Traditional Chinese medicine composition for reducing uric acid and relieving gout as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines for treating gouty arthritis and preparation methods, and particularly relates to a traditional Chinese medicine composition for reducing uric acid and relieving gout, a preparation method and application. Comprising the following components by weight: rhizoma corydalis, cortex phellodendri, rhizoma atractylodis, ephedra, rhizoma smilacis glabrae, gentiana macrophylla, angelica sinensis, peach kernel, caulis sinomenii, cortex acanthopanacis and semen plantaginis, and the cortex phellodendri and the rhizoma atractylodis are subjected to enzymolysis treatment and microbial fermentation treatment to obtain cortex phellodendri-rhizoma atractylodis fermentation liquor. The specific preparation method comprises the following steps: weighing the components, taking out the cortex phellodendri and the rhizoma atractylodis, adding the other components into water of which the volume is 5-8 times of that of the medicinal materials, soaking, then decocting, and after the decoction is completed, cooling liquid medicine and carrying out suction filtration to obtain filtered decoction. And finally, mixing the filtered decoction with the cortex phellodendri-rhizoma atractylodis fermentation liquor to obtain the traditional Chinese medicine composition for reducing uric acid and relieving gout. According to the traditional Chinese medicine composition prepared by the application, through scientific compatibility of monarch, minister, assistant and guide and an enzymolysis-fermentation process, multi-dimensional intervention on pain is realized.

Description

Technical Field

[0001] The present application belongs to the technical field of traditional Chinese medicines for treating gouty arthritis and their preparation methods, and specifically relates to a traditional Chinese medicine composition for lowering uric acid and relieving gout, a preparation method and application. Background Art

[0002] Gout is the most common inflammatory arthritis with a high incidence rate and can induce various serious complications. Its main cause is abnormal purine metabolism or obstructed uric acid excretion, which leads to increased uric acid concentration in the serum and exceeds the solubility, precipitating to form urate crystals that are deposited in the synovial membrane of the joints, cartilage, and other locations, thereby causing inflammation. An appropriate amount of uric acid can act as a powerful antioxidant, scavenging free radicals in the body and protecting cells from oxidative damage. Because uric acid plays a dual role in physiological and pathological processes, the lower the uric acid level in the human body, the better. Therefore, the role of anti-hyperuricemia drugs should focus on maintaining the steady-state balance of uric acid, rather than simply and continuously reducing the blood uric acid concentration.

[0003] Currently, clinical medications for hyperuricemia primarily work by reducing uric acid production or promoting uric acid excretion. Allopurinol lowers blood uric acid levels by inhibiting xanthine oxidase, but it can cause side effects such as gastrointestinal discomfort, liver dysfunction, and rash. Febuxostat, a non-purine xanthine oxidase inhibitor, demonstrates superior efficacy and safety. However, it may cause liver dysfunction, and studies have shown that it may increase the risk of angina, myocardial infarction, and heart failure. Benzbromarone is a highly pharmacologically active benzofuran derivative that primarily works by inhibiting renal tubular uric acid reabsorption. Furthermore, probenecid's primary mechanism of action is to inhibit the uric acid transporter in renal proximal tubular cells, reducing uric acid reabsorption and thereby promoting uric acid excretion, achieving its therapeutic effect for hyperuricemia. However, both drugs require caution regarding potential renal hazards.

[0004] While Western medicine has made significant progress in treating hyperuricemia, achieving rapid results and rapidly reducing pain in some acutely ill patients, satisfactory results remain unsatisfactory for some asymptomatic HUA patients. Traditional Chinese medicine (TCM) classifies gout as a "bi syndrome," which affects the joints, leading to severe joint pain. Traditional Chinese medicine treatments typically focus on clearing heat and dampness, dispelling wind, and unblocking the meridians. Dampness, a yin evil, obstructs Qi flow and impairs Yang. If dampness stagnates in the meridians and flows into the joints, it can cause joint pain, heaviness, and difficulty moving. TCM offers unique advantages in the treatment of gout and hyperuricemia, particularly in minimizing side effects, holistic regulation, and long-term management.

[0005] For example, Chinese patent publication number CN119139405B discloses a Chinese medicine composition for lowering uric acid and relieving gout and its preparation method. This patent uses pure herbal Chinese medicinal materials as raw materials to ensure that the prepared medicine has no toxic side effects while effectively improving the uric acid-lowering effect. Chinese patent publication number CN118615404B discloses a Chinese medicine composition, medicine, preparation method, and application for treating hyperuricemia with hyperlipidemia. It uses a formula of 11 pure Chinese herbal medicines to boil to obtain a uric acid-lowering Chinese medicine extract. Compared with traditional uric acid-lowering drugs, it can quickly reduce serum uric acid while having few side effects. Chinese patent publication number CN118340852B discloses a pharmaceutical composition for treating gouty arthritis and its preparation method and application. It uses 7 Chinese herbal medicines to boil according to a specific compatibility to obtain a Chinese medicine extract. It has a good therapeutic effect on cold-dampness arthritis with a low recurrence rate.

[0006] In summary, it can be seen that traditional Chinese medicine regulates metabolic disorders through multiple components and multiple targets, reduces uric acid while improving organ function, and its safety is significantly better than that of Western medicine. However, in the above technical documents, it is difficult to dissolve all the active ingredients by simply boiling. The traditional methods for improving the active ingredients in the monarch medicine are mainly ultrasonic treatment, enzymatic treatment, microwave treatment, etc., especially in the compatibility of traditional Chinese medicine, the monarch medicine plays an important role. Therefore, it is urgent to propose a traditional Chinese medicine composition for lowering uric acid and relieving gout that is more reasonably compatible and can give full play to the role of the monarch medicine and synergize with other drugs to enhance synergy and reduce toxicity. Summary of the Invention

[0007] In view of the fact that it is difficult to completely dissolve the active ingredients through simple boiling in the existing technology, traditional methods for improving the active ingredients in the monarch drug mainly include ultrasonic treatment, enzymatic hydrolysis, microwave treatment, etc., especially the monarch drug plays an important role in the compatibility of traditional Chinese medicine. Therefore, this application proposes a traditional Chinese medicine composition for lowering uric acid and relieving gout with a more reasonable compatibility, which can fully exert the role of the monarch drug and synergize with other drugs to enhance efficacy and reduce toxicity, as well as a preparation method and application.

[0008] On the one hand, the present application provides a traditional Chinese medicine composition for lowering uric acid and relieving gout, comprising 5-8 parts of Corydalis yanhusuo, 15-20 parts of phellodendron, 15-20 parts of atractylodes, 3-6 parts of ephedra, 12-15 parts of smilax glabra, 5-8 parts of gentiana macrophylla, 5-8 parts of angelica sinensis, 5-8 parts of peach kernel, 5-8 parts of Sinomenium sinomenium, 3-6 parts of acanthopanax cortex and 12-15 parts of plantain seeds.

[0009] The two medicinal materials, Phellodendron chinense and Atractylodes lancea, are firstly subjected to enzymatic hydrolysis and then to microbial fermentation to obtain Phellodendron chinense-Atractylodes lancea fermentation liquid.

[0010] In a specific embodiment, the following components are included by weight: 6 parts of Corydalis yanhusuo, 18 parts of phellodendron, 16 parts of atractylodes, 4 parts of ephedra, 13 parts of smilax glabra, 7 parts of gentiana macrophylla, 6 parts of angelica, 6 parts of peach kernel, 6 parts of Sinomenium sinomenium, 5 parts of acanthopanax bark and 13 parts of plantain seed.

[0011] The two medicinal materials, Phellodendron chinense and Atractylodes lancea, are firstly subjected to enzymatic hydrolysis and then to microbial fermentation to obtain Phellodendron chinense-Atractylodes lancea fermentation liquid.

[0012] In a specific embodiment, the specific method for enzymatic hydrolysis of the two medicinal materials of Phellodendron chinense and Atractylodes lancea is:

[0013] First, use a powder grinder to grind Phellodendron amurense and Atractylodes lancea into powder and sieve. Add the sieved powder into water and boil for 1 to 2 hours. Finally, add cellulase and hydrolyze for 36 to 48 hours. Boil again and remove the solid residue to obtain the enzymatic solution.

[0014] In a specific embodiment, the enzymatic hydrolysis temperature is 45-55° C., and the enzymatic hydrolysis pH is 5.0-6.0.

[0015] In a specific embodiment, the mass ratio of the powder of the pulverized Phellodendron chinense and Atractylodes lancea to water is 1:(5-7); and the added amount of the cellulase is 0.5-0.8% of the mass of the powder of the pulverized Phellodendron chinense and Atractylodes lancea.

[0016] In a specific embodiment, the method of microbial fermentation treatment is:

[0017] Bacillus subtilis (B.subtilis subsp.subtilis) is added to the enzymatic hydrolysate and cultured under aerobic conditions for 48 to 60 hours, then nitrogen is introduced until anaerobic, and then lactic acid bacteria (L.acidophilus) is added, cultured for another 24 to 36 hours, and finally boiled to obtain the Phellodendron amurense-Atractylodes lancea fermentation liquid.

[0018] In a specific embodiment, the aerobic culture temperature is 37±0.5°C, and the pH is 7-8; the anaerobic culture temperature is 32±0.5°C, and the pH is 5-6; the amount of Bacillus subtilis added is 5% of the enzymatic hydrolysate, and the amount of lactic acid bacteria added is 3% of the enzymatic hydrolysate.

[0019] In a second aspect, the present application provides a method for preparing a Chinese medicine composition for lowering uric acid and relieving gout, comprising the following steps:

[0020] Step S1. Weigh 5-8 parts of Corydalis yanhusuo, 15-20 parts of phellodendron, 15-20 parts of atractylodes, 3-6 parts of ephedra, 12-15 parts of smilax glabra, 5-8 parts of gentiana macrophylla, 5-8 parts of angelica sinensis, 5-8 parts of peach kernel, 5-8 parts of Sinomenium sinomenium, 3-6 parts of acanthopanax bark and 12-15 parts of plantain seed in proportion, then remove phellodendron and atractylodes, add the other components to water 5-8 times the volume of the medicinal materials and soak for 2-3 hours, then boil for 2-3 hours. After boiling, wait for the medicinal liquid to cool and filter to obtain a filtered soup.

[0021] Step S2: The filtered soup is mixed with the fermentation liquid of Phellodendron amurense and Atractylodes macrocephala to obtain a Chinese medicinal composition for lowering uric acid and relieving gout.

[0022] In a third aspect, the present application provides an application of a traditional Chinese medicine composition for lowering uric acid and relieving gout, which is used to lower uric acid and relieve gout.

[0023] The functions of each drug component in this application are as follows:

[0024] Corydalis yanhusuo: pungent, dispersing, bitter, purging, warming and unblocking, it enters the liver and spleen meridians. It promotes blood circulation, qi circulation and relieves pain, and is particularly effective in relieving internal and external pain, earning it the title of "essential analgesic."

[0025] Huang Bai: Bitter and cold, enters the kidney and bladder meridians. Clears heat and dampness, purges fire and detoxifies, and reduces fever, especially clearing damp heat in the lower jiao.

[0026] Atractylodes: Pungent, pungent and warm, enters the spleen and stomach meridians. It dries dampness and strengthens the spleen, dispels rheumatism, and is an important medicine for treating dampness blocking the middle jiao.

[0027] Ephedra: Pungent, slightly bitter and warm, enters the lung and bladder meridians. It induces sweating and relieves exterior symptoms, clears the lungs and relieves asthma, promotes diuresis and reduces swelling. It is an important medicine for wind-cold with no sweating.

[0028] Smilax glabra: sweet, mild and neutral, enters the liver and stomach meridians. Detoxifies and removes dampness, promotes joint function, and is good for treating syphilis and damp-heat sores.

[0029] Gentiana macrophylla: bitter, pungent and neutral, enters the stomach, liver and gallbladder meridians. It dispels rheumatism, relaxes tendons and meridians, clears away heat and is used to treat rheumatic pain and heat.

[0030] Angelica sinensis: sweet, pungent and warm, it enters the liver, heart and spleen meridians. It nourishes blood, promotes blood circulation, regulates menstruation and relieves pain, moistens the intestines and promotes bowel movements, and is an important medicine for blood diseases.

[0031] Peach kernel: Bitter, sweet and neutral, enters the heart, liver and large intestine meridians. It promotes blood circulation, removes blood stasis, moistens the intestines and promotes bowel movements. It is good for treating amenorrhea, abdominal masses, lung abscesses and intestinal abscesses.

[0032] Sinomenium sinomenium: bitter, pungent and neutral, enters the liver and spleen meridians. It dispels rheumatism, dredges the meridians, and promotes urination. It is good for treating rheumatic pain and edema.

[0033] Acanthopanax Cortex: Pungent, pungent and warm, enters the Liver and Kidney meridians. It dispels rheumatism, nourishes the liver and kidneys, and strengthens bones and tendons. It is especially suitable for those with chronic rheumatic arthritis and liver and kidney deficiency.

[0034] Plantago seed: sweet and cold, enters the kidney, liver, and lung meridians. It clears heat and promotes urination, dissipates dampness and relieves stranguria, improves eyesight and eliminates phlegm, and is good for treating edema, stranguria, and red and painful eyes.

[0035] Beneficial effects of this application:

[0036] The present application of Cortex Phellodendri and Atractylodes Rhizoma is a total of monarch medicine, Cortex Phellodendri clears away heat and dampness, purges fire and detoxifies, and is especially good at clearing damp-heat in the lower jiao; Cortex Phellodendri enhances the effect of clearing heat and dampness. Smilax glabra and Plantago seed are a total of ministerial medicine, Smilax glabra detoxifies and removes dampness, promotes joint function, and inhibits urate crystal deposition; Plantago seed is a diuretic and stranguria, containing adenine and succinic acid to inhibit purine enzyme activity, reduce uric acid production and promote excretion. Corydalis yanhusuo, Gentiana macrophylla, Caulis sinomenii, Semen persica and Angelica sinensis are a total of adjuvant medicine, Corydalis yanhusuo promotes blood circulation and relieves pain, and has both anti-inflammatory and analgesic effects; Gentiana macrophylla and Caulis sinomenii dispel rheumatism and dredge meridians, Gentiana macrophylla clears deficiency heat, Caulis sinomenii promotes water and reduces swelling, and synergistically relieves joint edema and chronic pain; Semen persica and Angelica sinensis promote blood circulation and removes blood stasis, Semen persica moisturizes the intestines and promotes metabolism, and Angelica sinensis replenishes blood and regulates menstruation, improves blood stasis and microcirculation. Acanthopanax bark and Ephedra are both guiding drugs. Acanthopanax bark can dispel rheumatism, nourish the liver and kidneys, and enhance the ability to repair tendons and bones. It is especially suitable for those with long-term arthritis and liver and kidney deficiency; Ephedra can induce sweating and promote diuresis, and promote the excretion of uric acid.

[0037] The Phellodendron amurense and Atractylodes lancea of the present application are jointly enzymatically hydrolyzed and fermented in two steps. Cellulase decomposes the cell walls of the medicinal materials to release more active ingredients such as flavonoids and alkaloids. The dissolution rate of berberine in Phellodendron amurense and atractylodes lancea in Atractylodes lancea is increased. Bacillus subtilis secretes protease and amylase to decompose large molecules into small molecular active peptides, enhancing the anti-inflammatory effect. Lactic acid bacteria metabolize to produce lactic acid, regulate intestinal flora, and improve drug absorption rate. At the same time, the bitter and cold nature of the medicinal materials is degraded to reduce gastrointestinal irritation. The fermentation products may generate new active metabolites such as short-chain fatty acids, which enhance immune regulation and uric acid excretion functions. Through the step-by-step treatment of enzymatic hydrolysis and fermentation, the bioavailability of the effective ingredients of Phellodendron amurense and Atractylodes lancea is significantly improved, and the medicinal properties are milder, suitable for long-term use.

[0038] In summary, the Chinese medicine composition prepared in this application achieves multi-dimensional intervention on pain through the scientific combination of monarch, minister, assistant and guiding ingredients and the innovation of enzymatic hydrolysis-fermentation process. The synergistic treatment of Phellodendron chinense and Atractylodes macrocephala significantly improves the uric acid-lowering and anti-inflammatory effects, while the addition of medicinal materials such as Corydalis yanhusuo and Smilax glabra further strengthens the balance between acute symptom relief and chronic pathological repair. DETAILED DESCRIPTION

[0039] In order to further illustrate the technical means and effects adopted by this application to achieve the predetermined invention purpose, the specific implementation methods, structures, features and effects of this application are described in detail below in combination with preferred embodiments.

[0040] Example 1

[0041] This embodiment provides a preparation method of a Chinese medicine composition for lowering uric acid and relieving gout, as follows:

[0042] Step 1: Weigh the raw materials

[0043] The following medicinal materials were weighed by weight: 6 parts of Corydalis yanhusuo, 18 parts of phellodendron, 16 parts of atractylodes, 4 parts of ephedra, 13 parts of smilax glabra, 7 parts of gentiana macrophylla, 6 parts of angelica sinensis, 6 parts of peach kernel, 6 parts of Sinomenium sinomenium, 5 parts of acanthopanax bark, and 13 parts of plantain seed.

[0044] Step 2: Enzymatic hydrolysis and crushing of Phellodendron amurense and Atractylodes lancea

[0045] 18 parts of Phellodendron chinense and 16 parts of Atractylodes lancea were crushed with a powder grinder and passed through a 60-mesh sieve to obtain a mixed powder. The mixed powder was mixed with water in a mass ratio of 1:6, boiled for 1.5 hours, then cooled to 50°C, adjusted to pH 5.5, and cellulase (added in an amount of 0.6% of the powder mass) was added. After constant temperature enzymatic hydrolysis for 40 hours, the enzymatic hydrolyzate was boiled for 10 minutes, allowed to stand, and filtered to remove the residue to obtain an enzymatic hydrolyzate.

[0046] Step 3: Microbial fermentation treatment

[0047] Bacillus subtilis was added to the enzymatic hydrolysate (5% of the volume of the enzymatic hydrolysate), and cultured with shaking at 37°C and pH 7.5 for 55 hours. Nitrogen was then introduced to displace oxygen, and lactic acid bacteria were added (3% of the volume of the enzymatic hydrolysate). Cultured with shaking at 32°C and pH 5.5 for 30 hours. The fermentation broth was boiled for 15 minutes, cooled, and filtered to obtain a Phellodendron amurense-Atractylodes lancea fermentation broth.

[0048] Step 4: Decoction of other herbs

[0049] Add 7 times the volume of water to 6 parts of Corydalis yanhusuo, 18 parts of phellodendron, 16 parts of atractylodes, 4 parts of ephedra, 13 parts of smilax glabra, 7 parts of gentiana macrophylla, 6 parts of angelica sinensis, 6 parts of peach kernel, 6 parts of Sinomenium sinomenium, 5 parts of acanthopanax cortex, and 13 parts of plantain seeds, soak for 2.5 hours, then boil and simmer for 2.5 hours, cool to room temperature, and filter to obtain a filtered soup.

[0050] Step 5: Mix the filtered soup with the Phellodendron amurense-Atractylodes lancea fermentation liquid to obtain the Chinese medicine composition.

[0051] Example 2

[0052] This embodiment provides a preparation method of a Chinese medicine composition for lowering uric acid and relieving gout, as follows:

[0053] Step 1: Weigh the raw materials

[0054] The following medicinal materials were weighed by weight: 5 parts of Corydalis yanhusuo, 18 parts of phellodendron, 16 parts of atractylodes, 4 parts of ephedra, 15 parts of smilax glabra, 5 parts of gentiana macrophylla, 6 parts of angelica sinensis, 6 parts of peach kernel, 5 parts of Sinomenium sinomenium, 5 parts of acanthopanax cortex, and 13 parts of plantain seeds.

[0055] Step 2: Enzymatic hydrolysis and crushing of Phellodendron amurense and Atractylodes lancea

[0056] 18 parts of Phellodendron chinense and 16 parts of Atractylodes lancea were crushed with a powder grinder and passed through a 60-mesh sieve to obtain a mixed powder. The mixed powder was mixed with water in a mass ratio of 1:5, boiled for 2 hours, then cooled to 55°C, adjusted to pH 6.0, and cellulase (added in an amount of 0.5% of the powder mass) was added. After constant temperature enzymolysis for 48 hours, the enzymatic hydrolysis solution was boiled for 10 minutes, allowed to stand, and filtered to remove residue to obtain an enzymatic hydrolysis solution.

[0057] Step 3: Microbial fermentation treatment

[0058] Bacillus subtilis was added to the enzymatic hydrolysate (5% of the volume of the enzymatic hydrolysate), and cultured with shaking at 37°C and pH 7 for 48 hours. Nitrogen was then introduced to replace oxygen, and lactic acid bacteria were added (3% of the volume of the enzymatic hydrolysate). Cultured with shaking at 32°C and pH 6 for 36 hours. The fermentation broth was boiled for 15 minutes, cooled, and filtered to obtain a Phellodendron amurense-Atractylodes lancea fermentation broth.

[0059] Step 4: Decoction of other herbs

[0060] Add 5 to 8 times the volume of water to 6 parts of Corydalis yanhusuo, 18 parts of phellodendron, 16 parts of atractylodes, 4 parts of ephedra, 13 parts of smilax glabra, 7 parts of gentiana macrophylla, 6 parts of angelica sinensis, 6 parts of peach kernel, 6 parts of Sinomenium sinomenium, 5 parts of acanthopanax cortex, and 13 parts of plantain seeds, soak for 2.5 hours, then boil and simmer for 2 to 3 hours, cool to room temperature, and filter to obtain a filtered soup.

[0061] Step 5: Mix the filtered soup with the Phellodendron amurense-Atractylodes lancea fermentation liquid to obtain the Chinese medicine composition.

[0062] Example 3

[0063] This embodiment provides a preparation method of a Chinese medicine composition for lowering uric acid and relieving gout, as follows:

[0064] Step 1: Weigh the raw materials

[0065] The following medicinal materials were weighed by weight: 8 parts of Corydalis yanhusuo, 15 parts of phellodendron, 20 parts of atractylodes, 3 parts of ephedra, 15 parts of smilax glabra, 8 parts of gentiana macrophylla, 5 parts of angelica sinensis, 5 parts of peach kernel, 5 parts of Sinomenium sinomenium, 3 parts of acanthopanax bark, and 13 parts of plantain seed.

[0066] Step 2: Enzymatic hydrolysis and crushing of Phellodendron amurense and Atractylodes lancea

[0067] 15 parts of Phellodendron chinense and 20 parts of Atractylodes lancea were crushed with a powder grinder and passed through a 60-mesh sieve to obtain a mixed powder. The mixed powder was mixed with water in a mass ratio of 1:7, boiled for 1 hour, then cooled to 45°C, adjusted to pH 6.0, and cellulase (added in an amount of 0.8% of the powder mass) was added. After constant temperature enzymatic hydrolysis for 1 hour, the enzymatic hydrolyzate was boiled for 10 minutes, allowed to stand, and filtered to remove the residue to obtain an enzymatic hydrolyzate.

[0068] Step 3: Microbial fermentation treatment

[0069] Bacillus subtilis was added to the hydrolyzate (5% of the volume of the hydrolyzate), and cultured with shaking at 37°C and pH 8 for 60 hours. Nitrogen was then introduced to displace oxygen, and lactic acid bacteria were added (3% of the volume of the hydrolyzate). Cultured with shaking at 32°C and pH 5 for 24 hours. The fermentation broth was boiled for 15 minutes, cooled, and filtered to obtain the Phellodendron amurense-Atractylodes lancea fermentation broth.

[0070] Step 4: Decoction of other herbs

[0071] Add 6 parts of Corydalis yanhusuo, 18 parts of phellodendron, 16 parts of atractylodes, 4 parts of ephedra, 13 parts of smilax glabra, 7 parts of gentiana macrophylla, 6 parts of angelica sinensis, 6 parts of peach kernel, 6 parts of sinomenine root, 5 parts of acanthopanax cortex, and 13 parts of plantain seeds, soak in 6 times the volume of water for 2.5 hours, then boil and simmer for 3 hours, cool to room temperature, and filter to obtain a filtered soup.

[0072] Step 5: Mix the filtered soup with the Phellodendron amurense-Atractylodes lancea fermentation liquid to obtain the Chinese medicine composition.

[0073] Example 4

[0074] This embodiment provides a preparation method of a Chinese medicine composition for lowering uric acid and relieving gout, as follows:

[0075] Step 1: Weigh the raw materials

[0076] The following medicinal materials were weighed by weight: 5 parts of Corydalis yanhusuo, 15 parts of phellodendron, 15 parts of atractylodes, 6 parts of ephedra, 12 parts of smilax glabra, 5 parts of gentiana macrophylla, 8 parts of angelica sinensis, 8 parts of peach kernel, 8 parts of Sinomenium sinomenium, 6 parts of acanthopanax cortex, and 12 parts of plantain seed.

[0077] Step 2: Enzymatic hydrolysis and crushing of Phellodendron amurense and Atractylodes lancea

[0078] 15 parts of Phellodendron chinense and 15 parts of Atractylodes lancea were crushed with a powder grinder and passed through a 60-mesh sieve to obtain a mixed powder. The mixed powder was mixed with water in a mass ratio of 1:6, boiled for 2 hours, then cooled to 50°C, adjusted to pH 5.0, and cellulase (added in an amount of 0.7% of the powder mass) was added. After constant temperature enzymolysis for 45 hours, the enzymatic hydrolysis solution was boiled for 10 minutes, allowed to stand, and filtered to remove the residue to obtain an enzymatic hydrolysis solution.

[0079] Step 3: Microbial fermentation treatment

[0080] Bacillus subtilis was added to the hydrolyzate (5% of the volume of the hydrolyzate), and cultured with shaking at 37°C and pH 8 for 50 hours. Nitrogen was then introduced to replace oxygen, and lactic acid bacteria were added (3% of the volume of the hydrolyzate). Cultured with shaking at 32°C and pH 6 for 32 hours. The fermentation broth was boiled for 15 minutes, cooled, and filtered to obtain the Phellodendron amurense-Atractylodes lancea fermentation broth.

[0081] Step 4: Decoction of other herbs

[0082] Add 6 parts of Corydalis yanhusuo, 18 parts of phellodendron, 16 parts of atractylodes, 4 parts of ephedra, 13 parts of smilax glabra, 7 parts of gentiana macrophylla, 6 parts of angelica sinensis, 6 parts of peach kernel, 6 parts of sinomenine root, 5 parts of acanthopanax cortex, and 13 parts of plantain seeds, soak in 5 times the volume of water for 2.5 hours, then boil and simmer for 2 hours, cool to room temperature, and filter to obtain a filtered soup.

[0083] Step 5: Mix the filtered soup with the Phellodendron amurense-Atractylodes lancea fermentation liquid to obtain the Chinese medicine composition.

[0084] Example 5

[0085] This embodiment provides a preparation method of a Chinese medicine composition for lowering uric acid and relieving gout, as follows:

[0086] Step 1: Weigh the raw materials

[0087] The following medicinal materials were weighed by weight: 6 parts of Corydalis yanhusuo, 20 parts of phellodendron amurense, 16 parts of atractylodes, 3 parts of ephedra, 13 parts of smilax glabra, 6 parts of gentiana macrophylla, 5 parts of angelica sinensis, 6 parts of peach kernel, 5 parts of Sinomenium sinomenium, 5 parts of acanthopanax cortex, and 15 parts of plantain seeds.

[0088] Step 2: Enzymatic hydrolysis and crushing of Phellodendron amurense and Atractylodes lancea

[0089] 20 parts of Phellodendron chinense and 16 parts of Atractylodes lancea were crushed with a powder grinder and passed through a 60-mesh sieve to obtain a mixed powder. The mixed powder was mixed with water in a mass ratio of 1:6, boiled for 1.5 hours, then cooled to 50°C, adjusted to pH 6.0, and cellulase (added in an amount of 0.6% of the powder mass) was added. After constant temperature enzymatic hydrolysis for 40 hours, the enzymatic hydrolyzate was boiled for 10 minutes, allowed to stand, and filtered to remove the residue to obtain an enzymatic hydrolyzate.

[0090] Step 3: Microbial fermentation treatment

[0091] Bacillus subtilis was added to the hydrolyzate (5% of the volume of the hydrolyzate), and cultured with shaking at 37°C and pH 8 for 55 hours. Nitrogen was then introduced to replace oxygen, and lactic acid bacteria were added (3% of the volume of the hydrolyzate). Cultured with shaking at 32°C and pH 6 for 35 hours. The fermentation broth was boiled for 15 minutes, cooled, and filtered to obtain a Phellodendron amurense-Atractylodes lancea fermentation broth.

[0092] Step 4: Decoction of other herbs

[0093] Add 8 times the volume of water to 6 parts of Corydalis yanhusuo, 18 parts of phellodendron, 16 parts of atractylodes, 4 parts of ephedra, 13 parts of smilax glabra, 7 parts of gentiana macrophylla, 6 parts of angelica sinensis, 6 parts of peach kernel, 6 parts of sinomenine root, 5 parts of acanthopanax cortex, and 13 parts of plantain seeds, soak for 2.5 hours, then boil and simmer for 3 hours, cool to room temperature, and filter to obtain a filtered soup.

[0094] Step 5: Mix the filtered soup with the Phellodendron amurense-Atractylodes lancea fermentation liquid to obtain the Chinese medicine composition.

[0095] Comparative Example 1

[0096] The difference between this comparative example and Example 1 is that the Phellodendron amurense and Atractylodes lancea in this comparative example are directly fermented without being enzymatically hydrolyzed.

[0097] Comparative Example 2

[0098] The difference between this comparative example and Example 1 is that the Phellodendron amurense and Atractylodes lancea in this comparative example are not subjected to biological fermentation after enzymatic hydrolysis.

[0099] Comparative Example 3

[0100] The difference between this comparative example and Example 1 is that the Phellodendron amurense and Atractylodes lancea in this comparative example are not subjected to enzymatic hydrolysis and biological fermentation, but are directly boiled with other components.

[0101] Comparative Example 4

[0102] The difference between this comparative example and Example 1 is that in this comparative example, Phellodendron amurense and Atractylodes lancea are subjected to separate enzymatic hydrolysis and biological fermentation.

[0103] Comparative Example 5

[0104] The difference between this comparative example and Example 1 is that no Phellodendron chinense was added in this comparative example.

[0105] Comparative Example 6

[0106] The difference between this comparative example and Example 1 is that no Atractylodes lancea was added in this comparative example.

[0107] Mouse test example

[0108] All animal experiments and procedures involved in this study were in compliance with the relevant laws and regulations on the use and management of experimental animals and the relevant regulations of the Institutional Animal Care and Use Committee (IACUC) of this center. Seventy-five male mice with an average body weight of 160 g were purchased and housed normally for one week to allow the mice to adapt. Seventy healthy male mice were selected and randomly divided into 14 groups, each numbered. The first group was the control group (the control group was fed only 15 g of normal feed per day), the second group was the model group (fed 15 g of high-purine feed per day), the third to seventh groups were the example groups (fed 15 g of high-purine feed per day), the eighth to thirteenth groups were the comparative groups (fed 15 g of high-purine feed per day), and the fourteenth group was the febuxostat group (fed 15 g of high-purine feed per day). In addition, each rat in the second to fourteenth groups was given 2 mL of the corresponding drug by gavage every day for 28 days. The mice were measured to obtain serum, and the uric acid data in the serum was measured. The average value of the data for each group was calculated and recorded. The experimental results are shown in Table 1.

[0109] Table 1

[0110] sample Serum uric acid level (μmol / L) Group 1 56.79 Group 2 98.15 Group 3 50.14 Group 4 52.87 Group 5 50.98 Group 6 51.44 Group 7 51.39 Group 8 66.34 Group 9 65.17 Group 10 69.48 Group 11 64.98 Group 12 72.09 Group 13 71.49 Group 14 48.57

[0111] Case test example

[0112] This test case is all outpatient, according to outpatient actual patient situation, screening asymptomatic hyperuricemia combined with hyperlipidemia patients 54 examples (no other complications), randomly divided into 6 groups, each group of 9 examples, no gender requirement, age 18 to 60 years old, but because the disease has the characteristics of more male than female patients, so the patients who receive treatment are more male than female. Control group: take Febuxostat, 1 time a day, each 20mg, taken before breakfast. The experimental group takes the medicine prepared by Examples 1 to 5 respectively, morning and evening warm, each 200mL, and is recorded as Experiment 1 group to Experiment 5 group successively. The above treatment regimen is all 1 month as a course of treatment, and the drug is discontinued after taking 3 courses of treatment. Wherein the patient is receiving treatment, ensure at least 2 hours of exercise every day, adjust the diet structure, and avoid the intake of high oil, high salt, high purine food. Test the index of patient's blood uric acid, the result is as shown in Table 2.

[0113] Table 2

[0114]

[0115] By the above-mentioned mice embodiment and pathological experiment, it can be seen that on the one hand, the important composition of the present application is reasonably compatible, and Phellodendron chinense and Atractylodes macrocephala are monarch drugs in total, and Phellodendron chinense clears away heat and dampness, purges fire and detoxifies, and is especially good at clearing damp-heat in the lower jiao; Phellodendron chinense enhances heat-clearing and damp-removing effect. Smilax glabra and Plantago seed are ministerial drugs in total, and Smilax glabra detoxifies and removes dampness, promotes joint function, and inhibits urate crystal deposition; Plantago seed is diuretic and relieves stranguria, and contains adenine and succinic acid to inhibit purine enzyme activity, reduces uric acid generation and promotes excretion. Corydalis yanhusuo, Gentiana macrophylla, Caulis sinomenii, Semen persicae and Angelica sinensis are adjuvant drugs in total, and Corydalis yanhusuo promotes blood circulation and relieves pain, and has anti-inflammatory and analgesic effects concurrently; Gentiana macrophylla and Caulis sinomenii dispel rheumatism, dredge meridians, Gentiana macrophylla clears deficiency heat, Caulis sinomenii promotes water excretion and reduces swelling, and works together to relieve joint edema and chronic pain; Semen persicae and Angelica sinensis promote blood circulation and remove blood stasis, and Semen persicae moistens the intestines and promotes metabolism, and Angelica sinensis replenishes blood and regulates menstruation, improves blood stasis and microcirculation. Acanthopanax cortex and ephedra are both guiding drugs. Acanthopanax cortex dispels rheumatism, nourishes the liver and kidneys, and enhances the ability to repair tendons and bones. It is especially suitable for those with long-term arthritis and liver and kidney deficiency; ephedra induces sweating and promotes diuresis, promoting uric acid excretion. On the other hand, the present application's Phellodendron chinense and Atractylodes macrocephala are combined with enzymatic hydrolysis and two-step fermentation. Cellulase decomposes the cell walls of the medicinal materials, releasing more active ingredients such as flavonoids and alkaloids. The dissolution rate of berberine in Phellodendron chinense and atractylodes ketone in Atractylodes macrocephala is increased. Bacillus subtilis secretes protease and amylase to decompose macromolecules into small molecular active peptides, enhancing anti-inflammatory effects. Lactic acid bacteria metabolize to produce lactic acid, regulate intestinal flora, and improve drug absorption rate. At the same time, the bitter and cold nature of the medicinal materials is degraded to reduce gastrointestinal irritation. The fermentation products may generate new active metabolites such as short-chain fatty acids, which enhance immune regulation and uric acid excretion functions. Through the step-by-step treatment of enzymatic hydrolysis and fermentation, the bioavailability of the effective ingredients of Phellodendron chinense and Atractylodes macrocephala is significantly improved, and the medicinal properties are milder, suitable for long-term use.

[0116] The above description is merely a preferred embodiment of the present application and does not constitute any form of limitation to the present application. Although the present application has been disclosed as above with preferred embodiments, it is not intended to limit the present application. Any person skilled in the art can make some changes or modifications to equivalent embodiments using the technical contents disclosed above without departing from the scope of the technical solution of the present application. However, any brief modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present application without departing from the content of the technical solution of the present application are still within the scope of the technical solution of the present application.

Claims

1. A Chinese medicine composition for lowering uric acid and relieving gout, characterized in that: The invention comprises the following components by weight: 5-8 parts of Corydalis yanhusuo, 15-20 parts of phellodendron, 15-20 parts of atractylodes, 3-6 parts of ephedra, 12-15 parts of smilax glabra, 5-8 parts of gentiana macrophylla, 5-8 parts of angelica sinensis, 5-8 parts of peach kernel, 5-8 parts of Sinomenium sinomenium, 3-6 parts of acanthopanax cortex and 12-15 parts of plantain seed. The two medicinal materials, Phellodendron chinense and Atractylodes lancea, are firstly subjected to enzymatic hydrolysis and then to microbial fermentation to obtain Phellodendron chinense-Atractylodes lancea fermentation liquid.

2. A Chinese medicine composition for lowering uric acid and relieving gout according to claim 1, characterized in that: The invention comprises the following components by weight: 6 parts of Corydalis yanhusuo, 18 parts of phellodendron, 16 parts of atractylodes, 4 parts of ephedra, 13 parts of smilax glabra, 7 parts of gentiana macrophylla, 6 parts of angelica sinensis, 6 parts of peach kernel, 6 parts of Sinomenium sinomenium, 5 parts of acanthopanax cortex and 13 parts of plantain seed.

3. A Chinese medicine composition for lowering uric acid and relieving gout according to claim 1, characterized in that: The specific method for enzymatic hydrolysis of the two medicinal materials of Phellodendron chinense and Atractylodes lancea is as follows: First, use a powder grinder to grind Phellodendron amurense and Atractylodes lancea into powder and sieve. Add the sieved powder into water and boil for 1 to 2 hours. Finally, add cellulase and hydrolyze for 36 to 48 hours. Boil again and remove the solid residue to obtain the enzymatic solution.

4. A Chinese medicine composition for lowering uric acid and relieving gout according to claim 3, characterized in that: The enzymatic hydrolysis temperature is 45-55° C., and the enzymatic hydrolysis pH value is 5.0-6.

0.

5. A Chinese medicine composition for lowering uric acid and relieving gout according to claim 3, characterized in that: The mass ratio of the powder of the pulverized Phellodendron chinense and Atractylodes lancea to water is 1:(5-7); and the added amount of the cellulase is 0.5-0.8% of the mass of the powder of the pulverized Phellodendron chinense and Atractylodes lancea.

6. A Chinese medicine composition for lowering uric acid and relieving gout according to claim 3, characterized in that: The method of microbial fermentation treatment is: Bacillus subtilis is added to the enzymatic hydrolysate and cultured under aerobic conditions for 48 to 60 hours, then nitrogen is introduced until anaerobic, and then lactic acid bacteria is added, cultured for 24 to 36 hours, and finally boiled to obtain the Phellodendron amurense-Atractylodes lancea fermentation liquid.

7. A Chinese medicine composition for lowering uric acid and relieving gout according to claim 6, characterized in that: The temperature of the aerobic culture is 37±0.5°C, and the pH is 7-8; the temperature of the anaerobic culture is 32±0.5°C, and the pH is 5-6; the amount of Bacillus subtilis added is 5% of the enzymatic hydrolysate, and the amount of lactic acid bacteria added is 3% of the enzymatic hydrolysate.

8. A method for preparing a Chinese medicinal composition for lowering uric acid and relieving gout according to any one of claims 1 to 7, characterized in that: The steps include: Step S1. Weigh 5-8 parts of Husuo, 15-20 parts of Huangbai, 15-20 parts of Atractylodes, 3-6 parts of Ephedra, 12-15 parts of Smilax glabra, 5-8 parts of Gentiana macrophylla, 5-8 parts of Angelica sinensis, 5-8 parts of Peach Kernel, 5-8 parts of Sinomenium sinomenium, 3-6 parts of Acanthopanax Cortex and 12-15 parts of Plantago seed in proportion, then remove Huangbai and Atractylodes, add the other components into water 5 to 8 times the volume of the medicinal materials and soak for 2-3 hours, then boil for 2-3 hours. After boiling, wait for the medicinal liquid to cool and filter to obtain a filtered soup. Step S2: The filtered soup is mixed with the fermentation liquid of Phellodendron amurense and Atractylodes macrocephala to obtain a Chinese medicinal composition for lowering uric acid and relieving gout.

9. Use of a traditional Chinese medicine composition for lowering uric acid and relieving gout according to any one of claims 1 to 7, characterized in that: Used to lower uric acid and relieve gout.

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