CN115607634B - Traditional Chinese medicine composition for preventing and treating hyperuricemia and gout and application thereof - Google Patents
Traditional Chinese medicine composition for preventing and treating hyperuricemia and gout and application thereof Download PDFInfo
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- CN115607634B CN115607634B CN202211235455.2A CN202211235455A CN115607634B CN 115607634 B CN115607634 B CN 115607634B CN 202211235455 A CN202211235455 A CN 202211235455A CN 115607634 B CN115607634 B CN 115607634B
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/52—Juglandaceae (Walnut family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
- A61K36/605—Morus (mulberry)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/732—Chaenomeles, e.g. flowering quince
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8969—Polygonatum (Solomon's seal)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Abstract
The invention belongs to the technical field of traditional Chinese medicine compounds, and in particular relates to a traditional Chinese medicine composition for preventing and treating hyperuricemia and gout and application thereof, wherein the traditional Chinese medicine composition is prepared from the following components in parts by weight: 5-40 parts of coix seed, 3-40 parts of rhizoma polygonati, 3-30 parts of mulberry leaf, 1-20 parts of papaya and 0-20 parts of walnut kernel. The traditional Chinese medicine composition disclosed by the invention is prepared from the raw materials of medicinal and edible traditional Chinese medicines, has high safety, can be taken in a sufficient amount for a long time and does not generate adverse effects, can be prepared into a medicinal preparation or food by adopting a conventional preparation method, and has obvious effects of treating hyperuricemia and gout through pharmacological research and clinical application. In view of the huge number of people suffering from metabolic disorder caused by hyperuricemia and uric acid elevation, the compound preparation or food prepared from the traditional Chinese medicine composition has the characteristics of no toxicity and long-term taking, and the traditional Chinese medicine composition provided by the invention has good application prospect.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicine compounds, and in particular relates to a traditional Chinese medicine composition for preventing and treating hyperuricemia and gout and application thereof.
Background
Gout is a crystal-related arthropathy caused by single sodium urate deposition caused by long-term hyperuricemia, and is manifested by red swelling and pain of joints, and severe cases can cause movement disorder of joints and damage of kidneys, and belongs to immune-related diseases.
Hyperuricemia is usually caused by hypersecretion or hypovolemia of Uric Acid (UA) in the body, and has been shown to be a key factor in causing gout, renal insufficiency, hypertension, hyperlipidemia, diabetes, obesity, and the like. Therefore, early prevention and treatment of hyperuricemia is of great importance for the prevention of such diseases.
Male blood uric acid > 420. Mu. Mol/L and female blood uric acid > 357. Mu. Mol/L are diagnostic criteria for hyperuricemia. Research shows that the number of patients with hyperuricemia in China reaches 1.8 hundred million, and the number of people is continuously rising at present. Serum Uric Acid (SUA) levels in the body are longer than 6.0mg/dL, sodium urate (MSU) crystals may be deposited in body parts such as joints and soft tissues, thereby inducing acute arthritis, and becoming one of the key factors for causing gout. Reducing high uric acid levels in the body and developing gouty arthritis treatment are two strategies for gout treatment. The effects of reducing blood uric acid level and preventing hyperuricemia are the control developed aiming at the cause of gout, and have become an effective means for treating gout.
The existing uric acid reducing drugs mainly comprise xanthine oxidase inhibitors allopurinol, febuxostat and the like for controlling uric acid generation, probenecid, benzbromarone and the like for promoting uric acid excretion. Among them, allopurinol and febuxostat are often used clinically as first-line drugs, which are also limited by the presence of impaired renal function or risk of cardiovascular death. The drugs such as benzbromarone have more side effects, can cause hyponatremia, hypokalemia and hypocalcemia, have obvious side effects on liver and kidney, and are not suitable for long-term use. The use of non-steroidal anti-inflammatory drugs, colchicine and analgesics are common drugs for the treatment of acute gouty arthritis, but these drugs have more prominent side effects and are not suitable for long-term administration. Therefore, it is urgent to find a drug which is safe, effective and suitable for long-term administration and has the effect of reducing urine and resisting gouty arthritis.
On the other hand, kidney stones, kidney dysfunction, ischemic heart disease, obesity, hyperlipidemia, diabetes, hypertension are the most common complications of gout. Therefore, treatment for the above complications should also be an important consideration for effective treatment of gout.
The safety of the medicine and food homologous traditional Chinese medicine is determined, and the medicine and food homologous traditional Chinese medicine is suitable for long-term administration. The research shows that a plurality of medicinal and edible traditional Chinese medicines have outstanding effects in preventing and treating hyperuricemia and gout, and have been widely applied in practice.
There are also some related researches on traditional Chinese medicine compositions at present, for example, patent document of publication No. CN109674958A discloses a traditional Chinese medicine composition with uric acid reducing effect, and a preparation method and application thereof, wherein the traditional Chinese medicine composition is prepared from 20-80 parts of poria cocos, 20-60 parts of coix seeds, 5-20 parts of cape jasmine fruits, 5-20 parts of peach kernels, 5-20 parts of papaya fruits, 5-15 parts of rhizoma polygonati, 5-15 parts of lophatherum gracile, 5-15 parts of liquorice, 2-20 parts of medlar, 30-90 parts of radix puerariae, 20-60 parts of mulberry leaves and 2-15 parts of ginseng. The patent document of publication No. CN109010655A discloses a medicinal and edible traditional Chinese medicine for preventing and treating hyperuricemia, which is prepared from 15-18 parts of raw material medicines of kudzuvine root, 10-20 parts of rhizoma polygonati, 20-30 parts of coix seed, 15-20 parts of lophatherum gracile, 15-20 parts of poria cocos, 15-20 parts of mulberry, 20-30 parts of Chinese yam and 15-20 parts of medlar. However, the compositions are prepared from a plurality of medicinal materials, the medicinal materials are various, and the medicinal materials interact with each other, so that the side effect of the medicament is easy to occur.
In view of pathogenesis and complications of gout, on the basis of enhancing immunity and improving liver and kidney functions, performing reduction of blood uric acid level (including inhibition of uric acid generation and promotion of uric acid excretion), control of inflammation, improvement of complications (including treatment for ischemic heart disease, obesity, hyperlipidemia, diabetes and hypertension), prevention of pathological changes of body functions would be an effective strategy for gout treatment.
On the basis, the medicinal and edible traditional Chinese medicine compound capable of preventing and treating hyperuricemia and gout is optimally screened, and the symptoms of hyperuricemia and gout and complications thereof can be safely and effectively controlled.
Disclosure of Invention
In order to solve the problems, the first aim of the invention is to provide a medicinal and edible traditional Chinese medicine composition for preventing and treating hyperuricemia and gout, in particular to a medicinal and edible traditional Chinese medicine composition for treating hyperuricemia and gout.
The second purpose of the invention is to provide an application of the traditional Chinese medicine composition in preparing medicines or foods for preventing and treating hyperuricemia and gout.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
gout is mainly characterized by long-term hyperuricemia and gouty arthritis, and hyperuricemia is mainly characterized by excessive uric acid production and difficult excretion. Therefore, an effective strategy for controlling gout is to inhibit uric acid generation, promote uric acid excretion or decomposition and perform analgesic and anti-inflammatory treatment. Because uric acid decomposition depends on uricase and has high cost and inconvenient use, the Chinese medicine with xanthine oxidase inhibition, diuretic and anti-inflammatory analgesic effects is selected from the Chinese medicines with homology of medicine and food, and the effective gout treatment and uric acid reduction compound is selected through scientific experimental design.
The first aspect of the invention provides a traditional Chinese medicine composition for preventing and treating hyperuricemia and gout, which is prepared from the following components in parts by weight: 5-40 parts of coix seed, 3-40 parts of rhizoma polygonati, 3-30 parts of mulberry leaf, 1-20 parts of papaya and 0-20 parts of walnut kernel.
Preferably, the traditional Chinese medicine composition for preventing and treating hyperuricemia and gout is prepared from the following components in parts by weight: 9-30 parts of coix seed, 5-20 parts of rhizoma polygonati, 5-20 parts of mulberry leaf, 3-15 parts of papaya and 0-15 parts of walnut kernel.
More preferably, the traditional Chinese medicine composition for reducing uric acid, preventing and treating hyperuricemia and gout is prepared from the following components in parts by weight: 18 parts of coix seed, 12 parts of rhizoma polygonati, 12 parts of mulberry leaf, 3 parts of papaya and 9 parts of walnut kernel.
Most preferably, the traditional Chinese medicine composition for reducing uric acid, preventing and treating hyperuricemia and gout is prepared from the following components in parts by weight: 18 parts of coix seed, 12 parts of rhizoma polygonati, 12 parts of mulberry leaf and 3 parts of papaya.
The traditional Chinese medicine composition is used for preparing medicines for treating or preventing various diseases such as hyperuricemia and the like which are mainly represented by hyperuricemia and gout which is mainly represented by hyperuricemia and gouty arthritis.
The invention also provides a preparation of the traditional Chinese medicine composition serving as a medicine and a form of the traditional Chinese medicine composition serving as food. The preparation used as the medicine can be prepared into common pharmaceutical dosage forms such as compound decoction, oral administration, granules, tablets, medicinal granules, powder, capsules, oral liquid, dripping pills, nasal feeding, anus suppository, rectal lavage, topical external application, navel pasting, traditional Chinese medicine fumigation and washing, external application foot bath and the like by adopting a conventional preparation method in the field; the food forms can be conventional food forms such as teabags, liquid or solid beverages, special nutritional foods and the like prepared by the conventional preparation method in the field.
The second aspect of the invention provides application of the traditional Chinese medicine composition in preparing medicines and foods for preventing and treating hyperuricemia and gout.
The third aspect of the invention provides a pharmaceutical preparation or food for preventing and treating hyperuricemia and gout, which is prepared from the traditional Chinese medicine composition.
The traditional Chinese medicine composition disclosed by the invention has the advantages of definite curative effect on hyperuricemia and gout, high safety and capability of relieving adverse reactions possibly brought by western medicines and making up for the limited effect of certain traditional Chinese medicine prescriptions clinically at present.
The traditional Chinese medicine belongs to the categories of 'arthromyodynia', 'calendar' and the like, and the cause of the hyperuricemia is related to deficiency of liver, spleen and kidney due to congenital deficiency, or spleen and stomach qi are lost due to overfeeding of fat, sweet and greasy, damp turbidity is accumulated in the spleen and stomach to transform heat, and fluid is decocted into phlegm. Phlegm-fluid retention and damp-turbidity flow are infused into blood vessels and between meat branches, so that excessive phlegm-fluid retention, clear-yang retention, turbid-yin retention and qi movement failure can be regulated, and hyperuricemia is caused. In short, the pathogenesis of hyperuricemia is characterized by deficiency without spleen and kidney separation, excess without phlegm separation, dampness, blood stasis and heat exchange resistance, which belongs to the symptoms of deficiency, principal and excess. Therefore, the treatment idea of the invention is as follows: based on the root cause of hyperuricemia, the Chinese herbal medicines with pure nature and homology of medicine and food are used for treating the deficiency of the root by strengthening the spleen and tonifying the kidney.
The traditional Chinese medicine composition provided by the invention is composed of five medicinal and edible traditional Chinese medicines such as coix seed, rhizoma polygonati, mulberry leaf, papaya, walnut kernel and the like. The prescription is formed by carefully selecting the prescription according to the syndrome differentiation analysis and the prescription optimization and the drug effect verification based on the traditional Chinese medicine characteristic and flavor meridian tropism and efficacy application and according to the modern pharmacological and clinical research results. The coix seed in the formula is sweet, light and cool, has the effects of invigorating spleen, relieving diarrhea, removing arthralgia, expelling pus, and detoxifying and resolving masses, and has the effects of promoting diuresis, removing dampness by diuresis, invigorating spleen, cooling and restoring menstrual flow; it is commonly used for edema, beriberi, difficult urination, spleen deficiency diarrhea, damp arthralgia, contracture, pulmonary abscess, intestinal abscess, wart and cancer. Modern pharmacological researches have shown that coix seed has pharmacological activities of enhancing immunity, resisting tumor, relieving pain and inflammation, regulating glycolipid metabolism, lowering blood pressure, resisting oxidation, resisting aging, whitening and the like. Polygonatum sibiricum is sweet in nature, and enters spleen, lung and kidney meridians; has the functions of invigorating qi, nourishing yin, strengthening spleen, moistening lung and tonifying kidney; it is indicated for deficiency of spleen and stomach qi, tiredness, debilitation, stomach yin deficiency, dry mouth, anorexia, cough due to lung deficiency, cough due to fatigue, hemoptysis, deficiency of essence and blood, soreness of waist and knees, premature graying of hair, internal heat and diabetes. Modern pharmacological researches show that rhizoma polygonati has the effects of regulating immunity, protecting kidney, resisting tumor, regulating blood sugar, resisting bacteria, diminishing inflammation, preventing cardiovascular and cerebrovascular diseases, resisting aging, improving cognitive dysfunction, preventing osteoporosis, protecting liver and the like, and also has the effect of inhibiting xanthine oxidase. Mulberry leaf is sweet, bitter and cold in nature and enters lung and liver meridians; has effects of dispelling pathogenic wind and heat, clearing lung-heat, moistening dryness, removing liver-fire, and improving eyesight; it is often used for wind-heat type common cold, cough due to lung heat, dizziness, headache, conjunctival congestion and dizziness. Modern pharmacological researches have shown that mulberry leaves have biological activities of reducing blood sugar, resisting inflammation, resisting bacteria and viruses, resisting aging, resisting cancer, reducing blood pressure, reducing blood fat, relaxing bowels, promoting urination and the like, and have the inhibition activity of xanthine oxidase. Papaya has the effects of relieving rigidity of muscles, activating collaterals, harmonizing stomach and eliminating dampness, and is warm in nature and enters liver and spleen channels. It is often used for treating spasm of damp arthralgia, soreness and pain of waist and knee joints, summer-heat and damp vomiting and diarrhea, spasm pain of tendons, and edema of beriberi. Modern pharmacological researches have shown that papaya has pharmacological activities of easing pain, resisting inflammation, enhancing immunity, protecting liver, resisting gastric ulcer, intestinal injury, resisting tumor and the like. The walnut kernel is sweet in nature, warm, enters kidney, lung and large intestine meridians, and has the effects of tonifying kidney, warming lung and moistening intestines. It is often used for deficiency of kidney yang, soreness and weakness of waist and knees, impotence, spermatorrhea, dyspnea and cough due to deficiency-cold, constipation due to intestinal dryness. Modern pharmacological researches have shown that walnut kernel has the effects of enhancing resistance, resisting oxidation, strengthening brain, protecting health, inhibiting bacteria, resisting tumor, resisting fatigue, reducing blood sugar and the like.
The five medicinal and edible traditional Chinese medicines are combined, coix seeds are taken as monarch medicines, spleen and stomach are strengthened, arthralgia is removed, and rhizoma polygonati is taken as ministerial medicine, spleen and kidney are strengthened, and monarch and ministerial medicine are matched, and spleen and kidney are strengthened. Papaya has the effects of relaxing tendons, activating collaterals, harmonizing stomach, resolving dampness, and helping coix seeds to invigorate spleen, harmonize stomach and remove arthralgia; the walnut kernels can tonify the kidney, and the rhizoma polygonati can strengthen the kidney-tonifying effect; the mulberry leaves can dispel wind and clear heat, and the three are combined as adjuvant drugs. The medicines are combined to invigorate the spleen and stomach, nourish the liver and kidney, dispel dampness and dredge collaterals, so as to achieve the effects of treating the root cause and tonifying deficiency.
From the modern pharmacological research thought, the coix seed in the recipe can strengthen the immunity of organisms and improve complications of gout and hyperuricemia through the effects of inhibiting gouty arthritis, regulating glycolipid metabolism, lowering blood pressure and the like; rhizoma polygonati can assist in enhancing organism immunity, improving kidney function and inhibiting uric acid generation, so that hyperuricemia and gout are fundamentally treated, gouty arthritis is assisted and improved through anti-inflammatory action, and complications are improved through the effects of preventing cardiovascular and cerebrovascular diseases, protecting liver and the like; the mulberry leaves can reduce blood uric acid level by inhibiting uric acid generation, promoting uric acid excretion, improve gouty arthritis by anti-inflammatory effect, and improve complications of gout and hyperuricemia by reducing blood sugar, blood pressure, blood fat and the like; papaya can improve body functions through the effects of enhancing immunity, easing pain and resisting inflammation, and plays a role in resisting gouty arthritis; the walnut kernel has the function of improving kidney function, improving the ability of the organism to resist gout and hyperuricemia, and improving complications.
According to the root cause and the generated complications of hyperuricemia, the invention skillfully composes, through compatibility of components, enhances the metabolism function of the spleen and stomach in the middle-jiao, accelerates excreting metabolic waste, enables the internal endogenous metabolism imbalance state to be restored rapidly, and effectively inhibits uric acid from generating, accelerates the treatment and excretion of uric acid, controls the complications, treats both symptoms and root causes, and achieves the aim of treating hyperuricemia and gout by recovering and strengthening the functions of human bodies.
The traditional Chinese medicine composition is derived from a medicine and food dual-purpose traditional Chinese medicine, the dosage of the traditional Chinese medicine composition is lower than the dosage specified in pharmacopoeia or is used in a low dosage range, and the safety guarantee of long-term taking is provided.
By adopting the technical scheme, the invention has the following advantages and beneficial effects:
the traditional Chinese medicine composition can be prepared into preparations or foods by adopting a conventional preparation method, and pharmacological researches and clinical application show that the traditional Chinese medicine composition has remarkable effects of treating hyperuricemia and gout.
The traditional Chinese medicine composition disclosed by the invention is prepared from the raw materials of medicinal and edible traditional Chinese medicines, is high in safety, can be taken sufficiently for a long time, does not generate adverse effects, is nontoxic, and can be taken for a long time due to the fact that the number of people suffering from metabolic disorder related to hyperuricemia and uric acid elevation is huge, and a compound preparation or food prepared from the traditional Chinese medicine composition disclosed by the invention has the characteristics of being good in application prospect.
The traditional Chinese medicine composition provided by the invention has the advantages of low cost of raw materials, simplicity and convenience in preparation and use, and convenience in application.
Detailed Description
In order to more clearly illustrate the present invention, the present invention will be further described with reference to preferred embodiments. It is to be understood by persons skilled in the art that the following detailed description is illustrative and not restrictive, and that this invention is not limited to the details given herein.
Example 1
Weighing 18 parts of coix seed, 12 parts of rhizoma polygonati, 12 parts of mulberry leaf and 3 parts of papaya, adding 10 times of water for decocting for 1 hour, filtering, adding the same water for decocting for 1 hour, filtering, combining the two water decoctions, concentrating, drying and crushing to obtain an extract. The extract can be directly packaged, taken with water or made into various Chinese medicinal preparations or foods.
Example 2
Weighing 18 parts of coix seed, 12 parts of rhizoma polygonati, 12 parts of mulberry leaf, 3 parts of papaya and 9 parts of walnut kernel, adding 10 times of water, decocting for 1h, filtering, adding the same water, decocting for 1h, filtering, combining the two water decoctions, concentrating, drying and crushing to obtain an extract. The extract can be directly packaged, taken with water or made into various Chinese medicinal preparations or foods.
Example 3
Weighing 20 parts of coix seed, 10 parts of rhizoma polygonati, 9 parts of mulberry leaf, 5 parts of papaya and 3 parts of walnut kernel, adding 10 times of water, decocting for 1h, filtering, adding the same water, decocting for 1h, filtering, combining the two water decoctions, concentrating, drying and crushing to obtain an extract. The extract can be directly packaged, taken with water or made into various Chinese medicinal preparations or foods.
Example 4 (preparation of granules)
100g of the extract prepared in the method of example 1 is added with 200g of dextrin, evenly mixed, added with a proper amount of 60% ethanol to prepare a soft material, sieved by a 24-mesh sieve for granulation, dried for 2 hours at 50 ℃, and the dried granules are sieved by a 30-mesh sieve for granulation and subpackaged, thus obtaining granules.
Example 5 (preparation of Special nutritional food)
100g of the extract prepared in the method of example 1 is added with 200g of dextrin, and sufficient amounts of carbohydrate (such as sucrose and dietary fiber), vitamin C (added according to 80mg per day) and D (added according to 8mg per day) are added according to the carbohydrate content, and the mixture is uniformly mixed and dried at 50 ℃ for 2 hours, so that the energy-supplementing sports nutrition food which is beneficial to uric acid reduction and energy supplement is obtained.
1. Traditional Chinese medicine compound compatibility optimization experiment
1. Animals: SPF-class male Kunming mice with mass of 18-22 g are fed by the university of medical science laboratory animal center of Guizhou, and are well ventilated, at 18-25 ℃, with relative humidity of 40-70%, and with 12h illumination/12 h day and night circulation. License number SCXK (black) 2018-0001. The relevant animal experiments were reviewed by the laboratory animal ethics committee of the university of Guizhou medical science (accession number 2000069).
2. Experimental method
After one week of adaptive feeding, the mice were randomly grouped by body weight, 6 per group. The traditional Chinese medicine prescription is respectively a normal group, a hyperuricemia group, a positive medicine allopurinol group and a different traditional Chinese medicine prescription group. In addition to the normal control group, the remaining mice were intraperitoneally injected with 100mg/kg of Potassium Oxazinate (PO) at 9:00 a.m. per day, and 500mg/kg of gastric Hypoxanthine (HX) was used to establish a hyperuricemia model. Normal control mice were given equal volumes of saline by intraperitoneal injection and lavage. On experiment day 3, the drug administration groups were given the corresponding drugs 1h after molding, respectively. Allopurinol (10 mg/kg.d) is given to the positive medicine group, the administration doses of the different proportion groups of the traditional Chinese medicine prescription are converted into the equivalent doses of mice according to the prescription doses (the proportion of the components of the different groups is matched according to an orthogonal design table in the results), and the normal control group and the hyperuricemia group are subjected to gastric lavage and are given with equal volumes of physiological saline. The stomach was irrigated once daily for 5 consecutive days. Before the last administration, the mice are fasted for 24 hours without water forbidden, after the last administration for 1 hour, the mice are taken from the eye sockets and kept stand for 2 hours at room temperature, 3000r/min and centrifuged for 10 minutes, and serum is taken for measuring uric acid and XOD.
The different formulations were subjected to design experiments at 5 factor 4 levels of table 1 and converted into mouse doses according to the following table to determine the daily doses.
TABLE 1 factor level Table
3. Experimental results
The results of the blood uric acid level and xanthine oxidase activity experiments and analysis of variance are shown in tables 2 and 3, respectively.
TABLE 2 orthogonal experiment design and results
Note that: compared to the blank (i.e. sample 1 group), ## P<0.01; in comparison with the set of models, * P<0.05， ** P<0.01
TABLE 3 analysis of variance table (blood uric acid level)
TABLE 4 analysis of variance table (xanthine oxidase Activity)
From Table 2, it is clear that the Chinese medicinal compositions with different proportions have remarkable uric acid reducing effect, and the uric acid reducing effect of the various compositions has correlation with the activity of xanthine oxidase.
According to the magnitude of the range R, the influence of all factors on the uric acid is as follows: the effect of A (coix seed) > C (rhizoma Polygonati) > E (walnut kernel) > D (papaya) > B (mulberry leaf) on uric acid level was found to be significant by analysis of variance (Table 3) for A factor (P=0.000), C factor (P=0.000) and E factor (P < 0.005). It is explained that A (coix seed), C (rhizoma Polygonati) and E (walnut kernel) are the main factors affecting the uric acid level in blood.
The main and secondary orders of the influence of each factor on xanthine oxidase can be seen according to the extremely poor R size: d (papaya) > C (Polygonatum sibiricum) A (Coix lacryma-jobi seed) > E (walnut kernel) > B (mulberry leaf), it is seen from analysis of variance (Table 4) that the effect of D factor (P < 0.05) on xanthine oxidase activity has significant significance. It is explained that D (papaya) is a major factor affecting xanthine oxidase activity in the formulation.
From Table 2, it can be seen that A1B3C3D1E1 is the best formulation from uric acid level, which is the lowest uric acid level, but A3B2C3D2E1 is the best formulation from xanthine oxidase inhibition point of view, which is the lowest xanthine oxidase activity.
For gout and hyperuricemia, uric acid reducing effect is a priority consideration, and the inhibition effect of xanthine oxidase shows the effect of fundamentally inhibiting uric acid generation, thus having important significance for treating gout and hyperuricemia. Because of the many factors affecting blood uric acid levels, the means for reducing uric acid levels are correspondingly many (such as inhibiting uric acid generation, promoting uric acid excretion through a large amount of drinking water, etc.), but the uric acid levels are reduced by fundamentally inhibiting uric acid generation, and the influence of external factors such as water intake and the like on uric acid reducing effects can be eliminated, so that the method is most effective for most patients (most of the first-line chemical medicines on the market at present can be described as xanthine oxidase inhibitors), so that the preservation of lower xanthine oxidase inhibiting activity under the condition of ensuring lower blood uric acid levels is the main basis for screening product formulas.
Based on the consideration of single drug efficacy and modern research, E4 has relatively low blood uric acid level and xanthine oxidase activity, and E1 has the lowest blood uric acid level and xanthine oxidase activity by combining two indexes of blood uric acid level reducing effect and xanthine oxidase inhibitory activity. Thus, E4 may be selected as the recipe composition and E1 as the optimal recipe composition.
For the blood uric acid, the difference between A3 and A1 is not obvious (the difference is 6.5%), and in consideration of various effects of A (coix seed) (see the design basis of the formula), especially the effects of strengthening spleen, removing arthralgia, eliminating dampness and harmonizing stomach in gout treatment, and the effects of enhancing immunity, easing pain and resisting inflammation in modern researches, A3 with the best xanthine oxidase inhibition activity is selected as the formula.
Whereas B3 and C3 each exhibit significantly lower values relative to the respective other dose levels at the critical indicators of haematuria, B3 and C3 are intended to be selected as formulation compositions.
Considering both the blood uric acid level and xanthine oxidase inhibitory activity, and simultaneously, since D (papaya) is a major factor affecting xanthine oxidase activity, D2 was selected (from the blood uric acid level, only 2.1% higher than the minimum level D1; from the xanthine oxidase inhibitory activity, this is the D level having the lowest xanthine oxidase activity, i.e., the strongest xanthine oxidase inhibitory activity).
By comprehensively considering the two levels and combining the theory of the compositions, the causes and complications of gout and hyperuricemia are fully considered, and finally, the more optimal composition is determined to be A3B3C3D2E4 (namely, 9g of coix seed, 6g of mulberry leaf, 6g of rhizoma polygonati, 1.5g of pawpaw and 4.5g of walnut kernel) (corresponding to 18 parts of coix seed, 12 parts of rhizoma polygonati, 12 parts of mulberry leaf, 3 parts of pawpaw and 9 parts of walnut kernel), and the optimal composition is determined to be A3B3C3D2E1 (namely, 9g of coix seed, 6g of mulberry leaf, 6g of rhizoma polygonati and 1.5g of pawpaw) (corresponding to 18 parts of coix seed, 12 parts of rhizoma polygonati, 12 parts of mulberry leaf and 3 parts of pawpaw).
2. Experimental verification of reducing uric acid by optimal formula
1. Animals and methods were as in example 6. The formulation was prepared according to the optimized formulation (9 g of coix seed, 6g of rhizoma polygonati, 6g of mulberry leaf and 1.5g of papaya per day) determined in example 6, and the formulation was converted into a mouse dosage in the same manner as in example 1.
2. Experimental results
From the experimental results (table 5), the blood uric acid level of the formulation was reduced to a slightly lower level than that of the normal control group. The xanthine oxidase activity is obviously lower than that of a normal control group, which shows that the formula has important significance for fundamentally improving hyperuricemia and treating hyperuricemia and gout from etiology.
TABLE 5 influence of optimal formulation on hyperuricemia mice serum uric acid and xanthine oxidase Activityn＝6)
Note that: compared to the blank, #p <0.01; p <0.01 compared to model group
3. Compared with single medicine, the uric acid reducing effect of the traditional Chinese medicine compound
With reference to the weight ratio and the preparation method of the example 1, the daily doses of coix seed (9 g), rhizoma polygonati (6 g), mulberry leaf (6 g) and papaya (1.5 g) of a human are used together or singly, and the daily doses are converted into the dose of mice, and the extracts are obtained after water decoction, concentration and drying for the experiments of the examples 8 and 9.
1. Animals: SPF-class male Kunming mice with mass of 18-22 g are fed by the university of medical science laboratory animal center of Guizhou, and are well ventilated, at 18-25 ℃, with relative humidity of 40-70%, and with 12h illumination/12 h day and night circulation. License number SCXK (black) 2018-0001. The relevant animal experiments were reviewed by the laboratory animal ethics committee of the university of Guizhou medical science (accession number 2000069).
2. Experimental method
After one week of adaptive feeding, the mice were randomly divided into 8 groups of 8 mice each according to body weight. The normal group, hyperuricemia group (model group), allopurinol positive drug group, example 1 and each single drug group. In addition to the normal control group, the remaining mice were intraperitoneally injected with 100mg/kg of Potassium Oxazinate (PO) at 9:00 a.m. per day, and 500mg/kg of gastric Hypoxanthine (HX) was used to establish a hyperuricemia model. Normal control miceAn equal volume of physiological saline was administered by intraperitoneal injection and lavage. On experiment day 3, the drug administration groups were given the corresponding drugs 1h after molding, respectively. Allopurinol (10 mg/kg) was administered to the positive drug group, and the dose of the drug administered in the group of example 2 was 3.41g/kg in terms of the equivalent dose to mice according to the prescribed dose, and the doses of coix seed, rhizoma Polygonati, mulberry leaf and papaya seed administered daily were 1.36, 0.91 and 0.23g/kg, respectively. The normal control group and hyperuricemia group were administered with equal volumes of physiological saline by gavage. The stomach was irrigated once daily for 5 consecutive days. Before the last administration, the mice are fasted for 24 hours without water forbidden, after the last administration for 1 hour, the eyes of the mice are taken for 1-2mL of blood, the mice are kept stand for 2 hours at room temperature, the mice are centrifuged for 10 minutes, and serum is taken for measuring blood uric acid. Statistical analysis was performed using SPSS 15.0 software, and the data obtained was used as followsThe comparison between groups is shown using the T test. With P<A difference of 0.05 is statistically significant.
3. Experimental results
TABLE 6 influence of Chinese medicinal composition and single medicine on hyperuricemia mice blood uric acid leveln＝8)
Note that: in comparison with the normal control group, # p is less than 0.05; in comparison with the set of models, * P＜0.05， ** P＜0.01
it can be seen from Table 6 that these medicinal and edible herbs have very limited uric acid lowering effect at the dosage of the formulation (most lower than the minimum dosage or the minimum dosage prescribed in the pharmacopoeia), and only Polygonatum sibiricum and Mulberry leaf show remarkable uric acid lowering effect (P < 0.01). However, the combined four medicines have outstanding uric acid reducing effect, compared with the control group, the blood uric acid level is obviously reduced (P is less than 0.01), and the effect is obviously better than that of single administration.
4. Compared with the anti-gouty arthritis effect of single medicine
1. Animals: clean SD rats, male, body weight (200+ -20) g, supplied by the university of medical science laboratory animal center, animal production license number SCXK (Qian) 2018-0001.
2. The method comprises the following steps: SD rats were randomly divided into 8 groups according to body weight, 8 of each group being respectively a normal group, a model group, a colchicine group as a positive drug, example 2 and each single drug group; example 1 groups were administered 3.41g/kg per lavage, and coix seed, rhizoma Polygonati, mulberry leaf and papaya groups were administered daily at 1.36g, 0.91 and 0.23g/kg for each drug. The colchicine as a positive drug is administered at a concentration of 0.135mg/mL and a dosage of 10mL/kg, and normal group and model group are administered with normal physiological saline and model group by gastric lavage for 7d continuously. Before the experiment, a clear straight line is drawn at a position of 0.5mm below the right rear ankle joint of each mouse by using a marker pen so as to be used for measuring the swelling degree of feet. After 1h of administration on the 6 th day, sodium urate is injected into the joint of the right back of the rat to form a mould, the thickness of the joint of the ankle of the right back of each group of rats is measured by a vernier caliper for 2, 6 and 24h before the mould is formed, and the foot swelling degree is calculated. About 5mL of heart blood is taken from a rat, the heart is kept stand at room temperature for 2 hours, then 3000r/min is performed, the heart is centrifuged for 10min, and the supernatant is used for measuring TNF-alpha and IL-1 beta.
3. Experimental results
TABLE 7 influence of Chinese medicinal composition and single medicinal preparation on ankle swelling degree of rats with acute gouty arthritisn＝8)
Note that: compared with the normal control group, the # P is less than 0.05, and the # P is less than 0.01; comparing with model group, P < 0.05, P <0.01
As shown in Table 7, the joint volumes of the 4 groups of rats before molding have no significant difference, and after molding, the model group is compared with the control group, the joint is swollen, and the volume is obviously increased (P is less than 0.01), so that the molding is successful. After 24h of molding, the joint volumes of rats in the colchicine group and the example 1 group (P < 0.01) and the coix seed group (P < 0.05) are obviously smaller than those of the model group (P <0.01 or P < 0.05), the joint swelling of rats in the rhizoma polygonati group, the mulberry leaf group and the papaya group is not obviously improved (P > 0.05), and the foot swelling improvement degree of the example 2 group is obviously better than that of the independent administration group, which shows that the four-medicine combination has more prominent effect of improving gouty arthritis and is obviously better than that of the independent administration.
5. Anti-gouty arthritis effect of traditional Chinese medicine formula
Referring to example 1, the optimal formulation and dosage determined in example 8 were used to determine the formulation and dosage of the traditional Chinese medicine for this experiment.
1. Animals: same as in example 8
2. The method comprises the following steps: SD rats are randomly divided into 4 groups, namely a normal group, a model group, a positive drug colchicine group and a traditional Chinese medicine group; each of the Chinese medicine groups is subjected to gastric lavage administration of 560mg/kg, the administration concentration of colchicine serving as a positive medicine is 0.135mg/mL, the dosage is 10mL/kg, normal groups and model groups are subjected to gastric lavage and other volumes of physiological saline every day, and each group is subjected to continuous gastric lavage administration for 7d. Before the experiment, a clear straight line is drawn at a position of 0.5mm below the right rear ankle joint of each mouse by using a marker pen so as to be used for measuring the swelling degree of feet. After 1h of administration on the 6 th day, sodium urate is injected into the joint of the right back of the rat to form a mould, the thickness of the joint of the ankle of the right back of each group of rats is measured by a vernier caliper for 2, 6 and 24h before the mould is formed, and the foot swelling degree is calculated. About 5mL of heart blood is taken from a rat, the heart is kept stand at room temperature for 2 hours, then 3000r/min is performed, the heart is centrifuged for 10min, and the supernatant is used for measuring TNF-alpha and IL-1 beta.
3. Experimental results
Influence of the Chinese herbal medicine group on the degree of ankle swelling in gouty arthritis rats in Table 8n＝6)
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Note that: in comparison with the normal group, ## P<0.01; in comparison with the set of models, ** P<0.01
TABLE 9 influence of Chinese herbal group on TNF-alpha and IL-1 beta in serum of gouty arthritis ratsn＝6)
Note that: in comparison with the normal group, ## P<0.01; in comparison with the set of models, ** P<0.01
from experimental results (table 8 and table 9), compared with a model group, the Chinese herbal compound group remarkably improves the swelling degree of ankle joints of gouty arthritis rats, and reduces the expression level of inflammatory factors in serum of gouty arthritis rats, so that the formula has remarkable curative effect on gouty arthritis.
6. Clinical observation of reducing uric acid by traditional Chinese medicine compound preparation
The formulation used in this test was the granules prepared in example 4.
Zhou Mou Male, 65 years old, jiangsu Wuxi people. Hyperuricemia and gout for many years. Before taking, creatinine 80. Mu. Mol/L (reference value 53.00-123.00. Mu. Mol/L), serum uric acid level 525. Mu. Mol/L (reference value 170-420. Mu. Mol/L), cholesterol 4.02mmol/L (reference value 2.59-5.17 mmol/L), triglyceride 1.1mmol/L (reference value 0.00-2.30 mmol/L). The granules of example 4 were taken for 4 weeks, after 3 days of withdrawal, creatinine 77. Mu. Mol/L, serum uric acid levels 418. Mu. Mol/L, cholesterol 3.4mmol/L, triglycerides 0.94mmol/L. The compound preparation has outstanding curative effect on hyperuricemia, and can improve renal function, hyperlipidemia and other symptoms.
Claims (9)
1. A traditional Chinese medicine composition for preventing and treating hyperuricemia and gout is characterized by being prepared from the following components in parts by weight: 5-40 parts of coix seed, 3-40 parts of rhizoma polygonati, 3-30 parts of mulberry leaf, 1-20 parts of papaya and 0-20 parts of walnut kernel.
2. The traditional Chinese medicine composition for preventing and treating hyperuricemia and gout according to claim 1, which is characterized by being prepared from the following components in parts by weight: 9-30 parts of coix seed, 5-20 parts of rhizoma polygonati, 5-20 parts of mulberry leaf, 3-15 parts of papaya and 0-15 parts of walnut kernel.
3. The traditional Chinese medicine composition for preventing and treating hyperuricemia and gout according to claim 2, which is characterized by being prepared from the following components in parts by weight: 18 parts of coix seed, 12 parts of rhizoma polygonati, 12 parts of mulberry leaf, 3 parts of papaya and 9 parts of walnut kernel.
4. The traditional Chinese medicine composition for preventing and treating hyperuricemia and gout according to claim 2, which is characterized by being prepared from the following components in parts by weight: 18 parts of coix seed, 12 parts of rhizoma polygonati, 12 parts of mulberry leaf and 3 parts of papaya.
5. Use of a Chinese medicinal composition according to any one of claims 1-4 in the preparation of a pharmaceutical preparation for preventing and treating hyperuricemia and gout.
6. The use of the Chinese medicinal composition according to claim 5 for preparing pharmaceutical preparations for preventing and treating hyperuricemia and gout, wherein the pharmaceutical preparations are prepared by combining the Chinese medicinal composition with pharmaceutically acceptable auxiliary materials.
7. Use of a Chinese medicinal composition according to any one of claims 1-4 for the preparation of a food product for aiding in the reduction of uric acid.
8. A pharmaceutical preparation for preventing and treating hyperuricemia and gout, which is characterized by being prepared from the traditional Chinese medicine composition according to any one of claims 1 to 4.
9. A food for assisting in reducing uric acid, characterized by being prepared from the traditional Chinese medicine composition according to any one of claims 1 to 4.
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| CN105169096A (en) * | 2014-08-06 | 2015-12-23 | 成都中医药大学附属医院 | Medicine composition for treating gout or/and hyperuricemia |
| CN109820971A (en) * | 2019-02-24 | 2019-05-31 | 通化师范学院 | A kind of drug with antigout effect |
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| CN105169096A (en) * | 2014-08-06 | 2015-12-23 | 成都中医药大学附属医院 | Medicine composition for treating gout or/and hyperuricemia |
| CN109820971A (en) * | 2019-02-24 | 2019-05-31 | 通化师范学院 | A kind of drug with antigout effect |
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| 中医药治疗痛风近况;陈元戈;广西中医药;第21卷(第01期);47-50 * |
| 健脾化湿泄浊法治疗原发性高尿酸血症35例的疗效观察;孙丽娜;王丽英;李学军;杨叔禹;;中医药通报;第05卷(第06期);42-45 * |
| 具有降尿酸功效的食品研究进展;张瑛毓;付劢;范海茹;张丽静;王凤忠;;中国食物与营养;第26卷(第01期);50-53 * |
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