A high altitude gout fermentation oral liquid traditional Chinese medicine preparation and a preparation method and application thereof

Abstract

The present application belongs to the technical field of traditional Chinese medicine compound fermentation preparation, and relates to a kind of highland gout fermentation drink oral liquid traditional Chinese medicine preparation and its preparation method and application.The preparation is composed of 14 kinds of traditional Chinese medicinal materials, such as ginseng, astragalus, ophiopogon, schisandra, rhodiola, gynostemma, chicory, smilax glabra, phragmites communis, giant knotweed, salvia miltiorrhiza, gentiana, radix puerariae and lily, and is prepared by ganoderma lucidum fungus composite biological fermentation process.The preparation has the core functions of tonifying primordial qi, invigorating spleen and lung, ascending clear and descending turbid, resolving stasis and detoxifying, and dredging collaterals and relieving pain, and is suitable for improving the clinical symptoms of high uric acid, hyperlipidemia and gout of highland population.The present application adopts high-speed homogenate extraction-ganoderma lucidum fungus directional fermentation-low temperature concentration-microemulsion homogenization integrated process, has the characteristics of sufficient extraction of medicinal efficacy substances, suitable taste, stable system without stratification, etc.;compared with traditional extraction preparation process, the process can improve the utilization rate of medicinal materials by 50%-75%, and the preparation has good safety.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine compound fermentation preparation technology, and relates to a traditional Chinese medicine preparation of high-altitude gout fermentation oral liquid, its preparation method and application. Background Technology

[0002] The information disclosed in this background section is intended only to enhance understanding of the overall background of the invention and is not necessarily to be construed as an admission or in any way implying that such information constitutes prior art known to those skilled in the art.

[0003] In a medical sense, high-altitude areas refer to plateaus or high-altitude regions above 2500 m, characterized by low pressure, low oxygen, low temperature, large diurnal temperature range, frequent sandstorms, and dry air. Local residents generally consume high-purine (animal organs) and high-protein foods and frequently drink alcohol. This unique geographical environment and dietary structure lead to a significantly increased prevalence of hyperuricemia and gout. Modern research indicates that the high-altitude environment is a contributing factor to hyperuricemia: low oxygen can cause problems such as increased red blood cell count, kidney damage, and competition for high blood lactate levels, affecting uric acid excretion, leading to elevated blood uric acid levels, and subsequently triggering diseases such as gout. Analysis of the disease spectrum of individuals undergoing high-altitude deacclimatization from 2019 to 2022 revealed that endocrine, nutritional, and metabolic diseases accounted for over 50%, ranking first; among these, hyperuricemia and hyperlipoproteinemia ranked first and second, respectively. Currently, there are no effective methods for the prevention and treatment of metabolic diseases (especially hyperuricemia) in high-altitude environments, and further research is needed on their underlying mechanisms and therapeutic targets. In the treatment of metabolic diseases at high altitudes, the integration of traditional Chinese and Western medicine has shown good results in prevention, treatment, and prognosis. Meanwhile, modern conventional extraction processes have drawbacks such as low utilization rate of medicinal materials, difficulty in absorbing large molecular components, poor taste, and gastrointestinal irritation. Summary of the Invention

[0004] To address the shortcomings of existing technologies, the purpose of this invention is to provide a traditional Chinese medicine preparation for high-altitude gout fermentation oral liquid, its preparation method, and its application. This invention achieves a high-efficiency enhancement of the efficacy of high-altitude gout fermentation oral liquid preparation through processes such as Ganoderma lucidum biotransformation, high-speed homogenization, low-temperature concentration, and microemulsification homogenization. At the same time, it has the characteristics of smooth taste, zero additives, and stable non-layering, thus filling the gap in existing technologies.

[0005] To achieve the above objectives, the technical solution of the present invention is as follows: Firstly, a traditional Chinese medicine preparation for treating gout in high-altitude areas, which is made from medicinal materials through biological fermentation with Ganoderma lucidum; the medicinal materials are composed of the following raw materials in parts by weight: ginseng 3-9 parts, astragalus 15-35 parts, ophiopogon japonicus 5-15 parts, schisandra chinensis 5-10 parts, rhodiola rosea 5-15 parts, gynostemma pentaphyllum 10-25 parts, chicory 10-15 parts, smilax glabra 15-30 parts, dioscorea hypoglauca 10-15 parts, polygonum cuspidatum 10-15 parts, salvia miltiorrhiza 5-15 parts, gentiana macrophylla 5-15 parts, kudzu root 10-20 parts, and lily bulb 10-15 parts.

[0006] The functions and indications of the traditional Chinese medicine preparation of fermented oral liquid for gout in high-altitude areas provided by this invention are as follows: Efficacy: Greatly replenishes vital energy, strengthens the spleen and lungs, promotes the upward movement of clear qi and the downward movement of turbid qi, removes blood stasis and detoxifies, and unblocks meridians and relieves pain.

[0007] Indications: This treatment is suitable for gout and hyperuricemia in high-altitude areas that are due to deficiency of vital energy, cold stagnation and blood stasis, and internal dampness and turbidity. Common symptoms include recurrent joint swelling and pain, difficulty in flexion and extension, fatigue, abdominal distension, light yellow urine, and abnormal Qi circulation. Other symptoms include dizziness, chest tightness, palpitations, purplish tongue, white and greasy tongue coating, and engorged sublingual veins, which are signs of phlegm and blood stasis.

[0008] Explanation of the formula for the traditional Chinese medicine preparation of fermented oral liquid for gout in high-altitude areas provided by this invention: The Shennong's Classic of Materia Medica records that ginseng "primarily nourishes the five internal organs and eliminates pathogenic factors," while the Golden Mirror of Medicine states that "nothing is better than ginseng for replenishing acquired qi," and the Record of Integrating Chinese and Western Medicine states that astragalus "treats the sinking of ancestral qi." When ginseng and astragalus are combined, they can greatly replenish the ancestral qi of the heart and lungs, as well as the acquired qi of the spleen and stomach, serving as the principal herbs.

[0009] The selected herbs are Ophiopogon japonicus, Schisandra chinensis, and Rhodiola rosea. These three herbs invigorate qi and moisten the lungs, which not only help the principal herbs to enhance their effect of replenishing vital qi, but also nourish yin. The Shennong Bencao Jing states that Ophiopogon japonicus "treats emaciation and shortness of breath," Schisandra chinensis "treats qi and replenishes deficiencies," and the Annotated Shennong Bencao Jing states that Rhodiola rosea "treats various deficiencies."

[0010] The adjuvant herbs include multiple combinations: Gynostemma pentaphyllum and chicory clear heat and detoxify while also tonifying deficiency; when combined with kudzu root, they can promote the upward movement of clear qi and downward movement of turbid qi. Chicory can inhibit uric acid production, promote excretion, and also strengthen the stomach and aid digestion. Smilax glabra and Dioscorea hypoglauca detoxify, remove dampness, reduce turbidity, and relieve joint pain; when combined with Gentiana macrophylla, which can dispel cold and clear heat—the *Shennong Bencao Jing* states that Gentiana macrophylla "treats cold and heat evil qi" and is good at dispelling wind and relieving pain; Polygonum cuspidatum and Salvia miltiorrhiza clear heat, resolve stasis, remove turbidity, relax muscles and tendons, and relieve pain. The combination of Gynostemma pentaphyllum, kudzu root, Gentiana macrophylla, Polygonum cuspidatum, and Salvia miltiorrhiza works synergistically to promote the upward movement of clear qi and downward movement of turbid qi, detoxify, remove dampness, resolve stasis, and relieve pain.

[0011] The herb is lily. According to the "Collected Annotations on Materia Medica", it "promotes urination and defecation, replenishes the middle and benefits qi, and treats pain throughout the body". It can guide the medicine into the lung meridian and spread throughout the body to clear acid toxins.

[0012] The combination of these herbs works synergistically to replenish vital energy, strengthen the spleen and lungs, promote the upward movement of clear qi and downward movement of turbid qi, resolve blood stasis and detoxify, and unblock the meridians and relieve pain.

[0013] This invention utilizes the metabolic capabilities of Ganoderma lucidum fungi to biotransform traditional Chinese medicinal materials, thereby enhancing efficacy, reducing toxicity, or expanding functionality. Ganoderma lucidum fungi secrete various extracellular enzymes, such as cellulase, hemicellulase, and protease, to break down macromolecules in traditional Chinese medicinal materials, such as cellulose, lignin, and proteins, into smaller sugars and amino acids, while simultaneously modifying the structure of complex chemical components. During metabolism, Ganoderma lucidum fungi can synthesize new secondary metabolites, creating synergistic effects with the original components of the traditional Chinese medicinal materials. Regarding polysaccharides and triterpenoids, Ganoderma lucidum mycelium synthesizes large amounts of active ingredients such as β-glucan and ganoderic acid during fermentation, while simultaneously promoting the release of similar components from the traditional Chinese medicinal materials. Regarding the synergistic effects of enzymatic hydrolysis products, for example, laccase secreted by Ganoderma lucidum can catalyze the oxidative polymerization of polyphenols in the traditional Chinese medicinal materials, generating new compounds with stronger antioxidant activity. Furthermore, through biotransformation by Ganoderma lucidum fungi, macromolecules such as cellulose and proteins can be decomposed, increasing the dissolution rate and activity of gastrodin, total flavonoids, and total polysaccharides, thus achieving enhanced efficacy and reduced toxicity.

[0014] Secondly, a method for preparing the traditional Chinese medicine preparation of the fermented oral liquid for gout in high-altitude areas as described in the first aspect of the present invention includes the following steps: The raw materials are crushed into raw material powder; Water is added to the raw material powder, and the mixture is heated to 95-100°C for extraction. Shear emulsification is performed during the extraction process. Centrifuge and filter the extracted material, and collect the supernatant; The supernatant was added to the fermentation medium of Ganoderma lucidum and sterilized; then the Ganoderma lucidum inoculum was inoculated and fermented. The fermented material is emulsified, cell walls broken, and homogenized.

[0015] The preparation method of this invention involves shearing and emulsification during the extraction process, which not only allows for complete extraction but also preserves the active ingredients. The fermented material is emulsified, cell walls are broken and homogenized to achieve microemulsification, resulting in a product with zero additives, no layering, and a good taste.

[0016] Thirdly, the application of a traditional Chinese medicine preparation of the fermented oral liquid for gout in high-altitude areas as described in the first aspect of the present invention in the preparation of a drug to improve the symptoms of hyperuricemia, hyperlipidemia or gout in people living in high-altitude areas.

[0017] The beneficial effects of this invention are as follows: 1. The traditional Chinese medicine preparation of fermented oral liquid for gout in high-altitude areas provided by this invention uses ginseng and astragalus as the principal herbs, ophiopogon japonicus, schisandra chinensis, and rhodiola rosea as the assistant herbs, gynostemma pentaphyllum, chicory, smilax glabra, dioscorea hypoglauca, gentiana macrophylla, polygonum cuspidatum, salvia miltiorrhiza, and kudzu root as adjuvant herbs, and lily bulb as the guiding herb. The combination of these herbs works synergistically to replenish vital energy, strengthen the spleen and lungs, promote the upward movement of clear qi and downward movement of turbid qi, resolve blood stasis and detoxify, and unblock the meridians and relieve pain. It can be used for the prevention and treatment of gout and hyperuricemia in high-altitude areas.

[0018] 2. This invention utilizes Ganoderma lucidum bio-fermentation to biotransform medicinal materials, which not only accelerates the absorption and metabolism of the active ingredients in the body, improving bioavailability and enhancing efficacy; but also reduces the irritation of the drug to the gastrointestinal tract, lowering the burden on the gastrointestinal tract and reducing toxic side effects; it also adds the efficacy of high-grade Ganoderma lucidum, thus enhancing the prescription.

[0019] 3. The preparation method provided by the present invention can save 50% to 75% of raw medicinal materials, improve the utilization rate of medicinal materials, reduce production costs, and significantly improve the taste of the product. Attached Figure Description

[0020] The accompanying drawings, which form part of this invention, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an improper limitation of the invention.

[0021] Figure 1 This is a graph showing the effect of the traditional Chinese medicine preparation of the plateau gout fermented oral liquid on serum indicators in rats with hyperuricemia and chronic functional constipation (dampness obstruction and qi stagnation type) in the experimental examples of this invention; compared with the CON group. * P <0.05, ** P <0.01, *** P <0.001; compared to the MOD group, # P <0.05, ## P <0.01, ### P <0.001. Detailed Implementation

[0022] It should be noted that the following detailed descriptions are exemplary and intended to provide further illustration of the invention. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0023] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of exemplary embodiments according to the invention. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0024] A typical embodiment of the present invention provides a traditional Chinese medicine preparation for fermented oral liquid for gout in high-altitude areas, which is made from medicinal materials through biological fermentation by Ganoderma lucidum. The medicinal materials are composed of the following raw materials in parts by weight: ginseng 3-9 parts, astragalus 15-35 parts, ophiopogon japonicus 5-15 parts, schisandra chinensis 5-10 parts, rhodiola rosea 5-15 parts, gynostemma pentaphyllum 10-25 parts, chicory 10-15 parts, smilax glabra 15-30 parts, dioscorea hypoglauca 10-15 parts, polygonum cuspidatum 10-15 parts, salvia miltiorrhiza 5-15 parts, gentiana macrophylla 5-15 parts, kudzu root 10-20 parts, and lily bulb 10-15 parts.

[0025] In some embodiments, the medicinal materials are composed of the following raw materials in parts by weight: ginseng 4-6 parts, astragalus 25-35 parts, ophiopogon japonicus 8-12 parts, schisandra chinensis 5-7 parts, rhodiola rosea 10-15 parts, gynostemma pentaphyllum 20-25 parts, chicory 13-15 parts, smilax glabra 15-20 parts, dioscorea hypoglauca 13-15 parts, polygonum cuspidatum 10-12 parts, salvia miltiorrhiza 8-12 parts, gentiana macrophylla 8-12 parts, kudzu root 15-20 parts, and lily bulb 13-15 parts.

[0026] In some embodiments, the medicinal materials are composed of the following raw materials in parts by weight: ginseng 4.5-5.5 parts, astragalus 23-35 parts, ophiopogon japonicus 9-11 parts, schisandra chinensis 5-6 parts, rhodiola rosea 13-15 parts, gynostemma pentaphyllum 23-25 ​​parts, chicory 14-15 parts, smilax glabra 15-17 parts, dioscorea hypoglauca 14-15 parts, polygonum cuspidatum 10-11 parts, salvia miltiorrhiza 9-11 parts, gentiana macrophylla 9-11 parts, kudzu root 18-20 parts, and lily bulb 14-15 parts.

[0027] In some embodiments, the medicinal materials are composed of the following raw materials in parts by weight: ginseng 5g, astragalus 35g, ophiopogon japonicus 10g, schisandra chinensis 5g, rhodiola rosea 15g, gynostemma pentaphyllum 25g, chicory 15g, smilax glabra 15g, dioscorea hypoglauca 15g, polygonum cuspidatum 10g, salvia miltiorrhiza 10g, gentiana macrophylla 10g, kudzu root 20g, and lily bulb 15g.

[0028] In some embodiments, lactic acid bacteria and / or yeast are added during the bio-fermentation process. The complex flora of lactic acid bacteria, yeast, and Bacillus can decompose the cell walls of medicinal materials, releasing active ingredients such as polysaccharides and flavonoids, while simultaneously producing beneficial metabolites such as probiotics and organic acids, thereby enhancing intestinal health and immune regulation. Lactic acid bacteria regulate the gut, and yeast increases aroma, thus improving taste and absorption.

[0029] Another embodiment of the present invention provides a method for preparing the above-mentioned fermented oral liquid for gout in high-altitude areas, comprising the following steps: The raw materials are crushed into raw material powder; Water is added to the raw material powder, and the mixture is heated to 95-100°C for extraction. Shear emulsification is performed during the extraction process. Centrifuge and filter the extracted material, and collect the supernatant; The supernatant was added to the fermentation medium of Ganoderma lucidum and sterilized; then the Ganoderma lucidum inoculum was inoculated and fermented. The fermented material is emulsified, cell walls broken, and homogenized.

[0030] In some embodiments, the amount of water added to the raw material powder is 10-15 times the total mass of the raw material powder.

[0031] In some embodiments, the extraction time is 40-50 minutes.

[0032] In some embodiments, the fermentation temperature is 26-28°C and the fermentation time is 168-240 hours.

[0033] In some embodiments, fermentation continues until the solids content stabilizes at 44-46%.

[0034] In some embodiments, the rotation speed of the emulsification and homogenization process is not less than 12,000 rpm. High-speed homogenization at a rotation speed of 12,000 rpm or higher achieves microemulsification, improving product stability and taste. Specifically, the rotation speed is 12,000-13,000 rpm.

[0035] In some embodiments, the emulsified, homogenized, and then filled and sterilized. Specifically, after filling, each bottle contains 4-12g of crude drug.

[0036] A third embodiment of the present invention provides the application of the above-mentioned plateau gout fermented oral liquid traditional Chinese medicine preparation in the preparation of drugs to improve the symptoms of hyperuricemia, hyperlipidemia or gout in people living in high-altitude areas.

[0037] To enable those skilled in the art to better understand the technical solution of the present invention, the technical solution of the present invention will be described in detail below with reference to specific embodiments.

[0038] The liquid fermentation strain of Ganoderma lucidum used in this invention comes from Jinan Anhao Biotechnology Co., Ltd. It is the company's standardized commercial food-grade Ganoderma lucidum strain, with the Latin name Ganoderma lucidum (listed in the National Health Commission's catalog of fungal strains that can be used in health foods) and the number AM-G01, which is a Ganoderma lucidum strain specifically for liquid fermentation.

[0039] Fermentation process 1. Powdered Chinese herbal medicine compound.

[0040] 2. Soaking, boiling and emulsifying the powder: Add an appropriate amount of pure water to the powder, stir and slowly heat to 95-100℃, maintain for 30 minutes, and intermittently turn on high-shear emulsification to fully extract the effective ingredients from the powder.

[0041] 3. Centrifugation: Centrifuge the above-mentioned cooking liquid to separate the solid and liquid, and collect the supernatant. Allow the extract to cool naturally to below 60℃, and then use a tubular centrifuge to separate the solid and liquid. Centrifuge at 8000 r / min for 15 min to thoroughly remove the residue and insoluble impurities. Collect the clear supernatant for later use.

[0042] 4. Ingredients: Weigh out the nutrients required for Ganoderma lucidum fermentation (culture medium, containing carbon source, nitrogen source, inorganic salts, vitamins, etc.) and dissolve them completely in the supernatant after centrifugation. Standard liquid culture medium formula (per 1000mL fermentation system): glucose 20.0g (carbon source), soybean peptone 10.0g (organic nitrogen source), yeast extract 5.0g, potassium dihydrogen phosphate 3.0g, magnesium sulfate heptahydrate 1.5g, vitamin B1 0.01g, and the remainder purified water; the basic pH is 5.8±0.3, which is naturally maintained in the optimal range of 5.5-6.5 after mixing with the supernatant of the Chinese herbal medicine.

[0043] 5. Material sterilization: The mixed material is transferred to a 15L fully automatic mechanically stirred fermenter and sterilized using a high-temperature moist heat process: sterilization temperature 121℃, relative humidity 100%, sterilization pressure 0.1MPa, constant temperature and pressure sterilization for 20 minutes; after sterilization, the material is rapidly cooled to a constant fermentation temperature of 26-28℃ through the fermenter's built-in cooling water circulation system and then stored for later use. The entire process is carried out under aseptic and closed conditions to avoid contamination by other microorganisms.

[0044] 6. Inoculation: The inoculation is carried out in a sterile, ultra-clean environment and at the sterile inoculation port of a closed fermenter. The activated Ganoderma lucidum inoculum solution is inoculated, and the inoculation volume is 10% of the total fermentation material system. The Ganoderma lucidum inoculum solution used is a liquid seed solution that has been pre-activated and cultured for 7 days, with mycelial activity ≥95% and free from contamination by other microorganisms.

[0045] 7. Fermentation Culture: Control the temperature, aeration rate, stirring speed, and pH of the fermentation medium to optimize microbial growth and metabolism. Details are as follows: After inoculation, the fermentation tank is sealed, and the fully automatic fermentation control system is turned on. Fermentation is carried out under constant temperature and parameters throughout the entire process. The core control parameters are as follows: Fermentation temperature: constant 26-28℃; Stirring speed: constant at 150 r / min throughout to ensure thorough mixing of materials and oxygen and prevent mycelial sedimentation; Aeration rate: The sterile air ventilation rate is kept constant at 1.0 vvm (volume of air per minute per volume of fermentation broth) to maintain stable dissolved oxygen in the fermentation system; pH value: The pH value is naturally regulated throughout the process, maintaining the system pH at 5.5-6.5 without additional acid-base adjustment, which is suitable for the metabolic characteristics of Ganoderma lucidum. Fermentation cycle: 168-240h (7-10d). The solid content of the fermentation system is monitored in real time. Fermentation is terminated when the solid content stabilizes at 45% and there are no fluctuations in two consecutive tests.

[0046] During the fermentation process, samples are taken every 24 hours to test the solid content, mycelial biomass, and effective component content, and fermentation data is recorded to ensure that the fermentation process is stable and controllable.

[0047] 8. Process monitoring: During fermentation, samples are taken to monitor changes in biomass and various effective components, and the fermentation is terminated based on the monitoring data.

[0048] 9. Emulsification and homogenization: After fermentation, emulsification and homogenization are performed to completely break down the cell walls of microorganisms and retain all the effective substances produced during fermentation.

[0049] 10. Filling and Inner Packaging: Fill the homogenized liquid into oral liquid bottles, and then stopper and screw on the caps in sequence.

[0050] 11. Sterilization: Place the inner-packaged oral liquid in a sterilization cabinet, sterilize it at high temperature and humidity, and then let it cool naturally to room temperature.

[0051] 12. Labeling: Labeling and coding the sterilized oral liquid on an automatic labeling machine.

[0052] 13. Outer Packaging: Pack the labeled and coded oral liquid into the outer box and print the date code.

[0053] 14. Product Inspection: Conduct necessary quality inspections on the products.

[0054] 15. Warehousing: Products that pass inspection are registered and put into storage.

[0055] Example: High-altitude gout fermented oral liquid Prescription: Ginseng 5 parts by weight, Astragalus membranaceus 35 parts by weight, Ophiopogon japonicus 10 parts by weight, Schisandra chinensis 5 parts by weight, Rhodiola rosea 15 parts by weight, Gynostemma pentaphyllum 25 parts by weight, Chicory 15 parts by weight, Smilax glabra 15 parts by weight, Dioscorea hypoglauca 15 parts by weight, Polygonum cuspidatum 10 parts by weight, Salvia miltiorrhiza 10 parts by weight, Gentiana macrophylla 10 parts by weight, Pueraria lobata 20 parts by weight, Lilium brownii 15 parts by weight.

[0056] Preparation method: 1. Weigh all Chinese medicinal materials according to the above prescription ratio, clean and wash them with water, and then pulverize them into coarse powder of 20-40 mesh; add 12 times the amount of purified water, extract at a constant temperature of 98℃ for 45 minutes, and intermittently perform high-shear emulsification extraction during the process, emulsify at 8000r / min, 2 minutes at a time, and repeat the operation every 10 minutes.

[0057] 2. Centrifuge the extract at 8000 r / min for 15 min, take the supernatant, add Ganoderma lucidum-specific compound fermentation medium at a mass ratio of supernatant to culture medium solids of 100:3.5, and stir at 300 r / min at room temperature for 20 min until completely dissolved.

[0058] 3. Transfer the material to a 15L fermenter and sterilize it with moist heat at 121℃, 100% relative humidity, and 0.1MPa for 20 minutes, then cool it down to 27℃.

[0059] 4. Under aseptic conditions, inoculate with 10% volume of activated Ganoderma lucidum culture solution, and ferment at a constant temperature of 27℃, stirring speed of 150r / min, aeration rate of 1.0vvm, and pH of 5.5-6.5 for 168-240h. Terminate fermentation when the solid content stabilizes at 45%.

[0060] 5. The fermentation broth is homogenized at 12000r / min for 30min, and after cell wall breaking and emulsification, it is aseptically filled into 50ml / bottle, each bottle containing 6g of raw medicinal material; after filling, it is terminally sterilized at 115℃ for 30min, and after quality inspection, labeling, outer packaging, and inspection, it is put into storage.

[0061] Usage: Oral administration, 50ml twice daily.

[0062] Experimental Example 1.1 Grouping and Modeling After one week of acclimatization, rats were randomly divided into a normal control group (n=8) and a model group (n=48) using a random number table. The model group was fed a high-sugar, high-fat diet and administered loperamide suspension (3 mg / kg) daily by gavage, and was placed in an artificial climate chamber (32℃, 95% relative humidity, 24 hours per session, 3 times per week). The normal control group was fed a regular diet and administered an equal volume of physiological saline daily by gavage. After 4 weeks, the model group rats exhibited stringy, soft, irregularly sized, and irregularly shaped feces, indicating successful model establishment. The successfully modeled rats were then randomly divided into a model group, a low-dose high-altitude gout fermentation drink group, a medium-dose high-altitude gout fermentation drink group, a high-dose high-altitude gout fermentation drink group, and a linaclotide group (0.20 mg / kg). -1 ), prucalopride succinate group (15 μg·kg) -1 ), 8 in each group.

[0063] 1.2 Administration Using an adult body weight of 60 kg as a baseline, and employing the rat conversion factor formula, the low, medium, and high doses of the fermented gout drink from the plateau were calculated to be 1.90, 3.80, and 7.60 g·kg, respectively. -1 (Corresponding to 0.5, 1, and 2 times the clinically equivalent dose); the linaclotide group received a dose of 0.20 mg / kg. -1 The prucalopride succinate group was 15 μg·kg -1 All medications were administered at a dose of 1 mL / 100g. -1 The dose was administered by gavage, while the normal group and the model group were administered the same volume of physiological saline by gavage, once a day for 4 consecutive weeks.

[0064] 1.3 The regulatory effects of the plateau gout formula on serum gastrointestinal hormones, uric acid levels, and lipid metabolism in rats with hyperuricemia and constipation (dampness-dampness stagnation type). The results are as follows Figure 1 As shown: Regarding gastrointestinal hormones: Compared with the normal group (CON group), the serum vasoactive intestinal peptide (VIP) level in the model group (MOD group) showed an increasing trend, while the levels of substance P (SP) and motilin (MTL) were significantly decreased (P<0.05), suggesting that the comorbid model rats had gastrointestinal hormone disorders, manifested as increased inhibition and insufficient excitability. After intervention with the high-altitude gout fermented drink, the SP level in the high-dose group was significantly increased (P<0.05), while VIP showed a decreasing trend and MTL showed an increasing trend in all dose groups, indicating that the high-altitude gout fermented drink can regulate gastrointestinal hormones and restore intestinal motility overall.

[0065] Regarding uric acid and lipid metabolism: Compared with the CON group, the MOD group showed significantly elevated serum uric acid (UA), total cholesterol (TC), and triglyceride (TG) levels (P<0.05, P<0.01), suggesting that the rat model of hyperuricemia combined with chronic functional constipation (dampness-induced qi stagnation type) exhibits significant abnormalities in uric acid and lipid metabolism. After treatment with the high-altitude gout fermented beverage, the UA and TC levels in the low, medium, and high dose groups were significantly reduced (P<0.05, P<0.01); the TG levels in the low and medium dose groups were significantly reduced (P<0.05, P<0.01), and the TG level in the high dose group also showed a decreasing trend. These results indicate that the high-altitude gout fermented beverage can regulate uric acid levels in the body and correct lipid metabolism disorders.

[0066] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine preparation of fermented oral liquid for gout in high-altitude areas, characterized in that, It is made from medicinal materials through biological fermentation with Ganoderma lucidum fungus; the medicinal materials are composed of the following raw materials in parts by weight: ginseng 3-9 parts, astragalus 15-35 parts, ophiopogon japonicus 5-15 parts, schisandra chinensis 5-10 parts, rhodiola rosea 5-15 parts, gynostemma pentaphyllum 10-25 parts, chicory 10-15 parts, smilax glabra 15-30 parts, dioscorea hypoglauca 10-15 parts, polygonum cuspidatum 10-15 parts, salvia miltiorrhiza 5-15 parts, gentiana macrophylla 5-15 parts, kudzu root 10-20 parts, and lily bulb 10-15 parts.

2. The traditional Chinese medicine preparation of fermented oral liquid for gout in high-altitude areas as described in claim 1, characterized in that, The medicinal materials are composed of the following raw materials in parts by weight: ginseng 4-6 parts, astragalus 25-35 parts, ophiopogon japonicus 8-12 parts, schisandra chinensis 5-7 parts, rhodiola rosea 10-15 parts, gynostemma pentaphyllum 20-25 parts, chicory 14-15 parts, smilax glabra 15-20 parts, dioscorea hypoglauca 13-15 parts, polygonum cuspidatum 10-12 parts, salvia miltiorrhiza 8-12 parts, gentiana macrophylla 8-12 parts, kudzu root 15-20 parts, and lily bulb 13-15 parts.

3. The traditional Chinese medicine preparation of fermented oral liquid for gout in high-altitude areas as described in claim 1, characterized in that, The medicinal materials are composed of the following raw materials in parts by weight: ginseng 4.5-5.5 parts, astragalus 23-35 parts, ophiopogon japonicus 9-11 parts, schisandra chinensis 5-6 parts, rhodiola rosea 13-15 parts, gynostemma pentaphyllum 23-25 ​​parts, chicory 14-15 parts, smilax glabra 15-17 parts, dioscorea hypoglauca 14-15 parts, polygonum cuspidatum 10-11 parts, salvia miltiorrhiza 9-11 parts, gentiana macrophylla 9-11 parts, kudzu root 18-20 parts, and lily bulb 14-15 parts.

4. The traditional Chinese medicine preparation of fermented oral liquid for gout in high-altitude areas as described in claim 1, characterized in that, The medicinal materials are composed of the following ingredients in parts by weight: ginseng 5g, astragalus 35g, ophiopogon japonicus 10g, schisandra chinensis 5g, rhodiola rosea 15g, gynostemma pentaphyllum 25g, chicory 15g, smilax glabra 15g, dioscorea hypoglauca 15g, polygonum cuspidatum 10g, salvia miltiorrhiza 10g, gentiana macrophylla 10g, kudzu root 20g, and lily bulb 15g.

5. The traditional Chinese medicine preparation of fermented oral liquid for gout in high-altitude areas as described in claim 1, characterized in that, Lactic acid bacteria and / or yeast are also added during the bio-fermentation process.

6. A method for preparing a traditional Chinese medicine preparation of the fermented oral liquid for gout in high-altitude areas according to any one of claims 1 to 5, characterized in that, Includes the following steps: The raw materials are crushed into raw material powder; Water is added to the raw material powder, and the mixture is heated to 95-100°C for extraction. Shear emulsification is performed during the extraction process. Centrifuge and filter the extracted material, and collect the supernatant; The supernatant was added to the fermentation medium of Ganoderma lucidum and then sterilized. Then, inoculate with Ganoderma lucidum spawn and ferment; The fermented material is emulsified, cell walls broken, and homogenized.

7. The preparation method according to claim 6, characterized in that, The amount of water added to the raw material powder is 10-15 times the total mass of the raw material powder; Alternatively, the extraction time is 40-50 minutes.

8. The preparation method according to claim 6, characterized in that, The fermentation temperature is 26-28℃, and the fermentation time is 168-240 hours; Alternatively, ferment until the solids content stabilizes at 44-46%.

9. The preparation method according to claim 6, characterized in that, The rotation speed for emulsification, cell disruption, and homogenization should not be less than 12,000 rpm; Alternatively, the mixture can be emulsified, homogenized, filled, and sterilized; or, after filling, each bottle contains 6g-12g of raw medicinal material.

10. The use of any one of the traditional Chinese medicine preparations described in claims 1 to 5 in the preparation of a drug for improving symptoms of hyperuricemia, hyperlipidemia, or gout in people living in high-altitude areas.

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