CN115607634A - 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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- CN115607634A CN115607634A CN202211235455.2A CN202211235455A CN115607634A CN 115607634 A CN115607634 A CN 115607634A CN 202211235455 A CN202211235455 A CN 202211235455A CN 115607634 A CN115607634 A CN 115607634A
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Abstract
The invention belongs to the technical field of traditional Chinese medicine compound, and particularly 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 seeds, 3-40 parts of rhizoma polygonati, 3-30 parts of mulberry leaves, 1-20 parts of pawpaw and 0-20 parts of walnut kernels. The raw materials of the traditional Chinese medicine composition are all medicinal and edible traditional Chinese medicines, the safety is high, adverse effects cannot be generated after long-term sufficient administration, the traditional Chinese medicine composition can be prepared into medicinal preparations or foods by adopting a conventional preparation method, and pharmacological research and clinical application show that the traditional Chinese medicine composition has obvious effects of treating hyperuricemia and gout. In view of the fact that the number of people suffering from metabolic disorder related diseases caused by hyperuricemia and uric acid rise is large, and the compound preparation or food prepared from the traditional Chinese medicine composition has the characteristics of no toxicity and long-term taking, the traditional Chinese medicine composition provided by the invention has a good application prospect.
Description
Technical Field
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.
Background
Gout is a crystal-related arthropathy caused by the deposition of monosodium urate caused by long-term hyperuricemia, is manifested by red swelling and pain of joints, and severe cases can cause the movement disorder of the joints and the damage of kidneys, and belongs to immune-related diseases.
Hyperuricemia is usually caused by excessive Uric Acid (UA) secretion or insufficient excretion in the body, and is proved to be a key factor causing gout, renal insufficiency, hypertension, hyperlipidemia, diabetes, obesity and the like. Therefore, early prevention and treatment of hyperuricemia is of great significance 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 high uric acid in China is up to 1.8 hundred million, and the number of the patients is continuously increased at present. Serum Uric Acid (SUA) level in vivo is higher than 6.0mg/dL for a long time, and sodium urate (MSU) crystals can deposit on body parts (such as joints and soft tissues), so that acute arthritis is induced, and the crystal becomes one of key factors causing gout. Reducing hyperuricemia in the body and developing gouty arthritis treatment are two strategies for gout treatment. The reduction of the blood uric acid level and the prevention and treatment of hyperuricemia are the control developed aiming at the gout etiology and become the effective means for treating gout.
The existing medicines for reducing uric acid mainly comprise xanthine oxidase inhibitors allopurinol, non-bestatin and the like for controlling the production of uric acid, probenecid, benzbromarone and the like for promoting the excretion of uric acid. Among them, allopurinol and febuxostat are clinically used as first-line drugs, and both drugs are also limited due to the existence of renal impairment or cardiovascular death risk. The benzbromarone and other medicines have more side effects, which can cause hyponatrium, hypokalemia and hypokalemia, and have obvious side effects on liver and kidney, so that the benzbromarone and other medicines are not suitable for long-term use. The use of non-steroidal anti-inflammatory drugs, colchicine and analgesics is a common drug for treating acute gouty arthritis, but the drugs have prominent side effects and are not suitable for long-term administration. Therefore, the search for safe and effective medicaments with urine reducing effect and anti-gouty arthritis effect suitable for long-term administration is urgent.
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-food homologous traditional Chinese medicine is determined, and the medicine is suitable for long-term administration. Researches find that a plurality of medicinal and edible traditional Chinese medicines have prominent effects on preventing and treating hyperuricemia and gout and have been widely applied in practice.
At present, some related traditional Chinese medicine formula researches are carried out, for example, a patent document with a publication number of CN109674958A discloses a traditional Chinese medicine composition with the efficacy of reducing uric acid, and a preparation method and application thereof, wherein the traditional Chinese medicine composition is prepared from 20-80 parts of tuckahoe, 20-60 parts of coix seed, 5-20 parts of gardenia, 5-20 parts of peach kernel, 5-20 parts of pawpaw, 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 leaf and 2-15 parts of ginseng. The patent document with the publication number of CN109010655A discloses a medicine-food homologous 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 components are all prepared from multiple medicinal materials, the types of the medicinal materials are multiple, and the medicinal materials interact with each other, so that the side effects of the medicines are easy to appear.
In view of the pathogenesis and complications of gout, on the basis of enhancing immunity and improving liver and kidney functions, the gout treatment strategy is to reduce blood uric acid levels (including inhibiting uric acid generation and promoting uric acid excretion), control inflammation, improve complications (including treatment on ischemic heart disease, obesity, hyperlipidemia, diabetes and hypertension) and prevent body dysfunction.
On the basis, a medicine-food homologous traditional Chinese medicine compound capable of preventing and treating hyperuricemia and gout is optimized and screened, and the hyperuricemia can be safely and effectively controlled, and the symptoms of gout and complications thereof can be relieved.
Disclosure of Invention
In order to solve the problems, the first object 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 as main manifestations.
The second purpose of the invention is to provide application of the traditional Chinese medicine composition in preparation of medicines or foods for preventing and treating hyperuricemia and gout.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
gout is mainly manifested by long-term hyperuricemia and gouty arthritis, and the hyperuricemia is mainly characterized by over-production of uric acid and difficult excretion. Therefore, an effective strategy for controlling gout is to inhibit uric acid production, promote uric acid excretion or decomposition, and perform analgesic and anti-inflammatory therapy. Because uric acid decomposition depends on uricase, the cost is high, the use is inconvenient, the traditional Chinese medicine with xanthine oxidase inhibiting effect, diuresis effect, anti-inflammatory and analgesic effects is screened from the medicine-food homologous traditional Chinese medicine, and the effective gout treatment and uric acid reducing compound is screened through scientific experimental design.
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 seeds, 3-40 parts of rhizoma polygonati, 3-30 parts of mulberry leaves, 1-20 parts of pawpaw and 0-20 parts of walnut kernels.
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 seeds, 5-20 parts of sealwort, 5-20 parts of mulberry leaves, 3-15 parts of pawpaw and 0-15 parts of walnut kernels.
More preferably, the traditional Chinese medicine composition for reducing uric acid and preventing and treating hyperuricemia and gout is prepared from the following components in parts by weight: 18 parts of coix seeds, 12 parts of sealwort, 12 parts of mulberry leaves, 3 parts of pawpaw and 9 parts of walnut kernels.
Most preferably, the traditional Chinese medicine composition for reducing uric acid and preventing and treating hyperuricemia and gout is prepared from the following components in parts by weight: 18 parts of coix seeds, 12 parts of sealwort, 12 parts of mulberry leaves and 3 parts of pawpaw.
The traditional Chinese medicine composition is used for preparing medicines for treating or preventing various symptoms such as hyperuricemia mainly manifested by hyperuricemia and gout mainly manifested by hyperuricemia and gouty arthritis.
The invention also provides a preparation of the traditional Chinese medicine composition as a medicine and a form of a food. The preparation used as the medicine can be prepared into the common medicine dosage forms of compound decoction oral administration, granules, tablets, medicinal granules, powder, capsules, oral liquid, dripping pills, nasal feeding, anal suppository, rectal lavage, local external administration, navel pasting, chinese medicine fumigation, external foot bath and the like by adopting the conventional preparation method in the field; the food can be prepared into tea bag, liquid or solid beverage, special nutritious food, etc.
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 has definite curative effect and high safety in treating hyperuricemia and gout, can slow down adverse reaction possibly brought by western medicines, and makes up for limited action of certain traditional Chinese medicine formulas in clinic at present.
The hyperuricemia is classified into the categories of 'arthralgia syndrome', 'calendar festival' and the like in traditional Chinese medicine, and the causes of the hyperuricemia are related to the congenital deficiency, the deficiency of the liver, spleen and kidney to cause the malnutrition of tendons and vessels, or the spleen and stomach are caused to lose transport and transformation due to overeating, the dampness and the turbidity are accumulated and heat is transformed, and the body fluid is decocted into phlegm. Phlegm-fluid retention, damp turbidity flowing into the blood vessels and between the muscles can cause hyperuricemia due to accumulation of phlegm and saliva, failure of ascending of clear yang, failure of descending of turbid yin and failure of qi activity regulation. In a word, the traditional Chinese medicine pathogenesis of the hyperuricemia is characterized in that deficiency does not leave spleen and kidney, excess does not leave phlegm, dampness, stasis and heat exchange resistance, and belongs to the symptoms of deficiency and excess. Therefore, the treatment idea of the invention is as follows: based on the root cause of hyperuricemia, the Chinese medicinal composition treats both the root cause and the deficiency from strengthening the spleen and tonifying the kidney through the compatibility of pure natural and medicinal and edible Chinese medicinal herbs.
The traditional Chinese medicine composition provided by the invention is prepared from five medicinal and edible traditional Chinese medicines such as coix seed, rhizoma polygonati, mulberry leaf, pawpaw, walnut kernel and the like. The formation of the formula is based on the nature, flavor, channel tropism and efficacy application of the traditional Chinese medicine, according to the results of modern pharmacology and clinical research, dialectical analysis, meticulous selection of the formula, and the formula optimization and the efficacy verification. The coix seeds in the formula are sweet, bland and cool in nature, enter spleen, stomach and lung channels, and have the effects of promoting diuresis, removing dampness, invigorating spleen, relieving diarrhea, removing arthralgia, expelling pus, removing toxin and dissipating stagnation; it is commonly used for edema, beriberi, dysuria, spleen deficiency, diarrhea, damp arthralgia, spasm, pulmonary abscess, intestinal abscess, wart and cancer. Modern pharmacological research shows that the coix seed has the pharmacological activities of enhancing immunity, resisting tumors, easing pain, resisting inflammation, regulating glycolipid metabolism, reducing blood pressure, resisting oxidation, resisting aging, whitening and the like. Sealwort is sweet in nature and neutral, and enters spleen, lung and kidney meridians; has effects in invigorating qi, nourishing yin, invigorating spleen, moistening lung, and invigorating kidney; it is commonly indicated for deficiency of spleen-stomach qi, fatigue, stomach yin deficiency, dry mouth, poor appetite, lung deficiency, dry cough, hemoptysis, essence and blood deficiency, soreness and weakness of waist and knees, premature graying of hair, internal heat and diabetes. Modern pharmacological research shows that the sealwort has the functions of regulating immunity, protecting kidney, resisting tumor, regulating blood sugar, resisting bacteria, diminishing inflammation, preventing cardiovascular and cerebrovascular diseases, resisting aging, improving cognitive disorder, preventing osteoporosis, protecting liver and the like, and also has the inhibitory effect of xanthine oxidase. Mulberry leaves are sweet, bitter and cold in nature and enter lung and liver meridians; has effects of dispelling pathogenic wind and heat, clearing lung-heat, moistening dryness, clearing liver-fire and improving eyesight; it is commonly used for wind-heat type common cold, lung heat dry cough, dizziness, headache, conjunctival congestion and blurred vision. Modern pharmacological research shows that mulberry leaves have the biological activities of reducing blood sugar, resisting inflammation, resisting bacteria, resisting virus, resisting aging, resisting cancer, reducing blood pressure, reducing blood fat, relaxing the bowels, promoting urination and the like, and also have the inhibitory activity of xanthine oxidase. The pawpaw is sour and warm, enters liver and spleen channels, and has the effects of relaxing tendons, activating collaterals, harmonizing stomach and eliminating dampness. It is commonly used for spasm of damp arthralgia, soreness and pain of waist and knee joint, vomiting and diarrhea due to summer-heat and dampness, spasm and pain of tendon, and edema of beriberi. Modern pharmacological research shows that the pawpaw has pharmacological activities of analgesia, anti-inflammation, immunity enhancement, liver protection, gastric ulcer and intestinal injury resistance, tumor resistance and the like. The walnut kernels are sweet in nature and warm, enter kidney, lung and large intestine channels, and have the effects of tonifying kidney, warming lung and lubricating intestines. It is indicated for kidney yang deficiency, soreness and weakness of loins and knees, impotence, seminal emission, dyspnea and cough due to deficiency cold, constipation due to intestinal dryness. Modern pharmacological research shows that the walnut kernel has the effects of enhancing resistance, resisting oxidation, strengthening brain, protecting health, resisting bacteria, resisting tumors, resisting fatigue, reducing blood sugar and the like.
The five medicinal and edible traditional Chinese medicines are combined, the coix seeds are used as monarch medicines, the spleen and stomach are strengthened, the arthralgia is removed, the sealwort is used as minister medicines for strengthening the spleen and tonifying the kidney, and the monarch medicines and the minister medicines are compatible for tonifying the spleen and tonifying the kidney. The pawpaw has the effects of relaxing tendons, activating collaterals, harmonizing stomach, eliminating dampness, assisting the coix seed to strengthen spleen and stomach and eliminating arthralgia; the walnut kernels tonify the kidney and enhance the kidney-tonifying effect of the sealwort; the mulberry leaves, which have the effects of dispelling wind and clearing heat, are used as adjuvant drugs. The medicines are combined to strengthen the spleen and stomach, nourish the liver and kidney, eliminate dampness and dredge collaterals, thereby achieving the effect of treating the root cause and tonifying deficiency.
According to the modern pharmacological research idea, the coix seed in the formula enhances the immunity of the organism, and improves the complications of gout and hyperuricemia by inhibiting gouty arthritis, regulating glycolipid metabolism, lowering blood pressure and the like; rhizoma polygonati can assist in enhancing the immunity of the organism, improving the kidney function and inhibiting the generation of uric acid, fundamentally treat hyperuricemia and gout, assist in improving gouty arthritis through anti-inflammatory action, and improve complications through preventing cardiovascular and cerebrovascular diseases, protecting liver and the like; the mulberry leaves can reduce the blood uric acid level through the actions of inhibiting the generation of uric acid and promoting the excretion of uric acid, improve gouty arthritis through the anti-inflammatory action, and improve the complications of gout and hyperuricemia through the actions of reducing blood sugar, blood pressure, blood fat and the like; the pawpaw can improve the body function by enhancing the immunity, easing the pain and resisting the inflammation, and plays a role in resisting the gouty arthritis; the semen Juglandis has effects of improving renal function, improving the ability of resisting gout and hyperuricemia, and improving complications.
According to the invention, the composition is ingenious according to the root cause and complications generated by hyperuricemia, the compatibility of the components enhances the metabolic function of the spleen and stomach in the middle jiao, accelerates the excretion of metabolic waste, enables the endogenous metabolic imbalance state in the body to be rapidly recovered, effectively inhibits the generation of uric acid by recovering and enhancing the function of the human body, accelerates the excretion of uric acid, controls the complications, treats both the symptoms and root causes, and achieves the purpose of treating hyperuricemia and gout.
The traditional Chinese medicine composition is derived from a medicine-food dual-purpose traditional Chinese medicine, the dosage is lower than the dosage specified in pharmacopeia or used in a low dosage range, and the traditional Chinese medicine composition has the safety guarantee of long-term taking.
Due to the adoption of 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 research and clinical application show that the traditional Chinese medicine composition has a remarkable effect of treating hyperuricemia and gout.
The raw materials of the traditional Chinese medicine composition provided by the invention are medicinal and edible traditional Chinese medicines, the safety is high, adverse effects cannot be generated after long-term sufficient taking, and in view of the fact that the number of people with metabolic disorders related to hyperuricemia and uric acid rise is large, a compound preparation or food prepared from the traditional Chinese medicine composition provided by the invention has the characteristics of no toxicity and long-term taking, and the traditional Chinese medicine composition provided by the invention has a good application prospect.
The traditional Chinese medicine composition has the advantages of low price of raw materials, simple and convenient preparation, convenient use, low cost and convenient application.
Detailed Description
In order to more clearly illustrate the present invention, the present invention is further described below in conjunction with preferred embodiments. It is to be understood by persons skilled in the art that the following detailed description is intended to be illustrative and not restrictive, and is not intended to limit the scope of the invention.
Example 1
Weighing the traditional Chinese medicines according to 18 parts of coix seeds, 12 parts of rhizoma polygonati, 12 parts of mulberry leaves and 3 parts of pawpaw, adding 10 times of water, decocting for 1 hour, filtering, adding the same amount of water, decocting for 1 hour, filtering, combining the water decoctions, concentrating, drying and crushing to obtain the extract. The extract can be directly packaged, taken with water or made into various Chinese medicinal preparations or foods.
Example 2
Weighing the traditional Chinese medicines according to 18 parts of coix seeds, 12 parts of rhizoma polygonati, 12 parts of mulberry leaves, 3 parts of pawpaw and 9 parts of walnut kernels, adding 10 times of water, decocting for 1 hour, filtering, adding the same amount of water, decocting for 1 hour, filtering, combining the water decoctions, concentrating, drying and crushing to obtain the extract. The extract can be directly packaged, taken with water or made into various Chinese medicinal preparations or foods.
Example 3
Weighing the traditional Chinese medicines of 20 parts of coix seeds, 10 parts of rhizoma polygonati, 9 parts of mulberry leaves, 5 parts of pawpaw and 3 parts of walnut kernels, adding 10 times of water, decocting for 1 hour, filtering, adding the same amount of water, decocting for 1 hour, filtering, combining the water decoctions, concentrating, drying and crushing to obtain the 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 by the method in the embodiment 1 is added with 200g of dextrin, evenly mixed, added with a proper amount of 60 percent ethanol to prepare a soft material, sieved by a 24-mesh sieve for granulation, dried at 50 ℃ for 2 hours, sieved by a 30-mesh sieve for granulation, and subpackaged to obtain the granular preparation.
Example 5 preparation of Special Nutrition food
Adding 200g dextrin into 100g of the extract prepared in the example 1, adding enough carbohydrates (such as cane sugar and dietary fiber), vitamin C (added according to 80mg per day) and D (added according to 8mg per day) according to the content of the carbohydrates, uniformly mixing, and drying at 50 ℃ for 2 hours to obtain the energy-supplementing sports nutritional food which is beneficial to reducing uric acid and supplementing energy.
1. Optimization experiment of Chinese herbal compound compatibility
1. Animals: the SPF male Kunming mouse, with the body mass of 18-22 g, is provided by the experimental animal center of Guizhou medical university and is raised in good ventilation, the temperature is 18-25 ℃, the relative humidity is 40-70%, and the illumination is 12 h/day and night circulation is 12 h. License number SCXK (Qian) 2018-0001. The relevant animal experiments were reviewed by the ethical committee on laboratory animals of the university of medical, guizhou (accession number 2000069).
2. Experimental methods
Mice were acclimatized for one week and then randomly assigned to 6 mice per group by weight. Respectively a normal group, a hyperuricemia group, a positive allopurinol group and different traditional Chinese medicine prescription groups. Except for the normal control group, the remaining mice were intraperitoneally injected with 100mg/kg of Potassium Oxonate (PO) and 500mg/kg of intragastric Hypoxanthine (HX) for establishing a hyperuricemia model at 9. Normal control mice were injected intraperitoneally and gavaged with an equal volume of saline. On the 3 rd day of the experiment, the administration group was administered with the corresponding drugs 1h after molding. Allopurinol (10 mg/kg. D) is administered to the positive drug group, the administration doses of different proportion groups of the traditional Chinese medicine prescription are converted into equivalent doses of mice according to the prescription dose (the proportions of different components are matched according to an orthogonal design table in the result), and the normal control group and the hyperuricemia group are intragastrically administered with physiological saline with the same volume. The administration is carried out once a day for 5 days. Before the last administration, fasting is carried out for 24h without water prohibition, 1-2mL of blood is taken from the eye orbit of the mouse after 1h of the last administration, the mouse is kept stand at room temperature for 2h,3000r/min and centrifuged for 10min, and serum is taken for measuring blood uric acid and XOD.
Experiments were designed with the different formulations at the 5-factor 4 level of table 1 and the single daily dose was determined after conversion to mouse dose according to the table below.
TABLE 1 factor horizon
3. Results of the experiment
The results of the assay for the levels of uric acid and xanthine oxidase activity and the analysis of variance are shown in tables 2 and 3, respectively.
TABLE 2 orthogonal experimental design and results
Note: compared to the blank group (i.e. sample 1 group), ## P<0.01; in comparison with the set of models, * P<0.05， ** P<0.01
TABLE 3 ANOVA (blood uric acid level)
TABLE 4 ANOVA (xanthine oxidase Activity)
As can be seen from Table 2, the Chinese medicinal formulas with different proportions have obvious effect of reducing uric acid, and the uric acid reducing effect of the plurality of the formulas has correlation with the activity of reducing xanthine oxidase.
According to the size of the range R, the main and secondary sequence of the influence of various factors on the blood uric acid is as follows: a (coix seed) > C (sealwort) > E (walnut kernel) > D (pawpaw) > B (mulberry leaf), and the influence of A factor (P = 0.000), C factor (P = 0.000) and E factor (P < 0.005) on uric acid level can be seen according to variance analysis (Table 3) and has significant significance. It is demonstrated that A (coix seed), C (sealwort) and E (walnut kernel) are the main factors affecting the level of hematuria.
According to the size of the range R, the main and secondary sequences of the influence of various factors on xanthine oxidase are as follows: d (pawpaw) > C (sealwort) > A (coix seed) > E (walnut kernel) > B (mulberry leaf), and according to the analysis of variance (table 4), the influence of a D factor (P is less than 0.05) on the activity of xanthine oxidase has significant significance. The D (pawpaw) is a main factor influencing the xanthine oxidase activity in the formula.
As can be seen from table 2, A1B3C3D1E1 is the best formulation from the standpoint of uric acid levels, with the lowest uric acid levels, but A3B2C3D2E1 is the best formulation from the standpoint of xanthine oxidase inhibition, with the lowest xanthine oxidase activity.
For gout and hyperuricemia, the effect of reducing uric acid is a priority, and the strong and weak xanthine oxidase inhibition shows the effect of fundamentally inhibiting the generation of uric acid, so the method has important significance for treating gout and hyperuricemia. Because the factors influencing the blood uric acid level are more, the means for reducing the uric acid level are correspondingly more (such as inhibiting the uric acid generation, promoting the uric acid excretion by drinking a large amount of water and the like), but the uric acid level is reduced by fundamentally inhibiting the uric acid generation, the influence of external factors such as the water drinking amount and the like on the uric acid reducing effect can be eliminated, and therefore the xanthine oxidase inhibitor is most effective for most patients (the point can be explained by the fact that most of first-line chemical drugs on the market are xanthine oxidase inhibitors at present), and therefore, the retention of the lower xanthine oxidase inhibition activity under the condition of ensuring the lower blood uric acid level is the main basis for screening the product formula.
On the basis of considering single medicine efficacy and modern research, by combining two indexes of blood uric acid level reduction effect and xanthine oxidase inhibition activity, 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. Thus, E4 may be selected as the formulation composition and E1 as the optimal formulation composition.
For blood uric acid, the difference between A3 and A1 is not obvious (6.5 percent), and considering various effects of A (coix seed) (see formula design basis), 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 research, the A3 with the best xanthine oxidase inhibitory activity is selected as the formula.
Given that B3 and C3 show significantly lower values relative to the respective other dose levels on the key indicator of blood uric acid, B3 and C3 are to be selected as formulation constituents.
The combination of the blood uric acid level and the xanthine oxidase inhibitory activity was considered, and D2 was selected because D (papaya) is a major factor affecting the xanthine oxidase activity (from the viewpoint of blood uric acid level, it is only 2.1% higher than the lowest level D1; from the viewpoint of xanthine oxidase inhibitory activity, it is the D level having the lowest xanthine oxidase activity, i.e., the most potent xanthine oxidase inhibitory activity).
The two levels are comprehensively considered, the theory of the formula is combined, the etiology and complications of gout and hyperuricemia are fully considered, the optimized formula is A3B3C3D2E4 (namely coix seed 9g, mulberry leaf 6g, sealwort 6g, pawpaw 1.5g and walnut kernel 4.5 g) (corresponding to coix seed 18 parts, sealwort 12 parts, mulberry leaf 12 parts, pawpaw 3 parts and walnut kernel 9 parts), and the optimized formula is A3B3C3D2E1 (namely coix seed 9g, mulberry leaf 6g, sealwort 6g and pawpaw 1.5 g) (corresponding to coix seed 18 parts, sealwort 12 parts, mulberry leaf 12 parts and pawpaw 3 parts).
2. Experimental verification for reducing uric acid by optimal formula
1. Animals and methods were as in example 6. The formulation was prepared in the same manner as in example 1, except that the optimized formulation determined in example 6 (each person had 9g of coix seed, 6g of polygonatum rhizome, 6g of mulberry leaf and 1.5g of pawpaw per day) was converted into a mouse dose.
2. Results of the experiment
From the experimental results (table 5), the blood uric acid level of the formulation is remarkably reduced to a level slightly lower than that of the normal control group. The xanthine oxidase activity is more 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 causes.
TABLE 5 Effect of optimal formulation on the Activity of serum uric acid and xanthine oxidase in hyperuricemic mice: (
n＝6)
Note: # P <0.01 compared to blank; p <0.01 in comparison with model groups
3. The uric acid reducing effect of the Chinese medicinal composition is compared with that of single Chinese medicinal composition
Referring to the weight ratio and preparation method of example 1, the daily dosage of human coix seed (9 g), polygonatum rhizome (6 g), mulberry leaf (6 g) and pawpaw (1.5 g) are used in combination or singly used, and converted into the dosage of mouse, and the extract is obtained after water decoction, concentration and drying, and then the experiments of example 8 and example 9 are carried out.
1. Animals: the SPF male Kunming mouse, with the body mass of 18-22 g, is provided by the experimental animal center of Guizhou medical university and is raised in good ventilation, the temperature is 18-25 ℃, the relative humidity is 40-70%, and the illumination is 12 h/day and night circulation is 12 h. License number SCXK (Qian) 2018-0001. The relevant animal experiments were reviewed by the ethical committee on laboratory animals of the university of medical, guizhou (accession number 2000069).
2. Experimental method
After one week of adaptive feeding, the mice were randomly divided into 8 groups of 8 mice each by weight. The treatment is performed on a normal group, a hyperuricemia group (model group), a positive allopurinol group, example 1 and each single-ingredient medicine group. Except for the normal control group, the other mice were intraperitoneally injected with 100mg/kg of Potassium Oxonate (PO) and 500mg/kg of intragastric Hypoxanthine (HX) for establishing a hyperuricemia model at 9. Normal control mice were injected intraperitoneally and gavaged with an equal volume of saline. On the 3 rd day of the experiment, the administration group was administered with the corresponding drugs 1h after molding. Allopurinol (10 mg/kg) is administered in the positive drug group, the administration dosage of the group in example 2 is converted into the equivalent dosage of mice of 3.41g/kg according to the prescription dosage, and the daily administration dosages of the group of coix lachryma-jobi seed, rhizoma polygonati, mulberry leaf and pawpaw are respectively 1.36, 0.91 and 0.23g/kg. The normal control group and the hyperuricemia group were intragastrically administered with an equal volume of physiological saline. The administration is carried out once a day for 5 days. Before the last administration, fasting is carried out for 24h without water prohibition, blood is taken from eye sockets of the mice for 1-2mL after the last administration for 1h, the mice are stood for 2h at room temperature, 3000r/min and centrifuged for 10min, and serum is taken for blood uric acid determination. Statistical analysis was performed using SPSS 15.0 software, and the data obtained were analyzed using a computer
Indicated, the group comparisons were performed using the T test. With P<A difference of 0.05 is statistically significant.
3. Results of the experiment
TABLE 6 influence of the Chinese medicinal composition and single herb on the level of uric acid in hyperuricemia mice: (
n＝8)
Note: compared with the normal control group, # p is less than 0.05; compared with the model group, the model group is compared, * P＜0.05， ** P＜0.01
as can be seen from table 6, under the dosage of the formula (mostly lower than the minimum dosage or the minimum dosage specified in pharmacopoeia), the uric acid reducing effect of the medicinal and edible traditional Chinese medicines is very limited, and only rhizoma polygonati and folium mori show obvious uric acid reducing effect (P is less than 0.01). However, the effect of reducing uric acid by combining the four medicines is more prominent, the blood uric acid level is obviously reduced (P is less than 0.01) compared with the control group, and the effect is obviously better than that of single administration.
4. The effect of the Chinese medicinal composition on treating gouty arthritis is compared with that of the single Chinese medicinal composition
1. Animals: clean grade SD rat, male, body weight (200 + -20) g, provided by Experimental animals center of Guizhou medical university, animal production license number SCXK (Gui) 2018-0001.
2. The method comprises the following steps: the SD rats are randomly divided into 8 groups according to the weight, each group comprises 8 rats, namely a normal group, a model group, a positive drug colchicine group, an example 2 and each single-herb group; example 1 groups were administered 3.41g/kg per gavage, while the daily dose of the group of Coicis semen, rhizoma Polygonati, folium Mori and fructus Chaenomelis was 1.36g 0.91, 0.91 and 0.23g/kg respectively. The administration concentration of the positive colchicine is 0.135mg/mL, the dosage is 10mL/kg, the normal group and the model group are irrigated with the same volume of physiological saline every day, and each group is continuously irrigated with stomach for 7d. Before the experiment, a clear straight line is drawn at a position 0.5mm below the right rear ankle joint of each mouse by using a marking pen for measuring the foot swelling and distension. After administration for 1h on day 6, sodium urate is injected into the right rear joint of the rat for model making, and the thickness of the right rear ankle joint of each group of rats at the position of 0.5mm below the right rear ankle joint of each group of rats is measured by a vernier caliper before model making and 2, 6 and 24h after model making, so as to calculate the foot swelling degree. Blood is taken from heart of a rat by about 5mL, the rat is stood for 2 hours at room temperature and then is centrifuged at 3000r/min for 10min, and supernatant is taken and used for measuring TNF-alpha and IL-1 beta.
3. Results of the experiment
TABLE 7 influence of the Chinese medicinal composition and single herb on the degree of swelling of ankle joint of rats with acute gouty arthritis: (
n＝8)
Note: compared with the normal control group, # P < 0.05, # P <0.01; comparison with model group, P < 0.05, P <0.01
As shown in Table 7, the joint volumes of the rats in the 4 groups before molding have no significant difference, and after molding, compared with the control group, the model group has the symptoms of joint swelling and obvious volume increase (P is less than 0.01), which indicates that molding is successful. After 24 hours of molding, the joint volume of rats in the positive drug colchicine group and the example 1 group (P is less than 0.01) and the coix seed group (P is less than 0.05) is obviously smaller than that of the model group (P is less than 0.01 or P is less than 0.05), the joint swelling of rats in the rhizoma polygonati group, the mulberry leaf group and the pawpaw group is not obviously improved (P is more than 0.05), and the improvement degree of the foot swelling of the example 2 group is obviously better than that of the single drug group, which shows that the effect of the four drugs on improving the gouty arthritis is more prominent and obviously better than that of the single drug administration.
5. Anti-gouty arthritis effect of traditional Chinese medicine formula
Referring to example 1, the prescription and dose of the Chinese medicine used in the present experiment were determined according to the optimal prescription and dose determined in example 8.
1. Animals: same as example 8
2. The method comprises the following steps: the 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; 560mg/kg is administrated by each intragastric administration of the traditional Chinese medicine, the administration concentration of the positive colchicine is 0.135mg/mL, the dosage is 10mL/kg, the normal group and the model group are administrated by intragastric administration of the same volume of normal saline every day, and each group is administrated by continuous intragastric administration for 7d. Before the experiment, a clear straight line is drawn at a position 0.5mm below the right rear ankle joint of each mouse by using a marking pen for use when measuring the foot swelling degree. After administration for 1h on day 6, sodium urate is injected into the right posterior joints of rats for molding, and the thickness of 0.5mm below the right posterior ankle joints of each group of rats is measured by a vernier caliper 2, 6 and 24h before molding, so as to calculate the foot swelling degree. Blood is taken from rat heart about 5mL, after standing for 2h at room temperature, 3000r/min, centrifugation is carried out for 10min, and supernatant is taken for measuring TNF-alpha and IL-1 beta.
3. Results of the experiment
TABLE 8 influence of Chinese medicinal group on swelling degree of ankle joint of rat with gouty arthritis: (
n＝6)
Note: in comparison with the normal group, ## P<0.01; in comparison with the set of models, ** P<0.01
TABLE 9 Effect of Chinese herbal groups on TNF-alpha and IL-1 beta in the serum of gouty arthritis rats: (
n＝6)
Note: as compared with the normal group, the test results, ## P<0.01; in comparison with the set of models, ** P<0.01
from the experimental results (tables 8 and 9), compared with the model group, the traditional Chinese medicine compound group obviously improves the swelling degree of ankle joints of rats with gouty arthritis, and regulates the expression level of inflammatory factors in serum of rats with gouty arthritis, which indicates that the formula has obvious curative effect on gouty arthritis.
6. Clinical observation of Chinese herbal medicine compound preparation for reducing uric acid
The formulation used in this test was the granulate prepared in example 4.
Zhou Zhi, male, 65 years old, jiangsu Wuxi. Hyperuricemia and gout have been known for many years. Checking before taking medicine, creatinine 80 μmol/L (reference value 53.00-123.00 μmol/L), serum uric acid level 525 μmol/L (reference value 170-420 μmol/L), cholesterol 4.02mmol/L (reference value 2.59-5.17 mmol/L), and triglyceride 1.1mmol/L (reference value 0.00-2.30 mmol/L). After taking the granules of example 4 for 4 weeks and stopping taking the granules for 3 days, creatinine of 77 mu mol/L, serum uric acid level of 418 mu mol/L, cholesterol of 3.4mmol/L and triglyceride of 0.94mmol/L are detected. The compound preparation has outstanding curative effect on hyperuricemia and may improve renal function, hyperlipemia and other symptoms.
Claims (7)
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 seeds, 3-40 parts of rhizoma polygonati, 3-30 parts of mulberry leaves, 1-20 parts of pawpaw and 0-20 parts of walnut kernels.
2. The traditional Chinese medicine composition for preventing and treating hyperuricemia and gout of claim 1, wherein 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 seeds, 5-20 parts of rhizoma polygonati, 5-20 parts of mulberry leaves, 3-15 parts of pawpaw and 0-15 parts of walnut kernels.
3. The traditional Chinese medicine composition for preventing and treating hyperuricemia and gout of claim 2, wherein the traditional Chinese medicine composition for preventing and treating hyperuricemia and gout is prepared from the following components in parts by weight: 18 parts of coix seeds, 12 parts of sealwort, 12 parts of mulberry leaves, 3 parts of pawpaw and 9 parts of walnut kernels.
4. The traditional Chinese medicine composition for preventing and treating hyperuricemia and gout of claim 2, wherein the traditional Chinese medicine composition for preventing and treating hyperuricemia and gout is prepared from the following components in parts by weight: 18 parts of coix seeds, 12 parts of sealwort, 12 parts of mulberry leaves and 3 parts of pawpaw.
5. Use of the Chinese medicinal composition of any one of claims 1-4 in the preparation of pharmaceutical preparations and foods for preventing and treating hyperuricemia and gout.
6. The application of the traditional Chinese medicine composition in preparing medicinal preparations and foods for preventing and treating hyperuricemia and gout according to claim 5, wherein the medicinal preparation is prepared by combining the traditional Chinese medicine composition with pharmaceutically acceptable auxiliary materials.
7. A pharmaceutical preparation and food for preventing and treating hyperuricemia and gout, which is characterized by being prepared from the Chinese medicinal composition of 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 |
Non-Patent Citations (3)
| Title |
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| 孙丽娜;王丽英;李学军;杨叔禹;: "健脾化湿泄浊法治疗原发性高尿酸血症35例的疗效观察", 中医药通报, vol. 05, no. 06, pages 42 - 45 * |
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