CN118304369B

CN118304369B - A traditional Chinese medicine composition for treating phlegm-dampness obstruction type hyperuricemia

Info

Publication number: CN118304369B
Application number: CN202410457830.0A
Authority: CN
Inventors: 伍小华; 王海岩; 彭程熙
Original assignee: Guangdong Yunfu Vocational College Of Traditional Chinese Medicine
Current assignee: Guangdong Yunfu Vocational College Of Traditional Chinese Medicine
Priority date: 2024-04-16
Filing date: 2024-04-16
Publication date: 2026-03-24
Anticipated expiration: 2044-04-16
Also published as: CN118304369A

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating phlegm stagnation type hyperuricemia, and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from rhizoma alismatis, bighead atractylodes rhizome, herba lycopi, honeysuckle stem, rhizoma smilacis glabrae, corn silk, radix salviae miltiorrhizae, purslane, silkworm excrement, chinese angelica tail, cinnamon and trigeminal picrorhiza, and has the effects of eliminating phlegm, reducing turbidity and smoothing joints. The traditional Chinese medicine has wide medicine sources, can be prepared into 5 g/package concentrated pills, is convenient to use, low in price, good in curative effect and small in toxic and side effects in the taking process of patients, and can regulate the physique of the patients from the whole concept, and the total effective rate can reach 93.2%.

Description

Traditional Chinese medicine composition for treating phlegm stagnation type hyperuricemia

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating phlegm stagnation type hyperuricemia, and a preparation method and application thereof.

Background

Hyperuricemia is a chronic disease caused by purine metabolic disorder and uric acid excretion abnormality of an organism, and can be caused by excessive uric acid generation or insufficient uric acid excretion in the body, so that gout and other diseases are formed, and the damage to human health is great.

Currently, the most commonly used western medicine preparations for reducing uric acid are prepared by inhibiting uric acid production. For example, drugs that inhibit uric acid synthesis act by inhibiting xanthine oxidase, blocking the conversion of hypoxanthine to xanthine and uric acid, thereby reducing the concentration of uric acid in blood. Representative drugs include allopurinol and febuxostat. Another group is to promote uric acid excretion. The mechanism of action of uric acid excretion-promoting drugs is mainly to inhibit active reabsorption of the uric acid salt in the proximal tubular, increase excretion of the uric acid salt, reduce uric acid concentration in blood and promote dissolution of the uric acid salt, and mainly comprises probenecid, benzbromarone and the like. Tribromone is limited to use by some countries in europe due to potential hepatotoxicity, and is still widely used clinically in China as a main medicine for promoting uric acid excretion. In addition, sodium bicarbonate can promote uric acid excretion by alkalizing urine, and can also be used for treating gout. Although the western medicine preparations can effectively reduce serum uric acid level, certain limitations and side effects exist, and abnormal conditions such as bone marrow suppression, nephrotoxicity and hypersensitivity syndromes can be caused for patients after long-term administration. Therefore, it is necessary to find a safer and more effective drug for treating hyperuricemia.

The hyperuricemia has more and less clinical symptoms before gout attack, and belongs to the Chinese medicine of 'no disease' or 'pathogenic factor'. "wind-cold-dampness three-qi miscellaneous to each other" in Huangdi's interior meridian, together with other qi obstruction, also called arthralgia ". When arthritis or kidney damage is complicated, joint swelling and pain, deformation, urinary tract stones or renal insufficiency occur, the diseases can be classified into the categories of gout, arthralgia syndrome, advanced joint, stranguria syndrome, edema and the like. The rising of blood uric acid is caused by the condition that the paste is full of the body, qi and blood are not smooth, and the paste is accumulated into turbid urine or flows into the channels and collaterals further, and belongs to the category of turbid uric acid. In addition, the disease is related to genetic, physical constitution, diet, exogenous factors, environment, emotion, fatigue and other factors. The disease is located in the channels and collaterals of the muscular exterior, then deeply reaches the tendons and bones, and finally hurts the spleen, liver and kidney in the long term.

The traditional Chinese medicine considers that hyperuricemia is mostly caused by the occurrence of male with young and strong age, body strengthening and obesity, and is caused by the deficiency of spleen, damp turbidity accumulation and heat toxin accumulation due to the excessive eating of fat, greasy and alcoholic meat. The traditional Chinese medicine can be used for clearing damp turbidity and damp heat evil, especially for expelling toxin and clearing stasis to treat hyperuricemia, so that not only can the hardness be eliminated and detumescence be realized, the PH value of blood be regulated, damp turbidity and toxin stasis be prevented, but also the damp stasis of heat toxin can be stopped finally, the damage to the kidney can be avoided, and the tophus can be prevented from forming. However, the traditional Chinese medicine compound preparation for treating hyperuricemia has the defects of inconvenient administration, poor taste, limited using course and the like.

Therefore, in the field of traditional Chinese medicine, the development of a traditional Chinese medicine composition for treating hyperuricemia, which has the advantages of good effect, small adverse reaction, low cost and convenient use, is urgently needed.

Disclosure of Invention

The invention aims to overcome the defects existing in the prior art and provide a traditional Chinese medicine composition for treating phlegm stagnation type hyperuricemia, and a preparation method and application thereof.

Specifically, the invention is realized through the following technical schemes:

in a first aspect, the invention provides a traditional Chinese medicine composition for treating phlegm stagnation type hyperuricemia, which is prepared from the following traditional Chinese medicine raw materials, by weight, 1-30 parts of rhizoma alismatis, 1-30 parts of bighead atractylodes rhizome, 1-30 parts of herba lycopi, 1-40 parts of honeysuckle stem, 1-40 parts of glabrous greenbrier rhizome, 1-40 parts of corn silk, 1-30 parts of radix salviae miltiorrhizae, 1-30 parts of purslane, 1-30 parts of silkworm excrement, 1-20 parts of Chinese angelica tail, 1-20 parts of cinnamon and 1-20 parts of radix sophorae flavescentis.

In an alternative mode, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials, by weight, 1-20 parts of rhizoma alismatis, 1-20 parts of bighead atractylodes rhizome, 1-20 parts of herba lycopi, 5-30 parts of honeysuckle stem, 5-30 parts of rhizoma smilacis glabrae, 5-30 parts of corn silk, 1-20 parts of radix salviae miltiorrhizae, 1-20 parts of purslane, 1-20 parts of silkworm excrement, 1-10 parts of Chinese angelica tail, 1-10 parts of cinnamon and 1-10 parts of radix sophorae falvescentis.

In an alternative mode, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials, by weight, 10 parts of rhizoma alismatis, 10 parts of bighead atractylodes rhizome, 10 parts of herba lycopi, 20 parts of honeysuckle stem, 20 parts of glabrous greenbrier rhizome, 20 parts of corn silk, 10 parts of radix salviae miltiorrhizae, 10 parts of purslane, 10 parts of silkworm excrement, 5 parts of Chinese angelica tail, 5 parts of cinnamon and 5 parts of radix sophorae falvescentis.

As an alternative way, in the above traditional Chinese medicine composition, the traditional Chinese medicine composition has the effects of eliminating phlegm, reducing turbidity and dredging joints.

In a second aspect, the present invention provides a method for preparing the traditional Chinese medicine composition according to the first aspect, the method comprising the following steps:

Weighing the traditional Chinese medicine raw materials according to the first aspect, firstly decocting, soaking the traditional Chinese medicine raw materials in cold water until the cold water is over the medicine surface, then decocting, boiling with strong fire, decocting with slow fire for a period of time, filtering residues to obtain juice, secondly decocting, soaking the traditional Chinese medicine raw materials in cold water until the cold water is over the medicine surface, decocting for a period of time, filtering residues to obtain juice, mixing the two liquid medicines, and concentrating.

Alternatively, in the above preparation method, the first time of decoction, cold water is about 3cm above the medicine surface, soaking for 30min, then decocting with strong fire, then decocting with slow fire for 30-40 min, and the second time of decoction, cold water is about 2cm above the medicine surface, and decocting with water for 20min after boiling.

In a third aspect, the invention provides an application of the traditional Chinese medicine composition described in the first aspect or the traditional Chinese medicine composition prepared by the preparation method described in the second aspect in preparing medicines for treating hyperuricemia.

Alternatively, in the above use, the medicament inhibits xanthine oxidase activity.

Alternatively, in the above use, the medicament reduces uric acid levels, and/or the medicament ameliorates kidney damage in patients with hyperuricemia.

Preferably, the improving kidney damage in hyperuricemia patients comprises reducing tubular lumen expansion and/or edema.

Alternatively, in the above use, the medicament is a decoction piece, a decoction, a powder, an oral liquid, a paste, a pill, a granule, a tablet or a capsule.

Preferably, the medicament is a pill.

Preferably, the pill has a size of 5 g/pack, one pill after breakfast and supper, and warm water is used for blessing. The administration is continued for half a month.

More preferably, the half month is 1 course of treatment, requiring about 2-3 courses of treatment.

The invention has the beneficial effects that:

(1) The invention is based on the dialectical treatment of traditional Chinese medicine, combines clinical practice to carry out scientific compatibility, and repeatedly experiments to determine the optimal dosage of each traditional Chinese medicine, and has particularly obvious curative effect on the hyperuricemia with turbid phlegm blocking.

(2) The traditional Chinese medicine composition is common in clinic, easy to obtain materials, low in price, simple in preparation, good in curative effect and high in patient compliance, and has the characteristics of treating both symptoms and root causes and being difficult to relapse.

(3) The total effective rate of the traditional Chinese medicine composition is 93.2%. Only 13.3% of patients relapse within 1 year of follow-up visit, but symptoms and signs are obviously reduced before, the treatment period is obviously shortened, and the life quality of the patients is obviously improved.

Detailed Description

The present invention will be described in further detail with reference to the following examples in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the detailed description is intended to illustrate the invention only and is not intended to limit the invention.

The principal drugs in the invention are glabrous greenbrier rhizome, herba lycopi and rhizoma alismatis. Rhizoma smilacis glabrae, sweet and light, calm, enter liver and stomach meridians, and has the effects of detoxifying, dehumidifying and activating and benefiting joints. The compendium of materia medica is "strengthening spleen and stomach, strengthening tendons and bones, expelling wind-damp, benefiting joints and stopping diarrhea". For spasm and bone pain, malignant sores, abscess and swelling. Herba Lycopi, bitter and pungent, slightly warm, and has the effects of invigorating liver and spleen channels, promoting blood circulation, regulating menstruation, removing blood stasis, resolving carbuncles, inducing diuresis and relieving edema. The present meridian is used in treating female hemorrhage, apoplexy Yu Ji, ascites, edema of body surface and limbs, water in condyle, golden sore, carbuncle, swelling and suppuration. Alismatis rhizoma has sweet and light taste and cold nature, and enters kidney and bladder meridians to promote diuresis and remove dampness and dispel heat. The compendium of materia medica is "excrete damp-heat, promote phlegm-fluid retention, stop vomiting, diarrhea, hernia pain and beriberi".

The ministerial drugs comprise radix Salviae Miltiorrhizae, radix Angelicae sinensis, and faeces Bombycis. Dan Shen is bitter in flavor and slightly cold in nature, enters heart and liver meridians. Replenishing blood, promoting blood circulation, dredging channels and relieving pain. The miscellaneous records of the patent publication, blood nourishing, heart and abdomen disease removing, qi stagnation eliminating, waist and spine strengthening, foot obstruction eliminating, pathogenic wind and heat retaining. Is beneficial for people after long-term administration. The salvia miltiorrhiza has the effects of eliminating evil without damaging the body resistance, and the four-ingredient decoction of the same body resistance and the same taste as the salvia miltiorrhiza can not only play roles of activating blood and removing stasis, but also has the effects of nourishing blood and strengthening waist and knee, and both principal and secondary aspects of the disease are treated. Dang Gui is sweet in flavor, pungent in flavor and warm in nature, and enters liver, heart and spleen meridians. Break blood and remove stasis, regulate menstruation and relieve pain, moisten intestines and relieve constipation. The radix Angelicae sinensis is dry root of Angelica sinensis Diels of Umbelliferae. Lishizhen is written in Ben Cao gang mu in the form of "ancient people want wife is a subsequent step, dang Gui regulates blood, so it is a key herb for women, so it has the meaning of Si Fu. The efficacy of different medicinal parts is completely different and even opposite. The traditional medication habit considers that the Chinese angelica head is used for stopping bleeding, the Chinese angelica body is used for replenishing blood, the Chinese angelica tail is used for breaking blood, and the whole Chinese angelica is used for regulating blood, so that the Chinese angelica can promote blood circulation and also can replenish blood. Silkworm excrement has sweet and warm nature and enters liver, spleen and stomach meridians, and has the effects of drying dampness, dispelling wind, harmonizing stomach, eliminating turbid pathogen, activating blood and relieving pain. Silkworm excrement is often used for arthralgia due to wind-dampness, headache, itch of skin, cold pain in waist and legs, abdominal pain, vomiting and diarrhea, etc. For instance, it is indicated for rheumatism, because of its original silkworm excrement, it is a special herb for rheumatism, and it is also added to tonic herbs for cases where it is slow and firm due to rheumatism, i.e. blood deficiency can not nourish meridians.

The adjuvant drugs include herba Portulacae, coicis semen, stigma Maydis, cortex Cinnamomi, and three-fork bitter. Purslane is cold in nature, sweet and sour in taste, enters heart, liver, spleen and large intestine meridians, cools blood and eliminates phlegm. Yi ren is sweet and bland in flavor, cool in nature, and enters spleen, stomach and lung meridians. Has effects of promoting diuresis, removing dampness, invigorating spleen, relieving diarrhea, removing arthralgia, expelling pus, removing toxic substances, and resolving hard mass. The materia medica outline of materia medica is that coix seed yangming herb can also strengthen spleen and benefit stomach. For the treatment of yang-Ming, it is indicated for spasm, urgent tendons and wind arthralgia. It can remove dampness by using earth, so it is indicated for diarrhea and edema. Corn silk is effective in inducing diuresis to alleviate edema, removing heat from the liver and promoting function of gallbladder, and can be used for treating edema, stranguria, turbid urine, diabetes, jaundice, cholecystitis, cholelithiasis, hypertension, acute mastitis, and galactostasis. The "Dian nan Ben Cao" records its "Wide intestine and descending qi". For women's mammary gland hyperplasia, galactostasis, swelling and pain, aversion to cold and fever, headache and body constitution. "national Chinese herbal medicine Assemble:" (corn silk) induce diuresis to alleviate edema, pacify liver and promote bile flow. The cinnamon, which is an anti-adjuvant drug, restricts the nature of the herbs in the self-made pain recipe to be cold and cool, eliminates phlegm and reduces turbidity without damaging yang. Rou Gui is pungent and sweet in flavor and has strong heat property, and enters kidney, spleen, heart and liver meridians. Has effects of invigorating fire, supporting yang, inducing fire, restoring primordial qi, dispelling cold, relieving pain, and warming and dredging channels. Cinnamon is recorded in Shennong Ben Cao Jing, zhen Shen, lian Zhen Shen: all of the leaves and hearts of the Chinese fan are in a longitudinal arrangement, and the single Chinese cinnamon is in a shape of a Chinese yerba, so the Chinese yerba is a Chinese yerba. Its color is like meat, so it is called. In Ben Cao Hui Yan, rou Gui is also indicated for cold syndrome due to sinking cold. The cinnamon is used for treating impotence, cold womb, cold pain of waist and knee, asthma due to kidney deficiency, deficient yang floating up, dizziness, conjunctival congestion, cold pain of heart and abdomen, vomiting and diarrhea due to deficiency cold, cold hernia and abdominal pain, dysmenorrhea and amenorrhea and the like. Bitter in flavor, enters liver meridian, lung meridian and stomach meridian. Has effects in clearing away heat and toxic materials, promoting qi circulation, relieving pain, eliminating dampness, and relieving itching. The Chinese herbal medicine guide records the trigeminal bitter in that the traumatic injury medicine has bitter taste, cold property, heat toxin clearing, and the traumatic injury fever pain relieving, and the antipyretic medicine is decocted for administration. "

The guiding drug is honeysuckle stem and bighead atractylodes rhizome. The honeysuckle stem is the stem of honeysuckle, which is the guiding drug in the recipe, up to the diseased part. Honeysuckle stem, caulis Lonicerae, sweet and bitter in taste and slightly cold in nature. Enters heart and lung meridians to clear heat, detoxify and unblock collaterals, and Ben Cao gang mu (compendium of materia Medica) 'it is called as a good herb for treating wind, removing distention, relieving dysentery and expelling cadaver'. Atractylodis rhizoma is the guiding drug in the recipe, and has the effects of strengthening spleen, protecting middle warmer, nourishing acquired root, and strengthening illness state. Atractylodis rhizoma has warm nature, sweet and bitter taste, has effects of invigorating spleen and replenishing qi, eliminating dampness and promoting diuresis, suppressing sweating, and preventing miscarriage, is dry rhizome of Atractylodis rhizoma of Compositae, has effects of invigorating spleen and invigorating qi, eliminating dampness and promoting diuresis, suppressing sweating, and preventing miscarriage, and is commonly used for spleen deficiency and anorexia, abdominal distention and diarrhea, phlegm and fluid, dizziness and palpitation, edema, spontaneous sweat, fetal movement, etc. Modern researches have shown that white atractylodes rhizome has diuretic, antibacterial, antiaging and antitumor effects, and also has the function of regulating immunity. It is often used for treating spleen deficiency, anorexia, abdominal distention, diarrhea, phlegm retention, dizziness, palpitation, edema, spontaneous perspiration, fetal movement, etc. Modern researches have shown that white atractylodes rhizome has diuretic, antibacterial, antiaging and antitumor effects, and also has the function of regulating immunity.

The specific techniques or conditions are not identified in the examples and are described in the literature in this field or are carried out in accordance with the product specifications. The reagents or equipment used were conventional products available for purchase through regular channels, with no manufacturer noted.

The experimental methods in the following examples are conventional methods unless otherwise specified. The test materials used in the examples described below, unless otherwise specified, are all commercially available products.

Preparation examples:

example 1:

A traditional Chinese medicine composition for treating phlegm stagnation type hyperuricemia is prepared from the following traditional Chinese medicine raw materials of 10g of rhizoma alismatis, 10g of bighead atractylodes rhizome, 10g of herba lycopi, 20g of honeysuckle stem, 20g of glabrous greenbrier rhizome, 20g of corn silk, 10g of radix salviae miltiorrhizae, 10g of purslane, 10g of silkworm excrement, 5g of Chinese angelica tail, 5g of cinnamon and 5g of trigeminal bitter herb.

The preparation method of the traditional Chinese medicine composition comprises the steps of decocting for the first time, adding 1000mL of cold water which is about 3cm above the medicine surface, soaking for 30 minutes, decocting with strong fire, decocting with slow fire for 30-40 minutes, filtering residues to obtain juice, decocting for the second time, adding 1000mL of cold water which is about 2cm above the medicine surface, decocting for 20 minutes after boiling with water, filtering residues to obtain juice, mixing the two liquid medicines, and concentrating under reduced pressure to obtain 300mL of concentrated solution.

Example 2:

A traditional Chinese medicine composition for treating phlegm stagnation type hyperuricemia is prepared from the following traditional Chinese medicine raw materials of 20g of rhizoma alismatis, 10g of bighead atractylodes rhizome, 20g of herba lycopi, 10g of honeysuckle stem, 10g of glabrous greenbrier rhizome, 20g of corn silk, 10g of radix salviae miltiorrhizae, 10g of purslane, 10g of silkworm excrement, 5g of Chinese angelica tail, 5g of cinnamon and 5g of trigeminal bitter herb.

The preparation method is the same as in example 1.

Comparative example 1:

the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials of 10g of rhizoma alismatis, 10g of bighead atractylodes rhizome, 10g of herba lycopi, 40g of glabrous greenbrier rhizome, 20g of corn silk, 10g of radix salviae miltiorrhizae, 10g of purslane, 10g of silkworm excrement, 5g of Chinese angelica tail, 5g of cinnamon and 5g of trigeminal bitter.

The preparation method is the same as in example 1.

Comparative example 2:

The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials of 10g of poria cocos, 10g of bighead atractylodes rhizome, 10g of herba lycopi, 20g of honeysuckle stem, 20g of rhizoma smilacis glabrae, 20g of corn silk, 10g of radix salviae miltiorrhizae, 10g of purslane, 10g of silkworm excrement, 5g of Chinese angelica tail, 5g of cinnamon and 5g of trigeminal bitter.

The preparation method is the same as in example 1.

Comparative example 3:

the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials of 10g of rhizoma alismatis, 10g of bighead atractylodes rhizome, 20g of herba lycopi, 20g of honeysuckle stem, 20g of rhizoma smilacis glabrae, 20g of corn silk, 10g of purslane, 10g of silkworm excrement, 5g of Chinese angelica tail, 5g of cinnamon and 5g of trigeminal bitter herb.

The preparation method is the same as in example 1.

Effect examples:

Effect example 1 pharmacodynamics study of the Chinese medicinal composition for treating hyperuricemia

1.1 Main Experimental materials

Experimental medicine the traditional Chinese medicine composition prepared in the above examples 1-2 and comparative examples 1-3. Potassium oxazinate and febuxostat were purchased from Merck life sciences (purity > 99.5%).

Animals 64 SPF grade C57BL/6 male mice (8 weeks old, weight 18-22 g) were purchased from Chengdu laboratory animal Co. All mice were kept in an environment with a temperature of 22.+ -. 1 ℃ and a humidity of 55.+ -. 5%. The mice can freely ingest food and water by keeping 12 hours of illumination/12 hours of darkness and uniformly illuminating natural light.

Detection kits uric Acid (AU) and Xanthine Oxidase (XOD) were purchased from the Nanjing institute of biological engineering, and all of the kit detection methods were performed according to the instructions provided in the kit.

1.2 Experimental methods

The mice were grouped and dosed with 64 SPF-grade healthy C57BL/6 male mice, randomly 8 groups of 8 mice each, each of the group consisting of a blank control group, a model group, a febuxostat group (60 mg/kg), a example 1 group (120 mg/kg, calculated as crude drug, the same applies hereinafter), a example 2 group (120 mg/kg), a comparative example 1 group (120 mg/kg), a comparative example 2 group (120 mg/kg), and a comparative example 3 group (120 mg/kg).

Each group was diluted with distilled water to the appropriate drug concentration just before use. The mice in the blank and model groups were given distilled water by gavage at a gavage volume of 10mL/kg body weight in 9:00 a.m., for 8 consecutive days. Each group was injected intraperitoneally with 300mg/kg of a potassium oxazinate-physiological saline suspension once daily, except for the blank mice, 1 hour prior to the last three morning dosing. The yeast extract is administered by gastric lavage at 3 pm every day for 8 days. After the last dose, mice were fasted for 12 hours. Blood was taken from the tail vein, allowed to stand at room temperature for 30min, centrifuged at 3000rpm for 5min, and the supernatant was collected by repeated centrifugation and stored in a-80 ℃ refrigerator. The mice were then euthanized by carbon dioxide inhalation. Mouse livers were collected rapidly and stored in a-80 ℃ refrigerator.

And (3) determining the UA content in the mouse serum, namely testing the collected mouse serum according to a specification provided by a kit, and detecting the UA content in the mouse serum.

XOD activity assay in mouse liver tissue collected mouse liver tissue was homogenized with physiological saline and protein concentration was detected by BCA kit (Millipore). The assay was performed according to the instructions provided in the kit to detect XOD activity in mouse liver.

Data processing method experimental data are expressed as mean ± standard deviation (mean ± s.d.). Statistically significant differences were examined for group differences (LSD test after the fact) according to one-way ANOVA analysis by IBM SPSS STATISTICS software, and when P <0.05, group differences were considered significant, with statistical significance.

1.3 Experimental results

1.3.1 Mouse serum UA results

The results of the serum UA experiments for each group of mice are shown in table 1 below. The blood uric acid level of mice in the model group is obviously increased, which indicates that the model is successful, the mice have hyperuricemia symptoms, and the positive control drug febuxostat can obviously reduce the serum UA level of the mice with hyperuricemia, and the UA result of the mice in the febuxostat group is similar to that of the mice in the blank group.

For both the example 1 and example 2 groups, the serum UA levels were significantly reduced in mice compared to the model group (^** p < 0.01). The reduction effect of the traditional Chinese medicine composition of the comparative example 1-3 on the serum UA level of mice is obviously inferior to that of the traditional Chinese medicine composition of the example 1-2, which shows that each medicine taste and the dosage proportion thereof in the traditional Chinese medicine composition are very important for the reduction effect of the serum UA, and the medicine effect is inferior to that of the traditional Chinese medicine composition after removing part of the medicine taste or replacing part of the medicine taste with the same or similar effect clinically.

1.3.2 Results of liver XOD activity in mice

The results of liver XOD activity of mice in each group were consistent with the trend of changes in the results of serum UA of mice. The details are shown in table 1 below. The liver XOD activity of the mice in the model group is obviously increased, which indicates that the model is successful, the mice have hyperuricemia symptoms, and the positive control drug febuxostat can obviously reduce the liver XOD activity of the mice with hyperuricemia, and the XOD result of the mice in the febuxostat group is similar to that of the mice in the blank group.

For both the example 1 and example 2 groups, the mouse liver XOD levels were significantly reduced compared to the model group (^** p < 0.01). The effect of the traditional Chinese medicine composition of the comparative example 1-3 on reducing the liver XOD level of mice is obviously inferior to that of the traditional Chinese medicine composition of the example 1-2, which shows that each medicine taste and the dosage proportion thereof are very important for the effect of reducing the liver XOD, and the medicine effect is inferior to that of the traditional Chinese medicine composition after removing part of the medicine taste or replacing part of the medicine taste with the same or similar effect clinically.

TABLE 1 influence of the Chinese medicinal composition of the invention on the activity of serum UA and liver XOD of hyperuricemia mice

Group of	UA(μmol/L)	XOD(U/g)
			Blank group	75.46±12.23	4.18±0.51
Model group	131.28±14.26	6.74±0.63
			Febuxostat group	79.39±7.18^**	4.52±0.53^**
Example 1 group	86.32±11.51^**	4.98±0.42^**
			Example 2 group	92.47±13.39^**	5.03±0.49^**
Comparative example 1 group	114.18±15.49	6.29±0.78
			Comparative example 2 group	122.54±15.25	6.32±0.64
Comparative example 3 group	112.31±12.57^*	5.87±0.48^*

Note that ^*p<0.05,^** p <0.01 compared to the model set.

Effect example 2 summary of clinical efficacy of the Chinese medicinal composition for treating turbid phlegm blocking type hyperuricemia

General data the traditional Chinese medicine composition (example 1) is clinically applied to patients with gouty arthritis for many years, and the disease course of the patients is 1 month at the minimum and 10 years at the maximum. The clinical symptoms are that the single joint at the far end of the lower limb is red, swelling, heat, pain and dysfunction, the first toe joint is the first joint, and the joints of the instep, ankle, heel, knee, wrist, metacarpophalangeal joint and the like are involved. The laboratory test index showed elevated uric acid. Hyperuricemia is the root cause of gouty arthritis, and the traditional Chinese medicine composition (example 1) has great curative effect on hyperuricemia, and the hyperuricemia is within the normal value of haematuria. Therefore, the subject of the scientific research project of the Guangdong province, namely the clinical observation of the pain relieving prescription for treating phlegm stagnation type hyperuricemia, is successfully declared. The main clinical efficacy data of this topic are listed below.

Efficacy assessment criteria:

clinical cure, the disappearance of clinical symptoms and signs, and the normal uric acid is checked in the laboratory.

Has obvious effect that clinical symptoms disappear and the uric acid is slightly higher than normal value in laboratory examination.

The traditional Chinese medicine composition has the advantages that clinical symptoms are obviously improved compared with those before treatment, and uric acid level is obviously reduced in laboratory examination.

It is ineffective, clinical symptoms and laboratory indexes are unchanged.

The traditional Chinese medicine composition (example 1) has the treatment effects that 59 cases of phlegm turbidity blocking type hyperuricemia patients are treated, 17 cases are clinically cured, 28.8% are occupied, 19 cases are obvious, 32.2% are occupied, 19 cases are effective, 32.2% are occupied, 4 cases are ineffective, and 6.7% are occupied. Only 6 patients had symptoms relapsing with a recurrence rate of 13.3% within one year of follow-up.

Effect example 3 typical cases of phlegm-turbidity blocking type hyperuricemia treated by the Chinese medicinal composition of the present invention

Leaf is somewhere, male, 18 years old. The patient is treated in 10 months of 2021, joint pain is sudden for 5 days, the joint is not obviously red, swelling and pain are not obvious in physical examination, and laboratory indexes show that uric acid is 620 mu mol/L. The traditional Chinese medicine composition (example 1) is taken for 1 treatment course, symptoms disappear, and uric acid is reduced to be normal. Follow-up has not yet been recurrent.

Zhao Mou Male, 62 years old, 10 years old, with uninterrupted onset of gouty arthritis. ALT 167U/L, poor treatment effect, transfer to Guangzhou praying hospital for hospitalization, during which hormone impact treatment and liver protection treatment are matched with a traditional Chinese medicine external treatment method, after 1 month, the treatment is carried out after the discharge, the follow-up febuxostat is taken for controlling the disease state, but the repeated attack is still carried out, after the doctor of the doctor is invited to jointly carry out the diagnosis of difficult cases in a multi-family trimethyl hospital, the doctor of the doctor is recommended to inject adalimumab for carrying out the immunotherapy, one injection is carried out every two weeks later, the pain is repeated after stopping the medicine, after half a year of continuous injection, the medicine resistance is obvious, the medicine end pain effect is obvious, the medicine composition (example 1) is taken after the treatment, the oral administration of the medicine composition is carried out for 1 course, the symptoms are obviously relieved, the medicine is taken for 2 courses of treatment continuously, and the symptoms disappear, and the abnormality is not seen.

It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention also include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

1. A traditional Chinese medicine composition for treating phlegm-dampness obstruction type hyperuricemia, characterized in that: the traditional Chinese medicine composition is made from the following traditional Chinese medicine raw materials in parts by weight: Alisma plantago-aquatica 10 parts, Atractylodes macrocephala 10 parts, Lycopus lucidus 10 parts, Lonicera japonica vine 20 parts, Smilax glabra 20 parts, Zea mays silk 20 parts, Salvia miltiorrhiza 10 parts, Portulaca oleracea 10 parts, Bombyx mori excrement 10 parts, Angelica sinensis tail 5 parts, Cinnamomum cassia 5 parts, and Trichosanthes kirilowii 5 parts.

The preparation method of the traditional Chinese medicine composition is as follows: Weigh each traditional Chinese medicine raw material according to the weight proportions. For the first decoction, cover the surface of the medicine with cold water about 3 cm, soak for 30 minutes, and then decoct. First bring to a boil over high heat, then simmer over low heat for 30-40 minutes. Filter the residue and take the juice. For the second decoction, cover the surface of the medicine with cold water about 2 cm, boil for 20 minutes after the water boils, filter the residue and take the juice. Mix the two decoctions and concentrate them.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: the traditional Chinese medicine composition has the effects of relieving phlegm and clearing turbidity, and promoting joint mobility.

3. The method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that: the method for preparing the traditional Chinese medicine composition is as follows: weigh each traditional Chinese medicine raw material according to the weight proportions described in claim 1; for the first decoction, cover the surface of the medicine with cold water by about 3 cm, soak for 30 minutes, and then decoct; first bring to a boil over high heat, then simmer over low heat for 30-40 minutes, filter the residue and take the juice; for the second decoction, cover the surface of the medicine with cold water by about 2 cm, boil for 20 minutes, filter the residue and take the juice; mix the two decoctions and concentrate.

4. The use of the traditional Chinese medicine composition according to claim 1 or the traditional Chinese medicine composition prepared by the preparation method according to claim 3 in the preparation of a drug for treating hyperuricemia.

5. The use according to claim 4, characterized in that: the drug can inhibit xanthine oxidase activity.

6. The use according to claim 4, characterized in that: the drug can lower uric acid levels and the drug can improve kidney damage in patients with hyperuricemia.

7. The use according to claim 4, wherein the drug is a decoction, powder, oral liquid, ointment, pill, granule, tablet or capsule.