CN115317574A

CN115317574A - Composition for treating hyperuricemia and application thereof

Info

Publication number: CN115317574A
Application number: CN202211009450.8A
Authority: CN
Inventors: 马玫
Original assignee: Shiziyang Biotechnology Guangzhou Co ltd
Current assignee: Shiziyang Biotechnology Guangzhou Co ltd
Priority date: 2022-08-19
Filing date: 2022-08-19
Publication date: 2022-11-11

Abstract

The invention discloses a composition for treating hyperuricemia and application thereof, wherein the composition comprises 110-310 parts of diglyceride oil, 5-15 parts of exocarpium citri rubrum, 5-15 parts of poria cocos, 10-30 parts of Chinese yam, 10-20 parts of coix seeds, 5-15 parts of perilla seeds, 5-15 parts of radish seeds, 10-20 parts of seaweed, 10-30 parts of hawthorn, 5-15 parts of kudzu roots, 5-15 parts of sophora japonica and 20-50 parts of lotus leaves. The novel food raw material diglyceride oil with the special pearl metabolic pathway and the lipid metabolism conditioning function is added to the formula of the composition, the effect of reducing the blood uric acid of a medicine-food homologous formula can be cooperated, the combination of traditional Chinese medicine and modern pharmacology avoids that the existing medicine can only treat the hyperuricemia and can condition the whole body, the formula screening design is carried out according to the mouthfeel of hyperuricemia people so as to enhance the edible compliance of patients, the consideration of both the principal and secondary aspects is realized, and the hyperuricemia and the complications thereof are improved.

Description

Composition for treating hyperuricemia and application thereof

Technical Field

The invention relates to the field of hyperuricemia treatment, and in particular relates to a composition for treating hyperuricemia and application thereof.

Background

Hyperuricemia is a common biochemical abnormality, and refers to that under the normal purine diet state, the level of non-twice-daily fasting blood uric acid is higher than 420mmol/L in men and higher than 360mmol/L in women, namely, the hyperuricemia is called. 420mmol/L and 360mmol/L are saturated concentrations of uric acid in blood of male and female populations, respectively, above which urate can be deposited in various tissues such as kidney, joint synovium, causing tissue damage.

The blood uric acid is increased, and urate can be deposited on joints to form gouty arthritis; precipitating in kidney to form gouty nephropathy and uremia; the vascular wall is stimulated to cause atherosclerosis, and coronary heart disease and hypertension are aggravated; pancreatic B cells are damaged, inducing or exacerbating diabetes. Hyperuricemia is the basis of gout, and the higher the blood uric acid level is, the higher the possibility of gout in the next 5 years is; a plurality of epidemiological studies prove that the blood uric acid is an independent risk factor of the hypertension, and the relative risk of the hypertension is increased by 25 percent for every 59.5 mu mol/L increase of the blood uric acid level. Clinical studies find that 90% of patients with primary hypertension have hyperuricemia; long-term hyperuricemia can destroy pancreatic beta cell function to induce diabetes, and researches prove that the long-term hyperuricemia has a causal relationship with sugar tolerance abnormality and diabetes onset; the epidemiological data at home and abroad show that the blood uric acid and the triglyceride are related, and a prospective queue research on the relationship between the uric acid and the triglyceride finds that the basic triglyceride is an independent prediction factor of the future hyperuricemia; the pathophysiological basis of the metabolic syndrome is hyperinsulinemia and insulin resistance, the insulin resistance enables the generation of blood uric acid to be increased in the glycolysis process and the free fatty acid metabolism process, hyperuricemia is directly caused by increasing the reabsorption of uric acid by the kidney, and 70% of patients with the metabolic syndrome are simultaneously combined with the hyperuricemia; research shows that uric acid is an independent risk factor for coronary heart disease death of the general population regardless of sex. When the blood uric acid rises by 1mg/dl, the death risk is increased by 48 percent in males and 126 percent in females. Blood uric acid >6mg/dl is an independent risk factor for coronary heart disease; blood uric acid >7mg/dl is an independent risk factor for stroke; many epidemiological investigations and animal studies have shown that uric acid can directly cause microangiopathy of the glomerular arteriole, leading to chronic kidney disease.

Therefore, the modern medicine needs a composition for treating hyperuricemia and reducing the uric acid content of a human body under pathological conditions. However, in the prior art, including chemical drugs and traditional Chinese medicines, for example, patent CN111617072A provides an application of phthalide compound and pharmaceutically acceptable salts, esters, prodrugs, solvates, polymorphs, hydrates or derivatives thereof in combination with hyperuricemia drugs in preparation of combined drugs for treating hyperuricemia, the chemical drugs have good effect of reducing uric acid, but have obvious side effects and poor compliance, can only treat hyperuricemia, cannot perform whole body conditioning, do not significantly reduce the incidence rate of complications, and are contraindicated in combination, and are not suitable for being used in cooperation with other complications treatment drugs, and cannot relieve symptoms of diabetes, hypertension and the like of patients. For example, patent CN101199750B discloses a Chinese medicinal composition comprising five Chinese medicinal herbs of glabrous greenbrier rhizome, sevenlobed yam rhizome, edible tulip, cowherb seed and twotooth achyranthes root, which has no significant effect of reducing uric acid and is also not suitable for being used in combination with other complications treatment medicines.

Disclosure of Invention

Aiming at the technical defects, the invention aims to provide a composition for treating hyperuricemia and application thereof.

According to the research result, in order to solve the prior technical problem, the invention adopts the following technical scheme:

the invention aims to provide a composition for treating hyperuricemia, which comprises the following raw materials in parts by mass: 110-310 parts of diglyceride oil, 5-15 parts of tangerine peel, 5-15 parts of poria cocos, 10-30 parts of Chinese yam, 10-20 parts of coix seeds, 5-15 parts of perilla seeds, 5-15 parts of radish seeds, 10-20 parts of seaweed, 10-30 parts of hawthorn, 5-15 parts of kudzu roots, 5-15 parts of sophora flower buds and 20-50 parts of lotus leaves.

Further, 132-248 parts of diglyceride oil, 6-12 parts of tangerine peel, 6-12 parts of poria cocos, 15-25 parts of Chinese yam, 12-18 parts of coix seeds, 6-12 parts of perilla seeds, 6-12 parts of radish seeds, 12-18 parts of seaweed, 15-25 parts of hawthorn, 6-12 parts of kudzu roots, 6-12 parts of sophora flower buds and 20-30 parts of lotus leaves.

Further, the traditional Chinese medicine composition comprises 240 parts of diglyceride oil, 10 parts of tangerine peel, 10 parts of poria cocos, 20 parts of Chinese yam, 15 parts of coix seeds, 10 parts of perilla seeds, 10 parts of radish seeds, 15 parts of seaweed, 20 parts of hawthorn, 10 parts of kudzu roots, 10 parts of sophora japonica and 30 parts of lotus leaves.

The second purpose of the invention is to provide the application of the composition for treating hyperuricemia in medicines for treating hyperuricemia.

Further, the dosage form of the composition comprises tablets, pills, granules, capsules, soft capsule preparations, liquid preparations or gel candies.

The third purpose of the invention is to provide a preparation method of the composition for treating hyperuricemia, which comprises the steps of weighing medicinal and edible medicinal materials in the formula according to the mass parts, carrying out water extraction, concentration, drying and crushing on the medicinal and edible medicinal materials to prepare extract powder, sieving the extract powder by a 200-mesh sieve, and adding the extract powder into new food raw material diglyceride oil to prepare the composition.

Further, the gelatin, the glycerol, the sorbitol solution and other components are added into the composition, and the gel candy is prepared by the processes of batching, pressing, shaping, drying, sorting and packaging.

Modern medicine considers that disorders of lipid metabolism and protein metabolism (purine metabolism) are major causes of hyperuricemia, and are related to factors such as age, sex, and life. The traditional Chinese medicine considers that spleen qi deficiency and phlegm-blood stasis are the main pathogenesis of the disease.

Because the formation mechanism of hyperuricemia is complex and easy to react repeatedly, the curative effect of the existing medicament for reducing the blood uric acid in clinical use is not satisfactory, and the existing medicament has larger side effect, and the actual curative effect of the western medicine in the clinical treatment of the hyperuricemia is difficult to achieve the ideal condition. Lifestyle intervention is therefore the first measure to regulate purine metabolic disorders. Lifestyle modifications (including healthy diet, adherence to exercise and weight control, etc.), appropriate dietary conditioning, pharmacological intervention and health education management are currently common means for preventing and treating disorders of purine metabolism.

The traditional Chinese medicine has no traditional Chinese medicine names which completely correspond to the hyperuricemia in the traditional Chinese medicine, the hyperuricemia is simply classified into gout, arthralgia, fever with tiger, pyretic fever and the like, and the majority of hyperuricemia patients have no obvious symptoms from the syndrome differentiation condition of clinical patients, and the blood uric acid level is higher than the normal value only by physical examination.

The traditional Chinese medicine considers that hyperuricemia is the syndrome of principal deficiency and secondary excess, and is mainly caused by deficiency of spleen and kidney, liver and kidney deficiency, essence and blood deficiency, damp turbidity, blood stasis and blocking of channels and collaterals due to natural deficiency, or overstrain, cold and heat imbalance, diet loss (excessive drinking, eating) and the like. Or stagnation in channels can cause swelling and pain of bone joint, calculus malformation, even rupture, and fat leakage; or stagnation transforming into heat, accumulating into toxicity and damaging spleen and kidney. Therefore, deficiency of liver and kidney and dysfunction of spleen in transportation and transportation are the primary symptoms of the disease, and stagnation of turbid phlegm is the secondary symptom of the disease. In general, the pathogenesis of this disease is no external dampness, phlegm, heat, stasis or deficiency of the five extremities, while the affected viscera are heavily located in the liver, spleen and kidney. The literature on treating hyperuricemia shows that the traditional Chinese medicine has the symptoms of turbid phlegm and blood stasis, long-term phlegm and blood stasis blocking collaterals, insufficiency of yang qi and deficiency of liver and kidney.

The traditional Chinese medicine carries out comprehensive syndrome differentiation treatment from the overall view and the preventive treatment of diseases, regulates metabolism and corrects the source thereof, clears heat and promotes diuresis to treat the symptoms thereof, dissolves turbidity and breaks stasis to dredge channels and collaterals, and regulates and tonifies liver and kidney to consolidate the basis, and the traditional Chinese medicine is applied to patients with hyperuricemia to achieve good effect.

The invention applies the theory of traditional Chinese medicine physique and combines the research result of the identification relationship between hyperuricemia and traditional Chinese medicine physique. Constitutions are inherent characteristics of the human body which are relatively stable in function and form and are expressed on the basis of heredity and acquirement, but are also adjustable. The theory related to physical diseases of the theory of constitutions of traditional Chinese medicine says that the purpose of treating related diseases can be achieved through conditioning and intervening constitutions. From the research results of the relationship between traditional Chinese medicine physique and hyperuricemia, patients with hyperuricemia are not always in phlegm-dampness physique, people belonging to the phlegm-dampness physique do not all suffer from hyperuricemia, but the population with the phlegm-dampness physique is a high-incidence population with the hyperuricemia, the probability of suffering from the hyperuricemia is far higher than that of a common person, and the research shows that 84.5 percent of the traditional Chinese medicine physique of the population with the hyperuricemia is in the phlegm-dampness physique, so that the hyperuricemia can be treated by conditioning the phlegm-dampness physique.

Meanwhile, by combining the theory of metabolism of three nutrients of a human body, the fact that lipid metabolism can influence the metabolism of proteins and saccharides is considered, the content of purine substances which are metabolic intermediates is higher due to the disturbance of protein metabolism (amino acid metabolism), and the content of uric acid in blood is abnormal due to the excessive production of uric acid by purine after being oxidized by liver, so that hyperuricemia is caused, so that the regulation of hyperuricemia caused by purine metabolic abnormality by regulating lipid metabolism is a basis of modern medicine. In conclusion, the new resource food raw material diglyceride oil with the special pearl metabolic pathway and the lipid metabolism conditioning function is added to the formula in clinical experiments, the action of reducing the blood uric acid of the medicine-food homologous formula can be cooperated, and the traditional Chinese medicine and the modern pharmacology are combined to realize the consideration of both the symptoms and root causes.

The diglyceride oil (DAG) in the formula is a new food raw material approved by the national ministry of health, has special bead metabolic pathway and lipid metabolism and protein metabolism regulation functions, and is shown by modern medical research and clinical experiments: diglyceride oil is effective in improving chronic metabolic syndrome disorders including lipid metabolism and purine metabolism.

The tangerine peel and the tuckahoe in the formula have the effects of tonifying spleen and qi, reducing phlegm and eliminating dampness, and are designed aiming at main pathogenesis, so the tangerine peel and the tuckahoe are monarch drugs together. The Chinese yam has the effects of tonifying spleen and qi, and modern pharmacological studies show that the Chinese yam has the effect of reducing blood sugar; the coix seeds have the effects of tonifying spleen and excreting dampness, and inducing diuresis to alleviate edema, and the perilla seeds (perilla seeds) and the radish seeds have the effects of regulating qi and reducing phlegm, and accord with the theory that the phlegm is treated first to treat qi, the phlegm rises along with the rising of qi, and the phlegm falls along with the falling of qi in the traditional Chinese medicine; the four medicines are used as ministerial medicines. The modern pharmacological research shows that fucoidan sulfate in the seaweed can reduce serum cholesterol, and in addition, the seaweed water extract has the function of reducing blood pressure; the hawthorn has the effects of tonifying spleen, stimulating appetite, promoting digestion, removing food stagnation, promoting blood circulation, removing blood stasis, expanding blood vessels, reducing blood sugar and reducing blood pressure; puerarin has obvious functions of lowering blood sugar, expanding blood vessel, lowering peripheral resistance and lowering blood pressure; modern pharmacological research shows that the sophora flower bud has obvious blood pressure lowering effect. The lotus leaf can promote diuresis and reduce blood fat. The five medicines are used as adjuvant and guiding medicines. The medicines are combined to play the roles of strengthening spleen and replenishing qi, reducing phlegm and eliminating dampness, and activating blood circulation to dissipate blood stasis.

The pharmacological actions of the compatible food materials in the formula are described as follows:

diglyceride (DAG) is a structural lipid in which one fatty acid in Triglyceride (TAG) is substituted by a hydroxyl group, is a trace component of natural vegetable fat and oil, and is a food component recognized as safe (GRAS) in the world. In 2009, the derivatives (diglyceride oil) of the edible oil are listed as national new resource foods in China, and strict quality requirement evaluation standards are established for the derivatives. Diglyceride has special metabolic path and function in vivo, and the existing toxicological evaluation results at home and abroad are safe. The scientific literature in the international publication section on the study of the health impact of diglyceride oils shows: diglycerides lower serum triglycerides by altering hepatic fatty acid metabolism; repeated eating of diglyceride can promote fat metabolism after meal and reduce visceral fat area; the consumption of diglyceride obviously improves the energy utilization rate of the dietary fat. Clinical experiments and modern research of a plurality of domestic hospitals prove that: the diglyceride oil has the functions of regulating lipid metabolism and purine metabolism, and can obviously reduce the concentration of uric acid in blood serum.

Exocarpium citri rubrum is an immature or near-mature dried outer pericarp of Osbeck, citrus grandis (L.) grandis (Citrus grandis) of Rutaceae. Pungent and bitter taste, warm in nature. It enters lung and spleen meridians. Has the functions of dispelling cold, eliminating dampness, promoting qi circulation and eliminating phlegm. Can be used for treating cough due to wind-cold evil, itching throat, excessive phlegm, food stagnation, alcohol injury, nausea, vomiting, and stuffiness. Contains volatile oil, and the main components are citral, geraniol, linalool, o-methyl carbamate, limonene, alpha-pinene, etc. And (3) flavonoid components: naringin, neohesperidin, poncirin, fortunella margarita, nobiletin, 5,7,4' -trimethoxyflavone, etc.; stachydrine, umbelliferone, auraptene, glycine, beta-sitosterol glucoside, montanane, etc. It also contains protein, fat, saccharide, carotene, vitamins B1, B2, C, nicotinic acid, etc. Modern researches have proved that the composition has effects of resisting inflammation, reducing blood viscosity, and promoting blood circulation.

Poria is dry sclerotium of Wolf of Poriacocos (Schw.) of Polyporaceae. Sweet and bland in flavor and mild in nature. Enter heart, lung, liver and kidney meridians. Has effects of promoting diuresis, eliminating dampness, invigorating spleen, and calming heart. It is used clinically in treating edema, oliguria, phlegm and fluid retention, dizziness, palpitation, spleen deficiency, anorexia, loose stool, diarrhea, uneasiness, palpitation, insomnia, etc. The main ingredients include beta-pachyman and triterpenoid such as acetylpachymic acid, pachymic acid, 3 beta-hydroxylanostadienoic acid, gum, chitin, protein, fat, sterol, lecithin, glucose, adenine, histidine, choline, beta-pachyman decomposition enzyme, lipase, protease, etc. The pharmacological verification shows that the product has the effects of resisting bacteria, promoting urination, reducing blood sugar, resisting ulcer, etc.

The rhizoma Dioscoreae is dried rhizome of Dioscorea opposita Thunb of Dioscoreaceae or Dioscorea opposita Thunb of the same genus. It enters lung, spleen and kidney meridians, and is sweet in taste and neutral in nature; has the functions of invigorating spleen and stomach, promoting the production of body fluid and benefiting lung, and tonifying kidney and arresting seminal emission. Can be used for treating spleen deficiency, anorexia, chronic diarrhea, lung deficiency, cough, asthma, spermatorrhea, leukorrhagia, frequent micturition, and diabetes due to deficiency heat. Bran-fried Chinese yam can tonify spleen and strengthen stomach. Can be used for treating spleen deficiency, anorexia, diarrhea, loose stool, and leukorrhagia. The rhizoma Dioscoreae tuber and root contains diosgenin, dopamine, cholesterol, ergosterol, campesterol, stigmasterol, beta-sitosterol, polyphenol oxidase, allantoin, estutinin, glycoprotein, lysine, histidine, arginine, aspartic acid, threonine, serine, glutamic acid, proline, glycine, alanine, valine, leucine, isoleucine, tyrosine, phenylalanine, methionine, polysaccharide with blood sugar lowering effect, and various microelements. Modern pharmacology proves that the traditional Chinese medicine composition has the effects of reducing blood sugar, resisting stress reaction, improving the immunity of organisms and the like.

The Coicis semen is derived from dried mature kernel of Coixlacryma-jobil of Gramineae, coicis semen Coixlacryma-yuen (Roman.) Stapf. In autumn, the fruit is ripe, the plant is cut, dried in the sun, the fruit is removed, dried in the sun again, and the shell, the tawny seed coat and impurities are removed. Coix seed, sweet and bland in taste, cool in nature, enters spleen, stomach and lung meridians. Has the functions of invigorating spleen, eliminating dampness, eliminating arthralgia, stopping diarrhea, clearing away heat and expelling pus. Can be used for treating edema, loempe, dysuresia, damp arthralgia, spasm, diarrhea due to spleen deficiency, pulmonary abscess, and intestinal abscess; flat warts, and the like. Coicis semen contains protein, fat, carbohydrate, small amount of vitamin B1, amino acids (such as leucine, lysine, arginine, tyrosine, etc.), coixol ester, and triterpene compounds. Coix seed oil or saturated fatty acids containing 10-18 carbon atoms (C) can prevent or reduce contraction of striated muscle (non-neuromuscular junction site), while unsaturated fatty acids (such as oleic acid) do not. Coix seed oil (0.5 g/kg subcutaneously injected in rabbit) and fatty acid with C number of more than 12 can reduce blood sugar, which can be antagonized by pyruvic acid, reduce serum calcium, and fatty acid with lower C number (such as capric acid) has no influence on blood sugar and blood calcium. Coix seed oil (mainly palmitic acid and its esters) is responsible for respiration, small amount of excitement, and large amount of paralysis (central); can remarkably expand pulmonary vessels. For in vitro frog heart and in vitro rabbit intestine, the low concentration shows the excitation function, the high concentration shows the inhibition function; generally has excitation effect on the uterus of rabbits and guinea pigs, and epinephrine can reverse the excitation effect; it also has diuretic effect; a large amount of the medicine can paralyze animals and stop breathing. Coixol has effects of inhibiting striated muscle, inhibiting central nerve, relieving pain, and preventing lethality of strychnine or pentaerythrine; has good heat-relieving effect on the heat caused by the compound polysaccharide refined by the thalli, but has no effect on the heat caused by the dinitrophenol. Coix seeds have been reported to have growth-arresting and injuring effects on cancer cells.

The fructus Perillae is dried mature fruit of Perilla frutescens (L.) Britt. Collected in autumn when the fruit is ripe, removed of impurities and dried in the sun. It is pungent and warm in flavor. It enters lung meridian. Has the functions of depressing qi, eliminating phlegm, relieving asthma and moistening intestines. Can be used for treating phlegm obstruction, adverse rising of qi, cough, asthma, and constipation due to intestinal dryness. Perilla contains protein, lipid sterol, etc. Wherein the oil contains fatty acid, linolenic acid, and linoleic acid; lecithin, cephalin, phosphatidylserine, and the like. The sterols are mainly beta-sitosterol. Modern researches prove that the traditional Chinese medicine composition has the effects of resisting tumors, improving learning ability, prolonging survival time of spontaneous hypertensive rats and the like.

The Raphani semen is dried mature seed of Raphanus sativus L. Harvesting plants when fruits are mature in summer, drying in the sun, rubbing out seeds, removing impurities, and drying in the sun again. Pungent and sweet in flavor and mild in nature. It enters lung, spleen and stomach meridians. Has the functions of promoting digestion, relieving flatulence, descending qi and eliminating phlegm. Can be used for treating food stagnation, abdominal distention and pain, constipation, stagnation, dysentery, phlegm stagnation, and cough and asthma. Contains protein, fatty oil, volatile oil and sinapine. The volatile oil contains methyl mercaptan, etc. The fatty oil contains high content of erucic acid, linoleic acid, linolenic acid, erucic acid glyceride, etc. Also contains antibacterial substance called sulforaphane. Modern researches prove that the traditional Chinese medicine composition has the function of resisting pathogenic microorganisms: the radish seed aqueous extract has obvious inhibiting effect on staphylococcus, escherichia coli and the like, and the water extract has inhibiting effect on trichophyton concentricum, yellow ringworm of Schwannion, microsporum austrianum, microsporum ferrugineum, microsporum lanugineum and Nocardia stellaton with different degrees. Neutralizing endotoxin, lowering blood pressure, and reducing peripheral vascular resistance.

The seaweed is dried fronds of Sargassaceae Sargassum pallidum (Turn.) C.Ag. or Sargassum fusiforme (Harv.) Setch. The former is known as "kelp", and the latter is known as "lobular seaweed". Collected in summer and autumn, cleaned and dried in the sun after removing impurities. Bitter, salty and cold. It enters liver, stomach and kidney meridians. Has the effects of softening and resolving hard mass, eliminating phlegm and inducing diuresis. It can be used for treating goiter, scrofula, swelling and pain of testis, and edema due to phlegm and fluid retention. Contains alginic acid 20.8%, crude protein 7.95%, mannitol 10.25%, ash 37.19%, potassium 12.82%, and iodine 0.03%. Modern pharmacological actions include improvement of thyroid hypofunction caused by iodine deficiency, temporary suppression of metabolic rate of hyperthyroidism, and alleviation of symptoms, but they are not durable. Iodide, after entering tissues and blood, can also promote the absorption of pathological products such as inflammatory exudates. And can cause the collapse and dissolution of diseased tissues, so it is not generally used for active tuberculosis. In addition, it has anticoagulant, blood pressure lowering, and blood lipid reducing effects.

The fructus crataegi is dried mature fruit of Crataegus Pinnatifida Bge.var.majorn.E.Br. or Crataegus Pinnatifida Bge.of Rosaceae, and is removed of impurities and shed kernel. Pungent and sweet in flavor, slightly warm in nature. Enter spleen, stomach and liver meridians. Has effects of resolving food stagnation, invigorating stomach, activating qi-flowing and removing blood stasis. The traditional Chinese medicine composition is clinically used for treating meat food stagnation, gastric cavity fullness, dysentery and abdominal pain, blood stasis and amenorrhea, postpartum blood stasis, heart and abdominal stabbing pain and hernia pain; hyperlipidemia and the like. The modern research mainly contains flavonoid and triterpenes, including L-epi-theanine, quercetin, hyperin, ursolic acid, chlorogenic acid, citric acid, monomethyl citrate, dimethyl citrate, trimethyl citrate, flavan polymer, etc. The pharmacological verification shows that the health food has the effects of promoting digestion, strengthening heart, reducing blood pressure, reducing blood fat, resisting oxidation, improving immunity and the like.

Kudzu root is dried root of Pueraria lobata (Willd.) Ohwi, a leguminous plant. Sweet, pungent and cool in nature. It enters spleen and stomach meridians. Has the functions of expelling pathogenic factors from muscles, allaying fever, promoting the production of body fluid, promoting eruption, invigorating yang and relieving diarrhea. Contains puerarin, puerarin glycoside, daidzein glycoside, beta-sitosterol, and arachidic acid. The pharmacological research has the functions of dilating coronary artery, relieving spasm, reducing blood sugar, relieving fever and the like. The traditional Chinese medicine composition is mainly clinically used for fever and headache caused by exogenous pathogens, strong pain of neck and back, thirst, diabetes, measles without adequate eruption, dysentery caused by heat and diarrhea; high blood pressure, neck and neck pain.

Flos Sophorae Immaturus is flower bud of Sophora japonica L. of Leguminosae. Collected in summer when the flower buds are formed, dried in time and removed of branches, stalks and impurities. Bitter and slightly cold in nature. It enters liver and large intestine meridians. Has the functions of cooling blood, stopping bleeding, clearing liver-fire and purging fire. Can be used for treating hematochezia, hemorrhoidal bleeding, bloody flux, metrorrhagia, hematemesis, epistaxis, liver heat with conjunctival congestion, headache, and vertigo. Contains flavonoid components such as rutin, sophora japonica Makino A, etc.; other sterols, such as sophoricoside B and C, triterpenoid saponin, betulin, sophoricediol, glucose, glucuronic acid, and tannin. Has effects in improving capillary elasticity, reducing capillary permeability, relieving inflammation, relieving spasm, resisting ulcer, dilating coronary artery, improving myocardial circulation, reducing cholesterol, and inhibiting bacteria.

The folium Nelumbinis is dried leaf of Nelumbo nucifera Gaertn of Nymphaeaceae. Collected in summer and autumn, sun-dried to seven or eight dry, removed leaf stalk, folded into semicircle or fan shape, and dried. The bitter taste is neutral, and enters liver, spleen and stomach meridians. Has the functions of clearing away summer-heat, raising the body's vital energy, cooling blood and arresting bleeding. Can be used for treating summer heat, polydipsia, summer damp diarrhea, spleen deficiency diarrhea, hematemesis, epistaxis, hematochezia, metrorrhagia, and metrostaxis. The lotus leaf charcoal astringes to remove blood stasis to stop bleeding. Can be used for treating various hemorrhagic diseases and puerperal blood fainting. The leaf contains liensine, nuciferine, protopanabasine, meyersinine, protopanabasine, N-demethylnuciferine, D-N-methylcoumarin, annonacin, liriodenine, quercetin, isoquercitrin, liensin, tartaric acid, citric acid, malic acid, gluconic acid, oxalic acid, succinic acid, and tannin. Also contains alkaline components with antimitotic effect.

Clinical study

The clinical application of the inventor on 90 patients with hyperuricemia is carried out on the dietary formula disclosed by the invention, and the effect of the dietary formula is observed by self-contrast before and after the formula is eaten. Wherein the diagnostic criteria are: it is necessary to have:

(1) BMI body mass index: male is more than or equal to 25, female is more than or equal to 23;

(2) Any two of the following 5 factors: (1) increase of uric acid: > 420. Mu. Mol/L (male) and > 360. Mu. Mol/L (female); (2) elevated Triglyceride (TG) levels: > 150mg/dl (1.70 mmol/L), or has received special treatment for this lipid abnormality; (3) reduced high density lipoprotein cholesterol (HDL-C) levels: male < 40mg/dl (1.03mm01-L), female < 50mg/dl (1.29 mmol/L) or has received special treatment for this lipid abnormality; (4) elevation of fasting blood glucose: fasting glucose is greater than or equal to 100mg/dl (5.6 mmol/L, or has been diagnosed as type 2 diabetes if fasting glucose is greater than or equal to 100mg/dl (5.6 mmol/L), the Oral Glucose Tolerance Test (OGTT) is strongly recommended, but OGTT is not necessary in diagnosing metabolic syndrome.

The treatment scheme comprises the following steps: all subjects had diet control, moderate exercise and weight loss; a low-salt and low-fat diet is adopted; moderate intensity aerobic exercise for at least 30 minutes per day; eating the gel candy prepared by the formula of the invention twice a day; patients with diabetes take metformin, patients with hypertension take captopril, valsartan amlodipine tablets and the like; the treatment course is 8-16 weeks.

And (4) observation indexes are as follows: the uric acid, the blood fat and the blood sugar are measured once before and after eating.

As a result:

index (I)	Before eating (average)	After eating (average)
			BMI	26.85	26.1
Uric acid (mu mol/L)	495	368
			Triglyceride (mmol/L)	1.97	1.63
Total cholesterol (mmol/L)	4.69	4.02
			LDL-C(mmol/L)	3.11	2.61
HDL-C(mmol/L)	1.11	1.15
			Fasting blood glucose (mmol/L)	7.34	6.48

The results show that the indexes of BMI index, uric acid, triglyceride, total cholesterol, fasting blood glucose and the like are reduced, wherein the uric acid and the triglyceride are obviously reduced, and the complications are improved. No adverse events occurred during the treatment period.

Typical clinical cases

Case 1:

huang-some, male, 71 years old. Obesity was more than 5 years, and the trial began in 6 months of 2020, BMI before the trial: 27.28kg/m ² 626 mu mol/L uric acid, fat body, heavy limbs, lassitude, easy fatigue, good sleep, pale tongue with white and greasy coating, slippery pulse, and red and swollen joints. And (3) Western diagnosis: hyperuricemia, accompanied with type 2 diabetes, hypertension, diagnosis in traditional Chinese medicine: phlegm-dampness stagnates in the spleen. The valsartan amlodipine tablets and the metformin hydrochloride tablets are used at present. The prescription of the invention is given to try to take after reasonable diet, low-purine food is taken as the main food and proper exercise is performed. After the preparation is continuously used for conditioning for 2 months, the symptoms and various physical and chemical inspection indexes are obviously improved, and the uric acid is reduced to 359 mu mol/L. Without arthritis, tophus and uric acid calculi.

Case 2:

a certain woman in the piece is aged 64 years and starts to eat in 6 months in 2020. BMI before tasting: 26.56kg/m ² 590 mu mol/L uric acid, fat body, hypodynamia, dizziness, pale red tongue, white and greasy coating and slippery pulse. The past medical history: hypertension is 10 years old, hyperlipidemia, type 2 diabetes mellitus, hyperuricemia, thyroidectomy is performed, and the traditional Chinese medicine diagnosis is as follows: syndrome of intermingled phlegm and blood stasis. And (3) Western diagnosis: metabolic syndrome, hyperuricemia, hypertension, type 2 diabetes. The traditional medicine is irbesartan hydrochlorothiazide tablets, aspirin, metformin hydrochloride, pioglitazone hydrochloride, febuxostat and Youmetone. The formula of the invention is given to eat after people order reasonable diet, drink more water and exercise properly. After 2 weeks the symptoms were significantly reduced and after 8 weeks the uric acid was reduced to 359. Mu. Mol/L.

Case 3:

plum, a certain one, male, 36 years old, starts to eat in 6 months of 2020. BMI before tasting: 37.38kg/m ² Uric acid 700 mu mol/L, obesity, dizziness, heaviness of the limbs, white and greasy tongue coating, slippery pulse, red swelling and pain of joints. Western medicine can diagnose hyperuricemia, obesity, hyperlipidemia and hypertension. Traditional Chinese medicine diagnosis: syndrome of intermingled phlegm and blood stasis. The conventional medicaments of valsartan, nifedipine sustained release tablets, bisoprolol fumarate, ezetimibe and atorvastatin are adopted. After the formula is eaten after 3 weeks, the symptoms are obviously relieved, and after 8 weeks, the uric acid is reduced to 452 mu mol/L by repeating examination.

Case 4:

li Shi, male, 62 years old, started the trial at 3 months 2020. BMI before test diet: 26.13kg/m ² Uric acid 510 μmol/L, overweight body, dizziness, lassitude, white and greasy tongue coating, and slippery pulse. Western medicine can diagnose hyperuricemia, accompanied with type 2 diabetes and hypertension. Traditional Chinese medicine diagnosis: phlegm-dampness stagnates in the spleen. The existing medicines of losartan potassium, nifedipine controlled release tablets, saxagliptin and dapagliflozin are adopted. After the formula is eaten after the reasonable diet and proper exercise, the symptoms are obviously relieved after 4 weeks, and after 8 weeks, the uric acid is reduced to 309 mu mol/L.

The invention has the beneficial effects that:

1. according to the composition for hyperuricemia, through the compatibility of diglyceride oil and other components, new resource food raw material diglyceride oil with special pearl metabolic pathway and lipid metabolism conditioning functions in clinical experiments is added into the formula, the uric acid reducing effect is obvious, the effect of reducing the uric acid in blood can be cooperated with a medicine-food homologous formula, and the traditional Chinese medicine and the modern pharmacology are combined to realize both the treatment of principal and subordinate symptoms; the medicine is not contraindicated when taken together with the complication medicine;

2. the invention avoids the problems that the existing medicines can only be used for treating and can be used for conditioning the whole body, particularly, the effect of treating chronic diseases such as hyperuricemia is obvious, and the traditional medicines start from conditioning phlegm-dampness constitution and regulating lipid metabolism and protein metabolism aiming at the hyperuricemia, have the effect of obvious conditioning effect while reducing uric acid, have few adverse reactions, reduce the incidence rate of complications in a targeted manner, and relieve the symptoms of diabetes, hypertension and the like of a patient;

3. the medicinal materials of the formula are medicinal and edible, the safety is high, the formula is screened and designed aiming at the mouthfeel of hyperuricemia crowds to enhance the edible compliance of patients, and the medicinal materials can be prepared into different dosage forms, so that the treatment requirements of different patients are met.

4. The composition for hyperuricemia provided by the invention is refined and safe in formula, and is particularly suitable for development of food and drug industries.

Detailed Description

The process of the present invention is described and illustrated in detail below with reference to specific examples. The content is to explain the invention and not to limit the scope of protection of the invention.

Example 1

240 parts of diglyceride oil, 10 parts of tangerine peel, 10 parts of poria cocos, 20 parts of Chinese yam, 15 parts of coix seeds, 10 parts of perilla seeds, 10 parts of radish seeds, 15 parts of seaweed, 20 parts of hawthorn, 10 parts of kudzu roots, 10 parts of sophora flower buds and 30 parts of lotus leaves are weighed according to the weight ratio.

Extracting medicinal and edible medicinal materials in the formula with water, concentrating, drying, pulverizing to obtain extract powder (sieving with 200 mesh sieve), adding into new food material diglyceride oil, and making into composition according to conventional method.

Example 2

240 parts of diglyceride oil, 15 parts of tangerine peel, 15 parts of poria cocos, 10 parts of Chinese yam, 10 parts of coix seeds, 5 parts of perilla seeds, 15 parts of radish seeds, 10 parts of seaweed, 30 parts of hawthorn, 15 parts of kudzu roots, 15 parts of sophora japonica and 20 parts of lotus leaves are weighed according to weight ratio.

The procedure was as in example 1.

Example 3

255 parts of diglyceride oil, 5 parts of tangerine peel, 5 parts of poria cocos, 30 parts of Chinese yam, 20 parts of coix seeds, 15 parts of perilla seeds, 5 parts of radish seeds, 20 parts of seaweed, 10 parts of hawthorn, 5 parts of kudzu roots, 5 parts of sophora japonica and 50 parts of lotus leaves are weighed according to weight ratio.

The procedure was as in example 1.

Example 3

220 parts of diglyceride oil, 6 parts of tangerine peel, 6 parts of poria cocos, 25 parts of Chinese yam, 12 parts of coix seeds, 12 parts of perilla seeds, 12 parts of radish seeds, 18 parts of seaweed, 15 parts of hawthorn, 12 parts of kudzu roots, 6 parts of sophora flower buds and 25 parts of lotus leaves are weighed according to the weight ratio.

The procedure was as in example 1.

Example 4

The procedure was as in example 1.

Example 5

180 parts of diglyceride oil, 9 parts of exocarpium citri rubrum, 12 parts of poria cocos, 18 parts of Chinese yam, 18 parts of coix seeds, 9 parts of perilla seeds, 9 parts of radish seeds, 12 parts of seaweed, 18 parts of hawthorn, 9 parts of kudzu roots, 12 parts of sophora japonica and 24 parts of lotus leaves are weighed according to weight ratio.

The procedure was as in example 1.

Example 6

According to the weight ratio, 210 parts of diglyceride oil, 10 parts of tangerine peel, 9 parts of poria cocos, 20 parts of Chinese yam, 15 parts of coix seeds, 10 parts of perilla seeds, 6 parts of radish seeds, 15 parts of seaweed, 20 parts of hawthorn, 9 parts of kudzu roots, 10 parts of sophora japonica and 27 parts of lotus leaves are respectively weighed.

The procedure was as in example 1.

Example 7

160 parts of diglyceride oil, 12 parts of tangerine peel, 10 parts of poria cocos, 15 parts of Chinese yam, 12 parts of coix seeds, 9 parts of perilla seeds, 12 parts of radish seeds, 12 parts of seaweed, 18 parts of hawthorn, 10 parts of kudzu roots, 9 parts of sophora japonica and 30 parts of lotus leaves are weighed according to weight ratio.

The procedure is as in example 1.

Example 8

280 parts of diglyceride oil, 10 parts of tangerine peel, 10 parts of poria cocos, 18 parts of Chinese yam, 15 parts of coix seeds, 12 parts of perilla seeds, 10 parts of radish seeds, 18 parts of seaweed, 24 parts of hawthorn, 10 parts of kudzu roots, 12 parts of sophora japonica and 20 parts of lotus leaves are weighed according to the weight ratio.

The procedure was as in example 1.

Example 9

The composition prepared in example 1 can be prepared into dosage forms such as tablets, pills, granules, capsules, soft capsule preparations, liquid preparations, gel candies and the like through dosage form design, and gelatin, glycerol, sorbitol and the like are added for adjusting the mouthfeel, and the gel candies are prepared through the processes of proportioning, pressing, sizing, drying, sorting, packaging and the like. The above-mentioned embodiments, objects, technical solutions and advantages of the present invention are further described in detail, it should be understood that the above-mentioned embodiments are only illustrative of the present invention and are not intended to limit the present invention, and any modifications, equivalents, improvements and the like made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. The composition for treating hyperuricemia is characterized by comprising the following raw materials in parts by mass: 110-310 parts of diglyceride oil, 5-15 parts of tangerine peel, 5-15 parts of poria cocos, 10-30 parts of Chinese yam, 10-20 parts of coix seeds, 5-15 parts of perilla seeds, 5-15 parts of radish seeds, 10-20 parts of seaweed, 10-30 parts of hawthorn, 5-15 parts of kudzu roots, 5-15 parts of sophora flower buds and 20-50 parts of lotus leaves.

2. The composition for treating hyperuricemia according to claim 1, wherein the diglyceride oil comprises 132-248 parts, 6-12 parts of exocarpium citri rubrum, 6-12 parts of poria cocos, 15-25 parts of Chinese yam, 12-18 parts of semen coicis, 6-12 parts of perilla seed, 6-12 parts of radish seed, 12-18 parts of seaweed, 15-25 parts of hawthorn, 6-12 parts of radix puerariae, 6-12 parts of sophora flower bud and 20-30 parts of lotus leaf.

3. The composition for treating hyperuricemia according to claim 1, wherein the diglyceride oil is 240 parts, red tangerine peel 10 parts, poria cocos wolf 10 parts, chinese yam 20 parts, coix seed 15 parts, perilla seed 10 parts, radish seed 10 parts, seaweed 15 parts, hawthorn fruit 20 parts, kudzu root 10 parts, sophora flower bud 10 parts, and lotus leaf 30 parts.

4. The use of the composition of claim 1 for the treatment of hyperuricemia in a medicament for the treatment of hyperuricemia.

5. The composition for use in the medicine for treating hyperuricemia according to claim 4, wherein the dosage form of the composition comprises tablets, pills, granules, capsules, soft capsule preparations, liquid preparations and gel candies.

6. The preparation method of the composition for treating hyperuricemia according to claim 1, characterized by weighing the medicinal materials with homology of medicine and food in the formula according to the mass parts, extracting with water, concentrating, drying, crushing to obtain extract powder, sieving with a 200-mesh sieve, and adding into new food raw material diglyceride oil to prepare the composition.

7. The method for preparing a composition for treating hyperuricemia according to claim 6, wherein the composition is added with a solution comprising gelatin, glycerin and sorbitol, and is prepared into the gel candy through the processes of batching, pressing, sizing, drying, sorting and packaging.