A composition, preparation and preparation method and application for protecting liver, strengthening kidney and reducing uric acid

Abstract

The application discloses a composition for protecting liver and strengthening kidney and reducing uric acid, which is made of the following raw material components: Anoectochilus roxburghii, dried tangerine or orange peel, chicory, gardenia, turmeric, Hovenia dulcis Thunb, Cistanche deserticola Y.C.Ma, Rehmannia glutinosa, potassium citrate, sodium citrate and goose myo-peptide. The composition combines the immortal concept of TCM (Traditional Chinese Medicine) "treating disease from the root" and the uric acid control method of modern nutritional medicine as an organic whole, and achieves multiple effects of protecting liver and strengthening kidney, mutual benefit of yin and yang and reducing uric acid through multiple action targets. Animal experiment results show that the composition can effectively reduce the activities of transaminase ALT and AST, relieve liver damage, reduce serum creatinine level and improve urea ammonia excretion rate, improve kidney function, inhibit the activities of xanthine oxidase and adenosine dehydrogenase and reduce uric acid level. The composition is safe and has no toxic side effects, is suitable for people with insufficient liver and kidney functions and hyperuricemia and has a wide application prospect.

Description

Technical Field

[0001] This invention relates to the fields of pharmaceuticals, health foods, and functional food preparations, specifically to a composition for protecting the liver, strengthening the kidneys, and lowering uric acid, and its application. Background Technology

[0002] As the main organ of metabolism, the liver participates in various important physiological activities and the metabolism of substances and energy, maintaining normal bodily functions. After food is ingested orally, it undergoes the action of gastric acid and various digestive enzymes in the gastrointestinal tract. Nutrients and harmful substances are absorbed in the small intestine and mainly enter the liver via the portal vein. The liver plays a first-pass role, filtering harmful substances and reducing the potential risk of damage to downstream organs in the systemic circulation. Therefore, liver damage can affect the physiological health of other organs in the body from the source. In addition, the kidneys are key functional organs in the human urinary system, responsible for filtering metabolic products and producing urine for excretion. They also have important functions such as regulating fluid balance, maintaining acid-base balance, and regulating blood pressure. Kidney dysfunction may lead to the accumulation of metabolic products in the kidneys, and in severe cases, damage to the normal kidney structure.

[0003] Uric acid primarily originates from the body's own metabolism and dietary intake. Nucleoproteins and nucleic acids in the body, along with dietary purines, are metabolized and broken down by the liver to form uric acid, which exists in the blood. Most uric acid is excreted through the kidneys. Hyperuricemia is a metabolic disease caused by purine metabolism disorders or impaired uric acid excretion, leading to elevated blood uric acid levels. Early-stage hyperuricemia is generally asymptomatic, but as serum uric acid levels continue to rise, urate crystals precipitate, crystallize, and deposit in body tissues. This can not only trigger gout but also lead to various complications such as kidney damage, liver damage, urinary tract stones, arteriosclerosis, and myocardial infarction, severely impacting the patient's quality of life.

[0004] Clinically, medications for treating hyperuricemia mainly include those that inhibit uric acid production and those that promote uric acid excretion. However, these medications often have certain side effects, such as gastrointestinal irritation, skin rashes, and liver damage. Long-term use may further harm the patient's health. In traditional medicine, various natural plants have been used to treat hyperuricemia and related diseases. These natural plants have been proven in long-term clinical practice to have certain uric acid-lowering and liver and kidney-protecting effects. In addition, functional active ingredients such as polyphenols, polysaccharides, active peptides, terpenes, saponins, and alkaloids have been verified in vitro or in vivo to have potential efficacy in combating hyperuricemia. Compared with clinical drugs, developing a safe, low-toxicity composition that reduces uric acid production and promotes uric acid excretion by protecting the liver and kidneys, thereby exerting uric acid-lowering activity, has a better application prospect in the treatment of hyperuricemia. Summary of the Invention

[0005] The purpose of this invention is to develop a composition that has multiple effects of protecting the liver, strengthening the kidneys, and lowering uric acid. This composition uses non-toxic and non-food-grade active substances that can be used in both medicine and food. By strengthening and repairing the functions of the liver and kidneys, it regulates the synthesis and excretion of uric acid, thereby achieving a significant effect of lowering uric acid.

[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0007] This invention discloses a composition for protecting the liver, strengthening the kidneys, and lowering uric acid, which is composed of the following raw materials in parts by weight: 2-20 parts of Anoectochilus roxburghii, 10-50 parts of dried tangerine peel, 10-50 parts of chicory, 20-80 parts of gardenia, 2-40 parts of turmeric, 5-50 parts of Japanese raisin tree fruit, 20-50 parts of Cistanche deserticola, 10-50 parts of Rehmannia glutinosa, 10-50 parts of potassium citrate, 20-60 parts of sodium citrate, and 20-80 parts of chebulic myokinase.

[0008] Furthermore, the composition comprises the following raw materials in parts by weight: 5-15 parts of Anoectochilus roxburghii, 20-40 parts of dried tangerine peel, 20-50 parts of chicory, 30-60 parts of gardenia, 3-30 parts of turmeric, 10-40 parts of Japanese raisin tree fruit, 25-45 parts of Cistanche deserticola, 20-40 parts of Rehmannia glutinosa, 20-40 parts of potassium citrate, 20-40 parts of sodium citrate, and 30-80 parts of serotonin.

[0009] Furthermore, the composition comprises the following raw materials in parts by weight: 5-10 parts of Anoectochilus roxburghii, 30-40 parts of dried tangerine peel, 30-50 parts of chicory, 30-50 parts of gardenia, 3-20 parts of turmeric, 15-30 parts of Japanese raisin tree fruit, 25-35 parts of Cistanche deserticola, 25-35 parts of Rehmannia glutinosa, 25-35 parts of potassium citrate, 25-35 parts of sodium citrate, and 35-60 parts of chebulic myosin.

[0010] This invention also provides a method for preparing the aforementioned liver-protecting, kidney-strengthening, and uric acid-lowering composition, comprising the following steps:

[0011] (1) Preparation of materials: Weigh each raw material according to the weight parts;

[0012] (2) Grinding: Grind the following ingredients separately: Anoectochilus roxburghii, dried tangerine peel, chicory, gardenia, turmeric, Japanese raisin tree fruit, Cistanche deserticola, and Rehmannia glutinosa to obtain the raw materials.

[0013] (3) Extraction: Soak and extract the pulverized raw material in solvent;

[0014] (4) Preparation of extract: The extract solutions are filtered, concentrated and dried, and then combined to obtain the extract;

[0015] (5) Product: Potassium citrate, sodium citrate and cheesin were added to the extract and mixed to prepare the composition.

[0016] Furthermore, the solvent is water or ethanol, the extraction is carried out under heating conditions, the extraction is performed 1-3 times, each time for 2-3 hours, and the drying is spray drying.

[0017] Another objective of this invention is to provide a preparation for protecting the liver and kidneys and lowering uric acid, the raw materials of which include the aforementioned composition and commonly used excipients.

[0018] Furthermore, the commonly used excipients are those that are pharmaceutically or food-grade acceptable.

[0019] Furthermore, the excipients include one or more of the following: fillers, disintegrants, binders, lubricants, sweeteners, thickeners, release agents, diluents, suspending agents, and flavoring agents.

[0020] Furthermore, the compound preparation is a powder, tea, tablet, pill, granule, capsule, solution, soft candy, emulsion, suspension or oil.

[0021] The present invention also provides the use of the described composition or the described compound preparation in the preparation of health foods, functional foods or drugs that protect the liver, strengthen the kidneys and lower uric acid.

[0022] This composition, through reasonable formulation, fully leverages the synergistic effects of its components to achieve multiple benefits including liver protection, kidney strengthening, and uric acid reduction. It is safe and free of toxic side effects, making it suitable for the prevention and management of hyperuricemia and related complications for those who require liver and kidney protection and strengthening.

[0023] The liver-protecting, kidney-strengthening, and uric acid-lowering composition of the present invention is made from the following raw material components: Anoectochilus roxburghii, dried tangerine peel, chicory, gardenia, turmeric, Japanese raisin tree fruit, Cistanche deserticola, Rehmannia glutinosa, potassium citrate, sodium citrate, and goose muscle peptide.

[0024] *Anoectochilus roxburghii* (Golden Thread Orchid): Sweet and neutral in nature. Rich in alkaloids, polysaccharides, saponins, flavonoids, esters, volatile oils, and other bioactive components, it possesses various effects including clearing heat and cooling blood, detoxifying and reducing swelling, dispelling wind and dampness, calming the nerves and liver, tonifying the kidneys and strengthening bones, promoting urination and relieving strangury, and moistening the lungs and relieving cough. Among these, *Anoectochilus roxburghii* glycosides are glycosides formed by glucose and the chiral carbon of a five-membered lactone ring linked by an oxygen-glycosidic bond, and are widely found in *Anoectochilus roxburghii*. Studies have shown that *Anoectochilus roxburghii* glycosides have a wide range of pharmacological activities, including protecting the liver, lowering blood lipids, lowering blood sugar, relieving pain, and reducing inflammation. Furthermore, *Anoectochilus roxburghii* glycosides can protect blood vessels under high glucose conditions.

[0025] Dried tangerine peel: It has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm. It contains a variety of volatile oils and flavonoids, which can promote gastrointestinal motility and aid digestion, reduce the absorption of purine foods, control the production of uric acid from the source, reduce the burden on the liver, and at the same time, it also has a diuretic effect, which can help excrete uric acid by promoting urine excretion.

[0026] Chicory: With a bitter and cold nature, it has the effects of clearing heat and detoxifying, clearing the liver and gallbladder, and promoting diuresis and reducing swelling. It contains active ingredients such as fraxin and chicoric acid, which have effects such as lowering blood lipids, lowering blood sugar, and protecting the liver. It can regulate uric acid metabolism and promote uric acid excretion. Modern research shows that chicory can accelerate phospholipid synthesis and speed up liver cell repair, thus achieving the purpose of liver protection.

[0027] Gardenia: It is bitter and cold in nature, and has the effects of purging fire and relieving irritability, clearing heat and promoting diuresis, cooling blood and detoxifying. It contains active ingredients such as geniposide, which have anti-inflammatory and antioxidant effects, and can promote uric acid excretion and lower blood uric acid levels.

[0028] Turmeric: Pungent, bitter, and warm in nature. It enters the spleen and liver meridians. It can promote blood circulation, regulate qi, and relieve pain. Modern research shows that curcumin can exert good preventive and therapeutic effects on various experimental liver injuries, including those caused by chemicals, alcohol, and drugs, by regulating oxidative stress, inhibiting the release of inflammatory factors, and regulating hepatocyte apoptosis.

[0029] Hovenia dulcis fruit: Sweet and neutral in nature, it enters the heart, spleen, and kidney meridians. It has the effects of quenching thirst, relieving irritability, nourishing the five internal organs, and detoxifying alcohol. Modern research shows that Hovenia dulcis fruit can not only accelerate the metabolism and excretion of alcohol in the body, reducing the degree of intoxication and shortening the sobering time, but also has the effect of clearing heat and promoting diuresis, significantly improving symptoms such as difficulty urinating and edema. Its active ingredient, dihydromyricetin, has been proven to have broad liver protective effects, including improving acute liver injury, alleviating alcoholic and non-alcoholic fatty liver, regulating liver regeneration, inhibiting malignant transformation of hepatocytes, and reducing the incidence of liver cancer.

[0030] Cistanche deserticola: It tastes sweet and salty, and is warm in nature. It tonifies kidney yang, benefits essence and blood, is warm but not drying, and nourishes without being drastic. It nourishes the five internal organs, strengthens yin, and benefits essence and qi. It contains Cistanche deserticola polysaccharides and other components, and is used to treat kidney deficiency, bone weakness, and soreness in the waist and knees.

[0031] Rehmannia root: It has a sweet taste and the effects of nourishing yin and tonifying the kidneys, clearing heat and promoting body fluids, cooling blood and stopping bleeding. It contains ingredients such as Rehmannia polysaccharides, which can protect the liver and enhance the body's metabolic function.

[0032] Potassium citrate and sodium citrate, as food additives, play a role in regulating acid-base balance. They can alkalize urine, increase the solubility of uric acid, and promote uric acid excretion, thereby lowering blood uric acid levels. Citrate can also act as an inhibitor of endogenous stone formation, dissolving existing uric acid stones and preventing new stones. This application uses sodium and potassium citrates. By employing two different forms of citrate, it maintains electrolyte balance in the body while synergistically regulating urine pH through different mechanisms of action.

[0033] Goose muscle peptides: As a novel food supplement, they inhibit uric acid production and promote uric acid excretion. They can improve liver and kidney function in patients with hyperuricemia, thus helping to regulate uric acid metabolism. Furthermore, they have the advantages of no toxic side effects and no dependence with long-term use. Goose muscle peptides are histidine dipeptides found in the skeletal muscle and brain tissue of vertebrates. They can be extracted from chicken, beef, and deep-sea fish muscle, and can also be prepared through enzymatic synthesis, chemical synthesis, and other methods.

[0034] In Traditional Chinese Medicine (TCM) theory, the liver and kidneys reside in the lower burner (lower abdomen), and their physiological and pathological relationships are closely intertwined. The liver stores blood, while the kidneys store essence. Kidney essence can transform into liver blood, ensuring sufficient liver blood and nourishing and restraining liver yang to prevent hyperactivity; liver blood can also nourish kidney essence, ensuring sufficient kidney essence and thus maintaining the harmonious balance of yin and yang within the kidneys. Pathologically, due to the close relationship between essence and blood, deficiencies in essence and blood can mutually affect each other. If kidney essence is insufficient, it is difficult to generate enough liver blood, leading to liver blood deficiency; if liver blood is insufficient, it cannot effectively nourish kidney essence, leading to kidney essence deficiency, thus causing deficiency of essence and blood or liver and kidney yin deficiency. Deficiency of liver and kidney yin can lead to internal heat disturbance, resulting in impaired circulation of qi and blood, which in turn affects the production and excretion of uric acid. By protecting the liver and strengthening the kidneys, and ensuring sufficient essence and blood, water metabolism can be promoted, reducing the obstruction of dampness in the body on qi, blood, and internal organs, improving the metabolism and excretion of uric acid, thereby lowering the concentration of uric acid in the body.

[0035] This application's composition utilizes the combined effects of *Anoectochilus roxburghii*, chicory, and gardenia to clear heat, detoxify, and promote diuresis; tangerine peel to strengthen the spleen, regulate qi, and promote diuresis; and turmeric and Japanese raisin tree fruit to reduce the burden on the liver and enhance its cleansing capacity. *Cistanche deserticola* and *Rehmannia glutinosa* nourish the liver and kidneys, fulfilling the function of regulating water metabolism. The combined ingredients achieve the effects of tonifying the liver and kidneys and clearing away dampness and turbidity, thus treating both the spleen and kidneys to address the root cause and eliminating dampness and turbidity to clear the source. To significantly enhance the uric acid-lowering effect, this invention innovatively integrates modern nutritional medicine theory, adding potassium citrate and sodium citrate—two different citrate salts—to synergistically alkalize urine and promote uric acid excretion. Simultaneously, it introduces goose muscle peptides to construct a dual regulatory mechanism, which can both block the uric acid production pathway and improve liver and kidney damage caused by hyperuricemia. The rational integration of these ingredients complements and promotes each other, forming a three-in-one metabolic regulatory network of "protecting the liver and blocking the source, strengthening the kidneys and promoting excretion, and dual-effect inhibition of synthesis," comprehensively enhancing the uric acid-lowering effect.

[0036] The composition of this application utilizes the advantages of holistic conditioning in traditional Chinese medicine and combines it with modern medical methods for regulating uric acid. As an organic whole, it works through multiple target sites to achieve liver protection, kidney strengthening, and uric acid reduction. It can not only effectively inhibit uric acid production and promote uric acid excretion, but also protect metabolic organs such as the liver and kidneys. Attached Figure Description

[0037] Figure 1 The effects of each group on the levels of uric acid, xanthine oxidase, and adenosine deaminase in the serum of hyperuricemic mice; among them Figure 1 In this context, A represents the serum uric acid content. Figure 1 In this context, B represents the xanthine oxidase content. Figure 1 The C in the figure represents the content of adenosine deaminase.

[0038] Figure 2 The effects of each group on the serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels in hyperuricemic mice were investigated. Figure 2 In this context, A represents the serum alanine aminotransferase (ALT) level. Figure 2 B in the figure represents the aspartate aminotransferase (AST) content.

[0039] Figure 3 The effects of each group on serum creatinine and blood urea nitrogen levels in hyperuricemic mice; among them Figure 3 In this context, A represents the serum creatinine level. Figure 3 B in the figure represents the urea nitrogen content.

[0040] Note: Compared with the model control group, * P <0.05, ** P <0.01. Detailed Implementation

[0041] The present invention will now be clearly and completely described with reference to specific embodiments, but the present invention is not limited thereto. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0042] Example 1

[0043] A composition for protecting the liver, strengthening the kidneys, and lowering uric acid, characterized in that the composition is composed of the following raw materials in parts by weight: 20 parts of Anoectochilus roxburghii, 50 parts of dried tangerine peel, 50 parts of chicory, 80 parts of gardenia, 40 parts of turmeric, 50 parts of Japanese raisin tree fruit, 50 parts of Cistanche deserticola, 50 parts of Rehmannia glutinosa, 50 parts of potassium citrate, 60 parts of sodium citrate, and 80 parts of chebulic myosin.

[0044] Example 2

[0045] A composition for protecting the liver, strengthening the kidneys, and lowering uric acid, characterized in that the composition is composed of the following raw materials in parts by weight: 10 parts of Anoectochilus roxburghii, 40 parts of dried tangerine peel, 40 parts of chicory, 50 parts of gardenia, 20 parts of turmeric, 30 parts of Japanese raisin tree fruit, 35 parts of Cistanche deserticola, 35 parts of Rehmannia glutinosa, 35 parts of potassium citrate, 35 parts of sodium citrate, and 60 parts of serotonin.

[0046] Example 3

[0047] A composition for protecting the liver, strengthening the kidneys, and lowering uric acid, characterized in that the composition is composed of the following raw materials in parts by weight: 5 parts of Anoectochilus roxburghii, 35 parts of dried tangerine peel, 30 parts of chicory, 45 parts of gardenia, 10 parts of turmeric, 20 parts of Japanese raisin tree fruit, 30 parts of Cistanche deserticola, 30 parts of Rehmannia glutinosa, 30 parts of potassium citrate, 30 parts of sodium citrate, and 50 parts of serotonin.

[0048] Example 4

[0049] A composition for protecting the liver, strengthening the kidneys, and lowering uric acid, characterized in that the composition is composed of the following raw materials in parts by weight: 5 parts of Anoectochilus roxburghii, 30 parts of dried tangerine peel, 30 parts of chicory, 30 parts of gardenia, 3 parts of turmeric, 15 parts of Japanese raisin tree fruit, 25 parts of Cistanche deserticola, 25 parts of Rehmannia glutinosa, 25 parts of potassium citrate, 25 parts of sodium citrate, and 35 parts of serotonin.

[0050] Example 5

[0051] A composition for protecting the liver, strengthening the kidneys, and lowering uric acid, characterized in that the composition is composed of the following raw materials in parts by weight: 2 parts of Anoectochilus roxburghii, 10 parts of dried tangerine peel, 10 parts of chicory, 20 parts of gardenia, 2 parts of turmeric, 5 parts of Japanese raisin tree fruit, 20 parts of Cistanche deserticola, 10 parts of Rehmannia glutinosa, 10 parts of potassium citrate, 20 parts of sodium citrate, and 20 parts of serotonin.

[0052] Example 6

[0053] A method for preparing a liver-protecting, kidney-strengthening, and uric acid-lowering composition includes the following steps:

[0054] (1) Preparation of materials: Weigh each raw material according to the weight parts;

[0055] (2) Grinding: Grind the following ingredients separately: Anoectochilus roxburghii, dried tangerine peel, chicory, gardenia, turmeric, Japanese raisin tree fruit, Cistanche deserticola, and Rehmannia glutinosa to obtain the raw materials.

[0056] (3) Extraction: Soak the pulverized raw material in water equal to 8 times the amount of medicinal material for 0.5 hours, heat to boiling and extract for 2 hours, and repeat the extraction twice;

[0057] (4) Preparation of extract: The extract solutions are filtered, concentrated, spray-dried and combined to obtain the extract;

[0058] (5) Product: Potassium citrate, sodium citrate and cheesin were added to the extract and mixed to prepare the composition.

[0059] Comparative Example 1

[0060] A composition for protecting the liver, strengthening the kidneys, and lowering uric acid, characterized in that the composition is composed of the following raw materials in parts by weight: 5 parts Poria cocos, 35 parts dried tangerine peel, 30 parts chicory, 45 parts gardenia, 10 parts turmeric, 20 parts Japanese raisin tree fruit, 30 parts Morinda officinalis, 30 parts Rehmannia glutinosa, 30 parts potassium citrate, 30 parts sodium citrate, and 50 parts cheesin.

[0061] Comparative Example 2

[0062] A composition for protecting the liver, strengthening the kidneys, and lowering uric acid, characterized in that the composition is composed of the following raw materials in parts by weight: 5 parts of Anoectochilus roxburghii, 35 parts of dried tangerine peel, 30 parts of chicory, 45 parts of gardenia, 10 parts of turmeric, 20 parts of Japanese raisin tree fruit, 30 parts of Cistanche deserticola, 30 parts of Rehmannia glutinosa, 30 parts of potassium citrate, 30 parts of sodium bicarbonate, and 50 parts of carnosine.

[0063] Comparative Example 3

[0064] A composition for protecting the liver, strengthening the kidneys, and lowering uric acid, characterized in that the composition is composed of the following raw materials in parts by weight: 5 parts of Anoectochilus roxburghii, 35 parts of dried tangerine peel, 30 parts of chicory, 45 parts of gardenia, 10 parts of turmeric, 20 parts of Japanese raisin tree fruit, 30 parts of Cistanche deserticola, and 30 parts of Rehmannia glutinosa.

[0065] Comparative Example 4

[0066] A composition for protecting the liver, strengthening the kidneys, and lowering uric acid, characterized in that the composition is composed of the following raw materials in parts by weight: 30 parts potassium citrate, 30 parts sodium citrate, and 50 parts chemoresin.

[0067] The invention is further illustrated below with specific effect experiments:

[0068] The animal experiments of this invention used SPF-grade male Kunming mice, weighing 18-22g. The animals were housed under specific pathogen-free conditions, with the temperature maintained at 20-25℃, 12 hours of light per day, and free access to food and water. The experiments were conducted after one week of acclimatization.

[0069] Potassium oxonate used in the experiment was purchased from Sigma-Aldrich. The kits for detecting uric acid (UA), xanthine oxidase (XOD), adenosine deaminase (ADA), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine (CRE), and blood urea nitrogen (BUN) were purchased from Nanjing Jiancheng Bioengineering Research Institute Co., Ltd. All other reagents and raw materials were commercially available products.

[0070] Animal grouping: Mice that had been acclimatized for 1 week were randomly divided into 9 groups: blank group, model control group, example groups 1-3, and comparative groups 1-4, with 10 mice in each group.

[0071] Animal model establishment and administration: Potassium oxanoate was suspended in 0.5% sodium carboxymethyl cellulose solution. Except for the normal control group, mice in other groups were intraperitoneally injected with potassium oxanoate at a dose of 500 mg / kg daily to establish a mouse model of hyperuricemia. One hour after injection, the example and control groups were administered the same dose of potassium oxanoate by gavage at 100 mg / kg daily, while the normal control and model groups were administered the same volume of the solvent by gavage, once daily for 21 consecutive days. Blood samples were collected from the eyeballs two hours after the last administration on day 21. After the blood samples were allowed to stand, they were centrifuged to separate the serum for subsequent indicator detection. After blood collection, the liver and kidneys were quickly removed on an ice plate, and various indicators were measured according to the kit instructions.

[0072] Experimental Results and Analysis:

[0073] (1) Effects on serum uric acid (UA), xanthine oxidase (XOD) and adenosine deaminase (ADA) levels in hyperuricemic mice

[0074] Potassium oxonate is a uricase inhibitor that inhibits uric acid breakdown, increases serum uric acid levels, and creates an animal model of hyperuricemia. It is widely used to evaluate the uric acid-lowering effects of drugs. Serum uric acid concentration is an indicator of the success of the mouse model. The results showed that the serum uric acid concentration in the model group was significantly higher than that in the control group, indicating that the hyperuricemia model had been successfully established.

[0075] The results are shown in Table 1 and Figure 1 As shown, compared with the model control group, the serum uric acid concentrations of the compositions in Examples 1-3 of this application were significantly reduced, indicating that the compositions of the examples can effectively reduce uric acid. However, in Comparative Example 1, which used Poria cocos and Morinda officinalis with similar effects to replace Anoectochilus roxburghii and Cistanche deserticola, and in Control Group 2, which adjusted the alkaline salts and histidine dipeptide, and in Comparative Examples 3-4, which used only plant raw materials or directly mixed with potassium citrate, sodium citrate, and anserine peptide, the uric acid levels did not show a significant reduction compared with the model group. This indicates that there is a synergistic effect between the raw material components of this application.

[0076] ADA and XOD are key enzymes in the catabolism of purine nucleotides and play an important role in the formation of uric acid in vivo. The activities of XOD and ADA in the serum and liver tissue of the model group mice were significantly increased compared to the control group, indicating that intraperitoneal injection of potassium oxonate can significantly increase the activity of XOD and ADA in mice, thereby promoting uric acid production. The compositions of Examples 1-3 effectively inhibited the concentration of XOD and ADA in mouse serum, achieving a uric acid-lowering effect by inhibiting the activity of xanthine oxidase and adenosine deaminase in the liver. In contrast, the activities of xanthine oxidase and adenosine deaminase in Comparative Examples 1-4 did not show a significant reduction.

[0077] Table 1. Serum uric acid (UA), xanthine oxidase (XOD), and adenosine deaminase (ADA) levels in each group of mice (x̄±s, n=10)

[0078]

[0079] (2) Effects on serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels in hyperuricemic mice

[0080] Serum ALT and AST levels are important indicators for clinical evaluation of liver function. The experimental results are shown in Table 2 below. Figure 2 As shown, compared with the blank group, the serum AST and ALT activities of the model group mice were significantly increased, indicating that the liver function of hyperuricemic mice was significantly damaged. Compared with the model control group, the compositions of this application in Examples 1-3 all significantly reduced the serum AST and ALT levels in mice, indicating that they can effectively inhibit AST and ALT activities, thereby improving liver damage caused by hyperuricemia. Although the control group also showed a certain decreasing trend, there was no significant difference compared with the model group.

[0081] Table 2. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels in mice (x̄±s, n=10)

[0082]

[0083] (3) Effects on serum creatinine (CRE) and blood urea nitrogen (BUN) levels in mice with hyperuricemia.

[0084] The kidneys are vital organs for regulating blood uric acid levels. Serum creatinine and blood urea nitrogen are important indicators of kidney function, both of which are metabolized by the kidneys. Their levels rise significantly when the kidneys are damaged, reflecting the degree of kidney function impairment. The results of this experiment are shown in Table 3 below. Figure 3 The results showed that, compared with the blank group, the levels of urea nitrogen and creatinine in the model group were significantly increased, indicating that persistent hyperuricemia can cause kidney damage. In contrast, the serum creatinine and urea nitrogen levels in Examples 1-3 were significantly lower than those in the model group, demonstrating that the composition of this application effectively alleviates hyperuricemia-mediated renal tissue pathological damage through multiple pathways and has an appropriate protective effect against kidney damage caused by hyperuricemia. In the comparative groups, except for Comparative Example 2, which showed a more significant decrease in urea nitrogen compared to the model group (…),… P <0.05), and the serum creatinine and urea nitrogen in the other control groups were not statistically different from those in the model group. This shows that the control groups could not effectively improve the damage of hyperuricemia to the kidney function of the experimental animals.

[0085] Table 3 Effects of different groups of mice on serum creatinine (CRE) and blood urea nitrogen (BUN) levels (x̄±s, n=10)

[0086]

[0087] The above experimental results indicate that the composition can effectively reduce serum uric acid, xanthine oxidase, and adenosine deaminase levels in mice with potassium oxonate-induced hyperuricemia. Serum aspartate aminotransferase, alanine aminotransferase, blood urea nitrogen, and creatinine levels were also significantly reduced, thus improving liver and kidney damage caused by hyperuricemia. This study found that the composition of this application can significantly reduce serum uric acid in hyperuricemic mice and has a protective effect on the liver and kidneys.

[0088] Although embodiments of the invention have been disclosed for illustrative purposes, those skilled in the art will understand that various substitutions, variations, deletions, additions, and modifications are possible without departing from the spirit and scope of the invention and the appended claims. Therefore, the scope of the invention is not limited to the contents disclosed in the embodiments.

Claims

1. A composition for protecting the liver and kidneys and lowering uric acid, characterized in that, The composition comprises the following raw materials in parts by weight: 2-20 parts of Anoectochilus roxburghii, 10-50 parts of dried tangerine peel, 10-50 parts of chicory, 20-80 parts of gardenia, 2-40 parts of turmeric, 5-50 parts of Japanese raisin tree fruit, 20-50 parts of Cistanche deserticola, 10-50 parts of Rehmannia glutinosa, 10-50 parts of potassium citrate, 20-60 parts of sodium citrate, and 20-80 parts of chebulic myosin.

2. The composition for protecting the liver, strengthening the kidneys, and lowering uric acid according to claim 1, characterized in that, The composition comprises the following raw materials in parts by weight: 5-15 parts of Anoectochilus roxburghii, 20-40 parts of dried tangerine peel, 20-50 parts of chicory, 30-60 parts of gardenia, 3-30 parts of turmeric, 10-40 parts of Japanese raisin tree fruit, 25-45 parts of Cistanche deserticola, 20-40 parts of Rehmannia glutinosa, 20-40 parts of potassium citrate, 20-40 parts of sodium citrate, and 30-80 parts of chebulic myosin.

3. The composition for protecting the liver, strengthening the kidneys, and lowering uric acid according to claim 1 or 2, characterized in that, The composition comprises the following raw materials in parts by weight: 5-10 parts of Anoectochilus roxburghii, 30-40 parts of dried tangerine peel, 30-50 parts of chicory, 30-50 parts of gardenia, 3-20 parts of turmeric, 15-30 parts of Japanese raisin tree fruit, 25-35 parts of Cistanche deserticola, 25-35 parts of Rehmannia glutinosa, 25-35 parts of potassium citrate, 25-35 parts of sodium citrate, and 35-60 parts of chebulic myosin.

4. A method for preparing the composition according to any one of claims 1-3, characterized in that, Includes the following steps: (1) Preparation of materials: Weigh each raw material according to the weight parts; (2) Grinding: Grind the following ingredients separately: Anoectochilus roxburghii, dried tangerine peel, chicory, gardenia, Cistanche deserticola, Rehmannia glutinosa, Hovenia dulcis, and turmeric to obtain the raw materials. (3) Extraction: Soak and extract the pulverized raw material in solvent; (4) Preparation of extract: The extract solutions are filtered, concentrated, dried and combined to obtain the extract; (5) Product: Potassium citrate, sodium citrate and angel peptide were added to the extract and mixed to prepare the composition. The solvent is water, the extraction is carried out under heating conditions, the extraction is performed 1-3 times, each time for 2-3 hours, and the drying is spray drying.

5. A preparation for protecting the liver and kidneys and lowering uric acid, characterized in that, The formulation is made from the composition according to any one of claims 1-3 and commonly used excipients.

6. The formulation according to claim 5, characterized in that, The excipients include one or more of the following: fillers, disintegrants, binders, lubricants, thickeners, release agents, diluents, suspending agents, and flavoring agents.

7. The formulation according to claim 5 or 6, characterized in that, The preparation is a pharmaceutical product.

8. The formulation according to claim 5 or 6, characterized in that, The dosage form of the preparation is powder, tablet, pill, granule, capsule, solution, soft candy, emulsion, suspension or oil.

9. The formulation according to claim 8, characterized in that, The solution is a tea preparation.

10. The use of the composition according to any one of claims 1-3 or the formulation according to any one of claims 5-9 in the preparation of a hepatoprotective, renal tonifying, and uric acid-lowering drug.

Images