Application of traditional Chinese medicine composition in preparation of uric acid reducing medicine

Abstract

The invention provides a new application of a traditional Chinese medicine composition in preparing a uric acid reducing medicine, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is mainly prepared from polygonum multiflorum, aloe, semen cassiae, ginseng, fructus lycii, colla corii asini, fructus aurantii immaturus and rhizoma atractylodis macrocephalae. Experiments prove that the traditional Chinese medicine composition has an effect of reducing uric acid of a hyperuricemia rat model and can be used for preparing medicines for reducing uric acid and preventing gout, arthritis and pain. Meanwhile, the oral preparation of the traditional Chinese medicine composition is high in safety and small in toxic and side effects, and has the functions of nourishing yin, tonifying qi, purging turbidity and relaxing bowels.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a use of a traditional Chinese medicine composition in preparation of a drug for lowering uric acid. BACKGROUND

[0003] Hyperuricemia is closely related to gout, which is equivalent to "tongbi" and "lizheng" in traditional Chinese medicine. Hyperuricemia is a metabolic abnormality syndrome caused by purine metabolism disorder, and is the main factor inducing gout. Hyperuricemia without gout is called asymptomatic hyperuricemia. There is a disease name "gout" in traditional Chinese medicine, and ancient physicians have discussed it. In Yuan Dynasty, Zhu Danxi's "Gewu Lun" lists gout as a special chapter: "Gout is usually caused by blood being heated and boiling. After that, it may involve water or stand in wet ground... Cold and cool external attack, hot blood gets cold, sweat turbidity condenses and stagnates, so it causes pain, and the pain is more severe at night, and it is related to yang." In Qing Dynasty, Lin Peiqin's "Lizheng Zhicai" said: "Gout is one of the symptoms of tongbi... It is caused by wind, cold and dampness stagnation in yin, and it becomes heat and pain after a long time, and it is more severe at night." Traditional Chinese medicine believes that gout is a syndrome of deficiency in origin and excess in superficiality, and the deficiency of spleen and kidney is the root, and dampness is the superficiality. It is caused by factors such as deficiency of spleen and kidney, improper diet, damage to spleen and stomach, disorder of transportation and transformation, clear yang not rising, and generation of dampness, which is injected into skin and joints and retained in viscera, resulting in the disease.

[0004] Chinese patent CN1748765A discloses a composition with the functions of benefiting qi and nourishing yin, purging turbidity and defecating, and a preparation method, which has obtained production approval and is a product of Shouhui Defecating Capsule. The product is a compound traditional Chinese medicine preparation prepared by extracting and processing eight traditional Chinese medicines of Radix Polygoni Multiflori, Aloe, Cassia Seed, Fructus Lycii, Colla Corii Asini, Radix Ginseng, Rhizoma Atractylodis Macrocephalae, and Fructus Aurantii Immaturus, and can be used for treating functional constipation. The prescription of Shouhui Defecating Capsule is a clinical experience prescription of famous old Chinese medicine doctors. According to the theory of traditional Chinese medicine, the prescription combines clinical experience, and adds blood tonics, dryness tonics, qi tonics and spleen tonics to the products for lubricating intestines, defecating, purging turbidity and detoxifying, so that the drugs for descending turbidity and removing stasis are used, and the drugs for tonifying and purging are used, and the drugs for descending and ascending are used, and the drugs for purging and tonifying are used, and the drugs for quick and slow are used, and the drugs for mutual restriction and mutual use are used, so that the drugs for tonifying without stagnation and the drugs for purging without damaging normal function are used. Thus, the whole prescription acts on the spleen and stomach, and the middle-jiao spleen and stomach restore the normal function of ascending clear and descending turbidity.

[0005] Chinese patent CN111298005A discloses the use of Shouhui Tongbian Capsules for treating enteritis; Chinese patent CN112336799A discloses the use of a traditional Chinese medicine composition, specifically the use of Shouhui Tongbian Capsules for relieving or treating perinatal diseases in women of childbearing age; Chinese patent CN114450021A discloses the use of a traditional Chinese medicine composition, specifically the use of Shouhui Tongbian Capsules for treating edema; Chinese patent CN111228389A discloses the use of a traditional Chinese medicine composition, specifically the use of Shouhui Tongbian Capsules for preparing drugs for preventing and treating abdominal distension; Chinese patent CN113117006A discloses the use of a traditional Chinese medicine composition, specifically the use of Shouhui Capsules in anti-skin aging drugs or cosmetics. Chinese patent CN113995801A discloses the use of Shouhui Tongbian Capsules for alcoholism.

[0006] At present, there is no research or report on the use of Shouhui Tongbian Capsules for reducing uric acid. SUMMARY

[0007] In view of the above problems, the present application provides the use of a traditional Chinese medicine composition for preparing drugs for reducing uric acid, which can be used for any of the purposes of preventing gout, arthritis and pain.

[0008] Preferably, the traditional Chinese medicine composition mainly consists of Radix Polygoni Multiflori, Aloe, Cassia Seed, Ginseng, Fructus Lycii, Colla Corii Asini, Fructus Aurantii, and Rhizoma Atractylodis.

[0009] Preferably, the traditional Chinese medicine composition mainly includes the following components by weight fraction: Radix Polygoni Multiflori 25-400 parts, Aloe 40-400 parts, Cassia Seed 40-250 parts, Ginseng 20-100 parts, Fructus Lycii 30-100 parts, Colla Corii Asini 20-180 parts, Fructus Aurantii 40-280 parts, and Rhizoma Atractylodis 10-80 parts.

[0010] Preferably, the traditional Chinese medicine composition mainly includes the following components by weight fraction: Radix Polygoni Multiflori 40-200 parts, Aloe 50-200 parts, Cassia Seed 60-160 parts, Ginseng 40-80 parts, Fructus Lycii 50-80 parts, Colla Corii Asini 30-150 parts, Fructus Aurantii 60-160 parts, and Rhizoma Atractylodis 30-60 parts.

[0011] Preferably, the pharmaceutical preparation consists of the traditional Chinese medicine composition of any one of claims 1-3 and a pharmaceutically acceptable excipient.

[0012] Preferably, the traditional Chinese medicine composition pharmaceutical preparation is a capsule, a tablet, a granule, a mixture, a pill, a dripping pill, a powder or a decoction.

[0013] Preferably, the traditional Chinese medicine composition preparation is a capsule.

[0014] Preferably, the capsule is prepared from the traditional Chinese medicine composition of any one of claims 1-3 and pharmaceutically acceptable adjuvants in a weight ratio of 1:1.5-8.5; preferably, the traditional Chinese medicine composition and the pharmaceutically acceptable adjuvants are prepared in a weight ratio of 1:2.0-5.5.

[0015] Preferably, the pharmaceutically acceptable adjuvants of the capsule include fillers and binders, the fillers are one or more of mannitol, lactose, sorbitol, sucrose, cyclodextrin; the binders are one or more of 3% PVP in 75% ethanol solution, 3% hydroxypropyl methyl cellulose in 50% ethanol solution, 10% povidone K30 in water solution, 30% starch paste.

[0016] Preferably, the fillers are a mixture of cyclodextrin and sorbitol, and the ratio of cyclodextrin and sorbitol is 1:0.5-1.4 by weight; preferably, the cyclodextrin is hydroxypropyl-β-cyclodextrin.

[0017] Preferably, the preparation method of the traditional Chinese medicine composition drug preparation comprises the following steps:

[0018] (1) grinding and sieving Ejiao and ginseng into fine powder for standby;

[0019] (2) soaking, boiling and filtering Fructus Lycii, Atractylodes and Fructus Aurantii according to the proportion, and concentrating to obtain a concentrated solution;

[0020] (3) removing impurities, washing and drying Radix Polygoni Multiflori, Semen Cassiae and Aloe vera, grinding and sieving to obtain fine powder;

[0021] (4) combining the fine powder obtained in step (1) and the concentrated solution obtained in step (2), mixing uniformly, concentrating into thick paste, adjusting the pH value to 5.5-6.5, drying under reduced pressure, and crushing and sieving to mix with the fine powder of step (3) to obtain a traditional Chinese medicine composition;

[0022] (5) mixing the traditional Chinese medicine composition of step (4) with fillers uniformly, and then mixing with binders to granulate, drying, and loading into capsules to obtain a traditional Chinese medicine composition drug preparation.

[0023] Compared with the prior art, the present application has the following beneficial effects:

[0024] The present application provides a new use of the traditional Chinese medicine composition for reducing uric acid to prevent gout, arthritis and pain, which significantly improves the gait and arthritis index of rats, and the effect is better than that of positive drugs; can reduce the uric acid level of rats with hyperuricemia combined with acute gouty arthritis, thereby achieving a therapeutic effect; can reduce the expression of Bax and cleaved Caspase-3 and increase the expression of Bcl-2, suggesting that the first aloe preparation can reduce cell apoptosis, improve kidney damage and reduce serum uric acid level, and can be used for reducing uric acid to prevent gout. Attached Figure Description

[0025] Figure 1 Effects of Shouhui preparations on serum uric acid in rats with hyperuricemia and acute gouty arthritis (n=20)

[0026] Figure 2 Effects of Shouhui preparations on blood urea nitrogen in rats with hyperuricemia and acute gouty arthritis (n=20)

[0027] Figure 3 Effects of Shouhui preparations on serum creatinine in rats with hyperuricemia and acute gouty arthritis (n=20)

[0028] Figure 4 Effects of Shouhui preparations on Bcl-2 protein in rats with hyperuricemia and acute gouty arthritis (n=20)

[0029] Figure 5 Effects of Shouhui preparations on Bax protein in rats with hyperuricemia and acute gouty arthritis (n=20)

[0030] Figure 6 Effects of Shouhui preparations on cleaved Caspase-3 protein in rats with hyperuricemia and acute gouty arthritis (n=20)

[0031] Figure 7 Effects of Shouhui preparations on Bcl-2, Bax, and cleaved Caspase-3 proteins in rats with hyperuricemia and acute gouty arthritis (n=20) Detailed Implementation

[0032] The following are specific embodiments of the present invention, which further illustrate the technical solutions of the present invention in detail. However, they should not be construed as limiting the scope of the present invention to the following implementation examples. Any modifications or substitutions made based on ordinary technical knowledge and common practices in the art without departing from the above-described technical premises of the present invention are all included within the scope of the present invention.

[0033] I. Preparation of Capsules Based on Traditional Chinese Medicine Compositions

[0034] Example 1

[0035] One embodiment of the capsule formulation of the present invention is shown in Table 1, wherein the raw material composition of the traditional Chinese medicine composition in the capsule formulation of this embodiment is as shown in Table 1.

[0036] The herbal composition of the capsules described in this embodiment is shown in Table 1, and the preparation method is as follows:

[0037] (1) Grind the prescribed amount of donkey-hide gelatin and ginseng into a fine powder through an 80-mesh sieve and set aside;

[0038] (2) Weigh out wolfberry, atractylodes macrocephala, and immature bitter orange according to the ratio, add 12 times the amount of water and soak for 1.5 hours, boil over high heat for 15 minutes, filter to obtain filtrate, and set aside the residue. Add 6 times the amount of water to the residue, boil over high heat and then simmer over low heat for 1.5 hours, filter to obtain filtrate, combine the two filtrates, and concentrate the filtrate to a relative density of 1.10 at 70℃ to obtain concentrated solution;

[0039] (3) Weigh out Polygonum multiflorum, Cassia tora, and Aloe vera according to the proportion, remove impurities, wash, dry, grind and sieve through 60-80 mesh to obtain fine powder;

[0040] (4) Combine the concentrated liquid obtained in step (2) and the fine powder obtained in step (1), mix them evenly, concentrate them into a thick paste, adjust the pH value to 5.5, dry under reduced pressure, pulverize and sieve through a 70-mesh sieve, and mix with the fine powder in step (3) to obtain the traditional Chinese medicine composition.

[0041] (5) Weigh the Chinese herbal composition obtained in step (4), add 1 times its weight of sorbitol and hydroxypropyl-β-cyclodextrin and mix evenly (the weight ratio of sorbitol and hydroxypropyl-β-cyclodextrin is 1:1), then mix with an appropriate amount of 3% hydroxypropyl methylcellulose 50% ethanol solution with a pH of 6.0 to granulate, dry and fill into capsules to obtain capsules.

[0042] Example 2

[0043] The raw material composition of the traditional Chinese medicine composition in the capsule of Example 2 is shown in Table 1. Step (5) in the preparation method is as follows: Weigh the traditional Chinese medicine composition obtained in step (4), add 0.5 times its weight of sorbitol and hydroxypropyl-β-cyclodextrin and mix evenly (the weight ratio of sorbitol and hydroxypropyl-β-cyclodextrin is 0.8:1), then mix with an appropriate amount of 3% hydroxypropyl methylcellulose 50% ethanol solution with a pH of 6.0 and granulate. After drying, fill into capsules to obtain the capsule.

[0044] Example 3

[0045] The raw material composition of the traditional Chinese medicine composition in the capsules described in Example 3 is shown in Table 1, and the preparation method is the same as in Example 1.

[0046] Comparative Examples 1-2

[0047] The components of the traditional Chinese medicine composition in the capsules described in Comparative Examples 1 and 2 are shown in Table 1.

[0048] The preparation method of the capsules described in Comparative Example 1 is the same as that in Example 1, but step (5) in the preparation method is as follows: the traditional Chinese medicine composition obtained in step (4) is mixed evenly with hydroxypropyl-β-cyclodextrin, and then mixed with an appropriate amount of 3% hydroxypropyl methylcellulose 50% ethanol solution with a pH of 6.0 to form granules. After drying, it is filled into capsules to obtain the capsules.

[0049] The preparation method of the capsule of Comparative Example 2 is as follows:

[0050] 1) Take 8 kinds of raw medicinal materials of Radix Polygoni Multiflori, Cassiae Fructus, Aloe, Colla Corii Asini, Lycium Fruit, Atractylodes, Citrus aurantium, and Ginseng, wherein, Radix Polygoni Multiflori, Ginseng, Atractylodes and Citrus aurantium are sliced, Colla Corii Asini is melted, Aloe is crushed, Lycium Fruit and Cassiae Fructus are cleaned and selected, and are ready for use;

[0051] 2) Mix Cassiae Fructus and Aloe, and extract once by refluxing with 6 times of 50% ethanol for 1 hour each time, filter, combine the filtrates, recover ethanol under reduced pressure, and concentrate into extract I for standby, and the residue is standby;

[0052] 3) Extract volatile oil from Atractylodes and Citrus aurantium with 8 times of water, and obtain volatile oil, medicinal liquid and residue for standby;

[0053] 4) Mix Radix Polygoni Multiflori and Ginseng, soak for 1.5 hours with 8 times of water, add the residue of step 2) and the residue of step 3) to decoct for 2 hours, discharge the decocting liquid, decoct again with 9 times of water for 2 hours, discharge the decocting liquid, combine the decocting liquid and the medicinal liquid of step 3), filter, concentrate under reduced pressure to extract with a relative density of 1.2-1.4, add 95% ethanol to make the alcohol content reach 65%, cold settle for 48 hours, filter, recover ethanol under reduced pressure, and concentrate into extract II for standby;

[0054] 5) Combine extract I and extract II, mix uniformly, dry, obtain dry extract, crush the dry extract, add 0.5 kg of Colla Corii Asini melted solution, add the amount of dextrin and 85% ethanol solution according to the formula, mix uniformly, granulate, dry, and integrate the granules, add the volatile oil of step 3), mix uniformly, obtain granules, and fill the granules into capsules to obtain the capsules.

[0055] Table 1: Content of medicinal materials in each group of examples (unit: g)

[0056] Chinese herbal medicine Example 1 Example 2 Example 3 Comparative Example 1 Comparative Example 2 Radix Polygoni Multiflori 40 200 120 30 120 Aloe 50 200 130 40 130 Semen Cassiae 60 160 110 50 110 Radix Ginseng 40 80 65 40 65 Fructus Lycii 50 80 75 10 75 Colla Corii Asini 30 150 90 20 90 Fructus Aurantii Immaturus 60 160 110 50 110 Rhizoma Atractylodis Macrocephalae 30 60 45 20 45

[0057] Verification example:

[0058] (1) Stability test

[0059] Determination of physicochemical indexes of examples 1-3 and comparative examples 1-2 of the application

[0060] The capsules prepared by examples 1-3 and comparative examples 1-2 of the application were tested for dispersion uniformity, disintegration time, water content and long-term detection, and the test results are shown in Table 2.

[0061] The determination method of water content: the water content of the capsule is calculated by drying method.

[0062] The detection method of dispersion uniformity is as follows: 2 capsules of each of the capsules prepared in Examples 1-3 and Comparative Examples 1-2 are placed in 100 mL of water at 20℃±1℃, and shaken for 3 min, and then passed through a No. 2 sieve.

[0063] The detection method of disintegration time is as follows: 6 capsules of each of the capsules prepared in Examples 1-3 and Comparative Examples 1-2 are placed in water at 37℃±1℃, and then detected by using a disintegration tester.

[0064] Long-term detection: after being placed at a temperature of 25℃±2℃ and a relative humidity of 60%±10% for 36 months, the disintegration time and the water content are detected.

[0065] The results of the stability test of each example group in Table 2 are as follows:

[0066]

[0067] As can be seen from Table 2, the capsules of Examples 1-3 have good disintegration effect, and can be disintegrated completely within the specified time (disintegrated completely within 30 min according to the pharmacopoeia), and in particular, each index of Example 3 is better than those of the other examples; the weight parts of the traditional Chinese medicine composition of Comparative Example 1 are not within the scope of the present application, and in the long-term stability test, the disintegration time is significantly prolonged, and the water content is significantly increased; the weight parts of the traditional Chinese medicine composition of Comparative Example 2 are within the scope of the present application, but the preparation method is different from the present application, and the technical effects of the present application cannot be achieved.

[0068] II. Animal experiment

[0069] 1. Materials

[0070] Animals: SD rats, SPF level; number 100, male; body weight 180.0-220.0 g; source: Beijing Vantoll Life Science and Technology Co., Ltd.

[0071] Reagent: allopurinol, Baiyunshan Pharmaceutical General Factory of Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd.

[0072] Potassium oxonate: Jinan Shangsheng Chemical Co., Ltd.

[0073] Sodium urate: Shanghai Maikelin Biochemical Technology Co., Ltd.

[0074] Cleaved Caspase-3 antibody: CST Company, USA.

[0075] Bcl-2 associated X protein (Bax) antibody: Beyotime.

[0076] B lymphocyte lymphoma-2 (Bcl-2) antibody: Abeam, UK.

[0077] 2 Method

[0078] 2.1 Grouping

[0079] After the SD rats were adapted to the feeding for 1 week, they were randomly divided into 5 groups, 20 rats in each group, namely the blank group, the model group, the allopurinol group, the Shouhui preparation-high dose group and the Shouhui preparation-low dose group.

[0080] 2.2 Establishment of hyperuricemia combined with acute gouty arthritis model

[0081] The model group, the allopurinol group, the Shouhui preparation-high dose group and the Shouhui preparation-low dose group were established according to the following method.

[0082] The rats were injected intraperitoneally with 3% potassium oxonate at 1 mL / 100 g, 2 times / day, for 4 weeks. On the 4th day after the modeling began, the rats were anesthetized, and the right ankle joint lateral posterior was selected as the puncture point. The rats were punctured into the joint cavity along the medial side of the Achilles tendon at an angle of 30-40° on the lateral side of the right ankle joint. After feeling the empty feeling, 0.05 mL (25 mg / mL) of uric acid sodium solution was injected into the joint cavity. The opposite side of the joint capsule was swollen as the injection standard to induce the acute gouty arthritis model. After injection, the rats showed lameness, joint swelling and inability to bear weight, which was considered as successful modeling. The blank group was injected with the same volume of 0.9% normal saline at the same site.

[0083] 2.3 Dose and administration

[0084] 2.3.1 Dose

[0085] The recommended dose of Shouhui laxative capsule is 0.7 g. According to the body weight of 60 kg, the equivalent dose is 0.012 g / kg BW. Two dose groups, low and high, were set up, which were 0.12 g / kg BW and 0.24 g / kg BW (equivalent to 10 times and 20 times of the recommended dose for human body) respectively.

[0086] 2.3.2 Administration

[0087] After the initial injection of potassium oxonate, the administration was carried out continuously for 4 weeks. The blank group and the model group were given the same volume of distilled water by gavage. The allopurinol group was given allopurinol at a dose of 20 mg / kg BW by gavage. The Shouhui preparation-high dose group was given 0.24 g / kg by gavage, and the Shouhui preparation-low dose group was given 0.12 g / kg by gavage. The required dose of Shouhui capsule was dissolved and diluted to 2 mL with 2 mL of distilled water, and the rats were given 1 time of gavage per day.

[0088] 2.4 Observation items

[0089] (1) Change of joint swelling degree: Before modeling and 0, 1, 2, 3, 4 weeks after modeling, the length and width of the same part of the right hind ankle joint were measured with a vernier caliper, the circumference was calculated (taking the average value), and the swelling rate was calculated.

[0090] Swelling rate (%) = (ankle circumference after inflammation - ankle circumference before inflammation) / ankle circumference before inflammation x 100%.

[0091] (2) Gait score and arthritis index evaluation of rats

[0092] Gait score: 0 (0 points): normal walking; 1 (1 point): limp, lower limbs slightly bent; 2 (2 points): walking with limp, lower limbs can only touch the ground; 3 (3 points): severe limp and no three-foot walking.

[0093] Arthritis index: 0 (0 points): normal joint, no swelling; 1 (2 points): joint skin redness and swelling with obvious bony landmarks; 2 (4 points): joint skin redness and swelling; 3 (6 points): redness and swelling inside and outside the joint.

[0094] (3) Biochemical indicators: about 2.0 ml of venous blood was collected from rats, and the blood was naturally coagulated at 25℃ for 1 h, then centrifuged at 2500 r / min for 5 min, and the serum was separated to determine the levels of uric acid, urea nitrogen and creatinine.

[0095] (4) Western blotting detection of Bax, Bcl-2 and cleaved Caspase-3 protein expression in kidney tissue: the right kidney tissue of each group of rats was taken, ground thoroughly, and lysed in ice-cold RIPA lysis buffer for 30 min, then centrifuged at 9000 r / min for 10 min, and the supernatant was taken, and the protein concentration was determined with BCA detection kit. The protein sample was subjected to 12% sodium dodecyl sulfate-polyacrylamide gel electrophoresis, transferred to PVDF membrane, 5% skim milk was added, and the membrane was blocked at room temperature for 2 h, the corresponding primary antibody (1:1000) was added, and the membrane was incubated at 4℃ overnight; after washing with purified water, the secondary antibody (1:5000) was added, and the membrane was incubated at room temperature for 2 h, then washed with purified water, and ECL luminescent reagent was added for development. The band was visualized by chemiluminescence imaging system, and the gray value of the band was analyzed by Image J software.

[0096] 2.5 Statistical method

[0097] GraphPad Prism 8 statistical software, the measurement value was represented by mean ± standard deviation, and t test was used for pairwise comparison. P<0.05 indicates that the difference is statistically significant, and P<0.01 indicates that the difference is statistically significant.

[0098] 3 Experimental results

[0099] 3.1 Change of joint swelling degree and synovial membrane

[0100] The results of change of joint swelling degree of rats are shown in Table 3.

[0101] Table 3 Effect of Shoujiao Preparation on joint swelling degree of rats with hyperuricemia combined with acute gouty arthritis (n=20)

[0102]

[0103] Note: Compared with the model group, *P<0.05, **P<0.01; and compared with the allopurinol group, # P<0.05, ## P<0.01.

[0104] The above results show that at 1 week, the joint swelling degree of the allopurinol group and the Shoujiao Preparation-high dose group is significantly lower than that of the model group; at 4 weeks, the joint swelling degree of the allopurinol group and the Shoujiao Preparation-high dose group is significantly lower than that of the model group, the joint swelling degree of the Shoujiao Preparation-low dose group is higher than that of the allopurinol group, and there is no statistical difference between the allopurinol group and the Shoujiao Preparation-high dose group (P>0.05).

[0105] 3.2 Gait score and inflammation index of rats

[0106] The results of gait score and inflammation index of rats are shown in Table 4.

[0107] Table 4 Effect of Shoujiao Preparation on gait score and inflammation index of rats with hyperuricemia combined with acute gouty arthritis (n=20)

[0108]

[0109]

[0110] Note: Compared with the model group, ▲ P<0.05, ▲▲ P<0.01.

[0111] The above results show that the gait score and inflammation index of the Shoujiao Preparation-high dose group, the Shoujiao Preparation-low dose group and the allopurinol group are lower than those of the model group, and there is no statistical difference among the Shoujiao Preparation-high dose group, the Shoujiao Preparation-low dose group and the allopurinol group (P>0.05). That is, it indicates that the Shoujiao Preparation can significantly improve the gait and inflammation index of rats, and the effect is better than that of the positive drug.

[0112] 3.3 Results of biochemical indicators

[0113] The results of biochemical indicators of rats, including blood uric acid, urea nitrogen and serum creatinine, are shown in Table 5.

[0114] Table 5 Influence of Shoujiao preparation on blood uric acid, urea nitrogen and serum creatinine of rats with hyperuricemia combined with acute gouty arthritis (n=20)

[0115] Group Blood uric acid (μmol / L) Urea nitrogen (μmol / L) Blood creatinine (μmol / L) Blank group 173.04±3.27 6.01±0.45 20.11±1.10 Model group 280.55±4.25 8.55±0.77 26.77±2.08 Allopurinol group 179.35 ± 3.79 □□ ]] 6.42 ± 0.46 □□ ]] 22.52 ± 1.88 □□ ]] High-dose group 185.70 ± 3.55 □□ ]] 6.39 ± 0.57 □□ ]] 22.40 ± 1.60 □□ <!-- 7 -->]] Low-dose group 190.37 ± 3.66 □□ ]] 6.71 ± 0.88 □□ ]] 23.01 ± 1.56 □□ ]]

[0116] Note: compared with the model group □ P<0.05, □□ P<0.01; compared with the allopurinol group, ▲ P<0.05, ▲▲ P<0.01.

[0117] The blood uric acid, urea nitrogen and serum creatinine of the Shoujiao preparation-high dose group, the Shoujiao preparation-low dose group and the allopurinol group are lower than those of the model group, and there is no statistical difference between the allopurinol group and the Shoujiao preparation-high dose group and the Shoujiao preparation-low dose group (P>0.05).

[0118] The above results show that the Shoujiao preparation can reduce the uric acid level of rats with hyperuricemia combined with acute gouty arthritis, thereby achieving a therapeutic effect.

[0119] 3.4 Influence on expression of apoptosis-related proteins in kidney tissue

[0120] Table 6 Influence of Shoujiao preparation on expression of apoptosis-related proteins in kidney tissue of rats with hyperuricemia combined with acute gouty arthritis (n=20)

[0121] Group Bcl-2 Bax cleaved Caspase-3 Blank group 1.30±0.07 1.05±0.05 0.45±0.02 Model group 0.65 ± 0.02 ** ]] 1.49 ± 0.05 ** ]] 1.12 ± 0.04 ** ]] Allopurinol group 0.95 ± 0.06 □□ ]] 0.95 ± 0.06 □□ ]] 0.40 ± 0.04 □□ ]] High-dose group 0.89 ± 0.07 □□ ]] 0.75 ± 0.04 □□ ]] 0.30 ± 0.06 □□ ]] Low-dose group 0.85 ± 0.06 □ ]] 1.11 ± 0.08 □ ]] 0.68 ± 0.05 □ ]]

[0122] Note: compared with the blank group * P<0.05, ** P<0.01, compared with the model group □ P<0.05, □□ P<0.01; compared with the allopurinol group, ▲ P<0.05, ▲▲ P<0.01.

[0123] Compared with the blank group, the expression levels of Bax and cleaved Caspase-3 proteins in the kidney tissues of the model group were significantly increased (P<0.01), and the expression level of Bcl-2 protein was significantly decreased (P<0.01); compared with the model group, the expression level of Bcl-2 protein in each administration group was significantly increased (P<0.01), and the expression levels of Bax and cleaved Caspase-3 proteins in the Choujia preparation-high dose group and the allopurinol group were significantly decreased (P<0.01). It is shown that the Choujia preparation can reduce the expression of Bax and cleaved Caspase-3, and increase the expression of Bcl-2, suggesting that the Choujia preparation can improve the kidney damage and reduce the serum uric acid level by reducing the cell apoptosis.

[0124] The above-described embodiments only express several embodiments of the present application, which are described in a more specific and detailed manner, but cannot be understood as a limitation on the scope of the patent right of the present application. It should be noted that, for those skilled in the art, several modifications and improvements can be made without departing from the concept of the present application, which all belong to the protection scope of the present application. Therefore, the protection scope of the patent right of the present application should be subject to the appended claims.

Claims

1. The use of a traditional Chinese medicine composition in the preparation of uric acid-lowering drugs, characterized in that, The traditional Chinese medicine composition mainly consists of Polygonum multiflorum, aloe vera, cassia seed, ginseng, wolfberry, donkey-hide gelatin, immature bitter orange, and Atractylodes macrocephala; the intended use can be any of the following: prevention of gout, arthritis, and pain.

2. The use according to claim 1, characterized in that, The traditional Chinese medicine composition, by weight, mainly comprises the following components: 25-400 parts of Polygonum multiflorum, 40-400 parts of Aloe vera, 40-250 parts of Cassia tora, 20-100 parts of Ginseng, 30-100 parts of Lycium barbarum, 20-180 parts of Colla corii asini, 40-280 parts of Citrus aurantium, and 10-80 parts of Atractylodes macrocephala.

3. The use according to claim 2, characterized in that, The traditional Chinese medicine composition, by weight, mainly includes the following components: 40-200 parts of Polygonum multiflorum, 50-200 parts of Aloe vera, 60-160 parts of Cassia tora, 40-80 parts of Ginseng, 50-80 parts of Lycium barbarum, 30-150 parts of Colla corii asini, 60-160 parts of Citrus aurantium, and 30-60 parts of Atractylodes macrocephala.

4. A traditional Chinese medicine composition pharmaceutical preparation, characterized in that, The pharmaceutical preparation is composed of the traditional Chinese medicine composition according to any one of claims 1 to 3 and pharmaceutically acceptable excipients.

5. The traditional Chinese medicine composition pharmaceutical preparation according to claim 4, characterized in that, The traditional Chinese medicine composition is a pharmaceutical preparation in the form of capsules, tablets, granules, mixtures, pills, drop pills, powders, or granules.

6. The traditional Chinese medicine composition pharmaceutical preparation according to claim 5, characterized in that, The traditional Chinese medicine composition preparation is in the form of capsules.

7. The traditional Chinese medicine composition pharmaceutical preparation according to claim 6, characterized in that, The capsules are prepared by the traditional Chinese medicine composition according to any one of claims 1 to 3 and pharmaceutically acceptable excipients in a weight ratio of 1:1.5 to 8.5; preferably, the traditional Chinese medicine composition and pharmaceutically acceptable excipients are prepared in a weight ratio of 1:2.0 to 5.

5.

8. The traditional Chinese medicine composition pharmaceutical preparation according to claim 7, characterized in that, The pharmaceutically acceptable excipients for the capsules include fillers and binders, wherein the fillers are one or more selected from mannitol, lactose, sorbitol, sucrose, and cyclodextrin; and the binders are one or more selected from 3% PVP in 75% ethanol, 3% hydroxypropyl methylcellulose in 50% ethanol, 10% povidone K30 in aqueous solution, and 30% starch paste.

9. The traditional Chinese medicine composition pharmaceutical preparation according to claim 8, characterized in that, The filler is a mixture of cyclodextrin and sorbitol, with a weight ratio of 1:0.5-1.

4.

10. The traditional Chinese medicine composition pharmaceutical preparation according to claim 9, characterized in that, The cyclodextrin is hydroxypropyl-p-cyclodextrin.

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