, capsules, pills, decoctions, and ointments.

4. The method for preparing the Chinese medicine composition having uric acid lowering effect according to claim 3, characterized in that: The preparation method of the powder comprises the following steps: 1) Pretreatment of medicinal materials: Select the compatible Chinese medicinal materials, wash and dry them, and use them directly or roughly grind them to a specific particle size; 2) Extraction: Mix the Chinese medicinal materials evenly according to the proportion and add water for extraction; 3) Solid-liquid separation: separate the extract from the residue and collect the extract; 4) Nanofiltration purification: Nanofiltration separation of the extract to remove macromolecular impurities and retain effective ingredients; 5) Spray drying: The extract after nanofiltration is spray dried to obtain the product.

5. The method for preparing the Chinese medicine composition having uric acid lowering effect according to claim 6, characterized in that: In the step 1), the particle size is controlled at 10-20 meshes.

6. The method for preparing the Chinese medicine composition having uric acid lowering effect according to claim 4, characterized in that: In the step 2), the extraction conditions are as follows: adding 8-10 times the amount of deionized water as the API, extracting at 80-120° C. for 1-3 times, each time for 0.5-2 hours.

7. The method for preparing the Chinese medicine composition having uric acid lowering effect according to claim 4, characterized in that: In the step 4), the molecular cutoff range is 100-1000 Daltons, and the operating conditions are a pressure of 0.4 MPa and a temperature of 25°C.

8. The method for preparing the Chinese medicine composition having uric acid lowering effect according to claim 4, characterized in that: In the step 5), the inlet air temperature of the spray drying is set to 160° C., the outlet air temperature is set to 90° C., and the spray drying rate is 10 mL / min.

9. Use of the Chinese medicine composition according to any one of claims 1 to 2 in the preparation of a medicament having a uric acid-lowering effect.