Oral preparation of medicinal and edible extract composition capable of rapidly reducing uric acid and preparation method of oral preparation

Abstract

The invention discloses an oral preparation of a medicinal and edible extract composition capable of rapidly reducing uric acid and a preparation method of the oral preparation. The preparation method comprises the following steps: S1, compatibility of a traditional Chinese medicine combination group, wherein the traditional Chinese medicine combination group comprises celery seeds, sour cherries, sophora flower buds, cichorium intybus, dandelions, coix seeds, poria cocos, turmeric, fresh lalang grass rhizome and chrysanthemum. S2, extracting, concentrating, spray-drying and crushing the traditional Chinese medicine composition to obtain dry powder, and adding pharmaceutic adjuvants to prepare the traditional Chinese medicine preparation. The traditional Chinese medicine preparation prepared by the invention has an inhibiting effect on oxidative stress of an organism caused by increase of uric acid, effectively removes free radicals such as hydroxyl radicals, DPPH, superoxide anions and ABTS, remarkably inhibits the activity of xanthine oxidase, and is beneficial to reduction of generation of uric acid in the body of a patient.

Description

Technical Field

[0001] The invention belongs to the technical field of functional foods, and in particular to an oral preparation of a medicine-food homologous extraction composition capable of rapidly lowering uric acid and a preparation method thereof. Background Art

[0002] There are two main sources of uric acid (UA) in the human body, exogenous and endogenous. Among them, exogenous uric acid comes from the decomposition of food ingested by the human body, and endogenous uric acid comes from the synthesis of small molecule compounds or nucleic acid decomposition in the body. In a normal human body, more than 99% of uric acid in the blood circulation exists in the form of urate, and blood uric acid fluctuates in a narrow range; the normal uric acid value is: 210-416μmol / L for men, 150-357μmol / L for women before menopause, and close to the male value after menopause.

[0003] However, if a person is in a normal diet state and the fasting blood uric acid level is tested twice at different times, and the level is >420μmol / L for men and >360μmol / L for women, it is called hyperuricemia. Hyperuricemia refers to a state in which uric acid accumulates in the blood due to purine metabolism disorders, excessive uric acid secretion or renal excretion dysfunction; it is a direct cause of gout. When the blood uric acid concentration is too high or in an acidic environment, uric acid can precipitate crystals and deposit in bone joints, kidneys, subcutaneous tissues, causing histopathological changes; it can mainly manifest as acute arthritis, tophi, chronic arthritis, joint deformities, chronic interstitial nephritis and uric acid urinary stones. In recent years, with the rapid development of the economy, people's living and eating habits have changed, and the intake of animal protein and fat has increased significantly. At the same time, factors such as changes in lifestyle and reduced physical activity have significantly increased the prevalence of gout, and the onset has also tended to be younger. Hyperuricemia has become the fourth highest after the "three highs" (high blood pressure, high blood lipids, and high blood sugar), and has also become the second largest metabolic disease in the world after diabetes. Relevant epidemiological studies have shown that the global prevalence of hyperuricemia is 5% to 25%.

[0004] Tophi are a common chronic clinical manifestation of gout, characterized by recurrent inflammation and the formation of chronic granulomas, and are typical features of refractory gout. Tophi generally appear 10 years after the first attack of gouty arthritis. Patients with long-term tophi often experience loss of joint function and acute, as well as complications such as skin ulcer infection, hypertension, diabetes, chronic kidney disease, and cardiovascular accidents, which seriously affect the patient's quality of life. Current drug treatments have limited efficacy for tophi, and surgical treatment is the last line of defense for tophi. However, because tophi are not clearly defined, intraoperative removal is less effective.

[0005] There are three main types of uric acid-lowering drugs commonly used on the market. One type is drugs that inhibit uric acid production. The principle is to inhibit the activity of xanthine oxidase, such as Febuxostat and allopurinol; one type is drugs that promote the excretion of uric acid by the kidneys, such as benzbromarone and probenecid; and another type is painkillers for gout attacks, such as colchicine. These three types of drugs are single-target drugs and have obvious side effects, such as liver and kidney damage, severe allergic reactions, etc. Traditional Chinese medicine is mostly in the form of tea bags, which has few side effects, but the effect is slow and cannot relieve the pain of gout patients in time.

[0006] Chinese medicine has had the theory of "medicine and food have the same origin" (also known as "medicine and food have the same origin, food and medicine have the same origin") since ancient times. This theory holds that many foods are both food and medicine, and food and medicine can prevent and treat diseases. If such substances can be used as the basic formula to develop foods or drinks that can quickly reduce uric acid, it will be of great significance to reduce the damage to liver and kidney function and allergic reactions caused by chemical drugs, and improve the slow effect of Chinese medicine slices. Summary of the invention

[0007] 1. Technical problems to be solved

[0008] In view of the shortcomings and deficiencies of existing formulas and technologies, the present invention provides an oral preparation of a medicine-food extract composition with the ability to quickly lower uric acid and a preparation method thereof. The formula of a traditional Chinese medicine composition is designed, specific medicine-food products are screened, the traditional Chinese medicine composition is subjected to water treatment and distillation purification, and the purified product is further made into a uric acid-lowering oral liquid or concentrated and then added with an excipient to form an oral preparation. The oral administration test proves that the preparation 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 traditional Chinese medicine decoctions and Chinese patent medicines.

[0009] 2. Technical solution

[0010] In order to achieve the above purpose, the main technical solutions adopted by the present invention include:

[0011] In a first aspect, the present invention provides an oral preparation of a medicinal and edible extract composition having the effect of rapidly lowering uric acid and a preparation method thereof, comprising:

[0012] S1. The Chinese medicine composition is composed of celery seeds, sour cherries, sophora japonica seeds, chicory, dandelions, coix seeds, poria cocos, turmeric, fresh white imperata roots and chrysanthemums.

[0013] S2. Water treatment and distillation purification for oral preparations: decoct the Chinese medicine in water, combine the decoction, filter, combine the filtrate with the distilled aqueous solution, concentrate, precipitate with alcohol, take the supernatant and concentrate it under reduced pressure to dry powder, grind it, mix it with the inclusion compound obtained above, add pharmaceutical excipients, and prepare oral preparations.

[0014] According to a preferred embodiment of the present invention, in S1, the Chinese medicine composition is composed of 5-30 parts by mass of celery seeds, 5-10 parts by mass of sour cherries, 5-10 parts by mass of sophora japonica seeds, 5-10 parts by mass of chicory, 10-40 parts by mass of dandelions, 1-10 parts by mass of coix seeds, 10-40 parts by mass of poria, 10-30 parts by mass of turmeric, 10-30 parts by mass of fresh white imperata roots, and 10-40 parts by mass of chrysanthemums.

[0015] Further preferably, the traditional Chinese medicine composition comprises 0 parts by mass of celery seeds, 10 parts by mass of sour cherries, 10 parts by mass of sophora japonica seeds, 10 parts by mass of chicory, 20 parts by mass of dandelions, 10 parts by mass of coix seeds, 15 parts by mass of poria, 10 parts by mass of turmeric, 10 parts by mass of fresh white imperata roots, and 10 parts by mass of chrysanthemums.

[0016] According to a preferred embodiment of the present invention, in S2, mixing: the raw Chinese medicinal materials are mixed together and soaked in pure water for 1 hour.

[0017] According to a preferred embodiment of the present invention, in S2, extraction: the feed in each tank is ≤600kg, the extraction solvent is water, the extraction is performed twice, the liquid input volume is 8 times the amount of the raw material, each extraction is performed for 1 hour, the temperature in the tank is controlled to 95-98°C, and the extract is filtered.

[0018] According to a preferred embodiment of the present invention, in S2, concentration: the filtrate is concentrated under vacuum, the concentration temperature is controlled to 75-78°C, the liquid is discharged within 3 hours, and the discharged liquid has a specific gravity of 1.15-1.18.

[0019] According to a preferred embodiment of the present invention, in S2, spray drying: the concentrated liquid is spray dried using a spray drying tower, the inlet air temperature of the spray drying tower is 150-170°C, the temperature inside the tower is controlled to 85-90°C, the outlet air temperature is 75-85°C, the pressure inside the drying tower is controlled to -200--300Pa, and the dry powder is obtained within 3 hours.

[0020] According to a preferred embodiment of the present invention, in S2, crushing: in a 100,000-class clean area, crushing is performed using a stainless steel crusher, and the crushing mesh number is ≥100 mesh.

[0021] According to a preferred embodiment of the present invention, in S2, screening: in a 100,000-grade clean area, a 100-mesh screen is used for screening.

[0022] According to a preferred embodiment of the present invention, in S2, mixing: using a two-dimensional mixer to mix, mixing for 1 hour, adding excipients to form oral ointments, tablets, granules or capsules, when preparing oral preparations, it also includes adding additives such as one or more of flavoring agents, antioxidants, and preservatives.

[0023] In a second aspect, the present invention provides an oral preparation of a medicinal and edible extract composition with the ability to rapidly lower uric acid and a preparation method thereof, which is prepared by any of the preparation methods described above.

[0024] Preferably, the oral preparation is an oral liquid, oral paste, tablet, granule or capsule.

[0025] 3. Beneficial effects

[0026] (1) The fermentation substrate formula used in the present invention is a medicine-food formula, wherein celery seeds can promote blood circulation and relieve pain, clear away heat and toxic substances, promote diuresis and reduce swelling, dispel wind and dampness, soothe the liver and lower blood pressure, dandelion can reduce swelling and resolve stagnation, promote diuresis and relieve stranguria, Poria can promote joints, promote diuresis and eliminate dampness, coix seed can remove toxic substances and resolve stagnation, remove numbness and discharge pus, sour cherry can replenish qi and blood, invigorate the spleen and promote diuresis, astringe and relieve pain, dispel wind and remove dampness, sophora japonica seed can clear heat and detoxic substances, cool blood and stop bleeding, moisten the intestines and relieve constipation, chicory can clear heat and detoxic substances, promote diuresis and reduce swelling, fresh Imperata root can cool blood and stop bleeding, clear heat and promote diuresis, chrysanthemum can disperse wind and clear heat, soothe the liver and improve eyesight, clear heat and detoxic substances, turmeric can promote blood circulation and menstruation, dispel wind and remove numbness, promote qi and relieve pain, and the whole formula can dissolve qi and blood stagnation, damp-heat stasis and promote body fluid circulation and uric acid excretion by tonifying the kidney and invigorating the spleen, dispelling dampness and turbidity, clearing dampness and heat, promoting blood circulation and unblocking collaterals.

[0027] From the traditional Chinese medicine angle, it is believed that kidney and spleen breed each other to complete water metabolism, kidney is the innate foundation, spleen is the acquired foundation, spleen governs transportation and transformation, kidney governs water, the interaction of kidney and spleen, completes the metabolism of human body water all the time; so the applicant believes that the cause of hyperuricemia or gout symptoms is: spleen deficiency, causing kidney deficiency at the same time, spleen deficiency loses key transportation, kidney deficiency loses gasification, causes body dampness turbidity endogenous, water dampness internal stagnation, phlegm dampness accumulation, blood stasis, phlegm stasis mutual knot, obstruction meridian, deep joints, finally make joint swelling, pain, deformity. Therefore, the present invention can help reduce the uric acid concentration in patient's blood by the Chinese medical treatment principles such as tonifying kidney and consolidating essence, dispelling dampness and turbidity, clearing away dampness and heat, promoting blood circulation and unblocking collaterals.

[0028] The Chinese medicine extract composition prepared by the present invention has been tested for its antioxidant index and found that the scavenging rate of hydroxyl radicals can reach more than 75%, the scavenging rate of hydroxyl radicals can reach more than 92%, the scavenging rate of superoxide anions can reach more than 18%, and the scavenging rate of ABTS can reach more than 95%. This shows that the Chinese medicine extract combination prepared by the present invention has an inhibitory effect on the body's oxidative stress caused by increased uric acid, effectively removes free radicals such as hydroxyl radicals, DPPH, superoxide anions, ABTS, etc., can achieve anti-oxidation by removing free radicals, reduce the body's oxidative stress in the process of uric acid generation, thereby reducing or inhibiting the occurrence of inflammation.

[0029] In addition, the traditional Chinese medicine extract composition was tested and found to have an inhibition rate of more than 95% on xanthine oxidase, indicating that the extract composition can inhibit the production of uric acid by inhibiting xanthine oxidase, thereby helping to reduce the content of uric acid in the body.

[0030] The Chinese medicine extract composition is coarsely filtered, centrifuged, finely filtered, the filtrate is sterilized, and aged in a refrigerator at 4°C for 72 hours, and packaged to obtain a uric acid-lowering oral liquid. The uric acid-lowering oral liquid is taken twice a day, 30 ml each time. After taking it for 14 days, the uric acid levels of patients with hyperuricemia return to normal, and the effective rate can reach 100%. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 It is the scavenging ability of the oral preparation prepared by the present invention on hydroxyl free radicals.

[0032] Figure 2 It is the scavenging ability of the oral preparation prepared by the present invention on DPPH.

[0033] Figure 3 It is the scavenging ability of the oral preparation prepared by the present invention on superoxide anions.

[0034] Figure 4 It is the scavenging ability of the oral preparation prepared by the present invention on ABTS.

[0035] Figure 5 It is the inhibitory ability of the oral preparation prepared by the present invention on xanthine oxidase. DETAILED DESCRIPTION

[0036] 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.

[0037] The main features of the oral preparation for lowering uric acid of the present invention are: by designing the formula of the Chinese medicine composition, screening specific medicine and food products, subjecting the Chinese medicine composition to water treatment and distillation purification, and further preparing the purified product into a uric acid lowering oral liquid or concentrating it and adding an excipient to prepare an oral preparation.

[0038] Among them, the formula of the Chinese medicine composition is: celery seeds, sour cherries, sophora japonica seeds, chicory, dandelions, coix seeds, poria cocos, turmeric, fresh white grass roots and chrysanthemums.

[0039] Preferably, the Chinese medicine composition is composed of 5-30 parts by mass of celery seeds, 5-10 parts by mass of sour cherries, 5-10 parts by mass of Sophora japonica, 5-10 parts by mass of chicory, 10-40 parts by mass of dandelions, 1-10 parts by mass of coix seeds, 10-40 parts by mass of Poria cocos, 10-30 parts by mass of turmeric, 10-30 parts by mass of fresh white imperata root, and 10-40 parts by mass of chrysanthemum. Further preferably, the Chinese medicine composition comprises 20 parts by mass of celery seeds, 10 parts by mass of sour cherries, 10 parts by mass of Sophora japonica, 10 parts by mass of chicory, 20 parts by mass of dandelions, 10 parts by mass of coix seeds, 15 parts by mass of Poria cocos, 10 parts by mass of turmeric, 10 parts by mass of fresh white imperata root, and 10 parts by mass of chrysanthemum.

[0040] In the claimed Chinese medicine composition, the functions of each medicinal component are as follows:

[0041] 1. Celery seeds: sweet, bitter, cool, non-toxic, and enter the lung, stomach, and liver meridians. It has the effects of promoting blood circulation and relieving pain, clearing away heat and detoxifying, diuresis and swelling, dispelling wind and dampness, calming the liver and lowering blood pressure. It is often used clinically to treat hypertension, headache, dizziness, sudden fever and thirst, jaundice, edema, hot and astringent urination, irregular menstruation in women, red and white vaginal discharge, scrofula, mumps and other diseases. It has a therapeutic effect on wind-heat syndrome, rheumatoid arthritis, gout, hyperuricemia, etc.

[0042] 2. Sour cherry: sweet in taste, warm in nature, enters the spleen, stomach, and kidney meridians. It has the effects of replenishing qi and blood, strengthening the spleen and promoting diuresis, astringing and relieving pain, and dispelling wind and dampness. It is often used clinically to treat symptoms such as numbness of limbs, pain in waist and legs, and spermatorrhea due to kidney deficiency.

[0043] 3. Sophora japonica seeds: bitter in nature, slightly cold, and enter the liver and large intestine meridians. It has the effects of clearing away heat and detoxifying, cooling blood and stopping bleeding, and moistening the intestines and relieving constipation. It is often used clinically to treat blood in the stool, hemorrhoids, hematuria, hematemesis, metrorrhagia, liver heat and red eyes, etc.

[0044] 4. Dandelion: Sweet, bitter, cold in nature. Enters the liver and stomach meridians. Has the effects of clearing away heat and detoxifying, eliminating carbuncle and dispersing knots, promoting dampness and relieving stranguria. It is commonly used in clinical treatment of carbuncle, breast carbuncle, internal carbuncle, hot stranguria, damp-heat jaundice and other diseases.

[0045] 5. Chicory: bitter, slightly sweet, slightly cold in nature, and enters the liver, gallbladder, and kidney meridians. It has the effects and functions of clearing away heat and detoxification, diuresis and swelling, and strengthening the stomach and digestion. It is often used clinically to treat damp-heat jaundice, gastrointestinal food accumulation, edema, and urinary problems.

[0046] 6. Coix seeds: sweet, light, cool in nature, enter the spleen, stomach, and lung meridians. It has the effects of promoting water, penetrating dampness, strengthening the spleen and stopping diarrhea, removing numbness and pus, and detoxifying and dispersing nodules. It is often used clinically to treat edema, beriberi, urinary problems, spleen deficiency diarrhea, dampness and stiffness, lung abscess, intestinal abscess, warts, and cancer.

[0047] 7. Poria: Sweet and mild in taste, neutral in nature, enters the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen and stomach, nourishing the heart and calming the mind. It is often used clinically to treat edema, phlegm and fluid, spleen deficiency diarrhea, palpitations, insomnia and other symptoms.

[0048] 8. Fresh Imperata Root: sweet in taste, cold in nature, enters the lung, stomach and bladder meridians. It has the effects of cooling blood and stopping bleeding, clearing away heat and promoting diuresis. It is often used clinically to treat blood heat vomiting blood, epistaxis, hematuria, fever and thirst, lung heat cough, stomach heat vomiting, damp-heat jaundice, edema and oliguria, and hot stranguria and painful symptoms.

[0049] 9. Chrysanthemum: bitter and sweet, slightly cold in nature, enters the lung and liver meridians. It has the effects of dispersing wind and clearing heat, calming the liver and improving eyesight, clearing heat and detoxifying. It is often used clinically to treat wind-heat colds, headaches and dizziness, red and swollen eyes, blurred vision, and sores, carbuncles, and swelling.

[0050] 10. Turmeric: It tastes bitter and warm in nature. It enters the spleen and liver meridians. It has the effects of promoting blood circulation and menstruation, dispelling wind and removing numbness, promoting qi and relieving pain. It is often used clinically to treat rheumatic pain, periarthritis of the shoulder, postpartum stasis, dysmenorrhea, bone spurs and other symptoms.

[0051] The present invention utilizes water treatment distillation to purify the Chinese medicine composition, so that the active ingredients of the Chinese medicine can be released from the cell wall, thereby improving the efficacy. The purification process also decomposes the macromolecular substances of the Chinese medicine into small molecules, making it easier for them to combine with human proteins and be transported into human cells, so that they can be fully metabolized in the body, avoid drug residues, and improve bioavailability. The efficacy at low doses and the speed of drug utilization by biological organisms can be reduced, the amount of Chinese medicine used can be reduced, the toxic and side effects of Chinese medicine can be reduced, and the speed of onset can be improved.

[0052] The oral preparation for strengthening the kidney and yang of the present invention is prepared by:

[0053] 1. Weigh the Chinese medicinal materials according to the proportion: celery seeds, sour cherries, sophora japonica seeds, chicory, dandelions, coix seeds, tuckahoe, turmeric, fresh white grass roots and chrysanthemums

[0054] 2. Mixing: Mix the raw Chinese medicinal materials together and soak them in purified water.

[0055] 3. Extraction: The feed volume of each tank is ≤600kg, the extraction solvent is water, extraction is performed twice, the liquid input volume is 8 times the amount of raw materials, each extraction takes 1 hour, the temperature in the tank is controlled to 95-98℃, and the extract is filtered.

[0056] 4. Concentration: The filtrate is concentrated under vacuum, the concentration temperature is controlled at 75-78°C, the liquid is discharged within 3 hours, and the specific gravity of the discharged liquid is 1.15-1.18.

[0057] 5. Spray drying: The concentrated liquid is spray dried in a spray drying tower. The inlet air temperature of the spray drying tower is 150-170°C, the temperature inside the tower is controlled to 85-90°C, the outlet air temperature is 75-85°C, the pressure inside the drying tower is controlled to -200--300Pa, and the dry powder is obtained within 3 hours.

[0058] 6. Crushing: Use a stainless steel crusher to crush in a 100,000-class clean area, with a crushing mesh size of ≥100 mesh.

[0059] 7. Screening: In the 100,000-class clean area, use a 100-mesh screen for screening.

[0060] 8. Mixing: Use a two-dimensional mixer to mix for 1 hour. Add excipients to make oral pastes, tablets, granules or capsules. When making oral preparations, it also includes adding additives such as flavoring agents, antioxidants, and preservatives.

[0061] Experimental testing revealed that the oral preparation for lowering uric acid has the following properties:

[0062] (1) Effectively remove free radicals such as hydroxyl free radicals, DPPH, superoxide anions, ABTS, etc., which can achieve antioxidant effects and reduce the body's oxidative stress during the production of uric acid by removing free radicals.

[0063] (2) Effectively inhibit the enzymatic activity of xanthine oxidase, thereby inhibiting the production of uric acid in the body and reducing the uric acid content in the body.

[0064] The following are preferred embodiments of the present invention.

[0065] Step 1: Preparation of uric acid-lowering oral solution

[0066] (1) Weigh 20 parts by weight of celery seeds, 10 parts by weight of sour cherry, 10 parts by weight of Sophora japonica seeds, 10 parts by weight of chicory, 20 parts by weight of dandelion, 10 parts by weight of Coix seeds, 15 parts by weight of Poria cocos, 10 parts by weight of turmeric, 10 parts by weight of fresh Imperata cylindrica roots, and 10 parts by weight of chrysanthemum.

[0067] (2) Mix the Chinese medicinal materials together, soak them in purified water, decoct the Chinese medicinal materials, combine the decoctions, filter, combine the filtrate with the distilled aqueous solution, concentrate, precipitate with alcohol, take the supernatant and concentrate it under reduced pressure to dry powder, grind it, mix it with the inclusion compound obtained above, add pharmaceutical excipients, and prepare an oral preparation.

[0068] The scavenging ability of the prepared oral uric acid-lowering preparation on hydroxyl radicals, DPPH, superoxide anions, and ABTS was tested, and the detection method was carried out according to the instructions of the corresponding detection kit.

[0069] like Figure 1As shown, the scavenging rates of the prepared oral uric acid-lowering preparations for hydroxyl radicals were 79.52% and 74.36%, respectively. This result shows that the prepared oral uric acid-lowering preparations can effectively scavenge hydroxyl radicals. Hydroxyl free radicals act on biological molecules such as proteins, nucleic acids, and lipids in the body, causing damage to cell structure and function, which in turn leads to metabolic disorders in the body and causes diseases. The ability to scavenge hydroxyl free radicals is one of the important indicators of the sample's antioxidant capacity, which shows that oral uric acid-lowering preparations can protect cell structure and function, maintain normal metabolism of the body, and have certain effects on the prevention and treatment of metabolic diseases.

[0070] like Figure 2 As shown, the scavenging rate (inhibition rate) of the uric acid-lowering oral preparations prepared in the embodiment for DPPH (diphenyl picrohydrazyl free radical) is 93.62% and 92.41%, respectively. DPPH (diphenyl picrohydrazyl free radical) is a stable free radical used for in vitro antioxidant evaluation of antioxidant ingredients. This result shows that the uric acid-lowering oral preparations prepared in Example 1-2 can effectively remove DPPH, indicating that the uric acid-lowering oral preparations prepared in the present invention have good antioxidant effects.

[0071] like Figure 3 As shown, the scavenging rate (inhibition rate) of the prepared oral uric acid-lowering preparation for superoxide anions is 15.54% and 29.36%. Superoxide anion free radicals, as a kind of free radicals produced in the biological metabolism process, can attack biological macromolecules, such as lipids, proteins, nucleic acids and polyunsaturated fatty acids, causing cross-linking or rupture, causing damage to cell structure and function, which is closely related to body aging and pathological changes. This result shows that the prepared oral uric acid-lowering preparation has a certain effect on clearing superoxide anions, indicating that the oral uric acid-lowering preparation of the present invention has a certain effect of protecting cell structure and function, and can resist body aging and prevent pathological changes caused by damaged cell structure / function.

[0072] like Figure 4 As shown, the scavenging rate (inhibition rate) of the uric acid-lowering oral preparation prepared in the present invention on ABTS free radicals is 98.21% and 100%. ABTS is used to determine the antioxidant capacity of hydrophilic and lipophilic substances. This result shows that the uric acid-lowering oral preparation prepared in the present invention can efficiently remove ABTS free radicals, indicating that the uric acid-lowering oral preparation prepared in the present invention has a very excellent antioxidant function.

[0073] Further, the ability of the oral uric acid-lowering preparation of the present invention to inhibit the activity of xanthine oxidase is tested. Xanthine oxidase is a flavoproteinase that is mainly distributed in the liver and kidneys. Xanthine oxidase can catalyze xanthine to produce hypoxanthine and can also catalyze hypoxanthine to produce uric acid. When the human body ingests too much purine food, or the activity of xanthine oxidase is enhanced, and the purine metabolism is disordered, the uric acid concentration in the body will increase, forming hyperuricemia. When the uric acid concentration is too high, it is easy to precipitate in the joints to form crystals and cause gout. Therefore, inhibiting the activity of xanthine oxidase is the key to reducing the production of uric acid and treating gout. By evaluating the ability of the compound / composition to inhibit the activity of xanthine oxidase, it is judged that the compound / composition has a therapeutic effect on the treatment of hyperuricemia.

[0074] Xanthine oxidase activity detection method:

[0075] (1) In a sterile clean bench, operate on an ice box and dissolve 5 U (500 μL) of xanthine oxidase in 7264 μL of KHPO (50 mmol / L) buffer. Mix well to obtain 6.44 x 10'U / μL. Aliquot and store at -20°C until needed.

[0076] (2) Xanthine oxidase activity (whole enzyme activity) was measured using an ELISA instrument and a xanthine oxidase kit was used for the experiment. The experiment was set up in a blank group and an experimental group. The experimental group was added with 25uL PBS and 25uL xanthine oxidase solution. The blank group was replaced with an equal volume of PBS instead of xanthine oxidase, and 50μL PBS was directly added. Reagents 1 to 4 were added in sequence according to the kit instructions, mixed, and reacted at 37℃ in the dark for 20 minutes. 1mL of the termination reaction solution was added, mixed, and the absorbance (OD value) was measured at 530nm. The operation was repeated three times in parallel, and the average value was taken as the final result.

[0077] (3) After determining the xanthine oxidase activity, the uric acid-lowering oral preparations obtained during the implementation were respectively selected as test samples.

[0078] (4) Accurately weigh 4.0 mg of allopurinol and dissolve it in 1 mL of DDMSO. Mix thoroughly and dilute it in a gradient manner with phosphate buffered saline (PBS) to 0.4, 0.2, 0.1, 0.05, and 0.025 for later use.

[0079] (5) The inhibitory effect of allopurinol and oral uric acid-lowering preparations on xanthine oxidase activity was determined using a xanthine oxidase kit. The experiment was set up with a blank group and an experimental group. The experimental group was added with 25 μL of sample solution and 25 μL of xanthine oxidase solution. The blank group replaced xanthine oxidase with an equal volume of PBS, added with 25 μL of sample solution and 25 μL of PBS, and added reagents 1 to 4 in sequence according to the kit instructions, mixed, reacted at 37°C in the dark for 20 minutes, added 1 mL of the termination reaction solution, mixed, and measured the absorbance (OD value) at 530 nm. The operation was repeated three times, and the average value was taken as the final result.

[0080] (6) The activity of the whole enzyme is the difference between the OD value of the experimental group and the OD value of the blank group, that is, A experimental group - A blank group. Allopurinol can inhibit the activity of xanthine oxidase. Allopurinol was added to the experimental group, and the OD value of the purple product generated after the action of allopurinol at different concentrations on xanthine oxidase was measured. The OD value of the blank group was subtracted as the final result, and B experimental group - B blank group

[0081] The calculation formula of inhibition rate (%) is:

[0082] Inhibition rate (%) = (1-B experimental group-B blank group / A experimental group-A blank group) X 100%.

[0083] like Figure 5 As shown, the uric acid-lowering oral preparations prepared in the present invention have inhibition rates of 95.42% and 99.74% on xanthine oxidase activity, respectively. This result shows that the uric acid-lowering oral preparations prepared in the present invention can significantly inhibit the activity of xanthine oxidase, which is beneficial to reducing the production of uric acid in patients and treating gout.

[0084] Comparative Example 1

[0085] In this comparative example, the Chinese medicine composition is not fermented, and a water extract is directly prepared. The Chinese medicine composition is weighed according to the raw materials used in Example 1, and a water extract is prepared. The extract is concentrated to a volume of a Chinese medicine oral preparation equal to that of Example 1.

[0086] The scavenging ability of the above concentrated water extract on hydroxyl radicals, DPPH, superoxide anions, ABTS, and the inhibitory ability on xanthine oxidase activity were tested.

[0087] The results showed that the comparative example had a hydroxyl radical inhibition rate of 31.25%, a DPPH inhibition rate of 30.62%, a superoxide anion inhibition rate of 5.34%, and an ABTS inhibition rate of 46.33%, and had no inhibitory ability for xanthine oxidase.

[0088] Comparative Example 2

[0089] The composition of the Chinese medicine composition implemented by the comparative proportion change is: 10 parts by mass of sour cherry, 10 parts by mass of sophora japonica seeds, 10 parts by mass of chicory, 10 parts by mass of coix seeds, 15 parts by mass of Poria cocos, 10 parts by mass of fresh Imperata root, and 10 parts by mass of chrysanthemum.

[0090] Prepare the uric acid-lowering oral solution according to the same method and conditions as step 2 in the implementation.

[0091] The scavenging ability of the comparative uric acid-lowering oral liquid on hydroxyl free radicals, DPPH, superoxide anions, and ABTS, as well as the inhibitory ability on xanthine oxidase activity were tested.

[0092] The results showed that the hydroxyl radical inhibition rate of this comparative example was 31.25%, the DPPH inhibition rate was 29.92%, the superoxide anion inhibition rate was 3.47%, the ABTS inhibition rate was 51.25%, and the xanthine oxidase inhibition rate was 28%. This shows that when the Chinese medicine composition lacks celery seeds, dandelions, turmeric and other medicinal materials, the Chinese medicine oral preparation obtained has reduced hydroxyl radical, DPPH, superoxide anion, ABTS scavenging ability, xanthine oxidase activity inhibition ability, etc.

[0093] Comparative Example 3

[0094] In this comparative example, the composition of the Chinese medicine composition of Example 1 is changed, that is, the composition of the Chinese medicine composition is: 20 parts by mass of celery seeds, 10 parts by mass of Sophora japonica seeds, 10 parts by mass of chicory, 20 parts by mass of dandelion, 15 parts by mass of Poria cocos, 10 parts by mass of turmeric, and 10 parts by mass of chrysanthemum. The oral preparation for lowering uric acid is prepared according to the same method and conditions.

[0095] The scavenging ability of the comparative uric acid-lowering oral liquid on hydroxyl free radicals, DPPH, superoxide anions, and ABTS, as well as the inhibitory ability on xanthine oxidase activity were tested.

[0096] The results showed that the hydroxyl radical inhibition rate of this comparative example was 50.69%, the DPPH inhibition rate was 48.312%, the superoxide anion inhibition rate was 3.36%, the ABTS inhibition rate was 57.72%, and the xanthine oxidase inhibition rate was 34%.

[0097] Clinical use trial

[0098] Recruit patients with high uric acid levels, have them try the product, and use the change in their uric acid levels before and after taking it as a judgment indicator.

[0099] (1) Inclusion criteria

[0100] ① The blood uric acid level is greater than 420μmol / L and no uric acid-lowering drugs have been taken in the past month.

[0101] ②Good compliance in taking products and timely feedback of data.

[0102] (2) Exclusion criteria

[0103] ① Those under 18 years old or over 65 years old, pregnant or lactating women, or those who are allergic to the test samples.

[0104] ② Those suffering from cardiovascular and cerebrovascular diseases, thyroid diseases, tumors, and liver and kidney dysfunction.

[0105] ③ Those who cannot take the product as required and refuse to cooperate with blood uric acid testing.

[0106] (3) How to take

[0107] Take 1 vial before breakfast and dinner each day, each vial is 30 mL; the dosage cycle is 14 days.

[0108] The oral solution used in this clinical trial is the original solution of Chinese herbal uric acid-lowering oral solution (without adding other ingredients) prepared according to the implementation method steps and conditions.

[0109] (4) Monitoring indicators and data statistics

[0110] Test the blood uric acid level before the trial and every day after the trial, and observe and record the changes in uric acid level.

[0111] Name Patient No. 1 Patient No. 2 Patient No. 3 Patient No. 4 Patient No. 5 Patient No. 6 Patient No. 7 First day value 590.4 740.3 580.1 670.8 640.8 630 590.44 The third day value 504.3 660.5 560.4 660.2 608.4 580.2 580.2 Seventh day value 460.1 640.2 480.7 520.1 510.3 470.3 460.2 Tenth day value 390.7 520.4 370.5 410.2 430.2 425.7 320.5 Day 14 Values 330.8 410 310.8 370.2 390.1 390.5 230.8

[0112] From the data in the table, it can be seen that after the 7 people took the probiotic Chinese medicine oral preparation, the uric acid levels all dropped significantly, and the effective rate could reach 100%. This further proves that the Chinese medicine extract composition prepared by the present invention has a good application prospect for reducing blood uric acid.

[0113] 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 by 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. An oral preparation of a medicinal and edible extract composition with rapid uric acid lowering effect and a preparation method thereof, characterized in that: It includes S1. A Chinese medicine composition comprising: celery seeds, sour cherries, sophora japonica seeds, chicory, dandelions, coix seeds, poria cocos, turmeric, fresh white imperata roots and chrysanthemum. S2. Water treatment and distillation purification of Chinese medicine preparations: decoct the Chinese medicine in water and combine the decoction, filter, combine the filtrate with the distilled aqueous solution, concentrate, precipitate with alcohol, take the supernatant and concentrate it under reduced pressure to dry powder, crush it, mix it with the inclusion compound obtained above, add pharmaceutical excipients, and prepare the Chinese medicine preparation. In S1, the claimed traditional Chinese medicine composition is composed of 5-30 parts by mass of celery seeds, 5-10 parts by mass of sour cherries, 5-10 parts by mass of sophora japonica seeds, 5-10 parts by mass of chicory, 10-40 parts by mass of dandelions, 1-10 parts by mass of coix seeds, 10-40 parts by mass of poria, 10-30 parts by mass of turmeric, 10-30 parts by mass of fresh white imperata roots, and 10-40 parts by mass of chrysanthemums.

2. The oral preparation and preparation method thereof according to claim 1, characterized in that: The claimed traditional Chinese medicine composition consists of 20 parts by mass of celery seeds, 10 parts by mass of sour cherries, 10 parts by mass of sophora japonica seeds, 10 parts by mass of chicory, 20 parts by mass of dandelions, 10 parts by mass of coix seeds, 15 parts by mass of poria, 10 parts by mass of turmeric, 10 parts by mass of fresh white imperata roots, and 10 parts by mass of chrysanthemums.

3. The oral preparation and preparation method thereof according to claim 1, characterized in that: In S2, mixing: the raw Chinese medicinal materials are mixed together and soaked in purified water for 1 hour.

4. The oral preparation and preparation method thereof according to claim 1, characterized in that: In S2, extraction: each tank is charged with ≤600 kg of material, the extraction solvent is water, the extraction is performed twice, the liquid input volume is 8 times the amount of the raw material, each extraction is performed for 1 hour, the temperature in the tank is controlled to 95-98°C, and the extract is filtered.

5. The oral preparation and preparation method thereof according to claim 1, characterized in that: In S2, concentration: the filtrate is concentrated in vacuo, the concentration temperature is controlled at 75-78°C, the liquid is discharged within 3 hours, and the specific gravity of the discharged liquid is 1.15-1.

18.

6. The oral preparation and preparation method thereof according to claim 1, characterized in that: In S2, spray drying: the concentrated liquid is spray dried by a spray drying tower, the inlet air temperature of the spray drying tower is 150-170°C, the temperature inside the tower is controlled to 85-90°C, the outlet air temperature is 75-85°C, the pressure inside the drying tower is controlled to -200--300Pa, and the dry powder is obtained within 3 hours.

7. The oral preparation and preparation method thereof according to claim 1, characterized in that: In S2, crushing: in a Class 100,000 clean area, use a stainless steel crusher to crush, and the crushing mesh size is ≥100 mesh.

8. The oral preparation and preparation method thereof according to claim 1, characterized in that: In S2, screening: In the 100,000-class clean area, a 100-mesh screen is used for screening.

9. The oral preparation and preparation method thereof according to claim 1, characterized in that: In S2, mixing: using a two-dimensional mixer to mix for 1 hour, adding excipients to prepare oral ointments, tablets, granules or capsules. When preparing oral preparations, it also includes adding additives such as one or more of flavoring agents, antioxidants, and preservatives.

10. An oral preparation of a medicinal and edible extract composition with rapid uric acid lowering effect and a preparation method thereof, characterized in that: The oral preparation is prepared by the preparation method claimed in any one of claims 1 to 9; the oral preparation is an oral liquid, oral paste, tablet, granule or capsule.

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