Traditional Chinese medicine composition for preventing and treating hyperuricemia and gout and application

Abstract

The invention belongs to the technical field of traditional Chinese medicine compounds, and particularly relates to a traditional Chinese medicine composition for preventing and treating hyperuricemia and gout and application thereof, and the traditional Chinese medicine composition is prepared from the following components in parts by weight: 1-18 parts of broadleaf holly leaf and 1-12 parts of galangal. The raw materials used in the traditional Chinese medicine composition are all traditional Chinese medicines with homology of medicine and food, the traditional Chinese medicine composition is simple in component and high in safety, can be sufficiently taken for a long time and does not generate adverse effects, the traditional Chinese medicine composition can be prepared into a medicinal preparation or food by adopting a conventional preparation method, and pharmacological research shows that the traditional Chinese medicine composition has a remarkable effect of preventing and treating hyperuricemia. In view of a huge number of people suffering from metabolic disorder related diseases caused by hyperuricemia and uric acid rise, the traditional Chinese medicine composition provided by the invention can be prepared into related compound preparations or foods, and the traditional Chinese medicine composition provided by the invention has a good application prospect.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine compound prescriptions, and in particular, relates to a traditional Chinese medicine composition for preventing and treating hyperuricemia and gout and an application thereof. Background Art

[0002] Hyperuricemia (HUA) is a common metabolic disease caused by excessive production and / or reduced excretion of uric acid. Studies have shown that HUA is a key factor in causing gout, renal insufficiency, hypertension, hyperlipidemia, diabetes, and obesity. Therefore, early prevention and treatment of hyperuricemia is of great significance for the prevention of such diseases.

[0003] When the serum uric acid (SUA) level exceeds the saturation concentration (420 μmol / L) for a long time, sodium urate (MSU) crystals may be deposited in parts of the body (such as joints and soft tissues), causing chronic damage and inflammatory reactions in the soft tissues around the joints, thereby inducing acute arthritis, which is one of the key factors causing gout (Gout). Lowering the serum uric acid level and preventing and treating hyperuricemia are controls aimed at the cause of gout, and have become an effective means of preventing and treating gout.

[0004] Reducing uric acid production and promoting uric acid excretion are two effective strategies for preventing and treating hyperuricemia and gout. For patients with poor uric acid excretion, uricosuric drugs such as benzbromarone and lecithin can be used to promote uric acid excretion; for patients with excessive uric acid production, xanthine oxidase (XOD) inhibitors such as allopurinol and febuxostat can be used to inhibit uric acid production. However, since the prevention and treatment of hyperuricemia or gout requires long-term use of uric acid-lowering drugs, the side effects of existing drugs limit their widespread and long-term use. Long-term use of the above-mentioned chemical drugs may cause hyponatremia, hypokalemia, and hypocalcemia, and also have obvious side effects on the liver and kidneys. Therefore, it is necessary to find a safer and more effective drug to prevent and treat hyperuricemia and gout. On the other hand, the cause of hyperuricemia is often not single. There may be both excessive uric acid production and insufficient uric acid excretion. Drugs with a single mechanism of action cannot achieve the desired preventive and therapeutic effects for quite a few patients. The use of drugs that have both uricosuric and XOD inhibitory effects can often significantly reduce blood uric acid levels, and are more effective when the target blood uric acid level cannot be achieved by using uricosuric drugs and XOD inhibitors alone, or when the tolerance to high doses of a single drug is poor. Therefore, the development of uric acid-lowering drugs with low toxicity and side effects, which can be used for a long time and have both uricosuric and XOD inhibitory effects, has become an important research and development direction for hyperuricemia prevention and treatment drugs.

[0005] Traditional Chinese medicines that are both edible and medicinal have clear safety and are suitable for long-term use. They are a natural treasure trove for discovering long-term drugs for the prevention and treatment of hyperuricemia and gout. Studies have shown that many traditional Chinese medicines that are both edible and medicinal play a significant role in the prevention and treatment of hyperuricemia and gout, and have been widely used in clinical practice.

[0006] Discovering multi-mechanism compound prescriptions for the prevention and treatment of hyperuricemia from traditional Chinese medicines that are both medicinal and edible has become an important strategy for the prevention and treatment of hyperuricemia and gout.

[0007] Most of the existing invention patents have complex formulas, and most of them have no verification of the necessity and rationality of the formula. For example, the Chinese patent with application number CN201711288895.3 discloses a Chinese medicine composition for preventing and treating hyperuricemia and its preparation method, which is composed of 2-7 parts of coix seeds, 1-6 parts of papaya, 1-5 parts of honeysuckle, 1-5 parts of lily, 1-5 parts of bamboo leaves, 1-4 parts of mulberry leaves and 1-5 parts of kudingcha. The patent verifies the effectiveness of the Chinese medicine composition through efficacy tests and clinical trials, but the rationality and necessity of the formula are not explained. A Chinese patent with application number CN201910757765.2 discloses a Chinese medicine composition for preventing and treating gout caused by high uric acid, its preparation and preparation method. The composition is composed of eight medicinal and edible medicinal materials, namely, Ilex grandiflora, Plantago seed, Herba Cynoglossi, Alpinia officinalis, Coix lachryma-jobi, Poria cocos, Tangerine peel and Licorice. However, in fact, Plantago seed and Herba Cynoglossi are not Chinese medicines with medicinal and edible properties listed in the catalogue of the National Health Commission, and there is insufficient evidence for their safety. Moreover, the patent is mainly used to prevent and treat gouty inflammation caused by high uric acid, and no evidence of the uric acid-lowering effect is provided. Summary of the invention

[0008] To solve the above problems, the purpose of the present invention is to provide a Chinese medicine compound for preventing and treating hyperuricemia or gout, specifically a Chinese medicine compound for preventing and treating hyperuricemia and gout as the main manifestations.

[0009] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0010] The first aspect of the present invention provides a traditional Chinese medicine compound for preventing and treating hyperuricemia or gout, which is prepared from the following components in parts by weight: 1-18 parts of Kudingcha and 1-15 parts of Alpinia officinalis.

[0011] More preferably, the Chinese medicine complex for preventing and treating hyperuricemia or gout is made of the following components in parts by weight: 5-15 parts of Kudingcha and 4-12 parts of Alpinia officinalis.

[0012] Most preferably, the Chinese medicine complex for preventing and treating hyperuricemia or gout is made of the following components in parts by weight: 12 parts of Kudingcha and 9 parts of Alpinia officinalis.

[0013] The traditional Chinese medicine complex of the invention is used for preparing a method for preventing or treating hyperuricemia and gout with hyperuricemia as the main symptom.

[0014] The second aspect of the present invention provides an application of the traditional Chinese medicine composition in the preparation of drugs and functional foods for preventing and treating hyperuricemia or gout.

[0015] The Chinese medicine compound of the present invention is a Chinese medicine that is both a medicine and a food, has simple ingredients, is effective in preventing and treating hyperuricemia and gout, is highly safe, can mitigate possible adverse reactions caused by Western medicine, and makes up for the limited effects of some Chinese medicine prescriptions currently used in clinical practice.

[0016] The Chinese medicine composition of the present invention is composed of galangal and kudingcha, wherein the galangal (AlpiniaeOfficinarum Rhizoma) is the dried rhizome of the zingiberaceae plant galangal (Alpinia officinarum Hance), and the kudingcha is the dried leaves of large-leaf kudingcha or small-leaf kudingcha. Among them, the large-leaf kudingcha can be large-leaf holly (Ilexlatifolia Thumb.ex Muray) or kudingcha holly (Ilex kudingcha CJTseng); the small-leaf kudingcha can be robust privet [Ligustrum robustum (Roxb.) Bl.] of the genus Ligustrum of the family Oleaceae, Ligustrumhenryi Hemsl., Ligustrumpricei Hayata or Ligustrum sinensevar.myrianthum.

[0017] The formula mainly uses Alpinia officinalis to inhibit the activity of xanthine oxidase and thus inhibit the production of uric acid, and fundamentally prevents and treats hyperuricemia and gout by inhibiting the production of uric acid; the formula mainly uses Kudingcha's diuretic effect, supplemented by xanthine oxidase inhibition activity, to enhance the effect of lowering uric acid by promoting uric acid excretion and assisting in inhibiting xanthine oxidase activity; the combination of the two can not only effectively inhibit uric acid production, but also promote uric acid excretion, and significantly reduce blood uric acid levels through multiple mechanisms.

[0018] Hyperuricemia belongs to the category of "arthralgia", "rheumatism" and "gout" in traditional Chinese medicine. Deficiency of spleen and kidney and endogenous dampness are important pathogenesis. Zhu Danxi discussed the pathogenesis of gout in "Gezhi Yu Lun·Gout Theory", believing that the onset of gout is due to the blood boiling due to heat, and then the cold evil invades the outside by wading in cold water, standing in wetlands, or fanning to cool down. The coldness of hot blood and the phlegm turbidity are condensed and astringent, so pain occurs. In terms of treatment, he proposed "using pungent and hot medicine to disperse cold and dampness, disperse the pores, make the qi and blood harmonious, and the disease will be relieved by itself". In the prescription, Gaoliangjiang is pungent and hot, and it enters the spleen and stomach meridians. It has the effects of warming the stomach to stop vomiting, dispersing cold and relieving pain. Kudingcha is bitter, sweet, and cold, and it enters the liver, lung, and stomach meridians. It has the effects of clearing heat and detoxification, improving eyesight and promoting fluid production, and resolving phlegm. The pungent and hot nature of Alpinia officinalis can dissipate cold and dampness in the body to relieve pain. For gout patients, the painful area is red, swollen and burning. It is combined with Kuding tea to clear away dampness and heat, and eliminate phlegm. The two are used together to dispel cold and heat, relieve pain, clear heat and eliminate phlegm, which embodies the theory that "hot blood gets cold, and phlegm becomes coagulated and astringent".

[0019] At the same time, the experiment confirmed that the combination of the two traditional Chinese medicines has a synergistic effect on hyperuricemia. It effectively reduces serum uric acid levels by strengthening the inhibition of uric acid production and the promotion of uric acid excretion.

[0020] The present invention can be used as a pharmaceutical preparation and can be prepared by conventional preparation methods in the art into commonly used pharmaceutical dosage forms such as compound decoction for oral administration, granules, tablets, granules, powders, capsules, oral liquids, pills, topical external administration, navel application, Chinese medicine fumigation, external foot bath, etc.

[0021] Due to the adoption of the above technical solution, the present invention has the following advantages and beneficial effects:

[0022] Any single drug in the traditional Chinese medicine complex of the present invention is a traditional Chinese medicine that is both a medicine and a food, and can be taken for a long time in sufficient amounts without causing adverse effects. In view of the huge number of people suffering from metabolic disorders related diseases caused by hyperuricemia and elevated uric acid, and the fact that the compound preparation made from the traditional Chinese medicine complex of the present invention is non-toxic and can be taken for a long time, the traditional Chinese medicine complex provided by the present invention has good application prospects.

[0023] The Chinese medicine composite of the present invention has cheap raw materials, simple ingredients, simple preparation, convenient use, and has the advantages of low cost and convenient application. DETAILED DESCRIPTION

[0024] In order to explain the present invention in more detail, the present invention is further described below in conjunction with preferred embodiments. It should be understood by those skilled in the art that the content described below is illustrative rather than restrictive, and should not be used to limit the scope of protection of the present invention.

[0025] Example 1 Study on the rationality of the formula of large-leaf kudingcha and galangal

[0026] 1. Sample preparation: Weigh 12 parts of Ilexlatifolia Thumb.exMuray, 10 parts of Alpinia galanga, 12 parts of Ilexlatifolia Thumb.exMuray, and 10 parts of Alpinia galanga, add 10 times the amount of water to each and boil for 1 hour, filter, then add the same volume of water and boil for 1 hour, filter, combine the two decoctions, concentrate, dry, and crush to prepare Chinese medicine composition 1, Ilexlatifolia Thumb.exMuray and Alpinia galanga three extracts.

[0027] 2. Animals: SPF male Kunming mice, weighing 20 ± 2 g, were purchased from Changsha Tianqin Biotechnology Co., Ltd. (License No.: SCXK (Xiang) 2019-0014). All mice were adaptively fed and raised at 23-27 ° C and 50-70% humidity for one week, with free access to water and food. All animal experiments followed the protocol approved by the Ethics Committee of Guizhou Medical University (No.: 201800246).

[0028] 3. Experimental Methods

[0029] After one week of adaptive feeding, the mice were randomly divided into 6 groups according to body weight, with 8 mice in each group. They were normal control group, model group, allopurinol group, combination group and different single-flavor drug groups (galangal and large-leaf kudingcha). Except for the normal control group, the other groups were gavaged with hypoxanthine (PO) 500mg / kg and intraperitoneally injected with potassium oxonate (HX) 100mg / kg at 9 o'clock every day for 7 consecutive days. The mice in the normal control group were gavaged and intraperitoneally injected with the same volume of normal saline every day. Starting from the third day of the experiment, the drug-treated group was gavaged with the corresponding drug 1 hour after modeling, while the normal control group and the model group were gavaged with the same volume of normal saline. The allopurinol group was given 10mg / kg·d, the combination dose was converted to the corresponding dose of 1.67g / kg·d for mice, the large-leaf kudingcha dose was converted to the corresponding dose of 0.91g / kg·d for mice, and the galangal dose was converted to the corresponding dose of 0.76g / kg·d for mice. On the seventh day of the experiment, one hour after administration, the animals were anesthetized, blood was collected from their eye sockets, and then they were killed and whole blood samples were collected. After clotting for 2 hours at room temperature, the blood was centrifuged (3000 rpm, 10 min), and the resulting serum was used for the detection and analysis of uric acid and xanthine oxidase activity kits.

[0030] 4. Experimental Results

[0031] Table 1. Effects of Composition 1 and single herbs on serum uric acid and xanthine oxidase in hyperuricemia mice ( n=8)

[0032]

[0033] Note: Compared with the normal control group, ## P<0.01; compared with the model group,** P<0.01, *** P<0.001

[0034] As shown in Table 1, compared with the normal control group, the serum uric acid and xanthine oxidase activity of the mice in the model group were significantly increased; compared with the model group, the combination of Kudingcha oleracea and Alpinia officinalis could significantly reduce the blood uric acid level of the hyperuricemia mice by inhibiting the xanthine oxidase activity in the serum of the hyperuricemia mice ( *** P<0.001). The combination of Kudingcha and Alpinia officinalis showed stronger uric acid-lowering effect and xanthine oxidase inhibitory activity, and its effect was significantly better than that of single administration, with a synergistic effect, indicating the necessity and rationality of the combination of the two.

[0035] Example 2 Study on the rationality of the formula of small leaf kudingcha and galangal

[0036] 1. Sample preparation: Weigh composition 2, 12 parts of small-leaf kudingcha (Ligustrum robustum (Roxb.) Bl. of the genus Ligustrum of the family Oleaceae) and 10 parts of galangal, add 10 times the amount of water to each of them, boil for 1 hour, filter, then add the same volume of water and boil for 1 hour, filter, combine the two decoctions, concentrate, dry, and crush to obtain different extracts.

[0037] 2. Animals: SPF male Kunming mice, weighing 20±2 g, were purchased from Sbefor (Beijing) Biotechnology Co., Ltd. (License No.: SCXK (Beijing) 2023-0002). All mice were adaptively fed and raised at 23-27°C and 50-70% humidity for one week, with free access to water and food. All animal experiments followed the protocol approved by the Ethics Committee of Guizhou Medical University (No.: 201800246).

[0038] 3. Experimental Methods

[0039] After one week of adaptive feeding, the mice were randomly divided into 6 groups according to body weight, with 8 mice in each group. They were normal control group, model group, allopurinol group, combination group and different single-drug groups (galangal and small-leaf kudingcha). Except for the normal control group, the other groups were gavaged with hypoxanthine (PO) 500mg / kg and intraperitoneally injected with potassium oxonate (HX) 100mg / kg at 9 o'clock every day for 7 consecutive days. The mice in the normal control group were gavaged and intraperitoneally injected with the same volume of normal saline every day. Starting from the third day of the experiment, the drug-treated group was gavaged with the corresponding drug 1 hour after modeling, while the normal control group and the model group were gavaged with the same volume of normal saline. The allopurinol group was given 10mg / kg·d, the combination dose was converted to the corresponding dose of 1.67g / kg·d for mice, the small-leaf kudingcha dose was converted to the corresponding dose of 0.91g / kg·d for mice, and the galangal dose was converted to the corresponding dose of 0.76g / kg·d for mice. On the seventh day of the experiment, one hour after administration, the animals were anesthetized, blood was collected from the eye sockets, and then they were killed and whole blood samples were collected. After clotting for 2 hours at room temperature, the blood was centrifuged (3000 rpm, 10 min), and the resulting serum was used for the detection and analysis of uric acid and XOD activity kits.

[0040] 4. Experimental Results

[0041] Table 2. Effects of Composition 2 and single herbs on serum uric acid and xanthine oxidase in hyperuricemia mice ( n=8)

[0042]

[0043]

[0044] Note: Compared with the normal control group, ### P<0.001; compared with the model group, *** P<0.001

[0045] As shown in Table 2, compared with the normal control group, the serum uric acid and xanthine oxidase activity of the model group mice were significantly increased; compared with the model group, the combination of small-leaf Kudingcha and galangal can also significantly reduce the blood uric acid level of hyperuricemia mice by inhibiting the xanthine oxidase activity in the serum of hyperuricemia mice ( *** P<0.001). The combination of small-leaf Kudingcha and galangal showed stronger uric acid-lowering effect and xanthine oxidase inhibitory activity, and its effect was significantly better than that of single administration, with a synergistic effect, indicating the necessity and rationality of the combination of the two.

[0046] Example 3 Comprehensive analysis of the effects of small leaf kudingcha and galangal on hyperuricemia mice

[0047] 1. Sample preparation: Weigh a composition according to 12 parts of small-leaf Kudingcha and 10 parts of galangal, add 10 times the amount of water and boil for 1 hour, filter, then add the same volume of water and boil for 1 hour, filter, combine the two decoctions, concentrate, dry, and crush to obtain different extracts.

[0048] 2. Animals: SPF male Kunming mice, weighing 20 ± 2 g, were purchased from Changsha Tianqin Biotechnology Co., Ltd. (License No.: SCXK (Xiang) 2019-0014). All mice were adaptively fed and raised at 23-27 ° C and 50-70% humidity for one week, with free access to water and food. All animal experiments followed the protocol approved by the Ethics Committee of Guizhou Medical University (No.: 201800246).

[0049] 3. Experimental Methods

[0050] After one week of adaptive feeding, the mice were randomly divided into 7 groups according to body weight, with 10 mice in each group. They were blank control group, model group, allopurinol group, benzbromarone group, and low, medium and high dose groups of the composition. Except for the normal group, the other groups were gavaged with hypoxanthine (PO) 500mg / kg at 9 o'clock every day and intraperitoneally injected with potassium oxonate (HX) 100mg / kg for 7 consecutive days. The mice in the normal control group were gavaged and intraperitoneally injected with the same volume of normal saline every day. Starting from the third day of the experiment, the drug administration group was gavaged with the corresponding drugs 1 hour after modeling, while the normal control group and the model group were gavaged with the same volume of normal saline. Allopurinol group and benzbromarone group were both given 10mg / kg·d, and the composition was administered at different doses in the same proportion as in Example 2. The low, medium and high dose groups were converted to the corresponding doses of 0.42g / kg·d, 0.84g / kg·d, and 1.67g / kg·d for mice. On the sixth day of the experiment, one hour after the administration of the corresponding drug, the mice were placed in metabolic cages according to the groups, and the 24-hour urine of the mice was collected. On the seventh day of the experiment, one hour after the administration, the mice were anesthetized, blood was collected from the orbits, and then they were killed and whole blood samples were collected. After settling for 2 hours at room temperature, the blood was centrifuged (3000rpm, 10min), and the resulting serum was used for the detection and analysis of uric acid, xanthine oxidase, creatinine, and urea nitrogen kits.

[0051] 4. Experimental Results

[0052] 4.1 Effects of the composition on serum uric acid levels and xanthine oxidase activity in hyperuricemia mice

[0053] Table 3. Effects of the composition on serum uric acid level and xanthine oxidase activity in hyperuricemia mice ( n=10)

[0054]

[0055] Note: Compared with the normal control group,### P<0.001; compared with the model group, ** P<0.01, *** P<0.001

[0056] As shown in Table 3, compared with the normal control group, the blood uric acid level and serum XOD activity of mice in the model group were significantly increased ( ### P<0.001). Compared with the model group, different doses of the combination can significantly reduce the blood uric acid level of hyperuricemia mice ( *** P<0.001) and xanthine oxidase activity ( ** P<0.01 or *** P<0.001) and was dose-dependent.

[0057] 4.2 Effect of the composition on uric acid in the urine of hyperuricemia mice

[0058] Table 4. Effects of the composition on uric acid levels in hyperuricemia mice ( n=10)

[0059]

[0060] Note: Compared with the normal control group, ### P<0.001; compared with the model group, * P<0.05, *** P<0.001

[0061] As shown in Table 4, compared with the blank control group, the uric acid level in the hyperuricemia group was significantly reduced ( ### P<0.001); compared with the model group, the urinary uric acid level in benzbromarone and the combination group was significantly increased ( *** P<0.001), indicating that both benzbromarone and the combination can significantly promote the excretion of uric acid in the body and reduce the level of blood uric acid.

[0062] 4.3 Effect of the composition on serum urea nitrogen and urine creatinine in hyperuricemia mice

[0063] Table 5. Effects of the composition on serum urea nitrogen and creatinine levels in hyperuricemia mice ( n=10)

[0064]

[0065] Note: Compared with the normal control group, # P<0.05; compared with the model group, ** P<0.01, *** P<0.001

[0066] As shown in Table 5, compared with the normal control group, the serum creatinine and urea nitrogen levels of mice in the model group were significantly increased ( # P<0.05), indicating that hyperuricemia has damaged the renal function of mice. Compared with the model group, the serum creatinine and urea nitrogen levels of mice in the allopurinol group were significantly increased ( *** P < 0.001, ** P<0.01), indicating that allopurinol significantly deteriorated the renal function of hyperuricemia mice. Compared with the model group, the serum urea nitrogen content of mice in each group of the combination did not change significantly (P>0.05), but the blood creatinine content of the medium and high dose groups of the combination was significantly reduced ( ** P<0.01). The above results show that the composition has a significant improvement effect on the renal function of hyperuricemia mice.

[0067] 4.4 Effects of the composition on body weight and organ indexes of hyperuricemia mice

[0068] Table 6. Effects of the composition on the body weight of hyperuricemia mice ( n=10)

[0069]

[0070] Note: Compared with the normal control group, # P<0.05; compared with the model group, ** P<0.01, *** P<0.001

[0071] As shown in Table 6, compared with the normal control group, the body weight of mice in the model group was significantly reduced on the 5th and 7th days ( # P<0.05), indicating that hyperuricemia had toxic side effects on mice. Compared with the model group, the body weight of mice in the allopurinol group was significantly reduced on the 5th and 7th days after administration ( ** P<0.01 or *** P<0.001), indicating that the toxic side effects of allopurinol inhibited the natural growth of the body weight of mice, and the body weight of mice in each dose group of the combination did not change significantly (P>0.05), indicating that the combination had no toxic side effects on hyperuricemia mice.

[0072] Table 7. Effects of the composition on organ indexes of hyperuricemia mice ( n=10)

[0073]

[0074] Note: Compared with the normal control group, ### P<0.001; compared with the model group, *** P<0.001

[0075] Compared with the normal control group, the renal index of mice in the model group and allopurinol group was significantly increased ( *** P < 0.001), indicating that the modeling agents potassium oxonate, hypoxanthine and the positive drug allopurinol have serious toxic side effects on the kidneys of mice. Compared with the model group, the liver index and kidney index of mice in each dose group of the combination were reduced (P > 0.05), indicating that each dose of the combination can alleviate the renal damage caused by hyperuricemia.

[0076] The above activity test results show that the composition of Alpinia officinalis and Kudingcha or small-leaf Kudingcha can significantly reduce the content of uric acid in the serum of hyperuricemia model mice by inhibiting the activity of xanthine oxidase in serum and promoting uric acid excretion in the body, and the effect is better than that of a single drug, with a synergistic effect. The results of serum urea nitrogen and creatinine and organ indexes show that each dose of the composition is safe and has no side effects. The composition of Kudingcha and Alpinia officinalis can be used to regulate uric acid, prevent and treat diseases related to hyperuricemia, or be used to prepare drugs for preventing and treating diseases related to hyperuricemia.

[0077] Example 4 Experiment on optimizing the ratio of the combination of small-leaf Kudingcha and galangal

[0078] 1. Sample preparation: The orthogonal experimental design Table 8 was used. According to the dosage (i.e., level) in Table 9, small-leaf Kudingcha and Alpinia officinalis were weighed respectively to prepare 9 different prescriptions. 10 times the amount of water was added to each of them and boiled for 1 hour, filtered, and then the same volume of water was added to boil for 1 hour, filtered, and the two decoctions were combined, concentrated, dried, and crushed to obtain extracts of different prescriptions.

[0079] 2. Animals: SPF male Kunming mice, weighing 20 ± 2 g, were purchased from Changsha Tianqin Biotechnology Co., Ltd. (License No.: SCXK (Xiang) 2019-0014). All mice were adaptively fed and raised at 23-27 ° C and 50-70% humidity for one week, with free access to water and food. All animal experiments followed the protocol approved by the Ethics Committee of Guizhou Medical University (No.: 201800246).

[0080] 3. Experimental Methods

[0081] After one week of adaptive feeding, the mice were randomly divided into 11 groups according to their body weight, with 8 mice in each group. They were normal control group, model group, and different Chinese medicine prescription groups. Except for the normal group, the other groups were gavaged with hypoxanthine (PO) 500mg / kg and intraperitoneally injected with potassium oxonate (HX) 100mg / kg at 9 o'clock every day for 7 consecutive days. The mice in the normal control group were gavaged and intraperitoneally injected with the same volume of normal saline every day. Starting from the third day of the experiment, the drug-treated group was gavaged with the corresponding drugs 1 hour after modeling, while the normal control group and the model group were gavaged with the same volume of normal saline. On the seventh day of the experiment, one hour after the drug administration, the mice were anesthetized, blood was collected from the eye sockets, and then they were killed and whole blood samples were collected. After settling for 2 hours at room temperature, the blood was centrifuged (3000rpm, 10min), and the resulting serum was used for detection and analysis of the uric acid kit.

[0082] The experiments of different formulations were designed according to the 2 factors and 3 levels in the table, and the daily dosage was determined after conversion into the mouse dosage according to the table below.

[0083] Table 8. Factor level table

[0084]

[0085] 4. Experimental Results

[0086] The results of the blood uric acid level test are shown in Table 9.

[0087] Table 9. Orthogonal design and results

[0088]

[0089]

[0090] Note: Compared with the normal control group, ### P<0.001; compared with the model group, *** P<0.001

[0091] From Table 9, we can see that the order of influence of each factor on the blood uric acid level is: B (galangal) > A (kudingcha). In terms of blood uric acid level, A2B2 is the best formula, and its blood uric acid level is the lowest, so A2B2 (kudingcha 6g, galangal 4.5g) is selected as the best formula ratio.

[0092] Example 5 Preparation of teabag of the present invention

[0093] 1. Raw material preparation: select high-quality large-leaf Kudingcha or small-leaf Kudingcha and galangal without impurities, and weigh 12 parts of large-leaf Kudingcha or small-leaf Kudingcha and 9 parts of galangal respectively.

[0094] 2. Grinding: Grind the large-leaf Kuding tea or small-leaf Kuding tea and galangal into appropriate particle sizes and pass through a 4-mesh sieve to facilitate rapid release of tea ingredients during packaging and brewing.

[0095] 3. Making tea bags: Select non-woven fabric as the material of the tea bag, cut the selected material into a suitable shape, and make it into a small bag by heat sealing or sewing. Put the crushed tea composition into the tea bag in a certain amount to complete the production.

[0096] Example 6 Preparation of capsules of the present invention

[0097] Weigh 12 parts of large-leaf Kudingcha or small-leaf Kudingcha and 9 parts of galangal, add 10 times the amount of water and boil for 1 hour, filter, then add the same volume of water and boil for 1 hour, filter, combine the two decoctions to obtain the aqueous extract of the medicine of the present invention.

[0098] Take the water decoction, concentrate it, dry it, add dextrin in an amount of 1 to 3 times the weight of the dry extract, use 10% starch slurry as a binder, use a 20-mesh sieve to prepare granules, mix the obtained granules with an appropriate amount of lubricant, and then put them into a hard capsule shell, put the capsule body and the capsule cap on it, and seal it.

[0099] Finally, it should be pointed out that the above embodiments are only representative examples of the present invention.

[0100] The solution is not limited to the above-mentioned embodiments, and there may be many variations. All variations that can be directly derived or associated with the contents disclosed by ordinary technicians in this field should be considered as the protection scope of the present invention.

Claims

1. A Chinese medicine composition for preventing and treating hyperuricemia and gout, characterized in that , is made of the following components in parts by weight: 1-18 parts of Kudingcha and 1-15 parts of Alpinia officinalis.

2. A Chinese medicine composition for preventing and treating hyperuricemia and gout according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following components in parts by weight: 5-15 parts of Kudingcha tea and 4-12 parts of Alpinia officinalis.

3. A Chinese medicine composition for preventing and treating hyperuricemia and gout according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following components in parts by weight: 12 parts of Kudingcha tea and 9 parts of Alpinia officinalis.

4. A Chinese medicine composition for preventing and treating hyperuricemia and gout according to claim 1, characterized in that: The galangal is the dried rhizome of the galangal plant of the ginger family, and the kudingcha is the dried leaves of large-leaf kudingcha or small-leaf kudingcha; wherein the large-leaf kudingcha can be large-leaf holly or kudingcha holly; and the small-leaf kudingcha can be robust privet, beautiful-leaf privet, pedunculate privet or smooth-calyx waxy waxy waxy waxy waxy waxy waxy waxy waxy waxy waxy waxy waxy waxy waxy waxy waxy waxy waxy waxy waxy 5. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a pharmaceutical preparation for preventing and treating hyperuricemia and gout.

6. Use of the Chinese medicine composition according to claim 5 in preparing a pharmaceutical preparation for preventing and treating hyperuricemia and gout, characterized in that: The pharmaceutical preparation is prepared by combining a Chinese medicine composition with pharmaceutically acceptable auxiliary materials to prepare the desired preparation.

7. A pharmaceutical preparation for preventing and treating hyperuricemia and gout, characterized in that: The invention is prepared from the Chinese medicine composition according to any one of claims 1 to 4.

8. Use of the Chinese medicine composition according to any one of claims 1 to 4 in preparing food that assists in reducing uric acid.

9. A food for assisting in reducing uric acid, characterized in that: The invention is prepared from the Chinese medicine composition according to any one of claims 1 to 4.

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