Traditional Chinese medicine preparation for preventing and treating hyperuricemia and preparation method thereof

Abstract

The invention relates to the field of traditional Chinese medicine, in particular to a traditional Chinese medicine preparation for preventing and treating hyperuricemia, which is prepared from the following raw materials by weight: 5-20g of gynostemma pentaphyllum, 10-20g of selaginella doederleinii hieron, 5-15g of berchemia lineate, 5-15g of parthenocissus parvifolia, 12-15g of lotus leaf, 12-15g of cassia seed, 12-15g of white paeony root and 3-6g of raw liquorice. The traditional Chinese medicine composition has no obvious influence on the normal blood sugar level, has stable hypoglycemic activity when being used by diabetes patients, cannot reduce the normal blood sugar state when being taken, can reduce the uric acid level, protect the kidney, improve the glomerular filtration rate and promote uric acid excretion, and can effectively treat, inhibit or prevent hyperuricemia.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine preparation for preventing and treating hyperuricemia and a preparation method thereof. Background Art

[0002] Hyperuricemia, also known as gout, is a group of diseases caused by purine metabolism disorders. Its clinical characteristics are hyperuricemia and the repeated attacks of acute gouty arthritis, tophi deposition, chronic tophi-induced arthritis and joint deformities caused by it. It often involves the kidneys and causes chronic interstitial nephritis and uric acid kidney stones. The disease can be divided into two categories: primary and secondary. The cause of primary cases is mostly unknown, except for a few cases caused by enzyme defects. It is often accompanied by hyperlipidemia, obesity, diabetes, hypertension, arteriosclerosis and coronary heart disease, and is a hereditary disease. Secondary cases can be caused by kidney disease, blood disease, drugs and other reasons.

[0003] At present, Western medicine is the main treatment for hyperuricemia. According to the different targets of the drugs, Western medicine can be divided into four categories, including uric acid production inhibitors, uricosuric agents, drugs that accelerate uric acid dissolution, and drugs that inhibit uric acid production and promote uric acid excretion. However, studies have found that there are many complications, namely drug-related adverse reactions, caused by the use of the above-mentioned Western medicines, such as the skin adverse reactions of allopurinol, the potential hepatotoxicity of benzbromarone, and the use of rasburicase may cause patients to have transient increases in uric acid levels. Some intolerant patients experience vomiting, fever, rash and other adverse reactions, which have caused obvious adverse consequences for patients.

[0004] In the prior art, patent application number 2022115268169 discloses the application of Eleutherococcus trifoliatus polysaccharide in the treatment of hyperuricemia. Eleutherococcus trifoliatus polysaccharide extracted from Eleutherococcus trifoliatus is used to treat hyperuricemia. Eleutherococcus trifoliatus (Latin name: Eleutherococcus trifoliatus) is a shrub that often climbs on other shrubs or trees. The palmate compound leaves usually have 3 leaflets, the petioles have thorns, and the leaflets are elliptical and ovate. The roots and leaves are used as medicine, which have the effects of clearing away heat and detoxifying, dispelling wind and removing dampness. At present, studies have found that Eleutherococcus trifoliatus has the effects of treating hyperglycemia and anti-fatigue.

[0005] According to research, Bletilla striata polysaccharide can indeed lower high uric acid levels, but it will also lower blood sugar levels at the same time. Too low blood sugar levels can lead to dizziness, inattention, drowsiness and other adverse symptoms. Therefore, after taking Bletilla striata polysaccharide, driving a vehicle or working is risky. Therefore, Bletilla striata polysaccharide can only be used as a drug for the treatment of hyperuricemia and cannot be used in the prevention of hyperuricemia. For this reason, a Chinese medicine preparation for the prevention and treatment of hyperuricemia and a preparation method thereof are proposed. Summary of the invention

[0006] The purpose of the present invention is to provide a Chinese medicine preparation for preventing and treating hyperuricemia and a preparation method thereof, so as to solve the problems raised in the background technology. The specific technical scheme is as follows:

[0007] To achieve the above purpose and other related purposes, the present invention provides a traditional Chinese medicine preparation for preventing and treating hyperuricemia, which is made of the following raw materials: 5-20g of Gynostemma pentaphyllum, 10-20g of Cypress, 5-15g of Iron-clad Gold, 5-15g of Microphylla, 12-15g of Lotus leaf, 12-15g of Cassia seed, 12-15g of White Peony Root, and 3-6g of Raw Licorice.

[0008] Preferably, the Chinese medicine preparation is made of the following raw materials: 15g of Gynostemma pentaphyllum, 15g of Cyperus rotundus, 12g of Iron-wrapped Gold, 10g of Microphylla chrysantha, 14g of Lotus leaf, 13g of Cassia seed, 13g of White Peony Root, and 4g of Raw Licorice.

[0009] Preferably, the Chinese medicine preparation is in the form of any one of tablets, granules, capsules, pills and oral liquid.

[0010] The present invention also provides a method for preparing a Chinese medicine preparation for preventing and treating hyperuricemia, the method comprising the following steps:

[0011] S1: Weigh the corresponding amount of raw materials and rinse them with clean water;

[0012] S2: extracting the small-leaf goldenrod, lotus leaf and raw licorice with 30-90% ethanol solution under reflux, concentrating and drying the extract into a dry paste;

[0013] S3: Gynostemma pentaphyllum is subjected to alcohol precipitation through water extraction and alcohol precipitation, and then deproteinized, purified by chromatography column, and finally concentrated and dried to obtain a dry paste;

[0014] S4: crushing the cypress, iron-wrapped gold, cassia seed and white peony root, precipitating with 30-90% ethanol aqueous solution, filtering and concentrating the filtrate to remove ethanol, and then purifying with a macroporous resin column, wherein eluting is performed with 30-90% ethanol aqueous solution, and the eluate is concentrated and dried to obtain a dry paste;

[0015] S5: Mix the dry pastes prepared in S1-S4 evenly.

[0016] Preferably, the water extraction and alcohol precipitation method comprises crushing the dried Gynostemma pentaphyllum, adding 12-16 times the weight of distilled water, soaking for 30 minutes, boiling for 1-3 hours, filtering, adding 12-16 times the weight of distilled water to the filter residue again, boiling again for 1-2 hours, filtering, repeating the process several times, combining the filtrate, concentrating to a solid content of 10-20%, standing for 6-8 hours, centrifuging, concentrating the centrifuge to a solid content of 20-30%, and filtering.

[0017] The pharmacological effects of the medicinal raw materials used in the present invention are as follows:

[0018] Gynostemma pentaphyllum: cold in nature, bitter in taste, has the effects of clearing away heat and detoxification, relieving cough, clearing the lungs and removing phlegm, nourishing the heart and calming the mind, replenishing qi and producing essence, and can be used to lower blood pressure, lower blood lipids, protect the liver, and promote sleep;

[0019] Shishangbai: sweet, slightly bitter, astringent, cool in nature, heat-clearing and detoxifying, anti-cancer, hemostatic;

[0020] Iron-wrapped gold: bitter, slightly astringent, neutral in nature, can reduce swelling and detoxify, stop bleeding and relieve pain, dispel wind and dampness, and is effective in treating carbuncle, furuncle and furuncle;

[0021] Small-leaved goldenrod: bitter in taste, cold in nature. It can clear the respiratory tract and the anal canal, regulate the dragon path, eliminate sha poison, clear away heat poison, remove dampness poison, and stop bleeding.

[0022] Lotus leaf: bitter, astringent, cool in nature, enters the heart, liver, and spleen meridians, has a refreshing fragrance, and has the effects of relieving heat and dampness, strengthening the spleen and raising yang, dispersing blood stasis, and stopping bleeding;

[0023] Cassia seed: sweet, bitter, salty, slightly cold in nature. Enters the liver and large intestine meridians; clears the liver, improves eyesight, and promotes bowel movements;

[0024] White peony root: bitter and sour, slightly cold in nature, enters the liver and spleen meridians, nourishes blood and nourishes the body, relieves pain, and astringes yin and soothes the liver;

[0025] Raw licorice: sweet in taste, neutral in nature, enters the spleen, stomach, heart, and lung meridians, nourishes the spleen and replenishes qi, nourishes the heart and moistens the lungs, relieves pain, purges fire and detoxifies, and harmonizes various medicines;

[0026] It has the following beneficial effects:

[0027] The Gynostemma pentaphyllum in the present invention has the effects of clearing away heat and detoxifying, relieving cough, clearing lungs and removing phlegm, nourishing the heart and calming the nerves, and replenishing qi and producing essence. Thanks to the Gynostemma pentaphyllum polysaccharide in the Gynostemma pentaphyllum, it can have no obvious effect on normal blood sugar level, and has stable hypoglycemic activity when used for diabetic patients. In addition, the combination of Cypress, Iron-clad Gold, and Small-leaf Goldenrod with Gynostemma pentaphyllum makes up for the shortcoming of Gynostemma pentaphyllum in lowering uric acid levels, has the effects of significantly lowering uric acid levels and protecting the kidneys, can significantly improve the glomerular filtration rate and promote uric acid excretion. Lotus leaf, Cassia seed, White Peony Root, and Raw Licorice are adjuvants, which have the effects of invigorating the spleen and raising yang, clearing the liver, improving eyesight, relieving constipation, replenishing the spleen and replenishing qi, and harmonizing various medicines.

[0028] In summary, the Chinese medicine preparation of the present invention, when taken, will not reduce the normal blood sugar state, and at the same time can reduce the uric acid level, protect the kidneys, improve the glomerular filtration rate, promote uric acid excretion, and can effectively treat, inhibit or prevent hyperuricemia. DETAILED DESCRIPTION

[0029] The advantages and features of the present invention will be more clearly understood from the following description.

[0030] Example 1

[0031] Weigh: 5g of Gynostemma pentaphyllum, 10g of Cypress, 5g of Iron-wrapped Gold, 5g of Small-leaf Goldenrod, 12g of Lotus Leaf, 12g of Cassia Seed, 12g of White Peony Root, and 3g of Raw Licorice; rinse thoroughly; reflux extract the Small-leaf Goldenrod, Lotus Leaf, and Raw Licorice with 30% ethanol solution, concentrate and dry the extract to form a dry paste; crush the dried Gynostemma pentaphyllum, add 12 times the weight of distilled water, soak for 30 minutes, boil for 1 hour, filter, add 12 times the weight of distilled water to the filter residue again, boil for 1 hour again, filter, and repeat multiple times. The steps of: combining the filtrate, concentrating the filtrate to a solid content of 10%, standing for 6 hours, and then centrifuging the centrifuge to a solid content of 20%, filtering, deproteinizing, and purifying the filtrate by a chromatographic column, and finally concentrating and drying the filtrate to obtain a dry paste; crushing the cypress, iron-clad gold, cassia seed, and white peony root, precipitating the filtrate with a 30% ethanol aqueous solution, filtering, concentrating the filtrate to remove the ethanol, and then purifying the filtrate with a macroporous resin column, eluting the filtrate with a 30% ethanol aqueous solution, and concentrating the eluate to obtain a dry paste; mixing the dry pastes prepared above evenly to obtain a finished product.

[0032] Example 2

[0033] Weigh: 20g of Gynostemma pentaphyllum, 20g of Cyperus rotundus, 15g of Iron-wrapped Gold, 15g of Small-leaf Goldenrod, 15g of Lotus Leaf, 15g of Cassia Seed, 15g of White Peony Root, and 6g of Raw Licorice; rinse thoroughly; extract the Small-leaf Goldenrod, Lotus Leaf, and Raw Licorice with 90% ethanol solution by reflux, and concentrate and dry the extract to form a dry paste; crush the dried Gynostemma pentaphyllum, add 16 times the weight of distilled water, soak for 30 minutes, boil for 3 hours, filter, add 16 times the weight of distilled water to the filter residue again, boil for 2 hours again, filter, and repeat The process is repeated for several times, and the filtrate is combined and concentrated to a solid content of 20%. After standing for 8 hours, the centrifuge is concentrated to a solid content of 30%, filtered, and then deproteinized and purified by a chromatographic column. Finally, the dry paste is concentrated and dried; the cypress, iron-clad gold, cassia seed, and white peony root are crushed, precipitated with 90% ethanol aqueous solution, filtered, concentrated, and the filtrate is purified with a macroporous resin column after removing ethanol, eluted with 90% ethanol aqueous solution, and the eluent is concentrated and dried to a dry paste; the dry paste prepared above is mixed evenly to obtain a finished product.

[0034] Example 3

[0035] Weigh: 15g of Gynostemma pentaphyllum, 15g of Cyperus rotundus, 12g of Iron-wrapped Gold, 10g of Small-leaf Goldenrod, 14g of Lotus Leaf, 13g of Cassia Seed, 13g of White Peony Root, and 4g of Raw Licorice; rinse thoroughly; reflux extract the Small-leaf Goldenrod, Lotus Leaf, and Raw Licorice with 80% ethanol solution, and concentrate and dry the extract to form a dry paste; crush the dried Gynostemma pentaphyllum, add 15 times the weight of distilled water, soak for 30 minutes, boil for 2 hours, filter, add 12 times the weight of distilled water to the filter residue again, boil for 1 hour again, filter, and repeat. The process is repeated for several times, and the filtrate is combined and concentrated to a solid content of 15%. After standing for 6 hours, the centrifuge is concentrated to a solid content of 30%, filtered, and then deproteinized and purified by a chromatographic column. Finally, the dry paste is concentrated and dried; the cypress, iron-clad gold, cassia seed, and white peony root are crushed, precipitated with 80% ethanol aqueous solution, filtered, concentrated, and the filtrate is purified with a macroporous resin column after removing ethanol, eluted with 80% ethanol aqueous solution, and the eluent is concentrated and dried to a dry paste; the dry paste prepared above is mixed evenly to obtain a finished product.

[0036] Comparative Example 1

[0037] Weigh: 15g of Gynostemma pentaphyllum; crush the dried Gynostemma pentaphyllum, add 15 times the weight of distilled water, soak for 30 minutes, decoct for 2 hours, filter, add 12 times the weight of distilled water to the filter residue again, decoct for 1 hour, filter, repeat several times, combine the filtrate, concentrate to a solid content of 15%, stand for 6 hours and then centrifuge, concentrate the centrifuge to a solid content of 30%, filter, then deproteinize, purify through a chromatographic column, and finally concentrate and dry to a dry paste to obtain a finished product.

[0038] Comparative Example 2

[0039] Weigh: 15g of Cyperus rotundus, 12g of Iron-wrapped Gold, 10g of Herba Lycopodii, 14g of Lotus Leaf, 13g of Cassia Seed, 13g of White Peony Root, and 4g of Raw Licorice; rinse them clean; reflux extract the Herba Lycopodii, Lotus Leaf, and Raw Licorice with 80% ethanol solution, and concentrate the extract to form a dry paste; crush Cyperus rotundus, Iron-wrapped Gold, Cassia Seed, and White Peony Root, and precipitate them with 80% ethanol aqueous solution, filter, concentrate the filtrate to remove ethanol, and then purify it with a macroporous resin column, wherein elution is carried out with 80% ethanol aqueous solution, and the eluent is concentrated and dried to form a dry paste; mix the dry pastes prepared above evenly to obtain a finished product.

[0040] Comparative Example 3

[0041] Weigh: 15g of white peony root medicinal material, crush the dried white peony root medicinal material, add 10 times the weight of distilled water, extract in a water bath at 100°C for 2h, filter, add 10 times the weight of distilled water to the filter residue again, extract in a water bath at 100°C for 1h, filter, combine the two water extracts, concentrate to a solid content of 15%, centrifuge after standing for 7h, concentrate the centrifuge to a solid content of 25%, filter, deproteinize the filtrate by Sevag method, and perform preliminary separation on a DEAE-52 chromatographic column, sequentially elute with distilled water, 0.05mol / L and 0.2mol / L sodium chloride solutions at a flow rate of 1.3mL / min, collect the polysaccharide components, and then purify with a SephadexG-75 chromatographic column, elute with distilled water at a flow rate of 0.5mL / min, combine the fractions, concentrate, dialyze, and dry to obtain a dry paste to obtain white peony root polysaccharide.

[0042] Experimental Example 1

[0043] 1. Animal Grouping

[0044] 54 18-22 g male KM mice were selected, fed in an SPF environment for one week, and randomly divided into 9 groups, 6 mice in each group, of which 6 groups corresponded to Examples 1-3 and Comparative Examples 1-3, and the remaining 3 groups were model group, blank group and positive group, respectively.

[0045] 2. Animal Modeling and Drug Administration

[0046] Except for the blank group, the animals in the other groups were given potassium oxonate (250 mg / kg) combined with hypoxanthine (300 mg / kg) by intraperitoneal injection to establish a hyperuricemia mouse model. After the mice were grouped, they were given modeling medication at 9 am, and the treatment medication was given 2 hours after modeling medication.

[0047] The dry paste products prepared in Examples 1-3 and Comparative Examples 1-3 were administered by gavage at a dose of 200 mg / kg / d. The administration lasted for 3 weeks, and the positive group was given 5 mg / kg of allopurinol.

[0048] During the experiment, the body weight of mice was measured at a fixed time each week and the changes in the animals were observed. After the first administration at the end of the fourth week, the mice were fasted but not deprived of water for 12 h, blood was collected from the eye sockets, centrifuged at 4000 r / min at 4°C for 15 min, serum was collected and stored at -80°C for later use, and kidneys were collected and stored in 4% paraformaldehyde.

[0049] 3. Experimental testing and result analysis

[0050] After the experiment, the uric acid and urea nitrogen in the mouse serum were detected by automatic biochemical analyzer. The results are shown in Table 1:

[0051] Table 1 Effects of Examples 1-3 and Comparative Examples 1-3 on uric acid and urea nitrogen levels in mouse serum

[0052]

[0053] Note: Compared with the model group, *P<0.05, **P<0.01

[0054] Analysis of results: As shown in Table 1, the uric acid and urea nitrogen values ​​in the serum of the model group mice were significantly higher than those in the blank group, and it was obvious that the hyperuricemia model was successfully replicated; Examples 1-3 were able to significantly reduce the uric acid and urea nitrogen in the serum of the hyperuricemia model mice. Urea nitrogen is a classic indicator for evaluating renal function. The results showed that Examples 1-3 were able to significantly reduce uric acid levels while protecting renal function.

[0055] Experimental Example 2

[0056] 1. Animal Grouping

[0057] Thirty-six adult Wistar rats weighing 170-190 g were selected, fed in an SPF environment for one week, and randomly divided into two groups, 18 rats in each group, one as a blank group and the other as a model group.

[0058] 2. Animal Modeling and Drug Administration

[0059] After fasting for 12 hours, Wistar rats were injected with 2.5% alloxan in saline solution at a dose of 50 mg / kg body weight into the tail vein. Blood was collected from the tail vein 96 hours after the injection and fasting blood glucose was measured by glucose oxidase method. The model was considered to be successfully established if the blood glucose level was higher than 11.1 mmol / L. The hyperglycemic rats were divided into the model group according to the blood glucose level; the normal blood glucose rats were divided into the blank group.

[0060] The model group and the blank group rats were gavaged with 2 mL of 7.5% starch solution, and the dry paste products prepared in Example 3 and Comparative Example 3 were gavaged to the model group and the blank group rats, respectively, at a dose of 200 mg / kg / d; the administration was continued for 1 week;

[0061] During the experiment, the rats' body weight was measured at a fixed time every day and the changes in the animals were observed. The rats were given drugs by gavage according to their body weight. After one week of administration, the rats were fasted but not watered for 10 h. Blood was collected from their eye sockets and centrifuged at 4000 r / min at 4°C for 15 min. The serum was stored at -80°C for later use, and the kidneys were stored in 4% paraformaldehyde.

[0062] 3. Experimental testing and result analysis

[0063] 3.1 After the experiment, the fasting blood glucose of rats in the model group was measured by glucose oxidase method. The results are shown in Table 2:

[0064] Table 2 Effects of the products prepared in Example 1 and Comparative Example 1 on blood glucose in model group hyperglycemic rats

[0065]

[0066] Note: Compared with the model group, *P<0.05, **P<0.01

[0067] Result analysis: Both Example 3 and Comparative Example 3 can significantly reduce the blood glucose level of the hyperglycemic rats in the model group.

[0068] 3.2 After the experiment, the fasting blood glucose of blank rats was tested by glucose oxidase method. The results are shown in Table 3:

[0069] Table 3 Effects of the products prepared in Example 1 and Comparative Example 1 on blood glucose in the normal blood glucose rats in the blank group

[0070]

[0071] Note: Compared with the model group, *P<0.05, **P<0.01

[0072] Result analysis: The product prepared in Example 3 can lower the blood sugar of rats and will not lower the blood sugar to the range of hypoglycemia, while the product prepared in Comparative Example 3 can continuously lower the blood sugar of rats and induce hypoglycemia symptoms.

[0073] In summary, when the Chinese medicine preparation prepared by the present invention is taken, the normal blood sugar state will not be reduced, and at the same time it can reduce the uric acid level, protect the kidneys, improve the glomerular filtration rate, promote uric acid excretion, and can effectively treat, inhibit or prevent hyperuricemia.

[0074] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the spirit and scope of the technical solution of the present invention.

Claims

1. A Chinese medicine preparation for preventing and treating hyperuricemia, characterized in that: The invention is made from the following raw materials: 5-20g of Gynostemma pentaphyllum, 10-20g of Cypress, 5-15g of Iron-wrapped Gold, 5-15g of Microphylla, 12-15g of Lotus Leaf, 12-15g of Cassia Seed, 12-15g of White Peony Root, and 3-6g of Raw Licorice.

2. A Chinese medicine preparation for preventing and treating hyperuricemia according to claim 1, characterized in that The Chinese medicine preparation is prepared from the following raw materials: 15g of Gynostemma pentaphyllum, 15g of Cyperus rotundus, 12g of Iron-wrapped Gold, 10g of Microphylla chrysantha, 14g of Lotus leaf, 13g of Cassia seed, 13g of White Peony Root, and 4g of Raw Licorice.

3. A Chinese medicine preparation for preventing and treating hyperuricemia according to claim 1, characterized in that: The Chinese medicine preparation is in the form of tablets, granules, capsules, pills, and oral liquid.

4. A method for preparing a Chinese medicine preparation for preventing and treating hyperuricemia according to any one of claims 1 to 3, characterized in that: The method comprises the following steps: S1: Weigh the corresponding amount of raw materials and rinse them with clean water; S2: extracting the small-leaf goldenrod, lotus leaf and raw licorice with 30-90% ethanol solution under reflux, concentrating and drying the extract into a dry paste; S3: Gynostemma pentaphyllum is subjected to alcohol precipitation through water extraction and alcohol precipitation, and then deproteinized, purified by chromatography column, and finally concentrated and dried to obtain a dry paste; S4: crushing the cypress, iron-wrapped gold, cassia seed and white peony root, precipitating with 30-90% ethanol aqueous solution, filtering and concentrating the filtrate to remove ethanol, and then purifying with a macroporous resin column, wherein eluting is performed with 30-90% ethanol aqueous solution, and the eluate is concentrated and dried to obtain a dry paste; S5: Mix the dry pastes prepared in S1-S4 evenly.

5. A Chinese medicine preparation for preventing and treating hyperuricemia according to claim 4, characterized in that: The water extraction and alcohol precipitation method comprises the following steps: crushing the dried Gynostemma pentaphyllum, adding 12-16 times the weight of distilled water, soaking for 30 minutes, boiling for 1-3 hours, filtering, adding 12-16 times the weight of distilled water to the filter residue again, boiling for 1-2 hours, filtering, repeating the process for multiple times, combining the filtrate, concentrating the filtrate to a solid content of 10-20%, standing for 6-8 hours, centrifuging, concentrating the centrifuge to a solid content of 20-30%, and filtering.

6. A Chinese medicine preparation for preventing and treating hyperuricemia according to claim 4, characterized in that: The chromatographic column purification is performed using a DEAE-52 chromatographic column.

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