阅读说明：本技术 黄芪痛风片及其制备方法 (Astragalus root gout tablet and preparation method thereof ) 是由 龚定海 杨怀 于 2021-10-08 设计创作，主要内容包括：本发明公开了一种黄芪痛风片,主要包括以下原料：土茯苓10-30重量份,威灵仙10-30重量份,黄芪10-30重量份,秦皮5-15重量份,炒苍术5-15重量份,防风5-15重量份,银杏叶5-15重量份,卷柏5-15重量份,鸡血藤5-15重量份,猫须草5-15重量份。本发明的黄芪痛风片崩解时间短,抗湿性强,具有良好的治疗痛风性关节炎的效果。不仅如此,本发明的黄芪痛风片的耐磨性佳,能够有效避免运输过程中片剂破碎,降低破碎失效的风险。(The invention discloses an astragalus mongholicus gout tablet which mainly comprises the following raw materials: 10-30 parts of glabrous greenbrier rhizome, 10-30 parts of clematis root, 10-30 parts of astragalus, 5-15 parts of ash bark, 5-15 parts of fried rhizoma atractylodis, 5-15 parts of divaricate saposhnikovia root, 5-15 parts of ginkgo leaf, 5-15 parts of selaginella tamariscina, 5-15 parts of suberect spatholobus stem and 5-15 parts of Chinese alpine rush herb. The astragalus gout tablet provided by the invention is short in disintegration time and strong in moisture resistance, and has a good effect of treating gouty arthritis. Moreover, the astragalus membranaceus gout tablet provided by the invention is good in wear resistance, and can effectively avoid the breakage of the tablet in the transportation process and reduce the risk of breakage failure.)

1. The preparation method of the astragalus mongholicus gout tablet is characterized by comprising the following steps:

s1 drying the raw materials, pulverizing, and sieving to obtain a mixture; the raw materials are prepared by mixing 10-30 parts by weight of glabrous greenbrier rhizome, 10-30 parts by weight of clematis root, 10-30 parts by weight of astragalus root, 5-15 parts by weight of ash bark, 5-15 parts by weight of fried rhizoma atractylodis, 5-15 parts by weight of divaricate saposhnikovia root, 5-15 parts by weight of ginkgo leaf, 5-15 parts by weight of selaginella tamariscina, 5-15 parts by weight of suberect spatholobus stem and 5-15 parts by weight of clerodendrum spicatum;

s2, carrying out reflux extraction on the traditional Chinese medicine mixture obtained in the step S1 by using an ethanol water solution with the volume percentage concentration of 60-80%, wherein the weight of the ethanol water solution is 8-12 times of that of the traditional Chinese medicine mixture, extracting for 2-3 times, and each time lasts for 0.5-2h, filtering the extracted mixed solution, separating filtrate and filter residue, concentrating the filtrate to an extract with the relative density of 1.20-1.30 when the filtrate is concentrated to 60-80 ℃, so as to obtain an extracted extract A, and reserving the medicine residue;

s3, adding water into the dregs obtained in the step S2, heating to 90-110 ℃, extracting for 2-3 times, wherein the weight of the water is 5-10 times of that of the dregs, each time lasts for 0.5-2h, filtering the mixture after extraction, separating filtrate and filter residue, concentrating the filtrate to an extract with the relative density of 1.20-1.30 when the temperature is 60-80 ℃, and obtaining an extract B;

s4, combining the extract A and the extract B to obtain a total extract, drying in vacuum at 60-80 ℃, and grinding to obtain extract powder, wherein the water content of the extract powder is 2-3%;

s5, weighing the following components in percentage by weight: 2-3% of adhesive, 60-85% of filling agent, 2-3% of additive and the balance of extract powder; mixing, granulating by dry method, drying, and tabletting to obtain radix astragali TONGFENG tablet.

2. The method of claim 1, wherein the binder in step S5 is one or a mixture of two or more of polyvinylpyrrolidone, polyvinyl acetate, and gelatin.

3. The method of claim 1, wherein the filler in step S5 is at least one of microcrystalline cellulose, isomaltulose, and silica gel micropowder.

4. The method of claim 1, wherein the additive in step S5 is potato starch or modified starch.

5. The method for preparing the astragalus mongholicus gout tablet according to claim 4, wherein the modified starch is prepared by the following steps: adding 5-20g of potato starch into 50-100mL of water; heating and stirring at 80-90 deg.C until starch is completely gelatinized; cooling to 20-30 deg.C to obtain gel; putting the gel in water of 0-10 deg.C for 10-12 h; taking out the gel, and soaking in 60-80 wt% ethanol water solution for 24-48 h; taking out the gel, drying at 40-60 ℃ for 6-8h, and grinding uniformly to obtain gel powder; adding 5-15g of gel powder into 20-50mL of water, adding 10-20mL of crotonic acid aqueous solution, and stirring and mixing at room temperature for 30min to obtain a mixed solution; adjusting the pH of the mixed solution to 2-5 by using NaOH aqueous solution, and then stirring at room temperature for 10-30 h; filtering and washing to remove unreacted crotonic acid; drying and grinding to obtain the modified starch.

6. An astragalus gout tablet, which is prepared by the method of any one of claims 1 to 5.

Technical Field

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to an astragalus gout tablet and a preparation method thereof.

Background

Gout is inflammatory joint disease caused by hyperuricemia caused by purine metabolic disorder in human body and deposition of MSU (monosodium urate) on joints or around joints, and the occurrence of gout is influenced by race, age, sex, regional distribution, environmental factors, life style, diseases, occupation, diet and the like, and clinically, symptoms such as acute gouty arthritis, hyperuricemia, tophaceous deposition, gouty nephropathy, nephritis and the like can appear.

Modern medicine is divided into two main categories, primary gout and secondary gout, according to different causes of gout. Primary gout refers to gout caused by congenital purine metabolic disorder or uric acid excretion disorder, on the basis of excluding other diseases. Clinically, primary gout is divided into four stages, namely, an asymptomatic stage, an acute arthritis stage, a tophus and chronic arthritis stage, and a chronic gouty nephrosis stage. The secondary gout refers to gout caused by reduced uric acid excretion caused by kidney diseases or certain medicines, myeloproliferative diseases, increased uric acid generation caused by tumor chemotherapy and the like.

In the aspect of treating gout, western medicine mostly adopts symptomatic treatment of inhibiting formation of blood uric acid, promoting excretion of blood uric acid, relieving fever, diminishing inflammation, relieving pain and the like, has good clinical curative effect, but has obvious adverse reaction to limit the wide application of the gout. Later, people gradually know that the problems of toxic and side effects, adverse reactions, high recurrence rate and the like of the chemical drugs after long-term use are obvious. For a long time, the traditional Chinese medicine accumulates abundant experiences in the aspect of gout treatment, the traditional Chinese medicine emphasizes the overall treatment, the prevention of both symptoms and root causes is mainly achieved, and the traditional Chinese medicine is famous for little adverse reaction. The traditional Chinese medicine indicates that gout belongs to the syndrome of rheumatism and heat arthralgia and is manifested by internal accumulation of damp-heat, obstruction of qi and blood and stagnation of heat evil. Many traditional Chinese medicines have the effects of eliminating dampness and removing arthralgia, inducing diuresis to alleviate edema, promoting qi and blood circulation, and removing blood stasis and relieving pain, and can be used for treating gout. Researches prove that the traditional Chinese medicine has complex chemical components and multi-target therapeutic effect, and the screening of the traditional Chinese medicine for treating gout from the traditional Chinese medicine has important significance.

The tablet is a round-sheet or special-shaped sheet solid preparation prepared by uniformly mixing and pressing the medicine and proper auxiliary materials, and is also called as three major medicine forms together with a capsule and an injection. The tablet has the characteristics that: 1) compared with injection, the tablet is convenient to transport and carry. 2) The production of tablet pharmaceuticals is automated to a higher degree than other dosage forms and therefore is less expensive to produce. 3) The tablet medicine has better chemical stability, is slightly influenced by the storage environment under the protection of the coating film, and is not easy to deteriorate. 4) The tablet has good appearance, and its outer coating can mask the smell of the medicine. 5) The tablet is convenient to swallow compared with powder, can save measuring tools compared with liquid medicine, does not need to be weighed when a pharmacist prepares a tablet prescription, and is convenient and time-saving. Thus, tablets have many advantages not available with other types of drugs.

CN 112023012 a discloses a traditional Chinese medicine for treating gout, which is prepared from 29 raw materials such as aloe leaf, tribulus terrestris, folium artemisiae argyi, exsiccated sodium sulfate, leech, raw rhubarb, etc., wherein the raw material components are too many and the total effective rate for treating gouty arthritis is only 97%.

CN 112641908A discloses a composition for treating gouty arthritis and a preparation method thereof, the method extracts the effective components of the medicine by respectively collecting clear paste by means of alcohol extraction of rhubarb and diverse wormwood herb and water extraction of the other components, then mixing, drying and crushing the two clear pastes, adding auxiliary materials to prepare an oral dosage form, and the optimal total effective rate in clinical experiments for treating gouty arthritis is 98%.

Disclosure of Invention

In view of the above-mentioned defects of the prior art, the technical problem to be solved by the present invention is to provide a medicament with better effect for treating gouty arthritis.

In order to achieve the purpose, the invention provides the astragalus root gout tablet which has a good effect on treating the gouty arthritis. The astragalus mongholicus gout tablets have the advantages of short disintegration time, strong moisture resistance and good wear resistance, and can effectively avoid tablet crushing in the transportation process and reduce the risk of crushing failure.

In order to achieve the purpose of the invention, the invention adopts the following technical scheme:

the invention discloses a preparation method of astragalus mongholicus gout tablets, which comprises the following steps:

s1 drying the raw materials, pulverizing, and sieving to obtain a mixture; the raw materials are prepared by mixing 10-30 parts by weight of glabrous greenbrier rhizome, 10-30 parts by weight of clematis root, 10-30 parts by weight of astragalus root, 5-15 parts by weight of ash bark, 5-15 parts by weight of fried rhizoma atractylodis, 5-15 parts by weight of divaricate saposhnikovia root, 5-15 parts by weight of ginkgo leaf, 5-15 parts by weight of selaginella tamariscina, 5-15 parts by weight of suberect spatholobus stem and 5-15 parts by weight of clerodendrum spicatum;

s2, carrying out reflux extraction on the traditional Chinese medicine mixture obtained in the step S1 by using an ethanol water solution with the volume percentage concentration of 60-80%, wherein the weight of the ethanol water solution is 8-12 times of that of the traditional Chinese medicine mixture, extracting for 2-3 times, and each time lasts for 0.5-2h, filtering the extracted mixed solution, separating filtrate and filter residue, concentrating the filtrate to an extract with the relative density of 1.20-1.30 when the filtrate is concentrated to 60-80 ℃, so as to obtain an extracted extract A, and reserving the medicine residue;

s3, adding water into the dregs obtained in the step S2, heating to 90-110 ℃, extracting for 2-3 times, wherein the weight of the water is 5-10 times of that of the dregs, each time lasts for 0.5-2h, filtering the mixture after extraction, separating filtrate and filter residue, concentrating the filtrate to an extract with the relative density of 1.20-1.30 when the temperature is 60-80 ℃, and obtaining an extract B;

s4, combining the extract A and the extract B to obtain a total extract, drying in vacuum at 60-80 ℃, and grinding to obtain extract powder, wherein the water content of the extract powder is 2-3%;

s5, weighing the following components in percentage by weight: 2-3% of adhesive, 60-85% of filling agent, 2-3% of additive and the balance of extract powder; mixing, granulating by dry method, drying, and tabletting to obtain radix astragali TONGFENG tablet.

In the step S5, the adhesive is one or a mixture of two or more of polyvinylpyrrolidone, polyvinyl acetate and gelatin; a preferred binder is polyvinylpyrrolidone.

The filler in the step S5 is at least one of microcrystalline cellulose, isomaltulose and silica gel micropowder. More preferably, the filler is prepared by mixing 40-60 wt% of microcrystalline cellulose, 10-30 wt% of isomaltulose and 10-30 wt% of superfine silica gel powder.

The additive in the step S5 is potato starch or modified starch.

The preparation method of the modified starch comprises the following steps: adding 5-20g of potato starch into 50-100mL of water; heating and stirring at 80-90 deg.C until starch is completely gelatinized; cooling to 20-30 deg.C to obtain gel; putting the gel in water of 0-10 deg.C for 10-12 h; taking out the gel, and soaking in 60-80 wt% ethanol water solution for 24-48 h; taking out the gel, drying at 40-60 deg.C for 6-8h, and grinding to obtain modified starch.

Further preferably, the preparation method of the modified starch comprises the following steps: adding 5-20g of potato starch into 50-100mL of water; heating and stirring at 80-90 deg.C until starch is completely gelatinized; cooling to 20-30 deg.C to obtain gel; putting the gel in water of 0-10 deg.C for 10-12 h; taking out the gel, and soaking in 60-80 wt% ethanol water solution for 24-48 h; taking out the gel, drying at 40-60 ℃ for 6-8h, and grinding uniformly to obtain gel powder; adding 5-15g of gel powder into 20-50mL of water, adding 10-20mL of crotonic acid aqueous solution, and stirring and mixing at room temperature for 30min to obtain a mixed solution; adjusting the pH of the mixed solution to 2-5 by using NaOH aqueous solution, and then stirring at room temperature for 10-30 h; filtering and washing to remove unreacted crotonic acid; drying and grinding to obtain the modified starch.

The components used in the present invention are illustrated below:

smilax glabra L.is dried rhizome of Smilax glabra Roxb. of Smilax glabra L.of Liliaceae, and has sweet and mild taste and mild property. Has the effects of removing toxic substances, eliminating dampness, and relieving joint pain, and is mainly used for treating limb spasm and arthralgia and myalgia caused by syphilis and mercury poisoning; stranguria with turbid damp-heat, leukorrhagia, abscess, scrofula, scabies and tinea.

The Clematis root is dry root and rhizome of Clematis chinensis Osbeck, Clematis hexapetala pall or Clematis manshurica rupr of Ranunculaceae, and is pungent, salty and warm in nature. It enters bladder meridian. Has effects of dispelling pathogenic wind, removing dampness, and dredging channels and collaterals. Can be used for treating rheumatalgia, numbness of limbs, spasm of tendons and vessels, and difficulty in flexion and extension.

Astragalus membranaceus is dried root of Astragalus membranaceus Bge. Astragalus membrane aceus (Fisch.) of Leguminosae family or Astragalus membranaceus Bge. Hsiao. Sweet in nature and slightly warm. It enters lung and spleen meridians. Has the effects of invigorating qi, invigorating yang, consolidating superficial resistance, arresting sweating, inducing diuresis, relieving swelling, promoting fluid production, nourishing blood, removing stagnation, relieving arthralgia, removing toxic substance, expelling pus, healing sore, and promoting granulation. Can be used for treating deficiency of vital energy, asthenia, anorexia, loose stool, collapse of middle-warmer energy, chronic diarrhea, rectocele, hematochezia, spontaneous perspiration due to exterior deficiency, edema due to qi deficiency, internal heat, diabetes, blood deficiency, hemiplegia, arthralgia, numbness, carbuncle, cellulitis, and intractable ulcer.

Cortex Fraxini, the name of Chinese medicine. Is dry branch bark or dry bark of Carpinus laxiflora, Fraxinus rhynchophylla, Fraxinus pinnata or Fraxinus pinnitafida of Oleaceae. Bitter and astringent taste, cold in nature. The main treatment is as follows: clear heat and dry dampness, astringe and stop dysentery, stop leukorrhagia and improve vision. Can be used for treating dysentery due to heat toxin, leucorrhea with red and white discharge, conjunctival congestion, swelling and pain, and nebula.

Stir-baked rhizoma Atractylodis, also known as bran-baked rhizoma Atractylodis, is pungent, bitter and warm. It enters spleen, stomach and liver meridians. Dry dampness and invigorate spleen, dispel wind and cold, improve vision. Can be used for treating abdominal distention, diarrhea, edema, rheumatalgia, wind-cold type common cold, and nyctalopia.

Radix Saposhnikoviae, is dried root of Saposhnikovia divaricata (Turcz.) Schischk of Umbelliferae, and is pungent, sweet and slightly warm in nature. Has the effects of dispelling pathogenic wind, relieving exterior syndrome, eliminating dampness, relieving pain, and relieving spasm. Can be used for treating common cold, headache, rheumatalgia, rubella, pruritus, and tetanus.

Ginkgo biloba, a dry root of the Ginkgo biloba plant Ginkgo biloba l. Sweet, bitter, astringent and neutral in nature. It enters heart and lung meridians. Promoting blood circulation, removing blood stasis, dredging collaterals, relieving pain, astringing lung, relieving asthma, eliminating turbid pathogen, and reducing blood lipid. Can be used for treating blood stasis, obstruction of collaterals, thoracic obstruction, cardialgia, apoplexy, hemiplegia, cough with asthma due to lung deficiency, and hyperlipidemia.

Selaginella tamariscina (Selaginella tamariscina) Spring, a plant of the Selaginellaceae family, or Selaginella pulvinata (Hook, etGrev.) Maxim. Pungent and mild in nature. It enters liver and heart meridians. Promoting blood circulation and restoring menstrual flow. Can be used for treating amenorrhea, dysmenorrhea, abdominal mass, and traumatic injury. Herba Selaginellae is carbonized to remove blood stasis and stop bleeding. Can be used for treating hematemesis, metrorrhagia, hematochezia, and rectocele.

Caulis Spatholobi is dried rattan of Spatholobus suberectus Dunn of Leguminosae. Bitter and sweet in property and warm in nature. It enters liver and kidney meridians. Promoting blood circulation, tonifying blood, regulating menstruation, relieving pain, relaxing muscles and tendons, and activating collateral flow. Can be used for treating menoxenia, dysmenorrhea, amenorrhea, rheumatalgia, numbness, paralysis, and sallow complexion due to blood deficiency.

Herba Clerodendranthi Spicati Thunb (Clerodendranthus spicatus Thunb) is called mistura elegant, also called folium orthosiphoni, is a plant of Clerodendranthus of Labiatae, is a precious medicinal health plant, contains inositol, calcium sulfate, flavonoids, volatile oil, pentose, saponin, pentose, glucuronic acid and calcium salt and potassium salt of various organic acids, is sweet in nature, bitter in taste and cool in taste, and has the effects of clearing heat and eliminating dampness, and removing calculus and promoting diuresis. Can be used for treating various renal diseases such as acute nephritis, cystitis, jaundice, lithangiuria, and rheumarthritis.

The scholars of traditional Chinese medicine think that phlegm turbidity and blood stasis affect the internal organs of liver, spleen and kidney and the like to cause the attack of hyperuricemia. The "Nei Jing" (the internal classic) says that "wind-cold-dampness is complicated in qi and causes both symptoms and disadvantages", which indicates that the disadvantages are related to the invasion of exogenous pathogenic factors and that patients with deficiency of both qi and blood are susceptible to attack of acute gouty arthritis by pathogenic wind. Hyperuricemia is mainly caused by body deficiency, and is caused by pathogenic dampness, wind and blood stasis, and accumulates in the body to form syndromes of excess marked by dampness, phlegm dampness, blood stasis and the like; gout occurs internally and externally, and is caused by phlegm-damp constitution, fat body, preference for fat, sweet and greasy food, damage to spleen and stomach due to excessive drinking, endogenous dampness, long-term obstruction of body interior, and gout after long-term retention of phlegm in joints.

The invention is based on the understanding of the Chinese medicine on the pathogenesis of gout and the treatment principle, refers to the research achievement of modern pharmacology, combines the modern related research data and long-term clinical practice, and considers that the spleen and the kidney are in an inseparable relationship. The invention screens out the medicinal formulas for eliminating dampness, purging turbidity, dredging collaterals, relieving pain, promoting blood circulation and clearing heat, the glabrous greenbrier rhizome, the clematis root, the fried rhizoma atractylodis and the divaricate saposhnikovia root can discharge turbidity, promote joint movement, invigorate spleen and remove dampness, the astragalus root can tonify middle-jiao and Qi, the suberect spatholobus stem can tonify blood and promote blood circulation, and the Chinese alpine rush can tonify spleen and kidney, and the medicinal formulas are reasonably compatible, thereby achieving the effect of treating gout.

The invention is suitable for symptoms: can be used for treating swelling and pain of joint, gout, etc. caused by damp-heat toxin, downward flow of spleen dampness, and cold-heat conflict.

The invention has the beneficial effects that: (1) according to the invention, through reasonable compatibility of the components, the total effective rate of the prepared medicament for treating gout in clinical experiments for treating gouty arthritis reaches 100 percent; (2) the invention selects specific auxiliary materials, and the prepared tablet has the characteristics of short disintegration time, strong moisture absorption resistance and the like.

Detailed Description

The present invention will be described in further detail with reference to the following specific examples. The procedures, conditions, experimental methods and the like for carrying out the present invention are common knowledge and common general knowledge in the art except for the contents specifically mentioned below, and the present invention is not particularly limited.

The polyvinylpyrrolidone content is 99%, and the polyvinylpyrrolidone is in food grade.

Microcrystalline cellulose, purchased from Ofu Biotechnology, Inc., Jiangsu, the content of active substances is 99%, and the type is food grade.

Isomaltulose, purchased from yofeng biotechnology limited, henna, 99% in content, was food grade.

Gum silica gel, available from Ganzhou Luohua pharmaceuticals GmbH, with a density of 2.2g/cm³The melting point was 1723 deg.C, and the refractive index was 1.6.

The potato starch is purchased from Suzhou flood qi environmental protection science and technology Limited, the content is more than or equal to 98 percent, and the density is 2.5g/cm³The model is JQ-019.

Example 1

The preparation method of the astragalus mongholicus gout tablet comprises the following steps:

s1 weighing 20g of rhizoma smilacis glabrae, 20g of radix clematidis, 20g of radix astragali, 10g of cortex fraxini, 10g of fried rhizoma atractylodis, 10g of radix sileris, 10g of folium ginkgo, 10g of selaginella tamariscina, 10g of caulis spatholobi and 10g of herba orthosiphoni, drying, crushing, sieving with a 10-mesh sieve, and uniformly mixing to obtain a traditional Chinese medicine mixture;

s2, heating the traditional Chinese medicine mixture obtained in the step S1 to 75 ℃ by using 75% ethanol aqueous solution in volume percentage concentration for extraction, wherein the weight of the ethanol aqueous solution is 10 times of the weight of the traditional Chinese medicine mixture, extracting for 2 times, 1 hour each time, filtering the mixture after extraction, separating filtrate and filter residue, concentrating the filtrate to 80 ℃, determining the relative density of the extract to be 1.25, obtaining extract A, and reserving the medicine residue for later use;

s3, adding water into the medicine residues obtained in the step S2, extracting the medicine residues by heating to 90 ℃, extracting for 2 times, wherein the weight of the water is 10 times of the weight of the medicine residues, filtering the mixture after extraction for 1 hour each time, separating filtrate and filter residues, and concentrating the filtrate to an extract with the relative density of 1.25 when the filtrate is concentrated to 80 ℃ to obtain an extract B;

s4, mixing the extract A and the extract B to obtain a total extract, vacuum-drying at 60 ℃ for 24h, and grinding to obtain extract powder; the water content of the extract powder is 2%;

s5, weighing the following components in percentage by weight: uniformly mixing 2% of polyvinylpyrrolidone, 60% of filler, 2% of potato starch and the balance of extract powder, performing dry granulation, drying at 37 ℃, and tabletting, wherein the weight of each tablet is controlled to be 0.5g, so as to obtain the astragalus mongholicus gout tablets; the filler comprises 70% of microcrystalline cellulose and 30% of isomaltulose by mass percentage.

Example 2

The preparation method of the astragalus mongholicus gout tablet comprises the following steps:

s1 weighing 20g of rhizoma smilacis glabrae, 20g of radix clematidis, 20g of radix astragali, 10g of cortex fraxini, 10g of fried rhizoma atractylodis, 10g of radix sileris, 10g of folium ginkgo, 10g of selaginella tamariscina, 10g of caulis spatholobi and 10g of herba orthosiphoni, drying, crushing, sieving with a 10-mesh sieve, and uniformly mixing to obtain a traditional Chinese medicine mixture;

s2, heating the traditional Chinese medicine mixture obtained in the step S1 to 75 ℃ by using 75% ethanol aqueous solution in volume percentage concentration for extraction, wherein the weight of the ethanol aqueous solution is 10 times of the weight of the traditional Chinese medicine mixture, extracting for 2 times, 1 hour each time, filtering the mixture after extraction, separating filtrate and filter residue, concentrating the filtrate to 80 ℃, determining the relative density of the extract to be 1.25, obtaining extract A, and reserving the medicine residue for later use;

s3, adding water into the medicine residues obtained in the step S2, extracting the medicine residues by heating to 90 ℃, extracting for 2 times, wherein the weight of the water is 10 times of the weight of the medicine residues, filtering the mixture after extraction for 1 hour each time, separating filtrate and filter residues, and concentrating the filtrate to an extract with the relative density of 1.25 when the filtrate is concentrated to 80 ℃ to obtain an extract B;

s4, mixing the extract A and the extract B to obtain a total extract, vacuum-drying at 60 ℃ for 24h, and grinding to obtain extract powder; the water content of the extract powder is 2%;

s5, weighing the following components in percentage by weight: uniformly mixing 2% of polyvinylpyrrolidone, 60% of filler, 2% of potato starch and the balance of extract powder, performing dry granulation, drying at 37 ℃, and tabletting, wherein the weight of each tablet is controlled to be 0.5g, so as to obtain the astragalus mongholicus gout tablets; the filler consists of 30% of isomaltulose and 70% of superfine silica powder in percentage by mass.

Example 3

The preparation method of the astragalus mongholicus gout tablet comprises the following steps:

s1 weighing 20g of rhizoma smilacis glabrae, 20g of radix clematidis, 20g of radix astragali, 10g of cortex fraxini, 10g of fried rhizoma atractylodis, 10g of radix sileris, 10g of folium ginkgo, 10g of selaginella tamariscina, 10g of caulis spatholobi and 10g of herba orthosiphoni, drying, crushing, sieving with a 10-mesh sieve, and uniformly mixing to obtain a traditional Chinese medicine mixture;

s2, heating the traditional Chinese medicine mixture obtained in the step S1 to 75 ℃ by using 75% ethanol aqueous solution in volume percentage concentration for extraction, wherein the weight of the ethanol aqueous solution is 10 times of the weight of the traditional Chinese medicine mixture, extracting for 2 times, 1 hour each time, filtering the mixture after extraction, separating filtrate and filter residue, concentrating the filtrate to 80 ℃, determining the relative density of the extract to be 1.25, obtaining extract A, and reserving the medicine residue for later use;

s3, adding water into the medicine residues obtained in the step S2, extracting the medicine residues by heating to 90 ℃, extracting for 2 times, wherein the weight of the water is 10 times of the weight of the medicine residues, filtering the mixture after extraction for 1 hour each time, separating filtrate and filter residues, and concentrating the filtrate to an extract with the relative density of 1.25 when the filtrate is concentrated to 80 ℃ to obtain an extract B;

s4, mixing the extract A and the extract B to obtain a total extract, vacuum-drying at 60 ℃ for 24h, and grinding to obtain extract powder; the water content of the extract powder is 2%.

S5, weighing the following components in percentage by weight: uniformly mixing 2% of polyvinylpyrrolidone, 60% of filler, 2% of potato starch and the balance of extract powder, performing dry granulation, drying at 37 ℃, and tabletting, wherein the weight of each tablet is controlled to be 0.5g, so as to obtain the astragalus mongholicus gout tablets; the filler is composed of microcrystalline cellulose 50% and superfine silica gel 50% in percentage by mass.

Example 4

The preparation method of the astragalus mongholicus gout tablet comprises the following steps:

s1 weighing 20g of rhizoma smilacis glabrae, 20g of radix clematidis, 20g of radix astragali, 10g of cortex fraxini, 10g of fried rhizoma atractylodis, 10g of radix sileris, 10g of folium ginkgo, 10g of selaginella tamariscina, 10g of caulis spatholobi and 10g of herba orthosiphoni, drying, crushing, sieving with a 10-mesh sieve, and uniformly mixing to obtain a traditional Chinese medicine mixture;

s2, heating the traditional Chinese medicine mixture obtained in the step S1 to 75 ℃ by using 75% ethanol aqueous solution in volume percentage concentration for extraction, wherein the weight of the ethanol aqueous solution is 10 times of the weight of the traditional Chinese medicine mixture, extracting for 2 times, 1 hour each time, filtering the mixture after extraction, separating filtrate and filter residue, concentrating the filtrate to 80 ℃, determining the relative density of the extract to be 1.25, obtaining extract A, and reserving the medicine residue for later use;

s3, adding water into the medicine residues obtained in the step S2, extracting the medicine residues by heating to 90 ℃, extracting for 2 times, wherein the weight of the water is 10 times of the weight of the medicine residues, filtering the mixture after extraction for 1 hour each time, separating filtrate and filter residues, and concentrating the filtrate to an extract with the relative density of 1.25 when the filtrate is concentrated to 80 ℃ to obtain an extract B;

s4, mixing the extract A and the extract B to obtain a total extract, vacuum-drying at 60 ℃ for 24h, and grinding to obtain extract powder; the water content of the extract powder is 2%.

S5, weighing the following components in percentage by weight: uniformly mixing 2% of polyvinylpyrrolidone, 60% of filler, 2% of potato starch and the balance of extract powder, performing dry granulation, drying at 37 ℃, and tabletting, wherein the weight of each tablet is controlled to be 0.5g, so as to obtain the astragalus mongholicus gout tablets; the filler consists of 60% of microcrystalline cellulose, 20% of isomaltulose and 20% of superfine silica gel powder in percentage by mass.

Example 5

The preparation method of the astragalus mongholicus gout tablet comprises the following steps:

s1 weighing 20g of rhizoma smilacis glabrae, 20g of radix clematidis, 20g of radix astragali, 10g of cortex fraxini, 10g of fried rhizoma atractylodis, 10g of radix sileris, 10g of folium ginkgo, 10g of selaginella tamariscina, 10g of caulis spatholobi and 10g of herba orthosiphoni, drying, crushing, sieving with a 10-mesh sieve, and uniformly mixing to obtain a traditional Chinese medicine mixture;

s2, heating the traditional Chinese medicine mixture obtained in the step S1 to 75 ℃ by using 75% ethanol aqueous solution in volume percentage concentration for extraction, wherein the weight of the ethanol aqueous solution is 10 times of the weight of the traditional Chinese medicine mixture, extracting for 2 times, 1 hour each time, filtering the mixture after extraction, separating filtrate and filter residue, concentrating the filtrate to 80 ℃, determining the relative density of the extract to be 1.25, obtaining extract A, and reserving the medicine residue for later use;

s3, adding water into the medicine residues obtained in the step S2, extracting the medicine residues by heating to 90 ℃, extracting for 2 times, wherein the weight of the water is 10 times of the weight of the medicine residues, filtering the mixture after extraction for 1 hour each time, separating filtrate and filter residues, and concentrating the filtrate to an extract with the relative density of 1.25 when the filtrate is concentrated to 80 ℃ to obtain an extract B;

s4, mixing the extract A and the extract B to obtain a total extract, vacuum-drying at 60 ℃ for 24h, and grinding to obtain extract powder; the water content of the extract powder is 2%;

s5, weighing the following components in percentage by weight: uniformly mixing 2% of polyvinylpyrrolidone, 60% of filler, 2% of modified starch and the balance of extract powder, performing dry granulation, drying at 37 ℃, and tabletting, wherein the weight of each tablet is controlled to be 0.5g, so as to obtain the astragalus mongholicus gout tablets; the filler consists of 60% of microcrystalline cellulose, 20% of isomaltulose and 20% of superfine silica gel powder in percentage by mass.

The preparation method of the modified starch comprises the following steps: adding 10g of potato starch to 100mL of water; heating and stirring at 90 ℃ until the starch is completely gelatinized; cooling to 30 ℃ to form gel; placing the gel in water at 8 deg.C for 12 hr; taking out the gel and soaking the gel in 75 wt% ethanol water solution for 48 h; taking out the gel, drying at 50 ℃ for 6h, and grinding to obtain the modified starch.

Example 6

The preparation method of the astragalus mongholicus gout tablet comprises the following steps:

s1 weighing 20g of rhizoma smilacis glabrae, 20g of radix clematidis, 20g of radix astragali, 10g of cortex fraxini, 10g of fried rhizoma atractylodis, 10g of radix sileris, 10g of folium ginkgo, 10g of selaginella tamariscina, 10g of caulis spatholobi and 10g of herba orthosiphoni, drying, crushing, sieving with a 10-mesh sieve, and uniformly mixing to obtain a traditional Chinese medicine mixture;

s2, heating the traditional Chinese medicine mixture obtained in the step S1 to 75 ℃ by using 75% ethanol aqueous solution in volume percentage concentration for extraction, wherein the weight of the ethanol aqueous solution is 10 times of the weight of the traditional Chinese medicine mixture, extracting for 2 times, 1 hour each time, filtering the mixture after extraction, separating filtrate and filter residue, concentrating the filtrate to 80 ℃, determining the relative density of the extract to be 1.25, obtaining extract A, and reserving the medicine residue for later use;

s3, adding water into the medicine residues obtained in the step S2, extracting the medicine residues by heating to 90 ℃, extracting for 2 times, wherein the weight of the water is 10 times of the weight of the medicine residues, filtering the mixture after extraction for 1 hour each time, separating filtrate and filter residues, and concentrating the filtrate to an extract with the relative density of 1.25 when the filtrate is concentrated to 80 ℃ to obtain an extract B;

s4, mixing the extract A and the extract B to obtain a total extract, vacuum-drying at 60 ℃ for 24h, and grinding to obtain extract powder; the water content of the extract powder is 2%;

s5, weighing the following components in percentage by weight: uniformly mixing 2% of polyvinylpyrrolidone, 60% of filler, 2% of modified starch and the balance of extract powder, performing dry granulation, drying at 37 ℃, and tabletting, wherein the weight of each tablet is controlled to be 0.5g, so as to obtain the astragalus mongholicus gout tablets; the filler consists of 60% of microcrystalline cellulose, 20% of isomaltulose and 20% of superfine silica gel powder in percentage by mass.

The preparation method of the modified starch comprises the following steps: adding 10g of potato starch to 100mL of water; heating and stirring at 90 ℃ until the starch is completely gelatinized; cooling to 30 ℃ to form gel; placing the gel in water at 8 deg.C for 12 hr; taking out the gel and soaking the gel in 75 wt% ethanol water solution for 48 h; taking out the gel, drying for 6h at 50 ℃, and grinding uniformly to obtain gel powder; adding 10g of gel powder into 25mL of water, adding 15mL of crotonic acid aqueous solution, and stirring and mixing at room temperature for 30min to obtain a mixed solution; adjusting the pH of the mixed solution to 3.5 by using NaOH aqueous solution, and then stirring for 24 hours at room temperature; filtering and washing to remove unreacted crotonic acid; drying and grinding to obtain the modified starch. The crotonic acid aqueous solution is obtained by uniformly mixing 10g of crotonic acid solution and 10mL of water.

Test example 1

The astragalus mongholicus gout tablet in the embodiment 5 is taken 3 times a day, 2g at a time, and is taken with warm boiled water.

In order to show the effect of the medicine on treating gout, the medicine prepared in the embodiment 5 is used for treating 100 cases of gout patients in outpatient clinics of Chongqing Tongkang orthopedic hospitals in 2018.

The traditional Chinese medicine gout diagnosis standard is as follows: patients with hyperuricemia often suffer from severe pain of joints at midnight, redness, local swelling, burning and pain of the skin of toe joints, light day and heavy night, polydipsia and sweating, effusion in joint cavities, and repeated attack of the hyperuricemia can be accompanied with tophus deposits around joints and between auricles, helix and toe bones. If the above symptoms appear, the diagnosis can be confirmed.

Of the subjects observed for diagnosis, 75 males and 25 females, without other serious diseases, were between 30 and 70 years of age, with a mean age of 45.3 years. The astragalus mongholicus tablets prepared in example 5 are taken 3 times a day, 2g at a time, and are taken with warm boiled water for 30 days continuously. During the clinical experiment, other medicines and health care nutriments are stopped taking, wine and high purine food are forbidden, and the follow-up visit is 3 months after the treatment is finished.

And (3) judging the curative effect:

the clinical cure is as follows: constitution strengthening, body strength, joint redness, swelling, heat and pain; no obvious abnormality on the part, free movement, and blood uric acid value reduced to normal range.

Improvement: strengthening physique, strengthening body, reducing joint redness, swelling, heat and pain, and reducing blood uric acid value, but not reaching the normal range.

The disease is not cured: the red, swollen, hot and painful joints are not obviously improved, the movement is limited, and the blood uric acid value is not reduced.

As a result: 68 patients are cured, 32 patients are improved, and the total effective rate reaches 100%. The traditional Chinese medicine is used for treating gout, has no toxic or side effect and adverse reaction, and is suitable for long-term treatment of gout patients.

Typical cases are:

the patient is Mr. Wang, male, the age is 56 years old, the history of gout is 8 years, and the blood uric acid is 538 umol/L; the red swelling and pain of the left foot thumb joint and the movement disorder are caused, the gout and astragalus tablet of the embodiment 5 is taken 3 times a day and 2g at a time, the tablet is taken with warm boiled water, after the tablet is taken for 30 days, the red swelling and pain of the left foot thumb joint disappears, the blood uric acid is 450umol/L, after the tablet is continuously taken for 15 days, the blood uric acid is 436umol/L, the left foot thumb joint moves freely, no adverse reaction exists, and the patient can be followed with a diagnosis until now without relapse.

Test example 2

Testing the disintegration time: the tablets of examples 1 to 5 were tested by disintegration time limit test (basket type) according to the pharmacopoeia of the people's republic of China 2015 edition, fourth part, general rule 0921. Adding a baffle plate in each tube, starting a disintegration tester to detect, recording the disintegration time of each tablet, and taking an average value to obtain the finished product. All traditional Chinese medicine tablets should be disintegrated within 1 hour. The test results are shown in Table 1.

Table 1: examples 1-5 disintegration time of the drugs produced

	Tablet weight	Disintegration time
			Example 1	0.5 g/tablet	250s
Example 2	0.5 g/tablet	300s
			Example 3	0.5 g/tablet	120s
Example 4	0.5 g/tablet	20s
			Example 5	0.5 g/tablet	15s
Example 6	0.5 g/tablet	12s

Moisture absorption resistance test: the tablets obtained in examples 1 to 5 were placed at 37 ℃ and a relative humidity of 75% and tested for hygroscopicity (percentage of increase in moisture absorption) after 7 days and 14 days, the results of which are shown in Table 2:

table 2: example 1-5 hygroscopicity of the drugs prepared

	7-day hygroscopicity (%)	14 days hygroscopicity (%)
			Example 1	1.6	2.5
Example 2	2.0	3.0
			Example 3	1.8	2.7
Example 4	1.2	1.9
			Example 5	1.0	1.6

The traditional Chinese medicine extract powder has complex components, contains a large amount of water-soluble and hydrophilic components, has strong capability of absorbing and combining water, is easy to gather and bond under the actions of mechanical winding, three-dimensional effect, electrostatic attraction, free liquid, solid bridge and the like, causes the reduction of fluidity and even hardening and blocking, not only brings great difficulty to the preparation process of the traditional Chinese medicine preparation, but also is a main factor influencing the stability of the traditional Chinese medicine preparation. As can be seen from the data in Table 2, the anti-hygroscopic property of the drug prepared in example 5 is superior to that of the drugs prepared in other examples, and a significant improvement is achieved.

Test example 3

Tablet friability test:

adopting a friability inspection method of tablets of 0923 in the 'Chinese pharmacopoeia' 2015 edition, using a tablet hardness tester, taking 13 tablets, wherein each tablet is 0.5g, and the total weight of the 13 tablets is about 6.5 g; the powder falling off the tablets was blown off with a blower. Precisely weighing, placing in a cylinder, rotating for 100 times, taking out, removing powder by the same method, precisely weighing, reducing weight by less than 1%, and detecting broken, cracked and crushed pieces. If the weight loss exceeds 1%, the weight loss should be measured 2 times, and the average weight loss of 3 times should not exceed 1%, and no fracture, crack or crushed piece should be detected.

Table 3: examples 5-6 friability of gouty Astragalus membranaceus tablets

	Weight loss
		Example 5	0.53％
Example 6	0.12％

As can be seen from table 3, the friability of the gouty radix astragali tablet of example 6 is significantly less than that of example 5. Therefore, after the starch is modified by the crotonic acid, the wear resistance of the gouty radix astragali tablet can be obviously improved, and the risk of crushing and failure of the gouty radix astragali tablet due to transportation and the like is reduced.