Anti-gout traditional Chinese medicine composition, preparation method of extract of anti-gout traditional Chinese medicine composition, pharmaceutical composition and application

Abstract

The invention discloses a traditional Chinese medicine composition composed of medicinal and edible medicinal materials such as celery seeds, endothelium corneum gigeriae galli, rhizoma phragmitis and angelica sinensis, a pharmaceutical composition and a preparation method and application thereof. The traditional Chinese medicine composition has an exact treatment effect on gouty arthritis and hyperuricemia by inhibiting inflammatory factors, promoting removal of uric acid and creatinine and protecting kidneys. Compared with chemical medicines for treating gout, the medicine is safe, effective and free of toxic and side effects. The medicine can be prepared into different dosage forms according to clinical requirements, and is flexible to use. The preparation process is stable and reliable, and easy to operate and amplify.

Description

Technical Field

[0001] The invention relates to an anti-gout Chinese medicinal composition and a preparation method of an extract thereof, a pharmaceutical composition and an application thereof, and in particular to an anti-gout Chinese medicinal composition which is both a medicine and food and a preparation method of an extract thereof, a pharmaceutical composition and an application thereof. Background Art

[0002] Gout is a joint disease caused by excessive deposition of uric acid, which is directly related to hyperuricemia caused by purine metabolism disorders and / or reduced uric acid excretion. Gout patients are gradually getting younger, and adolescent patients are not uncommon. In the acute attack stage of gout, the onset is rapid, and the pain progressively intensifies, reaching a peak in about 12 hours. The pain is tearing, cutting, or biting, and is unbearable. The affected joints and surrounding soft tissues are red and swollen, the skin temperature is increased, and tenderness is obvious. In the chronic tophi stage, subcutaneous tophi and chronic tophi arthritis often coexist. Subcutaneous tophi are common sites of occurrence. After rupture, white powder or paste is discharged and it is not easy to heal. Continuous joint swelling, tenderness, deformity and dysfunction can cause destruction of joint bones, fibrosis of periarticular tissues, secondary degenerative lesions, etc., seriously affecting work and normal life. In addition to joint damage, gout patients may also suffer from kidney disease and other manifestations of metabolic syndrome, such as hyperlipidemia, hypertension, diabetes, etc., and may also cause cardiovascular disease and nervous system diseases, such as coronary heart disease and ischemic stroke, which endanger people's physical health and life safety in many ways.

[0003] At present, the treatment of gout mainly involves two aspects: one is symptomatic treatment, that is, analgesia, anti-inflammatory and swelling; the other is to reduce blood uric acid in the body to eliminate the soil that produces gout and cure gout. Whether gout is in the attack period, intermittent period, or chronic lesion period, uric acid lowering treatment is carried out throughout. Chemical drugs are used to treat gout, especially acute gout, mainly for symptomatic treatment, and their drug toxicity and side effects are large, especially for liver and kidney damage. In terms of lowering uric acid levels to treat gout, although chemical drugs also have relatively obvious therapeutic effects, the efficacy cycle is short. Most cured patients will have elevated uric acid levels after a period of time due to factors such as lifestyle, diet or disease, and repeated attacks require lifelong medication prevention. In addition, the drug toxicity and side effects of chemical drugs will bring safety risks and cause serious harm to human health.

[0004] Traditional Chinese medicine refers to gout as arthralgia, and divides it into different syndromes, and treats it with different prescriptions. Although the toxic and side effects of traditional Chinese medicine are relatively small, the absorption and utilization of traditional Chinese medicine is poor and the absorption time is long, resulting in a slow effect of the medicine. At the same time, due to the dialectical treatment, one prescription is used for one person, and the repeatability is poor. In addition, traditional Chinese medicine also has the disadvantages of being difficult to take, large dosage, and unstable quality of medicinal materials. Summary of the invention

[0005] Purpose of the invention: The first purpose of the present invention is to provide a Chinese medicine composition that is widely used, safe and effective against gout. The second purpose is to provide a method for preparing an extract of the Chinese medicine composition. The third purpose is to provide a pharmaceutical composition containing the extract of the Chinese medicine composition, which has clear applicable symptoms, is easy to take, has a small dosage, good palatability, and can be taken for a long time. The fourth purpose is a pharmaceutical application of the Chinese medicine composition, its extract, and the pharmaceutical composition.

[0006] Technical solution: The anti-gout Chinese medicine composition of the present invention comprises, by weight, 10-40 parts of celery seeds, 8-35 parts of chicken gizzard lining, 5-30 parts of reed roots, 5-30 parts of angelica, 5-30 parts of peach kernels, 1-15 parts of buzia leaves, 1-15 parts of lilies, 1-15 parts of licorice, 1-15 parts of kudzu roots, 1-15 parts of yam, 1-12 parts of longan seeds, 1-12 parts of durian peels, 1-6 parts of cinnamon, 1-6 parts of turmeric, 1-6 parts of pepper and 1-6 parts of hawthorn leaves.

[0007] Preferably, the anti-gout Chinese medicine composition of the present invention comprises, by weight, 15-30 parts of celery seeds, 12-25 parts of chicken gizzard lining, 8-20 parts of reed roots, 8-20 parts of angelica, 8-20 parts of peach kernels, 3-10 parts of buzia leaves, 3-5 parts of lily, 3-5 parts of licorice, 3-5 parts of kudzu root, 3-5 parts of yam, 2-8 parts of longan seeds, 2-8 parts of durian peel, 1.5-4 parts of cinnamon, 1.5-4 parts of turmeric, 1.5-4 parts of pepper and 1.5-4 parts of hawthorn leaves.

[0008] Preferably, the anti-gout Chinese medicine composition of the present invention comprises, by weight, 20 parts of celery seeds, 15 parts of chicken gizzard lining, 10 parts of reed root, 10 parts of angelica, 10 parts of peach kernel, 5 parts of buzia leaf, 4 parts of lily, 4 parts of licorice, 4 parts of kudzu root, 4 parts of yam, 3 parts of longan kernel, 3 parts of durian peel, 2 parts of cinnamon, 2 parts of turmeric, 2 parts of pepper and 2 parts of hawthorn leaf.

[0009] Gout belongs to the category of "bi syndrome" and "baihulijie" in traditional Chinese medicine. It is mostly caused by long-term improper diet, craving for fatty and greasy food, which damages the spleen and stomach, generates dampness and heat, dampness blocks qi stagnation, and blocks the meridians, resulting in insufficient qi and blood, and poor circulation. The main symptoms are redness, swelling, heat, pain in the affected area, and limited joint movement. According to the gout clause of the "Standards for Diagnosis and Treatment of Diseases and Syndromes in Traditional Chinese Medicine", the symptoms of gout are divided into 4 categories, namely: damp-heat accumulation syndrome, stasis-heat obstruction syndrome, phlegm turbidity obstruction syndrome, and liver and kidney yin deficiency syndrome, and emphasizes that the treatment principle should be based on syndrome differentiation and treatment according to the individual.

[0010] The Chinese medicine composition of the present invention targets the pathogenesis of gout and combines the gout treatment method of Western medicine. It is different from the treatment principles of traditional Chinese medicine and takes a new approach to symptomatic treatment, giving priority to relieving symptoms. It starts with analgesia, anti-inflammation and detumescence, and relieves or alleviates the redness, swelling, heat, pain and joint restriction of the affected area, reduces the pain of the patient's symptoms, and wins treatment time for later treatment.

[0011] The four major syndromes of gout in traditional Chinese medicine only reveal the cause of gout, but ignore the key to the pathogenesis of the disease - the stress response of multiple parts and organs caused by high uric acid levels. The stress symptoms are symptoms of acute attack of gout. After the body's positive and negative forces fight each other, or passively increase uric acid excretion for a short time, or passively reduce uric acid production for a short time, to relieve gout symptoms, thus entering the intermittent period of gout. However, since the channel problem of producing or excreting uric acid has not been solved, uric acid remains high, causing gout to recur. The Chinese medicine composition of the present invention is aimed at the channel for producing uric acid, i.e., the pathogenesis of gout, as the key to curing gout.

[0012] Traditional Chinese medicine believes that the common cause of the four major symptoms of gout is turbidity, which accumulates into turbidity and turbid phlegm into stasis. Wind, cold, dampness, and heat are only external causes of disease. The internal cause of the disease is the turbidity that causes the body to produce turbidity. Wherever the turbidity is, the corresponding symptoms will occur. With respect to gout, dampness and heat bet on the liver and kidneys, causing turbidity and stasis, liver acid production abnormalities, kidney deficiency acid excretion is weak, blocking the channels for uric acid production and circulation, making the uric acid concentration too high, accumulating in the body, absorbed by the blood, forming hyperuricemia; depositing in joints or cartilage tissues, forming tophi; depositing in organs such as the kidneys, forming kidney stones, urinary stones, etc., and leading to inflammation of organs.

[0013] The Chinese medicine composition of the present invention takes "purging liver fire, resolving depression, clearing kidney heat, and cooling heart blood" as the treatment principle for the inter-gout period and chronic gout period of gout. The liver is a key organ that dominates the uric acid channel. The liver is responsible for dredging and dispersing, and the liver qi is unblocked and reaches the whole body qi, thereby regulating the operation and distribution of essence, blood, body fluids, the rise and fall of spleen and stomach qi, the secretion and excretion of bile, and emotional activities. If there is a problem with the dredging and dispersing function of the liver, damp heat will be deposited, and liver acid will produce more uric acid. At the same time, the dredging and dispersing function of the liver also directly affects the operation of the kidneys. The essence and blood of the liver and kidney are of the same origin, and they are mutually generated and transformed, and the storage and discharge are mutually used, and the yin and yang are mutually supported. The kidney governs water and dominates the body's water metabolism. The kidney qi also regulates the body fluid metabolism of the lungs, spleen, liver, and triple energizer, and generates urine. Liver depression and fire transformation involve the kidneys, resulting in poor uric acid excretion. Therefore, the treatment of gout must first treat the liver, that is, purging liver fire, resolving liver depression, clearing heat and cooling blood, and promoting blood circulation and removing blood stasis.

[0014] The Chinese medicine composition described in the present invention is mainly composed of drugs with analgesic, anti-inflammatory and detumescent effects, which are mainly used to relieve gout symptoms in patients in the acute attack period of gout; at the same time, it is supplemented with drugs with the effects of purging fire and relieving depression, protecting the liver and protecting the kidneys, so as to dredge the uric acid channel, thereby achieving the purpose of inhibiting uric acid production, increasing uric acid excretion, and reducing or preventing gout attacks.

[0015] Among them, celery seeds, angelica, reed root, peach kernel, and slag leaf are all monarch drugs. Celery seeds are cool in nature and sweet and spicy in taste. They belong to the lung, stomach, and liver meridians. They are non-toxic. The main effects are strengthening tendons and bones, dispelling wind and dampness, diuresis and detumescence, promoting blood circulation and relieving pain, and clearing away heat and detoxification. The present invention reuses celery seeds as the first monarch drug because it belongs to the meridians appropriately, has comprehensive effects, relieves pain and detumescence, detoxifies and resists inflammation, and the seed drugs are mostly downward, especially for joint pain, congestion and swelling, and can lead all drugs to reach the lesion directly and show rapid effects. Angelica is warm in nature and sweet in taste. It belongs to the liver, heart, and spleen meridians. It has the effects of nourishing blood and activating blood circulation, moistening the intestines and relieving constipation, protecting the liver and protecting the kidneys. While playing analgesic effects together with celery seeds, it also plays a guarding role in protecting the liver and protecting the kidneys. Reed root is cold in nature and sweet in taste. It belongs to the lung and stomach meridians. It is good at clearing heat and purging fire, promoting body fluid, and promoting diuresis and detumescence. Peach kernel is flat in nature and bitter and sweet in taste. It belongs to the heart, liver, and large intestine meridians. It is good at promoting blood circulation and moistening the intestines, removing blood stasis and relieving pain. Buza leaves are cool and sour in nature, and belong to the spleen and stomach meridians. They can help digestion and eliminate stagnation, clear away heat and dampness, relieve pain and anti-inflammatory. The overall monarch medicine belongs to the liver meridian, which is balanced and stable, and can treat swelling, pain, and inflammation. It is comprehensive, offensive and defensive, and warm and cool complement each other.

[0016] Chicken gizzard lining, kudzu root, lily, yam, and hawthorn leaf are all ministerial drugs. Chicken gizzard lining is mild in nature and sweet in taste. It enters the spleen, stomach, small intestine, and bladder meridians. It is good at harmonizing the stomach and helping digestion, softening hard masses and dissolving stones, and assisting the monarch drug in reducing swelling and relieving pain. Kudzu root is cool in nature and sweet and pungent in taste. It enters the spleen and stomach meridians. It is good at raising yang and stopping diarrhea. It assists the monarch drug and protects the liver and kidneys. Lily is slightly cold in nature and sweet in taste. It enters the heart and lung meridians. It is a yin-tonifying drug that can clear the heart and calm the mind, balance pungent heat, and prevent the disadvantages of damaging yin. Yam is warm in nature and sweet in taste. It enters the lung, spleen, kidney meridians, and the blood of the hand and foot taiyin meridians. It strengthens the spleen, nourishes the lungs, consolidates and nourishes the kidneys, and improves the essence. Although it is a ministerial drug, it is because it mainly treats the liver and supplements the kidneys. Hawthorn leaf is slightly warm in nature and sour and sweet in taste. It enters the spleen, stomach, and liver meridians. It is good at promoting qi and dispersing blood stasis, removing turbidity and reducing fat. It is a ministerial drug because of its limited weight. The overall efficacy of the assistant medicine is consistent with that of the main medicine, which is to harmonize the stomach and spleen, soothe the liver and tonify the kidney, remove dampness and resolve blood stasis. Moreover, the medicinal properties are mild, and it assists the main medicine with all its strength.

[0017] Turmeric, cinnamon, longan seeds, and durian peel are all adjuvants. Turmeric is warm in nature and bitter in taste. It enters the spleen and liver meridians. It is non-toxic and has the effects of promoting qi and blood circulation, warming the meridians and relieving pain. It assists the main medicine and is a pioneer. Although the amount is small, with the blessing of pepper, the effect is greatly increased. Cinnamon is very hot and spicy and sweet in taste. It enters the kidney, spleen, heart, and liver meridians. It has the effects of replenishing fire and yang, dispersing cold and relieving pain, warming and unblocking the meridians, and assisting the main medicine to overcome the numbness of the husband. Longan seeds are sweet in taste, mild and warm in nature, non-toxic, and enter the heart, spleen, and stomach meridians. They nourish the heart and spleen, replenish qi and blood, and strengthen the spleen and stomach. They are the rear guard of the main medicine. Durian peel is spicy and hot in nature and sweet in taste. It enters the liver, kidney, and lung meridians. It works in anti-inflammation and edema.

[0018] Pepper and licorice are both adjuvant drugs. Pepper is hot and pungent in taste, and it enters the large intestine and stomach meridians, dispels wind and swelling, warms the middle and dispels cold. At the same time, most of the seed drugs go downward, and together with the main drug celery seeds, they lead all the drugs to go downward to the limbs, find lesions, dispel rheumatism, and eliminate swelling. Licorice is cold in nature and sweet in taste, and enters the spleen, stomach, heart, lung, and meridians, replenishes qi and nourishes the middle, relieves pain, and harmonizes the properties of the drug. The present invention has found through pharmacological studies that curcumin and piperine have a synergistic effect when used together. When curcumin and piperine are used in combination, the bioavailability of oral curcumin is significantly improved.

[0019] The combination of various drugs, on the basis of analgesia, anti-inflammation, swelling and symptom relief, emphasizes the use of drugs for protecting the liver and kidneys to solve the root cause of gout - liver depression and heat stagnation. While treating the lesions during the gout attack period, the cause of gout is always grasped, and the problem of "liver acid" is treated at the same time. In addition to using medicinal materials that are both medicinal and edible, the formula also uses celery seeds from vegetable seeds as the main medicine, and even uses fruit plants such as longan seeds and durian peels as medicine. The various medicinal materials are used synergistically to enhance the effect, thereby reducing the amount of medicinal materials used; especially the combination of turmeric and pepper, which significantly improves the in vivo bioavailability of turmeric's effective ingredients and greatly reduces the amount of turmeric taken.

[0020] The active ingredients of the extracts of the Chinese medicine composition of the present invention are all plant (mostly Chinese medicine pieces) extracts, and each extract contains a certain pharmacologically active pharmaceutical ingredient. Compared with traditional Chinese medicine preparations, plant extracts are used as medicines, and the content and purity of active substances used to treat diseases are improved, and the efficacy is also greatly improved. Compared with chemical drug preparations, it has no artificial synthetic ingredients, and most of them have no side effects. In addition, the pharmaceutical composition of the present invention, in addition to treating gout, also has the effects of protecting the liver and kidney, lowering blood lipids, relieving drunkenness and promoting alcohol decomposition. In addition, the preparation method of the extract of the Chinese medicine composition of the present invention is safe and stable, mature and reliable, and industrial production has strong reproducibility.

[0021] Among them, the main medicine celery seeds contain eucalyptol, phosphomethoxyphenol, cymene lactone, apigenin, linolenic acid, volatile oils, and flavonoids, which have a soothing effect on rheumatism, rheumatoid arthritis, gout, hyperuricemia, etc. The extraction method of secondary alcohol extraction and primary water extraction is adopted to ensure the extraction rate of the target active ingredients.

[0022] The main drug Angelica contains volatile oil, Angelica polysaccharide, organic acid, amino acid, flavonoids, and has significant pharmacological effects such as anti-inflammatory, analgesic, liver and kidney protection, hematopoietic, anti-tumor, anti-asthmatic and lung ventilation. The extraction rate of the target active ingredients is guaranteed by using secondary alcohol extraction and primary water extraction.

[0023] The main herb, Phragmites australis, contains polysaccharides, flavonoids, anthraquinones, and steroid active substances, and has pharmacological effects such as antioxidant and liver protection. Three hot water extractions were used to ensure the extraction rate of the target active ingredients.

[0024] The main medicine peach kernel contains fat-soluble substances, proteins, sterols and their glycosides, flavonoids, and phenolic acid active substances. It has anti-coagulation, anti-thrombosis, prevention of liver fibrosis, antioxidant, anti-inflammatory, and hypoglycemic pharmacological effects. Three hot water extractions are used to ensure the extraction rate of the target active ingredients.

[0025] The leaves of Junyao Buzha contain flavonoids, volatile oils, alkaloids, and triterpenoid vitexin, which have the pharmacological effects of lowering blood lipids, relieving pain, promoting digestion, and regulating gastrointestinal function. Three hot water extractions were used to ensure the extraction rate of the target active ingredients.

[0026] The ministerial drug chicken gizzard contains gastric hormone, keratin, pepsin, vitamins, and 17 kinds of amino acids. It has pharmacological effects such as regulating the functions of the digestive system, regulating the functions of the blood system, regulating the endocrine and reproductive systems, promoting blood circulation and menstruation, treating stranguria, improving chronic renal failure, regulating heart function, regulating the content of enzymes such as superoxide dismutase and nitric oxide synthase, and the level of lactate dehydrogenase. Three hot water extractions were used to ensure the extraction rate of the target active ingredients.

[0027] The auxiliary drug Pueraria contains puerarin and flavonoids, which have the pharmacological effects of anti-oxidation, anti-inflammation, liver protection, improvement of kidney function, increase of bone density, immunomodulation, anti-tumor, protection of cardiovascular and cerebrovascular, lowering of blood sugar, lowering of blood lipids, and lowering of blood pressure. The extraction rate of the target active ingredients is guaranteed by using secondary ethanol extraction and primary hot water extraction.

[0028] The auxiliary drug lily contains steroidal saponins, sterols, phenolic acid glycerides, flavonoids, phenylpropanoids, polysaccharides, colchicine and other alkaloids, starch, protein, and fat. It has the pharmacological effects of antioxidant, anti-inflammatory, anti-stress injury, sedative and hypnotic, immunomodulatory, hypoglycemic, and anti-tumor. Three ethanol extractions are used to ensure the extraction rate of the target active ingredients.

[0029] The ministerial drug yam contains diosgenin, dopamine, allantoin, polyphenol oxidase, and yam alkaloid hydrochloride. The glycosides have the pharmacological effects of protecting the liver, anti-inflammatory, lowering uric acid, nourishing the kidney and astringing semen, and lowering blood sugar. The extraction method of water extraction and alcohol precipitation is adopted to ensure the extraction rate of the target active ingredients.

[0030] The auxiliary drug hawthorn leaves contain flavonoids, volatile oils, alkaloids, and triterpenoid active substances, which have pharmacological effects such as lowering blood lipids, relieving pain, promoting digestion, and regulating gastrointestinal function. The extraction method of water extraction and alcohol precipitation is adopted to ensure the extraction rate of the target active ingredients.

[0031] The adjuvant turmeric contains sesquiterpenoids and curcuminoids, which have pharmacological effects such as anti-oxidation, anti-inflammatory, anti-cancer, anti-Alzheimer's disease, and anti-diabetes. The crude product was extracted with ethanol three times, and the extraction rate of active substances was high.

[0032] The adjuvant cinnamon contains cinnamaldehyde, cinnamyl acetate, eugenol, cinnamyl alcohol, and coumarin, and has pharmacological effects such as anti-inflammatory, lowering uric acid, lowering blood sugar, and helping intestinal health. Three ethanol extractions were used to ensure the extraction rate of the target active ingredients.

[0033] The adjuvant longan kernel contains active ingredients such as polysaccharides, polyphenols, flavonoids, and proteins, and has the pharmacological effects of nourishing the heart and spleen, replenishing qi and blood, strengthening the spleen and stomach, and promoting the dissolution of urate in tissues. Three ultrasonic-assisted ethanol extractions were used to ensure the extraction rate of the target active ingredients.

[0034] The adjuvant durian peel contains hydrogen sulfide, sulfide, ethyl acetate, palmitic acid, and the proteolytic enzyme extracted from durian juice and peel can enhance the hydrolysis of fibrin in the body after oral administration, dissolve blood clots, and eliminate inflammation and edema; it can reduce uric acid precipitation and promote urate dissolution. The extraction method of water extraction and alcohol precipitation is adopted to ensure the extraction rate of the target active ingredients.

[0035] The medicinal pepper contains volatile oil, dihydropiperamide, piperamide, piperine, piperine, piperine, cyperamide, cryptopinene, dihydrocarbendazole, which has pharmacological effects such as inhibiting the central nervous system, promoting bile secretion, anti-inflammatory, anticonvulsant, sedative and analgesic; it can cure fatigue, rheumatoid arthritis, numbness of limbs, edema and trauma. Three ethanol extractions are used to ensure the extraction rate of the target active ingredients.

[0036] Licorice contains glycyrrhizin, glycyrrhizic acid, glycyrrhetinic acid of the glycyrrhizin saponins, glycyrrhizin, isoliquiritigenin, glabridin, and glycyrrhizin polysaccharide of the glycyrrhizin flavonoids. It has pharmacological effects such as liver protection, anti-inflammatory and bactericidal, anti-myocardial ischemia, and anti-fibrosis. Licorice water extract has a dual uric acid-lowering effect of significantly inhibiting uric acid production and increasing uric acid excretion. Three hot water extractions are used to ensure the extraction rate of the target active ingredients.

[0037] The preparation method of the extract of the Chinese medicine composition of the present invention is selected from any of the following methods:

[0038] Method 1:

[0039] Add 1.5 to 3 times the total weight of the medicinal materials in water, soak, extract, and obtain a first extract; add the remaining medicinal residues in water equal to the first extraction, soak, extract, and obtain a second extract; add the remaining medicinal residues in water half the first extraction, soak, and obtain a third extract; combine the three extracts to obtain the extract of the traditional Chinese medicine composition;

[0040] Method 2:

[0041] Prepare the extract of each medicinal material, concentrate, and dry to obtain the extract of each medicinal material; or add a pharmaceutically acceptable carrier after concentration to obtain the extract of each medicinal material; mix the extracts of each medicinal material to obtain the extract of the traditional Chinese medicine composition.

[0042] Preferably, the content of each medicinal material extract of celery seed, chicken gizzard lining, reed root, angelica, peach kernel, buzia leaf, lily, licorice, kudzu root, yam, longan kernel, durian peel, cinnamon, turmeric, pepper, and hawthorn leaf in the second method is the mass ratio of the medicinal material decoction pieces to the extract, and is 30:1, 20:1, 30:1, 20:1, 20:1, 30:1, 30:1, 30:1, 10:1, 10:1, 30:1, 10:1, 30:1, 30:1, 30:1, 20:1, respectively.

[0043] Preferably, in the second method, the mixing mass ratio of the medicinal material extracts of celery seeds, chicken gizzard lining, reed root, angelica, peach kernel, buzia leaf, lily, licorice, kudzu root, yam, longan kernel, durian peel, cinnamon, turmeric, pepper, and hawthorn leaf is (10-30):(10-20):(5-15):(5-15):(5-15):(3-8):(2-6):(2-6):(2-6):(2-6):(1-5):(1-5):(1-3):(1-3):(1-3):(1-3).

[0044] Further preferably, in the second method, the mixing mass ratio of the medicinal material extracts of celery seeds, chicken gizzard lining, reed root, angelica, peach kernel, buzia leaf, lily, licorice, kudzu root, yam, longan kernel, durian peel, cinnamon, turmeric, pepper, and hawthorn leaf is 20:15:10:10:10:5:4:4:4:4:3:3:2:2:2:2.

[0045] The preparation method of the extract of the Chinese medicine composition described in the present invention uses Chinese medicine pieces as raw materials, takes the extraction yield of the target component as the assessment standard, and determines each process parameter. Among them, celery seeds use apigenin and other flavonoid compounds, unsaturated fatty acids and polysaccharide compounds as the main target extraction components; chicken gizzard lining uses protein, amino acids, polysaccharides, etc. as the target extraction components; reed root uses coumaric acid and reed root polysaccharides and glycosides as the target extraction components; angelica uses angelica polysaccharides, flavonoids, organic acids, etc. as the main target extraction components; peach kernel uses peach kernel protein, amygdalin, and flavonoids as the target extraction components; Buza leaf uses Buza leaf total flavonoids (mainly vitexin), Buza leaf alkaloids, and Buza leaf polyphenol compounds as the target extraction components; lily uses lily polysaccharides, lily saponins and alkaloids as the main target extraction components; licorice uses licorice polysaccharides, licorice flavonoids, isoglycyrrhizin as the main extraction components. The main target extraction components of Pueraria lobata are puerarin and other Pueraria flavonoids and Pueraria saponins, Pueraria polysaccharides, puerarin, etc.; the target extraction components of yam are yam polysaccharides, yamin, flavonoids, etc.; the main target extraction components of longan kernel are polyphenols, polysaccharides, organic acids, flavonoids, and alkaloids; the main target extraction components of durian peel are flavonoids, polysaccharides and proteins; the main target extraction components of cinnamon are cinnamaldehyde, cinnamic acid, cinnamone, etc.; the main target extraction components of turmeric are curcumin, turmericone, turmeric polysaccharides, etc.; the main target extraction components of pepper are piperine, flavonoids, organic acids, etc.; the target extraction components of hawthorn leaves are flavonoids, organic acids and other active ingredients.

[0046] Specifically, the preparation method of each medicinal material extract according to the extraction solvent and process method is as follows:

[0047] 1. Water extraction

[0048] With water as the extraction solvent, the medicinal slices are crushed and extracted three times. For the first time, water is added according to the solid-liquid ratio (slices: water, mass volume ratio, the same below) of 1: (8-12), and the mixture is soaked under stirring. The mixture is heated to 80-95°C for extraction while continuing to stir. The mixture is cooled and separated by solid-liquid separation, and the supernatant is collected. The solid matter is extracted for the second time with a solid-liquid ratio of 1: (6-10), heated to 80-95°C under stirring, extracted by stirring, and separated by solid-liquid separation after cooling, and the supernatant is collected. The solid matter is extracted for the third time with a solid-liquid ratio of 1: (6-10), heated to 80-95°C under stirring, extracted by stirring, and separated by solid-liquid separation after cooling, and the supernatant is collected. Combine the three extracts.

[0049] The prepared water extract is converted into concentrated extract amount (deducting the water difference between the extract and the extract) and extract specific gravity (or water content) according to the amount of medicinal pieces fed and 90% of the extract content, and concentrated to a concentrated solution with a specific gravity of 1.25 to 1.35 at 60 to 65° C., 10% β-dextrin is added under stirring at room temperature, and the extract powder is obtained by spray drying.

[0050] 2. Ethanol extraction

[0051] Using ethanol of different concentrations as the extraction solvent, the Chinese herbal medicine pieces were crushed and extracted three times. The solid-liquid ratio (g / mL) was 1:12, 1:(10-12), and 1:(8-12), respectively. The ethanol concentration (volume fraction) was 70%-95% for all three times. The extractions were performed at 50-80°C under stirring. The solid-liquid separation was performed after each extraction, and the three extracts were combined.

[0052] 3. Ethanol / water extraction

[0053] The first or first two extractions are extracted with ethanol, and the last two or third extractions are extracted with water. The Chinese herbal medicine pieces are crushed, and the first and second alcohol extractions are added with ethanol at a solid-liquid ratio (g / ml) of 1:12, and the ethanol concentration (volume fraction) is 70% to 80%. Soak under stirring, extract at 70 to 80°C under stirring, cool the extract, and combine the first two extracts after solid-liquid separation. The third extraction is water extraction, with a solid-liquid ratio (g / min) of 1:(10 to 16), add water, soak under stirring, extract at 70 to 80°C under stirring, cool the extract, and collect the third extract after solid-liquid separation.

[0054] Or the Chinese herbal medicine slices are crushed, and the first alcohol extraction is performed, ethanol is added at a solid-liquid ratio (g / ml) of 1:12, and the ethanol concentration (volume fraction) is 70% to 80%, and the mixture is soaked under stirring, and the extraction is performed at 70 to 80°C under stirring. The extract is cooled, and the first extract is collected after solid-liquid separation. The second and third water extractions are performed, and water is added at a solid-liquid ratio (g / min) of 1:10, and the mixture is soaked under stirring, and the extraction is performed twice at 70 to 80°C under stirring. The extract is cooled, and the second and third extracts are combined after solid-liquid separation.

[0055] 4. Ultrasonic assisted ethanol extraction

[0056] The Chinese herbal medicine pieces are crushed and extracted with alcohol for three times, with the same process parameters each time, according to the solid-liquid ratio of 1: (12-15), ethanol is added, the ethanol concentration (volume fraction) is 60%-70%, stirring and soaking, ultrasonic extraction is performed at 70-72 DEG C, the extract is cooled, and the three extracts are combined after solid-liquid separation.

[0057] The obtained extract, alcohol-water extract or ultrasonic-assisted alcohol extract is converted into the amount of concentrated extract (deducting the water difference between the extract and the extract) and the specific gravity (or water content) of the extract according to the amount of the decoction pieces and 90% of the extract content. The extract is decompressed to recover ethanol, and after the sample is smelled without ethanol odor, it is decompressed and concentrated at 60-80° C. to an extract with a specific gravity of 1.28-1.35 at 60-65° C., 12% of the total amount of the finished product β-dextrin and 3% of micro-powder silica gel are added under stirring at room temperature, water is added to adjust the feed liquid to a specific gravity of 1.20, and the extract powder is spray-dried.

[0058] 5. Water extraction and alcohol precipitation

[0059] Add water to the Chinese herbal medicine slices at a material-liquid ratio of 1: (6-15), extract at 80-90°C under stirring, cool the extract, separate the solid and liquid, and collect the supernatant. Concentrate to an extract with a relative density of 1.35-1.40 at 60-65°C. Cool and precipitate with alcohol, separate the solid and liquid, and collect the supernatant.

[0060] The obtained water-extracted alcohol-precipitated extract is converted into the total amount of the concentrated extract and the alcohol-precipitated product after mixing (deducting the water difference between the extract and the extract) according to the amount of the decoction pieces and 90% of the content of 1 / 10 of the extract. The dry powder is prepared in two steps: the supernatant after the alcohol precipitation is firstly recovered with ethanol, and after the sample is smelled without ethanol odor, it is concentrated under reduced pressure at a temperature of 60-70°C to an extract with a specific gravity of 1.22-1.30, solid-liquid separation is performed, 7% of the total amount of the finished product beta-dextrin and 3% of micro-powder silica gel are added under stirring at room temperature, and the alcohol-precipitated product is added, stirred evenly, dried, crushed and sieved, and the water-extracted alcohol-precipitated extract powder is obtained.

[0061] The anti-gout Chinese medicinal composition or its extract and medicinal composition of the present invention are used in preparing medicines for treating gouty arthritis and hyperuricemia.

[0062] Preferably, the drug is a drug that relieves pain, fights inflammation and reduces swelling, dissolves uric acid crystals, inhibits uric acid production, promotes uric acid excretion, and protects the liver and kidneys.

[0063] The Chinese medicine composition or its extract and the pharmaceutical composition of the present invention have the effects of analgesia, anti-inflammatory, liver protection, kidney protection and reducing the toxic and side effects of chemical drugs, and can be used in combination with chemical drugs for treating gout attacks; for patients with gout attacks who have large side effects of chemical drugs, it can be used alone as a drug for treating gout attacks. At the same time, the medicinal materials used in the present invention, except for the three fruit and vegetable plants, are all medicinal and edible medicinal materials, which are basically non-toxic and can be used as drugs for preventing gout attacks and taken for a long time.

[0064] Specifically, the Chinese medicine composition of the present invention is taken in the gout attack period using traditional Chinese medicine decoction (Chinese medicine decoction recipe). According to 300g of initial medicinal materials per dose, 3 times, 2 times, and 1.5 times the weight of water are added respectively, soaked and boiled, and then slowly decocted for 40min, 30min, and 20min respectively, and 900ml of decoction is obtained. One dose per day, three times a day, each time 300ml of Chinese medicine decoction. In the gout interval period, chronic period, and long-term use as a medicine for preventing gout attacks, two doses every three days, twice a day, each time 300ml of Chinese medicine decoction.

[0065] The pharmaceutical composition of the present invention comprises the extract of the anti-gout traditional Chinese medicine composition of the present invention and a pharmaceutically acceptable carrier.

[0066] Preferably, the pharmaceutical composition of the present invention is in the form of granules, tablets, capsules, pastes, and oral solutions.

[0067] Specifically, the pharmaceutical composition of the present invention, taking a solid powder of 10 g per bag as an example, is taken twice a day during a gout attack, 1 bag each time; during the gout interval, 1 bag each time, once a day; during the chronic stage of gout and when taken long-term as a medicine for preventing gout attacks, once a day, half a bag (5 g) each time.

[0068] Beneficial effects: Compared with the prior art, the present invention has the following significant advantages:

[0069] The anti-gout Chinese medicine composition designed by the present invention adopts medicinal materials with the same origin as medicine and food, prioritizes symptom relief, starts with analgesia, anti-inflammatory and detumescence, and takes "relieving liver fire, resolving stagnation, clearing kidney heat and cooling heart blood" as the treatment principle; by inhibiting inflammatory factors and promoting the dissolution of uric acid crystals to achieve the curative effect of analgesia and detumescence, by promoting the removal of uric acid and creatinine and protecting the liver and kidney, it has a definite therapeutic effect on gouty arthritis and hyperuricemia. The compatibility and synergistic effect between the medicinal materials also reduces the dosage of the medicine, and the medicine is safe and effective, can be used to alleviate the relevant symptoms of gout attack period, interval period and chronic period, and can also be used as a long-term medication for preventing gout-related diseases. The preparation can be flexibly adjusted according to clinical needs, the preparation process is stable and reliable, and it is easy to operate and scale up. BRIEF DESCRIPTION OF THE DRAWINGS

[0070] Figure 1 The results are as follows: the effect of the Chinese medicine composition on the swelling rate of the foot joints of gout rats (mean ± standard deviation, compared with the model group at 24 hours: **P<0.01, *P<0.05);

[0071] Figure 2 The results are as follows: the effect of the Chinese medicine composition on the serum IL-1β level in gout rats (mean ± standard deviation, compared with the model group: **P<0.01, *P<0.05);

[0072] Figure 3 The results are as follows: the effect of the Chinese medicine composition on the serum TNF-α level in gout rats (mean ± standard deviation, compared with the model group: **P<0.01, *P<0.05);

[0073] Figure 4 The results are as follows: The effect of the Chinese medicine composition on the levels of serum uric acid (SUA) and urine uric acid (UUA) in hyperuricemia mice (mean ± standard deviation, compared with the model group: **P<0.01, *P<0.05);

[0074] Figure 5The results are as follows: The effect of the Chinese medicine composition on the serum creatinine (SCR) and urine creatinine (UCR) levels of hyperuricemia mice (mean ± standard deviation, compared with the model group: **P<0.01, *P<0.05);

[0075] Figure 6 The results are as follows: the effect of the Chinese medicine composition on the levels of serum urea nitrogen (SBUN) and urine urea nitrogen (UBUN) in hyperuricemia mice (mean ± standard deviation, compared with the model group: **P<0.01, *P<0.05);

[0076] Figure 7 The results show the protective effect of the Chinese herbal composition on the kidneys of hyperuricemia mice (40×, the lower left black line is 50 μm long). DETAILED DESCRIPTION

[0077] The technical solution of the present invention is further described below in conjunction with embodiments.

[0078] Example 1: Preparation and application of Chinese medicine decoction recipe

[0079] 1. Proportion and weighing of Chinese herbal medicines

[0080] According to the proportions of each Chinese herbal medicine slice: celery seeds, chicken gizzard lining, reed root, angelica, peach kernel, buzia leaves, lily, licorice, kudzu root, yam, longan kernel, durian peel, cinnamon, turmeric, pepper, and hawthorn leaves, the mass ratio of the mixture is 20:15:10:10:10:5:4:4:4:4:3:3:2:2:2:2. Based on the total weight of each dose of medicinal materials being 300g, the weight of each medicinal material is converted to 3g. Accurately weigh each Chinese herbal medicine slice and put it into a non-iron container.

[0081] 2. Preparation of Chinese medicine decoction

[0082] The method of three decoctions is adopted: for the first time, add drinking water (about 900 ml) 3 times the weight of the medicinal materials, soak for 120 minutes, boil over high heat, simmer over low heat for 60 minutes, and pour out the first decoction (about 300 ml); continue to add drinking water of the same weight as the first time (about 900 ml) into the medicine pot, soak for 60 minutes, boil over high heat, simmer over low heat for 40 minutes, and pour out the second decoction (about 400 ml); continue to add drinking water (about 450 ml) 1.5 times the weight of the original medicinal materials into the medicine pot, soak for 30 minutes, boil over high heat, simmer over low heat for 20 minutes, pour out the third decoction (about 200 ml), combine the three decoctions, and store at low temperature.

[0083] 3. Application of Chinese medicine decoction

[0084] During gout attacks, take it three times a day, 300 ml each time. One course of treatment is 15 days. Take 3-5 courses of treatment depending on the condition. It can also be used as a long-term drug for gout patients to prevent gout attacks, and the dosage can be reduced to twice a day or once a day.

[0085] Example 2: Preparation of extract powders of various medicinal materials

[0086] 1. Hot water extraction of chicken gizzard lining, reed root, sedge leaf, peach kernel, licorice, etc. and preparation of extract powder

[0087] (1) Chicken gizzard lining: grind to 60 mesh and extract in three times. For the first time, add pure water according to the material-liquid ratio (decoction piece: water, the same below) of 1:10, soak for 20 minutes under stirring, continue stirring and heat to 85°C, stir and extract for 150 minutes, cool and separate solid and liquid by centrifuge, collect the supernatant and put it into the extract storage tank. The solid is put into the extraction tank for the second extraction, with a material-liquid ratio of 1:7, heat to 85°C under stirring, stir and extract for 100 minutes, cool and separate solid and liquid by centrifuge, collect the supernatant and put it into the extract storage tank, and the solid is extracted for the third time. Except for the stirring and leaching time of 60 minutes, other process parameters are the same as the second extraction. Combine the three extracts and store them in a storage tank for concentration.

[0088] Chicken gizzard lining water extract, dry extract conversion rate: 1 / 20 of the chicken gizzard lining decoction piece feeding amount, concentration vacuum degree -0.06MPa ~ -0.08MPa, concentration time 120 minutes, concentrated pot temperature 60℃, specific gravity 1.25, put into the concentrate batching tank, add the calculated proportion of β-dextrin and micro powder silica gel, add pure water and stir evenly, adjust the specific gravity to 1.20, and get the spray liquid. Use a high-speed centrifugal spray drying tower for spray drying, control the inlet temperature at 180℃, the feed temperature at 60℃, and the sample flow rate at 4.4cm 3 / s, centrifugal speed 20000r / min, exhaust temperature 70℃, to obtain chicken gizzard lining extract powder with a content ratio of 20:1.

[0089] (2) Phragmites australis: The fineness of the powder is 20-30 mesh, and the powder is extracted three times. The first time, pure water is added at a solid-liquid ratio of 1:10 (medicinal material: water) to soak for 2 hours, the temperature is raised to 82°C, and the extraction is carried out under stirring for 154 minutes. After filtering, the extract is added to a storage tank; the second and third times, pure water is added at a solid-liquid ratio of 1:7, the powder is soaked for 1 hour, the temperature is raised to 80°C, and the extraction is carried out under stirring for 90 minutes. After filtering, the extract is obtained, and the three extracts are combined and mixed into an extract storage tank, and stored at low temperature until concentrated.

[0090] Phragmites australis water extract, dry extract conversion rate: 1 / 30 of the amount of Phragmites australis slices, concentration vacuum -0.08MPa ~ -0.095MPa, concentration time 150 minutes, concentrated pot temperature 70℃, specific gravity 1.35, put into the concentrate batching tank, add the calculated proportion of β-dextrin and micro powder silica gel, add pure water and stir evenly, adjust the specific gravity to 1.20, and get the spray liquid. Use a high-speed centrifugal spray drying tower for spray drying, control: inlet air temperature 220℃, feed temperature 80℃, sample flow rate 3.88cm 3 / s, centrifugal speed 28000r / min, exhaust temperature 80℃, to obtain rhizoma reed extract powder with a content ratio of 30:1.

[0091] (3) Buza leaves: grind to a fineness of 20-60 mesh, and extract in three times. The first time, the solid-liquid ratio is 1:10, add pure water to soak for 30 minutes, heat to 95°C, and extract for 90 minutes under stirring; the second and third times, the solid-liquid ratio is 1:8, add pure water to soak for 30 minutes, heat to 95°C, and extract for 60 minutes under stirring. After centrifugation and filtration, mix the three extracts, store in an extract storage tank, and store at low temperature until concentrated.

[0092] Buzha leaf water extract, dry extract conversion rate: 1 / 30 of the amount of Buzha leaf slices, concentration vacuum -0.06MPa ~ -0.065MPa, concentration time 150 minutes, concentrated pot temperature 85℃, specific gravity 1.35, put into the concentrate batching tank, add the calculated proportion of β-dextrin and micro-powder silica gel, add pure water and stir evenly, adjust the specific gravity to 1.20, and get the spray liquid. Use a high-speed centrifugal spray drying tower for spray drying, control: inlet air temperature 200℃, feed temperature 70℃, sample flow rate 4.1cm 3 / s, centrifugal speed 26000r / min, exhaust temperature 75℃, to obtain Buza leaf extract powder with a content ratio of 30:1.

[0093] (4) Peach kernel: Grind into coarse powder (particle size 2 mm), extract three times, the first time with a solid-liquid ratio of 1:8, add pure water to soak for 30 minutes, stir and heat to 95°C, soak for 120 minutes, centrifuge to dry and filter for solid-liquid separation, collect the supernatant, and extract the solid for the second time with a solid-liquid ratio of 1:6 for 90 minutes. The soaking and extraction time and other aspects are the same as the first extraction; the third extraction is the same as the second extraction. Combine the three extracts and store at low temperature for concentration.

[0094] Peach kernel water extract, dry extract conversion rate: 1 / 20 of the amount of peach kernel slices, concentration vacuum degree -0.085MPa ~ -0.095MPa, concentration time 120 minutes, concentrated pot temperature 60℃, specific gravity 1.30, put into the concentrate batching tank, add β-dextrin and micro powder silica gel in calculated proportion, add pure water and stir evenly, adjust the specific gravity to 1.20, and get the spray liquid. Use a high-speed centrifugal spray drying tower for spray drying, control: inlet air temperature 180℃, feed temperature 60℃, sample flow rate 3.76cm 3 / min, centrifugal speed 25000r / min, exhaust temperature 70℃, to obtain peach kernel extract powder with a content ratio of 20:1.

[0095] (5) Licorice: Grind into 20-49 mesh powder, extract in three times, the solid-liquid ratio is 1:12, 1:10, 1:10, stirring speed is 200r / min, soaking time is 120 minutes, 60 minutes, 60 minutes, insulation extraction temperature is 90°C, stirring extraction time is 200 minutes, 160 minutes, 120 minutes. Centrifuge to dry and filter for solid-liquid separation, combine the three extracts into a storage tank, and store at low temperature until concentrated.

[0096] Licorice water extract, according to the liquorice slice feed amount (minus the slice water) 1 / 30 of 90% calculation of concentrated dry liquid extract (minus water), the extract is concentrated to a relative density of 1.28 thick paste concentrate (water content of 49.9%), put into the concentrate batching tank, cool to room temperature, add the calculated proportion of β-dextrin and micro powder silica gel, add pure water and stir evenly, adjust the specific gravity to 1.20, and obtain the spray liquid. Use a high-speed centrifugal spray drying tower for drying, control the inlet temperature at 200 ° C, the feed temperature at 80 ° C, and the sample flow rate at 3.26 cm 3 / s, centrifugal speed of 25000r / min, exhaust temperature of 70°C, to obtain licorice extract powder with a content ratio of 30:1.

[0097] 2. Ethanol extraction of turmeric, cinnamon, pepper, lily, etc. and preparation of extract powder

[0098] (1) Turmeric: crushed to a fineness of 60-80 mesh, extracted three times, solid-liquid ratio (g / mL) of 1:12, 1:10, 1:8, ethanol concentration (volume fraction): 70% for all three times, stirring speed: 120 r / min for all times, heat preservation and extraction temperature: 80°C, 60°C, 50°C, extraction time: 150 min, 100 min, 60 min, after vacuum filtration for solid-liquid separation, the three extracts were combined and put into a storage tank, and stored at low temperature for ethanol recovery and concentration.

[0099] The ethanol extract of turmeric slices is converted into the total amount of dry extract and the specific gravity of the concentrated liquid according to 1 / 30 of the amount of slices, pumped into a vacuum concentration pot, and ethanol is recovered under vacuum. After no alcohol smell, it is concentrated for 120 minutes at a vacuum degree of -0.08 to -0.09Mpa and a temperature of 70°C. When the specific gravity is 1.30, it is discharged from the pot and pumped into a concentrated liquid storage tank. β-dextrin and micro-powdered silica gel in the calculated proportion are added, pure water is added and stirred evenly, and the specific gravity is adjusted to 1.20 to obtain a spray liquid. The airflow spray drying tower is used for drying, and the control parameters are: inlet temperature 160°C, feed temperature 80°C, nozzle pressure 0.5MPa, exhaust temperature 105°C, and a 30:1 turmeric ethanol extract powder is obtained.

[0100] (2) Pepper: crushed to a fineness of 40-80 mesh, extracted three times, with the same control parameters each time, solid-liquid ratio (g / ml) 1:12, ethanol concentration 70%, stirring speed: 120 r / min, extraction temperature 75°C, extraction time each time 2 hours, after each extraction, cooled to room temperature, vacuum filtered to separate solid and liquid, combined the three extracts into a storage tank, stored at low temperature for recovery of ethanol and concentrated.

[0101] The piperine alcohol extract is converted into the total amount of dry extract and the specific gravity of the concentrated liquid according to 1 / 30 of the amount of the decoction piece, pumped into a vacuum concentration pot, and ethanol is recovered under vacuum. After no alcohol smell is found, it is concentrated for 180 minutes at a vacuum degree of -0.06 to -0.08Mpa and a temperature of 80°C. When the specific gravity is 1.35, it is taken out of the pot and pumped into a concentrated liquid storage tank. β-dextrin and micro-powdered silica gel in the calculated proportion are added, pure water is added and stirred evenly, and the specific gravity is adjusted to 1.20 to obtain a spray liquid. The airflow spray drying tower is used for drying, and the control parameters are: inlet temperature 170°C, feed temperature 85°C, nozzle pressure 0.55MPa, exhaust temperature 110°C, and a 30:1 pepper ethanol extract powder is obtained.

[0102] (3) Cinnamon: grind to a fineness of 40-80 mesh, extract three times, with the same process parameters each time, solid-liquid ratio (g / ml) 1:12, ethanol concentration (volume fraction) 95%, stirring speed 120 r / min, extraction temperature 70°C, extraction time 120 minutes each time, the extract solution is cooled to below 40°C, vacuum filtered, solid-liquid separation, the three extract solutions are combined and put into a storage tank, and stored at low temperature for recovery of ethanol and concentration.

[0103] The ethanol extract of cinnamon slices is converted into the total amount of dry extract and the specific gravity of the concentrated liquid according to 1 / 30 of the amount of slices, pumped into a vacuum concentration pot, and ethanol is recovered under vacuum. After no alcohol smell, it is concentrated for 180 minutes at a vacuum degree of -0.06 to -0.08Mpa and a temperature of 70°C. When the specific gravity is 1.35, it is taken out of the pot and pumped into a concentrated liquid storage tank. β-dextrin and micro-powdered silica gel in the calculated proportion are added, pure water is added and stirred evenly, and the specific gravity is adjusted to 1.20 to obtain a spray liquid. The airflow spray drying tower is used for drying, and the control parameters are: inlet temperature 150°C, feed temperature 80°C, nozzle pressure 0.45MPa, exhaust temperature 100°C, and 30:1 cinnamon ethanol extract powder is obtained.

[0104] (4) Lily: crush to 20 mesh coarse powder, extract with ethanol reflux three times, with the same process parameters each time, solid-liquid ratio (g / ml) 1:12, ethanol concentration (volume fraction) 80%, soaking time under stirring for 30 minutes, stirring speed 120r / min, extraction temperature 80°C, reflux extraction time 180 minutes each time, the extract was cooled to below 40°C, vacuum filtered, mixed the three extracts, put into a storage tank, and stored at low temperature for recovery of ethanol and concentration.

[0105] Lily slices ethanol extract, according to 1 / 30 of the slices feed amount, the total amount of dry extract and the specific gravity of the concentrate are converted, pumped into a vacuum concentration pot, ethanol is recovered under vacuum, and after no alcohol smell, it is continued to be concentrated for 120 minutes at a vacuum degree of -0.06 to -0.095Mpa and a temperature of 60°C. When the specific gravity is 1.30, it is taken out of the pot and pumped into a concentrated liquid storage tank, and β-dextrin and micro-powdered silica gel in the calculated proportion are added, pure water is added and stirred evenly, and the specific gravity is adjusted to 1.20 to obtain a spray liquid. The airflow spray drying tower is used for drying, and the control parameters are: inlet temperature 140°C, feed temperature 90°C, nozzle pressure 0.4MPa, exhaust temperature 110°C, and a 30:1 lily ethanol extract powder is obtained.

[0106] 3. Preparation of ethanol / water extracts and extract powders of celery seeds, angelica and kudzu root

[0107] (1) Celery seeds: Celery seeds are ground to a fineness of 40-60 mesh. For the first and second alcohol extractions, edible ethanol is added at a solid-liquid ratio (g / ml) of 1:12, and the ethanol concentration (volume fraction) is 80%. The mixture is stirred and soaked for 60 minutes at a stirring speed of 120 r / min. The mixture is heated to 70°C and stirred and soaked for 120 minutes. The extract is cooled to below 40°C. After vacuum filtration, the two extracts are mixed and placed in a storage tank. The mixture is stored at low temperature for ethanol recovery and concentration. The third extraction is water extraction. The solid-liquid ratio (g / min) is 1:10. Pure water is added. The mixture is stirred and soaked for 60 minutes. The mixture is heated to 80°C and stirred and soaked for 150 minutes. The mixture is cooled to below 40°C, centrifuged to separate the solid and liquid, and the supernatant is collected and placed in a water extract storage tank. The supernatant is stored at low temperature for concentration.

[0108] The alcohol and water extracts of celery seed slices are converted into the total amount and specific gravity of the concentrate according to 1 / 30 of the amount of slices fed. The alcohol extract is first pumped into a vacuum concentration pot to recover ethanol under vacuum. After sampling and smelling no alcohol, add the water extract and continue to concentrate for 150 minutes at a vacuum degree of -0.08 to -0.095Mpa and a temperature of 70°C. When the specific gravity is 1.35, it is removed from the pot and pumped into the concentrate batching tank. β-dextrin and micro-powdered silica gel in the calculated proportion are added. Pure water is added and stirred evenly. The specific gravity is adjusted to 1.20 to obtain the spray liquid. The airflow spray drying tower is used for drying. The control parameters are: inlet temperature 160°C, feed temperature 90°C, nozzle pressure 0.6MPa, exhaust temperature 110°C, and 30:1 celery seed slice alcohol and water extract powder is obtained.

[0109] (2) Angelica: The Angelica slices were crushed to 20-40 meshes, and the first alcohol extraction was performed. Edible ethanol was added at a solid-liquid ratio (g / ml) of 1:12, and the ethanol concentration (volume fraction) was 70%. The slices were stirred and soaked for 60 minutes at a stirring speed of 120 r / min. The temperature was raised to 70°C, stirred and soaked for 150 minutes, cooled to below 40°C, vacuum filtered for solid-liquid separation, and the supernatant was placed in an alcohol extract storage tank. The supernatant was stored at low temperature until the ethanol was recovered and concentrated. The second and third water extractions were performed. Pure water was added at a solid-liquid ratio (g / min) of 1:10, stirred and soaked for 30 minutes at a stirring speed of 120 r / min. The temperature was raised to 80°C, stirred and soaked for 150 minutes. The parameters of the two water extractions were the same. The slices were cooled to below 40°C, centrifuged to separate the solid and liquid, and the supernatant was placed in a water extract storage tank. The supernatant was stored at low temperature until concentrated.

[0110] The alcohol and water extracts of Angelica sinensis slices are converted into the total amount and specific gravity of the concentrate according to 1 / 20 of the amount of slices fed. The alcohol extract is first pumped into a vacuum concentration pot to recover ethanol under vacuum. After sampling and smelling without alcohol, the water extract is added and the concentration is continued at a vacuum degree of -0.08 to -0.095Mpa and a temperature of 70°C for 150 minutes. When the specific gravity is 1.35, the concentrate is removed from the pot and filtered in a vacuum filtration tank. The concentrate is pumped into a batching tank, and the calculated proportion of β-dextrin and micro-powdered silica gel is added. Pure water is added and stirred evenly, and the specific gravity is adjusted to 1.20 to obtain a spray liquid. The airflow spray drying tower is used for drying, and the control parameters are: inlet temperature 145°C, feed temperature 70°C, nozzle pressure 0.6MPa, and exhaust temperature 90°C to obtain a 20:1 Angelica sinensis slice alcohol and water extract powder.

[0111] (3) Pueraria root: For the first and second alcohol extractions, the Pueraria root slices were crushed to 80 mesh, the solid-liquid ratio was 1:12, the ethanol concentration (volume fraction) was 70%, the stirring speed was 120 r / min, the immersion time was 90 minutes under stirring, the extraction temperature was 80°C, and the immersion was kept warm for 120 minutes under stirring. The extract was cooled to below 40°C, and after vacuum filtration, the two extracts were mixed and placed in a storage tank, and stored at low temperature until the ethanol was recovered and concentrated; for the third water extraction, pure water was added at a solid-liquid ratio of 1:16, the stirring speed was 120 r / min, the extract was immersed for 60 minutes, the temperature was raised to boil, and the extract was refluxed at 100°C for 210 minutes, cooled to below 40°C, centrifuged to separate the solid and liquid, and the supernatant was taken and placed in a water extract storage tank, and stored at low temperature until it was concentrated.

[0112] The alcohol and water extracts of Pueraria root slices are converted into the total amount of dry extract and the specific gravity of the concentrated solution according to 1 / 10 of the amount of slices. The alcohol extract is first pumped into a vacuum concentration pot to recover ethanol under vacuum. After sampling and smelling no alcohol, add the water extract and continue to concentrate for 120 minutes at a vacuum degree of -0.09 to -0.095Mpa and a temperature of 60°C. When the specific gravity is 1.30, the extract is removed from the pot, filtered in a vacuum filtration tank, and pumped into a concentrated solution batching tank. β-dextrin and micro-powdered silica gel in the calculated proportion are added, pure water is added and stirred evenly, and the specific gravity is adjusted to 1.20 to obtain a spray liquid. The airflow spray drying tower is used for drying, and the control parameters are: inlet temperature 140°C, feed temperature 70°C, nozzle pressure 0.45MPa, and exhaust temperature 80°C to obtain a 10:1 Pueraria root slice alcohol and water extract powder.

[0113] 4. Ultrasonic-assisted ethanol extraction of hawthorn leaves and longan seeds

[0114] (1) Hawthorn leaf: The hawthorn leaf slices were crushed into 40-60 mesh, and extracted with alcohol three times. The process parameters were the same each time. Ethanol was added according to a solid-liquid ratio of 1:12, and the ethanol concentration (volume fraction) was 70%. The mixture was stirred and soaked for 120 minutes. The temperature was raised to 72°C, the ultrasonic power was 600w, the extraction time was 40 minutes, and the mixture was cooled to below 40°C. The solid-liquid separation was performed by vacuum filtration. The supernatant was taken, and the three extracts were mixed and placed in an extract storage tank, which was stored at low temperature until concentrated.

[0115] Ultrasonic assisted ethanol extract of hawthorn leaf slices, combine ultrasonic assisted ethanol extract of hawthorn leaf slices, convert the total amount of dry extract and the specific gravity of the concentrate according to 1 / 20 of the slice feeding amount, pump into a vacuum concentration pot, recover ethanol under vacuum, take a sample and smell no alcohol, continue to concentrate for 150 minutes at a vacuum degree of -0.09 to -0.095Mpa and a temperature of 60°C, remove from the pot at a specific gravity of 1.30, filter in a hot vacuum filtration tank, pump into a concentrate batching tank, add β-dextrin and micro-powder silica gel in a calculated proportion, add pure water and stir evenly, adjust the specific gravity to 1.20, and obtain a spray liquid. Drying is carried out in an airflow spray drying tower, and the control parameters are: inlet temperature 140°C, feed temperature 80°C, nozzle pressure 0.5MPa, exhaust temperature 80°C, and a 20:1 hawthorn leaf slice ultrasonic assisted ethanol extract powder is obtained.

[0116] (2) Longan kernel: Fresh longan kernel was pretreated to remove moldy, damaged and contaminated parts, dried under hot air at 50° C., crushed to 40 mesh coarse powder, and extracted with ethanol assisted by ultrasonic three times, with the same process parameters each time, and the solid-liquid ratio (g / ml) was 1:15, edible ethanol was added, and the ethanol concentration (volume fraction) was 60%, and the kernel was soaked for 120 minutes under stirring, heated to 70° C., ultrasonic power was 400 W, and assisted extraction was performed for 60 minutes, cooled to below 40° C., vacuum filtered to separate the solid and liquid, and the filtrate was mixed for three times and stored in an alcohol extract storage tank, and stored at low temperature for recovery of ethanol and concentration.

[0117] The ultrasonic-assisted alcohol extract of longan kernels is converted into the total amount of dry extract and the specific gravity of the concentrated liquid according to 1 / 30 of the amount of the decoction pieces, and pumped into a vacuum concentration pot to recover ethanol under vacuum. After no alcohol smell is found, it is concentrated for 150 minutes at a vacuum degree of -0.07 to -0.08Mpa and a temperature of 60°C. When the specific gravity is 1.35, it is removed from the pot, filtered by a hot vacuum filtration tank, and pumped into a concentrated liquid batching tank. β-dextrin and micro-powdered silica gel in the calculated proportion are added, pure water is added and stirred evenly, and the specific gravity is adjusted to 1.20 to obtain a spray liquid. The airflow spray drying tower is used for drying, and the control parameters are: inlet temperature 200°C, feed temperature 80°C, nozzle pressure 0.5MPa, and exhaust temperature 100°C to obtain a 30:1 longan kernel ultrasonic-assisted ethanol extract powder.

[0118] 5. Water extraction and alcohol precipitation of yam and durian peel

[0119] (1) Chinese Yam: Wash, peel and weigh fresh Chinese Yam, add pure water (based on fresh Chinese Yam) at a solid-liquid ratio of 1:6, heat to 90°C under stirring, keep warm and extract for 150 minutes under stirring, cool to room temperature, centrifuge (3000r / min) for 15 minutes, separate solid and liquid, add to concentration pot, vacuum and reduce pressure, keep boiling and concentrating below 60°C, concentrate the extract to a relative density of 1.35-1.40 to obtain an extract, put it into an alcohol precipitation tank, cool to room temperature, slowly add edible ethanol while stirring, so that the ethanol concentration of the extract in the tank reaches 70% by volume, seal and refrigerate for 24 hours, put it into a filter tank, vacuum filter, collect the supernatant to obtain an alcohol-soluble extract, recover ethanol, and after sampling the liquid in the tank and smelling no ethanol, concentrate it to a specific gravity of 1.30 at 60°C to obtain an extract, put it into a batching tank, and store it at low temperature for powder spraying. The solid precipitate is dried in an oven at 60°C and crushed to 120 mesh to obtain a crude Chinese Yam polysaccharide extract.

[0120] The alcohol-soluble extract concentrate is placed in a batching tank, 10% of the dry extract is β-dextrin and 2% of micro-powder silica gel, pure water is added to adjust the specific gravity to 1.20 and stirred evenly to obtain a spray liquid. A high-speed centrifugal spray drying tower is used for spray drying, and the inlet air temperature is controlled at 180°C, the feed temperature is 60°C, and the sample flow rate is 4.4cm 3 / s, centrifugal speed 20000r / min, exhaust temperature 70℃, to obtain yam alcohol-soluble powder.

[0121] The yam polysaccharide crude extract powder and the yam alcohol-soluble powder are mixed to obtain the yam extract powder.

[0122] (2) Durian peel: Pretreatment of fresh durian peel: Take the durian white flesh inner skin and dry it under 50℃ hot air, crush it into 40 mesh powder, add pure water according to the solid-liquid ratio (g / ml) of 1:15, soak it for 60 minutes under stirring (speed 60r / min), heat it to 80℃, extract it under stirring for 150 minutes, cool it to below 40℃, centrifuge it to separate the solid and liquid, and take the supernatant; extract the filter cake twice under the same conditions, mix the extracts three times, and vacuum concentrate it below 60℃ to a specific gravity of 1.35-1.40 to obtain an extract, which is placed in an alcohol precipitation tank. Cool it to room temperature, slowly add edible ethanol under stirring to make the ethanol concentration of the extract in the tank reach 70% by volume, seal it and refrigerate it for 24 hours, put it in a filter tank, vacuum filter it, collect the supernatant, and recover ethanol. After the liquid in the tank is sampled and no ethanol smells, continue to concentrate it to a specific gravity of 1.30 to obtain an alcohol-soluble extract, and store it at low temperature for powder spraying. The static precipitate was placed in an oven and dried with hot air at 60°C to a moisture content of 7%, and then crushed to 120 mesh to obtain a crude durian polysaccharide extract.

[0123] Put the alcohol soluble extract into the batching tank, add 10% of the dry extract β-dextrin and 2% of the micro powder silica gel, add pure water to adjust the specific gravity to 1.20 and stir evenly to obtain the spray liquid. Use a high-speed centrifugal spray drying tower for spray drying, control the inlet temperature at 180℃, the feed temperature at 60℃, and the sample flow rate at 4.4cm 3 / s, centrifugal speed 20000r / min, exhaust temperature 70℃, to obtain durian endothelial alcohol extract powder.

[0124] The durian endothelial polysaccharide crude extract powder and the durian endothelial alcohol extract powder are mixed to obtain the durian extract powder.

[0125] Example 3: Preparation and application of granules

[0126] 1. Preparation of medicinal material extract powder mixture

[0127] Formula: Based on the weight of each medicinal material extract powder, there are 20 parts of celery seeds, 15 parts of chicken gizzard lining, 10 parts of reed roots, 10 parts of angelica, 10 parts of peach kernels, 5 parts of buzia leaves, 4 parts of lily, 4 parts of licorice, 4 parts of kudzu root, 4 parts of yam, 3 parts of longan seeds, 3 parts of durian peel, 2 parts of cinnamon, 2 parts of turmeric, 2 parts of pepper and 2 parts of hawthorn leaves.

[0128] Weighing: Accurately weigh the powder of each medicinal material extract according to a total amount of 100 kg, put it into the HD-100 multi-directional motion mixer, and mix it for 20 minutes to obtain a medicinal material extract powder mixture.

[0129] 2. Preparation of Chinese herbal medicine extract granules

[0130] The powder mixture of the medicinal material extracts prepared in the above steps is formulated according to the designed formulation prescription, and a pharmaceutically acceptable carrier is added, and wet granulated to prepare granules, tablets, and capsules.

[0131] The specific method is as follows:

[0132] (1) Ingredients: According to the above formula ratio, accurately weigh the powder of each medicinal material extract and put it into the ingredient tank.

[0133] (2) Preparation of wetting agent: according to the weight of the mixture of medicinal material extract powder, weigh 0.3% sodium carboxymethyl cellulose, 0.7% Tween 80, and 14% medical ethanol, wherein the ethanol concentration (volume fraction) is 70%; the three solvents are fully mixed and placed in a wetting agent tank for later use.

[0134] (3) Mixing: Suck the powder prepared in step (1) into the granulation bin, seal the bin lid, turn on the agitator, stir at a speed of 600 r / min, and rotate and mix the various herbal extract powders for 6 to 7 minutes.

[0135] (4) Granulation: While continuing to stir, turn on the peristaltic pump, spray and add the wetting agent, and start granulation. After 2 minutes, turn on the shear head at a speed of 900 r / min. Spray the wetting agent within 12 minutes, continue stirring and shearing for 45 seconds, and the granulation fineness is 60-100 mesh.

[0136] (5) Discharging: Close the shear rotor, run the agitator at a low speed, open the pneumatic discharge valve, and send the discharged material into the boiling dryer.

[0137] (6) Fluidized bed drying: Heating chamber temperature: 65-101°C, air inlet temperature: 36-60°C, material temperature: 27-41°C, fan frequency: 25-35Hz.

[0138] (7) Finished product: After drying, pass through a 60-mesh sieve and a 100-mesh sieve. The particles with an intermediate size are qualified products, that is, the Chinese herbal medicine extract granules are obtained.

[0139] The above prepared Chinese herbal medicine extract granules are packaged as solid powders, with 10 g per bag, and taken 1-2 times a day, 1 bag each time.

[0140] Example 4: Preparation of chewable tablets

[0141] 1. Preparation of medicinal material extract powder mixture

[0142] Same as Example 3.

[0143] 2. Preparation of anti-gout chewable tablets

[0144] (1) Ingredients: The medicinal material extract powder mixture is prepared according to the formula of Example 3. Based on the total weight of the chewable tablet, the prescription composition is the medicinal material extract powder mixture: 60%, magnesium stearate: 1.3%, microcrystalline cellulose: 12.7%, xylitol: 1%, and lactose: 25%. Accurately weigh and pour into the ingredient tank.

[0145] (2) Mixing: Open the batching tank and stir for 10 minutes. Open the cage and send it into the mixer to mix for 30 minutes.

[0146] (3) Preparation of wetting agent: same as in Example 3.

[0147] (4) Wet granulation: same as Example 3.

[0148] (5) Tablet pressing: Use ZP420-19B tablet press machine for large tablets at a speed of 8,000 to 10,000 tablets per hour, with each tablet weighing 1 gram.

[0149] (6) Fluidized bed drying: Pour the compressed tablets into the fluidized bed dryer, adjust the induced draft fan damper to a level where the tablets are slightly lifted, and start heating. Adjust the inlet temperature to 120°C and the outlet temperature to 90°C. Dry for 10 minutes and then discharge. Send the tablets to the factory for inspection. The moisture content should be less than 4%. If it exceeds the standard, the fluidized bed drying time should be extended.

[0150] (7) Finished product:

[0151] The dry tablets are packaged by DPP-80 aluminum-plastic blister packaging machine, with 9 tablets per plate. The finished product is packaged and boxed.

[0152] Example 5: Preparation of capsules and oral solutions

[0153] The granules obtained by wet granulation in Example 3 were directly poured into capsule shells to prepare capsules according to conventional preparation methods.

[0154] The concentrated extracts of the medicinal materials before spray drying in Example 2 were used, and food additives for flavoring and fragrance were added according to the proportions in Example 3, and a concentrated oral solution was prepared according to a conventional preparation method.

[0155] Example 6: Evaluation of the inhibitory effect of a Chinese medicine composition on gouty arthritis in rats induced by sodium urate crystals (MSU)

[0156] 1. Experimental methods

[0157] Fifteen male SD rats weighing 180-220 g were randomly divided into five groups after adaptive feeding for one week: (1) normal group, (2) model group, (3) positive control group: indomethacin 3 mg / kg, (4) Chinese medicine group (Chinese medicine decoction of Example 1, referred to as "Chinese medicine decoction", the same below): 300 mg / kg, (5) extract group (Chinese medicine extract and granules of Example 3, referred to as "Chinese medicine extract", the same below): 300 mg / kg. The normal group rats and the model control group rats were gavaged with normal saline, and the other groups of rats were gavaged for 5 consecutive days. One hour after the third day of administration, except for the normal group, the other groups of rats were injected with 50 μL of sterile MSU (20 mg / mL) suspension into the right ankle joint cavity, and the normal group rats were injected with 50 μL of sterile PBS into the right ankle joint cavity. The joint circumference of rats was measured before injection, 0 h and 24 h after injection by the wire-tying method, and the ratio of the difference between the value before administration and the circumference before administration was used to express the joint swelling rate.

[0158] 2. Experimental results

[0159] Table 1 Effect of the prescription on the joint swelling rate of gout rats (mean ± SD)

[0160] Group 0h 24h Normal group 13.74±3.48 2.90±2.02** Model Group 13.92±3.19 12.83±1.96 Indomethacin 14.52±4.25 6.73±2.37** Chinese herbal medicine decoction 14.73±3.12 7.83±0.98* Chinese herbal medicine extract 14.80±3.91 7.56±1.96*

[0161] Note: Compared with the model group at 24h, **P<0.01, *P<0.05.

[0162] Table 2 Effects of the prescription on serum and synovial markers in gout rats (mean ± SD)

[0163] Group Serum IL-1β Synovial TNF-α Normal group 35.02±3.14** 208.30±82.31** Model Group 114.70±8.52 580.01±99.06 Indomethacin 29.67±4.04** 210.35±84.64** Chinese herbal medicine decoction 59.26±11.79** 358.74±109.92* Chinese herbal medicine extract 38.67±10.02** 322.35±39.68*

[0164] Note: Compared with the model group, **P<0.01, *P<0.05.

[0165] As can be seen from the above, the indomethacin group, the Chinese medicine decoction and the Chinese medicine extract can significantly inhibit the MSU-induced joint swelling in rats (Table 1 and Figure 1 ); inhibited serum IL-1β levels and synovial TNF-α levels (Table 2 and Figure 2-3 ). This indicates that both the Chinese herbal decoction and Chinese herbal extract can significantly inhibit MSU-induced gouty arthritis in rats.

[0166] Example 7: Evaluation of the inhibitory effect of the Chinese medicine composition on hyperuricemia induced by potassium oxonate and hypoxanthine in mice

[0167] 1. Experimental methods

[0168] Sixty male Kunming mice weighing 18-22 g and aged 6 weeks were randomly divided into 6 groups after adaptive feeding for 1 week: (1) normal group, (2) model group, (3) positive control group: allopurinol 10 mg / kg, (4) positive control group: benzbromarone 10 mg / kg, (5) Chinese herbal medicine decoction: 300 mg / kg, (6) Chinese herbal medicine extract: 300 mg / kg. The mice in the normal group were intragastrically and intraperitoneally injected with 0.5% CMC-Na solution, and the mice in the other groups were intraperitoneally injected with 300 mg / kg potassium oxonate and intragastrically injected with 300 mg / kg hypoxanthine; 1 hour later, the mice in the normal group and model group were intragastrically injected with 0.5% CMC-Na solution, and the mice in the other groups were intragastrically administered for 7 consecutive days. One hour after administration on the 7th day, the eyeballs were removed to collect blood and the bladder was collected to collect urine. The levels of uric acid, creatinine, and urea nitrogen in the serum and urine of the mice were determined according to the kit method.

[0169] 2. Experimental results

[0170] Table 3 Effects of the prescription on serum biochemical markers in hyperuricemia mice (mean ± SD)

[0171] Group Serum uric acid (μM) Serum creatinine (μM) Blood urea nitrogen (μM) Normal group 70.60±31.26** 40.60±30.24** 4.30±1.89** Model Group 270.40±76.86 247.70±60.84 24.30±4.74 Allopurinol 55.60±29.01** 134.60±14.82* 14.10±2.33* Benzbromarone 208.70±30.96 214.00±23.78 12.40±2.59* Chinese herbal medicine decoction 123.70±51.19* 95.30±19.36** 9.60±2.59** Chinese herbal medicine extract 91.00±45.99* 57.00±28.55** 7.10±3.54**

[0172] Note: Compared with the model group, **P<0.01, *P<0.05.

[0173] Table 4 Effects of the prescription on urine biochemical markers in hyperuricemia mice (mean ± SD)

[0174] Group Urine uric acid (μM) Urine creatinine (μM) Urine urea nitrogen (μM) Normal group 22.70±11.06 1672.00±290.50 396.10±113.90 Model Group 112.30±28.44 708.40±260.80 188.10±77.94 Allopurinol 34.40±16.11 1021.00±194.50 196.00±65.42 Benzbromarone 223.60±26.69* 2184.00±310.90** 479.60±70.21* Chinese herbal medicine decoction 164.00±41.20 2395.00±300.60** 525.40±46.28** Chinese herbal medicine extract 208.70±34.43* 3358.00±452.40** 525.70±50.74**

[0175] Note: Compared with the model group, **P<0.01, *P<0.05.

[0176] As can be seen from the above, the allopurinol (positive drug) group, the Chinese herbal decoction and the Chinese herbal extract can significantly reduce the blood uric acid (SUA) concentration, blood creatinine (SCR) concentration and blood urea nitrogen (SBUN) level in mice (Table 3, Figures 4 to 6 ). The benzbromarone (positive drug) group, the Chinese herbal decoction and the Chinese herbal extract group all significantly promoted the excretion of uric acid through urine, increased the concentration of urinary uric acid (UUA), promoted the clearance of creatinine through the kidneys, promoted the excretion of urinary creatinine (UCR), and increased the level of urea nitrogen (UBUN) in urine (Table 4, Figures 4 to 6 ).

[0177] Example 8: Evaluation of the protective effect of Chinese medicine composition on kidney

[0178] 1. Experimental methods

[0179] Take the mouse kidneys of the normal group, model group, Chinese medicine decoction prescription, and Chinese medicine extract prescription in Example 6, cut appropriate parts and put them into 4% paraformaldehyde (PFA) for fixation. After fixation, rinse with running water 3 times, 5 minutes each time. Dehydration: 30% ethanol → 50% ethanol → 70% ethanol → 95% ethanol 1 → 95% ethanol 2 → anhydrous ethanol. Transparent: 50% ethanol + 50% xylene → xylene 1 → xylene 2 → xylene 3. Paraffin infiltration and embedding, slices are 2μm thin slices, unfolded on an adhesive slide, placed in a 60℃ oven for baking, baked overnight, taken out and stored at room temperature for use. Put the slices into xylene 110min → xylene 210min → anhydrous ethanol 15min → anhydrous ethanol 25min → 95% alcohol 5min → 90% alcohol 5min → 80% alcohol 5min → 70% alcohol 5min → distilled water wash. Slices were stained with Harris hematoxylin for 3-8 minutes, washed with tap water, differentiated with 1% hydrochloric acid alcohol for a few seconds, rinsed with tap water, blued with 0.6% ammonia water, and rinsed with running water. Slices were stained with eosin stain for 1-3 minutes; slices were placed in 95% alcohol for 15 minutes → 95% alcohol for 25 minutes → anhydrous ethanol for 15 minutes → anhydrous ethanol for 25 minutes → xylene for 15 minutes → xylene for 25 minutes to dehydrate and make them transparent, and slices were taken out of xylene to dry slightly and sealed with neutral gum. Microscope examination, image acquisition and analysis (40×, lower left black line 50 μm long).

[0180] 2. Experimental results

[0181] The kidney cells of mice in the normal group were dense and uniform, without obvious inflammatory cell infiltration, vacuolar degeneration, renal interstitial edema or renal interstitial fibrosis; the renal tubular epithelial cells of mice in the model group had moderate granular and vacuolar degeneration, red blood cells accumulated in the renal tubules, and red blood cell casts; the renal tubular lumen was dilated, renal interstitial edema, and renal interstitial fibrosis; the kidneys of mice in the Chinese medicine decoction and Chinese medicine extract prescriptions had no obvious lesions, damage, renal interstitial edema or renal interstitial fibrosis, cavitation was reduced, and there was no obvious red blood cell accumulation in the renal tubules. The above results show that the anti-gout Chinese medicine composition designed by the present invention can inhibit the renal damage of hyperuricemia mice ( Figure 7 ).

Claims

1. An anti-gout Chinese medicine composition, characterized in that: Calculated by weight, the invention comprises 10 to 40 parts of celery seeds, 8 to 35 parts of chicken's gizzard lining, 5 to 30 parts of reed roots, 5 to 30 parts of angelica sinensis, 5 to 30 parts of peach kernels, 1 to 15 parts of buzia leaves, 1 to 15 parts of lilies, 1 to 15 parts of licorice, 1 to 15 parts of kudzu roots, 1 to 15 parts of yam, 1 to 12 parts of longan seeds, 1 to 12 parts of durian peel, 1 to 6 parts of cinnamon, 1 to 6 parts of turmeric, 1 to 6 parts of pepper and 1 to 6 parts of hawthorn leaves.

2. The anti-gout Chinese medicine composition according to claim 1, characterized in that: Calculated by weight, the invention comprises 15-30 parts of celery seeds, 12-25 parts of chicken's gizzard lining, 8-20 parts of reed roots, 8-20 parts of angelica sinensis, 8-20 parts of peach kernels, 3-10 parts of buzia leaves, 3-5 parts of lily, 3-5 parts of licorice, 3-5 parts of kudzu root, 3-5 parts of yam, 2-8 parts of longan seeds, 2-8 parts of durian peel, 1.5-4 parts of cinnamon, 1.5-4 parts of turmeric, 1.5-4 parts of pepper and 1.5-4 parts of hawthorn leaves.

3. The anti-gout Chinese medicine composition according to claim 1, characterized in that: Calculated by weight, it includes 20 parts of celery seeds, 15 parts of chicken gizzard lining, 10 parts of reed roots, 10 parts of angelica, 10 parts of peach kernels, 5 parts of buzia leaves, 4 parts of lily, 4 parts of licorice, 4 parts of kudzu root, 4 parts of yam, 3 parts of longan seeds, 3 parts of durian peel, 2 parts of cinnamon, 2 parts of turmeric, 2 parts of pepper and 2 parts of hawthorn leaves.

4. A method for preparing an extract of the Chinese medicine composition according to claim 1, characterized in that: Choose from any of the following methods: Method 1: Add 1.5 to 3 times the total weight of the medicinal materials in water, soak, extract, and obtain a first extract; add the remaining medicinal residues in water equal to the first extraction, soak, extract, and obtain a second extract; add the remaining medicinal residues in water half the first extraction, soak, and obtain a third extract; combine the three extracts to obtain the extract of the traditional Chinese medicine composition; Method 2: Prepare the extract of each medicinal material, concentrate, and dry to obtain the extract of each medicinal material; or add a pharmaceutically acceptable carrier after concentration to obtain the extract of each medicinal material; mix the extracts of each medicinal material to obtain the extract of the traditional Chinese medicine composition.

5. The preparation method according to claim 4, characterized in that: In the second method, the content of each medicinal material extract of celery seed, chicken gizzard lining, reed root, angelica, peach kernel, buzia leaf, lily, licorice, kudzu root, yam, longan kernel, durian peel, cinnamon, turmeric, pepper, and hawthorn leaf is the mass ratio of the medicinal material decoction pieces to the extract, and is 30:1, 20:1, 30:1, 20:1, 30:1, 30:1, 30:1, 10:1, 10:1, 30:1, 10:1, 30:1, 30:1, 30:1, 20:1, respectively.

6. The preparation method according to claim 4, characterized in that: In the second method, the mixing mass ratio of the medicinal material extracts of celery seeds, chicken gizzard lining, reed root, angelica, peach kernel, buzia leaf, lily, licorice, kudzu root, yam, longan kernel, durian peel, cinnamon, turmeric, pepper, and hawthorn leaf is (10-30):(10-20):(5-15):(5-15):(5-15):(3-8):(2-6):(2-6):(2-6):(2-6):(1-5):(1-5):(1-3)(1-3):(1-3):(1-3).

7. A pharmaceutical composition, characterized in that An extract comprising the anti-gout traditional Chinese medicine composition according to claim 1 and a pharmaceutically acceptable carrier.

8. The pharmaceutical composition according to claim 7, characterized in that The dosage forms include granules, tablets, capsules, ointments, and oral solutions.

9. Use of the anti-gout Chinese medicinal composition or its extract according to claim 1, or the pharmaceutical composition according to claim 7 in the preparation of a medicament for treating gouty arthritis and hyperuricemia.

10. The use according to claim 9, characterized in that: The drug is an anti-inflammatory, analgesic and detumescent drug that dissolves uric acid crystals, inhibits uric acid production, promotes uric acid excretion, and protects the liver and kidneys.

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