CN118078930A - Traditional Chinese medicine composition for treating hyperuricemia and complications thereof, and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for treating hyperuricemia and complications thereof, and preparation method and application thereof Download PDFInfo
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Classifications
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Abstract
The application relates to the technical field of traditional Chinese medicines and provides a traditional Chinese medicine composition and a preparation method thereof, wherein the traditional Chinese medicine composition comprises the raw materials of giant knotweed rhizome, yam rhizome, medicinal cyathula root, suberect spatholobus stem, pseudo-ginseng powder and glabrous greenbrier rhizome; the application also provides an oral preparation which is prepared from the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials according to a preparation process; the application also provides application of the traditional Chinese medicine composition or the oral preparation in preparing medicines with at least one of the effects of clearing heat, eliminating dampness, eliminating evil, tonifying liver and kidney and strengthening tendons and bones, preparing medicines for treating hyperuricemia, or preparing medicines for treating at least one of gout, gouty nephropathy and gouty arthritis. The traditional Chinese medicine composition has the effects of treating hyperuricemia and complications thereof, has definite curative effect and small side effect, can be used for treating gout, gouty nephropathy and gouty arthritis, and provides a new medicine choice for clinic.
Description
Technical Field
The application relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating hyperuricemia and complications thereof, a preparation method and application thereof.
Background
Hyperuricemia (hyperuricemia, HUA) is caused by excessive uric acid production and/or insufficient excretion in the body, and under the normal purine diet state, the hyperuricemia can be diagnosed by aiming at fasting blood uric acid level twice on the same day, wherein male is higher than 420 mu mol/L, and female is higher than 360 mu mol/L. The occurrence and development of hyperuricemia is considered to be associated with uric acid metabolic disorders caused by gender, eating habits, occupation, environmental factors, and the like. With the development of social economy in China, the incidence rate of hyperuricemia is in an annual rising trend due to the improvement of the living standard and the change of living habits of people, and particularly, the incidence rate of hyperuricemia is increased from 1.4% in 1980 to 14.1% in 2019. In the general consensus of Chinese experts for treating hyperuricemia and gout, it is pointed out that hyperuricemia is the most important biochemical basis and the most direct causative factor for gout, and whether gout occurs and the frequency of the gout is directly related to the blood uric acid level; hyperuricemia can cause vascular endothelial injury and chronic damage to the kidneys, exacerbate insulin resistance, and increase the risk of developing diabetes and metabolic syndrome, as well as hypertension, coronary heart disease, cerebral stroke, and the like.
Hyperuricemia can cause a series of complications, such as gouty kidney disease. With the occurrence of gouty nephropathy hidden, most patients enter the renal failure stage after visiting the doctor. Physicians in modern clinics mostly attribute this disease to the category of "kidney turbidity", and consider its basic pathogenesis as: the yang deficiency failing to transform, the body fluid being disregulated, damp turbidity being generated internally, phlegm toxin being stagnant turbidity blocking the channels and collaterals; the yang deficiency of the lung, spleen and kidney can not lead to the transformation of yang deficiency, the metabolism disorder of body fluids, the interior of damp turbidity can lead to the generation of blood stasis, the accumulation of phlegm toxin and blood stasis, the blockage of kidney collaterals, the ascending and descending of qi can lead to the internal viscera, the external meridians and joints can lead to the lingering and difficult recovery, and the change of qi is more and more.
The treatment period of hyperuricemia is longer, and the safe and effective western medicine variety is not abundant. The whole treatment of the traditional medicine in China is unique in appearance, and the traditional Chinese medicine in the golden period has the disease name of 'gout' as early as the national medicine in the golden period. Ancient doctors considered gout to be a category of arthralgia syndrome, which is characterized by joint movement and severe pain, and is also called "white tiger calendar festival". "Su-Bi Lun" states that: wind-cold-dampness pathogen and three qi are mixed to form arthralgia. "Zhang Zhongjing" indicates in the "jin Kui Yao Lv: the cunkou pulse is deep and weak, namely the main bone and weak, namely the main tendon; sinking is the main kidney, weak is liver, sweat enters water, such as water hurts heart, yellow sweat of the calendar node, so it is called calendar node. … … the main body has a small pulse, short breath, spontaneous sweating, pain in the joints, and inability to flex and stretch, all of which are caused by drinking alcohol and sweating as wind. It can be seen that the joint diseases are caused by deficiency of liver and kidney, wind-cold-dampness, joint invasion, blockage of channels and collaterals, and four-end injection, and the treatment is carried out by harmonizing ying and wei, dispelling wind and removing dampness, warming channels and dredging collaterals.
Aiming at the traditional Chinese medicine formula for treating hyperuricemia, in the prior art, a Chinese patent document CN114848766A discloses a pharmaceutical composition for treating gout, which contains 20 traditional Chinese medicines in total, has the effects of clearing heat, promoting diuresis, dredging collaterals and relieving pain, but has the advantages of complex formula, high preparation cost, weak drug effect and slow effect; chinese patent document CN103432477A discloses a traditional Chinese medicine preparation for treating gout, which comprises oral medicines and external medicines, but the prescription also comprises more than 20 traditional Chinese medicines, the preparation cost is high, and the traditional Chinese medicine preparation is proved to have radically cured uric acid blood disease through clinical verification, but is not proved through research. Therefore, although the traditional Chinese medicine formula for treating hyperuricemia is studied in the prior art, the problems of complex formula, high preparation cost, unsatisfactory drug effect, slow effect and the like of the traditional Chinese medicine formula generally exist, namely, the components can generate good synergistic effect when being matched for use at present are not known, so that the problems are solved.
In view of the foregoing, there is a need for a traditional Chinese medicine composition for treating hyperuricemia and complications thereof, so that each component in the composition can produce good synergistic effect when being matched for use, and at least the effects of good efficacy, quick response and low preparation cost are achieved.
Disclosure of Invention
The application aims to overcome the defects of the prior art and provide a traditional Chinese medicine composition for treating hyperuricemia and complications thereof, and a preparation method and application thereof, so that all medicinal materials in the traditional Chinese medicine composition can generate good synergistic effect, thereby achieving at least the effects of good efficacy, quick response and low preparation cost.
The aim of the application is realized by the following technical scheme:
in one aspect, a Chinese medicinal composition is provided. The traditional Chinese medicine composition comprises the following raw materials: rhizoma Polygoni Cuspidati, rhizoma Dioscoreae Septemlobae, radix Cyathulae, caulis Spatholobi and Notoginseng radix powder, and rhizoma Smilacis Glabrae.
In some embodiments, the raw materials include, in parts by weight: 35-65 parts of giant knotweed, 47.6-86.9 parts of yam rhizome, 35-65 parts of medicinal cyathula root, 47.6-86.9 parts of suberect spatholobus stem, 21.4-39.1 parts of pseudo-ginseng powder and 35-65 parts of glabrous greenbrier rhizome.
In some embodiments, the feedstock further comprises: caulis et folium Sargentodoxae, radix Dipsaci, radix Puerariae, rhizoma Drynariae, and radix Glycyrrhizae Preparata.
In some embodiments, the raw materials include, in parts by weight: 35-65 parts of giant knotweed, 47.6-86.9 parts of yam rhizome, 35-65 parts of medicinal cyathula root, 47.6-86.9 parts of suberect spatholobus stem, 21.4-39.1 parts of pseudo-ginseng powder, 47.6-86.9 parts of sargentgloryvine stem, 35-65 parts of glabrous greenbrier rhizome, 35-65 parts of dipsacus root, 35-65 parts of kudzuvine root, 35-65 parts of drynaria rhizome and 14.3-26.1 parts of honey-fried licorice root.
In some embodiments, the raw materials include, in parts by weight: 50 parts of giant knotweed, 66.6 parts of yam rhizome, 50 parts of medicinal cyathula root, 66.6 parts of suberect spatholobus stem, 30 parts of pseudo-ginseng powder, 66.6 parts of sargentgloryvine stem, 50 parts of glabrous greenbrier rhizome, 50 parts of dipsacus root, 50 parts of kudzuvine root, 50 parts of drynaria rhizome and 20 parts of honey-fried licorice root.
In another aspect, there is provided a method of preparing a Chinese medicinal composition as in any of the above embodiments. The method comprises the following steps: weighing the raw materials of the traditional Chinese medicine composition, extracting, filtering, concentrating and drying to obtain the traditional Chinese medicine composition.
The forms of the raw materials of the traditional Chinese medicine composition can be various, and the application is not limited to the above. For example, the morphology of the raw materials of the Chinese medicinal composition includes decoction pieces.
In some embodiments, the solvent employed for the extraction comprises at least one of water, an organic solvent, and an oil.
In some examples, the means of extraction includes at least one of leaching and extraction.
In some examples, the organic solvent includes at least one of ethanol, ethyl acetate, and diethyl ether.
In some examples, the oil comprises at least one of a vegetable oil and an animal oil.
In some embodiments, the method further comprises: and (5) purifying.
In some examples, where the purification treatment is performed after the concentrating, the purification treatment includes alcohol precipitation.
In other examples, where the purification treatment is performed prior to the concentrating, the purification treatment includes at least one of ultrafiltration, chromatography column, and activated carbon decolorization, such as: the chromatographic column.
In some embodiments, the method further comprises: drying and pulverizing the concentrated soft extract.
In yet another aspect, an oral formulation is provided. The oral preparation is prepared from the traditional Chinese medicine composition according to any one of the above embodiments and pharmaceutically acceptable auxiliary materials according to a preparation process.
In some embodiments, the dosage form of the oral formulation includes at least one of a granule, a tablet, a capsule, a concentrated pill, an oral liquid, and a mixture.
In some examples, where the dosage form is the granule, the excipients include dextrin, lactose, and ethanol.
In other examples, where the dosage form is the tablet, the excipients include soluble starch, lactose, microcrystalline cellulose, and magnesium stearate.
In still other examples, where the dosage form is the capsule, the adjunct includes a soluble starch and magnesium stearate.
In still other examples, where the dosage form is the oral liquid, the adjunct comprises potassium sorbate.
In still other examples, where the dosage form is the cocktail, the adjunct comprises sodium benzoate.
In some examples, where the dosage form is the granule, the formulation process comprises: mixing the traditional Chinese medicine composition with the auxiliary materials, and then granulating, drying and finishing.
In other examples, where the dosage form is the tablet, the formulation process comprises: mixing the traditional Chinese medicine composition with the auxiliary materials, and then drying, granulating and tabletting.
In still other examples, where the dosage form is the concentrated pill, the formulation process comprises: weighing the rest materials except for Notoginseng radix powder, extracting, filtering, concentrating, mixing with Notoginseng radix powder, making pill, and drying.
In still other examples, where the dosage form is the oral liquid, the formulation process comprises: adding water into the traditional Chinese medicine composition, stirring, standing, filtering, adding the auxiliary materials, filling, sealing and sterilizing.
In still other examples, where the dosage form is the co-formulation, the formulation process comprises: adding water into the traditional Chinese medicine composition, stirring, standing, filtering, adding the auxiliary materials, filling, sealing and sterilizing.
In a further aspect, there is provided a use of the Chinese medicinal composition according to any one of the above embodiments or the oral preparation according to any one of the above embodiments in the preparation of a medicament having at least one of the effects of clearing heat, eliminating dampness, eliminating pathogenic factors, nourishing liver and kidney, and strengthening tendons and bones.
In a further aspect, there is provided a use of the Chinese medicinal composition according to any one of the above embodiments or the oral formulation according to any one of the above embodiments in the manufacture of a medicament for treating hyperuricemia.
In a further aspect, there is provided a use of the Chinese medicinal composition according to any one of the above embodiments or the oral formulation according to any one of the above embodiments in the manufacture of a medicament for treating at least one of gout, gouty nephropathy and gouty arthritis.
In the application, the efficacy and medicinal taste of each component are as follows:
giant knotweed rhizome: activating blood circulation to relieve pain, clearing heat and promoting diuresis; bitter and cold in nature and enters liver, gall bladder and lung meridians;
Rhizoma Dioscoreae Septemlobae: removing dampness and turbid urine, and dispelling wind-dampness; bitter in taste and flat in nature, enters liver, stomach and bladder meridians;
Caulis et folium Rhododendri mollis: clearing away heat and toxic materials, promoting blood circulation and relieving pain; bitter in taste and flat in nature, enter large intestine meridian;
Rhizoma smilacis glabrae: dehumidifying and benefiting joints; sweet, light and flat in nature and taste, and noble in liver and stomach meridians;
teasel root: liver and kidney tonifying, blood circulation promoting, and tendons and bones replenishing; bitter, sweet and pungent in nature, slightly warm, and enter liver and kidney meridians;
radix Cyathulae: promoting blood circulation, removing blood stasis, tonifying liver and kidney, strengthening tendons and bones, inducing diuresis, treating stranguria, and guiding blood downward; bitter in taste, sour, flat, and good for liver and kidney meridians;
radix Puerariae: relieving exterior syndrome, relieving muscles, relieving fever, promoting salivation, dredging collaterals, and relieving pain; sweet, pungent and cool in nature, and enters spleen and stomach meridians;
rhizoma drynariae: kidney tonifying and blood circulation promoting; bitter and warm in nature, enters liver and kidney meridians;
caulis Spatholobi: promoting blood circulation, replenishing blood, relaxing tendons, and activating collaterals; bitter and slightly sweet in taste, warm in nature, and enters liver meridian;
licorice root: invigorating spleen, replenishing qi, relieving spasm, relieving pain, and alleviating drug properties; sweet and flat in nature and taste, and enters heart, lung, spleen and stomach meridians;
Pseudo-ginseng: removing blood stasis, promoting blood circulation and relieving pain; sweet and slightly bitter in nature, warm in nature, enter liver and stomach meridians.
The gout is caused by deficiency of liver and kidney, turbid dampness Yu Bi, stagnation of the channels and collaterals, depression and heat transformation, and belongs to the deficiency, excess and blockage of the damp stasis. The yam rhizome in the prescription can dispel wind-damp, unblock collaterals and relieve pain, and is good for treating lumbar and knee pain, and the joint of tendons and vessels is not easy to bend and stretch; polygonum cuspidatum has the effects of dispelling wind and promoting diuresis, removing stasis and relieving pain, and relieving cough and reducing sputum, and is used for arthralgia, and is taken as a monarch drug. Rhizoma smilacis glabrae detoxifies and dehumidifies, and can promote the circulation of joints; notoginseng radix has effects of removing blood stasis, stopping bleeding, relieving swelling and relieving pain; radix dipsaci can tonify liver and kidney, strengthen tendons and bones, regulate blood vessels, and treat soreness and pain of waist and back. Caulis Spatholobi has effects of promoting blood circulation, replenishing blood, regulating menstruation, relieving pain, relaxing tendons, and activating collaterals. It is indicated for wind-damp arthralgia, numbness and paralysis, sallow complexion due to blood deficiency, and it can activate blood, unblock collaterals and alleviate pain, and nourish blood and nourish tendons. Caulis et folium Rhododendri mollis for clearing heat and detoxicating, promoting blood circulation, dispelling pathogenic wind and relieving pain. The five flavors are all ministerial drugs. The kudzuvine root is used for relieving muscles and allaying fever, promoting the production of body fluid to quench thirst and clearing and activating the channels and collaterals; rhizoma drynariae, tonifying kidney, strengthening bones, and relieving pain; chuan Xue, radix Cyathulae, with the combining action of tonifying liver and kidney, can induce blood to flow downwards. Licorice root, radix Glycyrrhizae Praeparata is used to tonify qi of the middle-jiao and regulate the effects of the other drugs. The whole formula has the effects of clearing heat, eliminating dampness, eliminating pathogenic factors, tonifying liver and kidney, strengthening tendons and bones, strengthening the body resistance, clearing and activating the channels and collaterals, and relieving pain, and mainly eliminates pathogenic factors, and has the effects of strengthening the body resistance, removing damp-heat, dredging channels and collaterals, strengthening tendons and bones, and relieving arthralgia.
The beneficial effects of the application are as follows:
1. The traditional Chinese medicine composition can reduce the serum uric acid concentration of patients with hyperuricemia and increase the renal uric acid clearance rate; reducing the joint swelling degree of gouty arthritis patients and reducing the expression of inflammatory cytokines and vascular adhesion factors in the joints; improving the kidney tissue morphology and structure of patients suffering from gouty kidney and improving kidney function.
2. The traditional Chinese medicine composition provided by the application contains no 28 toxic traditional Chinese medicines published in 1988 of the national institute, is rich in resources and low in preparation cost, and can meet the requirement of large-scale industrial production.
3. In the traditional Chinese medicine composition, three medicines of teasel root, medicinal cyathula root and drynaria rhizome have the effects of tonifying liver and kidney, strengthening bones and muscles and promoting blood circulation, kudzuvine root, suberect spatholobus stem, liquorice and pseudo-ginseng have the effects of activating blood and removing obstruction in collaterals and relieving pain, giant knotweed rhizome, sargentgloryvine stem, yam rhizome and glabrous greenbrier rhizome have the effects of activating blood and relieving pain, dehumidifying turbidity and benefiting joints, and all three medicinal materials have certain curative effects on treating hyperuricemia, but when the three medicinal materials are combined together, the uric acid reducing effect is obviously improved, so that the traditional Chinese medicine composition has the synergistic effect among the raw materials and the effect of treating hyperuricemia.
Detailed Description
Example 1
A Chinese medicinal composition is prepared by the following steps:
Weighing Chinese medicinal decoction pieces: 120g of giant knotweed, 173.9g of yam rhizome, 129g of sargentgloryvine stem, 75g of glabrous greenbrier rhizome, 83.3g of dipsacus root, 130.4g of medicinal cyathula root, 90.9g of kudzuvine root, 75g of drynaria rhizome, 160g of suberect spatholobus stem, 48g of moxibustion licorice and 66.7g of pseudo-ginseng powder; decocting with 8 times volume of water for 3 times, each time for 1 hr, mixing the obtained extractive solutions, filtering, concentrating the filtrate under reduced pressure (0.07 Mpa) at 70deg.C (+ -5deg.C) to obtain soft extract, drying under reduced pressure (0.08 Mpa) at 70deg.C (+ -5deg.C) to obtain dry extract, and pulverizing to obtain the Chinese medicinal composition of example 1.
Example 2
A Chinese medicinal composition is prepared by the following steps:
Weighing Chinese medicinal decoction pieces: 93.6g of giant knotweed, 142.8g of yam rhizome, 133.3g of sargentgloryvine stem, 83.3g of glabrous greenbrier rhizome, 103.4g of dipsacus root, 88.2g of medicinal cyathula root, 90.9g of kudzuvine root, 103.4g of drynaria rhizome, 129g of suberect spatholobus stem, 52.1g of liquorice which are processed by moxibustion and 60g of pseudo-ginseng powder; decocting with 8 times volume of water for 3 times each time for 1 hr, mixing the obtained extractive solutions, filtering, concentrating the filtrate under reduced pressure (0.07 Mpa) at 70deg.C (+ -5deg.C) to obtain soft extract with relative density of 1.20, adding ethanol to ethanol content of 70%, standing overnight, filtering, collecting ethanol precipitation, recovering ethanol under reduced pressure (0.07 Mpa) at 70deg.C (+ -5deg.C), and concentrating to obtain the final product.
Example 3
A Chinese medicinal composition is prepared by the following steps:
weighing Chinese medicinal decoction pieces: 123.4g of giant knotweed, 115.2g of yam rhizome, 137.9g of sargentgloryvine stem, 103.4g of glabrous greenbrier rhizome, 130.4g of dipsacus root, 103.4g of medicinal cyathula root, 100g of kudzuvine root, 103.4g of drynaria rhizome, 137.9g of suberect spatholobus stem, 41.3g of liquorice which are processed by moxibustion and 62g of pseudo-ginseng powder; reflux-extracting with 6 times volume of 85% ethanol for 3 times each for 1 hr, filtering, mixing filtrates, concentrating under reduced pressure (0.07 Mpa) at 70deg.C (5 deg.C) to obtain soft extract, drying under reduced pressure (0.08 Mpa) at 70deg.C (5 deg.C) to obtain dry extract, and pulverizing to obtain the Chinese medicinal composition of example 3.
Example 4
A Chinese medicinal composition is prepared by the following steps:
Weighing Chinese medicinal decoction pieces: 88.2g of giant knotweed, 127.6g of yam rhizome, 117.6g of sargentgloryvine stem, 98.2g of glabrous greenbrier rhizome, 88.2g of dipsacus root, 88.2g of medicinal cyathula root, 88.2g of kudzuvine root, 89.4g of drynaria rhizome, 117.6g of suberect spatholobus stem, 35.3g of liquorice root which is processed by moxibustion and 52.9g of notoginseng powder; adding 8 times of water, decocting for 3 times, each time for 1 hr, mixing the extractive solutions, filtering, eluting with 101 macroporous adsorbent resin column, washing with 7 times of water, removing water, eluting with 75% ethanol, collecting eluate, concentrating under reduced pressure (0.07 Mpa) at 70deg.C (+ -5deg.C) to obtain soft extract, drying under reduced pressure (0.08 Mpa) at 70deg.C (+ -5deg.C) to obtain dry extract, and pulverizing to obtain the Chinese medicinal composition of example 4.
Example 5
A Chinese medicinal composition is prepared by the following steps:
Weighing Chinese medicinal decoction pieces: 100g of giant knotweed, 133.3g of yam rhizome, 133.3g of sargentgloryvine stem, 100g of glabrous greenbrier rhizome, 100g of dipsacus root, 100g of medicinal cyathula root, 100g of kudzuvine root, 100g of drynaria rhizome, 133.3g of suberect spatholobus stem, 40g of moxibustion licorice and 60g of pseudo-ginseng powder; reflux-extracting with 70% ethanol of 6 times volume for 3 times each for 1 hr, filtering, mixing filtrates, concentrating under reduced pressure (0.07 Mpa) at 65deg.C (5 deg.C) to obtain soft extract, drying under reduced pressure (0.08 Mpa) at 70deg.C (5 deg.C) to obtain dry extract, and pulverizing to obtain the Chinese medicinal composition of example 5.
Example 6
A Chinese medicinal composition is prepared by the following steps:
Weighing Chinese medicinal decoction pieces: 75g of giant knotweed, 98.7g of yam rhizome, 100g of sargentgloryvine stem, 74.6g of glabrous greenbrier rhizome, 75g of wine teasel root, 75g of medicinal cyathula root, 80.3g of kudzuvine root, 75g of drynaria rhizome, 105.4g of suberect spatholobus stem, 30g of moxibustion licorice and 45g of pseudo-ginseng powder; reflux-extracting with 6 times of diluted ethanol for 3 times (1 hr each time), filtering, mixing filtrates, filtering, eluting with macroporous adsorbent resin (101) column, washing with 7 times of water, discarding water, eluting with 75% ethanol, collecting eluate, concentrating under reduced pressure (0.07 Mpa) to obtain soft extract, drying under reduced pressure (0.08 Mpa) at 70deg.C (5 deg.C) to obtain dry extract, and pulverizing to obtain the Chinese medicinal composition of example 6.
Example 7
A Chinese medicinal composition is prepared by the following steps:
Weighing Chinese medicinal decoction pieces: 115.3g of giant knotweed, 97.5g of yam rhizome, 105.3g of sargentgloryvine stem, 120g of glabrous greenbrier rhizome, 130.4g of dipsacus root, 125g of medicinal cyathula root, 115.3g of kudzuvine root, 115.3g of drynaria rhizome, 153.8g of suberect spatholobus stem, 46.1g of liquorice and 69.2g of pseudo-ginseng powder; reflux-extracting with 60% ethanol for 3 times (1 hr each time) with 6 times volume, filtering, mixing filtrates, concentrating under reduced pressure (0.07 Mpa) at 70deg.C (+ -5deg.C) to obtain soft extract, drying under reduced pressure (0.08 Mpa) at 70deg.C (+ -5deg.C) to obtain dry extract, and pulverizing to obtain the Chinese medicinal composition of example 7.
Example 8
A Chinese medicinal composition is prepared by the following steps: :
Weighing Chinese medicinal decoction pieces: 100g of giant knotweed, 133.3g of yam rhizome, 100g of medicinal cyathula root, 133.3g of suberect spatholobus stem, 60g of pseudo-ginseng powder and 100g of glabrous greenbrier rhizome; reflux-extracting with 70% ethanol of 6 times volume for 3 times each for 1 hr, filtering, mixing filtrates, concentrating under reduced pressure (0.07 Mpa) at 65deg.C (5 deg.C) to obtain soft extract, drying under reduced pressure (0.08 Mpa) at 70deg.C (5 deg.C) to obtain dry extract, and pulverizing to obtain the Chinese medicinal composition of example 8.
Example 9
An oral preparation is in the form of granules, and the preparation method comprises the following steps:
a Chinese medicinal composition was prepared according to example 5, sieved with a 100-mesh sieve, 200g of dextrin and 80g of lactose were added in proportion, mixed uniformly, granulated with 75% ethanol, dried and granulated.
Example 10
An oral preparation, the dosage form of which is a tablet, comprises the following preparation steps:
the preparation method of the traditional Chinese medicine composition comprises the steps of preparing the traditional Chinese medicine composition according to the example 4, sieving the traditional Chinese medicine composition by a 100-mesh sieve, adding 170g of soluble starch, 60g of lactose and 20g of microcrystalline cellulose according to a proportion, uniformly mixing, drying, granulating, adding magnesium stearate, and pressing into tablets.
Example 11
An oral preparation is in the form of a capsule, and the preparation method comprises the following steps:
A Chinese medicinal composition was prepared according to example 2, sieved with a 120 mesh sieve, added with 230g of soluble starch, mixed uniformly, granulated and dried, added with 5g of magnesium stearate, mixed uniformly and encapsulated, thus obtaining the final product.
Example 12
An oral preparation is concentrated pill, and the preparation steps are as follows:
Weighing Chinese medicinal decoction pieces: 103.4g of giant knotweed, 127.9g of yam rhizome, 117.9g of sargentgloryvine stem, 103.4g of glabrous greenbrier rhizome, 83g of dipsacus root, 124.3g of medicinal cyathula root, 112g of kudzuvine root, 99g of drynaria rhizome, 137.9g of suberect spatholobus stem and 41.4g of moxibustion licorice; decocting with 8 times volume of water for 3 times (each for 1 hr), mixing the extractive solutions, filtering, and concentrating the filtrate at 70deg.C (0.07 Mpa) under reduced pressure (0.07 Mpa) to obtain soft extract with relative density of 1.25; pulverizing Notoginseng radix into fine powder, mixing with the above soft extract, making pill, and drying.
Example 13
An oral preparation is an oral liquid, and the preparation steps are as follows:
a Chinese medicinal composition was prepared according to example 3, water was added to 1000ml, stirred well, left to stand, filtered, added with potassium sorbate, filled in a can, and sterilized.
Example 14
An oral preparation, the dosage form of which is mixture, the preparation steps are as follows:
A Chinese medicinal composition was prepared according to example 3, water was added to 1000ml, stirred well, left to stand, filtered, sodium benzoate was added, and the mixture was filled, encapsulated and sterilized to obtain the final product.
The following pharmacodynamic tests prove that the application has the beneficial effects:
Experimental example 1
The influence of the application on the hyperuricemia experimental animal model is verified. The Chinese medicinal composition of example 5 was diluted into high dose group (2.4 g/kg), medium dose group (1.2 g/kg) and low dose group (0.6 g/kg), respectively; the traditional Chinese medicine composition of example 8 was diluted to a high dose core prescription group (2.4 g/kg). 70 male SD rats were randomly divided into a blank group, a model group, a high dose group (2.4 g/kg), a medium dose group (1.2 g/kg), a low dose group (0.6 g/kg), a core formula group (2.4 g/kg) and a tribromoron group (12 mg/kg), and the blank group and the model group were given equal amounts of 0.5% CMC-Na solution by pouring 10g/kg of yeast extract into the stomach 1 time/d, 20d continuously, and the molding was started on day 11. Urine from rats (19-20) d was collected for 24 hours, urine volume was recorded, blood was collected 60 minutes after 20 days of administration, serum was separated, and serum and urine uric acid levels were measured as shown in Table 1.
Table 1 effect of the application on uric acid levels in hyperuricemia rats (n=10)
Note that: * P <0.05, < P <0.01, as compared to model group, the following.
The results show that: compared with the blank control group, the urine volume of the model group is obviously increased, the uric acid concentration in blood is obviously increased, the uric acid concentration in urine is reduced, the uric acid discharge amount is obviously reduced in 24 hours, and the difference is obvious (P < 0.01). The whole formula can reduce uric acid concentration in blood, increase uric acid discharge for 24 hours, and has obvious difference (P <0.05 or P < 0.01) compared with a model group, which proves that the application has better improvement effect on hyperuricemia rat uric acid increase; in addition, the core prescription group (2.4 g/kg) also has obvious uric acid reducing effect, which is basically equivalent to the medium dose group (1.2 g/kg) of the whole prescription group, but is slightly weaker than the high dose group (2.4 g/kg) of the whole prescription group, so that the core prescription has the effect of treating hyperuricemia, and the whole prescription has better effect of treating hyperuricemia.
Experimental example 2
And verifying the influence of the application on the experimental animal model of gouty arthritis. The Chinese medicinal composition of example 7 was diluted into high dose group (2.4 g/kg), medium dose group (1.2 g/kg) and low dose group (0.6 g/kg), respectively. 60 healthy SD rats were obtained, which were male, and had a body weight (200+ -20) g, and were randomly divided into 6 groups, i.e., a high dose group, a medium dose group, a low dose group, a positive control group, a model control group, and a blank control group. The high dose group (2.4 g/kg), the medium dose group (1.2 g/kg), the low dose group (0.6 g/kg), the positive control group (colchicine 0.5 mg/kg), the model control group (equal volume of 0.5% CMC-Na solution) were administered by gavage, respectively, 1 time a day for 7 days. 60min after the administration of animals of group 7d, 0.05 ml/dose (25 mg/Ml) of Sodium Urate (MSU) solution was injected into the left ankle joint of rats to form acute gouty arthritis. Equivalent normal saline is injected into ankle joint cavities of animals in the blank control group. And measuring the circumferences of the same parts of the tested ankle joints by using inelastic flexible tapes respectively at 1, 3, 4, 5, 6, 7, 8 and 24 hours before and after the molding, and calculating the joint swelling degree. Joint swelling degree calculation formula: swelling = post-dose joint circumference-pre-molding joint circumference, as shown in table 2.
Table 2 effect of the application on hyperuricemia rat uric acid level (n=10)
| Phase of time | Blank control group | Model control group | High dose group | Medium dose group | Low dose group | Positive control group |
| 1h | 0.01±0.04** | 0.35±0.16 | 0.15±0.17* | 0.16±0.16* | 0.25±0.21 | 0.24±0.11 |
| 3h | 0.02±0.05** | 0.58±0.22 | 0.26±0.27** | 0.30±0.21** | 0.34±0.19* | 0.37±0.20* |
| 4h | 0.04±0.05** | 0.60±0.31 | 0.31±0.22* | 0.38±0.28 | 0.51±0.17 | 0.45±0.15 |
| 5h | 0.03±0.04** | 0.71±0.31 | 0.34±0.21** | 0.39±0.22* | 0.52±0.18 | 0.46±0.19* |
| 6h | 0.04±0.05** | 0.68±0.29 | 0.40±0.17* | 0.39±0.23* | 0.51±0.13 | 0.45±0.17* |
| 7h | 0.03±0.06** | 0.60±0.28 | 0.34±0.14* | 0.33±0.25* | 0.46±0.16 | 0.40±0.16 |
| 8h | 0.03±0.07** | 0.55±0.24 | 0.31±0.13* | 0.32±0.24* | 0.39±0.12 | 0.35±0.16* |
| 24h | 0.00±0.06** | 0.41±0.18 | 0.21±0.14* | 0.24±0.26 | 0.29±0.12 | 0.28±0.15 |
The results show that: after MSU is injected into the ankle joint of the rat, the joint is red and swelled, the joint perimeter and the joint swelling degree of each phase model group are obviously increased compared with that of a blank control (P <0.05 or P < 0.01), and the large and medium doses of the application can reduce the joint swelling degree and have statistical significance compared with the model group (P <0.05 or P < 0.01).
The rats were sacrificed by exsanguination after anesthesia, and soft tissues and joint fluids around the joints to be tested were rapidly separated in a dry tray with ice cubes and stored in a low-temperature (-20 ℃) refrigerator for later use. At 4deg.C, taking soft tissue around joint and joint fluid, adding 0.2ml PH7.2PBS buffer solution for homogenizing, centrifuging at 4deg.C (3500 rpm,10 min), taking supernatant, and detecting content of homogenate IL-1β, IL-2, IL-6, IL-10, IFN- γ by double antibody sandwich enzyme-linked immunosorbent assay (ELISA), as shown in Table 3.
Table 3 effect of the invention on gouty arthritis rat cytokine levels (n=10)
| Group of | Dosage (g/kg) | IL-1β(pg/ml) | IL-2(pg/ml) | IL-6(pg/ml) | IL-10(pg/ml) | IFN-γ(pg/ml) |
| Blank control group | / | 42.0±21.5** | 34.1±15.2** | 41.4±20.1** | 80.5±18.4** | 45.9±15.1** |
| Model control group | / | 114.8±34.3 | 87.1±27.6 | 277.8±94.4 | 22.0±7.4 | 133.4±31.2 |
| Low dose group | 0.6 | 76.2±30.2* | 62.9±22.2* | 93.2±42.6** | 63.6±15.2** | 115.0±21.7* |
| Medium dose group | 1.2 | 74.7±23.3** | 58.7±20.9* | 84.7±55.2** | 65.1±21.6** | 100.7±27.5** |
| High dose group | 2.4 | 68.7±36.1** | 51.0±19.7** | 68.4±24.1** | 71.9±12.5** | 83.3±21.9** |
| Positive control group | 0.5mg/kg | 78.6±35.0* | 48.2±19.6** | 153.6±53.4** | 79.3±22.1** | 94.8±17.8** |
The results show that: compared with the blank control group, the serum IL-1 beta, IL-2, IL-6 and IFN-gamma levels of the model group are obviously increased, IL-10 is obviously reduced, and the model group has statistical significance (P <0.05 or P < 0.01). The application can obviously reduce the level of IL-1 beta, IL-2, IL-6 and IFN-gamma with high inflammatory effect after being administrated, and has statistical significance (P <0.05 or P < 0.01) compared with a model group. The administration group of the present application can increase the decreased IL-10 level.
Soft tissues around joints were taken, formalin fixed, dehydrated with conventional ethanol, paraffin embedded, 4 μm sectioned, immunohistochemical staining for vascular adhesion factor (VCAM-1) and cyclooxygenase (COX-2) according to the reagent specifications, observed under an optical microscope, and statistical experimental results are shown in tables 4 and 5.
Table 4 effect of the application on expression of VCAM-1 for gouty arthritis (n=10)
| Group of | Dosage (g/kg) | Area (x 10 4) | IOD(×104) |
| Blank control group | / | 5.14±1.50** | 1.43±0.38** |
| Model control group | / | 9.56±3.03 | 2.23±0.64 |
| Low dose group | 0.6 | 5.67±2.17** | 1.54±0.46* |
| Medium dose group | 1.2 | 5.54±1.65** | 1.23±0.46** |
| High dose group | 2.4 | 3.96±1.42** | 1.12±0.36** |
| Positive control group | 0.5mg/kg | 3.93±1.03** | 1.40±0.57** |
The results show that: the microscopic blood vessel adhesion factors are expressed in the whole synovial blood vessel and a small amount of fibroblasts; the blank group can also express vascular adhesion factors, and the expression area and the intensity of the model group are enhanced (P < 0.05) compared with the blank group; the expression area and intensity of each administration group are reduced to different degrees compared with the model group, and the expression area and intensity of each administration group have statistical significance (P <0.05 or P < 0.01) compared with the model group.
Table 5 effect of the application on COX-2 expression in gouty arthritis test animal model (n=10)
| Group of | Dosage (g/kg) | Area (x 10 2) | IOD(×102) |
| Blank control group | / | 6.21±1.84** | 1.47±0.47** |
| Model control group | / | 13.18±3.12 | 3.52±0.89 |
| Low dose group | 0.6 | 7.67±3.71** | 2.42±1.15* |
| Medium dose group | 1.2 | 7.40±2.36** | 2.26±0.59** |
| High dose group | 2.4 | 6.75±3.31** | 1.56±0.81** |
| Positive control group | 0.5mg/kg | 5.22±1.35** | 1.66±0.83** |
The results show that: the cyclooxygenase is mainly expressed in rat joint synovial cells, blood vessels and fibroblasts; the joints of the blank group can also be expressed by a small amount of cyclooxygenase; the model group cyclooxygenase expression area and intensity are obviously enhanced compared with the blank control (P < 0.01); the application has different degree of weakening in each administration group, has statistical significance (P <0.05 or P < 0.01) compared with a model,
Experimental example 3
The influence of the application on experimental animal models of gouty nephropathy is studied. The Chinese medicinal composition of example 3 was diluted to a high dose (2.4 g/kg), a medium dose (1.2 g/kg) and a low dose (0.6 g/kg), respectively. SPF-class SD experimental rats were randomly divided into a blank group, a model group, a high-dose group (2.4 g/kg) of the present application, a medium-dose group (1.2 g/kg), a low-dose group (0.6 g/kg), and a phenylbromarone group (12 mg/kg), 10 animals per group. Except for the blank animals, each animal group was treated with 10% dry yeast solution, ig10ml/kg, containing 1.25% adenine, once daily for 4 weeks to create a gouty kidney disease model. The treatment agent of the application is respectively administered with 2.4g/kg, 1.2g/kg and 0.6g/kg of the application for stomach irrigation; each rat of the tribromone control group is subjected to gastric lavage with 12mg/kg of tribromone every day; the blank and model groups were filled with an equal amount of distilled water daily. Collecting urine of 24 hours with a metabolism cage after continuous administration or 14 days of water, anesthetizing animals, collecting blood from abdominal aorta, killing, and separating serum; kidneys were taken. Kidneys were fixed with 10% formalin, paraffin embedded, and HE stained for pathology detection. Serum was assayed for uric acid, uric acid kidney clearance, uric acid by enzymatic method, serum creatinine by picric acid method, serum urea nitrogen by urease method, and serum Xanthine Oxidase (XOD) activity by colorimetric method, as shown in tables 6 and 7.
Table 6 effect of the present application on uric acid level of experimental animal model for gouty nephropathy (n=10)
The results show that: the animal urine volume of the model group is obviously increased, the uric acid concentration in blood is obviously increased, the uric acid concentration in urine is reduced, the uric acid discharge amount is obviously reduced in 24 hours, the uric acid clearance rate is obviously reduced, and compared with the blank control group, the animal urine volume is obviously different (P < 0.01). The application can reduce uric acid concentration in blood after 14 days of administration, increase uric acid discharge for 24 hours, increase uric acid clearance rate, and has obvious difference (P <0.05 or P < 0.01) compared with a model group, which proves that the application has better improving effect on the increase of uric acid in rat with gouty nephropathy.
Table 7 effect of the application on serum XOD levels and renal function in gouty kidney rats (n=10)
The results show that: the serum BUN, crea and XOD concentrations were significantly elevated in the animals of the model group, and were significantly different compared to the blank group (P < 0.01). The application can reduce BUN and Crea level in blood after 14 days of administration, inhibit the increased XOD activity, and has obvious difference (P <0.05 or P < 0.01) compared with a model group, which proves that the application has better improving effect on kidney function and XOD activity of gouty nephropathy rats.
Soft tissues around joints were taken, fixed in formalin, dehydrated in conventional ethanol, paraffin-embedded, sectioned at 4 μm, immunohistochemical staining for vascular adhesion factor (VCAM-1) and cyclooxygenase (COX-2) according to the reagent instructions, and observed under an optical microscope.
The kidney capsule of the blank control group is smooth and complete, and the morphological structure of glomerulus and tubular in the parenchyma is normal; the interstitium is free from congestion, inflammatory cell infiltration and fibroplasia, and the mucosa of the renal pelvis is smooth and intact.
The kidney morphological structure of the model group is seriously damaged, a great amount of urate deposition is seen in the kidney interstitium and accompanied by infiltration of a great amount of inflammatory cells, the renal tubules and glomeruli are obviously reduced, the kidney is replaced by a great amount of proliferated interstitium cells, the kidney volume is hypertrophic, the residual renal tubule lumen is expanded, and inflammatory or protein tubular type is seen in the lumen.
The administration group of the application can see the same lesions as the model group, but the injury quantity of glomerulus, infiltration of inflammatory cells, proliferation of interstitial cells and deposition of uric acid salt are obviously reduced.
Comparative examples 1 to 3
The formula of the application is disassembled into three formulas according to the efficacy, is respectively used for hyperuricemia and gouty nephropathy models, and compared with the original formulas and the like, the effects of different formulas on hyperuricemia and gouty nephropathy are discussed.
Comparative example 1: in the recipe, the drugs (three drugs of dipsacus root, cyathula root and drynaria rhizome) having the functions of nourishing liver and kidney, strengthening tendons and bones and promoting blood circulation
Comparative example 2: the prescription has the functions of promoting blood circulation, removing obstruction in channels and relieving pain (four medicines of kudzuvine root, suberect spatholobus stem, liquorice and pseudo-ginseng)
Comparative example 3: the recipe has the functions of promoting blood circulation to arrest pain, eliminating wetness evil and benefiting joint (four kinds of medicine including giant knotweed, sargentgloryvine stem, sevenlobed yam rhizome and smilax glabra)
Experimental example 4
The influence of the prescription of the application on the experimental animal model of hyperuricemia is studied. 70 male SD rats were randomly divided into a blank control group, a model group, a comparative example 1 group, a comparative example 2 group, a comparative example 3 group, a complete formula of the present application (example 5) and a core prescription of the present application (example 8) and were filled with 10g/kg yeast extract, 1 time/d, 20 days in succession, and the injection was started on day 11 of molding, 1 time/d, 10 days in succession, and the control group and the model group were given equal amounts of 0.5% CMC-Na solution. Urine from rats (19-20) d was collected for 24 hours, urine volume was recorded, blood was collected 60 minutes after 20 days of administration, serum was separated, and serum and urine uric acid levels were measured, and the results are shown in Table 8.
Table 8 effect of the inventive recipe on uric acid levels in hyperuricemia rats (n=10)
The results show that: compared with the blank control group, the urine volume of the model group is obviously increased, the uric acid concentration in blood is obviously increased, the uric acid concentration in urine is reduced, the uric acid discharge amount is obviously reduced in 24 hours, and the difference is obvious (P < 0.01). The three prescription disassembly groups of the prescription can only reduce the urine volume for 24 hours and increase the uric acid concentration of urine; the uric acid output is only slightly increased in 24 hours, and the reduction amplitude of the uric acid level in serum is not very large. The whole formula can obviously reduce serum uric acid level, increase uric acid discharge for 24 hours, and has obvious difference (P < 0.01) compared with a model group, which indicates that the compatibility of all parts of the formula has interaction effect. The core prescription group had weaker effect than the full prescription group, but was superior to the split prescription group of the comparative example. Compared with the prescription of the application, the prescription of the application has obviously improved effect of treating hyperuricemia under the same dosage, which indicates that the components of the application have synergistic effect.
Experimental example 5
The influence of the prescription of the application on experimental animal models of gouty nephropathy is studied. SPF-class SD rats were randomly divided into a blank group, a model group, a comparative example 1 group, a comparative example 2 group, a comparative example 3 group, and an overall group of the present application (example 3, 10 animals per group except for the blank group, each group was treated with 10% dry yeast solution containing 1.25% adenine, ig10ml/kg, once daily for 4 weeks to give a gouty kidney disease model the present application treatment group was respectively given a split or overall 1.8g/kg gastric lavage with the present application, and the blank group and the model group were daily perfused with an equal amount of distilled water. After continuous administration or 14 days with a metabolic cage, 24 hours urine was collected, anesthetized animals, sacrificed by abdominal blood sampling, serum was isolated, and serum and urine uric acid levels were measured as shown in Table 9.
Table 9 influence of the inventive recipe on uric acid level of experimental animal model for gouty nephropathy (n=10)
The results show that: the animal urine volume of the model group is obviously increased after 14 days of administration, the uric acid concentration in blood is obviously increased, the uric acid concentration in urine is reduced, the uric acid discharge rate is obviously reduced after 24 hours, and the uric acid clearance rate is obviously reduced, compared with the blank group, the animal urine volume of the model group is obviously different (P < 0.01). The parts of the drug administration and disassembly formula can reduce the concentration of uric acid in blood, increase the uric acid discharge amount for 24 hours and increase the uric acid clearance rate, but the change range is smaller, and compared with a model group, the drug administration and disassembly formula has no significant difference (P is more than 0.05); whereas the changes of the above index by the whole formula group are significantly different from those by the model group (P <0.05 or P < 0.01). Further, the components of the formula have interaction promotion effect on gouty nephropathy.
Experimental example 6
The safety of the application was evaluated. Toxicity test for single administration: the traditional Chinese medicine composition of the example 5 is taken, 18.9g/kg of the mice with the stomach filled for 1 time are subjected to the maximum dosage method, the transient activity of the animals is reduced, the phenomenon of hair shrugging occurs in a short time, and the normal state is restored within 1-2 hours. The feces were brown on the day of administration and recovered the next day. After 14 days of self-administration, the mice showed no abnormality in appetite, appearance, voluntary activity, secretion, weight gain, and the like, and no death. At the end of the observation period, the animals are sacrificed for gross dissection, and the main organs such as heart, liver, spleen, lung, kidney, stomach and the like are observed visually without swelling, blood stasis, bleeding and other abnormal phenomena, and the administration group is not obviously abnormal compared with the blank control group animals.
Repeat dosing toxicity test: the Chinese medicinal composition of example 5 was diluted, and rats were administered with 2.6g/kg, 5.2g/kg and 10.4g/kg by intragastric administration, and the administration was continued for 3 months, and the administration was stopped for 3 weeks. None of the groups died, and no obvious clinical toxic or side effects occurred, and according to weight gain, food intake, hematology, hematochemistry, system necropsy, organ coefficients and analysis of histopathological examination results, none of the three doses of the application had obvious toxicity.
The foregoing is merely a preferred embodiment of the application, and it is to be understood that the application is not limited to the form disclosed herein but is not to be construed as excluding other embodiments, but is capable of numerous other combinations, modifications and environments and is capable of modifications within the scope of the inventive concept, either as taught or as a matter of routine skill or knowledge in the relevant art. And that modifications and variations which do not depart from the spirit and scope of the application are intended to be within the scope of the appended claims.
Claims (11)
1. A traditional Chinese medicine composition is characterized by comprising the following raw materials: rhizoma Polygoni Cuspidati, rhizoma Dioscoreae Septemlobae, radix Cyathulae, caulis Spatholobi, notoginseng radix powder and rhizoma Smilacis Glabrae.
2. The traditional Chinese medicine composition according to claim 1, wherein the raw materials comprise, in parts by weight: 35-65 parts of giant knotweed, 47.6-86.9 parts of yam rhizome, 35-65 parts of medicinal cyathula root, 47.6-86.9 parts of suberect spatholobus stem, 21.4-39.1 parts of pseudo-ginseng powder and 35-65 parts of glabrous greenbrier rhizome.
3. The traditional Chinese medicine composition according to claim 1 or 2, wherein the raw materials further comprise: caulis et folium Sargentodoxae, radix Dipsaci, radix Puerariae, rhizoma Drynariae, and radix Glycyrrhizae Preparata.
4. The traditional Chinese medicine composition according to claim 3, wherein the raw materials comprise, in parts by weight: 35-65 parts of giant knotweed, 47.6-86.9 parts of yam rhizome, 35-65 parts of medicinal cyathula root, 47.6-86.9 parts of suberect spatholobus stem, 21.4-39.1 parts of pseudo-ginseng powder, 47.6-86.9 parts of sargentgloryvine stem, 35-65 parts of glabrous greenbrier rhizome, 35-65 parts of dipsacus root, 35-65 parts of kudzuvine root, 35-65 parts of drynaria rhizome and 14.3-26.1 parts of honey-fried licorice root.
5. The traditional Chinese medicine composition according to claim 4, wherein the raw materials comprise, in parts by weight: 50 parts of giant knotweed, 66.6 parts of yam rhizome, 50 parts of medicinal cyathula root, 66.6 parts of suberect spatholobus stem, 30 parts of pseudo-ginseng powder, 66.6 parts of sargentgloryvine stem, 50 parts of glabrous greenbrier rhizome, 50 parts of dipsacus root, 50 parts of kudzuvine root, 50 parts of drynaria rhizome and 20 parts of honey-fried licorice root.
6. A method of preparing the traditional Chinese medicine composition of any one of claims 1-5, comprising: weighing the raw materials of the traditional Chinese medicine composition, extracting, filtering, concentrating and drying to obtain the traditional Chinese medicine composition.
7. An oral preparation, which is prepared from the traditional Chinese medicine composition according to any one of claims 1-5 and pharmaceutically acceptable auxiliary materials according to a preparation process.
8. The oral formulation of claim 7, wherein the dosage form of the oral formulation comprises at least one of a granule, a tablet, a capsule, a concentrated pill, an oral liquid, and a mixture.
9. Use of the traditional Chinese medicine composition according to any one of claims 1-5 or the oral preparation according to claim 7 or 8 for preparing a medicament having at least one of the effects of clearing heat, eliminating dampness, eliminating pathogenic factors, tonifying liver and kidney and strengthening tendons and bones.
10. Use of a traditional Chinese medicine composition according to any one of claims 1-5 or an oral formulation according to claim 7 or 8 for the manufacture of a medicament for the treatment of hyperuricemia.
11. Use of a traditional Chinese medicine composition according to any one of claims 1-5 or an oral formulation according to claim 7 or 8 for the manufacture of a medicament for the treatment of at least one of gout, gouty kidney disease and gouty arthritis.
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| CN202311851746.9A CN118078930A (en) | 2023-12-29 | 2023-12-29 | Traditional Chinese medicine composition for treating hyperuricemia and complications thereof, and preparation method and application thereof |
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| CN202311851746.9A CN118078930A (en) | 2023-12-29 | 2023-12-29 | Traditional Chinese medicine composition for treating hyperuricemia and complications thereof, and preparation method and application thereof |
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