A traditional Chinese medicine composition for treating phlegm-retention type hyperuricemia

Abstract

The application belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating phlegm turbidity blocking type hyperuricemia, a preparation method and application thereof. The traditional Chinese medicine composition is prepared from Alisma orientalis (Sam.) Juzep, Atractylodes macrocephala Koidz, Lonicera japonica Thunb, Smilax glabra, corn silk, Salvia miltiorrhiza Bunge, Portulaca oleracea L, Bombyx mori, Angelica sinensis, Cinnamomum cassia, and Tripterygium regelii, and has the effects of eliminating phlegm, reducing turbidity and dredging joints. The traditional Chinese medicine has a wide source, can be prepared into 5g / pack concentrated pills, is convenient to use, low in price, good in curative effect, small in toxic and side effects during the taking process of patients, and can regulate the body constitution of patients from the whole concept, and the total effective rate can reach 93.2%.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating phlegm-dampness obstruction type hyperuricemia, its preparation method, and its uses. Background Technology

[0002] Hyperuricemia is a chronic disease caused by disordered purine metabolism and abnormal uric acid excretion. Both excessive uric acid production and insufficient excretion can lead to hyperuricemia, which in turn can cause gout and other diseases, posing a great threat to human health.

[0003] Currently, the most commonly used Western medicine preparations for lowering uric acid fall into two categories. One category works by inhibiting uric acid production. For example, drugs that inhibit uric acid synthesis work by inhibiting xanthine oxidase, blocking the conversion of hypoxanthine into xanthine and uric acid, thereby lowering blood uric acid concentration. Representative drugs include allopurinol and febuxostat. The other category works by promoting uric acid excretion. The mechanism of action of uricosuric drugs is mainly to inhibit the active reabsorption of urate in the proximal convoluted tubule, increase the excretion of urate and thus lower the blood uric acid concentration, and promote the dissolution of urate. These mainly include probenecid and benzbromarone. Benzbromarone is restricted in some European countries due to its potential hepatotoxicity, but it is still widely used clinically in China as a major uricosuric drug. In addition, sodium bicarbonate can promote uric acid excretion by alkalizing urine and can also be used to treat gout. Although these Western medicine preparations can effectively lower serum uric acid levels, they have certain limitations and side effects. Long-term use can lead to abnormalities such as bone marrow suppression, nephrotoxicity, and hypersensitivity syndrome. Therefore, it is necessary to find a safer and more effective drug to treat hyperuricemia.

[0004] Hyperuricemia often presents with few or no clinical symptoms before a gout attack, falling under the category of "pre-disease" or "latent pathogen" in Traditional Chinese Medicine (TCM). The *Huangdi Neijing* states, "When wind, cold, and dampness combine, they cause arthritis." When complicated by arthritis or kidney damage, resulting in joint swelling, pain, deformity, urinary tract stones, or renal insufficiency, it can be categorized under "gout," "arthritis," "spondylosis," "urinary tract infection," or "edema." Elevated blood uric acid levels are caused by fullness in the abdomen, impaired blood circulation, accumulation of turbidity, or further flow into the meridians, falling under the category of "turbid uric acid." Furthermore, this disease is also related to genetics, constitution, diet, external pathogens, environment, emotions, and overwork. Its location is initially in the superficial meridians, then extends to the muscles and bones, and over time damages the spleen, liver, and kidneys.

[0005] Traditional Chinese medicine (TCM) believes that hyperuricemia is more common in young and middle-aged men who are robust and obese. This is often attributed to a diet high in fatty, sweet, and greasy foods, as well as alcohol and meat, leading to spleen deficiency, internal dampness and turbidity, and internal accumulation of heat toxins. TCM treatments can focus on clearing dampness and heat, particularly by detoxifying and clearing stagnation. This approach not only reduces swelling and hardening, adjusts blood pH, and prevents dampness and stagnation, but also ultimately stops the accumulation of heat toxins and dampness, preventing kidney damage and the formation of tophi. However, TCM compound preparations for treating hyperuricemia have drawbacks such as inconvenience in administration, poor taste, and limited treatment duration.

[0006] Therefore, there is an urgent need in the field of traditional Chinese medicine to develop a Chinese medicine composition for treating hyperuricemia that is effective, has few adverse reactions, is low in cost, and is easy to use. Summary of the Invention

[0007] The purpose of this invention is to overcome the shortcomings of the existing technology and provide a traditional Chinese medicine composition for treating phlegm-dampness obstruction type hyperuricemia, its preparation method and uses.

[0008] Specifically, the present invention is achieved through the following technical solutions:

[0009] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating phlegm-dampness obstruction type hyperuricemia, said traditional Chinese medicine composition being made from the following traditional Chinese medicine raw materials in parts by weight: Alisma plantago-aquatica 1-30 parts, Atractylodes macrocephala 1-30 parts, Lycopus lucidus 1-30 parts, Lonicera japonica vine 1-40 parts, Smilax glabra 1-40 parts, Zea mays silk 1-40 parts, Salvia miltiorrhiza 1-30 parts, Portulaca oleracea 1-30 parts, Bombyx mori excrement 1-30 parts, Angelica sinensis tail 1-20 parts, Cinnamomum cassia 1-20 parts, and Trichosanthes kirilowii 1-20 parts.

[0010] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made from the following traditional Chinese medicine raw materials in parts by weight: Alisma plantago-aquatica 1-20 parts, Atractylodes macrocephala 1-20 parts, Lycopus lucidus 1-20 parts, Lonicera japonica vine 5-30 parts, Smilax glabra 5-30 parts, corn silk 5-30 parts, Salvia miltiorrhiza 1-20 parts, Portulaca oleracea 1-20 parts, Bombyx mori excrement 1-20 parts, Angelica sinensis tail 1-10 parts, Cinnamomum cassia 1-10 parts, and Trichosanthes kirilowii 1-10 parts.

[0011] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made from the following traditional Chinese medicine raw materials in parts by weight: 10 parts of Alisma plantago-aquatica, 10 parts of Atractylodes macrocephala, 10 parts of Lycopus lucidus, 20 parts of Lonicera japonica, 20 parts of Smilax glabra, 20 parts of corn silk, 10 parts of Salvia miltiorrhiza, 10 parts of Portulaca oleracea, 10 parts of Bombyx mori excrement, 5 parts of Angelica sinensis tail, 5 parts of Cinnamomum cassia, and 5 parts of Trichosanthes kirilowii.

[0012] Alternatively, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition has the effects of eliminating phlegm and clearing turbidity, and promoting joint mobility.

[0013] In a second aspect, the present invention provides a method for preparing the traditional Chinese medicine composition described in the first aspect above, the method comprising the following steps:

[0014] Weigh each Chinese herbal medicine ingredient according to the weight proportions described in the first aspect above. For the first decoction, cover the herbs with cold water, soak them, and then decoct them. First, bring to a boil over high heat, then simmer over low heat for a period of time. Filter out the residue and take the juice. For the second decoction, cover the herbs with cold water, bring to a boil, and then simmer for a period of time. Filter out the residue and take the juice. Mix the two decoctions and concentrate them.

[0015] As an optional method, in the above preparation method, during the first decoction, the cold water covers the surface of the herbs by about 3cm, and after soaking for 30 minutes, the herbs are decocted. First, bring to a boil over high heat, then simmer over low heat for 30-40 minutes. During the second decoction, the cold water covers the surface of the herbs by about 2cm, and after the water boils, the herbs are decocted for 20 minutes.

[0016] In a third aspect, the present invention provides the use of the traditional Chinese medicine composition described in the first aspect above, or the traditional Chinese medicine composition prepared by the preparation method described in the second aspect above, in the preparation of a medicament for treating hyperuricemia.

[0017] Alternatively, in the above-described uses, the drug inhibits xanthine oxidase activity.

[0018] Alternatively, in the above-described uses, the drug lowers uric acid levels and / or the drug improves kidney damage in patients with hyperuricemia.

[0019] Preferably, the improvement of kidney damage in patients with hyperuricemia includes reducing renal tubular dilation and / or edema.

[0020] Alternatively, in the above-mentioned uses, the drug may be in the form of decoction pieces, broth, powder, oral liquid, ointment, pill, granule, tablet or capsule.

[0021] Preferably, the drug is in the form of pills.

[0022] Preferably, the pills are packaged in 5g portions. Take one pill after breakfast and dinner with warm water. Continue taking for half a month.

[0023] More preferably, half a month is one course of treatment, and about 2-3 courses of treatment are required.

[0024] The beneficial effects of this invention are as follows:

[0025] (1) Based on the traditional Chinese medicine syndrome differentiation and treatment, this invention combines clinical practice with scientific formulation and repeatedly experiments to determine the optimal dosage of each Chinese medicine, which is particularly effective in treating hyperuricemia of phlegm-dampness obstruction type.

[0026] (2) The Chinese medicine formula is a commonly used clinical medicine. It is easy to obtain, inexpensive, simple to prepare, effective, and has high patient compliance. It has the characteristics of treating both the symptoms and the root cause and is not prone to recurrence.

[0027] (3) The total effective rate of the traditional Chinese medicine composition of the present invention is 93.2%. During the one-year follow-up, only 13.3% of patients relapsed, but the symptoms and signs were significantly reduced, the treatment cycle was significantly shortened, and the patients' quality of life was significantly improved. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

[0029] The principal herbs in this invention are Smilax glabra, Lycopus lucidus, and Alisma plantago-aquatica. Smilax glabra is sweet, bland, and neutral in nature, and enters the liver and stomach meridians. It has the effects of detoxification, dampness removal, and joint mobility. The Compendium of Materia Medica states: "It strengthens the spleen and stomach, strengthens tendons and bones, dispels wind and dampness, benefits joints, and stops diarrhea. It treats contractures and bone pain; malignant sores and carbuncles." Lycopus lucidus is bitter, pungent, and slightly warm, and enters the liver and spleen meridians. It invigorates blood circulation, regulates menstruation, removes blood stasis, eliminates carbuncles, and promotes diuresis and reduces swelling. The Shennong's Classic of Materia Medica states: "It treats epistaxis in breastfeeding women, residual effects of stroke, ascites, edema of the body, face, and limbs, fluid in the joints, traumatic injuries, and carbuncles and boils." Alisma plantago-aquatica is sweet, bland, and cold in nature, and enters the kidney and bladder meridians. It promotes diuresis, eliminates dampness, and clears heat. The Compendium of Materia Medica states: "It eliminates damp heat, resolves phlegm, stops vomiting, diarrhea, hernia pain, and beriberi."

[0030] The main ingredients are Salvia miltiorrhiza, Angelica sinensis (tail), and silkworm excrement. Salvia miltiorrhiza is bitter and slightly cold in nature, and enters the heart and liver meridians. It nourishes and invigorates blood, regulates menstruation, and relieves pain. The *Bielu* states, "It nourishes blood, removes chronic abdominal pain and stagnation, strengthens the waist and spine, alleviates numbness in the legs, and eliminates wind-evil and lingering heat. Long-term use benefits the body." Salvia miltiorrhiza eliminates pathogens without harming the body's vital energy; as the saying goes, "One dose of Salvia miltiorrhiza is equivalent to the Four-Substance Decoction." This medicine not only invigorates blood and removes blood stasis but also nourishes blood and strengthens the waist and knees, treating both the root cause and the symptoms. Angelica sinensis (tail) is sweet, pungent, and warm in nature, and enters the liver, heart, and spleen meridians. It breaks up blood stasis, regulates menstruation, relieves pain, and moistens the intestines to promote bowel movements. Angelica sinensis is the dried root of the Angelica sinensis plant (Apiaceae family). Li Shizhen wrote in *Compendium of Materia Medica*: "In ancient times, wives were needed to continue the family line. Angelica sinensis regulates blood and is a necessary medicine for women, implying longing for their husbands, hence the name 'Angelica sinensis'." Different medicinal parts have completely different, even opposite, effects. Traditional medicine believes that the head of Angelica sinensis stops bleeding, the body nourishes blood, the tail breaks up blood stasis, and the whole Angelica sinensis harmonizes blood, meaning it can both invigorate and nourish blood. Silkworm excrement is sweet and warm in nature, entering the liver, spleen, and stomach meridians. It has the functions of drying dampness, dispelling wind, harmonizing the stomach and resolving turbidity, invigorating blood and relieving pain. Silkworm excrement is often used for rheumatic pain, headache, pruritus, cold pain in the waist and legs, abdominal pain, vomiting, and diarrhea. *Seeking the Origins of Materia Medica* states: "Original silkworm excrement is a specific medicine for rheumatism. It is suitable for all cases of rheumatic paralysis. Even for those with blood deficiency that cannot nourish the meridians, it is also suitable to be added to tonifying medicines."

[0031] The adjuvant herbs are purslane, coix seed, corn silk, cinnamon, and bitter gourd. Purslane: cold in nature, sweet and sour in taste, enters the heart, liver, spleen, and large intestine meridians; it cools the blood and eliminates phlegm. Coix seed: sweet and bland in taste, cool in nature, enters the spleen, stomach, and lung meridians. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen and stopping diarrhea, relieving numbness, draining pus, and detoxifying and dispersing nodules. The *Compendium of Materia Medica* states: "Coix seed is a Yangming medicine; it can strengthen the spleen and benefit the stomach. For diseases of the muscles and bones, treatment is based on the Yangming meridian; therefore, it is used for contractures, muscle spasms, and wind-dampness. Earth can generate water and eliminate dampness; therefore, it is used for diarrhea and edema." Corn silk: neutral in nature, enters the liver, gallbladder, stomach, and kidney meridians; it has the effects of promoting diuresis and reducing swelling, clearing the liver and gallbladder, and is often used for edema, urinary tract infections, leukorrhea, diabetes, jaundice, cholecystitis, cholelithiasis, hypertension, mastitis, and insufficient lactation. The *Diannan Materia Medica* records that it "soothes the intestines and lowers qi. It treats women's breast lumps, redness and swelling, insufficient milk production, redness, swelling and pain, chills and fever, headache and fatigue." The *National Compendium of Chinese Herbal Medicine* states: "(Corn silk) promotes urination and reduces swelling, soothes the liver and gallbladder. It counteracts the cold nature of the herbs in the self-prepared pain-relieving formula, clearing phlegm and reducing turbidity without harming yang. Cinnamon: Its taste is pungent and sweet, and its nature is very hot; it enters the kidney, spleen, heart, and liver meridians. It has the effects of tonifying fire and assisting yang, guiding fire back to its source, dispelling cold and relieving pain, and warming and unblocking the meridians. Cinnamon was first recorded in the *Shennong's Classic of Materia Medica*, and it has been recorded in various materia medica throughout history. Li Shizhen said: "All tree leaves and heartwood have one longitudinal line, but cinnamon has two lines like a jade tablet, hence the character 'gui' (jade tablet). Its color is like flesh, hence the name." The *Compendium of Materia Medica* records, "Cinnamon is a medicine for treating deep-seated cold and stubborn cold." Cinnamon is used for impotence, cold uterus, lower back and knee pain, kidney deficiency causing shortness of breath, upward floating of deficient yang, dizziness and red eyes, cold pain in the heart and abdomen, vomiting and diarrhea due to deficiency and cold, abdominal pain due to cold hernia, dysmenorrhea, and amenorrhea. *Trifolium repens* (also known as bitter gourd): Cold in nature and bitter in taste; it enters the liver, lung, and stomach meridians. It has the effects of clearing heat and detoxifying, promoting qi circulation and relieving pain, and drying dampness and relieving itching. The *Guide to Mountain Herbs* records *Trifolium repens* as: "A medicine for traumatic injuries, bitter and cold in nature, clearing heat and toxins; for all traumatic injuries causing fever and pain, decoct and drink to stop the pain; also an antipyretic."

[0032] The guiding herbs are honeysuckle vine and atractylodes macrocephala. Honeysuckle vine, the vine of honeysuckle, is the guiding herb in the formula, reaching the affected area. Honeysuckle vine: sweet and bitter in taste, slightly cold in nature. It enters the heart and lung meridians, clearing heat, detoxifying, and unblocking the meridians. The Compendium of Materia Medica states that it is "an excellent medicine for treating wind, relieving bloating, dysentery, and expelling corpses." Atractylodes macrocephala is the guiding herb in the formula, strengthening the spleen and protecting the middle jiao, nourishing the acquired constitution, and consolidating the condition. Atractylodes macrocephala: warm in nature, sweet and bitter in taste, it has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. Atractylodes macrocephala is the dried rhizome of the Asteraceae plant Atractylodes macrocephala. It is warm in nature, sweet and bitter in taste, and has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. It is often used for symptoms such as spleen deficiency with poor appetite, abdominal distension and diarrhea, phlegm retention, dizziness and palpitations, edema, spontaneous sweating, and threatened abortion. Modern research shows that atractylodes macrocephala has diuretic, antibacterial, anti-aging, and anti-tumor effects, and also has immune-regulating functions. It is commonly used for symptoms such as spleen deficiency with poor appetite, abdominal distension and diarrhea, phlegm retention with dizziness and palpitations, edema, spontaneous sweating, and threatened abortion. Modern research shows that Atractylodes macrocephala has diuretic, antibacterial, anti-aging, and anti-tumor effects, and also has immune-regulating functions.

[0033] Where specific techniques or conditions are not specified in the examples, they shall be performed in accordance with the techniques or conditions described in the literature in this field, or in accordance with the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels.

[0034] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods. Unless otherwise specified, the experimental materials used in the following embodiments are commercially available products.

[0035] Preparation Example:

[0036] Example 1:

[0037] A traditional Chinese medicine composition for treating phlegm-dampness obstruction type hyperuricemia, the composition being made from the following traditional Chinese medicine raw materials: Alisma plantago-aquatica 10g, Atractylodes macrocephala 10g, Lycopus lucidus 10g, Lonicera japonica vine 20g, Smilax glabra 20g, corn silk 20g, Salvia miltiorrhiza 10g, Portulaca oleracea 10g, Bombyx mori excrement 10g, Angelica sinensis tail 5g, Cinnamomum cassia 5g, and Trichosanthes kirilowii 5g.

[0038] The preparation method of the traditional Chinese medicine composition is as follows: For the first decoction, add 1000mL of cold water to cover the surface of the medicine by about 3cm, 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, add 1000mL of cold water to cover the surface of the medicine by about 2cm, boil for 20 minutes, filter the residue and take the juice. Mix the two decoctions and concentrate under reduced pressure to obtain 300mL of concentrated solution.

[0039] Example 2:

[0040] A traditional Chinese medicine composition for treating phlegm-dampness obstruction type hyperuricemia, the composition being made from the following traditional Chinese medicine raw materials: Alisma plantago-aquatica 20g, Atractylodes macrocephala 10g, Lycopus lucidus 20g, Lonicera japonica vine 10g, Smilax glabra 10g, corn silk 20g, Salvia miltiorrhiza 10g, Portulaca oleracea 10g, Bombyx mori excrement 10g, Angelica sinensis tail 5g, Cinnamomum cassia 5g, and Trichosanthes kirilowii 5g.

[0041] The preparation method is the same as in Example 1.

[0042] Comparative Example 1:

[0043] A traditional Chinese medicine composition, wherein the traditional Chinese medicine composition is made from the following traditional Chinese medicine raw materials: Alisma plantago-aquatica 10g, Atractylodes macrocephala 10g, Lycopus lucidus 10g, Smilax glabra 40g, corn silk 20g, Salvia miltiorrhiza 10g, Portulaca oleracea 10g, Bombyx mori excrement 10g, Angelica sinensis tail 5g, Cinnamomum cassia 5g, and Trichosanthes kirilowii 5g.

[0044] The preparation method is the same as in Example 1.

[0045] Comparative Example 2:

[0046] A traditional Chinese medicine composition, wherein the traditional Chinese medicine composition is made from the following traditional Chinese medicine raw materials: 10g of Poria cocos, 10g of Atractylodes macrocephala, 10g of Lycopus lucidus, 20g of Lonicera japonica, 20g of Smilax glabra, 20g of corn silk, 10g of Salvia miltiorrhiza, 10g of Portulaca oleracea, 10g of Bombyx mori excrement, 5g of Angelica sinensis tail, 5g of Cinnamomum cassia, and 5g of Trichosanthes kirilowii.

[0047] The preparation method is the same as in Example 1.

[0048] Comparative Example 3:

[0049] A traditional Chinese medicine composition, said traditional Chinese medicine composition is made from the following traditional Chinese medicine raw materials: Alisma plantago-aquatica 10g, Atractylodes macrocephala 10g, Lycopus lucidus 20g, Lonicera japonica vine 20g, Smilax glabra 20g, corn silk 20g, Portulaca oleracea 10g, Bombyx mori excrement 10g, Angelica sinensis tail 5g, Cinnamomum cassia 5g, and Trichosanthes kirilowii 5g.

[0050] The preparation method is the same as in Example 1.

[0051] Example of effect:

[0052] Example 1: Pharmacodynamic study of the traditional Chinese medicine composition of the present invention in the treatment of hyperuricemia

[0053] 1.1 Main Experimental Materials

[0054] Experimental reagents: The traditional Chinese medicine compositions prepared in Examples 1-2 and Comparative Examples 1-3 above. Potassium oxazine and febuxostat were purchased from Merck Life Sciences (purity >99.5%).

[0055] Animals: Sixty-four SPF-grade male C57BL / 6 mice (8 weeks old, weighing 18-22g) were purchased from Chengdu Dashuo Experimental Animal Co., Ltd. All mice were housed in an environment with a temperature of 22±1℃ and humidity of 55±5%. A 12-hour light / 12-hour dark environment was maintained, with uniform natural light illumination. Mice had free access to food and water.

[0056] Test kits: The uric acid (AU) assay kit and the xanthine oxidase (XOD) assay kit were purchased from Nanjing Jiancheng Bioengineering Institute. All test methods were performed in accordance with the instructions provided in the kit.

[0057] 1.2 Experimental Methods

[0058] Mouse grouping and administration: Sixty-four healthy SPF-grade male C57BL / 6 mice were randomly divided into eight groups of eight each: blank control group, model group, febuxostat group (60 mg / kg), Example 1 group (120 mg / kg, calculated based on crude drug amount, the same below), Example 2 group (120 mg / kg), Comparative Example 1 group (120 mg / kg), Comparative Example 2 group (120 mg / kg), and Comparative Example 3 group (120 mg / kg).

[0059] Before use, each group was diluted with distilled water to an appropriate drug concentration. The drug was administered by gavage at 9:00 AM daily, with a gavage volume of 10 mL / kg body weight. The blank control group and model group mice were administered distilled water by gavage for 8 consecutive days. One hour before the last three morning administrations, except for the blank control mice, all other groups were intraperitoneally injected with 300 mg / kg potassium oxonate-physiological saline suspension once daily. Yeast extract was administered by gavage at 3:00 PM daily for 8 consecutive days. After the last administration, the mice were fasted for 12 hours. Blood was collected from the tail vein, allowed to stand at room temperature for 30 minutes, centrifuged at 3000 rpm for 5 minutes, and the supernatant was collected again by repeated centrifugation and stored at -80°C. The mice were then euthanized by carbon dioxide inhalation. The mouse livers were rapidly collected and stored at -80°C.

[0060] Determination of UA content in mouse serum: The collected mouse serum was tested according to the instructions provided with the kit to detect the UA content in the mouse serum.

[0061] XOD activity assay in mouse liver tissue: Collected mouse liver tissue was homogenized with physiological saline, and protein concentration was detected using a BCA (Millipore) kit. XOD activity in mouse liver was measured according to the kit's instructions.

[0062] Data processing methods: Experimental data are expressed as mean ± standard deviation (mean ± SD). Statistically significant differences were determined using one-way ANOVA analysis with IBM SPSS Statistics 23 software (with a post-hoc LSD test). A p-value < 0.05 was considered statistically significant.

[0063] 1.3 Experimental Results

[0064] 1.3.1 Results of serum UA in mice

[0065] The serum UA test results of each group of mice are shown in Table 1 below. The serum uric acid level of the model group mice was significantly increased, indicating that the model was successfully established and the mice showed symptoms of hyperuricemia. The positive control drug febuxostat was able to significantly reduce the serum UA level of hyperuricemic mice. The UA results of the febuxostat group mice were similar to those of the blank group.

[0066] For both Example 1 and Example 2 groups, the serum UA level in mice was significantly lower than that in the model group. **(p<0.01). The effects of the traditional Chinese medicine compositions in Comparative Examples 1-3 on reducing serum UA levels in mice were significantly less than those in Examples 1-2. This indicates that each herb and its dosage ratio in the traditional Chinese medicine composition of the present invention are very important for its effect on reducing serum UA. When some herbs are removed or replaced with herbs that have the same or similar effects in clinical practice, the efficacy is not as good as the original traditional Chinese medicine composition.

[0067] 1.3.2 Results of XOD activity in mouse liver

[0068] The trends of liver XOD activity in each group of mice were consistent with those of serum UA in mice. See Table 1 below for details. The significantly increased liver XOD activity in the model group indicated successful modeling and the development of hyperuricemia symptoms in the mice. Furthermore, the positive control drug febuxostat significantly reduced liver XOD activity in hyperuricemic mice, and the XOD results in the febuxostat group were similar to those in the control group.

[0069] For both Example 1 and Example 2 groups, the XOD level in the mouse liver was significantly lower compared to the model group. ** (p<0.01). The herbal compositions in Comparative Examples 1-3 showed significantly less effect on reducing XOD levels in mouse livers than those in Examples 1-2. This indicates that each herb and its dosage ratio in the herbal composition of the present invention are very important for its effect on reducing liver XOD. When some herbs are removed or replaced with herbs that have the same or similar effects in clinical practice, the efficacy is not as good as the original herbal composition.

[0070] Table 1: Effects of the herbal composition of the present invention on serum UA and liver XOD activity in hyperuricemic mice

[0071] Group 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 <![CDATA[79.39±7.18 ** ]]> <![CDATA[4.52±0.53 ** ]]> Example 1 Group <![CDATA[86.32±11.51 ** ]]> <![CDATA[4.98±0.42 ** ]]> Example 2 group <![CDATA[92.47±13.39 ** ]]> <![CDATA[5.03±0.49 ** ]]> Comparative Example 1 114.18±15.49 6.29±0.78 Comparative Example 2 122.54±15.25 6.32±0.64 Comparative Example 3 Groups <![CDATA[112.31±12.57 * ]]> <![CDATA[5.87±0.48 * ]]>

[0072] Note: Compared with the model group, * p<0.05, ** p<0.01.

[0073] Example 2: Summary of the clinical efficacy of the herbal composition of the present invention in treating phlegm-dampness obstruction type hyperuricemia

[0074] General Information: The herbal composition of this invention (Example 1) has been clinically applied to patients with gouty arthritis for many years, with the shortest course of disease being 1 month and the longest being over 10 years. Clinical symptoms include sudden onset of redness, swelling, heat, pain, and functional impairment in a single joint of the distal lower extremities, with the first metatarsophalangeal joint being the first to be affected, followed by the dorsum of the foot, ankle, heel, knee, wrist, and metacarpophalangeal joints. Laboratory tests show elevated uric acid levels. Long-term hyperuricemia is the root cause of gouty arthritis attacks. The herbal composition of this invention (Example 1) has also shown significant efficacy in treating hyperuricemia, bringing serum uric acid levels within the normal range. Therefore, a research project from the Guangdong Provincial Administration of Traditional Chinese Medicine—"Clinical Observation of the Self-Formulated Pain-Relieving Formula in the Treatment of Phlegm-Dampness Obstruction Type Hyperuricemia"—was successfully applied for. The main clinical efficacy data of this project are listed below.

[0075] Efficacy evaluation criteria:

[0076] Clinical cure: Clinical symptoms and signs disappear, and laboratory tests show that uric acid levels will return to normal.

[0077] Significant effect: Clinical symptoms disappear, and laboratory tests show that uric acid levels are slightly higher than normal.

[0078] Effective: Clinical symptoms improved significantly compared to before treatment, and laboratory tests showed a significant decrease in uric acid levels.

[0079] Ineffective: No change in clinical symptoms and laboratory indicators.

[0080] Therapeutic effects: The herbal composition of this invention (Example 1) was used to treat 59 patients with phlegm-dampness obstruction type hyperuricemia. 17 cases were clinically cured (28.8%), 19 cases showed significant improvement (32.2%), 19 cases showed improvement (32.2%), and 4 cases were ineffective (6.7%). During a one-year follow-up, only 6 patients experienced symptom recurrence, with a recurrence rate of 13.3%.

[0081] Example 3: A typical case of treating phlegm-dampness obstruction type hyperuricemia with the traditional Chinese medicine composition of the present invention.

[0082] Mr. Ye, male, 18 years old. He sought medical attention in October 2021 with a sudden onset of joint pain for 5 days. Physical examination revealed no obvious redness, swelling, heat, or pain in the joints. Laboratory tests showed a uric acid level of 620 μmol / L. After one course of treatment with the traditional Chinese medicine composition of this invention (Example 1), his symptoms disappeared, and his uric acid level returned to normal. He has not relapsed to date.

[0083] Mr. Zhao, male, 62 years old, had a history of gouty arthritis for more than 10 years, with intermittent flare-ups. In August 2020, he experienced a major flare-up. Treatment with colchicine and glucocorticoids at a local hospital did not improve his condition. His kidney function and uric acid levels were normal, but his liver function was impaired: ALT 167 U / L. Due to the poor treatment effect, he was transferred to Guangzhou Qifu Hospital for inpatient treatment. During his stay, he received hormone pulse therapy, liver protection therapy, and external application of traditional Chinese medicine. He was discharged after one month with improved condition. After discharge, he continued to take febuxostat to control his condition, but the flare-ups continued. His attending physician then invited several top-tier hospitals to conduct a joint consultation for difficult cases and recommended adalimumab injections for immunotherapy. He received one injection every two weeks. Pain would recur after stopping the medication. After six months of continuous injections, drug resistance developed, and the pain effect was significant at the end of the injections. He then switched to the traditional Chinese medicine composition of this invention (Example 1) for treatment. After one course of oral treatment, his symptoms were significantly reduced. He stopped adalimumab injections and continued to take this medicine orally for two more courses. His symptoms disappeared. Follow-up to date has shown no abnormalities.

[0084] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

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 parts by weight of raw materials: 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 preparation method of 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 them.

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 improve kidney damage in patients with high uric acid.

7. The use according to claim 4, characterized in that: The medicine is in the form of decoction, powder, oral liquid, ointment, pill, granule, tablet or capsule.