Preparation method and application of medicinal and edible composition for reducing uric acid and treating gout

Abstract

The invention discloses a preparation method and application of a medicinal and edible composition for reducing uric acid and treating gout, and belongs to the crossing field of medicine and food technologies. The composition is composed of celery seeds, sophora flower buds, chicory, dandelion, mulberry twigs, pawpaw and fresh lalang grass rhizomes, all the components have a synergistic effect, and the effects of inhibiting generation of uric acid, promoting excretion of uric acid, resisting inflammation, diminishing swelling and adjusting body metabolism at multiple target points are achieved. The preparation method comprises the steps of intelligent screening and fine pretreatment of raw materials, a multi-stage targeted extraction process and intelligent concentration and precise forming, and active ingredients can be efficiently extracted and prepared into various dosage forms. According to the composition, in the aspect of precise medical assistance, personalized medication schemes are customized according to different stages of gout, and whole-course digital management is achieved by means of intelligent equipment and a cloud platform; in daily smart health care of families, gout prevention of the families is facilitated through smart home kitchen equipment and a uric acid monitoring set; the method is used for innovative health food development, and provides a new natural, efficient and multifunctional health management approach for gout patients.

Description

Technical Field

[0001] The present invention relates to the intersection of medicine and food technology, and specifically belongs to a method for preparing a uric acid-lowering edible medicinal composition for treating gout and its application. The present invention is particularly focused on developing an innovative method for preparing a uric acid-lowering composition based on edible medicinal ingredients and its diversified applications for treating gout, aiming to fill the gap in natural, efficient and multifunctional products in existing gout treatment plans, and provide a new health management approach for the majority of gout patients and potential hyperuricemia patients. Background Art

[0002] With the change of lifestyle, gout has become a global health problem. The incidence of hyperuricemia has been rising year by year, causing patients with joint pain, kidney damage and many other pains. Although traditional drug treatment can control uric acid levels and relieve symptoms in the short term, long-term use is often accompanied by serious side effects, such as liver and kidney damage, gastrointestinal discomfort, etc., which greatly reduces patients' compliance with treatment. At the same time, consumers are increasingly advocating natural and healthy health concepts, and medicine and food products are highly favored because they have both medicinal effects and food safety. Celery seeds can effectively promote uric acid excretion with their significant diuretic and detumescent effects; Sophora japonica seeds are rich in flavonoids, which have both anti-inflammatory and antioxidant properties and can specifically relieve gout inflammation; chicory helps reduce uric acid levels by regulating the body's metabolic pathways; dandelion's heat-clearing and detoxifying effects have a good soothing effect on joint redness, swelling, heat and pain during acute gout attacks; mulberry branches are good at clearing meridians and benefiting joints, which can improve joint movement disorders in gout patients; papaya not only helps digestion and stomach, but also its bioactive ingredients can comprehensively regulate the body; the heat-clearing and diuretic function of fresh Imperata root opens up a path for uric acid to be excreted from the body. However, most of the medicinal and edible compositions for gout on the market currently have problems such as simple and extensive preparation processes, low extraction rates of effective ingredients, single efficacy and limited application scenarios, which are difficult to meet the precise treatment needs under the complex pathological mechanisms of gout and people's pursuit of convenient and daily health care. Therefore, it is urgent to develop a medicinal and edible composition with an innovative preparation method, a multi-target mechanism of action and a wide range of flexible applications. Summary of the invention

[0003] 1. Technical issues to be solved

[0004] In view of the shortcomings and deficiencies of existing formulas and technologies, the present invention provides a method for preparing a uric acid-lowering gout medicine-food homologous composition and its application. Although Western medicine can play a certain role in uric acid-lowering treatment, it is often accompanied by more obvious side effects, such as common damage to liver and kidney function, gastrointestinal discomfort (such as nausea, vomiting, diarrhea, etc.), and allergic reactions such as rashes may also occur. These side effects not only affect the patient's medication compliance, but also may bring other hidden dangers to the patient's health in the long run, limiting the wide application and long-term use of Western medicine in the field of uric acid lowering. There is a problem of inconvenience in taking Chinese medicine decoctions, which need to be boiled, which takes a long time, and tastes bitter and is not convenient to carry, which makes it difficult for many patients to adhere to long-term use. Although Chinese patent medicine has improved in convenience of taking, the overall onset is relatively slow, and the effect is not significant enough in terms of lowering uric acid and relieving gout symptoms. It often takes a long time to take it continuously to see a certain effect. For patients who are in urgent need of controlling uric acid levels and relieving acute gout attacks, their treatment needs cannot be met in time. By designing the formula of Chinese medicine composition, through carefully designing the formula of Chinese medicine composition, and screening specific medicine and food products, we can take advantage of the characteristics of medicine and food substances that are relatively safe, widely available, and easy to be accepted by patients. These medicine and food ingredients themselves may have the effects of regulating human metabolism, anti-inflammatory, diuresis and moisture-removing, etc. related to lowering uric acid. After reasonable combination, they are expected to work synergistically, regulate the body's uric acid metabolism and other physiological processes from the root, and improve the uric acid-lowering effect. By screening specific medicine and food products, and using water treatment distillation purification, the effective ingredients in the Chinese medicine composition can be selectively extracted, and impurities, macromolecular substances, and components that may be harmful to the human body can be removed. This purification method is relatively mild, which can retain the activity of the effective ingredients to the greatest extent, while increasing the concentration of the effective ingredients, so that the subsequent preparations can play a better uric acid-lowering effect when taken in a smaller dose, and can reduce the potential adverse effects of ineffective ingredients, such as reducing the burden on the gastrointestinal tract. The purified substance is made into an oral liquid for lowering uric acid or concentrated and then added with excipients to make an oral preparation. The oral liquid form is easy to take and absorbs quickly. It can quickly enter the human blood circulation to exert its effect. It can quickly affect the uric acid level in the body and help to promptly relieve the discomfort caused by high uric acid. Other oral preparations (such as tablets, capsules, etc.) prepared not only ensure efficacy, but also take into account the advantages of easy carrying and good storage stability, which are suitable for the use needs of patients in different scenarios. And it has been proved through taking tests that it has a good uric acid-lowering effect, effectively overcoming the problems of slow onset and insignificant effect of existing Chinese herbal decoctions and Chinese patent medicines, and providing a more effective and convenient treatment option for patients with hyperuricemia and gout.The Chinese medicine composition is subjected to water treatment and distillation purification, and the purified material is further made into a uric acid-lowering oral liquid or concentrated and then added with an excipient to be made into an oral preparation. The oral test has proved that it has a good uric acid-lowering effect, and solves the problems of side effects caused by Western medicine and slow onset and insignificant effects of Chinese herbal decoctions and Chinese patent medicines.

[0005] 2. Technical solution

[0006] In order to achieve the above purpose, the main technical solutions adopted by the present invention include:

[0007] In a first aspect, the present invention provides a method for preparing a uric acid-lowering and gout-treating medicinal and edible composition and its application, which comprises:

[0008] S1. A Chinese medicine composition comprising: celery seeds, sophora japonica seeds, chicory, dandelion, mulberry branches, papaya, and fresh Imperata cylindrica roots.

[0009] S2. Purification and preparation of Chinese medicine preparations: Its preparation method adopts intelligent screening and fine pretreatment of raw materials, multi-stage targeted extraction process, intelligent concentration and precise molding steps, which can efficiently extract active ingredients and make them into a variety of dosage forms.

[0010] S3. Application of Chinese medicine preparations: In terms of precision medical assistance, this combination can be used to customize personalized medication plans according to the different stages of gout, and achieve full digital management with the help of smart devices and cloud platforms; in daily smart family health care, it can facilitate family prevention of gout through smart home kitchen equipment and uric acid monitoring kits; it can also be used for the development of innovative healthy foods, such as uric acid regulating energy bars, gout prevention meal replacement powders, etc.

[0011] According to a preferred embodiment of the present invention, in S1, the Chinese medicine composition is composed of 10-15 parts by mass of celery seeds, 8-12 parts by mass of sophora japonica seeds, 12-18 parts by mass of chicory, 10-15 parts by mass of dandelion, 8-12 parts by mass of mulberry branches, 8-12 parts by mass of papaya, and 15-25 parts by mass of fresh Imperata cylindrica roots.

[0012] Further preferably, the traditional Chinese medicine composition comprises 15 parts by mass of celery seeds, 10 parts by mass of sophora japonica seeds, 12 parts by mass of chicory, 10 parts by mass of dandelion, 12 parts by mass of mulberry branches, 12 parts by mass of papaya, and 15 parts by mass of fresh Imperata cylindrica roots.

[0013] According to a preferred embodiment of the present invention, in S2, the raw materials are intelligently screened and finely pretreated: the raw materials are screened by means of spectral analysis technology and biological activity detection means, and for celery seeds, chicory, dandelions, and fresh white grass roots, batches of organic cultivation, no pesticide residues, and active ingredient content above a specific threshold are selected, and after harvesting, supercritical fluid cleaning technology is used to remove impurities, and then vacuum freeze-drying technology is used to dry the materials at -40°C to -50°C to a moisture content of less than 99%; after artificial selection to remove defects and insect-infested parts from the sophora japonica seeds, mulberry branches, and papayas, CNC cutting equipment is used to cut the sophora japonica seeds and mulberry branches into 2-3 cm small segments, and the papayas are cut into thin slices of about 0.5 cm.

[0014] According to a preferred embodiment of the present invention, in S2, a multi-stage targeted extraction process is used: first, the pretreated celery seeds, chicory, dandelion, and fresh Imperata root are mixed in a specific proportion, put into a dynamic countercurrent extraction device, deionized water is used as the solvent, the solid-liquid ratio is controlled to be 1:-1:7, the extraction temperature is 40-50°C, the extraction time is shortened to 0.5 hours, and the extract is purified by ultrafiltration of a ceramic membrane; then, for Sophora japonica seeds, mulberry branches, and papaya, subcritical fluid extraction technology is used to accurately extract fat-soluble active ingredients below the critical temperature and at a pressure of 0.6-0.9MPa, and after the extraction is completed, the solvent residue is removed by supercritical carbon dioxide extraction technology; finally, the above two extracts are combined, placed in an ultrasonic extraction device, and ultrasonicated at a frequency of 40kHz-60kHz for 30-45 minutes.

[0015] According to a preferred embodiment of the present invention, in S2, intelligent concentration and precise molding: the mixed extract after ultrasonic treatment is connected to an intelligent concentration control system, and is precisely concentrated to a thick extract with a relative density of 1.2-1.3 under the conditions of vacuum degree 0.08-0.1MPa and temperature 45-55°C; if an oral preparation is prepared, according to big data analysis and clinical feedback, suitable pharmaceutical excipients are added for different dosage forms, 3D printing technology is used when preparing capsules, each capsule contains 0.4-0.6g of dry powder of the composition, and a high-speed tablet press is used to make tablets, each tablet contains 0.5-0.7g of the composition, and an appropriate amount of flavoring agent and preservative are added to prepare the oral liquid, diluted to the specified concentration and canned; if used for dietary addition, low-temperature spray drying technology is used to convert the extract into ultrafine powder with a particle size distribution between 1-10μm, and sealed and packaged.

[0016] According to a preferred embodiment of the present invention, in S3, the application of the uric acid treatment of gout medicine and food composition in precision medical assistance: during the acute attack of gout, the patient's uric acid level, inflammatory indicators and pain level are monitored with the help of smart medical equipment, and a high-dose concentrated oral liquid treatment plan is tailored for the patient through big data analysis. It is taken once every 4 hours, 5 ml each time, and wearable devices are used to track the patient's recovery progress in real time, and the dosage and frequency of medication are adjusted in time; in the intermittent and chronic stages, it is switched to taking smart controlled-release capsules or sustained-release tablets for maintenance treatment. According to the individual metabolic characteristics of the patient, the release curve of the drug in the body is set. Through long-term regular medication, the uric acid level is stabilized, the recurrence of gout is prevented, and the damage of urate crystals to the joints and kidneys is reduced. At the same time, a patient health management cloud platform is established, and the patient's medication data, diet records, exercise conditions, uric acid monitoring values ​​and other information are uploaded in real time. Doctors use artificial intelligence algorithms to analyze data and provide patients with accurate lifestyle advice and medication guidance.

[0017] According to a preferred embodiment of the present invention, in S3, the application of the uric acid-lowering and gout-treating medicinal and edible composition in daily smart family health care: developing supporting smart home kitchen equipment with a built-in gout diet recommendation algorithm. When the family is preparing to cook, the user inputs the health information of family members, and the device automatically recommends personalized recipes containing the composition. When making soup, it accurately prompts to add 3-8g of the composition powder 2-3 times a week, and when cooking porridge, it prompts to sprinkle 2-5g of dry powder. The intelligent cooking program ensures that the ingredients of the composition are fully dissolved and retained during the cooking process; launching a family uric acid monitoring kit, including a portable uric acid detector, a mobile phone APP, etc. Family members can regularly test their uric acid levels by themselves. The APP uploads the test data to the cloud platform, combines it with the dietary intake data, and uses a machine learning model to analyze the uric acid fluctuation trend, timely warns of high uric acid risks, reminds users to adjust their diet structure, and increase the frequency of application of the composition in the diet.

[0018] According to a preferred embodiment of the present invention, in S3, the application of the uric acid-lowering edible medicinal composition for the treatment of gout in the in-depth development of innovative healthy foods: cooperate with food technology companies, based on the human nutritional demand model and gout prevention and treatment goals, use this composition to develop a series of high-tech, functional foods, such as developing uric acid regulating energy bars, using 3D printing food molding technology, and accurately combining the dry powder of the composition with high-quality protein, dietary fiber, low-sugar carbohydrates and other raw materials. Each energy bar contains 5g of dry powder of the composition, which meets the dual needs of sports enthusiasts for quick energy replenishment and regulation of uric acid before and after exercise; develop gout prevention meal replacement powder, combine intestinal microbial targeted regulation technology, add prebiotics, probiotics and other ingredients, so that the meal replacement powder can provide a sense of satiety while optimizing the intestinal flora and promoting uric acid excretion, providing busy office workers with a convenient and healthy gout prevention solution.

[0019] 3. Beneficial effects

[0020] (1) Pharmacological efficacy

[0021] Uric acid lowering effect: Multi-component synergistic regulation: Celery seeds contain apigenin and other ingredients, Sophora japonica beans are rich in flavonoids such as rutin, chicory contains compounds such as chicoric acid, dandelion has taraxasterols, mulberry pigments in mulberry branches, oleanolic acid contained in papaya and various sugars in fresh Imperata root. They work synergistically from different angles. For example, some can inhibit the activity of key enzymes in the process of uric acid production and reduce the production of uric acid; some can promote the excretion of uric acid. By increasing the kidney's filtration and excretion function of uric acid, the two-way regulation keeps the uric acid level in the body within the normal range, thereby effectively reducing blood uric acid concentration, alleviating hyperuricemia, and preventing gout attacks.

[0022] Improve metabolism from the root: These combinations of Chinese medicinal materials that are both medicinal and edible can help regulate the body's overall purine metabolism, water metabolism and other related physiological processes, and improve the disorder of uric acid metabolism from the root. It is not just a simple symptomatic relief, but can achieve a relatively long-lasting and stable uric acid-lowering effect.

[0023] Effects of treating gout: Anti-inflammatory, anti-swelling and analgesic: When gout attacks, the joints will show inflammatory symptoms such as redness, swelling, heat and pain. Many ingredients in the composition have anti-inflammatory activity. For example, flavonoids can inhibit the release of inflammatory mediators, reduce local inflammatory reactions in the joints, relieve pain and swelling symptoms, and at the same time reduce the formation of tophi, improve joint function, and improve the quality of life of gout patients.

[0024] Repairing damaged tissues: Long-term gout attacks can easily damage joints and surrounding tissues. Some ingredients in this composition (such as nutrients contained in mulberry branches) may help promote the repair and regeneration of damaged articular cartilage, synovium and other tissues, delay the further development of joint lesions, and protect joint health.

[0025] (2) Security

[0026] Guarantee of the medicinal and edible properties: Since the materials selected are all medicinal and edible, they are safer than some chemically synthesized drugs or some toxic Chinese medicinal materials. Under normal dosage, they generally do not cause obvious damage to important organs such as the liver and kidneys, nor are they prone to cause serious adverse reactions. They are suitable for long-term use to maintain stable uric acid levels and control gout conditions, and patients' acceptance and compliance will also be higher.

[0027] Few side effects: These natural medicinal and edible ingredients are relatively mild. While they can lower uric acid and treat gout, they basically do not cause common side effects like some Western medicines, such as gastrointestinal discomfort (such as nausea, vomiting, diarrhea), affecting hematopoietic function, and causing rash, thereby reducing the physical pain and additional health risks caused by the side effects of medication.

[0028] (3) Convenience of use and applicability

[0029] Widely applicable to the population: It can be used for patients who have been diagnosed with gout to help them relieve symptoms and control the progression of the disease, and is also suitable for people with hyperuricemia as a preventive conditioning method to regulate uric acid metabolism and prevent further increase in uric acid and the development of gout. Moreover, people of different ages and different physical conditions, as long as they meet the corresponding medication indications, can mostly tolerate this medicine-food combination, and it has a wide range of applications.

[0030] The preparations are in various forms and convenient to take: according to different preparation methods, they can be made into a variety of dosage forms, such as oral liquid, which is easy to take and absorbed quickly, and is suitable for patients with normal swallowing function; tablets and capsules are easy to carry and store, and can meet people's medication needs in different scenarios such as daily travel; powders, etc. can also flexibly adjust the dosage according to their own situation, making it convenient for patients to choose the appropriate dosage form according to their own preferences and actual conditions, thereby improving medication compliance.

[0031] (4) Economic costs

[0032] Raw material cost advantage: Most of these raw materials, such as celery seeds, sophora japonica beans, chicory, dandelion, mulberry branches, papaya, and fresh Imperata cylindrica roots, are widely available and have relatively considerable production in nature. The procurement cost is much lower than that of some rare and precious Chinese medicinal materials or imported uric acid-lowering drugs, which reduces the production cost of the entire composition and makes the final product more competitive in price. This makes it affordable for more patients and is conducive to the promotion and application of the product, benefiting more patients with hyperuricemia and gout. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 The present invention is a process flow chart of a method for preparing a uric acid-lowering and gout-treating medicinal and edible composition.

[0034] Figure 2 It is a 3D pie chart showing the proportions of various components of the edible and medicinal composition of the present invention.

[0035] Figure 3 This is a product picture of the appearance of the oral preparation made by the present invention.

[0036] Figure 4 It is a diagram of the nutritional porridge of the food state after the dietary supplementation of the present invention.

[0037] Figure 5 This is a picture of the diet matching interface of smart kitchen equipment. DETAILED DESCRIPTION

[0038] In order to better explain the present invention and facilitate understanding, the present invention is described in detail below through specific implementation modes in conjunction with the accompanying drawings.

[0039] The main features of the preparation method of a uric acid-lowering and gout-treating medicinal and edible composition and its application are as follows: The present invention discloses a preparation method of a uric acid-lowering and gout-treating medicinal and edible composition and its application, which belongs to the intersection of medicine and food technology. The composition is composed of celery seeds, sophora japonica seeds, chicory, dandelion, mulberry branches, papaya, and fresh white grass roots in specific weight portions, and each component acts synergistically to exert effects from multiple targets such as inhibiting uric acid production, promoting uric acid excretion, anti-inflammatory and detumescence, and regulating body metabolism. Its preparation method adopts intelligent screening and fine pretreatment of raw materials, multi-stage targeted extraction process, intelligent concentration and precise molding steps, which can efficiently extract active ingredients and make a variety of dosage forms. In terms of precision medical assistance, this combination can be used to customize personalized medication plans according to the different stages of gout, and achieve full digital management with the help of smart devices and cloud platforms; in daily smart family health care, it is convenient for families to prevent gout through smart home kitchen equipment and uric acid monitoring kits; it can also be used for the development of innovative healthy foods, such as uric acid regulating energy bars, gout prevention meal replacement powders, etc., providing gout patients and people with high uric acid levels with a new natural, efficient and multifunctional health management approach, and has been verified by animal experiments, human clinical trials and safety experiments to have good efficacy and safety.

[0040] Among them, the formula of the Chinese medicine composition is composed of celery seeds, sophora japonica seeds, chicory, dandelion, mulberry branches, papaya, and fresh white grass roots.

[0041] Preferably, the Chinese medicine composition is composed of 10-15 parts by mass of celery seeds, 8-12 parts by mass of sophora japonica seeds, 12-18 parts by mass of chicory, 10-15 parts by mass of dandelion, 8-12 parts by mass of mulberry branches, 8-12 parts by mass of papaya, and 15-25 parts by mass of fresh white imperata roots. Further preferably, the Chinese medicine composition comprises 15 parts by mass of celery seeds, 10 parts by mass of sophora japonica seeds, 12 parts by mass of chicory, 10 parts by mass of dandelion, 12 parts by mass of mulberry branches, 12 parts by mass of papaya, and 15 parts by mass of fresh white imperata roots.

[0042] In the claimed Chinese medicine composition, the functions of each medicinal component are as follows:

[0043] 1. Celery seeds: Celery seeds contain a variety of active ingredients, among which flavonoids such as apigenin and apigenin A have significant antioxidant stress resistance, which can reduce the oxidative damage caused by high uric acid in the body and protect cells from free radical attacks. At the same time, the butylphthalide substances it contains have the effect of vasodilation and improving microcirculation, which helps to promote blood circulation in excretion organs such as the kidneys, create a good hemodynamic environment for uric acid excretion, and thus enhance the excretion efficiency of uric acid.

[0044] 2. Sophora japonica seed: Sophora japonica seed is rich in flavonoids such as rutin and quercetin, which are the key ingredients for its pharmacological effects. On the one hand, these flavonoids can inhibit the activation and chemotaxis of inflammatory cells, reduce the release of local inflammatory mediators such as interleukin-1β and tumor necrosis factor-α in joints during acute gout attacks, and effectively relieve inflammatory symptoms such as joint redness, swelling, heat and pain; on the other hand, they can also indirectly affect uric acid metabolism by regulating lipid metabolism in the body and lowering blood lipid levels, because hyperlipidemia is often associated with hyperuricemia, and improving blood lipids helps restore uric acid homeostasis.

[0045] 3. Chicory: Chicory is rich in chicoric acid, chicory polysaccharides and other ingredients. Chicoric acid has the function of regulating the activity of key enzymes in purine metabolism, such as inhibiting xanthine oxidase, which is the key rate-limiting enzyme in the production of uric acid. Inhibiting its activity can reduce the production of uric acid from the source. Chicory polysaccharides can regulate the structure of intestinal flora, promote the proliferation of beneficial bacteria, improve intestinal barrier function, and thus affect the body's absorption and metabolism of purines, reduce the conversion of exogenous purines into uric acid, and achieve comprehensive regulation of uric acid levels.

[0046] 4. Dandelion: The active ingredients of dandelion, such as taraxasterol and taraxacin, have powerful heat-clearing and detoxifying effects. When gout attacks, they can quickly relieve the symptoms of redness, swelling, heat and pain in the joints. This is mainly due to its anti-inflammatory and anti-edema mechanism. It can inhibit the conduction of inflammatory signal pathways, reduce capillary permeability, reduce inflammatory exudation, promote blood circulation in local tissues, accelerate the removal of metabolic waste including urate crystals, and relieve inflammatory damage to joints.

[0047] 5. Mulberry branches: Mulberry branches are rich in mulberry pigments, alkaloids and other ingredients. In traditional Chinese medicine theory, they have the effect of dredging meridians and benefiting joints. From the perspective of modern medicine, mulberry branch extracts can regulate the function of joint synovial cells, inhibit excessive proliferation and inflammatory response of synovial cells, reduce intra-articular exudate, improve the internal environment of joints, create favorable conditions for the dissolution and excretion of urate crystals, and relieve the activity disorders caused by joint lesions in gout patients.

[0048] 6. Papaya: Papaya contains papain, oleanolic acid and other biologically active ingredients. Papain helps break down protein in food, promotes digestion and absorption, reduces the accumulation of food purines in the body due to indigestion, and controls the risk of elevated uric acid from the source of diet. Oleanolic acid has a liver-protecting effect, can reduce liver damage that may be associated with hyperuricemia, maintain normal metabolic function of the liver, and ensure the normal synthesis and secretion of enzymes related to uric acid synthesis and excretion.

[0049] 7. The main active ingredients of fresh Imperata root and fresh Imperata root include Imperatae cyperi, Arundin, etc., which have significant heat-clearing and diuretic properties. By increasing the blood flow to the kidneys, promoting the improvement of glomerular filtration rate, increasing urine production, providing sufficient carriers for uric acid excretion, accelerating uric acid excretion from the body with urine, and directly reducing the uric acid level in the body, it is a key aid in the uric acid excretion link in the composition.

[0050] Synergistic principle: In this combination, the various ingredients work together to form an organic whole that fully regulates uric acid metabolism and gout prevention and treatment. Celery seeds and fresh Imperata roots work together to strengthen the uric acid excretion pathway. The former improves the blood circulation of the excretory organs, and the latter directly promotes urine production and promotes uric acid excretion; Sophora japonica seeds and dandelions work together to fight gout inflammation, relieve acute symptoms, inhibit the release of inflammatory mediators, and relieve joint damage; chicory regulates purine metabolism from the source, reduces uric acid production, and works together with papain that controls dietary purine absorption to control uric acid production in a two-pronged approach; mulberry branches focus on improving the internal environment of the joints, which is conducive to urate disposal, and cooperates with other overall regulatory ingredients to fully guarantee the improvement of gout conditions; and in the process of each ingredient exerting its efficacy, papaya's liver-protecting effect supports liver metabolism and ensures the stable operation of the enzyme system related to uric acid metabolism, ultimately achieving the excellent effect of the combination in reducing uric acid efficiently, treating gout, and being highly safe.

[0051] The preparation method of the present invention adopts intelligent screening and fine pretreatment of raw materials, multi-level targeted extraction process, intelligent concentration and precise molding steps, which can efficiently extract active ingredients and make various dosage forms. The purification process can release the active ingredients of traditional Chinese medicine from the cell wall, improve the efficacy, and the purification process also decomposes the macromolecular substances of traditional Chinese medicine into small molecules, making it easier to combine with human proteins, transport into human cells, fully metabolize in the body, avoid drug residues, improve bioavailability, and improve the efficacy at low doses and the utilization rate of drugs by biological organisms, reduce the use of traditional Chinese medicine, reduce the toxic and side effects of traditional Chinese medicine, and improve the speed of onset.

[0052] The uric acid-lowering and gout-treating medicinal and edible composition of the present invention has a preparation method as follows:

[0053] 1. Intelligent screening and fine pretreatment of raw materials: With the help of advanced spectral analysis technology and biological activity detection methods, high-quality and highly active raw materials are screened out. For celery seeds, chicory, dandelions, and fresh white grass roots, organically grown, pesticide-free, and active ingredient content above a specific threshold are preferred. Immediately after harvesting, supercritical fluid cleaning technology is used to quickly remove impurities in a low-temperature, pollution-free environment. Subsequently, vacuum freeze-drying technology is used to dry the materials at -40°C to -50°C to a moisture content of less than 99%, thereby retaining the heat-sensitive active ingredients to the maximum extent. Sophora japonica, mulberry branches, and papaya are strictly manually selected to remove defects and insect-infested parts. Then, CNC cutting equipment is used to cut Sophora japonica and mulberry branches into 2-3 cm small segments and papaya into thin slices of about 0.5 cm according to precise size requirements to ensure uniformity and efficiency of subsequent extraction.

[0054] 2. Multi-stage targeted extraction process: The first multi-stage targeted extraction technology that integrates dynamic countercurrent extraction, subcritical fluid extraction and ultrasound-assisted extraction. First, the pretreated celery seeds, chicory, dandelion and fresh Imperata root are mixed in a specific proportion and put into the dynamic countercurrent extraction equipment. Deionized water is used as the solvent, the material-liquid ratio is controlled at 1:5-1:7, and the extraction temperature is 40-50°C. Through countercurrent circulation, continuous and efficient extraction of water-soluble components is achieved, and the extraction time is shortened to 0.5 hours, which is 80% more efficient than the traditional water extraction process; the extract is purified by ceramic membrane ultrafiltration to remove large molecular impurities and retain high-purity water-soluble effective ingredients.

[0055] Next, subcritical fluid (such as butane, propane, etc.) extraction technology was used for Sophora japonica, mulberry branches, and papaya. Under the conditions of below critical temperature and pressure of 0.6-0.9MPa, fat-soluble active ingredients were accurately extracted. This technology can effectively avoid the damage of heat-sensitive components by high temperature, and the extraction rate is 80% higher than that of traditional alcohol extraction process. After the extraction, supercritical carbon dioxide extraction technology is used to quickly remove the solvent residue to ensure the purity and safety of the extract.

[0056] 3. Finally, the two extracts are combined and placed in an ultrasonic extraction device for ultrasonic treatment at a frequency of 40kHz-60kHz for 30-45 minutes. With the help of ultrasonic cavitation effect, the plant cells are further broken up, the deeply bound components are released, and the comprehensive activity of the extract is enhanced.

[0057] Intelligent concentration and precise molding: The mixed extract after ultrasonic treatment is connected to the intelligent concentration control system. According to the real-time monitoring of the concentration of ingredients, density and other parameters, it is precisely concentrated to a thick extract with a relative density of 1.2-1.3 under the conditions of vacuum degree 0.08-0.1MPa and temperature 45-55℃. If oral preparations are prepared, appropriate pharmaceutical excipients are added for different dosage forms based on big data analysis and clinical feedback. For example, when preparing capsules, 3D printing technology is used to make extracts and excipients such as microcrystalline cellulose and magnesium stearate into personalized capsule shells and filling dry powders according to the optimal absorption model of the human body. Each capsule contains 0.4-0.6g of the dry powder of the composition; tablets are made using a high-speed tablet press, combined with the principle of drug release kinetics, and excipients such as lactose, starch, and disintegrants are mixed for tableting. Each tablet contains 0.5-0.7g of the composition to ensure stable and efficient release of the drug in the body; oral liquids are prepared, based on the taste optimization algorithm, appropriate amounts of flavoring agents and preservatives are added, and diluted to the specified concentration for canning. If used as a dietary supplement, low-temperature spray drying technology is used to convert the extract into ultra-fine powder with a particle size distribution between 1-10μm, and then sealed for consumers to use conveniently.

[0058] The uric acid-lowering and gout-treating medicinal and edible composition of the present invention is used as follows:

[0059] 1. Comprehensive expansion of multiple application scenarios:

[0060] 1.1. Precision medical assistance:

[0061] During the acute attack of gout, the patient's uric acid level, inflammatory indicators and pain level are monitored with the help of smart medical equipment. Through big data analysis, a high-dose concentrated oral liquid treatment plan is tailored for the patient. Take it once every 4 hours, 5 ml each time, to quickly reduce inflammation and pain, reduce uric acid, and relieve severe joint pain. At the same time, wearable devices are used to track the patient's recovery progress in real time, and the dosage and frequency of medication are adjusted in time. During the intermittent and chronic stages, switch to taking smart controlled-release capsules or sustained-release tablets for maintenance treatment. According to the individual metabolic characteristics of the patient, the release curve of the drug in the body is set. Through long-term regular medication, uric acid levels can be stabilized, gout recurrence can be prevented, and the damage of urate crystals to joints and kidneys can be reduced.

[0062] A patient health management cloud platform is established to upload patient medication data, diet records, exercise status, uric acid monitoring values ​​and other information in real time. Doctors use artificial intelligence algorithms to analyze data and provide patients with accurate lifestyle recommendations and medication guidance, realizing full digital management of gout treatment.

[0063] 1.2. Daily smart health care for the family:

[0064] Develop supporting smart home kitchen equipment with built-in gout diet recommendation algorithms. When the family is preparing to cook, the user only needs to enter the health information of the family members, and the device automatically recommends personalized recipes containing this composition. For example, when making soup, according to the principle of ingredient matching and nutritional balance, it accurately prompts to add 3-8g of dry powder of the composition 2-3 times a week, and ensures that the ingredients of the composition are fully dissolved and retained during the cooking process through the intelligent cooking program, which can not only add flavor to the dishes, but also allow the family to subtly regulate uric acid metabolism in their daily diet. When cooking porridge, the device also intelligently guides to sprinkle 2-5g of dry powder, and match it with vegetables, lean meat and other ingredients. While balancing nutrition, it provides a gentle preventive measure for people at risk of high uric acid.

[0065] A family uric acid monitoring kit has been launched, including a convenient uric acid tester, a mobile phone APP, etc. Family members can regularly test their uric acid levels by themselves. The APP uploads the test data to the cloud platform, combines it with dietary intake data, and uses machine learning models to analyze uric acid fluctuation trends, timely warn of high uric acid risks, remind users to adjust their dietary structure, increase the frequency of use of the combination in the diet, and achieve independent management of family health.

[0066] 2. In-depth development of innovative healthy food:

[0067] Cooperate with food technology companies to develop a series of high-tech and functional foods based on the human nutritional demand model and gout prevention and treatment goals using this composition. For example, develop uric acid regulating energy bars, use 3D printing food molding technology, accurately combine the dry powder of the composition with high-quality protein, dietary fiber, low-sugar carbohydrates and other raw materials. Each energy bar contains 5g of dry powder of the composition, which meets the dual needs of sports enthusiasts to quickly replenish energy and regulate uric acid before and after exercise; develop gout prevention meal replacement powder, combine intestinal microbial targeted regulation technology, add prebiotics, probiotics and other ingredients, so that the meal replacement powder can provide a sense of fullness while optimizing the intestinal flora and promoting uric acid excretion, providing busy office workers with a convenient and healthy gout prevention solution.

[0068] The following are preferred embodiments of the present invention.

[0069] Step 1: Preparation of uric acid-lowering oral solution

[0070] (1) Weigh 15 parts by weight of celery seeds, 10 parts by weight of Sophora japonica seeds, 12 parts by weight of chicory, 10 parts by weight of dandelion, 12 parts by weight of mulberry branches, 12 parts by weight of papaya, and 15 parts by weight of fresh Imperata cylindrica roots.

[0071] (2) Intelligent screening and fine pretreatment of Chinese medicinal raw materials, multi-stage targeted extraction technology, intelligent concentration and precise molding steps can efficiently extract active ingredients and make them into oral preparations.

[0072] Experimental design and data

[0073] Animal Experimentation:

[0074] Experimental purpose: To evaluate the uric acid-lowering and anti-inflammatory effects of the composition on hyperuricemia animal models.

[0075] Experimental animals: 60 male SD rats, weighing 200-220 g, were randomly divided into 6 groups, with 10 rats in each group.

[0076] Modeling method: The hyperuricemia model was established by intraperitoneal injection of potassium oxonate (300 mg / kg) once a day for 7 consecutive days.

[0077] Dosage regimen: After successful modeling, the control group was given an equal amount of normal saline, the low-dose group was given 100 mg / kg of the composition, the medium-dose group was given 200 mg / kg of the composition, the high-dose group was given 400 mg / kg of the composition, and the positive control group was given allopurinol (10 mg / kg), once a day by gavage for 14 consecutive days.

[0078] Detection indicators: After the administration, the blood of the rats was collected to detect the levels of serum uric acid, creatinine, and urea nitrogen; the synovial tissue of the joints was taken to detect the expression levels of inflammatory factors TNF-α and IL-6.

[0079] Experimental results: Compared with the control group, the serum uric acid level of each dose combination group was significantly reduced (low-dose group reduced by 16.3%, medium-dose group reduced by 33.6%, high-dose group reduced by 45.7%, P < 0.05), and the uric acid-lowering effect of the high-dose group was equivalent to that of the positive control group; the expression levels of TNF-α and IL-6 in the synovial tissue of the joint were also significantly downregulated in each dose group of the combination (low-dose group TNF-α reduced by 15.4%, IL-6 reduced by 19.3%, medium-dose group TNF-α reduced by 34.9%, IL-6 reduced by 26.7%, high-dose group TNF-α reduced by 46.8%, IL-6 reduced by 39.3%, P < 0.05), indicating that the combination has a good anti-inflammatory effect. Specific data are shown in Table 1.

[0080] Group Serum uric acid reduction rate (%) TNF-α reduction rate (%) IL-6 reduction rate (%) Low dose group 16.3 15.4 19.3 Medium dose group 33.6 34.9 26.7 High dose group 45.7 46.8 39.3 Positive control group 46.3 44.6 42.3

[0081] Table 1

[0082] Human clinical trials:

[0083] Experimental purpose: To verify the clinical efficacy and safety of the composition in gout patients.

[0084] Experimental subjects: 100 confirmed gout patients aged 35-65 years were recruited and randomly divided into an experimental group and a control group, with 50 people in each group.

[0085] Treatment plan: The patients in the experimental group took the Chinese medicine capsules prepared by the composition every day, 3 capsules each time, 3 times a day; the patients in the control group took placebo capsules, the same dosage. The course of treatment is 3 months.

[0086] Detection indicators: Detect the patient's serum uric acid, erythrocyte sedimentation rate, and C-reactive protein levels monthly; record the number of joint pain attacks and the degree of pain (using the visual analog scale, VAS) of the patient; observe the changes in the patient's liver and kidney function indicators.

[0087] Experimental results: After treatment, the serum uric acid level of the experimental group was reduced by an average of 120 μmol / L compared with that before treatment, which was significantly different from that of the control group (P<

[0088] 0.05); ESR and CRP levels also decreased significantly (ESR decreased by 15 mm / h, CRP decreased by 8 mg / L, P<0.05); the number of joint pain attacks decreased by 3 times / month, and the VAS score decreased by an average of 2.5 points; there was no obvious abnormal change in liver and kidney function indicators, indicating that the composition has good safety while effectively treating gout. Specific data are shown in Table 2.

[0089]

[0090] Table 2

[0091] Safety acute toxicity test:

[0092] Experimental animals: 20 healthy Kunming mice weighing 18-22 g, half male and half female, were selected.

[0093] Administration method: The extract of the composition was administered orally at the maximum tolerated dose (20 g / kg). The general condition, diet, drinking water, excretion and death of the mice were observed after a single administration for 14 consecutive days.

[0094] Experimental results: After administration, the mice showed no obvious toxic reaction, ate and drank water normally, there was no death, the fur was smooth, the mice moved freely, the eyes were bright and had no secretions, and the feces were normal in shape and color. This shows that the acute toxicity of the extract of the composition is extremely low, and it has basically no damage to the body at a very high dose, which preliminarily verifies its safety for consumption. The specific observation records are shown in Table 3.

[0095]

[0096] Table 3

[0097] Long-term toxicity test:

[0098] Experimental animals: 80 SD rats, half male and half female, weighing 150-180 g, were randomly divided into 4 groups, 20 rats in each group.

[0099] Dosage regimen: The control group was given an equal amount of normal saline, the low-dose group was given 2 g / kg of the composition extract, the medium-dose group was given 5 g / kg, and the high-dose group was given 10 g / kg, by gavage once a day for 90 days.

[0100] Test indicators: The rats' body weight, food intake, and water intake were recorded weekly; blood samples were collected every half month to test blood routine, liver and kidney function indicators (alanine aminotransferase, aspartate aminotransferase, creatinine, urea nitrogen, etc.); at the end of the experiment, the main organs (heart, liver, spleen, lung, kidney, stomach, intestine, etc.) were taken.

[0101] Perform histopathological examination.

[0102] Experimental results: During the entire test period, the weight growth trend of rats in each dose group was similar to that of the control group, with no significant difference (P>0.05); there was no significant fluctuation in food intake and water intake between the dose groups; all blood routine indicators were within the normal range; there was no statistically significant difference in liver and kidney function indicators between the dose groups and the control group (P>0.05); pathological histological examination showed that the tissue structure of each organ was clear, without obvious abnormal conditions such as lesions, inflammation and cell necrosis. Overall, the composition has no obvious toxic and side effects on the body when taken for a long time and at a large dose, and has good long-term safety for consumption. Detailed data are shown in Tables 4-7.

[0103]

[0104] Table 4: Body weight changes of rats in each dose group (unit: g, mean ± standard deviation)

[0105] Group Food intake in week 1 Food intake in week 2 Food intake in week 3 …… Control group 20±2 22±3 23±2 …… Low dose group 19±2 21±3 22±2 …… Medium dose group 21±2 23±3 24±2 …… High dose group 20±3 22±3 23±3 ……

[0106] Table 5: Changes in food intake of rats in each dose group (unit: g / day, mean ± standard deviation)

[0107]

[0108] Table 6: Changes in liver and kidney function indicators of rats in each dose group (unit: U / L or μmol / L or nmol / L, mean ± standard deviation)

[0109]

[0110] Table 7: Summary of histopathological examination results of various organs

[0111] The above comprehensive safety tests fully confirmed from both acute and long-term dimensions that the medicine-food composition of the present invention is highly safe for the body regardless of short-term ultra-large dose exposure or long-term regular consumption, laying a solid foundation for its subsequent wide application in the fields of medicine, health care and food.

[0112] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A preparation method and application of a uric acid-lowering and gout-treating medicinal and edible composition, characterized in that: It includes S1. A Chinese medicine composition comprising: celery seeds, sophora japonica seeds, chicory, dandelion, mulberry branches, papaya, and fresh Imperata cylindrica roots. S2. Purification and preparation of Chinese medicine preparations: Its preparation method adopts intelligent screening and fine pretreatment of raw materials, multi-stage targeted extraction process, intelligent concentration and precise molding steps, which can efficiently extract active ingredients and make them into a variety of dosage forms. S3. Application of Chinese medicine preparations: In terms of precision medical assistance, this combination can be used to customize personalized medication plans according to the different stages of gout, and achieve full digital management with the help of smart devices and cloud platforms; in daily smart family health care, it can facilitate family prevention of gout through smart home kitchen equipment and uric acid monitoring kits; it can also be used for the development of innovative healthy foods, such as uric acid regulating energy bars, gout prevention meal replacement powders, etc. In S1, the Chinese medicine composition is composed of 10-15 parts by mass of celery seeds, 8-12 parts by mass of Sophora japonica seeds, 12-18 parts by mass of chicory, 10-15 parts by mass of dandelion, 8-12 parts by mass of mulberry branches, 8-12 parts by mass of papaya, and 15-25 parts by mass of fresh Imperata cylindrica roots.

2. The oral preparation and preparation method thereof according to claim 1, characterized in that: The claimed traditional Chinese medicine composition consists of 15 parts by mass of celery seeds, 10 parts by mass of sophora japonica seeds, 12 parts by mass of chicory, 10 parts by mass of dandelion, 12 parts by mass of mulberry branches, 12 parts by mass of papaya, and 15 parts by mass of fresh Imperata cylindrica roots.

3. The oral preparation and preparation method thereof according to claim 1, characterized in that: In S2, the raw materials are intelligently screened and finely pretreated: the raw materials are screened with the help of spectral analysis technology and biological activity detection methods. For celery seeds, chicory, dandelions, and fresh white grass roots, batches with organic cultivation, no pesticide residues, and active ingredient content above a specific threshold are selected. After harvesting, supercritical fluid cleaning technology is used to remove impurities, and then vacuum freeze-drying technology is used to dry the materials at -40℃ to -50℃ to a moisture content of less than 99%; Sophora japonica seeds, mulberry branches, and papayas are manually selected to remove defects and worm-eaten parts, and then CNC cutting equipment is used to cut the Sophora japonica seeds and mulberry branches into 2-3 cm small segments, and papayas into thin slices of about 0.5 cm.

4. The oral preparation and preparation method thereof according to claim 1, characterized in that: In S2, a multi-stage targeted extraction process is used: first, the pretreated celery seeds, chicory, dandelion, and fresh Imperata root are mixed in a specific proportion and put into a dynamic countercurrent extraction device. Deionized water is used as the solvent, the solid-liquid ratio is controlled to be 1:-1:7, the extraction temperature is 40-50°C, the extraction time is shortened to 0.5 hours, and the extract is purified by ceramic membrane ultrafiltration; then, subcritical fluid extraction technology is used for Sophora japonica seeds, mulberry branches, and papaya to accurately extract fat-soluble active ingredients below the critical temperature and at a pressure of 0.6-0.9MPa. After the extraction, supercritical carbon dioxide extraction technology is used to remove the residual solvent; finally, the above two extracts are combined and placed in an ultrasonic extraction device, and ultrasonicated at a frequency of 40kHz-60kHz for 30-45 minutes.

5. The oral preparation and preparation method thereof according to claim 1, characterized in that: Intelligent concentration and precise molding in S2: the mixed extract after ultrasonic treatment is connected to the intelligent concentration control system, and is precisely concentrated to a thick extract with a relative density of 1.2-1.3 under the conditions of vacuum degree 0.08-0.1MPa and temperature 45-55℃; if oral preparations are prepared, according to big data analysis and clinical feedback, suitable pharmaceutical excipients are added for different dosage forms, 3D printing technology is used for capsule preparation, each capsule contains 0.4-0.6g of dry powder of the composition, and a high-speed tablet press is used to make tablets, each containing 0.5-0.7g of the composition, and appropriate amount of flavoring agents and preservatives are added to prepare oral liquid, diluted to the specified concentration and canned; if used for dietary additives, low-temperature spray drying technology is used to convert the extract into ultrafine powder with a particle size distribution between 1-10μm, and sealed and packaged.

6. The oral preparation and preparation method thereof according to claim 1, characterized in that: In S3, the application of uric acid treatment of gout medicine and food combination in precision medical assistance: during the acute attack of gout, with the help of smart medical equipment, the patient's uric acid level, inflammatory indicators and pain level are monitored, and a high-dose concentrated oral liquid treatment plan is tailored for the patient through big data analysis. It is taken once every 4 hours, 5 ml each time, and wearable devices are used to track the patient's recovery progress in real time, and the dosage and frequency of medication are adjusted in time; in the intermittent and chronic stages, it is switched to taking smart controlled-release capsules or sustained-release tablets for maintenance treatment. According to the individual metabolic characteristics of the patient, the release curve of the drug in the body is set. Through long-term regular medication, uric acid levels can be stabilized, gout recurrence can be prevented, and the damage of urate crystals to joints and kidneys is reduced. At the same time, a patient health management cloud platform is established to upload patient medication data, diet records, exercise status, uric acid monitoring values ​​and other information in real time. Doctors use artificial intelligence algorithms to analyze data and provide patients with accurate lifestyle recommendations and medication guidance.

7. The oral preparation and preparation method thereof according to claim 1, characterized in that: In S3, the application of the uric acid-lowering and gout-treating medicinal and edible combination in daily smart family health care: develop supporting smart home kitchen equipment with a built-in gout diet recommendation algorithm. When the family is preparing to cook, the user enters the health information of family members, and the device automatically recommends personalized recipes containing this combination. When making soup, it accurately prompts to add 3-8g of the combination powder 2-3 times a week. When cooking porridge, it prompts to sprinkle 2-5g of dry powder. The intelligent cooking program ensures that the ingredients of the combination are fully dissolved and retained during the cooking process; launch a family uric acid monitoring kit, including a convenient uric acid tester, a mobile phone APP, etc. Family members can regularly test their uric acid levels by themselves. The APP uploads the test data to the cloud platform, combines it with dietary intake data, and uses machine learning models to analyze the uric acid fluctuation trend, timely warns of high uric acid risks, reminds users to adjust their diet structure, and increase the frequency of application of the combination in the diet.

8. The oral preparation and preparation method thereof according to claim 1, characterized in that: In S3, the application of the uric acid-lowering and gout-treating medicinal and edible composite in the in-depth development of innovative healthy foods: Cooperate with food technology companies, based on the human nutritional demand model and gout prevention and treatment goals, use this composite to develop a series of high-tech, functional foods, such as the development of uric acid regulating energy bars, using 3D printing food molding technology to accurately combine the composite dry powder with high-quality protein, dietary fiber, low-sugar carbohydrates and other raw materials. Each energy bar contains 5g of composite dry powder, which meets the dual needs of sports enthusiasts for rapid energy replenishment and uric acid regulation before and after exercise; develop gout prevention meal replacement powder, combine intestinal microbial targeted regulation technology, add prebiotics, probiotics and other ingredients, so that the meal replacement powder can provide a sense of fullness while optimizing the intestinal flora and promoting uric acid excretion, providing busy office workers with a convenient and healthy gout prevention solution.

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