A traditional Chinese medicine composition for treating hyperuricemia, renal damage and fibrosis and its application

Abstract

The present invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition for treating hyperuricemia, renal damage and fibrosis, and its application. The technical problem to be solved by the present invention is to provide a new option for the treatment of hyperuricemia. The technical solution of the present invention is a traditional Chinese medicine composition for treating hyperuricemia, renal damage and fibrosis, comprising the following ingredients: mistletoe, phellodendron, oriental water chestnut, ginseng, astragalus, polygonatum, lotus leaf, cirsium japonicum and panax notoginseng. The traditional Chinese medicine composition of the present invention has the effects of inhibiting uric acid synthesis, promoting uric acid excretion, and improving renal damage, and can be used to treat hyperuricemia without causing liver damage.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating hyperuricemia, renal injury and fibrosis and application thereof. Background Art

[0002] Hyperuricemia (HUA) is a chronic metabolic disease caused by impaired purine metabolism. The direct cause of the disease is an imbalance in uric acid production and excretion, leading to abnormally elevated uric acid levels. In recent years, the prevalence of hyperuricemia has shown a significant increase, with a younger prevalence. It has become the fourth most common disease in my country, after hyperglycemia, hyperlipidemia, and hypertension. The prevalence of HUA ranges from 2.6% to 36% across different populations, and the number of people with HUA in my country has reached 190 million. HUA can harm multiple body systems, primarily including the following: ① Gouty arthritis. HUA most commonly affects joints, resulting in acute and chronic gouty arthritis, tophi, and joint deformities. ② Uric acid nephropathy. Uric acid crystals can form urinary stones, disrupting renal tubular function and leading to uric acid nephropathy. In severe cases, this condition can lead to renal failure. ③ HUA can affect endothelial metabolism, exacerbating atherosclerosis and inducing coronary artery disease. ④HUA is an independent risk factor for vascular dementia and cognitive decline. ⑤Hyperuricemia can exacerbate diabetes and its chronic complications.

[0003] Currently, clinical drug treatments for hyperuricemia can be divided into three categories: 1. Reducing uric acid synthesis, represented by xanthine oxidase (XOD) inhibitors such as allopurinol, febuxostat, and topiroxostat; 2. Enhancing uric acid excretion, represented by URAT1 inhibitors such as benzbromarone and probenecid; and 3. Regulating the metabolic hydrolysis of uric acid (uricase). However, all of these drugs have significant adverse reactions. For example, febuxostat and allopurinol have a higher incidence of acute renal failure than other drugs and can cause acute liver damage, making long-term use unsuitable. Benzbromarone and probenecid are both small molecule drugs and should be used with caution in patients with urinary tract stones, hepatic and renal insufficiency, gastrointestinal ulcers, the elderly, and children. Uricase has significant drawbacks, such as triggering an immune response and having a short efficacy. Therefore, the search for new drugs with greater safety and long-term efficacy remains a research priority for the treatment of hyperuricemia.

[0004] The pathogenesis of hyperuricemia is relatively complex, involving multiple links. Traditional Chinese medicine has obvious advantages in treating this type of disease. Traditional Chinese medicine does not have the names of hyperuricemia and gout. Acute attacks of gout are mainly classified as "gout", "heat arthralgia", "white tiger calendar" and other categories in traditional Chinese medicine, while the intervals between hyperuricemia and gout are mainly classified as "blood poison" and "turbid poison". Clinically, hyperuricemia is mainly divided into syndromes such as spleen and kidney yang deficiency, damp-heat accumulation, blood stasis, phlegm and turbidity obstruction, and liver and kidney yin deficiency. The treatment is mainly based on the method of clearing heat and dampness, tonifying the kidney and strengthening the spleen, strengthening the spleen and eliminating dampness, and clearing turbidity and removing blood stasis. At present, traditional Chinese medicine and its compound prescriptions have been increasingly studied in the treatment of hyperuricemia nephropathy. They have the advantages of definite efficacy, few side effects, and long-term use in the treatment of hyperuricemia and the chronic kidney damage caused by it. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a new option for the treatment of hyperuricemia.

[0006] The technical solution of the present invention is a traditional Chinese medicine composition for treating hyperuricemia, renal damage and fibrosis, comprising the following ingredients: rhizome of Alisma orientalis, ginseng, polygonatum, lotus leaf and cirsium japonicum.

[0007] Furthermore, the weight ratio of the ingredients is: 3 to 12 parts of oriental rhizome, 3 to 12 parts of ginseng, 5 to 20 parts of polygonatum, 5 to 20 parts of lotus leaves and 5 to 20 parts of cirsium japonicum.

[0008] Preferably, the weight ratio of the ingredients is: 6 parts of Alisma orientalis, 6 parts of ginseng, 10 parts of Polygonatum odoratum, 10 parts of lotus leaves and 10 parts of Cirsium japonicum.

[0009] Furthermore, the Chinese medicine composition also includes additional ingredients: mistletoe, phellodendron, astragalus and panax notoginseng.

[0010] The weight ratio of the additional ingredients is: 6 to 24 parts of mistletoe, 4 to 16 parts of phellodendron, 9 to 36 parts of astragalus and 2 to 10 parts of panax notoginseng.

[0011] Preferably, the weight ratio of the additional ingredients is: 12 parts of mistletoe, 8 parts of phellodendron, 18 parts of astragalus, 10 parts of cirsium and 5 parts of notoginseng.

[0012] Hyperuricemia is caused by congenital deficiency, spleen and kidney dysfunction, dietary inappropriateness, internal accumulation of dampness, and blood stasis that blocks the meridians. In this formula, Phellodendron amurense clears heat and dampness, purging fire and eliminating steam; Alisma orientalis promotes diuresis and dissipates dampness, relieving heat; Panax notoginseng disperses blood stasis and stops bleeding, reducing swelling and alleviating pain; Cirsium sibiricum cools blood and stops bleeding, dissipates stasis and detoxifies, and resolves carbuncle; Lotus leaf dissipates dampness, cools blood and stops bleeding; Polygonatum odoratum nourishes yin and moistens dryness, promotes fluid production and quenches thirst; Ginseng replenishes qi, tonifies the spleen and lungs, and promotes fluid production and blood nourishment; Astragalus membranaceus replenishes qi and elevates yang, promotes diuresis and reduces swelling, promotes fluid production and nourishes blood, and relieves stagnation and numbness; and Mulberry parasite dispels rheumatism, nourishes the liver and kidneys, and strengthens the bones and muscles. The entire formula works together to clear heat and dampness, eliminate turbidity and blood stasis, promote fluid production and nourish blood, and is highly effective in treating hyperuricemia.

[0013] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps:

[0014] a. Mix ginseng and rhizoma alismatis, add 70% ethanol and extract twice, filter the extract after each extraction, combine the filtrate, recover ethanol, and obtain an alcohol extract;

[0015] Alternatively, the herb Loranthus parasiticus, Phellodendron chinense and Rhizoma Alismatis are mixed, and extracted twice with 70% ethanol. The extract is filtered after each extraction, the filtrate is combined, and the ethanol is recovered to obtain an alcohol extract.

[0016] b. Mix the medicinal residues treated in step a with polygonatum, lotus leaves, and cirsium japonicum, extract them twice with water, filter the extracts after each extraction, and combine the filtrates to obtain an aqueous extract;

[0017] Alternatively, the medicinal residue treated in step a is mixed with ginseng, astragalus, polygonatum, lotus leaf, cirsium japonicum, and Panax notoginseng, and extracted twice with water. The extract is filtered after each extraction, and the filtrates are combined to obtain a water extract;

[0018] c. Combine the alcohol extract and the water extract, concentrate, and dry to obtain powder.

[0019] Furthermore, in step a, ethanol is recovered using reduced pressure or normal pressure technology.

[0020] Specifically, in step a, the mass-to-volume ratio of the feed liquid (g / mL) is 1:3 to 1:20.

[0021] Preferably, in step a, the mass-to-volume ratio of the feed to the liquid (g / mL) is 1:8.

[0022] Specifically, in step b, the mass-to-volume ratio of the feed liquid (g / mL) is 1:3 to 1:20.

[0023] Preferably, in step b, the mass-to-volume ratio of the feed to the liquid (g / mL) is 1:6.

[0024] Specifically, in step a, each extraction time is 1 to 3 hours.

[0025] Preferably, in step a, each extraction time is 1.5 h.

[0026] Specifically, in step b, each extraction time is 1 to 3 hours.

[0027] Preferably, in step b, each extraction time is 1.5 h.

[0028] The present invention also provides a traditional Chinese medicine composition obtained by the above preparation method.

[0029] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of medicines or health products for treating or improving hyperuricemia, renal damage and fibrosis.

[0030] Among them, the application is the use of the above-mentioned traditional Chinese medicine composition in the preparation of drugs for inhibiting xanthine oxidase, lowering uric acid levels, improving kidney damage caused by hyperuricemia, lowering inflammatory factor levels, improving renal fibrosis caused by hyperuricemia and / or reducing liver damage.

[0031] The present invention also provides a medicine or health product for treating or improving hyperuricemia, renal damage and fibrosis, comprising the above-mentioned Chinese medicine composition.

[0032] The present invention also provides a medicine or health product for inhibiting xanthine oxidase, lowering uric acid levels, improving kidney damage caused by hyperuricemia, lowering inflammatory factor levels, improving renal fibrosis caused by hyperuricemia and / or reducing liver damage, including the above-mentioned Chinese medicine composition.

[0033] In particular, the above-mentioned medicine also includes pharmaceutically acceptable adjuvants.

[0034] Further, the auxiliary agent is dextrin, sucrose or starch.

[0035] Furthermore, the dosage form of the drug is tablets, injections, capsules, pills or granules.

[0036] Beneficial effects of the present invention: The present invention addresses the deficiencies of existing drug treatments and, based on years of clinical practice, has been continuously optimized to form a fixed prescription for the treatment of hyperuricemia. The prescription is composed of mistletoe, phellodendron, ginseng, astragalus, rhizoma alismatis, odoratum, lotus leaf, cirsium japonicum, and Panax notoginseng. It has the effects of clearing heat and dampness, replenishing qi and strengthening the spleen, and promoting diuresis and purging turbidity. It is clinically used for the treatment of hyperuricemia and its complications, with definite efficacy and high safety. In order to further explore its effect characteristics, a hyperuricemia animal model was constructed to study the effects of the compound on uric acid synthesis and uric acid excretion in hyperuricemia mice and its protective effect on kidney damage and liver damage. The results showed that the compound can inhibit liver xanthine oxidase, reduce blood uric acid levels, blood creatinine, blood urea nitrogen and urine protein levels, increase urine uric acid levels, reduce serum IL-1β and IL-6 levels and kidney F4 / 80 and FN expressions, and have no effect on liver function indicators AST and ALT. The results indicate that the Chinese medicine composition of the present invention has the effects of inhibiting uric acid synthesis, promoting uric acid excretion, and improving kidney damage, and can be used to treat hyperuricemia without causing liver damage, providing a basis for further development of the composition into a health product or medicine for preventing or treating hyperuricemia. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 .HE staining of kidneys of mice in each group (20×).

[0038] Figure 2 .F4 / 80 staining images of kidneys of mice in each group (20×).

[0039] Figure 3 .Masson staining of kidneys of mice in each group (20×).

[0040] Figure 4 Fibronectin staining of kidneys of mice in each group (20×).

[0041] Figure 5 .α-SMA staining images of kidneys of mice in each group (20×).

[0042] Figure 6 .HE staining of the liver of mice in each group (10×). DETAILED DESCRIPTION

[0043] Sources of reagents and materials used in the following examples:

[0044] KM mice were purchased from Zhuhai Baishitong Laboratory Animal Co., Ltd.; medicinal materials were purchased from Guangdong Medicinal Materials Company; potassium oxonate (CAS No. 2207-75-2), hypoxanthine (CAS No. 68-94-0), and allopurinol (CAS No. 315-30-0) were purchased from Shanghai Yuanye Biotechnology Co., Ltd. Uric acid, XOD enzyme, creatinine, urea nitrogen, urine protein, ALT, and AST detection kits were purchased from Nanjing Jiancheng Bioengineering Research Institute Co., Ltd.; IL-1β, IL-6, and TNF-α detection kits were purchased from Jiangsu Enzyme Immunity Industry Co., Ltd.

[0045] Example 1 Preparation of the Chinese medicine composition of the present invention

[0046] Weigh 10 times the prescribed medicinal materials and extract the herb Morus altissima, Phellodendron chinense, and Rhizoma Alismatis twice with 70% ethanol: first extract for 1.5 hours with 8 times the volume and then extract for 1 hour with 6 times the volume. Filter and combine the filtrates, and recover the ethanol under reduced pressure. Extract the herb residue and the remaining medicinal materials (Ginseng, Astragalus, Polygonatum, Lotus Leaf, Cirsium japonicum, and Panax notoginseng) twice with water: first extract for 1.5 hours with 8 times the volume of water (based on the mass-to-volume ratio) and then extract for 1 hour with 6 times the volume of water. Filter, combine, and concentrate. Combine the ethanol and water extract concentrates, dry, and pulverize for later use. Add 0.5% sodium carboxymethyl cellulose to dissolve the extract to the desired concentration.

[0047] With reference to the above preparation method, a Chinese medicine composition with the following formula was prepared:

[0048] The medicinal materials of the first group of the high uric acid prescription No. 1 are composed of the following raw materials in parts by weight: 6 parts of mistletoe, 16 parts of phellodendron, 3 parts of oriental water chestnuts, 3 parts of ginseng, 32 parts of astragalus, 5 parts of polygonatum, 5 parts of lotus leaves, 5 parts of cirsium japonicum and 10 parts of panax notoginseng;

[0049] The medicinal materials of the second group of high uric acid prescription No. 1 are composed of the following raw materials in parts by weight: 16 parts of mistletoe, 4 parts of phellodendron, 12 parts of oriental water chestnuts, 12 parts of ginseng, 9 parts of astragalus, 10 parts of polygonatum, 10 parts of lotus leaves, 10 parts of cirsium japonicum and 2 parts of panax notoginseng;

[0050] The medicinal materials of the three groups of high uric acid prescription No. 1 are composed of the following raw materials in parts by weight: 12 parts of mistletoe, 8 parts of phellodendron, 6 parts of oriental water chestnuts, 6 parts of ginseng, 18 parts of astragalus, 10 parts of polygonatum, 10 parts of lotus leaves, 10 parts of cirsium japonicum, and 5 parts of panax notoginseng;

[0051] The prescription medicinal materials of Group 4 of Hyperuric Acid Prescription I are composed of the following raw materials in parts by weight: 12 parts of mistletoe, 8 parts of phellodendron, 15 parts of oriental Chinese medicine, 15 parts of ginseng, 18 parts of astragalus, 4 parts of polygonatum, 4 parts of lotus leaf, 4 parts of cirsium and 5 parts of Panax notoginseng; this prescription is a control prescription, in which the mass ratio of oriental Chinese medicine, ginseng, polygonatum, lotus leaf and cirsium is not within the range of 3-12 parts: 3-12 parts: 5-20 parts: 5-20 parts: 5-20 parts.

[0052] Example 2 Preparation of the Chinese medicine composition of the present invention

[0053] Male KM mice aged 7 to 8 weeks were divided into blank control group (Control), model group (Model), allopurinol group (AP, 10 mg / kg / d), hyperuric acid prescription I group 1 (F-1, 14.9 g / kg / d), hyperuric acid prescription I group 2 (F-2, 14.9 g / kg / d), hyperuric acid prescription I group 3 (F-3, 14.9 g / kg / d), and hyperuric acid prescription I group 4 (F-4, 14.9 g / kg / d) according to their body weight, with 6 mice in each group.

[0054] Seven- to eight-week-old male KM mice were fed a standard diet and given normal drinking water. After one week of adaptive feeding, mice in the control group were gavaged with 0.5% CMC-Na (0.1 ml / 10 g) and intraperitoneally injected with PBS (0.1 ml / 10 g) daily. The remaining groups received intraperitoneal injections of potassium oxonate (200 mg / kg / d) and hypoxanthine (500 mg / kg / d). The allopurinol group received gavage with allopurinol (10 mg / kg / d), while mice in the FL and FH groups received the corresponding doses of the compound extract at a volume of 0.1 ml / 10 g for 21 days. After 21 days of dosing, mice were placed in metabolic cages for 24-hour urine collection. All groups were fasted for 24 hours, anesthetized with isoflurane, and blood was collected by enucleation. After blood collection, the mouse hearts were perfused with 30 ml of normal saline. After perfusion, the kidneys and livers were removed.

[0055] Indicator Assays: Serum uric acid and liver XOD enzyme levels were measured according to the instructions of the uric acid and XOD enzyme assay kits. Creatinine, urea nitrogen, and urine protein were measured according to the instructions of the creatinine, urea nitrogen, and urine protein assay kits to assess renal function. The inflammatory cytokines IL-1β, IL-6, and TNF-α were measured according to the instructions of the IL-1β, IL-6, and TNF-α assay kits to assess renal inflammation. ALT and AST were measured according to the instructions of the ALT and AST assay kits to assess liver function. Kidney and liver tissues were collected and fixed in 4% paraformaldehyde for 24 hours. After dehydration, they were embedded in paraffin blocks and cut into 4-μm sections. The sections were oven-dried at 65°C for 1 hour. After gradient dewaxing with organic reagents, they were stained with hematoxylin and eosin, Masson staining, and immunohistochemistry to assess histopathology, inflammatory infiltration, and fibrosis. GraphPad Prism 9.4.1 software was used for data analysis and graphing. Two-group comparisons were performed with the two-tailed unpaired t-test, and multiple groups were compared with one-way analysis of variance (ANOVA) followed by Tukey's multiple comparison test. Data are expressed as mean ± standard error (x ± s). P < 0.05 indicated statistically significant differences.

[0056] Experimental results

[0057] 1. Inhibit xanthine oxidase and reduce uric acid levels

[0058] The uric acid levels of mice in each group are shown in Table 1. Compared with the blank control group, the model group showed significantly increased XOD levels in the liver and serum, significantly increased serum uric acid, and significantly decreased urinary uric acid levels. The different groups of Hyperuric Acid Prescription No. 1 can reduce blood uric acid and increase urinary uric acid levels. Group 3 showed significant differences and the best effect, and was superior to allopurinol in increasing urinary uric acid levels. Group 4 showed a trend, but no significant difference. The different groups of Hyperuric Acid Prescription No. 1 can reduce XOD enzyme levels in the liver and serum. Groups 2 and 3 showed significant differences, and Group 4 showed a trend, but no significant difference. This indicates that Hyperuric Acid Prescription No. 1 can inhibit xanthine oxidase, reduce uric acid synthesis, promote uric acid excretion, and improve hyperuricemia.

[0059] Table 1. Statistics of blood uric acid, urine uric acid and XOD levels in each group

[0060]

[0061] Note: Compared with the blank group: ** P<0.01, *** P<0.001, **** P<0.0001; compared with the model group: △ P<0.05, △△P<0.01, △△△△ P<0.0001.

[0062] 2. Improve kidney damage caused by hyperuricemia

[0063] (1) Biochemical indicators of renal function

[0064] The results of renal function-related indices are shown in Table 2. Compared with the blank group, the model group showed significantly increased blood urea nitrogen and urine protein levels, and a significantly decreased endogenous creatinine clearance rate. After administration of Hyperuricemia Formula I, blood urea nitrogen and urine protein levels decreased, and endogenous creatinine clearance rate increased. Groups 2 and 3 showed significant differences, with Group 1 significantly reducing blood urea nitrogen levels and increasing endogenous creatinine clearance rate. Group 4 showed a decreasing trend, but no significant difference was found. This indicates that Hyperuricemia Formula I can significantly improve the renal function of hyperuricemic mice.

[0065] Table 2. Statistical table of renal function indicators in each group

[0066]

[0067]

[0068] Note: Compared with the blank group: ** P<0.01, *** P<0.001; compared with the model group: △ P<0.05, △△ P<0.01, △△△ P<0.001, △△△△ P<0.0001.

[0069] (2) HE staining results

[0070] By HE staining ( Figure 1 ) observed that the control group mice had normal renal tubular cell morphology and no obvious infiltration in the kidneys, while the model group mice showed severe renal damage, loose and chaotic renal tubular structure, glomerular atrophy and other obvious morphological changes, and the high uric acid prescription No. 1 group, especially group 3, could significantly improve this lesion.

[0071] 3. Inflammatory index detection

[0072] (1) Levels of inflammatory factors

[0073] The results of serum inflammatory factor level detection are shown in Table 3. The levels of IL-1β, IL-6 and TNF-α in the model group were significantly higher than those in the blank group. The levels of IL-1β in each drug-treated group were reduced, among which the levels of IL-6 and TNF-α decreased significantly, and Group 3 was the best. This shows that High Uric Acid Recipe No. 1 can significantly improve the inflammatory phenotype of hyperuricemia mice.

[0074] Table 3. Statistical table of serum inflammatory indicators in each group

[0075] Group IL-1β (ng / L) IL-6 (ng / L) TNF-α (ng / L) Blank control group (control) 83.58±2.20 111.20±2.64 740.60±8.96 Model group (model) <![CDATA[104.30±1.96 *** ]]> <![CDATA[134.40±1.44 **** ]]> <![CDATA[987.20±26.07 **** ]]> High Uric Acid Formula I Group 1 (F-1) 98.66±2.96 <![CDATA[122.10±1.95 △ ]]> <![CDATA[824.30±24.81 △△△ ]]> High Uric Acid Prescription No. 1 Group 2 (F-2) 95.08±2.56 <![CDATA[123.32±2.25 △ ]]> <![CDATA[833.24±19.76 △△△ ]]> High Uric Acid Formula I Group 3 (F-3) 93.74±2.99 <![CDATA[118.50±3.40 △△△ ]]> <![CDATA[802.70±27.58 △△△△ ]]> High Uric Acid Formula I Group 4 (F-4) 98.55±3.14 <![CDATA[125.91±1.63 △ ]]> <![CDATA[856.30±34.77 △△ ]]> Allopurinol group (AP) 94.43±3.42 <![CDATA[117.60±2.44 △△△ ]]> <![CDATA[817.90±21.05 △△△ ]]>

[0076] Note: Compared with the blank group: *** P<0.001, **** P<0.0001; compared with the model group: △ P<0.05, △△△ P<0.001, △△△△ P<0.0001.

[0077] (2) Immunohistochemical staining results (F4 / 80)

[0078] like Figure 2 As shown in Table 4, compared with the blank group mice, the expression of F4 / 80 in the kidney of the model group mice was significantly increased, and the administration of high uric acid prescription No. 1 significantly reduced the infiltration of renal macrophages in the hyperuricemia mice.

[0079] Table 4. Statistics of F4 / 80 positive areas in the kidneys of mice in each group

[0080]

[0081]

[0082] Note: Compared with the blank group: *** P<0.001; compared with the model group: △△ P<0.001, △△△ P<0.001.

[0083] 4. Reduce renal fibrosis in mice with high uric acid levels

[0084] (1) Masson staining results

[0085] The results are as follows Figure 3 As shown in Table 5, the collagen deposition in the model group was significantly higher than that in the blank group, while the collagen deposition in each group treated with Hyperuricemia Recipe I was significantly reduced, indicating that this recipe can significantly reduce renal fibrosis in hyperuricemia mice.

[0086] Table 5. Statistics of positive areas in each group

[0087] Group Positive area (%) Blank control group (control) 2.776±0.128 Model group (model) 21.610±1.292**** High Uric Acid Formula I Group 1 (F-1) <![CDATA[5.338±0.352 △△△△ ]]> High Uric Acid Prescription No. 1 Group 2 (F-2) <![CDATA[4.130±0.551 △△△△ ]]> High Uric Acid Formula I Group 3 (F-3) <![CDATA[3.045±0.557 △△△△ ]]> High Uric Acid Formula I Group 4 (F-4) <![CDATA[9.666±0.606 △△ ]]> Allopurinol group (AP) <![CDATA[2.957±0.855 △△△△ ]]>

[0088] Note: Compared with the blank group: **** P<0.0001; compared with the model group: △△△△ P<0.0001.

[0089] (2) Immunohistochemical staining results (Fibronectin)

[0090] like Figure 4 As shown in Table 6, compared with the blank group mice, the expression of Fibronectin (FN) in the kidney of the model group mice was significantly increased. After administration of Hyperuricemia Prescription No. 1, the expression of FN in the kidney of hyperuricemia mice was significantly reduced in a dose-dependent manner, indicating that this prescription can improve renal fibrosis in hyperuricemia mice.

[0091] Table 6. Statistics of FN-positive areas in kidneys of each group

[0092] Group Positive area (%) Blank control group (control) 0.2163±0.0350 Model group (model) 2.6100±0.3946*** High Uric Acid Formula I Group 1 (F-1) <![CDATA[0.9687±0.2075 △△ ]]> High Uric Acid Prescription No. 1 Group 2 (F-2) <![CDATA[0.5127±0.0415 △△△ ]]> High Uric Acid Formula I Group 3 (F-3) <![CDATA[0.4340±0.0282 △△△ ]]> High Uric Acid Formula I Group 4 (F-4) <![CDATA[0.9880±0.0670 △△ ]]> Allopurinol group (AP) <![CDATA[0.3147±0.0448 △△△△ ]]>

[0093] Note: Compared with the blank group: *** P<0.001; compared with the model group: △△ P<0.01, △△△ P<0.001, △△△△ P<0.0001.

[0094] (3) Immunohistochemical staining results (α-SMA)

[0095] like Figure 5 As shown in Table 7, compared with the blank group mice, the expression of α-SMA in the kidney of the model group mice was significantly increased. After administration of Hyperuricemia Prescription I, the expression of α-SMA protein in the kidney of hyperuricemia mice was significantly reduced in a dose-dependent manner, indicating that this prescription can improve renal fibrosis in hyperuricemia mice.

[0096] Table 7. Statistical table of α-SMA positive area in the kidneys of mice in each group

[0097] Group Positive area (%) Blank control group (control) 0.1367±0.0163 Model group (model) 1.5580±0.1340**** High Uric Acid Formula I Group 1 (F-1) <![CDATA[0.6320±0.1496 △△△ ]]> High Uric Acid Prescription No. 1 Group 2 (F-2) <![CDATA[0.6550±0.0881 △△△ ]]> High Uric Acid Formula I Group 3 (F-3) <![CDATA[0.2907±0.0358 △△△△ ]]> High Uric Acid Formula I Group 4 (F-4) <![CDATA[0.8830±0.0488 △△ <!-- 7 -->]]> Allopurinol group (AP) <![CDATA[0.2123±0.0318 △△△△ ]]>

[0098] Note: Compared with the blank group: **** P<0.0001; compared with the model group: △△△ P<0.001, △△△△ P<0.0001.

[0099] 5. Liver function test results

[0100] like Figure 6 As shown in Table 8, the results of liver HE staining showed that although there was no obvious liver lesion among the mice in each group after short-term drug administration, the ALT values ​​of the model group and the positive drug group were significantly higher than those of the blank control group, while there was no significant difference between the high uric acid prescription No. 1 group and the blank group, and there was a downward trend compared with the model and positive drug groups, indicating that this prescription did not cause liver damage.

[0101] Table 8. Statistical table of serum liver function indicators of mice in each group

[0102] Group ALT(U / L) AST(U / L) Blank control group (control) 3.15±0.58 10.47±1.33 Model group (model) <![CDATA[6.31±0.65 * ]]> 16.70±1.58 High Uric Acid Formula I Group 1 (F-1) 4.05±0.78 15.01±1.82 High Uric Acid Prescription No. 1 Group 2 (F-2) 4.67±0.83 14.04±1.54 High Uric Acid Formula I Group 3 (F-3) 3.90±0.77 14.25±1.45 High Uric Acid Formula I Group 4 (F-4) 4.97±0.554 15.72±1.37 Allopurinol group (AP) <![CDATA[6.93±0.60 ** ]]> <![CDATA[17.57±2.12 * ]]>

[0103] Note: Compared with the blank group: * P<0.05, ** P<0.01.

Claims

1. A Chinese medicine composition for treating hyperuricemia, renal damage caused by hyperuricemia, and fibrosis caused by hyperuricemia, characterized in that: The invention is prepared from the following ingredients in parts by weight: 3-12 parts of rhizoma alismatis, 3-12 parts of ginseng, 5-20 parts of polygonatum, 5-20 parts of lotus leaf, 5-20 parts of cirsium japonicum, 6-24 parts of mistletoe, 4-16 parts of phellodendron, 9-36 parts of astragalus and 2-10 parts of notoginseng.

2. The Chinese medicine composition according to claim 1, characterized in that: It is made from the following ingredients in parts by weight: 6 parts of oriental rhizome, 6 parts of ginseng, 10 parts of polygonatum, 10 parts of lotus leaf, 10 parts of cirsium japonicum, 12 parts of mistletoe, 8 parts of phellodendron, 18 parts of astragalus and 5 parts of notoginseng.

3. The method for preparing the Chinese medicine composition according to claim 1 or 2, characterized in that: The steps include: a. Mix loranthus parasiticus, phellodendron chinense and rhizoma alismatis, add 70% ethanol and extract twice, filter the extract each time, combine the filtrate, recover ethanol, and obtain an alcohol extract; b. Mix the medicinal residue treated in step a with ginseng, astragalus, polygonatum, lotus leaf, cirsium japonicum, and Panax notoginseng, extract twice with water, filter the extract after each extraction, and combine the filtrates to obtain an aqueous extract; c. Combine the alcohol extract and the water extract, concentrate, dry and crush.

4. The preparation method according to claim 3, characterized in that: Have one of the following characteristics: A. In step a, ethanol is recovered by using a reduced pressure or normal pressure technique; B. In step a, the mass-to-volume ratio of the material to the liquid (g / mL) is 1:3 to 1:20; C. In step b, the mass-to-volume ratio of the material to the liquid (g / mL) is 1:3 to 1:20; D. In step a, each extraction time is 1 to 3 hours; E. In step b, each extraction time is 1 to 3 hours.

5. The preparation method according to claim 4, characterized in that: Have one of the following characteristics: F. In step a, the mass-to-volume ratio of the feed liquid (g / mL) is 1:8; G. In step b, the mass-to-volume ratio of the feed liquid (g / mL) is 1:6; H. In step a, each extraction time is 1.5 h; I. In step b, each extraction time is 1.5 h.

6. Use of the traditional Chinese medicine composition according to claim 1 or 2 or the traditional Chinese medicine composition prepared by the method according to any one of claims 3 to 5 in the preparation of a medicament for treating or improving hyperuricemia, hyperuricemia-induced renal damage, and hyperuricemia-induced fibrosis.

7. A drug for treating or ameliorating hyperuricemia, hyperuricemia-induced renal damage, and hyperuricemia-induced fibrosis, characterized by: The effective component is the traditional Chinese medicine composition according to claim 1 or 2 or the traditional Chinese medicine composition prepared by the method according to any one of claims 3 to 5.

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