A traditional Chinese medicine composition for treating acute or chronic gouty arthritis, and a preparation method and use thereof

Abstract

The present application belongs to the field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition for treating acute or chronic gouty arthritis, and a preparation method and application thereof. One of the purposes of the present application is to provide a traditional Chinese medicine composition comprising lotus leaf, cortex fraxini, atractylodes, smilax glabra, phellodendron, plantago seed and licorice. In the prescription, the lotus leaf is the monarch herb for clearing heat and resolving summer-heat, raising clear yang and cooling blood to stop bleeding; cortex fraxini, phellodendron and atractylodes are the ministerial herbs to strengthen the heat-clearing and dampness-drying effect of the monarch herb; plantago seed is diuretic and detoxicant, smilax glabra is detoxicant and dampness-removing and joint-activating, and licorice is heat-clearing and detoxicant and pain-relieving, which can not only relieve symptoms, but also has mild medicinal property. The whole prescription has the effects of removing dampness and discharging turbidity, removing blood stasis and heat, and relieving pain, and is effective in treating acute or chronic gouty arthritis with symptoms of joint redness and swelling, fever, pain or tenderness, and limited activity, or accompanied by systemic fever, thirst and yellowish urine.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition for treating acute or chronic gouty arthritis, and a preparation method and use thereof. BACKGROUND

[0002] Gout is a crystal-related arthropathy caused by monosodium urate (MSU) crystal deposition, and its pathological nature is directly related to hyperuricemia caused by purine metabolism disorder and / or uric acid excretion disorder, belonging to the category of metabolic rheumatic diseases. The disease is mainly characterized by repeated acute arthritis, gout stone formation and joint deformity, and long-term progression can involve the kidney, causing kidney stones, interstitial nephropathy and even renal failure. At the same time, it is often combined with metabolic syndrome such as hyperlipidemia, hypertension, diabetes, arteriosclerosis and coronary heart disease, significantly increasing the risk of all-cause mortality in patients.

[0003] Genetic factors play a key role in the pathogenesis of gout: single gene hereditary diseases (such as HGPRT enzyme deficiency) can directly affect the activity of key enzymes in the uric acid metabolism pathway, while single nucleotide polymorphism (SNP) mediates the transformation of hyperuricemia to gout by regulating the function of uric acid transport proteins and the intensity of inflammatory response. When the blood uric acid concentration continuously exceeds the saturation threshold (>6.8 mg / dL) (《Research Progress on Relationship between Hyperuricemia and Chronic Kidney Disease》, China Blood Purification), urate crystals are precipitated and deposited in the synovial membrane, cartilage and renal interstitium, triggering a cascade reaction (such as NLRP3) of neutrophil infiltration and inflammasome activation (《Clinical Experience of Treating Hyperuricemia from "Wet, Hot, Turbid, Stasis and Deficiency"》, Chinese Medicine), ultimately leading to acute arthritis and tissue damage.

[0004] The fundamental dilemma of gout treatment is that the existing drug system is always difficult to form synergy in the three battle lines of acute inflammation control, persistent uric acid reduction and purine metabolism regulation. Western medicine separates "pain relief" and "acid elimination" into two non-intersecting tracks: anti-inflammatory analgesics such as colchicine and indomethacin can suppress pain within a few hours, but they cannot shake the foundation of hyperuricemia and push the gastrointestinal tract to a high-risk area of ulceration - the incidence of indomethacin-related gastric ulcers is higher than 15% (Gastroscopic evaluation of anti-inflammatory agents, British Medical Journal); uric acid-lowering drugs such as allopurinol can inhibit xanthine oxidase or block renal tubular reabsorption, but they are often hindered by hypersensitivity reactions or rebound after drug withdrawal: the risk of death for allopurinol users carrying the HLA-B5801 gene can reach 30% (https: / / www.wehelpinc.com / product / detail / id / 24.html). As a result, patients have to repeatedly switch drugs in the "pain-drug change-pain" cycle and never get a sustainable long-term prescription.

[0005] Traditional Chinese medicine is expected to break this situation, but it still has the following problems: design of clinical research, use of methods, development of efficacy criteria in line with the laws of traditional Chinese medicine, coverage of patient groups, and selection of the number of medicinal herbs.

[0006] In addition, on the one hand, there are differences in understanding of those skilled in the art; on the other hand, the inventors have studied a large number of literatures and patents when making the present invention, but due to the limited space, all the details and contents are not listed in detail, which does not mean that the present invention does not have these characteristics of the prior art, on the contrary, the present invention has all the characteristics of the prior art, and the applicant reserves the right to add relevant prior art in the background art. SUMMARY

[0007] To solve the above technical problems, one of the purposes of the present application is to provide a traditional Chinese medicine composition comprising lotus leaf, cortex fraxini, atractylodes, smilax glabra, phellodendron, psyllium, and licorice.

[0008] According to a preferred embodiment, the traditional Chinese medicine composition comprises lotus leaf 8-12 parts, cortex fraxini 1-4 parts, atractylodes 1-3 parts, smilax glabra 1-2 parts, phellodendron 1-3 parts, psyllium 1-2 parts, and licorice 0.5-1.5 parts by weight.

[0009] According to a preferred embodiment, the traditional Chinese medicine composition comprises lotus leaf 5-10 parts, cortex fraxini 2-4 parts, atractylodes 1-2 parts, smilax glabra 1.5 parts, phellodendron 1-2 parts, psyllium 1.5 parts, and licorice 1 part by weight.

[0010] Preferably, the traditional Chinese medicine composition comprises, by weight, 10 parts of lotus leaf, 2 parts of cortex fraxini, 2 parts of atractylodes, 1.5 parts of smilax glabra, 2 parts of phellodendri cortex, 1.5 parts of plantago, and 1 part of licorice.

[0011] One of the purposes of the present application is also to provide a preparation method of a traditional Chinese medicine composition, comprising the following steps:

[0012] The medicinal materials are added according to the components of the above composition, and water is added for decoction twice, and the decoction is combined.

[0013] One of the purposes of the present application is also to provide a preparation method of a granule traditional Chinese medicine composition, comprising the following steps:

[0014] The medicinal materials are added according to the components of the above composition, and water is added for decoction twice, and the decoction is combined.

[0015] Filtering, and concentrating the filtrate to a thick paste with a relative density of 1.28-1.30 (70°C);

[0016] Adding an appropriate amount of excipients, mixing, drying, and obtaining.

[0017] According to a preferred embodiment, the excipients comprise dextrin.

[0018] According to a preferred embodiment, the calculation method of the amount of dextrin is as follows: specification x batch size - extract weight x extract solid content.

[0019] It should be noted that the specification is the weight of a single package, the batch size is the number of single packages, and the solid content is the mass percentage of solid substances in a certain substance.

[0020] According to a preferred embodiment, the preparation method of the granule traditional Chinese medicine composition further comprises granulation after drying, wherein the granulation refers to heating the extract to 60-80°C in a water bath, mixing with the weighed dextrin, adding an appropriate amount of 50% ethanol to make soft material, and passing through an 18-mesh sieve to obtain wet granules.

[0021] One of the purposes of the present application is also to provide a preparation method of a capsule traditional Chinese medicine composition, comprising the following steps:

[0022] The medicinal materials are added according to the components of the above composition, and water is added for decoction twice, and the decoction is combined.

[0023] Filtering, and concentrating the filtrate to a thick paste with a relative density of 1.28-1.30 (70°C);

[0024] Drying, crushing, sieving, and filling into capsules, and obtaining.

[0025] According to a preferred embodiment, the drying of the granules or capsules is, for example, oven drying. Preferably, the wet granules are dried in a fluidized bed drying with boiling drying or oven drying at atmospheric pressure (60-80°C), and the dried granules are sized in a 10-mesh, 60-mesh double-layer oscillating screen.

[0026] It is also an object of the present application to provide a preparation method of a tablet Chinese medicine composition, comprising the following steps:

[0027] The medicinal materials are mixed with water and decocted twice, and the decoction is combined;

[0028] The filtrate is concentrated to a thick paste with a relative density of 1.28-1.30 (70°C);

[0029] The dried product is pulverized, sieved, and compressed into tablets.

[0030] According to a preferred embodiment, the step of decocting twice with water comprises:

[0031] The medicinal materials are mixed with water in an amount of 20 times the amount of lotus leaf and decocted once;

[0032] The medicinal materials are mixed with water in an amount of 15 times the amount of lotus leaf and decocted twice.

[0033] Preferably, the length of time for the first decoction is 120 min, and the length of time for the second decoction is 60 min.

[0034] Preferably, the medicinal materials are soaked for 60 min before the first decoction.

[0035] According to a preferred embodiment, the sieving is performed using a 80-200 mesh sieve. Preferably, the sieving is performed using a 80 mesh sieve. Preferably, the sieving is performed using a 200 mesh sieve.

[0036] According to a preferred embodiment, the step of drying the tablets comprises reduced pressure drying (vacuum degree of 0.06-0.09 Mpa) or freeze drying (-40°C).

[0037] It is also an object of the present application to provide the use of the above-mentioned Chinese medicine composition or the Chinese medicine composition prepared based on the above-mentioned preparation method in the preparation of a medicament for treating gout or gout-induced arthritis.

[0038] It is also an object of the present application to provide the use of the above-mentioned Chinese medicine composition or the Chinese medicine composition prepared based on the above-mentioned preparation method in the preparation of a medicament for treating symptoms of joint redness, fever, pain or tenderness.

[0039] One of the purposes of the present application is also to provide the use of the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared based on the above-mentioned preparation method in the preparation of a medicament for treating thirst, general fever or yellowish urine caused by limited joint movement or inflammation.

[0040] One of the purposes of the present application is also to provide a method for treating acute or chronic gouty arthritis by orally taking the above-mentioned traditional Chinese medicine composition. Preferably, the traditional Chinese medicine composition is taken with boiling water. Preferably, the dosage is 2-3 bags (7 g / bag) each time, twice a day.

[0041] The beneficial effects of the present technical solution are as follows:

[0042] The traditional Chinese medicine composition has the effects of removing dampness and turbidity, removing blood stasis and heat, and relieving pain, and has excellent efficacy, stable drug properties, and low adverse reaction rate (see animal experiments).

[0043] Specifically, the lotus leaf in the prescription has the effects of clearing heat and resolving summer-heat, raising clear yang, and cooling blood to stop bleeding, and is the monarch drug; the cortex fraxini, phellodendri chinensis and atractylodes are the ministerial drugs to enhance the effect of the monarch drug in clearing heat and drying dampness; the plantago seed has the effects of diuresis and detoxification, and the smilax glabra has the effects of detoxification and dampness removal, and joint lubrication; the licorice root has the effects of clearing heat and resolving toxins, and relieving pain, and can not only relieve symptoms, but also has mild drug properties. The whole prescription has the effects of removing dampness and turbidity, removing blood stasis and heat, and relieving pain, and is an effective prescription for treating acute or chronic gouty arthritis, and has the effects of joint redness, fever, pain or tenderness, limited movement, or accompanied by general fever, thirst, and yellowish urine; the traditional Chinese medicine granules prepared by the traditional decoction process have accurate curative effect and are safe and reliable, are pure traditional Chinese medicine preparations, have a unique action range, low side effects, are safe to use, and have a good application prospect. DETAILED DESCRIPTION

[0044] In the description of the present application, the terms are only used for descriptive purposes, and cannot be understood as indicating or implying the relative importance or implicitly indicating the number of the indicated technical features. In the description of the present application, the meaning of "a plurality of" is two or more, unless otherwise specifically limited.

[0045] Unless otherwise specified, the test methods used in the following examples are conventional methods; the materials, reagents or instruments used are not marked with the manufacturer, and are reagents and materials that can be obtained through commercial channels; the specific conditions are not marked in the examples, and are carried out according to the conventional conditions or the conditions recommended by the manufacturer, and at the same time, the present application does not limit the source of the raw materials, and the raw materials used in the present application are ordinary commercially available products in the technical field, unless otherwise specified.

[0046] According to the "Dian Nan Ben Cao", lotus leaf has the effects of clearing heat and resolving summer-heat, stopping dizziness, clearing phlegm, relieving qi, stopping vomiting, and relieving headache and stuffy pain.

[0047] Materia Medica records: "According to the rules of human groups, 'Eighty-one' said that if the smallpox has come out, and the wind and cold attack again, the orifice will be closed and the blood will be condensed, the point will not grow, or it will turn black, this is the reverse of the mold, the body will be painful, the limbs will be slightly cold, but the warm muscles will disperse the evil, the heat will return and the spots will come out, so it is necessary to use purple back lotus leaf powder to treat it. Lotus leaves can raise the Yang Qi, disperse blood stasis, keep good blood, and cananabasis can also solve the stagnation of Qi. This medicine has saved many people, and it is better than human teeth and dragon's blood. Dai Yuanli's 'Essentials of Diagnosis and Treatment' said that lotus leaves can make people thin and weak, and single use can eliminate Yang water edema gas."

[0048] Medical Lin's Summary says: "Lotus leaves, similar to lotus and lotus heart, can enter the liver and spleen, and can clear heat and remove dampness, and can also clear Qi and enter the liver. However, the bitter and astringent taste can actually purge the heart and liver and clear the gold and solid water, so it can remove blood stasis, protect essence, eliminate false heat, and balance Qi and blood."

[0049] Materia Medica says: "Qinpi can treat eye diseases, convulsions, and take its flat wood. It can also treat dysentery and vaginal bleeding, and take its astringent. It can also treat men's low sperm, and take its astringent and tonic. This medicine is suitable for convulsions, convulsions, abortion, and diarrhea, but people only know that it can treat the eyes, and it is almost abandoned. It is a pity.

[0050] The Huainanzi said: Qinpi is blue in color and is the key medicine for treating the eyes. The Wanbi Shu said that Qinpi can stop water, which means it can collect tears. Gao You's interpretation is that it can make water boil, which is wrong.

[0051] Materia Medica records: Qinpi, bitter and astringent, can condense and disperse the essence and Qi.

[0052] Medicine and Its Properties: Aromatic and warm, astringent, and dry, it can remove dampness and enter the spleen and stomach, treating wind, cold, and dampness, and treating dampness, skin edema, and other symptoms. It is also used to treat dampness in the upper, middle, and lower parts of the body.

[0053] Materia Medica: Aromatic and warm, it can dispel dampness, regulate the stomach, and treat abdominal distension, cholera, and other symptoms. It can also treat dampness in the lower part of the body, such as the feet and knees.

[0054] Zhu Zhenhen: Huangbo, it can also be used to treat dampness and clear heat, and it is not suitable for treating dampness and clear heat.

[0055] Medical Enlightenment: Huangbo can treat kidney water and bladder deficiency, and can also treat dampness and clear heat.

[0056] "Compendium of Materia Medica": Smilax glabra (Tufuling) promotes diuresis and clears heat. It can enter the collaterals and eliminate the accumulated toxins of damp heat. While mercury and calomel poisons are detoxified by raising and astringing the toxins upwards, Smilax glabra (Tufuling) focuses on draining and guiding downwards. Therefore, it is specifically used to treat syphilis sores that penetrate deep into the collaterals, causing joint pain and even rotting. It also treats sores caused by upward movement of toxic heat, sore throat, and all kinds of malignant diseases.

[0057] The Compendium of Materia Medica states: Smilax glabra (Tufuling) strengthens the spleen and stomach, fortifies muscles and bones, dispels wind and dampness, benefits joints, and stops diarrhea. It treats muscle spasms and bone pain; malignant sores and carbuncles. It also detoxifies mercury powder and cinnabar poisoning.

[0058] Lei Gong's Explanation of the Processing and Properties of Medicinal Herbs: Plantago seed is suitable for promoting diuresis by entering the Foot Taiyang meridian and for promoting blood circulation by entering the Foot Jueyin meridian. However, diuretics often harm the eyes. The Materia Medica says that those that brighten the eyes do so by clearing liver heat, like removing firewood from under a pot, not because of their diuretic effect.

[0059] The Compendium of Materia Medica states: Plantain seed is used to treat urinary retention, relieve pain, and regulate kidney qi. Increased urination eliminates dampness, and the elimination of dampness relieves numbness.

[0060] The Compendium of Materia Medica states: Licorice is a medicine that harmonizes the middle jiao, benefits qi, replenishes deficiency, and detoxifies. It strengthens the spleen and stomach, consolidates the deficiency of the middle jiao, harmonizes yin and yang, and balances the imbalance of ying and wei.

[0061] According to the "Medicinal Properties of Medicinal Herbs", licorice, when used raw, is cooling and clears heat. It is mainly used to disperse external pathogens, reduce swelling and boils, relieve sore throat, detoxify various poisons, remove accumulated heat in the stomach, and relieve urinary tract pain. This is due to its cooling and heat-clearing properties.

[0062] In this invention, lotus leaf is the principal ingredient for clearing heat and relieving summer heat, and promoting the upward movement of clear yang. Fraxinus bark, Phellodendron bark, and Atractylodes are the assistant ingredients to enhance the heat-clearing and dampness-drying effects of the principal ingredient. Smilax glabra and Plantago seed are added to promote diuresis, relieve pain, detoxify, and dissipate nodules. Licorice is used as the guiding ingredient to harmonize the various ingredients and detoxify their toxicity.

[0063] Preferably, the dosage form of the drug includes, but is not limited to, any one or more of the following: oral liquid, decoction, tablet, capsule, granule, pill, powder, ointment, pill, medicated wine, suppository, aerosol, film or injection.

[0064] Specifically, the drug also includes pharmaceutically acceptable excipients or carriers.

[0065] Preferably, the pharmaceutically acceptable excipients or carriers include, but are not limited to, any one or more of the following: gas generating agents (sodium bicarbonate, citric acid), fillers (also known as diluents) (compressible starch, dextrin, microcrystalline cellulose (MCC)), disintegrants (carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (L-HPC)), binders (povidone (PVP), carboxypropyl cellulose (HPC), hydroxypropyl methyl cellulose (HPMC)), plasticizers (glycerol, ethylene glycol), anti-adherents (polyethylene glycol (PEG 4000 / 6000), mono / di-glycerides of stearic acid), wetting agents (distilled water, ethanol), lubricants (magnesium stearate, sodium stearyl fumarate, talc), solvents (water, ethanol), suspending agents (sodium carboxymethyl cellulose, polyvinyl alcohol), solubilizers (polyethylene glycol, glycerol), buffers (acetic acid-sodium acetate, citric acid-sodium citrate), emulsifiers (acacia, polysorbate, poloxamer), preservatives (benzoic acid, sorbic acid), antioxidants (sodium bisulfite, sodium metabisulfite, citric acid), thickening agents (gelatin, xanthan gum), stabilizers (syrup, carbomer, sucrose), sweeteners (mannitol, maltose, steviol glycosides), and flavorings.

[0066] Example 1

[0067] This example relates to a granule preparation method.

[0068] The method comprises the following steps:

[0069] S1 Take 1000 g of lotus leaves, 200 g of cortex fraxini, 200 g of atractylodes, 150 g of smilax glabra, 200 g of phellodendron, 150 g of isatis indigotica, and 100 g of licorice root for use;

[0070] S2 Take each medicinal material of S1, soak in 20 times the amount of drinking water for 1.0 hour, weigh the medicinal materials, soak for 60 min, add water to 20 times the amount of lotus leaf for the first extraction, and decoct for 120 min; add water to 15 times the amount of lotus leaf for the second extraction, and decoct for 60 min, combine the decoction, filter through a 200 mesh sieve, and reserve for use;

[0071] S3 Take the filtrate prepared in S2, concentrate to a relative density of 1.28~1.30 (70℃), and reserve for use;

[0072] S4 Heat the extract prepared in S3 in a water bath to 60~80℃, weigh an appropriate amount of dextrin (formula: dextrin usage = specification x batch size - extract weight x extract solid content), and reserve for use;

[0073] S5 Mix the extract prepared in S4 above with dextrin, add an appropriate amount of 50% ethanol to make soft material, and pass through an 18 mesh sieve to prepare wet granules;

[0074] S6 dry the wet granules prepared in S5 in a fluidized bed dryer or an oven under normal pressure (60-80°C), and then sieve the granules in a 10-mesh and 60-mesh double-layer oscillating sieve to obtain qualified granules, which are then packaged by a granule packaging machine.

[0075] Example 2

[0076] This example relates to a method for preparing capsules.

[0077] The method comprises the following steps:

[0078] S1 take Folium Nelumbinis 1000 g, Cortex Fraxini 200 g, Rhizoma Atractylodis 200 g, Smilax 150 g, Phellodendri 200 g, Plantaginis 150 g, and Glycyrrhizae 100 g for use;

[0079] S2 take each medicinal material in S1, soak in 20 times the amount of drinking water for 1.0 hour, weigh the medicinal materials, soak for 60 min, add water in an amount of 20 times the amount of Folium Nelumbinis for the first extraction, and decoct for 120 min; add water in an amount of 15 times the amount of Folium Nelumbinis for the second extraction, and decoct for 60 min, combine the decoction, filter through a 200-mesh sieve, and reserve for use;

[0080] S3 take the filtrate prepared in S2, concentrate to a relative density of 1.28-1.30 (70°C) to obtain an extract, and reserve for use;

[0081] S4 dry the extract prepared in S3 under reduced pressure (vacuum degree of 0.06-0.09 Mpa) or freeze-drying (-40°C);

[0082] S5 crush, sieve through an 80-mesh screen, and encapsulate to obtain the product.

[0083] Example 3

[0084] This example relates to a method for preparing tablets.

[0085] The method comprises the following steps:

[0086] S1 take Folium Nelumbinis 1000 g, Cortex Fraxini 200 g, Rhizoma Atractylodis 200 g, Smilax 150 g, Phellodendri 200 g, Plantaginis 150 g, and Glycyrrhizae 100 g for use;

[0087] S2 take each medicinal material in S1, soak in 20 times the amount of drinking water for 1.0 hour, weigh the medicinal materials, soak for 60 min, add water in an amount of 20 times the amount of Folium Nelumbinis for the first extraction, and decoct for 120 min; add water in an amount of 15 times the amount of Folium Nelumbinis for the second extraction, and decoct for 60 min, combine the decoction, filter through a 200-mesh sieve, and reserve for use;

[0088] S3 take the filtrate prepared in S2, concentrate to a relative density of 1.28-1.30 (70°C) to obtain an extract, and reserve for use;

[0089] S4 vacuum drying (vacuum degree is 0.06-0.09 MPa) or freeze drying (-40℃) the extract prepared in S3 above, crush, pass through 80 mesh screen, and prepare into tablets according to conventional method, to obtain the tablets.

[0090] Example 4

[0091] This example relates to a granule preparation method.

[0092] The method comprises the following steps:

[0093] S1 take Folium Nelumbinis 1000 g, Cortex Fraxini 100 g, Atractylodes 200 g, Smilax 150 g, Phellodendron 200 g, Plantago 150 g, and Licorice 100 g for use;

[0094] S2 take each medicinal material of S1, soak in 20 times the amount of drinking water for 1.0 hour, weigh the medicinal materials, soak for 60 min, add water in an amount of 20 times the amount of Folium Nelumbinis for the first extraction, and decoct for 120 min; add water in an amount of 15 times the amount of Folium Nelumbinis for the second extraction, and decoct for 60 min, combine the decoction, filter through a 200 mesh screen, and reserve for use;

[0095] S3 take the filtrate prepared in S2, concentrate to a relative density of 1.28-1.30 (70℃), and reserve for use;

[0096] S4 heat the extract prepared in S3 to 60-80℃ in a water bath, weigh an appropriate amount of dextrin (formula: dextrin amount = specification x batch size - extract weight x extract solid content), and reserve for use;

[0097] S5 mix the extract prepared in S4 above with dextrin, add an appropriate amount of 50% ethanol to make soft material, and pass through an 18 mesh screen to prepare wet granules;

[0098] S6 after drying the wet granules prepared in S5 in a fluidized bed dryer by boiling drying or in an oven by normal pressure drying (60-80℃), size the granules in a 10 mesh, 60 mesh double-layer oscillating screen, and package the qualified granules using a granule packaging machine.

[0099] Example 5

[0100] This example relates to a granule preparation method.

[0101] The method comprises the following steps:

[0102] S1 take Folium Nelumbinis 1000 g, Cortex Fraxini 400 g, Atractylodes 200 g, Smilax 150 g, Phellodendron 200 g, Plantago 150 g, and Licorice 100 g for use;

[0103] S2: Take each medicinal material of S1, soak in 20 times of drinking water for 1.0 hour, then weigh the medicinal materials, soak for 60 min, add water in an amount of 20 times of the amount of lotus leaf for the first extraction, and decoct for 120 min; add water in an amount of 15 times of the amount of lotus leaf for the second extraction, and decoct for 60 min, combine the decoction, filter through a 200-mesh sieve, and reserve;

[0104] S3: Take the filtrate prepared in S2, concentrate to a relative density of 1.28-1.30 (70°C), and reserve;

[0105] S4: Heat the extract prepared in S3 in a water bath to 60-80°C, weigh an appropriate amount of dextrin (formula: dextrin amount = specification x batch size - extract weight x extract solid content), and reserve;

[0106] S5: Mix the extract prepared in S4 above with dextrin, add an appropriate amount of 50% ethanol to make soft material, and pass through an 18-mesh sieve to make wet granules;

[0107] S6: After the wet granules prepared in S5 above are dried in a boiling fluidized bed or in an oven under normal pressure (60-80°C), the qualified granules are packaged using a granule packaging machine.

[0108] Example 6

[0109] This example relates to a granule preparation method.

[0110] The method comprises the following steps:

[0111] S1: Take lotus leaf 1000 g, cortex fraxini 100 g, atractylodes 200 g, smilax 150 g, cortex phellodendri 200 g, plantago 150 g, and liquorice 50 g, and reserve;

[0112] S2: Take each medicinal material of S1, soak in 20 times of drinking water for 1.0 hour, then weigh the medicinal materials, soak for 60 min, add water in an amount of 20 times of the amount of lotus leaf for the first extraction, and decoct for 120 min; add water in an amount of 15 times of the amount of lotus leaf for the second extraction, and decoct for 60 min, combine the decoction, filter through a 200-mesh sieve, and reserve;

[0113] S3: Take the filtrate prepared in S2, concentrate to a relative density of 1.28-1.30 (70°C), and reserve;

[0114] S4: Heat the extract prepared in S3 in a water bath to 60-80°C, weigh an appropriate amount of dextrin (formula: dextrin amount = specification x batch size - extract weight x extract solid content), and reserve;

[0115] S5: Mix the extract prepared in S4 above with dextrin, add an appropriate amount of 50% ethanol to make soft material, and pass through an 18-mesh sieve to make wet granules;

[0116] S6 The wet granules prepared in S5 above are dried in a fluidized bed dryer or oven drying (60-80℃) and then sized in a 10 mesh, 60 mesh double layer vibrating screen. The qualified granules are packed by a granule packing machine.

[0117] Comparative Example 1

[0118] The difference between this comparative example and Example 1 is that Folium Nelumbinis and Cortex Fraxini are not included.

[0119] Specifically, the one kind of traditional Chinese medicine composition for treating acute or chronic gouty arthritis is composed of the following raw medicinal materials in parts by weight: Atractylodes 200 g, Smilax 150 g, Phellodendron 200 g, Plantago 150 g, and Glycyrrhiza 100 g.

[0120] The preparation method of the traditional Chinese medicine composition is basically the same as that of Example 1.

[0121] Comparative Example 2

[0122] The difference between this comparative example and Example 1 is that the weight ratio of Folium Nelumbinis, Cortex Fraxini, Phellodendron and Atractylodes is different.

[0123] Specifically, the one kind of traditional Chinese medicine composition for treating acute or chronic gouty arthritis is composed of the following raw medicinal materials in parts by weight: Folium Nelumbinis 500 g, Cortex Fraxini 100 g, Atractylodes 100 g, Smilax 150 g, Phellodendron 100 g, Plantago 150 g, and Glycyrrhiza 100 g.

[0124] The preparation method of the traditional Chinese medicine composition is basically the same as that of Example 1.

[0125] Comparative Example 3

[0126] This comparative example relates to an existing traditional Chinese medicine preparation, which has the function of clearing heat and removing dampness. It is used for arthralgia caused by damp-heat downward transmission, with symptoms of red swelling of feet and knees, and pain in tendons and bones.

[0127] The traditional Chinese medicine preparation is Simiao Pill (produced by Jilin Zixin Pharmaceutical Co., Ltd.), which is one of the commonly used drugs for treating gout. Its components include Atractylodes, Radix Cyathulae, Phellodendron, and Coicis Semen, etc.

[0128] Comparative Example 4

[0129] This comparative example relates to an existing traditional Chinese medicine preparation, which has the functions of dispelling wind and cold, promoting blood circulation and relieving pain. It is used for arthralgia caused by wind-cold-dampness blockage and blood stasis in the collaterals, with symptoms of joint pain, cold pain, stabbing pain or severe pain, difficulty in flexion and extension, local cold, lumbago and leg pain, numbness of extremities, and local swelling and pain caused by contusion and injury.

[0130] The traditional Chinese medicine preparation is Shufeng Dingtong Pills (produced by Beijing Tongren Tang Science and Technology Development Co., Ltd. Pharmaceutical Factory), and its components are Strychni Semen, Ephedra, Olibanum (vinegar processed), Myrrha (vinegar processed), Radix Morindae Officinalis, Natrii Muriati, Cinnamomi Ramulus, Radix Achyranthis Bidentatae, Chaenomelis Fructus, Glycyrrhizae Radix et Rhizoma, Eucommiae Cortex (salt processed), Saposhnikoviae Radix, Notopterygii Herba, Angelicae Pubescentis Radix.

[0131] The following relates to the results of drug efficacy evaluation of Example 1 and Comparative Examples 1-4.

[0132] (I) Anti-inflammatory efficacy evaluation

[0133] a. Test method

[0134] Adults orally take 2-3 bags (7 g per bag) of Example 1, Comparative Example 1, and Comparative Example 2, twice a day, with a maximum daily dosage of 42 g / d. The method for converting the drug dosage between humans and mice according to the body surface area is as follows: mouse drug dosage = adult drug dosage [g / (kg·d)] × 60 kg × 0.0026 / 0.02 kg = 42 g / 60 kg × 60 kg × 0.0026 / 0.02 = 5.46 [g / (kg·d)].

[0135] According to the clinical Simiao Pill dosage, adults orally take 6 g once a day, twice a day, with a maximum daily dosage of 12 g / d. The Simiao Pill tablets are ground into fine powder with a mortar and dissolved in 2 mL of distilled water. The method for converting the drug dosage between humans and mice according to the body surface area is as follows: mouse drug dosage = adult drug dosage [g / (kg·d)] × 60 kg × 0.0026 / 0.02 kg = 12 g / 60 kg × 60 kg × 0.0026 / 0.02 = 1.56 [g / (kg·d)].

[0136] According to the clinical Simiao Pill dosage, adults orally take 6 g once a day, twice a day, with a maximum daily dosage of 12 g / d. The Simiao Pill tablets are ground into fine powder with a mortar and dissolved in 2 mL of distilled water. The method for converting the drug dosage between humans and mice according to the body surface area is as follows: mouse drug dosage = adult drug dosage [g / (kg·d)] × 60 kg × 0.0026 / 0.02 kg = 12 g / 60 kg × 60 kg × 0.0026 / 0.02 = 1.56 [g / (kg·d)].

[0137] Each group of drugs is ground into fine powder with a mortar and dissolved in 2 mL of distilled water.

[0138] Kunming mice [half male and half female, SPF Kunming mice, half male and half female, weighing (25±5) g, provided by Beijing Vital River Laboratory Animal Technology Co., Ltd.] were randomly divided into a control group and a drug administration group, wherein the drug administration group was administered the traditional Chinese medicine composition or the positive drug by gavage. After 1 week of adaptive feeding, the mice in each drug administration group were administered once a day by gavage, and the administration was continued for 7 days. One hour after the last administration, 0.2 mL of xylene was uniformly applied to the right auricle of all mice to cause inflammation, and the mice were sacrificed one hour later. A puncher with a diameter of 8 mm was used to punch the same part of the left and right ears to obtain the samples, and the difference between the right ear and the left ear was the degree of swelling. Swelling inhibition rate = (swelling degree of the control group - swelling degree of the drug administration group) / swelling degree of the control group x 100%.

[0139] b. Test results

[0140] Table 1 shows the swelling degree of the mouse auricle and the swelling inhibition rate ratio (average value ± standard deviation).

[0141] Table 1

[0142]

[0143] Note: compared with the control group, **** P <0.0001; *** P <0.001; ** P <0.01; * P <0.05.

[0144] According to the results of the xylene-induced auricle swelling test described above, compared with the control group, the swelling degrees of the examples and the comparative examples were decreased. However, according to the comparison with Comparative Examples 1 to 4, the traditional Chinese medicine composition involved in the present application had a significant effect, and the inhibition rate of Example 1 (47.10%) was significantly higher than that of Comparative Example 1 (19.71%), Comparative Example 2 (37.64%) and Comparative Example 4 (43.04%), and was comparable to that of Comparative Example 3 (48.11%).

[0145] The results show that the traditional Chinese medicine composition involved in the present application has good anti-inflammatory effect.

[0146] (II) Analgesic efficacy evaluation

[0147] a. Test method

[0148] Kunming mice (half male and half female, SPF Kunming mice, half male and half female, weighing (25±5) g) were randomly divided into a model control group and a drug administration group, wherein the drug administration group was administered with Example 1 and Comparative Examples 1-4 by gavage. After the mice were adaptively fed for 1 week, the mice in each drug administration group were administered by gavage once a day, and the administration was continued for 7 days. One hour after the last administration, all mice were intraperitoneally injected with 10% acetic acid 0.1 mL / 10 g, and the time of the first writhing (latent period) and the number of writhing within 20 minutes of each mouse were recorded.

[0149] The writhing reaction inhibition rate = (average number of writhing of the model control group - average number of writhing of the drug administration group) / average number of writhing of the model control group x 100%.

[0150] b. Test results

[0151] Table 2 shows the comparison of the writhing latency, the number of writhing within 20 minutes and the inhibition rate of mice (average value ± standard deviation).

[0152] Table 2

[0153]

[0154] Note: compared with the control group, **** P<0.0001; *** P<0.001; ** P<0.01; * P<0.05.

[0155] From the above mouse acetic acid-induced pain test results, compared with the control group, Examples 1 and Comparative Examples 1-4 all have analgesic effect. However, compared with the inhibition rates of Comparative Examples 1-4 (Comparative Example 3: 31.13%; Comparative Example 4: 47.48%; Comparative Example 1: 9.75%; Comparative Example 2: 19.28%), the writhing latency of the traditional Chinese medicine composition (44.19%) of Example 1 involved in the present application is prolonged, and the number of writhing is significantly reduced.

[0156] The results show that the traditional Chinese medicine composition involved in the present application has a significant analgesic effect on acetic acid-induced pain in mice.

[0157] (Three) Uric acid-lowering drug efficacy evaluation

[0158] a. Test method

[0159] 6-8-week-old C57 / B6J mice were used, which were provided by Beijing Vantoll Life Experimental Animal Technology Co., Ltd.

[0160] The mice live in 12-hour day-night cycles. According to the administration volume (mL) = mouse weight (g) / 100 administration. 10 mice in each group, half male and half female, are given 60 mg / mL xanthine + 25 mg / mL ethambutol hydrochloride by gavage, and 2 hours after the administration of the modeling drug, the above-mentioned traditional Chinese medicine composition is administered. The experimental period is 7 days, and on the 8th day, the mouse blood is collected, and the serum is taken to measure the uric acid content therein.

[0161] b. Test results

[0162] Table 3 shows the serum uric acid values of the mice.

[0163] Table 3

[0164]

[0165] Note: compared with the control group, **** P < 0.0001; *** P < 0.001; ** P < 0.01; * P < 0.05.

[0166] As can be seen from Table 3, compared with the blank group, the uric acid content in the serum of the model group rats is significantly increased, indicating that the hyperuricemia model is successfully modeled. Compared with the model group, the uric acid content in the serum of the rats of Example 1 and Comparative Examples 1-4 is reduced, and the uric acid content in the serum of the rats of Example 1 and Comparative Example 3 is significantly reduced, indicating that the traditional Chinese medicine composition provided by the Heqin Tongfeng granules of the present application can significantly reduce the uric acid content in the serum of hyperuricemia mice, and has the effects of reducing uric acid and relieving gout.

[0167] It should be noted that the above specific examples are exemplary, and those skilled in the art can come up with various solutions under the inspiration of the disclosure content, and these solutions also belong to the disclosed range of the present application and fall within the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition for treating gout or gout-induced arthritis, characterized in that, 10 parts of lotus leaf, 2 parts of cassia twig, 2 parts of Chinese atractylodes, 1.5 parts of smilax glabra, 2 parts of phellodendron, 1.5 parts of psyllium and 1 part of licorice by weight.

2. A method for preparing a traditional Chinese medicine composition for treating gout or gout-induced arthritis, characterized in that, The method comprises the following steps: The traditional Chinese medicine composition of claim 1 is combined with medicinal materials, water is added and decocted twice, and the decoction is combined.

3. The preparation method of the traditional Chinese medicine composition according to claim 2, characterized in that, The step of adding water and decocting twice comprises: 20 times the amount of lotus leaf is added with water and mixed with medicinal materials for decoction once; 15 times the amount of lotus leaf is added with water and mixed with medicinal materials for decoction twice.

4. A method for preparing granules for treating gout or gout-induced arthritis, characterized by, The method comprises the following steps: The traditional Chinese medicine composition of claim 1 is combined with medicinal materials, water is added and decocted twice, and the decoction is combined. Filtering, concentrating the filtrate to a thick paste with a relative density of 1.28-1.30; Adding an appropriate amount of excipients, mixing, drying, and obtaining.

5. A method for preparing a capsule for treating gout or gout-induced arthritis, characterized by, The method comprises the following steps: The traditional Chinese medicine composition of claim 1 is combined with medicinal materials, water is added and decocted twice, and the decoction is combined. Filtering, concentrating the filtrate to a thick paste with a relative density of 1.28-1.30; Drying, crushing, sieving, and obtaining capsules.

6. A method for preparing a tablet for treating gout or gout-induced arthritis, characterized by, The method comprises the following steps: The traditional Chinese medicine composition of claim 1 is combined with medicinal materials, water is added and decocted twice, and the decoction is combined. Filtering, concentrating the filtrate to a thick paste with a relative density of 1.28-1.30; Drying under reduced pressure or freeze-drying, crushing, sieving, and compressing into tablets.

7. Use of the traditional Chinese medicine composition of claim 1, the traditional Chinese medicine composition prepared by the preparation method of any one of claims 2-3, the granules prepared by the preparation method of claim 4, the capsules prepared by the preparation method of claim 5, or the tablets prepared by the preparation method of claim 6 in the preparation of a drug for treating gout or gout-induced arthritis.

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