A composition for lowering uric acid and improving renal function, and its preparation method, application and product

Abstract

The present invention provides a composition having the effects of lowering uric acid and improving renal function, and its preparation method, application and product, which belong to the field of application of traditional Chinese medicine. The composition is composed of the following components: raw astragalus, smilax glabra, mistletoe, salvia miltiorrhiza and orientalis. The composition provided by the present invention is used in combination with raw astragalus, smilax glabra, mistletoe, salvia miltiorrhiza and orientalis, and the obtained composition can be used to treat hyperuricemia or its related diseases, with significant efficacy and small toxic and side effects. The composition is used for the late treatment of hyperuricemia, treatment of joint pain, and poor flexion and extension. At the same time, the composition has a certain kidney protection effect, which can reduce renal inflammation and fibrosis.

Description

Technical Field

[0001] The present invention belongs to the field of application of traditional Chinese medicine, and relates to a composition having the effects of lowering uric acid and improving kidney function, and specifically relates to a composition having the effects of lowering uric acid and improving kidney function, and a preparation method, application and product thereof. Background Art

[0002] Hyperuricemia (HUA) is a metabolic disease caused by abnormal purine metabolism, excessive uric acid production or excretion disorder.

[0003] Currently, the treatment of HUA is mainly achieved by lowering uric acid levels. Drugs for the treatment of HUA are divided into three categories: xanthine oxidase inhibitors, uricosuric drugs, and urate oxidase. Among them, allopurinol is the first-line treatment for HUA, but due to the shortcomings of these drugs such as liver and kidney damage and the possibility of inducing severe hypersensitivity reactions, the use of uric acid-lowering drugs is subject to certain limitations. Therefore, it is of great clinical value to find a treatment strategy that can safely and effectively regulate uric acid levels and reduce the side effects of drugs.

[0004] Clinically, uric acid-lowering treatment is generally carried out by inhibiting uric acid production drugs such as febuxostat and allopurinol or promoting uric acid excretion drugs such as benzbromarone. However, these drugs have many side effects and precautions when used for a long time. Allopurinol is a xanthine oxidase inhibitor with good uric acid-lowering effect. The most common adverse reaction is rash. Skin allergic reactions can be serious and sometimes even fatal. In addition, patients with liver and kidney damage and the elderly need to take the drug with caution. Blood counts and liver and kidney function need to be tested regularly during medication. Febuxostat is a specific xanthine oxidase inhibitor with good uric acid-lowering effect, especially for patients with chronic renal insufficiency. However, due to its potential cardiovascular risks, it should be used with caution in the elderly with combined cardiovascular and cerebrovascular diseases, and cardiovascular events should be closely monitored. In clinical trials, the incidence of abnormal liver function in the febuxostat group was higher than that in the placebo group and the positive control allopurinol group. Benzbromarone inhibits the renal proximal tubular urate transporter-1 and inhibits the reabsorption of renal tubular uric acid to promote uric acid excretion and achieve the effect of lowering uric acid. However, it is not recommended for patients with increased uric acid synthesis or high risk of kidney stones. During medication, liver function should be closely monitored, and it should be used with caution in patients with chronic liver disease.

[0005] The invention patent with the publication number CN 102309705B discloses a drug for lowering blood uric acid, its preparation method and use. The drug is prepared from the following medicinal materials in weight ratio: 5-15 parts of Tripterygium wilfordii, 10-60 parts of Smilax glabra, 6-30 parts of Viscum album, 9-45 parts of raw Astragalus, 10-30 parts of Salvia miltiorrhiza, 10-60 parts of Coix seed, 9-20 parts of Gentiana macrophylla. The medicinal materials are boiled, concentrated, impurity-removed, dried and other processes to obtain effective parts for lowering blood uric acid. This effective part can be made into different dosage forms accepted clinically according to the routine. The invented drug can be used in drugs for lowering blood uric acid, lowering blood lipids and protecting liver and kidney. Among them, Gentiana macrophylla extract has certain toxicity, and the dosage needs to be controlled according to the actual situation when used clinically. Tripterygium wilfordii resources are not easy to obtain, and the ability of the drug to lower blood uric acid needs to be further improved.

[0006] Therefore, actively seeking safe, inexpensive and effective uric acid-lowering drugs has important clinical and public health significance. Summary of the invention

[0007] The present invention aims at the problems existing in the prior art and provides a composition for lowering uric acid and improving renal function and its preparation method, application and product. The present invention adopts raw astragalus, smilax glabra, mistletoe, salvia miltiorrhiza and orientalis to use in combination, and the obtained composition can be used to treat hyperuricemia or its related diseases, has significant efficacy, small toxic and side effects, has a certain kidney protection effect, and can reduce kidney inflammation and fibrosis.

[0008] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0009] In a first aspect, the present invention provides a composition for lowering uric acid and improving renal function, which is composed of the following components: raw astragalus, smilax glabra, red mulberry, salvia miltiorrhiza and orientalis.

[0010] The weight proportions of the components in the composition are: 5-45 parts of raw astragalus, 10-90 parts of smilax glabra, 9-45 parts of mistletoe, 5-45 parts of salvia miltiorrhiza, and 5-30 parts of oriental rhizome.

[0011] Preferably, the weight proportions of the components in the composition are: 15 parts of raw astragalus, 10-90 parts of smilax glabra, 9-45 parts of mistletoe, 5-45 parts of salvia miltiorrhiza, and 5-30 parts of oriental rhizome.

[0012] More preferably, the weight proportions of the components in the composition are: 15 parts of raw astragalus, 30 parts of smilax glabra, 15 parts of mistletoe, 15 parts of salvia miltiorrhiza, and 10 parts of oriental alisma.

[0013] In the composition provided by the present invention, raw astragalus is used as the main ingredient to strengthen the spleen, mistletoe is used as the auxiliary ingredient to nourish the kidney, smilax glabra is used to dissipate dampness, oriental water chestnut is used to dissipate turbidity, and salvia miltiorrhiza is used to dissipate blood stasis. The composition is used for joint pain and difficulty in flexion and extension in the late stage of hyperuricemia.

[0014] The composition provided by the present invention has the following differences compared with the solution of the prior art (publication number CN102309705B):

[0015] 1) Coix seeds are replaced by Alisma orientalis: Both have significant effects in promoting water and eliminating dampness, but coix seeds focus on strengthening the spleen, while Alisma orientalis focuses on clearing turbidity. Traditional Chinese medicine believes that hyperuricemia is mostly caused by insufficient congenital endowment, kidney deficiency, six exogenous pathogens, careless regulation, excessive appetite, excessive consumption of rich and greasy food, damage to the spleen and stomach, inability to digest food, endogenous dampness, accumulation of dampness and turbidity over time, causing blood stasis and toxicity. Dampness and heat are important initiating factors of this disease. Dampness and heat, phlegm and blood stasis are intertwined, aggravating each other, and are mutually causal, leading to repeated attacks of gout, which is difficult to cure. The existing technology focuses on the early stage of hyperuricemia to prevent the development of gout, and the treatment is mainly based on regulating the spleen, which is in line with the idea of ​​prevention before illness in traditional Chinese medicine. The composition of the present invention focuses on the late stage of hyperuricemia, and the treatment is mainly based on removing dampness, removing blood stasis, and clearing turbidity to relieve the improvement of gout symptoms.

[0016] 2) Removal of Trillium gracile: Trillium gracile raw materials have no industrial base and are expensive in the market. After Trillium gracile is removed from the composition of the present invention, the therapeutic effect is better, and its economic value can be better realized under the premise of ensuring the efficacy.

[0017] 3) Remove Gentiana macrophylla: Toxicological studies have shown that Gentiana macrophylla extract has a certain toxicity, with a median lethal dose (LD50) of 50 ) is in the range of 17.6-19.8 g crude drug / kg. Therefore, the dosage should be controlled according to the actual situation during clinical use, and overdose should not be taken to avoid the occurrence of poisoning. After removing Gentiana macrophylla from the composition of the present invention, it is safer than the prior art.

[0018] Therefore, compared with the prescription of the prior art, although the prescription of the patent of the present invention has four identical drugs, their applicable populations and action characteristics are quite different.

[0019] The composition provided by the present invention is used for the late-stage treatment of hyperuricemia, and has significant efficacy, good safety, and no adverse reactions.

[0020] In a second aspect, the present invention also provides a method for preparing the composition of the above technical solution, comprising the following steps:

[0021] The raw astragalus, smilax glabra, red mulberry, salvia miltiorrhiza and orientalis are decocted in water to obtain a decoction; the decoction is concentrated to obtain a composition.

[0022] Specifically, raw astragalus, smilax glabra, mistletoe, salvia miltiorrhiza and orientalis are decocted in water to obtain a decoction; the number of decoctions is 1-3 times, preferably 2 times; the time of each decoction is 1-3 hours, preferably 1.5 hours; and then the decoction is concentrated to obtain a composition.

[0023] Preferably, before the raw astragalus, smilax glabra, mistletoe, salvia miltiorrhiza and orientalis are decocted in water, the process further comprises: soaking the raw astragalus, smilax glabra, mistletoe, salvia miltiorrhiza and orientalis in water. In one embodiment, firstly, the raw astragalus, smilax glabra, mistletoe, salvia miltiorrhiza and orientalis are soaked in water for 1-3 hours, preferably 1 hour, and then decocted in water to obtain a decoction; the number of decoctions is 1-3 times, preferably 2 times; the time of each decoction is 1-3 hours, preferably 1.5 hours; then the decoction is concentrated, and the density of the concentrated decoction is 1.1-1.3 (60°C) to obtain a composition.

[0024] In a third aspect, the present invention also provides the use of the composition described in the above technical scheme or the composition prepared by the preparation method described in the above technical scheme in the preparation of drugs for treating hyperuricemia and / or its related diseases.

[0025] Among them, hyperuricemia-related diseases include chronic kidney disease.

[0026] In a fourth aspect, the present invention further provides a medicine, comprising: the composition described in the above technical solution or the composition prepared by the preparation method described in the above technical solution, and a pharmaceutically acceptable carrier.

[0027] The pharmaceutically acceptable carrier is a carrier commonly used in the art, and is used together with the composition to form a clinically acceptable oral preparation, which is not limited here and includes but is not limited to sucralose and dextrin.

[0028] The dosage form of the drug can be any oral dosage form, such as tablets, capsules, powders, granules, oral liquids or pills.

[0029] Compared with the prior art, the present invention has the following beneficial effects:

[0030] In the composition provided by the present invention, raw astragalus is used as the monarch to strengthen the spleen, parasitic loranthus is used as the minister to tonify the kidney, smilax glabra eliminates dampness, oriental water chestnuts eliminate turbidity, and salvia miltiorrhiza removes blood stasis as the assistant, and the obtained composition can be used for treating hyperuricemia or its related diseases, with significant efficacy and small toxic and side effects. The composition is used for the later treatment of hyperuricemia, treating joint pain, and flexion and extension are unfavorable. At the same time, the composition has a certain kidney protection effect, and can reduce renal inflammation and fibrosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 The figure shows the changes of serum uric acid in each group of mice; among them, the model control group was compared with the normal group. # P <0.05, ## P <0.01; compared with the model control group, * P <0.05, **P <0.01; compared with the control group 2, Λ P <0.05; ΛΛ P <0.01; Compared with the control group 3, ▲ P <0.05; ▲▲ P <0.01;

[0032] Figure 2 Figure 2 is the thickness and pain threshold of the soles of mice in each group; A is the thickness of the soles of mice in each group; B is the pain threshold of mice in each group; Compared with the normal group, the model control group # P <0.05, ## P <0.01; compared with the model control group, * P <0.05, ** P <0.01;

[0033] Figure 3 The figure shows the renal pathology scores of mice in each group. Compared with the normal group, the model control group ## P <0.01. DETAILED DESCRIPTION

[0034] It is worth noting that, unless otherwise specified, the raw materials used in the present invention are all common commercially available products, and their sources are not specifically limited.

[0035] Example 1

[0036] Preparation method of the composition:

[0037] Take 15 parts of raw astragalus, 30 parts of wild yam, 15 parts of mistletoe, 15 parts of salvia miltiorrhiza and 10 parts of oriental arisaema, add water and boil twice, soak for 1 hour before the first boiling, boil for 1.5 hours for the first boiling and 1.5 hours for the second boiling, filter, collect the filtrate, and concentrate the filtrate to a clear paste with a relative density of 1.1-1.3 (60°C) to obtain a composition.

[0038] Example 2

[0039] Preparation method of the composition:

[0040] Take 15 parts of raw astragalus, 10 parts of wild yam, 9 parts of mistletoe, 5 parts of salvia miltiorrhiza and 5 parts of oriental arisaema, add water and boil twice, soak for 1 hour before the first boiling, boil for 1.5 hours for the first boiling and 1.5 hours for the second boiling, filter, collect the filtrate, and concentrate the filtrate to a clear paste with a relative density of 1.1-1.3 (60°C) to obtain a composition.

[0041] Example 3

[0042] Preparation method of the composition:

[0043] Take 15 parts of raw astragalus, 90 parts of wild yam, 45 parts of mistletoe, 45 parts of salvia miltiorrhiza and 30 parts of oriental arisaema, add water and boil twice, soak for 1 hour before the first boiling, boil for 1.5 hours for the first boiling and 1.5 hours for the second boiling, filter, collect the filtrate, and concentrate the filtrate to a clear paste with a relative density of 1.1-1.3 (60°C) to obtain a composition.

[0044] Comparative Example 1

[0045] The difference from Example 1 is that the formula consists of 5 parts of Rhizoma Cibotii, 30 parts of Rhizoma Smilacis Glabrae, 15 parts of Herba Viscume, 15 parts of Radix Astragali, 15 parts of Radix Salviae Miltiorrhizae, 10 parts of Rhizoma Alismatis and 10 parts of Radix Gentianae Macrophyllae, and the composition is prepared according to the method of Example 1.

[0046] Comparative Example 2

[0047] The difference from Example 1 is that the formula consists of 30 parts of Smilax glabra, 15 parts of Viscum album, 15 parts of raw Astragalus, 15 parts of Salvia miltiorrhiza, and 10 parts of Coix seeds, and the composition is prepared according to the method of Example 1.

[0048] Comparative Example 3

[0049] The difference from Example 1 is that the formula consists of 30 parts of Smilax glabra, 15 parts of Viscum album, 15 parts of raw Astragalus membranaceus, and 15 parts of Salvia miltiorrhiza, and the composition is prepared according to the method of Example 1.

[0050] Test Example 1

[0051] Safety test: Acute toxicity of single administration of the composition to SD rats

[0052] 1. Experimental Animals

[0053] SD rats, grade: SPF grade; gender: half male and half female; age: 6-7 weeks; manufacturer: Zhejiang Weitonglihua Experimental Animal Technology Co., Ltd. Production license number: SCXK (Zhejiang) 2019-0001.

[0054] 2. Grouping and Dosing

[0055] After adaptive feeding, SD rats were divided into 6 groups, 10 rats in each group, half male and half female, respectively, including solvent control group, high-dose group of Example 1 (112g crude drug / kg / d), low-dose group of Example 1 (56g crude drug / kg / d), Example 2 group (112g crude drug / kg / d), Example 3 group (112g crude drug / kg / d) and comparative example 1 group (112g crude drug / kg / d). The rats in each group of drug administration group were given dry paste powder of corresponding concentration by oral gavage at a dosage volume of 40 mL / kg, and the rats in the solvent control group were given sterile water for injection of the same volume by oral gavage. The drug was administered twice at an interval of 6 hours within 24 hours, and the drug was observed for 14 days after administration. The day of administration was defined as the first day of the experiment.

[0056] 3. Observation indicators

[0057] During the experiment, the general condition of rats in each group was observed every day. The mortality rate of rats in each group was observed during the experiment.

[0058] 4. Experimental results

[0059] The results are shown in Table 1. The results showed that 2 days after administration, no death or dying was observed in the rats in the vehicle control group, the low-dose group of Example 1, the high-dose group of Example 1, and the rats in the Example 2-3 groups, and all the rats in the comparative example 1 group died. Before the death of the above rats, the main symptoms were hypoactivity, prone, arched back, erect hair, deep and large breathing, perianal dirt, drooling, etc. Gross anatomical observation did not find abnormal changes that could cause the death of the animals. Combined with the general condition, it is speculated that respiratory depression may be one of the causes of the death of the animals. After 14 days of administration, the rats in the vehicle control group, the low-dose group of Example 1, the high-dose group of Example 1, and the Example 2-3 groups still did not die or die, and no abnormal reactions were observed, and no abnormal changes were observed in gross anatomical observation.

[0060] The above results show that under the conditions of this experiment, a single oral gavage of the composition of Examples 1-3 to SD rats is safer than gavage of a high-dose composition of Comparative Example 1 to SD rats.

[0061] Table 1 Mortality of rats in each group

[0062]

[0063] Test Example 2

[0064] 1. Experimental methods

[0065] 1.1 Experimental animals

[0066] Uox-KO mice, grade: SPF grade; gender: male; age: 7-8 weeks; production unit: Jiangsu Jicui Pharmaceutical Biotechnology Co., Ltd., production license number is SCXK (Su) 2023-0009.

[0067] This study used Uox knockout (Uox-KO) mice, in which uricase synthesis was blocked and a hyperuricemia phenotype spontaneously developed.

[0068] C57BL / 6 (wild type) mice, grade: SPF grade; gender: male; age: 7-8 weeks; production unit: Jiangsu Jicui Pharmaceutical Biotechnology Co., Ltd., production license number is SCXK (Su) 2023-0009.

[0069] 1.2 Modeling and drug administration

[0070] After the mice were adapted to feeding for one week, 100 μL of blood was collected from the saphenous vein, and plasma was separated for the detection of serum uric acid (S-UA). According to S-UA and glomerular filtration rate, the mice were randomly divided into model control group, allopurinol group (40 mg / kg / d), low-dose group of Example 1 composition (3.5 g crude drug / kg / d, Chinese medicine group 1-1), high-dose group of Example 1 composition (7.1 g crude drug / kg / d, Chinese medicine group 1-2), high-dose group of Example 2-3 composition (7.1 g crude drug / kg / d, Chinese medicine group 2-3), high-dose of comparative example 2-3 (7.1 g crude drug / kg / d, comparative example 2-3), with 5 mice in each group. Each group was given the corresponding drug or pure water daily for 6 consecutive weeks. Five male C57BL / 6 (wild type) mice of the same age were taken as normal controls.

[0071] 1.3 Detection indicators

[0072] 1.3.1 General observation indicators

[0073] Random body weights were taken every morning, and the general conditions and mortality of the animals were observed and recorded during the experiment.

[0074] 1.3.2 Blood biochemical test

[0075] During the administration period, 100 μL of blood was collected from the saphenous vein of the mice after they fasted for 10 h every 2 weeks to detect the serum uric acid level in the mice.

[0076] At the end of administration (6 weeks), the levels of serum creatinine (CREA) and urea nitrogen (BUN) in mice were detected.

[0077] 1.3.3 Mouse paw thickness and pain threshold detection

[0078] At 6 weeks of drug administration, the thickness of the mouse hind paw was measured using a vernier caliper, and the pain threshold of the mouse was tested using a VonFrey fiber kit.

[0079] Method for testing the thickness and pain threshold of the mouse paw: Place the mouse in a transparent plastic box on an elevated wire mesh and cover it with a transparent plexiglass cover. Allow the mouse to adapt for about 20 minutes. After it is completely quiet (stop grooming and exploring), use vonFrey fibers to stimulate the middle part of the sole of the mouse's hind limb until the vonFrey fibers bend into an S shape. Then continue to stimulate for 5 seconds and observe whether the mouse has a paw retraction reaction. If the mouse has a paw retraction or paw licking reaction during the stimulation period, it is recorded as a positive reaction (recorded as X). If the paw retraction or paw licking reaction does not occur, it is recorded as a negative reaction (recorded as O). The measurement starts with 0.4g. If the vonFrey fiber stimulation of this strength does not cause a positive reaction, the fiber stimulation of the next higher strength is used; when a positive reaction occurs, the fiber stimulation of the next lower strength is given, and the detection is carried out continuously according to this method. The "O" before the first appearance of "X" is used as the starting point, and the results of the 6 consecutive tests at this starting point are used as the key sequence for calculating 50% PWT. The calculation formula is 50% PWT(g)=10^(xf+k*8-4). Here it is about 0.231, Xf is the logarithmic value of the last von Frey filament in the sequence, and k is obtained by looking up the table based on the "X" and "O" sequences obtained by detection.

[0080] 1.3.4 Gross and pathological observation of renal tissue

[0081] After 6 weeks of administration, the kidneys of mice were observed and weighed, and HE staining was performed to observe the condition and extent of renal lesions. The renal pathology scoring items and standards are as follows:

[0082] The items of renal tissue pathology evaluation include: 1) glomerular injury; 2) tubular dilatation; 3) tubular atrophy; 4) tubular epithelial injury (degeneration, necrosis); 5) interstitial inflammatory cell infiltration; 6) interstitial fibrosis. No lesions in each item are scored as 0 points, lesions less than 15% are scored as 1 point, 16-30% are scored as 2 points, 31-50% are scored as 3 points, and more than 50% are scored as 4 points. The maximum cumulative score of renal lesions is 24 points.

[0083] Data processing

[0084] SPSS 19.0 software was used for statistical analysis, and all data were expressed as mean standard deviation ( ) indicated that the measurement data were evaluated by ANOVA analysis of variance, and the two groups were compared using LSD test, with P < 0.05 indicating statistical significance.

[0085] 2. Experimental results

[0086] 2.1 Body weight changes of mice in each group

[0087] Compared with the normal control group, the body weight of mice in the model control group was significantly reduced at 0w, 1w, 2w, and 3w of administration ( # P <0.05, ## P <0.01); compared with the model control group, there was no significant difference in the body weight of mice in each drug-treated group. The changes in body weight of mice in each group are shown in Table 2.

[0088] Table 2 Changes in body weight of mice in each group

[0089]

[0090] Note: Compared with the normal group, the model control group # P <0.05; ## P <0.01. Compared with the model control group, * P <0.05; ** P <0.01.

[0091] 2.2 Changes of serum uric acid in each group of mice

[0092] The results are shown in Table 3 and Figure 1 Compared with the normal control group, the serum uric acid levels of mice in the model control group were significantly increased at 0w, 2w, 4w, and 6w of administration ( ## P <0.01).

[0093] Compared with the model control group, the serum uric acid levels of mice in the allopurinol group and the Chinese medicine 1-2 group were significantly reduced at 2 weeks of administration (*P<0.05); at 4 weeks and 6 weeks of administration, the serum uric acid levels of mice in the Chinese medicine 1-1 group, Chinese medicine 1-2 group, Chinese medicine 2 group, Chinese medicine 3 group, comparative example 2 group and comparative example 3 group were significantly reduced ( * P <0.05; ** P <0.01).

[0094] Compared with the control group 2, the uric acid level of mice in the Chinese medicine group 1-2 was significantly reduced after 4 and 6 weeks of administration ( Λ P <0.05).

[0095] Compared with the control group 3, the uric acid level of mice in the Chinese medicine group 1-2 was significantly reduced at 4 and 6 weeks of administration ( ▲ P <0.05).

[0096] Table 3 Changes of serum uric acid in each group of mice

[0097]

[0098] Note: Compared with the normal group, the model control group # P <0.05; ## P <0.01. Compared with the model control group, * P <0.05; ** P <0.01. Compared with the control group 2, Λ P <0.05; ΛΛ P <0.01. Compared with the control group 3, ▲ P <0.05; ▲▲ P <0.01.

[0099] 2.3 Changes of serum creatinine and urea nitrogen in each group of mice

[0100] The results are shown in Table 4. At 6 weeks of administration, the serum BUN and CREA levels in the model control group were significantly increased compared with the normal control group ( ## P <0.01); compared with the model control group, the serum CREA and BUN of the TCM 1-2 group, TCM 1-2 group, TCM 2 group, TCM 3 group, comparative example 2 group and comparative example 3 group showed a downward trend, among which the serum CREA of the TCM 1-2 group decreased significantly.

[0101] Table 4 Changes of serum BUN and CREA in each group of mice

[0102]

[0103] Note: Compared with the normal group, the model control group # P <0.05; ## P <0.01. Compared with the model control group, * P <0.05; ** P <0.01. ND: Not detected.

[0104] 2.4 Paw thickness and pain threshold of mice in each group

[0105] The results are as follows Figure 2 As shown, Figure 2 The results showed that compared with the normal control group, the thickness of the paws of the mice in the model control group increased significantly at the end of the drug administration week ( ## P<0.01, the pain threshold decreased significantly ( ## P <0.01). Compared with the model control group, the thickness of the soles of mice in the Chinese medicine 1-1 group, Chinese medicine 1-2 group, Chinese medicine 2 group, comparative example 2 group, and comparative example 3 group decreased significantly ( * P <0.05, ** P <0.01); the pain threshold of mice in the allopurinol group, Chinese medicine group 1-2, Chinese medicine group 2, comparative example group 2, and comparative example group 3 increased significantly ( * P <0.05).

[0106] 2.5 Results of routine HE pathological observation of kidneys in each group of mice

[0107] The renal pathological conditions of mice in each group were observed, and the renal injury scores of mice in each group were shown in Figure 3 The results are as follows:

[0108] Normal control group: After 6 weeks of administration, the structures of the cortex and medulla of the kidney tissue were clear, the volume of the glomerulus did not increase or decrease significantly, and one animal had mild hyperplasia of the mesangial matrix. There was no atrophy of the renal tubules in various parts, and no expansion of the tubular lumen. A small amount of mild epithelial edema was observed in two animals, and the rest had no degeneration or necrosis. There was no obvious inflammatory cell infiltration in the interstitium and no fibrous tissue hyperplasia.

[0109] Model control group: After 6 weeks of administration, the renal tissue structure was disordered, the cortical glomeruli were atrophied and decreased in number, the glomerular capsule was edematous, the mesangial matrix was hyperplastic, a large number of renal tubular lumens were severely dilated, and many renal tubular epithelial vacuolar and granular degenerations were observed. A small amount of epithelial necrosis and shedding were observed, and shedding epithelial cells were observed in the lumen. The brush border was missing, a small amount of vascular hyalinization was observed, and a large number of inflammatory cells infiltrated locally in the renal interstitium, accompanied by a small amount of bleeding, mild edema and a large number of fibrous cords.

[0110] Allopurinol group: After 6 weeks of administration, the renal tissue structure was disordered, the cortical glomeruli were atrophied and decreased in number, the glomerular capsule was edematous, the mesangial matrix was hyperplastic, a large number of renal tubular lumens were severely dilated, and many renal tubular epithelial vacuolar and granular degenerations were observed. A small amount of epithelial necrosis and shedding were observed, and shedding epithelial cells were observed in the tubular lumen. The brush border was missing, a small amount of vascular hyalinization was observed, and a large number of inflammatory cells infiltrated locally in the renal interstitium, accompanied by a small amount of bleeding, mild edema and the formation of a large number of fibrous cords.

[0111] Chinese medicine groups (Chinese medicine 1-1 group, Chinese medicine 1-2 group, Chinese medicine 2 group, Chinese medicine 3 group, comparative example 2 group and comparative example 3 group): after 6 weeks of administration, the renal tissue structure was disordered, the cortical glomeruli were atrophied and decreased in number, the glomerular capsule was edematous, the mesangial matrix was hyperplastic, a large number of renal tubular lumens were severely dilated, more renal tubular epithelial vacuolar and granular degeneration were seen, a small amount of epithelial necrosis and shedding were seen, shedding epithelial cells were seen in the tubular lumen, the brush border was missing, a small amount of vascular hyalinization was seen, and more inflammatory cell infiltration was seen in the local renal interstitium, accompanied by a small amount of bleeding, mild edema and the formation of more fibrous cords.

[0112] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A composition for lowering uric acid and improving renal function, characterized in that: It is composed of the following ingredients: raw astragalus, smilax glabra, mistletoe, salvia miltiorrhiza and orientalis; The weight proportions of the components are: 15 parts of raw astragalus, 10-90 parts of smilax glabra, 9-45 parts of mistletoe, 5-45 parts of salvia miltiorrhiza, and 5-30 parts of oriental rhizome.

2. The composition according to claim 1, characterized in that The weight proportions of the components in the composition are: 15 parts of raw astragalus, 30 parts of smilax glabra, 15 parts of mistletoe, 15 parts of salvia miltiorrhiza, and 10 parts of oriental rhizome.

3. A method for preparing the composition according to any one of claims 1 to 2, characterized in that: The following steps are involved: The raw astragalus, smilax glabra, red mulberry, salvia miltiorrhiza and orientalis are decocted in water to obtain a decoction; the decoction is concentrated to obtain a composition.

4. The preparation method according to claim 3, characterized in that: The water decoction is performed 1-3 times; and the water decoction time each time is 1-3 hours.

5. Use of the composition according to any one of claims 1 to 2 or the composition prepared by the preparation method according to claim 3 or 4 in the preparation of a medicament for treating hyperuricemia and / or its related diseases, wherein the hyperuricemia-related disease is chronic kidney disease.

6. A drug, characterized in that include: The composition according to any one of claims 1 to 2 or the composition prepared by the preparation method according to claim 3 or 4, and a pharmaceutically acceptable carrier.

7. The drug according to claim 6, characterized in that: The drug is available in the form of tablets, capsules, powders, granules, oral liquids or pills.

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