CN110693936A

CN110693936A - Traditional Chinese medicine composition for reducing uric acid and preventing and treating hyperuricemia or gout and application thereof

Info

Publication number: CN110693936A
Application number: CN201910986102.8A
Authority: CN
Inventors: 郑国银; 凌昌全; 翟笑枫; 程彬彬; 刘欣燕; 徐晓婉; 汪怀周; 郁莎沙; 潘波
Original assignee: Shanghai Changhai Hospital
Current assignee: Shanghai Changhai Hospital
Priority date: 2019-10-17
Filing date: 2019-10-17
Publication date: 2020-01-17
Anticipated expiration: 2039-10-17
Also published as: CN110693936B

Abstract

The invention discloses a traditional Chinese medicine composition for reducing uric acid and preventing and treating hyperuricemia or gout, which is prepared from the following components in parts by weight: 15-90 parts of astragalus membranaceus, 6-60 parts of rhizoma atractylodis, 9-90 parts of ligusticum wallichii, 6-30 parts of safflower carthamus, 0-30 parts of purslane and 3-30 parts of broadleaf holly leaf. The traditional Chinese medicine compound can be prepared into a preparation by adopting a conventional preparation method, and pharmacological research and clinical application show that the traditional Chinese medicine compound has the obvious effects of reducing uric acid and treating hyperuricemia and gout.

Description

Traditional Chinese medicine composition for reducing uric acid and preventing and treating hyperuricemia or gout and application thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicine compound preparations, and particularly relates to a traditional Chinese medicine composition for reducing uric acid and preventing and treating hyperuricemia or gout and application thereof.

Background

Hyperuricemia is a metabolic disease caused by the fact that uric acid in blood is increased due to disorder of metabolism of a substance called purine in a human body. In normal human bodies, the daily production and excretion of uric acid are approximately equal, one third of the production is from food, two thirds of the production is synthesized by the body, and one third of the excretion is from intestinal tract and two thirds of the excretion is from kidney. Any of the above routes, if problematic, will cause uric acid elevation. The rise of uric acid can obstruct the process of blood secreting uric acid, so that uric acid can not be discharged, and other diseases can be caused. Hyperuricemia is related to damage of various target organs, for example, when urate is deposited in joints, the urate is gout, when urate is deposited in kidneys, uric acid nephropathy is caused, when urate is deposited in blood vessels, atherosclerosis can be caused and coronary heart disease is caused, when urate is deposited in pancreatic islets, islet resistance is aggravated, and the hyperuricemia is closely related to various chronic diseases such as gout, chronic nephropathy, coronary heart disease, hypertension, hyperglycemia and hyperlipidemia, the incidence rate is higher and higher, and the disease progress is slow.

The current diagnosis standard of hyperuricemia is that male blood uric acid is more than 420 mu mol/L, and female blood uric acid is more than 357 mu mol/L. Research shows that the number of patients with high uric acid in China is as high as 1.8 hundred million, and the number of the patients is continuously increased and tends to be younger gradually. Data statistics of 4597 physical examination population cases in 2016 years of Shanghai Changhai hospital shows that the five diseases with the highest incidence rate sequentially comprise: overweight/obesity, diabetes, hyperuricemia, dyslipidemia and hypertension, the detection rates are respectively 51.99%, 7.22%, 17.29%, 32.28% and 16.77%, wherein the proportion of the hyperuricemia in the study population is 17.29%, and the data are further analyzed and judged: the first three of the age groups with the highest proportion of male hyperuricemia were 18-27 years old, 38-47 years old and 48-57 years old, and the first three of the age groups with the highest proportion of female hyperuricemia were >58 years old, 48-57 years old and 18-27 years old, respectively. There is a difference in age between male and female patients, and hyperuricemia tends to be younger in male, while it is more common in female.

The existing uric acid lowering drugs mainly comprise probenecid, sulindac, benzbromarone, allopurinol and the like. The medicines can prevent reabsorption of renal tubules on uric acid and increase discharge of uric acid, thereby playing a role in reducing blood uric acid level in human bodies, but the medicines have more side effects, can cause low blood sodium, low blood potassium and low blood calcium, have obvious side effects on liver and kidney, are not suitable for long-term use, and particularly have larger hidden trouble when being taken for a long time by old patients. Therefore, it is urgent to find a safe and effective drug for lowering uric acid which is suitable for long-term administration.

In the physical analysis of hyperuricemia population examined in 4597 cases in 2016 years in Changhai hospital, the distribution of the quality of hyperuricemia population is mostly qi deficiency (35.2%), damp-heat (15.0%) and yang deficiency (14.0%). While in long-term clinical practice: the Chinese herbal compound can effectively improve various symptoms of patients with high uric acid and can effectively reduce uric acid. Based on the above, clinical practice experience and analysis and observation of large sample data are combined, the principle of treatment based on syndrome differentiation of traditional Chinese medicine is followed, and a traditional Chinese medicine compound capable of preventing and treating hyperuricemia is optimally screened.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine compound for reducing uric acid and preventing and treating hyperuricemia or gout, in particular to a traditional Chinese medicine compound for treating metabolic disorder syndrome mainly expressed or induced by high uric acid.

The second purpose of the invention is to provide an application of the traditional Chinese medicine composition in preparing medicines for preventing and treating hyperuricemia or gout.

In order to achieve the purpose, the technical scheme adopted by the invention is as follows:

hyperuricemia is characterized by metabolic disorders such as obesity and the like as main clinical manifestations, and the physical analysis of patients with hyperuricemia discovers that the physical constitution mainly comprises qi deficiency and phlegm dampness, belongs to the category of qi deficiency, phlegm dampness and heat syndrome such as 'fat gas' and 'abdominal distension' in traditional Chinese medicine, and can cause diseases independently or by combination of multiple causes due to diet disorders, emotional disorders and weakness after diseases. The key pathogenesis of the disease is qi deficiency, damp stagnation, phlegm turbidity, endogenous production and obstruction of collaterals. Therefore, clinically benefiting qi and removing dampness is the main treatment method for treating the root cause and promoting qi circulation to remove meridian obstruction. Under the guidance of the theory, a traditional Chinese medicine compound preparation capable of preventing and treating hyperuricemia is screened out by combining with self clinical practice and taking the methods of tonifying qi, resolving dampness, promoting qi and dredging collaterals as the methods.

The invention provides a traditional Chinese medicine compound for reducing uric acid and preventing and treating hyperuricemia or gout, which is prepared from the following components in parts by weight:

15-90 parts of astragalus membranaceus, 6-60 parts of rhizoma atractylodis, 9-90 parts of ligusticum wallichii, 6-30 parts of safflower carthamus, 0-30 parts of purslane and 3-30 parts of broadleaf holly leaf.

Preferably, the traditional Chinese medicine compound for reducing uric acid and preventing and treating hyperuricemia or gout is prepared from the following components in parts by weight: 15-60 parts of astragalus membranaceus, 6-30 parts of rhizoma atractylodis, 9-30 parts of ligusticum wallichii, 6-30 parts of safflower carthamus, 15-30 parts of purslane and 3-15 parts of broadleaf holly leaf.

More preferably, the traditional Chinese medicine compound for reducing uric acid and preventing and treating hyperuricemia or gout is prepared from the following components in parts by weight: 30-60 parts of astragalus membranaceus, 6-15 parts of rhizoma atractylodis, 15-30 parts of ligusticum wallichii, 9-15 parts of safflower, 15-30 parts of purslane and 3-10 parts of broadleaf holly leaf.

Most preferably, the traditional Chinese medicine compound for reducing uric acid and preventing and treating hyperuricemia or gout is prepared from the following components in parts by weight: 30 parts of astragalus, 15 parts of rhizoma atractylodis, 15 parts of ligusticum wallichii, 15 parts of safflower, 15 parts of purslane and 6 parts of broadleaf holly leaf.

Most preferably, the traditional Chinese medicine compound for reducing uric acid and preventing and treating hyperuricemia or gout is prepared from the following components in parts by weight: 60 parts of astragalus, 15 parts of rhizoma atractylodis, 30 parts of ligusticum wallichii, 15 parts of safflower, 30 parts of purslane and 5 parts of broadleaf holly leaf.

In the traditional Chinese medicine compound for reducing uric acid and preventing and treating hyperuricemia or gout, the purslane can be selected from 1, 3, 5, 7, 9, 11, 13, 17, 19, 21, 23, 25, 27 and 29 in parts by weight.

The traditional Chinese medicine compound is used for preparing medicines for treating or preventing metabolic syndrome diseases which mainly show hyperuricemia, and comprises gout, hyperuricemia, obesity, nephropathy, gouty arthritis, fatty liver and the like.

The invention also provides a medicinal preparation using the Chinese medicinal composition as an active ingredient, which can be prepared into common dosage forms of pharmacy compound decoction for oral administration, granules, tablets, medicinal granules, powder, capsules, oral liquid, dripping pills, substitute tea drinks, nasal feeding, anal suppository, rectal lavage, local external administration, navel pasting, Chinese medicinal fumigation, external foot bath and the like by adopting a conventional preparation method in the field.

The second aspect of the invention provides an application of the traditional Chinese medicine composition in preparing a medicine for preventing and treating hyperuricemia, gout or fatty liver.

The third aspect of the invention provides a pharmaceutical preparation for preventing and treating hyperuricemia, gout or fatty liver, which is prepared from the traditional Chinese medicine composition.

The traditional Chinese medicine composition provided by the invention is prepared from astragalus, rhizoma atractylodis, ligusticum wallichii, safflower, purslane and broadleaf holly leaf, and is prepared by carefully selecting a medicine formula according to clinical feedback and the guidance of the traditional Chinese medicine theory on the basis of years of clinical practice. In the formula, the monarch drug astragalus root is sweet in taste and slightly warm in nature and enters lung and spleen channels. The medical history of Astragalus membranaceus is long, and the Shen nong Ben Cao Jing lists it as the "superior product". "the recipe of property of a medicine song" cloud: the astragalus root is used as a tonic and has the effects of benefiting vital qi, strengthening spleen and stomach, expelling pus and relieving pain and activating blood. Modern pharmacological research finds that astragalus contains a plurality of trace elements such as choline, coumarin, folic acid, amino acid, betaine, saponin, saccharides, protein, riboflavin, flavan compounds, iron, calcium, phosphorus, selenium, zinc, copper, manganese and the like. Has effects in invigorating qi, consolidating superficial resistance, promoting urination, tonifying heart, lowering blood pressure, inhibiting bacteria, removing toxic materials, promoting pus discharge, promoting granulation, enhancing capillary resistance, arresting sweating, and stimulating sex hormone.

The ministerial drug rhizoma atractylodis, pungent and bitter, warm. It enters spleen, stomach and liver meridians. Has the effects of eliminating dampness, strengthening spleen, dispelling pathogenic wind, removing dampness, and relieving exterior syndrome. The formula Zheng Zhi Zhun Sheng is used to treat spleen deficiency, damp accumulation, retention of water and dampness, phlegm and fluid retention, diarrhea or excessive edema. Modern pharmacological research considers that the rhizoma atractylodis contains volatile oil, and the main components in the oil comprise atractylol, atractylone, vitamin A-like substances, vitamin B, inulin and the like. The rhizoma Atractylodis volatile oil has effects of invigorating stomach, tranquilizing, lowering blood sugar, removing potassium and sodium, and inhibiting bacteria for experimental animals. The rhizoma atractylodis decoction has the effect of reducing blood sugar of experimental alloxan diabetic animals, and has the effects of discharging sodium and potassium, but does not have the effect of discharging urine; the effective component vitamin A-like substance can be used for treating nyctalopia and keratomalacia caused by vitamin A deficiency; the rhizoma atractylodis is smoked and disinfected, and has obvious killing effect on tubercle bacillus, staphylococcus aureus, escherichia coli, bacillus subtilis and pseudomonas aeruginosa.

The ministerial drug of rhizoma Chuanxiong, pungent in nature and warm in flavor, enters liver and gallbladder meridians. Has effects of activating qi-flowing, resolving stagnation, dispelling wind-dryness and dampness, promoting blood circulation and relieving pain. Rihuazi Bencao: for treating wind, qi, strain, blood, internal fatigue, strengthening bones and muscles, dredging channels, breaking symptoms, nourishing blood, promoting granulation, relieving rhinorrhea, hematemesis, hematuria, hemorrhoid, fistula, cerebral carbuncle, back pain, scrofula, wart, scabies, pus discharge and blood stasis. Modern pharmacological research finds that the rhizome of the ligusticum wallichii contains about 1 percent of volatile oil. The oil is identified to have 40 components accounting for 93.64% of the volatile oil, wherein the main components are ligustilide accounting for 58%, 3-butylidenephthalide accounting for 5.29% and sabinene accounting for 6.08%. Has effects in tranquilizing central nervous system, relieving pain, resisting bacteria, and inhibiting large intestine, dysentery (Sonne), deformity, pyocyanea, typhoid fever, Bacillus paratyphi and Vibrio cholerae. It also has inhibitory effect on certain pathogenic dermatophytes. Ligustrazine can increase blood flow volume of kidney of anesthetized rabbit, and promote diuresis. Can obviously reduce complement hemolysis and inhibit the combination of complement 3b (C36) and erythrocyte membrane.

Safflower, pungent in nature and warm in flavor, enters heart and liver meridians. Has effects in promoting blood circulation, dredging channels, removing blood stasis, and relieving pain. Compendium (compendium): promoting blood circulation, moistening dryness, relieving pain, relieving swelling, and dredging channels. Modern pharmacological studies prove that the safflower contains hundreds of effective components such as carthamin and has effects on cardiovascular systems, nervous systems and the like, the effects found at present mainly focus on analgesia, sedation, anti-inflammation, immunity enhancement and the like, and the safflower can dilate branch circulation and increase blood flow of cerebral ischemia areas so as to relieve cerebral edema. Safflower can also relieve metabolic disorder of monoamine neuromediators in brain tissue, and make the descending neuromediators return to normal or close to normal.

The adjuvant drug purslane is sour and cold in nature, and has the effects of clearing away heat and toxic materials, cooling blood and stopping bleeding, and stopping dysentery. Tang Ben Cao (materia Medica of Tang Dynasty): pounding and wiping mainly the fistula, wart and wart; fluid retention is mainly in regurgitation, stranguria, blood flow of incised wound, blood stasis and nodules, and is especially good for children; the medicine is used for treating lip tightening, face blister, horse sweat, and toxic and side effects of the injection. "(Yunnan Ben Cao >): replenishing qi, clearing away summer-heat, relieving epigastric distention and descending qi, moistening intestine, removing food retention, killing parasites, and treating sore, red swelling and pain. Modern researches prove that the purslane contains rich dihydroxyethylamine, malic acid, glucose, calcium, phosphorus, iron, vitamin E, carotene, vitamin B, vitamin C and other nutrient substances. The content of omega-3 fatty acid of purslane is higher than that of human and plants, the absorption of human body to cholesterol acid is inhibited, the blood cholesterol concentration is reduced, the elasticity of vessel wall is improved, and the purslane is very beneficial to preventing and treating cardiovascular metabolic diseases.

The herb of Kuding cha is sweet in nature and bitter and cold in taste. Enter liver, lung and stomach. Has the effects of dispelling wind and clearing heat; improving eyesight and promoting fluid production. The "Renzai of materia Medica": promote digestion, resolve phlegm, relieve restlessness, quench thirst, facilitate defecation and remove greasy food. In the Chiense on Sichuan Chinese herbs (Yan Zhi): clear heat and dispel wind, relieve restlessness and quench thirst. It is used to treat headache, toothache, tinnitus, conjunctival congestion, and food stagnation with phlegm. Modern pharmacological research proves that the broadleaf holly leaf contains over 200 components such as broadleaf holly leaf saponin, amino acid, vitamin, polyphenol, flavonoid, caffeine, protein, ursolic acid, beta-resinol, lupeol, dandelion terpene alcohol, trace elements such as zinc, manganese, rubidium and the like. Has effects of reducing blood lipid, increasing coronary blood flow, increasing myocardial blood supply, and resisting atherosclerosis, and can be used for preventing and treating dizziness, headache, chest distress, debilitation, insomnia, etc. of patients with cardiovascular disease and cerebrovascular disease.

Due to the adoption of the technical scheme, the invention has the following advantages and beneficial effects:

the traditional Chinese medicine compound can be prepared into a preparation by adopting a conventional preparation method, and pharmacological research and clinical application show that the traditional Chinese medicine compound has the obvious effects of reducing uric acid and treating hyperuricemia and gout.

The traditional Chinese medicine compound provided by the invention has the advantages of low price of raw materials, simple and convenient preparation and convenience in use, and has a good curative effect on hyperuricemia and gout through years of clinical application. In view of the fact that the number of people suffering from metabolic disorder related diseases caused by hyperuricemia and uric acid rise is large, and the compound preparation prepared from the traditional Chinese medicine compound has the characteristics of no toxicity and long-term taking, the traditional Chinese medicine compound provided by the invention has a good application prospect.

The traditional Chinese medicine compound disclosed by the invention has the effects of promoting qi circulation, removing dampness, reducing phlegm, dredging turbid and relieving pain, can be used for preventing and treating gout and hyperuricemia and metabolic disorder diseases (obesity, fatty liver, hyperlipidemia and the like) mainly manifested by hyperuricemia after being confirmed by clinical application and pharmacological research for many years, and has the advantages of definite curative effect, no toxic or side effect, low cost and convenience in application.

Detailed Description

In order to more clearly illustrate the invention, the invention is further described below in connection with preferred embodiments. It is to be understood by persons skilled in the art that the following detailed description is illustrative and not restrictive, and is not to be taken as limiting the scope of the invention.

Example 1

Weighing 3000g of astragalus root, 1500g of rhizoma atractylodis, 1500g of rhizoma ligustici wallichii, 1500g of safflower, 1500g of purslane and 600g of broadleaf holly leaf, extracting for 3 times (50000ml, 1 hour; 40000ml, 1 hour) by refluxing with water, combining the extracting solutions, concentrating, drying and crushing, wherein the extract can be directly packaged and taken with water.

Example 2

6000g of astragalus, 1500g of rhizoma atractylodis, 3000g of ligusticum wallichii, 900g of safflower, 3000g of purslane and 300g of broadleaf holly leaf are weighed and extracted by water under reflux for 3 times (50000ml for 1 hour; 40000ml for 1 hour), the extracting solutions are combined, concentrated, dried and crushed, and the extract can be directly packaged and taken with water.

Example 3

6000g of astragalus, 1500g of rhizoma atractylodis, 3000g of rhizoma ligustici wallichii, 900g of safflower and 300g of broadleaf holly leaf are weighed, water is used for reflux extraction for 3 times (50000ml for 1 hour; 40000ml for 1 hour), the extracting solutions are combined, concentrated and dried to obtain dry extract, and the dry extract is crushed and can be directly packaged and taken with water.

Example 4

6000g of astragalus, 1500g of rhizoma atractylodis, 1500g of rhizoma ligustici wallichii, 1200g of safflower and 600g of broadleaf holly leaf are weighed, water is used for reflux extraction for 3 times (50000ml for 1 hour; 40000ml for 1 hour), the extracting solutions are combined, concentrated, dried and crushed, and the extract can be directly packaged and taken with water.

Example 5

Weighing 600g of astragalus mongholicus, 150g of rhizoma atractylodis, 300g of ligusticum wallichii, 150g of safflower carthamus, 300g of purslane and 100g of broadleaf holly leaf, extracting for 3 times (50000ml for 1 hour; 40000ml for 1 hour) by refluxing with water, combining extracting solutions, concentrating, drying and crushing, wherein the extract can be directly packaged and taken with water.

Example 6

Weighing 60g of astragalus root, 15g of rhizoma atractylodis, 30g of rhizoma ligustici wallichii, 15g of safflower, 30g of purslane and 5g of broadleaf holly leaf, extracting for 3 times by water reflux (50000ml for 1 hour; 40000ml for 1 hour), combining the extracting solutions, and directly packaging and taking the extract with water.

Example 7 preparation of granules

150g of the extract prepared by the method of the embodiment 1 is added with 300g of dextrin, evenly mixed, added with a proper amount of 60 percent ethanol to prepare soft materials, sieved by a 24-mesh sieve for granulation, dried at 50 ℃ for 2 hours, sieved by a 30-mesh sieve for granulation, and subpackaged to obtain granules.

Example 8 (preparation of tablet)

Mixing the extract, microcrystalline cellulose and starch uniformly according to the above ratio, adding appropriate amount of 60% ethanol to obtain soft material, sieving with 24 mesh sieve, granulating, drying at 50 deg.C for 2 hr, sieving with 30 mesh sieve, grading, adding magnesium stearate, mixing uniformly, and tabletting to obtain tablet.

Example 9 influence of Compound Chinese medicinal preparation on uric acid metabolism in mice

The following Chinese herbal compound preparations were all the Chinese herbal compound preparations prepared in example 1.

Experiment I, the influence of the compound preparation of traditional Chinese medicine on the uric acid metabolism of mice in short term

1. Animals: clean-grade Kunming white mice, which are 4-6 weeks old and 18-20 g in weight, are bred in cages under the clean-grade condition of a laboratory animal house, and are free to find food and drink water. Provided by Shanghai Experimental animal center of Chinese academy of sciences, animal qualification number: SCXK (Shanghai) 2002-.

2. Experimental methods

Mice were randomly divided into five groups: the Chinese medicinal compound preparation comprises high and low dose groups, model control group, positive control group (benzbromarone), and blank control group. The administration group is the traditional Chinese medicine compound preparation prepared in the embodiment 1 of the invention, the medicine dosage is calculated according to 20g/kg (traditional Chinese medicine compound preparation high dose group) and 10g/kg body weight (traditional Chinese medicine compound preparation low dose group) (according to 0.2ml/10g), the stomach is irrigated according to physiological saline in the blank control group and the model control group, and the positive control group is prepared into 0.2ml/10g of emulsion of benzbromarone. After the treatment, four groups except the blank control group (no treatment) were subjected to intraperitoneal injection with uric acid (250mg/kg) at one time, and the blood uric acid level increased after 10 min. The mice were sacrificed by cervical dislocation after 4h of intraperitoneal injection, blood samples and urine were collected, and Blood Uric Acid (BUA) level and Blood Urea Nitrogen (BUN) level of the mice were detected by an automatic biochemical analyzer.

3. Results of the experiment

The high-dose group and the low-dose group of the Chinese medicinal compound preparation and the positive control groupThe difference is of statistical significance,^*p is less than 0.05, and is detailed in Table 1. It can be seen from table 1 that the compound Chinese medicinal preparation can effectively reduce the in vivo metabolism of blood uric acid and urea nitrogen of mice, and the curative effect of the compound Chinese medicinal preparation in the high-dose group is basically the same as that of the positive control drug.

TABLE 1 Effect of Chinese herbal compound preparation on uric acid metabolism in mice

Grouping	Number of animals n	Blood uric acid umol/L	Nitrogen mmol/L of urea
				Blank control group	10	223.1±3.3^△△	8.7±4.9^△
High dose group	10	215.7±3.4^△△	8.1±5.1*^△
				Low dose group	10	327.0±4.2^△△**	9.6±6.2**^△
Positive control group	10	226.5±3.0^△△	9.1±5.3*^△
				Model control group	10	526.5±3.0**	11.6±5.3**

VS normal group: p < 0.05, P < 0.01; VS model group:^△P＜0.05，^△△P＜0.01。

experiment II, study of influence of traditional Chinese medicine compound preparation on mouse auricle swelling

1. Animal(s) production

SPF male Kunming mice are 4-6 weeks old, the average weight is 20 +/-2 g, and the males are bred in cages under the clean condition of a laboratory animal room and are fed with free foraging and drinking water. Provided by Shanghai Experimental animal center of Chinese academy of sciences, animal qualification number: SCXK (Shanghai) 2002-.

2. Experimental methods

Model preparation xylene induced mouse auricular swelling experiment: taking 50 male mice of 18-22g, randomly dividing into a blank control group, a model control group, a positive control group of sanli pain and a high-dose group of a traditional Chinese medicine compound preparation according to a ratio of 20g/kg and a low-dose group of the traditional Chinese medicine compound preparation according to a ratio of 10g/kg body weight (according to 0.2ml/10g), and performing intragastric administration on the other groups for 1 time/d and continuously for 3d except for distilled water with the same volume of intragastric administration of the blank control group and the model control group. 60min after the last administration, 0.02 mL/xylene was dropped on the right ear except for the blank control group, the left ear was controlled, the cervical vertebra was removed after 45min and killed, the left and right ears were punched out by a punch with a diameter of 6mm, the mass was weighed, and the difference between the masses of the two ears was used as the swelling degree. The formula: swelling degree (g) ═ mass of right ear (g) -mass of left ear (g)

3. Results of the experiment

TABLE 2 results of the experiment of Chinese medicinal preparation on mice

Group of	N	Swelling degree (mg)
			Blank control group	10	0.60±1.52^△△
High dose group	10	2.10±1.45**^△△
			Low dose group	10	2.71±1.23**^△△
Positive control group	10	2.20±1.21**^△△
			Model control group	10	6.20±1.21**

VS blank control group: p < 0.01; VS model control group:^△△P＜0.01。

the difference between the high-dose group and the low-dose group of the compound Chinese medicinal preparation and the positive control group relative to the blank control group is statisticalThe significance is given to,^*p is less than 0.05, and is detailed in Table 2. It can be seen from the table that the compound traditional Chinese medicine preparation can effectively reduce the swelling degree of auricles of mice, and the curative effect of the compound traditional Chinese medicine preparation in a high-dose group is basically the same as that of a positive control drug.

Experiment III, Chinese medicine compound preparation for mouse hyperuricemia model caused by yeast extract

1. Animal(s) production

2. Experimental methods

Taking 50 male mice of Kunming species, weighing, and randomly dividing into blank control group, model control group, positive control group (benzbromarone), high-dose group of Chinese medicinal compound preparation, and low-dose group of Chinese medicinal compound preparation. Except for a blank control group, the other groups are perfused with yeast 30g/kg/d for 1 week continuously, the positive control group benzbromarone (20mg/kg) on the 7 th day is perfused with stomach, the traditional Chinese medicine compound preparation starts to perfuse the stomach with the traditional Chinese medicine according to 20g/kg and 10g/kg body weight (according to 0.2ml/10g), the blood is taken from the retroorbital venous plexus after 7 days continuously, and the serum UA and BUN values of the mice are measured.

3. Results of the experiment

TABLE 3 influence of the Compound preparation on uric acid metabolism in mice

VS blank control group with P < 0.05 and P < 0.01, VS model control group with △ P < 0.05 and △△ P < 0.01

As can be seen from the above Table 3, the high-dose and low-dose groups of the compound Chinese medicinal preparation can reduce the uric acid metabolism of mice with hyperuricemia caused by yeast extract, the effect of the compound Chinese medicinal preparation is basically the same as that of benzbromarone, and the compound Chinese medicinal preparation has no obvious influence on glutamic-oxalacetic transaminase and glutamic-pyruvic transaminase of the mice.

Experiment four, observation of clinical curative effect of Chinese herbal medicine compound preparation for reducing uric acid

60 patients with hyperuricemia are observed, the patients are 18-75 years old, the average age is (42 +/-8 years old), the experimental group is treated by using the traditional Chinese medicine compound preparation of the embodiment 6, 2 doses of decoction are taken every day, and each dose is 500 mL; the positive group uses benzbromarone, 50mg (1 tablet) is taken orally, once a day, and is taken after breakfast; the follow-up group is followed up regularly without treatment. Each group is included in 20 patients, and the serum uric acid concentration and the normal range of uric acid (150-420 umol/L) are checked after 2 weeks of drug administration. As shown in Table 4, the serum uric acid of patients after taking the Chinese medicinal compound preparation for two weeks is obviously reduced, the difference has statistical significance, and the curative effect of the Chinese medicinal compound preparation is basically the same as that of the positive medicament benzbromarone. In the follow-up visit of the liver function of the patients, the difference of the change of the liver function of the patients taking the traditional Chinese medicine compound preparation before and after the change is not obvious, and the statistical significance is not realized. Patients with benzbromarone had a slight tendency to increase ALT and AST.

TABLE 4 influence of compound Chinese medicinal preparation on hyperuricemia in 2 weeks

Experiment five, observation of clinical efficacy of Chinese herbal medicine compound preparation for treating fatty liver

The number of the taking cases was 45, wherein 28 men and 17 women were aged 50.9 years. The Chinese herbal compound preparation is used for treatment, 2 doses of decoction are taken every day, and each dose of the decoction is taken for 4 weeks with 500mL continuously, and the check is carried out again.

2.1 fatty liver severity

By carrying out statistical analysis on the fatty liver severity of the population with the fatty liver before and after the administration (specifically, as shown in table 5, the condition that the fatty liver severity is obviously reduced after the treatment of the traditional Chinese medicine compound preparation for 4 weeks is found, the fatty liver severity is moderate 45 times before the administration and is reduced to 38 times after the administration for 1 month, and the traditional Chinese medicine compound preparation shows obvious difference in the improvement degree for the population with the moderate and severe fatty liver.

TABLE 5 fatty liver degree Classification status before and after taking medicine

Fatty liver severity markers	Before taking medicine	After taking the medicine
			Mild degree of	29	33
Of moderate degree	12	4
			Moderate or severe degree	4	1
Fatty liver free	0	7

From table 5, 12 of 45 individuals participating in the administration of the medicine are moderate fatty liver patients, accounting for 26% of the patients, and 29 of the mild fatty liver patients accounting for 64% of the total amount of the administration of the medicine. After 1 month, mild patients reached 33 cases accounting for 73% of the total individuals, while moderate ones were 4 cases accounting for 9% of the total patients. The results of the degree of the fatty liver before and after the administration suggest that the Chinese herbal compound preparation can reverse the degree of the fatty liver and can reverse the conversion from moderate fatty liver to mild fatty liver.

In the aspect related to liver function indexes, after 4 weeks of treatment, the liver function of a patient changes, specifically, as shown in table 6 and table 7, the difference has statistical significance, and the difference is shown in that the indexes of glutamic-pyruvic transaminase and glutamic-oxalacetic transaminase are reduced, which shows that the traditional Chinese medicine compound preparation can improve the glutamic-pyruvic transaminase and the glutamic-oxalacetic transaminase of fatty liver patients, and has no influence on total bilirubin, direct bilirubin, total protein, albumin, globulin, albumin-globulin ratio, prealbumin, lactate dehydrogenase, alkaline phosphatase, total bile acid and gamma glutamyl transpeptidase.

TABLE 6 liver function test values of fatty liver individuals before and after administration

TABLE 7

In the aspect of blood sugar, after treatment for 4 weeks, the difference between the blood sugar of a patient and the blood sugar of the patient has statistical significance, which shows that the traditional Chinese medicine compound preparation can reverse the blood sugar of the population with fatty liver. Can effectively reduce partial high-blood-sugar fatty liver crowds and play a role in regulating blood sugar. Specifically, the results are shown in Table 8.

TABLE 8 blood glucose test of fatty liver individuals before and after administration

In the aspect of blood fat, after treatment for 4 weeks, the difference of 3 items of total cholesterol, triglyceride and low-density lipoprotein in four indexes of blood fat of a patient has statistical significance before and after, as shown in table 9, which shows that the traditional Chinese medicine compound preparation can reduce the total cholesterol, triglyceride and low-density lipoprotein of fatty liver crowds. The composition can improve the blood fat of the people with fatty liver while playing the role of relieving the fatty liver.

TABLE 9 blood lipid test values of fatty liver individuals before and after administration

After 4 weeks of treatment, the difference between the BMI and the abdominal circumference of the patient has no statistical significance, and as shown in Table 10, the effect of the Chinese herbal compound preparation on improving the BMI and the abdominal circumference is not particularly obvious within 4 weeks.

TABLE 10 BMI index, abdominal circumference of fatty liver individuals before and after administration

Example 10

Zhu Ching, male, born in 1974 in 9 months, Jiangsu, enlightenment. Clinic case number: 43581. the outpatient clinic treatment is required to be done because the little toe is red, swollen and sore, the diet is not restricted, the abdomen is distended and round, the stool and urine are normal, the sleep is normal, the fatigue is weak, the tongue is red, the coating is thin and white, and the pulse is wiry and thin. The liver and kidney function is normal, and the blood uric acid rise is obviously 4.1mmol/L (the reference value is 0.15-0.42). type-B ultrasonography suggests fatty liver. The traditional Chinese medicine prescription is as follows: 30g of astragalus, 10g of rhizoma atractylodis, 30g of ligusticum wallichii, 9g of safflower, 30g of purslane, 15g of rhizoma corydalis, 30g of rhizoma smilacis glabrae and 3g of broadleaf holly leaf, one dose of the traditional Chinese medicine composition is taken every day by decocting in the morning and at night, and meanwhile, the diet is controlled. The patient complains about the improvement of the feelings of weakness after a month, and the stool is normal. Blood uric acid 0.56mmol/L was reviewed. Adjusting the prescription of the medicine: 15g of astragalus, 6g of rhizoma atractylodis, 9g of ligusticum wallichii, 6g of safflower, 15g of purslane and 3g of broadleaf holly leaf, and the health of the patient is recovered after the patient continues to take the medicine for one month. Then, safflower, purslane and broadleaf holly leaf are taken as tea for making tea, and the uric acid is not increased after regular physical examination every year.

Example 11

Land, male, Shanghai Chong Ming ren. Born at 5 months in 1980, clinic case No.: 60168. the unit physical examination in 2017 at the end of 9 years shows that the blood uric acid is 2.1mmol/L (reference value is 0.15-0.42), the abnormal increase of triglyceride TG is 4.1(<1.8mmol/L), and the patient is diagnosed in a long-sea hospital at the beginning of 10 months, and the patient is weak, short breath, abdominal distension, dizziness, headache, dry mouth and bitter taste. The tongue is pale purple and dark, the tongue coating is white and greasy, and the pulse is slippery. The Chinese medicine has effects of invigorating qi, eliminating turbid pathogen, invigorating spleen and eliminating dampness. 30g of raw astragalus, 6g of rhizoma atractylodis, 9g of ligusticum wallichii, 6g of safflower, 15g of purslane, 3g of broadleaf holly leaf, 15g of coix seed, 15g of raw hawthorn and 12g of rhizoma alismatis. The patients can be retested after taking the medicine for one month, the patients have no obvious discomfort, the fatigue is improved, the blood uric acid is checked to be 0.7mmol/L, and the triglyceride TG is checked to be 2.1 mmol/L. The rhizoma alismatis and the semen coicis are removed from the original prescription, the medicine is continuously taken for 1 month, the blood uric acid is checked for 0.3mmol/L, and the triglyceride TG is checked for 1.1 mmol/L. And continuing to drink the safflower, the purslane and the broadleaf holly leaf instead of the tea for three months, and regularly rechecking, wherein the uric acid and the triglyceride are normal.

Although the present invention has been described with reference to a preferred embodiment, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. A traditional Chinese medicine compound for reducing uric acid and preventing and treating hyperuricemia or gout is characterized by being prepared from the following components in parts by weight:

2. The traditional Chinese medicine compound for reducing uric acid and preventing and treating hyperuricemia or gout according to claim 1, wherein the traditional Chinese medicine compound for reducing uric acid and preventing and treating hyperuricemia or gout is prepared from the following components in parts by weight: 15-60 parts of astragalus membranaceus, 6-30 parts of rhizoma atractylodis, 9-30 parts of ligusticum wallichii, 6-30 parts of safflower carthamus, 15-30 parts of purslane and 3-15 parts of broadleaf holly leaf.

3. The traditional Chinese medicine compound for reducing uric acid and preventing and treating hyperuricemia or gout according to claim 2, wherein the traditional Chinese medicine compound for reducing uric acid and preventing and treating hyperuricemia or gout is prepared from the following components in parts by weight: 30-60 parts of astragalus membranaceus, 6-15 parts of rhizoma atractylodis, 15-30 parts of ligusticum wallichii, 9-15 parts of safflower, 15-30 parts of purslane and 3-10 parts of broadleaf holly leaf.

4. The traditional Chinese medicine compound for reducing uric acid and preventing and treating hyperuricemia or gout according to claim 3, wherein the traditional Chinese medicine compound for reducing uric acid and preventing and treating hyperuricemia or gout is prepared from the following components in parts by weight: 30 parts of astragalus, 15 parts of rhizoma atractylodis, 15 parts of ligusticum wallichii, 15 parts of safflower, 15 parts of purslane and 6 parts of broadleaf holly leaf.

5. The traditional Chinese medicine compound for reducing uric acid and preventing and treating hyperuricemia or gout according to claim 3, wherein the traditional Chinese medicine compound for reducing uric acid and preventing and treating hyperuricemia or gout is prepared from the following components in parts by weight: 60 parts of astragalus, 15 parts of rhizoma atractylodis, 30 parts of ligusticum wallichii, 15 parts of safflower, 30 parts of purslane and 5 parts of broadleaf holly leaf.

6. Use of the Chinese medicinal composition of any one of claims 1 to 5 in the preparation of a medicament for preventing and treating hyperuricemia, gout or fatty liver.

7. A pharmaceutical preparation for preventing and treating hyperuricemia, gout or fatty liver, which is prepared from the Chinese medicinal composition according to any one of claims 1 to 5.