Preparation method of uric acid reducing medicine based on steam-exploded fresh pteridium aquilinum

Abstract

The invention relates to a preparation method of a uric acid reducing medicine based on steam-exploded fresh pteridium aquilinum, and belongs to the technical field of traditional Chinese medicines. The preparation method comprises the following steps: (1) removing impurities from fresh pteridium aquilinum, washing, and cutting into segments; (2) performing steam explosion treatment to obtain steam-exploded fresh pteridium aquilinum; (3) adding water into the steam-exploded fresh pteridium aquilinum for reflux extraction, filtering, concentrating under reduced pressure, and spray-drying the concentrated solution to obtain brown powdery steam-exploded fresh pteridium aquilinum water extract; the steam-exploded fresh pteridium aquilinum water extract contains the following components in percentage by mass: 15.9 to 41.5 percent of pteridium aquilinum polysaccharide, 5.0 to 10.2 percent of protein and small molecule polypeptide; and (4) uniformly mixing the steam-exploded fresh pteridium aquilinum water extract, an excipient, a disintegrating agent and a lubricating agent, adding a proper amount of water, granulating and tabletting to obtain the uric acid reducing tablets. The mass of each tablet is 0.40 g, and the mass content of the pteridium aquilinum water extract in each tablet is 80-88%. According to the uric acid reducing tablet, 67 mg of the steam-exploded fresh pteridium aquilinum water extract is taken every day according to each kilogram of body weight, and a remarkable uric acid reducing effect is achieved.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a preparation method of a uric acid-lowering medicine based on steam-exploded fresh bracken. Background Art

[0002] The essence of steam explosion technology is to release the compressed gas that has penetrated into the plant tissue in a short period of time, with the purpose of decomposing the raw materials according to the purpose with less energy. The steam explosion machine suspends the raw materials in the container in the form of explosion in the atmosphere within the millisecond range. Due to its short action time, high and concentrated energy density, steam molecules can penetrate between macromolecules such as cellulose and lignin, and can fully decompose the materials at the macromolecular level. At the same time, under the environment of high temperature, high pressure and water, the material molecules react to a certain extent, and the composition and material form change to a certain extent, creating basic conditions for later material processing. Steam explosion solves the problem that the dissolution rate of fern flavonoids is slow, the total amount of dissolution is low, and the fishy smell will increase with the decrease of water temperature.

[0003] The bracken is a plant of the genus Pteridaceae, Pteridium ( Pteridium aquilinum (L.) Kuhn var. a little wider (Desv.) Underw. ex Heller) has the effects of clearing away heat and resolving phlegm, diuresis and calming the nerves. The research team conducted in-depth research on the chemical composition of bracken water extracts and found that bracken contains polysaccharides, proteins, lipids, small molecule peptides, polyphenols, terpenes, organic acids, alkaloids and other compounds.

[0004] Uric acid is the end product of human purine metabolism, which is produced by hypoxanthine and xanthine under the action of xanthine oxidase (XO). Due to the lack of urate oxidase in the human body, it cannot be further broken down into soluble allantoin, making humans very prone to hyperuricemia. Any cause of increased uric acid production or decreased excretion can lead to hyperuricemia. Hyperuricemia is usually considered a sign of gout. According to statistics, about 5%-12% of hyperuricemia can eventually develop into gout. Studies have shown that hyperuricemia is not only the most important biochemical basis of gout, but also closely related to the occurrence of hypertension, hyperlipidemia, atherosclerosis, obesity, and insulin resistance. It has become a serious metabolic disease that threatens human health.

[0005] At present, the methods for relieving gout symptoms mainly start from two aspects: reducing uric acid production and increasing uric acid excretion, including the use of purine oxidase inhibitors such as allopurinol and febuxostat to reduce uric acid production, or the use of probenecid, benzbromarone and other drugs to inhibit uric acid reabsorption in the renal tubules, increase uric acid excretion to relieve gout symptoms, or use colchicine to neutralize and inhibit uric acid; however, allopurinol and febuxostat are very likely to cause allergic reactions or liver and kidney damage, probenecid cannot be used for patients with renal insufficiency, and colchicine has clear cytotoxicity. In recent years, drugs such as rasburicase, pegloticase, rasburicase and peglotidase have emerged to catalyze the conversion of uric acid into allantoin, but these drugs have great toxic side effects and are often intolerant to patients, which limits their use to a certain extent. Therefore, finding highly effective and low-toxic uric acid-lowering drugs is still a difficulty in the current development of new uric acid-lowering drugs. Summary of the invention

[0006] In order to reduce toxic side effects and achieve safe tolerance in patients with hyperuricemia, the present invention provides a method for preparing a uric acid-lowering drug based on steam-exploded fresh bracken.

[0007] The preparation steps of a uric acid-lowering drug based on steam-exploded fresh bracken are as follows: (1) Pretreatment of fresh bracken Remove the yellow leaves and impurities from the fresh bracken, wash it, and cut it into 1-5cm pieces; The fresh bracken is a plant of the genus Pteridaceae, Pteridaceae ( Pteridium aquilinum (L.) Kuhn var. a little wider (Desv.) Young leaves of Underw. ex Heller; (2) Steam explosion treatment The chopped fresh bracken is placed in a steam explosion chamber, and the chopped fresh bracken is subjected to steam explosion and pressure maintenance for 3-60 seconds under a pressure of 0.5-2.0 MPa to obtain steam-exploded fresh bracken; In the steam explosion chamber, the amount of chopped fresh bracken added is not less than 1 / 3 of the steam explosion chamber; (3) Preparation of steam-exploded fresh bracken water extract The steam-exploded fresh bracken is extracted by reflux with water, the amount of water added is 2-3 times the weight of the fresh bracken, the extraction water temperature is 50°C-100°C, and the extraction time is 2-5 hours; filtering to obtain a filtrate; concentrating under reduced pressure, the concentration temperature does not exceed 90°C, to obtain a concentrated solution; spray drying the concentrated solution to obtain a brown powdery steam-exploded fresh bracken water extract; The steam-exploded fresh bracken water extract contains: bracken polysaccharides with a mass content of 15.9-41.5%, and proteins and small molecule polypeptides with a mass content of 5.0-10.2%. (4) Preparation of uric acid-lowering tablets 80-88% steam-exploded fresh bracken water extract, 10-15% excipient, 1.5-3% disintegrant and 0.5-2% lubricant are mixed evenly, an appropriate amount of water is added, granules are obtained by a granulator, and tablets are pressed by a tablet press to obtain uric acid-lowering tablets; The excipient is microcrystalline cellulose; The disintegrant is two of cross-linked sodium carboxymethyl starch, sodium starch glycolate and cross-linked sodium carboxymethyl cellulose; The lubricant is one or two of talc, stearic acid and polyethylene glycol; The mass of each tablet is 0.40 g, and the mass content of bracken water extract in each tablet is 80-88%.

[0008] The technical solution is further defined as follows: In step (1), the fresh bracken is young leaves of a fern in the tender leaf curling period picked in April or May each year, specifically, young leaves of a fern with petioles that grow 15 to 25 cm above the ground.

[0009] In step (1), if the fresh bracken picked on the same day has no time for pre-processing, it can be frozen and stored at -20°C to -10°C.

[0010] The uric acid lowering drug based on steam-exploded fresh bracken has a daily dosage of 67 mg of steam-exploded fresh bracken water extract per kilogram of body weight, achieving a significant uric acid lowering effect.

[0011] The beneficial technical effects of the present invention are embodied in the following aspects: 1. The inventors found in the basic research on tracking the active substances of bracken in reducing uric acid that fresh bracken ( Pteridium eagle (L.) Kuhn var. a little wider (Desv.) Underw. ex Heller) as raw material, the steam-exploded fresh bracken prepared by the preparation method of steam-exploded bracken tea has the effect of significantly reducing the uric acid level of hyperuricemia rats. The present invention uses fresh bracken for steam explosion and then extracts with water to obtain the steam-exploded fresh bracken water extract, and the water extract has a good uric acid-lowering effect, is used to prepare uric acid-lowering drugs, has little toxicity and side effects, and is safe and tolerated by patients.

[0012] See also Figure 1 , which is a comparison of the HPLC-DAD fingerprints of the components of the water extract of fresh bracken before and after steam explosion: It can be seen that the HPLC fingerprints of fresh bracken before and after steam explosion are significantly different. After the fresh bracken was treated with high temperature and high pressure steam explosion, the types and quantities of small polar components in the water extract decreased ( Figure 1 A in the figure), fresh bracken water extract that has not been treated with steam explosion, high temperature and high pressure has more types and quantities of small polar components ( Figure 1B), steam explosion has a significant effect on the composition of fresh bracken water extract, and steam explosion causes changes in the composition of bracken.

[0013] 2. The results of the acute toxicity test of the steam-exploded fresh bracken water extract prove that the steam-exploded fresh bracken water extract of the present invention is non-toxic. The results of the animal test of the steam-exploded fresh bracken water extract tablets for lowering uric acid prove that the steam-exploded fresh bracken water extract tablets of the present invention have similar active effects in lowering uric acid.

[0014] 3. The clinical trial results of steam-exploded fresh bracken water extract tablets for lowering uric acid have shown that taking 67 mg steam-exploded fresh bracken water extract per kilogram of body weight per day can achieve a significant effect in lowering uric acid. The specific experimental results are as follows: 20 patients with hyperuricemia were treated clinically; 18 of them were male, with an average age of 52 years old, and took 4-7 tablets three times a day according to their body weight. After taking it for 20 consecutive days, their uric acid levels were normal or basically normal. 2 of them were female, with an average age of 53 years old, and took 4-7 tablets three times a day according to their body weight. After taking it for 20 consecutive days, their uric acid levels were normal or basically normal. 1 Materials and methods

[0015] 1.1 Animals Kunming mice, weighing (20±2) g, half male and half female, were purchased from the Medical Experimental Animal Center of Nanjing Medical University and were kept in the laboratory for one week for adaptation.

[0016] 1.2 Preparation of steam-exploded fresh bracken water extract According to the method for preparing the steam-exploded fresh bracken water extract of the present invention, a concentrated solution is prepared, and the concentrated solution is spray-dried into a brown powdery steam-exploded fresh bracken water extract.

[0017] 1.3 Animal experiment Forty mice weighing (20±2) g, half male and half female, were randomly divided into 4 groups according to Horn's method, namely 2.15, 4.64, 10.00 and 21.50 g / kg groups of steam-exploded fresh bracken water extract; the mice were fasted but not watered for 16 h before gavage, and were gavaged with 40 ml / kg of steam-exploded fresh bracken water extract of different concentrations according to the groups; after gavage, the mice's activity, diet, hair, defecation and urination, as well as death were observed for 7 consecutive days. For the dead mice, the tissue changes of their main organs such as heart, liver, spleen, lung and kidney were observed by dissection; the mice that did not die were killed on the 8th day of the experiment, and the tissue changes of their main organs such as heart, liver, spleen, lung and kidney were observed by dissection.

[0018] 1.4 Statistical methods The data of each group were expressed as x±s, and the differences among the means of each group were analyzed by variance analysis using statistical software.

[0019] 2 Results 2.1 Effects on general physical signs of mice Four groups of mice were gavaged with steam-exploded fresh bracken water extract at 2.15, 4.64, 10.00 and 21.50 g / kg, respectively. Within 10 minutes after gavage, the mice showed poor mental state and reduced activity. Ten minutes later, the mice were active again, which was considered to be due to the effects of gavage. After 7 consecutive days of observation, all the test mice had smooth fur, normal diet, activity and defecation, no abnormal secretions from the nose, eyes and mouth, and no adverse conditions occurred.

[0020] 2.2 Effects on the body weight of mice before and after administration As shown in Table 1, the steam-exploded fresh bracken water extract groups had no effect on the body weight of mice ( P >0.05).

[0021]

[0022] 2.3 Death of mice Seven days after oral administration, the mice in each group appeared normal and no death was observed.

[0023] 2.4 Effects on the heart, liver, spleen, lungs, kidneys and other organs All mice were killed and after autopsy, no abnormal changes were found in the heart, liver, spleen, lungs, kidneys, stomach and other major organs of the mice in the steam-exploded fresh bracken water extract groups.

[0024] From the above, it can be seen that the steam-exploded fresh bracken water extract 2.15, 4.64, 10.00 and 21.5 g / kg oral administration of mice showed no abnormal symptoms, indicating that the steam-exploded fresh bracken water extract has an LD50 effect on mice. 50 >21.50 g / kg, therefore, the steam-exploded fresh bracken water extract is non-toxic.

[0025] The steam-exploded fresh bracken water extract tablets prepared by the present invention were used in animal experiments on the effect of lowering uric acid. The results showed that the steam-exploded fresh bracken water extract tablets had a significant effect of lowering uric acid. The experimental process and conclusions are as follows: 1 Materials and methods 1.1 Animals Rats Clean grade adult male Kunming rats were purchased from the Medical Experimental Animal Center of Nanjing Medical University.

[0026] 1.2 Instruments and reagents High-speed refrigerated centrifuge (Beckman, USA), ultra-low temperature refrigerator (Thermo, USA), electric constant temperature water box (Shanghai Boxun Industrial Co., Ltd.), UV2100 ultraviolet visible spectrophotometer (Beijing Rayleigh Analytical Instrument Co., Ltd.), uric acid test kit (Nanjing Jiancheng Bioengineering Institute), adenine (SIGMA), allopurinol tablets (produced by Shanghai Xinyi Wanxiang Pharmaceutical Co., Ltd.); water was double distilled water, homemade. Steam-exploded fresh bracken water extract tablets were crushed and dissolved in water for rat gavage.

[0027] 1.3 Steam-exploded fresh bracken water extract slices (steam-exploded fresh bracken water extract slices obtained in Example 1) 1.4 Experimental methods Rats were randomly divided into 6 groups, including blank control group, hyperuricemia group (model group), allopurinol group (positive drug group), and steam-exploded fresh bracken water extract tablets high, medium, and low dose groups. The model group was fed with 10% high yeast feed and given intragastric administration of adenine solution to prepare a hyperuricemia model; the control group was fed with ordinary rat pellet feed and given intragastric administration of the same volume of distilled water. The treatment group was given high, medium, and low doses of steam-exploded fresh bracken water extract tablets by intragastric administration while being given high-purine feed and adenine by intragastric administration. The dosage was the amount of steam-exploded fresh bracken water extract in the steam-exploded fresh bracken water extract tablets. The high, medium, and low doses were 0.8 g·kg -1 , 0.4g·kg -1 , 0.2g·kg -1 The experimental time was 30 days. Blood samples were collected from rats in each group 1 hour after administration of the corresponding drugs on the 10th, 20th and 30th days, and the blood samples were centrifuged (3000 r·min -1 , 10 min), take the supernatant and determine the uric acid content according to the instructions of the kit.

[0028] 1.5 Statistical methods The data of each group were expressed as x±s, and the differences among the means of each group were analyzed by variance analysis using statistical software.

[0029] 2 Experimental Results The results of the blood sample analysis on the 10th day showed that the steam-exploded fresh bracken water extract tablets had no significant effect on lowering uric acid. The results of the blood sample analysis on the 20th and 30th days are shown in Table 2.

[0030]

[0031] As can be seen from Table 2, the high and medium dose groups of steam-exploded fresh bracken water extract tablets administered for 20 and 30 days had a significant inhibitory effect on rat hyperuricemia, reducing the uric acid level of the blank control group ( P >0.05); the low-dose group administered for 20 days and 30 days had no significant inhibitory effect on hyperuricemia in rats. Overall, there was a dose-effect relationship. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 This is the HPLC-DAD test result of water extract of fresh bracken before and after steam explosion. DETAILED DESCRIPTION

[0033] The present invention will be described in further detail below in conjunction with the embodiments.

[0034] The fresh bracken used in the following examples is a plant of the genus Pteridaceae, Pteridaceae ( Pteridium aquilinum (L.) Kuhnvar. a little wider (Desv.) Underw. ex Heller) young leaves. Fresh bracken refers to the young leaves of bracken in the tender leaf curling period picked in April and May each year, specifically the young leaves of bracken with petioles growing 15-25 cm above the ground. If the fresh bracken picked on the same day cannot be pre-processed in time, it can be frozen and stored at -20℃--10℃. Example 1

[0035] The preparation process of the uric acid-lowering drug based on the steam-exploded fresh bracken water extract is as follows: (1) Pretreatment of fresh bracken Remove yellow leaves and impurities from the fresh bracken, wash it, and cut it into 1cm pieces.

[0036] (2) Steam explosion treatment Put the chopped fresh bracken into the steam explosion chamber, fill the steam explosion chamber with no less than 1 / 3 of the fresh bracken each time, the steam explosion pressure is 0.5MPa, and the pressure holding time is 60 seconds to obtain the steam-exploded fresh bracken.

[0037] (3) Preparation of steam-exploded fresh bracken water extract 400 kg of water was added to 200 kg of steam-exploded fresh bracken, and the mixture was refluxed and extracted at 50° C. for 5 hours. The filtrate was filtered, concentrated under reduced pressure, and spray-dried to obtain 9.2 kg of brown powdered steam-exploded fresh bracken water extract.

[0038] The water extract of steam-exploded fresh bracken contains: 15.9% bracken polysaccharide by mass, 10.2% protein and small molecule peptides by mass, and a certain amount of small molecule substances such as dextrorotatory quinic acid, costus lactone, chlorogenic acid, choline, gluconic acid, and shikimic acid.

[0039] (4) Preparation of uric acid-lowering tablets Take 850g of steam-exploded fresh bracken water extract, 110g of microcrystalline cellulose, 10g of cross-linked sodium carboxymethyl starch, 10g of sodium starch glycolate and 20g of talc, mix them evenly; add appropriate amount of water to granulate; granulate with a granulator to obtain granules.

[0040] The granules are compressed by a tablet press to prepare uric acid lowering tablets; the mass of each tablet is 0.40 g, and the mass content of the steam-exploded fresh bracken water extract in each tablet is 85%, and the tablets are packaged to prepare finished products. Example 2

[0041] The preparation process of the uric acid-lowering drug based on the steam-exploded fresh bracken water extract is as follows: (1) Pretreatment of fresh bracken Remove yellow leaves and impurities from the fresh bracken, wash it, and cut it into 5cm pieces.

[0042] (2) Steam explosion treatment Put the chopped fresh bracken into the steam explosion chamber. Fill no less than 1 / 3 of the steam explosion chamber with fresh bracken each time. The steam explosion pressure is 2.0 MPa and the pressure holding time is 3 seconds to obtain the steam-exploded fresh bracken.

[0043] (3) Preparation of steam-exploded fresh bracken water extract 200 kg of steam-exploded fresh bracken was added to 600 kg of water, and the mixture was refluxed and extracted at 100° C. for 2 hours. The filtrate was filtered, concentrated under reduced pressure, and spray-dried to obtain 10.0 kg of brown powdered steam-exploded fresh bracken water extract.

[0044] The water extract of steam-exploded fresh bracken contains: 20.1% bracken polysaccharide by mass, 9.2% protein and small molecule peptides by mass, and a certain amount of small molecule substances such as dextrorotatory quinic acid, costus lactone, chlorogenic acid, choline, gluconic acid, and shikimic acid.

[0045] (4) Preparation of uric acid-lowering tablets Take 800g of steam-exploded fresh bracken water extract, 150g of microcrystalline cellulose, 10g of cross-linked sodium carboxymethyl starch, 20g of sodium starch glycolate and 20g of polyethylene glycol, mix them evenly; add appropriate amount of water to granulate; granulate with a granulator to obtain granules.

[0046] The granules are compressed by a tablet press to prepare uric acid lowering tablets; the mass of each tablet is 0.40 g, and the mass content of the steam-exploded fresh bracken water extract in each tablet is 80%, and the tablets are packaged to prepare finished products. Example 3

[0047] The preparation process of the uric acid-lowering drug based on the steam-exploded fresh bracken water extract is as follows: (1) Pretreatment of fresh bracken Take 200 kg of fresh bracken frozen at -20°C to -10°C and cut it into 2 cm pieces.

[0048] (2) Steam explosion treatment Put the chopped fresh bracken into the steam explosion chamber, fill the steam explosion chamber with no less than 1 / 3 of the fresh bracken each time, the steam explosion pressure is 1.5MPa, and the pressure holding time is 30 seconds to obtain the steam-exploded fresh bracken.

[0049] (3) Preparation of steam-exploded fresh bracken water extract 400 kg of water was added to 200 kg of steam-exploded fresh bracken, and the mixture was refluxed and extracted at 100° C. for 2 hours. The filtrate was filtered, concentrated under reduced pressure, and spray-dried to obtain 8.7 kg of brown powdered steam-exploded fresh bracken water extract.

[0050] The water extract of steam-exploded fresh bracken contains: 28.4% bracken polysaccharides by mass, 7.9% protein and small molecule peptides by mass, and a certain amount of small molecule substances such as dextrorotatory quinic acid, costus lactone, chlorogenic acid, choline, gluconic acid, and shikimic acid.

[0051] (4) Preparation of uric acid-lowering tablets Take 880g of steam-exploded fresh bracken water extract, 100g of microcrystalline cellulose, 5g of cross-linked sodium carboxymethyl starch, 10g of cross-linked sodium carboxymethyl cellulose and 5g of stearic acid, mix them evenly; add appropriate amount of water to granulate; granulate with a granulator; and obtain granules.

[0052] The granules are compressed by a tablet press to prepare steam-exploded fresh bracken water extract tablets; the weight of each tablet is 0.40 g, and the weight content of steam-exploded fresh bracken water extract in each tablet is 88%, and the tablets are packaged to prepare finished products. Example 4

[0053] The preparation process of the uric acid-lowering drug based on the steam-exploded fresh bracken water extract is as follows: (1) Pretreatment of fresh bracken Take 200 kg of fresh bracken frozen at -20°C to -10°C and cut it into 3 cm pieces.

[0054] (2) Steam explosion treatment Put the chopped fresh bracken into the steam explosion chamber. Fill no less than 1 / 3 of the steam explosion chamber with fresh bracken each time. The steam explosion pressure is 2.0 MPa. The pressure holding time is 10 seconds to obtain the steam-exploded fresh bracken.

[0055] (3) Preparation of steam-exploded fresh bracken water extract 600 kg of water was added to 200 kg of steam-exploded fresh bracken, and the mixture was refluxed and extracted at 50° C. for 5 hours. The filtrate was filtered, concentrated under reduced pressure, and spray-dried to obtain 9.6 kg of brown powdered steam-exploded fresh bracken water extract.

[0056] The water extract of steam-exploded fresh bracken contains: 37.7% bracken polysaccharides by mass, 6.7% protein and small molecule peptides by mass, and a certain amount of small molecule substances such as dextrorotatory quinic acid, costus lactone, chlorogenic acid, choline, gluconic acid, and shikimic acid.

[0057] (2) Preparation of uric acid-lowering drugs Take 880g of steam-exploded fresh bracken water extract, 100g of microcrystalline cellulose, 5g of cross-linked sodium carboxymethyl starch, 10g of cross-linked sodium carboxymethyl cellulose, 2g of talc and 3g of stearic acid, mix them evenly; add appropriate amount of water to granulate; granulate with a granulator to obtain granules.

[0058] The granules are compressed by a tablet press to prepare steam-exploded fresh bracken water extract tablets; the weight of each tablet is 0.40 g, and the weight content of steam-exploded fresh bracken water extract in each tablet is 88%, and the tablets are packaged to prepare finished products. Example 5

[0059] The preparation process of the uric acid-lowering drug based on the steam-exploded fresh bracken water extract is as follows: (1) Pretreatment of fresh bracken Take 200 kg of fresh bracken stored in a freezer at -20°C to -10°C and cut it into 4 cm pieces.

[0060] (2) Steam explosion treatment Put the chopped fresh bracken into the steam explosion chamber. Fill no less than 1 / 3 of the steam explosion chamber with fresh bracken each time. The steam explosion pressure is 1.0 MPa. The pressure holding time is 50 seconds to obtain the steam-exploded fresh bracken.

[0061] (3) Preparation of steam-exploded fresh bracken water extract 600 kg of water was added to 200 kg of steam-exploded fresh bracken, and the mixture was refluxed and extracted at 50° C. for 5 hours. The filtrate was filtered, concentrated under reduced pressure, and spray-dried to obtain 9.3 kg of brown powdered steam-exploded fresh bracken water extract.

[0062] The water extract of steam-exploded fresh bracken contains: 41.5% bracken polysaccharide by mass, 5.0% protein and small molecule peptides by mass, as well as a certain amount of small molecule substances such as dextrorotatory quinic acid, costus lactone, chlorogenic acid, choline, gluconic acid, and shikimic acid.

[0063] (4) Preparation of uric acid-lowering tablets Take 800g of steam-exploded fresh bracken water extract, 150g of microcrystalline cellulose, 20g of sodium starch glycolate, 10g of cross-linked sodium carboxymethyl cellulose, 10g of polyethylene glycol, and 10g of talc, mix them evenly; add appropriate amount of water to granulate; granulate with a granulator to obtain granules.

[0064] The granules are compressed by a tablet press to prepare uric acid lowering tablets; the mass of each tablet is 0.40 g, and the mass content of the steam-exploded fresh bracken water extract in each tablet is 80%, and the tablets are packaged to prepare finished products. Example 6

[0065] The preparation process of the uric acid-lowering drug based on the steam-exploded fresh bracken water extract is as follows: (1) Pretreatment of fresh bracken Take 200 kg of fresh bracken frozen at -20°C to -10°C and cut it into 5 cm pieces.

[0066] (2) Steam explosion treatment Put the chopped fresh bracken into the steam explosion chamber, fill the steam explosion chamber with no less than 1 / 3 of the fresh bracken each time, the steam explosion pressure is 1.5MPa, and the pressure holding time is 40 seconds to obtain the steam-exploded fresh bracken.

[0067] (3) Preparation of steam-exploded fresh bracken water extract 600 kg of water was added to 200 kg of steam-exploded fresh bracken, and the mixture was refluxed and extracted at 100° C. for 2 hours. The filtrate was filtered, concentrated under reduced pressure, and spray-dried to obtain 8.5 kg of brown powdered steam-exploded fresh bracken water extract.

[0068] The water extract of steam-exploded fresh bracken contains: 31.1% bracken polysaccharides by mass, 8.2% protein and small molecule peptides by mass, and a certain amount of small molecule substances such as dextrorotatory quinic acid, costus lactone, chlorogenic acid, choline, gluconic acid, and shikimic acid.

[0069] (4) Preparation of uric acid-lowering tablets Take 850g of steam-exploded fresh bracken water extract, 110g of microcrystalline cellulose, 10g of sodium starch glycolate, 10g of cross-linked sodium carboxymethyl starch and 20g of talc, mix them evenly; add appropriate amount of water to granulate; granulate with a granulator; and obtain granules.

[0070] The granules are compressed by a tablet press to prepare uric acid lowering tablets; the mass of each tablet is 0.40 g, and the mass content of the steam-exploded fresh bracken water extract in each tablet is 85%, and the tablets are packaged to prepare finished products. Example 7

[0071] The preparation process of the uric acid-lowering drug based on the steam-exploded fresh bracken water extract is as follows: (1) Pretreatment of fresh bracken Remove yellow leaves and impurities from the fresh bracken, wash it, and cut it into 1cm pieces.

[0072] (2) Steam explosion treatment Put the chopped fresh bracken into the steam explosion chamber, fill the steam explosion chamber with no less than 1 / 3 of the fresh bracken each time, the steam explosion pressure is 1.0 MPa, and the pressure holding time is 60 seconds to obtain the steam-exploded fresh bracken.

[0073] (3) Preparation of steam-exploded fresh bracken water extract 400 kg of water was added to 200 kg of steam-exploded fresh bracken, and the mixture was refluxed and extracted for 5 hours at 50° C. The filtrate was filtered, concentrated under reduced pressure, and spray-dried to obtain 9.2 kg of brown powdered steam-exploded fresh bracken water extract.

[0074] The water extract of steam-exploded fresh bracken contains: 27.9% bracken polysaccharides by mass, 5.6% protein and small molecule peptides by mass, and a certain amount of small molecule substances such as dextrorotatory quinic acid, costus lactone, chlorogenic acid, choline, gluconic acid, and shikimic acid.

[0075] (4) Preparation of uric acid-lowering tablets Take 880g of bracken water extract, 100g of microcrystalline cellulose, 5g of cross-linked sodium carboxymethyl starch, 10g of cross-linked sodium carboxymethyl starch, 2g of polyethylene glycol and 3g of stearic acid, mix them evenly; add appropriate amount of water to granulate; granulate with a granulator to obtain granules.

[0076] The granules are compressed by a tablet press to prepare uric acid lowering tablets; the mass of each tablet is 0.40 g, and the mass content of bracken water extract in each tablet is 88%, and the tablets are packaged to prepare finished products. Example 8

[0077] The preparation process of the uric acid-lowering drug based on the steam-exploded fresh bracken water extract is as follows: (1) Pretreatment of fresh bracken Take 200 kg of fresh bracken frozen at -20°C to -10°C and cut it into 5 cm pieces.

[0078] (2) Steam explosion treatment Put the chopped fresh bracken into the steam explosion chamber, fill the steam explosion chamber with no less than 1 / 3 of the fresh bracken each time, the steam explosion pressure is 1.0 MPa, and the pressure holding time is 60 seconds to obtain the steam-exploded fresh bracken.

[0079] (3) Preparation of steam-exploded fresh bracken water extract 600 kg of water was added to 200 kg of steam-exploded fresh bracken, and the mixture was refluxed and extracted for 2 hours at 100° C. The filtrate was filtered, concentrated under reduced pressure, and spray-dried to obtain 8.8 kg of brown powdered steam-exploded fresh bracken water extract.

[0080] The water extract of steam-exploded fresh bracken contains: 17.8% bracken polysaccharide by mass, 7.2% protein and small molecule peptides by mass, and a certain amount of small molecule substances such as dextrorotatory quinic acid, costus lactone, chlorogenic acid, choline, gluconic acid, and shikimic acid.

[0081] (4) Preparation of uric acid-lowering tablets Take 800g of bracken water extract, 150g of microcrystalline cellulose, 20g of sodium starch glycolate, 10g of cross-linked sodium carboxymethyl cellulose and 20g of polyethylene glycol, mix them evenly; add appropriate amount of water to granulate; granulate with a granulator; and obtain granules.

[0082] The granules are compressed by a tablet press to prepare uric acid lowering tablets; the mass of each tablet is 0.40 g, and the mass content of the steam-exploded fresh bracken water extract in each tablet is 80%, and the tablets are packaged to prepare finished products.

[0083] It will be easily understood by those skilled in the art that the above are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A method for preparing a uric acid-lowering drug based on steam-exploded fresh bracken, characterized in that: The steps are as follows: (1) Pretreatment of fresh bracken Remove the yellow leaves and impurities from the fresh bracken, wash it, and cut it into 1-5cm pieces; The fresh bracken is a plant of the genus Pteridaceae, Pteridaceae ( Pteridium aquilinum (L.) Kuhn var. latiusculum (Desv.) Underw. ex Heller) young leaves; (2) Steam explosion treatment The chopped fresh bracken is placed in a steam explosion chamber, and the chopped fresh bracken is subjected to steam explosion and pressure maintenance for 3-60 seconds under a pressure of 0.5-2.0 MPa to obtain steam-exploded fresh bracken; In the steam explosion chamber, the amount of chopped fresh bracken added is not less than 1 / 3 of the steam explosion chamber; (3) Preparation of steam-exploded fresh bracken water extract Add water to the steam-exploded fresh bracken for reflux extraction, the amount of water added is 2-3 times the weight of the fresh bracken, the extraction water temperature is 50°C-100°C, and the extraction time is 2-5 hours; Filter to obtain a filtrate; concentrate under reduced pressure at a concentration temperature not exceeding 90° C. to obtain a concentrated solution; spray-dry the concentrated solution to obtain a brown powdery steam-exploded fresh bracken water extract; The steam-exploded fresh bracken water extract contains: bracken polysaccharides with a mass content of 15.9-41.5%, and proteins and small molecule polypeptides with a mass content of 5.0-10.2%. (4) Preparation of uric acid-lowering tablets 80-88% steam-exploded fresh bracken water extract, 10-15% excipient, 1.5-3% disintegrant and 0.5-2% lubricant are mixed evenly, an appropriate amount of water is added, granules are obtained by a granulator, and tablets are pressed by a tablet press to obtain uric acid-lowering tablets; The excipient is microcrystalline cellulose; The disintegrant is two of cross-linked sodium carboxymethyl starch, sodium starch glycolate and cross-linked sodium carboxymethyl cellulose; The lubricant is one or two of talc, stearic acid and polyethylene glycol; The mass of each tablet is 0.40 g, and the mass content of the steam-exploded fresh bracken water extract in each tablet is 80-88%.

2. The method for preparing a uric acid-lowering drug based on steam-exploded fresh bracken according to claim 1, characterized in that: In step (1), the fresh bracken is young leaves of a fern in the tender leaf curling period picked in April or May each year, specifically, young leaves of a fern with petioles that grow 15 to 25 cm above the ground.

3. The method for preparing a uric acid-lowering drug based on steam-exploded fresh bracken according to claim 1, characterized in that: In step (1), if the fresh bracken picked on the same day has no time for pre-processing, it can be frozen and stored at -20°C to -10°C.

4. The method for preparing a uric acid-lowering drug based on steam-exploded fresh bracken according to claim 1, characterized in that: The uric acid lowering drug based on steam-exploded fresh bracken has a daily dosage of 67 mg of steam-exploded fresh bracken water extract per kilogram of body weight, achieving a significant uric acid lowering effect.

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