CN115554345B - A Chinese medicinal compound preparation for treating gout and hyperuricemia, and its preparation method - Google Patents

Abstract

The invention provides a traditional Chinese medicine compound preparation for treating gout and hyperuricemia and a preparation method thereof, and in particular provides a traditional Chinese medicine composition, which contains raw medicinal materials or extracts of the raw medicinal materials, wherein the raw medicinal materials comprise the following components: herba Artemisiae Scopariae, semen plantaginis, poria, pericarpium Citri Tangerinae, radix Pseudostellariae, saviae Miltiorrhizae radix and radix Glycyrrhizae Preparata, and the raw materials are as follows: 3-20 parts of virgate wormwood herb; 9-30 parts of semen plantaginis; 6-20 parts of poria cocos; 6-20 parts of dried orange peel; 9-50 parts of radix pseudostellariae; 3-20 parts of red sage root and 3-6 parts of honey-fried licorice root, and the composition can effectively treat gout and hyperuricemia.

Description

A Chinese medicinal compound preparation for treating gout and hyperuricemia, and its preparation method

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine compound preparation for treating gout and hyperuricemia and a preparation method thereof.

Background

Gout is a disease related to the deposition of monosodium urate (MSU), and if the gout is deposited on joints and tissues around the joints, crystalline arthritis can be caused, the acute stage joint swelling and pain, the movement is limited, and the diseases can be accompanied with tophus, joint destruction and the like after a long time; the early stage of gout is often hyperuricemia, and the risk factors are also independent risk factors of coronary heart disease, hypertension, diabetes, obesity and chronic kidney disease, so that the human health is seriously endangered; patients with gout have the characteristics of low compliance, frequent drug withdrawal and repeated illness.

Modern medical oral regimens commonly used for gout include: (1) uric acid reduction treatment: is basic treatment, can inhibit uric acid synthesis (allopurinol, febuxostat and the like), and can increase uric acid excretion (benzbromarone and the like), and has the advantages of convenient administration, definite curative effect mechanism, certain adverse reaction and limited part of people; (2) anti-inflammatory analgesic treatment: such as colchicine, diclofenac sodium, etoricoxib, hormone and the like, can prevent/treat acute onset of gout, has rapid effect, but may be accompanied with liver and kidney damage, gastrointestinal discomfort, cardiovascular risk and the like, and is limited in part of people and not suitable for long-term use. The current situation of the scheme is as follows: during uric acid lowering treatment, an acute gout attack can occur, and after uric acid lowering treatment is stopped, the disease is easy to relapse; some patients stop reducing uric acid drugs by themselves and rely on anti-inflammatory analgesics for a long time, and the disease conditions of the patients are not controlled and adverse reactions of the drugs can be caused. Summarizing: modern medical treatment of gout has the advantages of convenient medicine taking, quick effect taking and clear curative effect mechanism, and has the disadvantages of limited applicable crowd and treatment course part and difficult descending step treatment.

At present, many traditional Chinese medicines are inconvenient to take, poor in taste, undefined in curative effect mechanism and limited in popularization and application. In addition, the number of pills taken by the traditional Chinese medicine preparation for gout in the market at present is large, and the taking compliance of gout patients is inferior to that of western medicines. Therefore, the traditional Chinese medicine compound preparation for treating gout has the defects of inconvenient medicine taking, poor taste and limited using course.

And modern medical treatment of gout has the problems that applicable people and treatment with a limited treatment course part and a step-down treatment are difficult. The existing gout traditional Chinese medicine compound preparation has the problems to be solved, namely the gout traditional Chinese medicine preparation which has the advantages of both principal and secondary aspects of disease, promotion of organism healing, assistance of step-down treatment, definite curative effect, wider applicable crowd, convenient administration and better taste can be developed, and the current gout traditional Chinese medicine preparation on the market can simultaneously solve the problems and is in a rare period.

Therefore, the development of a traditional Chinese medicine compound preparation for treating gout and hyperuricemia with good development effect and small adverse reaction is urgently needed in the field.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine compound preparation for treating gout and hyperuricemia, which has good effect and small adverse reaction.

The invention also aims at providing a traditional Chinese medicine compound preparation scheme for treating gout and hyperuricemia, which is expected to promote the body to restore the function of reducing uric acid.

The first aspect of the invention provides a traditional Chinese medicine composition, which contains raw medicinal materials or extracts of the raw medicinal materials, wherein the raw medicinal materials comprise the following components in parts by weight: herba Artemisiae Scopariae, semen plantaginis, poria, pericarpium Citri Tangerinae, radix Pseudostellariae, saviae Miltiorrhizae radix and radix Glycyrrhizae Preparata, and the raw materials are as follows:

3-20 parts of virgate wormwood herb, preferably 3-15 parts, more preferably 3-9 parts;

9-30 parts of semen plantaginis, preferably 9-20 parts, more preferably 9-15 parts;

6-20 parts of poria cocos, preferably 6-15 parts, more preferably 6-9 parts;

6-20 parts of dried orange peel, preferably 6-15 parts of dried orange peel, more preferably 6-9 parts of dried orange peel;

9-50 parts of radix pseudostellariae, preferably 9-20 parts, more preferably 9-15 parts;

3-20 parts of red sage root, preferably 3-15 parts, more preferably 3-9 parts;

3-6 parts of honey-fried licorice root, preferably 3-6 parts, more preferably 3-5 parts.

In another preferred embodiment, the traditional Chinese medicine composition further comprises one or more raw medicinal materials selected from the following group: wrinkled giant hyssop, poria with hostwood and chicken's gizzard-skin.

In another preferred example, the following raw materials in parts by weight:

3-9 parts of wrinkled giant hyssop, preferably 3-6 parts of wrinkled giant hyssop, more preferably 3-5 parts of wrinkled giant hyssop; and/or

6-20 parts of poria cocos, preferably 6-15 parts of poria cocos, more preferably 6-9 parts of poria cocos; and/or

3-6 parts of chicken's gizzard-membrane, preferably 3-6 parts, more preferably 3-5 parts.

In another preferred example, the raw materials are composed of herba Artemisiae Scopariae, semen plantaginis, poria, pericarpium Citri Tangerinae, radix Pseudostellariae, saviae Miltiorrhizae radix and radix Glycyrrhizae Preparata.

In another preferred embodiment, the Chinese medicinal composition is used for treating gout and hyperuricemia.

In another preferred embodiment, the Chinese medicinal composition is used for (i) reducing the total use amount and frequency of western medicines for reducing uric acid and/or (ii) promoting the recovery of uric acid in the body.

In another preferred embodiment, the uric acid lowering western medicines are selected from the group consisting of: febuxostat and benzbromarone.

In another preferred embodiment, the Chinese medicinal composition further comprises other auxiliary raw medicinal materials.

In another preferred embodiment, the extract comprises: an aqueous extract, an ethanol extract, or an aqueous solvent extract.

In another preferred embodiment, the aqueous solvent is a mixed solvent of water and a water-compatible solvent (e.g., alcohol), wherein the water content is 10 to 99.5wt%, preferably 50 to 90wt%.

In another preferred embodiment, the alcohol is a C1-C4 alkyl alcohol, preferably ethanol, propanol.

In another preferred embodiment, the Chinese medicinal composition further comprises a pharmaceutically acceptable carrier.

In another preferred embodiment, the pharmaceutically acceptable carrier is present in an amount of 5 to 99wt%, preferably 10 to 90wt%, based on the total weight of the Chinese medicinal composition.

In another preferred embodiment, the pharmaceutically acceptable carrier comprises: water, fillers, flavoring agents, sweeteners, glycerin, other suitable additives, or combinations thereof.

In another preferred embodiment, the Chinese medicinal composition is an oral preparation.

In another preferred embodiment, the dosage form of the Chinese medicinal composition comprises: oral liquid, tablet, capsule, granule, and decoction.

In another preferred embodiment, the composition is a decoction of the raw materials.

In another preferred embodiment, the composition is a water decoction.

In another preferred embodiment, the decoction includes decoction with unadjusted (or unchanged) concentration, concentrated decoction, and diluted decoction.

The present invention provides a kit comprising:

(a1) A first container, wherein the Chinese medicinal composition according to the first aspect of the present invention or the medicament containing the Chinese medicinal composition according to the first aspect of the present invention is positioned in the first container; and

(b) Optionally a pharmaceutically acceptable carrier.

In another preferred embodiment, the medicament in the first container is a single formulation comprising the Chinese medicinal composition according to the first aspect of the present invention.

In another preferred embodiment, the dosage form of the medicament is selected from the group consisting of: oral liquid, tablet, capsule, granule, and decoction.

In another preferred embodiment, the pharmaceutical dosage form is an oral dosage form.

In another preferred embodiment, the kit further comprises instructions.

In a third aspect, the present invention provides the use of a composition according to the first aspect of the invention or a formulation comprising the composition or a kit according to the second aspect of the invention, for the preparation of a medicament or formulation for (i) the treatment of gout and hyperuricemia; and/or (ii) reduce the total amount and frequency of use of uric acid lowering western medicines, and/or (iii) promote the recovery of uric acid lowering ability of the body.

In another preferred embodiment, the medicament or formulation is further for one or more uses selected from the group consisting of:

(iv) Reducing blood uric acid and promoting blood uric acid to reach the standard;

(v) Protecting kidney function, and improving glomerular filtration rate;

(vi) Reducing the recurrence frequency of gout;

(vii) Has no influence on liver function.

According to a fourth aspect of the present invention there is provided a method of preparing a Chinese medicinal composition according to the first aspect of the present invention comprising the steps of:

(a) Providing raw medicinal materials, wherein the raw medicinal materials comprise: herba Artemisiae Scopariae, semen plantaginis, poria, pericarpium Citri Tangerinae, radix Pseudostellariae, saviae Miltiorrhizae radix, and radix Glycyrrhizae Preparata, and the raw materials are as follows:

3-20 parts of virgate wormwood herb, preferably 3-15 parts, more preferably 3-9 parts;

9-30 parts of semen plantaginis, preferably 9-20 parts, more preferably 9-15 parts;

6-20 parts of poria cocos, preferably 6-15 parts, more preferably 6-9 parts;

6-20 parts of dried orange peel, preferably 6-15 parts of dried orange peel, more preferably 6-9 parts of dried orange peel;

9-50 parts of radix pseudostellariae, preferably 9-20 parts, more preferably 9-15 parts;

3-20 parts of red sage root, preferably 3-15 parts, more preferably 3-9 parts;

3-6 parts of honey-fried licorice root, preferably 3-6 parts, more preferably 3-5 parts.

(b) Extracting the raw medicinal materials to obtain an extract of the raw medicinal materials, wherein the extract is the traditional Chinese medicine composition.

In another preferred embodiment, the raw medicinal materials further include: wrinkled giant hyssop, poria with hostwood and chicken's gizzard-skin.

In another preferred example, the following raw materials in parts by weight:

3-9 parts of wrinkled giant hyssop, preferably 3-6 parts of wrinkled giant hyssop, more preferably 3-5 parts of wrinkled giant hyssop; and/or

6-20 parts of poria cocos, preferably 6-15 parts of poria cocos, more preferably 6-9 parts of poria cocos; and/or

3-6 parts of chicken's gizzard-membrane, preferably 3-6 parts, more preferably 3-5 parts.

In another preferred embodiment, in step (b), the crude drug is decocted with water, thereby obtaining an extract of the crude drug.

In another preferred example, in step (b), the crude drug is provided, 800-1300 parts of water is added, the decoction is carried out for 2 times, and the filtrates are combined, thereby obtaining the extract of the crude drug.

In another preferred embodiment, the time of the decoction is 20-30 minutes, preferably 20-25 minutes.

In a fifth aspect, the present invention provides a method for preparing the Chinese medicinal composition according to the first aspect, comprising the steps of:

(a) Providing a first raw material, wherein the first raw material is radix pseudostellariae, and the radix pseudostellariae comprises the following components in parts by weight:

9-50 parts of radix pseudostellariae, preferably 9-30 parts, more preferably 9-20 parts;

(b) Grinding the first raw medicinal material into powder so as to prepare a powdery mixture;

(c) Providing a second raw material, the second raw material comprising: herba Artemisiae Scopariae, semen plantaginis, poria, pericarpium Citri Tangerinae, saviae Miltiorrhizae radix, and radix Glycyrrhizae Preparata, and the raw materials by weight part are as follows:

3-20 parts of virgate wormwood herb, preferably 3-15 parts, more preferably 3-9 parts;

9-30 parts of semen plantaginis, preferably 9-20 parts, more preferably 9-15 parts;

6-20 parts of poria cocos, preferably 6-15 parts, more preferably 6-9 parts;

6-20 parts of dried orange peel, preferably 6-15 parts of dried orange peel, more preferably 6-9 parts of dried orange peel;

3-20 parts of red sage root, preferably 3-15 parts, more preferably 3-9 parts;

3-6 parts of honey-fried licorice root, preferably 3-6 parts, more preferably 3-5 parts;

(d) Extracting the second raw medicinal material, thereby obtaining an extract of the second raw medicinal material; and

(e) Mixing the powdery mixture and the extract of the second raw medicinal material with a pharmaceutically acceptable carrier, thereby preparing the traditional Chinese medicine composition.

In another preferred embodiment, the second raw medicinal material further includes: poria, herba Agastaches, and endothelium corneum Gigeriae Galli.

In another preferred example, the following raw materials in parts by weight:

3-9 parts of wrinkled giant hyssop, preferably 3-6 parts of wrinkled giant hyssop, more preferably 3-5 parts of wrinkled giant hyssop; and/or

6-20 parts of poria cocos, preferably 6-15 parts of poria cocos, more preferably 6-9 parts of poria cocos; and/or

3-6 parts of chicken's gizzard-membrane, preferably 3-6 parts, more preferably 3-5 parts.

In another preferred embodiment, the step (b) further comprises a step of sterilizing and drying.

In another preferred embodiment, in step (d), the second crude drug is decocted with 6-10 (preferably 7-9) times the amount of water, thereby obtaining an extract of the second crude drug.

In another preferred example, in the step (d), the second raw material is provided, 8 times of water is added, the decoction is performed for 2 to 4 times, the filtrates are combined, filtered and concentrated, thereby obtaining the extract of the second raw material.

In another preferred embodiment, the time of the decoction is 3-4 hours.

In another preferred embodiment, the concentration is carried out under reduced pressure under the conditions that the steam pressure is less than 0.09Mpa and the vacuum degree is more than 0.06 Mpa.

In another preferred embodiment, the mixture is concentrated to a fluid extract having a relative density of 1.18g to 1.22.

In another preferred embodiment, the pharmaceutically acceptable carrier comprises dextrin, sweetener and flavoring agent.

In another preferred embodiment, in step (e), the steps of:

(c1) Mixing the powder mixture and the extract of the second raw material with a proper amount of dextrin, adding 60% ethanol to obtain a soft material, granulating, and vacuum drying to obtain the traditional Chinese medicine composition.

In another preferred embodiment, the granulation is a 12-16 mesh screen granulation, preferably a 12-15 mesh screen granulation.

In another preferred example, the conditions of the vacuum drying are: drying at 55+ -5deg.C for 3-6h, preferably 4-6h.

In another preferred embodiment, the method further comprises the step of dispensing.

In a sixth aspect, the present invention provides a method for the prophylaxis and/or treatment of gout and hyperuricemia by administering to a patient in need thereof a pharmaceutically effective amount of a Chinese medicinal composition according to the first aspect of the present invention or a kit according to the second aspect of the present invention.

In another preferred embodiment, the patient is a gout and hyperuricemia patient.

In another preferred example, the method can also be used for reducing the total use amount and frequency of western medicines for reducing uric acid and/or promoting the recovery of the body from uric acid reduction.

It is understood that within the scope of the present invention, the above-described technical features of the present invention and technical features specifically described below (e.g., in the examples) may be combined with each other to constitute new or preferred technical solutions. And are limited to a space, and are not described in detail herein.

Detailed Description

The inventor of the invention has studied extensively and intensively, and found a Chinese medicinal composition for treating gout and hyperuricemia for the first time unexpectedly, the composition comprises the following raw materials in parts by weight: 3-20 parts of virgate wormwood herb; 9-30 parts of semen plantaginis; 6-20 parts of poria cocos; 6-20 parts of dried orange peel; 9-50 parts of radix pseudostellariae; 3-20 parts of red sage root, 3-6 parts of honey-fried licorice root, and the composition of the invention can also comprise wrinkled gianthyssop herb, poria with hostwood and chicken's gizzard-membrane. The traditional Chinese medicine composition provided by the invention has the advantages of effectively treating gout and hyperuricemia, effectively reducing the total use amount and frequency of western medicines for reducing uric acid, and promoting the recovery of uric acid of an organism. On this basis, the present inventors have completed the present invention.

Terminology

In order that the present disclosure may be more readily understood, certain terms are first defined. As used in this application, each of the following terms shall have the meanings given below, unless expressly specified otherwise herein. Other definitions are set forth throughout the application.

Herba Artemisiae Scopariae

Has effects of eliminating dampness and clearing heat, and has antiinflammatory effect.

Semen plantaginis

Semen plantaginis plays a role in gout and hyperuricemia diseases by regulating various biological processes, cellular components and molecular functions, and Ma Linjiao acetic anhydride which is rich in the semen plantaginis can promote uric acid secretion, reduce creatinine level, remove active oxygen and improve renal function.

Poria cocos

Poria extract has antiinflammatory effect, and can regulate purine metabolism and reduce uric acid generation.

Dried orange peel

The effects of regulating qi and eliminating dampness are found by students after statistics of anti-gout traditional Chinese medicines, and clinical reports on compatibility of poria cocos, dried orange peel and capillary artemisia for treating gout are provided.

Radix Salviae Miltiorrhizae

The components of the red sage root, namely quercetin, luteolin, kaempferol and the like are main medicinal effect components acting on key targets for treating gout, and the quercetin can inhibit xanthine oxidase activity, promote uric acid excretion, reduce blood uric acid concentration, inhibit the generation and expression of inflammatory factors, and have good anti-inflammatory activity, relieve inflammatory response of acute gouty arthritis and improve kidney metabolism.

Radix pseudostellariae

Radix Pseudostellariae can regulate immunity, promote urate crystals to be phagocytized, and its uric acid reducing mechanism may be related to the effect of the drug on uric acid transporter in intestinal canal due to intestinal flora regulation.

Radix Glycyrrhizae Preparata

The licochalcone A component in the liquorice can directly or indirectly regulate and control inflammatory reaction by interfering an inflammatory signal path, and relieve gout inflammation.

According to the invention, the herba artemisiae scopariae and the radix pseudostellariae are creatively used as monarch drugs for the first time, the semen plantaginis, the poria cocos are used as ministerial drugs, the dried orange peel and the radix salviae miltiorrhizae are used as adjuvant drugs, and the honey-fried licorice root is used as guiding drug, so that the effects of treating gout and hyperuricemia can be obtained through a certain weight part of the medicines, and the effects of treating gout and hyperuricemia can be still achieved by properly adding wrinkled giant hyssop (adjuvant drugs), poria with hostwood (adjuvant drugs) and chicken's gizzard-skin (adjuvant drugs) on the basis of the medicines.

The traditional Chinese medicine composition is used for dispelling dampness and reducing turbid drink (herba artemisiae scopariae, poria cocos, semen plantaginis, dried orange peel, radix pseudostellariae, radix salviae miltiorrhizae, honey-fried licorice root and the like), wherein semen plantaginis enters the bladder and the liver, can guide damp and heat to flow out from urine, is compatible with herba artemisiae scopariae and poria cocos in the recipe, and has the effects of dispelling dampness, clearing heat and reducing turbid by taking herba artemisiae scopariae; "dampness easily repressing qi movement" can be seen as stasis, red sage root, root of red-rooted salvia, eliminating stagnation and symptoms, resolving carbuncles and swelling, the red-rooted salvia root and dried orange peel are compatible, and qi is regulated, stasis is removed, and swelling and pain are relieved; the radix pseudostellariae, the poria cocos and the liquorice take the purposes of strengthening spleen and stomach and eliminating dampness of the Sijunzi decoction, aim at regulating and treating the root of spleen and stomach weakness, recover qi and blood biochemical sources and eliminate dampness; licorice root, radix Glycyrrhizae and Chinese traditional medicine are used as the guiding drugs. The whole formula has the effects of strengthening spleen, eliminating dampness, harmonizing stomach, reducing turbid urine, regulating qi and removing blood stasis. When the source of spleen and stomach qi and blood are solid, the healthy qi is recovered and the turbid qi is self-descending; spleen qi is good for transportation, so that internal dampness is removed, external dampness is not invaded, and the disease is self-healed, so the recipe is named as "dampness-removing and turbidity-reducing drink".

Gout and hyperuricemia

Gout is a disease related to the deposition of monosodium urate (MSU), and if the gout is deposited on joints and tissues around the joints, crystalline arthritis can be caused, the acute stage joint swelling and pain, the movement is limited, and the diseases can be accompanied with tophus, joint destruction and the like after a long time; the early stage of gout is often hyperuricemia, and the risk factors are also independent risk factors of coronary heart disease, hypertension, diabetes, obesity and chronic kidney disease, so that the human health is seriously endangered; patients with gout have the characteristics of low compliance, frequent drug withdrawal and repeated illness.

Compositions of the invention

As used herein, the "traditional Chinese medicine composition" and "traditional Chinese medicine composition of the present invention" refer to a traditional Chinese medicine composition which is obtained by mixing a certain proportion of herba Artemisiae Scopariae, semen plantaginis, poria cocos, pericarpium Citri Tangerinae, radix Pseudostellariae and radix Salviae Miltiorrhizae, and radix Glycyrrhizae Preparata according to a certain preparation method, and can effectively prevent and/or treat gout and hyperuricemia.

The traditional Chinese medicine composition contains raw medicinal materials or extracts of the raw medicinal materials, wherein the raw medicinal materials comprise the following components: herba Artemisiae Scopariae, semen plantaginis, poria, pericarpium Citri Tangerinae, radix Pseudostellariae, saviae Miltiorrhizae radix and radix Glycyrrhizae Preparata.

In some embodiments, the traditional Chinese medicine composition of the present invention further comprises one or more raw medicinal materials selected from the group consisting of: poria, herba Agastaches, and endothelium corneum Gigeriae Galli.

In some embodiments, the present invention also includes a pharmaceutically acceptable carrier or excipient. Such vectors include (but are not limited to): saline, buffer, glucose, water, glycerol, ethanol, and combinations thereof. The pharmaceutical formulation should be compatible with the mode of administration. The pharmaceutical compositions of the invention may be formulated as injectables, e.g. by conventional means using physiological saline or aqueous solutions containing glucose and other adjuvants. Pharmaceutical compositions such as tablets and capsules can be prepared by conventional methods. The pharmaceutical compositions, such as injections, solutions are preferably manufactured under sterile conditions. The amount of active ingredient administered is a therapeutically effective amount, for example, from about 1 microgram per kilogram of body weight to about 5 milligrams per kilogram of body weight per day. In addition, the present invention may also be used with other therapeutic agents.

When a Chinese medicinal composition is used, a safe and effective amount of the composition is applied to mammals, wherein the administration dosage of the active ingredient of the invention is usually 0.001 mg/kg-1000000 mg/kg body weight.

Of course, the particular dosage should also take into account factors such as the route of administration, the health of the patient, etc., which are within the skill of the skilled practitioner.

Preparation method

The invention provides a preparation method, which comprises the following steps:

(a) Providing raw medicinal materials, wherein the raw medicinal materials comprise: herba Artemisiae Scopariae, semen plantaginis, poria, pericarpium Citri Tangerinae, radix Pseudostellariae, saviae Miltiorrhizae radix and radix Glycyrrhizae Preparata, and the raw materials are as follows:

3-20 parts of virgate wormwood herb, preferably 3-15 parts, more preferably 3-9 parts;

9-30 parts of semen plantaginis, preferably 9-20 parts, more preferably 9-15 parts;

6-20 parts of poria cocos, preferably 6-15 parts, more preferably 6-9 parts;

6-20 parts of dried orange peel, preferably 6-15 parts of dried orange peel, more preferably 6-9 parts of dried orange peel;

9-50 parts of radix pseudostellariae, preferably 9-30 parts, more preferably 9-20 parts;

3-20 parts of red sage root, preferably 3-15 parts, more preferably 3-9 parts;

3-6 parts of honey-fried licorice root, preferably 3-6 parts, more preferably 3-5 parts;

(b) Extracting the raw medicinal materials to obtain an extract of the raw medicinal materials, wherein the extract is the traditional Chinese medicine composition.

In addition, the invention also provides a preparation method, which comprises the following steps:

(a) Providing a first raw material, wherein the first raw material is radix pseudostellariae, and the radix pseudostellariae comprises the following components in parts by weight:

9-50 parts of radix pseudostellariae, preferably 9-30 parts, more preferably 9-20 parts;

(b) Grinding the first raw medicinal material into powder so as to prepare a powdery mixture;

(c) Providing a second raw material, the second raw material comprising: herba Artemisiae Scopariae, semen plantaginis, poria, pericarpium Citri Tangerinae, saviae Miltiorrhizae radix, and radix Glycyrrhizae Preparata, and the raw materials by weight part are as follows:

3-20 parts of virgate wormwood herb, preferably 3-15 parts, more preferably 3-9 parts;

9-30 parts of semen plantaginis, preferably 9-20 parts, more preferably 9-15 parts;

6-20 parts of poria cocos, preferably 6-15 parts, more preferably 6-9 parts;

6-20 parts of dried orange peel, preferably 6-15 parts of dried orange peel, more preferably 6-9 parts of dried orange peel;

3-20 parts of red sage root, preferably 3-15 parts, more preferably 3-9 parts;

3-6 parts of honey-fried licorice root, preferably 3-6 parts, more preferably 3-5 parts;

(d) Extracting the second raw medicinal material, thereby obtaining an extract of the second raw medicinal material; and

(e) Mixing the powdery mixture and the extract of the second raw medicinal material with a pharmaceutically acceptable carrier, thereby preparing the traditional Chinese medicine composition.

In a preferred embodiment, the invention provides a method for preparing a Chinese medicinal preparation (decoction) for treating gout and hyperuricemia:

the traditional Chinese medicine is prepared from the following raw materials in parts by weight: 3 parts of virgate wormwood herb, 15 parts of plantain seed, 6 parts of tuckahoe, 6 parts of dried orange peel, 9 parts of radix pseudostellariae, 3 parts of red sage root and 3 parts of honey-fried licorice root, and the medicines all meet the requirements of pharmacopoeia 2020 edition, and the decoction specifically comprises the following steps:

step one, taking virgate wormwood herb, plantain seed, indian buead, tangerine peel, pseudostellaria root, danshen root and honey-fried licorice root according to the weight parts of the raw materials, putting the virgate wormwood herb, plantain seed, indian buead, tangerine peel, pseudostellaria root, danshen root and honey-fried licorice root into a cooking container, adding 1200-1300 parts of water, boiling for 20-25min at normal pressure, and filtering to obtain filtrate a and filter residue a for later use;

step two, adding 800-900 parts of water into the filter residue a obtained in the step one, boiling for 20-25min at normal pressure, and then passing through

Filtering to obtain filtrate b and filter residue b for later use;

and thirdly, uniformly mixing the filtrate a prepared in the first step and the filtrate b prepared in the second step to obtain the traditional Chinese medicine decoction. Placing in a heat preservation container for 15-20 times of warm taking.

If the steps are not needed, the seven medicines can be directly placed in a heat preservation container, soaked in 100-degree water for 30min, replaced by tea, repeatedly soaked, and taken 2L per day for 15-20 times.

In a preferred embodiment, the invention provides a method for preparing a traditional Chinese medicine preparation (granule) for treating gout and hyperuricemia:

the traditional Chinese medicine is prepared from the following raw materials in parts by weight: 9 parts of virgate wormwood herb, 15 parts of plantain seed, 9 parts of Indian buead, 9 parts of tangerine peel, 15 parts of pseudostellaria root, 6 parts of red-rooted salvia root and 5 parts of honey-fried licorice root, wherein the medicaments meet the requirements of pharmacopoeia of 2020 edition, and the granule specifically comprises the following steps:

step one, the seven ingredients are taken, the radix pseudostellariae is subjected to damp-heat sterilization for 30min at 115 ℃ in a sterilizing cabinet, and dried for about 4 hours at 80 ℃ in a hot air circulation oven, wherein the moisture is controlled to be not more than 8.0%, and the radix pseudostellariae is crushed into fine powder by a crusher for standby.

And step two, adding the rest of the traditional Chinese medicines into a multifunctional extraction tank, and respectively adding 8 times of water for three times of decoction. The first time is 1.5 hours, the second time and the third time are 1 hour each time, the decoction is filtered, the filtrate is combined, and the filtrate is decompressed and concentrated to the clear paste with the relative density of 1.18 to 1.22 (50 ℃ to 55 ℃) for standby under the conditions that the steam pressure is less than 0.09Mpa and the vacuum degree is more than 0.06 Mpa.

And thirdly, adding the radix pseudostellariae fine powder and a proper amount of dextrin into the clear paste, mixing for 10min in a groove type mixer, and adjusting the mixture into a soft material by using 60% ethanol. Granulating with a rocking granulator, drying at 55deg.C+ -5deg.C in a vacuum drying oven for about 5 hr, and controlling water content to be less than 7.0%. After finishing the grains by a 12-mesh finishing machine, mixing for 15min by a three-dimensional motion mixer.

And step four, subpackaging the powder into aluminum foil bags by using a particle packaging machine, and controlling the heat sealing temperature to be 150+/-5 ℃ and the specification to be 10 g/bag to obtain the finished product.

The main advantages of the invention include:

(1) The invention discovers for the first time that the traditional Chinese medicine composition provided by the invention has the advantages of effectively treating gout and hyperuricemia, effectively reducing the total use amount and frequency of western medicines for reducing uric acid, and promoting the recovery of uric acid of organisms.

(2) The invention discovers for the first time that the traditional Chinese medicine composition can reduce blood uric acid, promote uric acid to continuously reach the standard, improve glomerular filtration rate, reduce gout recurrence and gout medicine usage amount, and promote gout relief and even cure. The formula has good taste, can replace tea, is convenient to take, is suitable for a wide range of people, and can be used for monitoring liver and kidney functions for a long time for many times without abnormality, attach importance to spleen and stomach, take account of both principal and secondary aspects of the disease, promote organism healing and help in step-down treatment.

(3) The invention discovers for the first time that the traditional Chinese medicine composition can reduce blood uric acid, protect kidney function, improve glomerular filtration rate, reduce gout recurrence frequency, promote blood uric acid to reach the standard, and has no influence on liver function during the administration period.

(4) The invention is discovered for the first time, the invention focuses on the basis of conditioning the spleen and stomach, treats gout by taking both principal and secondary aspects of the invention into consideration, not only can reduce uric acid, but also helps to cure gout, gradually reduces gout drugs and helps to reduce ladder treatment, and the drug composition of the invention has good taste, does not need to add flavoring agents, has higher acceptance of patients of different ages, has flexible using method, can be decocted for taking, can directly replace tea drinks, can be made into granules for taking after being infused, meets different taking demands of the patients, has low cost, is simple and convenient, has low efficiency, is cheaper than other compound preparations, has popularization value, has small toxic and side effects, is used for a long time, and has no abnormal liver and kidney functions.

(5) The traditional Chinese medicine composition, namely the dampness-dispelling turbid-removing drink, can provide a traditional Chinese medicine compound preparation with definite curative effect, small toxic and side effects, simplicity and low cost for gout.

(6) Compared with the modern medical scheme, the traditional Chinese medicine composition disclosed by the invention has the effects of reducing uric acid and treating the symptoms, and more importantly, can treat both principal and secondary aspects of disease, promote disease recovery and help to reduce ladder treatment while strengthening spleen and stomach and treating the root cause.

(7) Compared with other gout traditional Chinese medicine preparations, the traditional Chinese medicine composition disclosed by the invention has the advantages that the spleen and stomach strengthening effect is emphasized to penetrate through the whole course of treatment of gout, so that the traditional Chinese medicine composition can be used as a basic scheme of the whole course of treatment of gout.

The invention will be further illustrated with reference to specific examples. It is to be understood that these examples are illustrative of the present invention and are not intended to limit the scope of the present invention. The experimental procedure, which does not address the specific conditions in the examples below, is generally followed by routine conditions, such as, for example, sambrook et al, molecular cloning: conditions described in the laboratory Manual (New York: cold Spring Harbor Laboratory Press, 1989) or as recommended by the manufacturer. Percentages and parts are by weight unless otherwise indicated.

Materials and reagents used in the examples of the present invention were commercially available products unless otherwise specified.

Example 1

Preparation of Chinese medicinal composition

The traditional Chinese medicine composition is prepared according to the following steps:

1.1 preparation of Chinese medicinal preparation (decoction) for treating gout and hyperuricemia:

the traditional Chinese medicine is prepared from the following raw materials in parts by weight: 3 parts of virgate wormwood herb, 15 parts of plantain seed, 6 parts of tuckahoe, 6 parts of dried orange peel, 9 parts of radix pseudostellariae, 3 parts of red sage root and 3 parts of honey-fried licorice root, and the medicines all meet the requirements of pharmacopoeia 2020 edition, and the decoction specifically comprises the following steps:

step one, taking virgate wormwood herb, plantain seed, indian buead, tangerine peel, pseudostellaria root, danshen root and honey-fried licorice root according to the weight parts of the raw materials, putting the virgate wormwood herb, plantain seed, indian buead, tangerine peel, pseudostellaria root, danshen root and honey-fried licorice root into a cooking container, adding 1200-1300 parts of water, boiling for 20-25min at normal pressure, and filtering to obtain filtrate a and filter residue a for later use;

step two, adding 800-900 parts of water into the filter residue a obtained in the step one, boiling for 20-25min at normal pressure, and then filtering to obtain filtrate b and filter residue b for later use;

and thirdly, uniformly mixing the filtrate a prepared in the first step and the filtrate b prepared in the second step to obtain the traditional Chinese medicine decoction, namely the traditional Chinese medicine composition. Placing in a heat preservation container for 15-20 times of warm taking.

If the steps are not needed, the seven medicines can be directly placed in a heat preservation container, soaked in 100-degree water for 30min, replaced by tea, repeatedly soaked, and taken 2L per day for 15-20 times.

1.2 a preparation method of a traditional Chinese medicine preparation (granule) for treating gout and hyperuricemia:

the traditional Chinese medicine is prepared from the following raw materials in parts by weight: 9 parts of virgate wormwood herb, 15 parts of plantain seed, 9 parts of Indian buead, 9 parts of tangerine peel, 15 parts of pseudostellaria root, 6 parts of red-rooted salvia root and 5 parts of honey-fried licorice root, wherein the medicaments meet the requirements of pharmacopoeia of 2020 edition, and the granule specifically comprises the following steps:

step one, the seven ingredients are taken, the radix pseudostellariae is subjected to damp-heat sterilization for 30min at 115 ℃ in a sterilizing cabinet, and dried for about 4 hours at 80 ℃ in a hot air circulation oven, wherein the moisture is controlled to be not more than 8.0%, and the radix pseudostellariae is crushed into fine powder by a crusher for standby.

And step two, adding the rest of the traditional Chinese medicines into a multifunctional extraction tank, and respectively adding 8 times of water for three times of decoction. The first time is 1.5 hours, the second time and the third time are 1 hour each time, the decoction is filtered, the filtrate is combined, and the filtrate is decompressed and concentrated to the clear paste with the relative density of 1.18 to 1.22 (50 ℃ to 55 ℃) under the conditions that the steam pressure is less than 0.09Mpa and the vacuum degree is more than 0.06 Mpa.

And thirdly, adding the radix pseudostellariae fine powder and a proper amount of dextrin into the clear paste, mixing for 10min in a groove type mixer, and adjusting the mixture into a soft material by using 60% ethanol. Granulating with a rocking granulator, drying at 55deg.C+ -5deg.C in a vacuum drying oven for about 5 hr, and controlling water content to be less than 7.0%. After finishing the grains by a 12-mesh finishing machine, mixing for 15min by a three-dimensional motion mixer.

And step four, subpackaging the obtained product into aluminum foil bags by using a particle packaging machine, controlling the heat sealing temperature to be 150+/-5 ℃ and the specification to be 10 g/bag, and obtaining the traditional Chinese medicine composition.

Example 2

Application of traditional Chinese medicine composition

Clinical observations of damp-heat type gouty arthritis dispelling and turbid pathogen reducing drinks are carried out on wet-heat type gouty arthritis patients (92 cases) of the inventor in the unit of 12 months in 2020-6 months in 2021, and clinical effectiveness and safety are observed, and the results indicate that: the prescription can reduce blood uric acid, protect kidney function, improve glomerular filtration rate, reduce gout recurrence times, promote blood uric acid to reach standard, and has no influence on liver function during administration, and is specifically as follows:

2.1 grouping: clinical observations are divided into 2 groups

(1) Treatment group: dampness-dispelling turbidity-reducing drink (the traditional Chinese medicine composition of the embodiment 1 of the invention) +febuxostat. All the medicines for eliminating dampness and reducing turbid drink are provided by a traditional Chinese medicine pharmacy, and decoction is taken for 2L/day in a small number of times and frequently; febuxostat (use versus control);

(2) Control group: febuxostat (40 mg/tablet, manufactured by Jiangsu Hengrui medical Co., ltd., batch No. 210727 JA) has an initial dose of 20mg/d, and after 4 weeks, the blood uric acid level still does not reach the standard, and can be increased by 20mg/d, and the maximum dose is 80mg/d. The selection of the medicine and the dosage are according to the diagnosis and treatment guidelines for hyperuricemia and gout (2019) in China

2.2 course of treatment and follow-up time: all three groups are followed by diagnosis for 3 months, each month is 1 treatment course, no interval exists between the treatment courses, and the total treatment course is 3.

2.3 statistics:

table 1 comparison of baseline levels for two groups of patients

The above results of t-test and non-parametric rank-sum test using independent samples showed that all the indices were not statistically significant (P > 0.05) for differences between the two groups.

TABLE 2 comparison of the number of gout recurrence and the number of months of uric acid reaching the standard

The above results of non-parametric rank sum tests showed that the number of relapses and the number of months up to uric acid were both statistically significant (P < 0.05) between the two groups.

TABLE 3 changes in uric acid (BUA) before and after treatment

Note that: the same letter indicates that the difference between groups is not statistically significant (P > 0.05); the different letters indicate that the differences between groups are statistically significant (P < 0.05).

TABLE 4 treatment of changes in renal function (Scr-based) before and after treatment

Note that: the same letter indicates that the difference between groups is not statistically significant (P > 0.05); the different letters indicate that the differences between groups are statistically significant (P < 0.05).

TABLE 5 changes in liver function (AST-based) before and after treatment

Note that: the same letter indicates that the difference between groups is not statistically significant (P > 0.05); the different letters indicate that the differences between groups are statistically significant (P < 0.05).

TABLE 6 changes in glomerular filtration rate (eGFR) before and after treatment

Note that: the same letter indicates that the difference between groups is not statistically significant (P > 0.05); the different letters indicate that the differences between groups are statistically significant (P < 0.05).

The results in table 1 show that the two groups of patients are baseline identical and comparable.

The results in Table 2 show that the treatment group of the damp-clearing and turbid-lowering drink can reduce the recurrence frequency of gout and increase the standard month number of uric acid.

The results in Table 3 show that the therapeutic group of the damp-clearing and turbid-lowering drink has better effect in lowering blood uric acid than the control group of febuxostat.

The results in Table 4 show that the treatment group of the damp-clearing and turbid-reducing drink has better kidney function improvement than the control group of febuxostat.

The results in Table 5 show that both groups have no significant effect on liver function.

The results in Table 6 show that the treatment group of the damp-clearing and turbid-reducing drink has better glomerular filtration rate improvement than the control group of febuxostat.

Discussion of the invention

The formula of the 'damp-clearing and turbid-reducing decoction' focuses on the 'spleen and stomach damp-heat' pathogenic concept, helps gout patients regulate and treat the spleen and stomach, helps gout medicine to reduce the ladder treatment, and promotes gradual alleviation and even cure of diseases. Clinical observation shows that the prescription can reduce blood uric acid, promote uric acid to continuously reach the standard, resist inflammation and relieve pain, reduce gout recurrence and improve glomerular filtration rate; we synchronously find that the damp-heat symptoms of spleen and stomach such as yellow and greasy tongue coating of the gout patient with damp-heat type can be improved after taking the formula, and uric acid can be synchronously improved, and the formula is considered to be related to the function of regulating the damp-heat of spleen and stomach.

At present, the Chinese medicinal compound preparation for treating gout mainly has the effects of eliminating dampness and clearing heat, and takes importance of regulating the deficiency of dampness and heat in spleen and stomach, namely 'eliminating dampness and reducing turbid drink', is beneficial to regulating and treating the root cause of the spleen and the stomach of a patient with gout, and in the follow-up observation of 6 months to 12 months in 2021, the formula is found to help the patient with gout to reduce the ladder treatment, reduce the use of gout drugs, and promote the gradual alleviation and even cure of diseases. The proved recipe of the medical science of the 'damp-clearing and turbid-lowering decoction' is applied to gout patients, has effective clinical observation, and early-stage research suggests that the recipe can reduce blood uric acid, promote uric acid to continuously reach the standard, resist inflammation and relieve pain, and reduce gout recurrence; we synchronously find that the damp-heat symptoms of spleen and stomach such as yellow and greasy tongue coating of the patient with damp-heat type gout can be improved after taking the prescription, uric acid can be improved synchronously, the prescription is considered to be related to the function of regulating the damp-heat of spleen and stomach, and the prescription has good taste, is well-appreciated by the patient and has larger clinical requirement.

All documents mentioned in this application are incorporated by reference as if each were individually incorporated by reference. Further, it will be appreciated that various changes and modifications may be made by those skilled in the art after reading the above teachings, and such equivalents are intended to fall within the scope of the claims appended hereto.

Claims (5)

1. A kit, comprising:

(a1) A first container, and a Chinese medicinal composition or a medicament containing the Chinese medicinal composition in the first container; and

(b) Optionally a pharmaceutically acceptable carrier;

the traditional Chinese medicine composition contains raw medicinal materials or extracts of the raw medicinal materials, wherein the raw medicinal materials are as follows: herba Artemisiae Scopariae, semen plantaginis, poria, pericarpium Citri Tangerinae, radix Pseudostellariae, saviae Miltiorrhizae radix and radix Glycyrrhizae Preparata, and the raw materials are as follows:

3-9 parts of virgate wormwood herb;

9-15 parts of semen plantaginis;

6-9 parts of poria cocos;

6-9 parts of dried orange peel;

9-15 parts of radix pseudostellariae;

3-9 parts of red sage root;

3-5 parts of honey-fried licorice root.

2. The kit of claim 1, wherein the preparation of the traditional Chinese medicine composition comprises the steps of:

(a) Providing raw medicinal materials, wherein the raw medicinal materials are as follows: herba Artemisiae Scopariae, semen plantaginis, poria, pericarpium Citri Tangerinae, radix Pseudostellariae, saviae Miltiorrhizae radix, and radix Glycyrrhizae Preparata, and the raw materials are as follows:

3-9 parts of virgate wormwood herb;

9-15 parts of semen plantaginis;

6-9 parts of poria cocos;

6-9 parts of dried orange peel;

9-15 parts of radix pseudostellariae;

3-9 parts of red sage root;

3-5 parts of honey-fried licorice root;

(b) Extracting the raw medicinal materials to obtain an extract of the raw medicinal materials, wherein the extract is the traditional Chinese medicine composition.

3. The kit of claim 1, wherein the preparation of the traditional Chinese medicine composition comprises the steps of:

(a) Providing a first raw material, wherein the first raw material is radix pseudostellariae, and the radix pseudostellariae comprises the following components in parts by weight:

9-15 parts of radix pseudostellariae;

(b) Grinding the first raw medicinal material into powder so as to prepare a powdery mixture;

(c) Providing a second raw medicinal material, wherein the second raw medicinal material is as follows: herba Artemisiae Scopariae, semen plantaginis, poria, pericarpium Citri Tangerinae, saviae Miltiorrhizae radix, and radix Glycyrrhizae Preparata, and the raw materials by weight part are as follows:

3-9 parts of virgate wormwood herb;

9-15 parts of semen plantaginis;

6-9 parts of poria cocos;

6-9 parts of dried orange peel;

3-9 parts of red sage root;

3-5 parts of honey-fried licorice root;

(d) Extracting the second raw medicinal material, thereby obtaining an extract of the second raw medicinal material; and

(e) Mixing the powdery mixture and the extract of the second raw medicinal material with a pharmaceutically acceptable carrier, thereby preparing the traditional Chinese medicine composition.

4. Use of a kit according to any one of claims 1 to 3 for the preparation of a medicament or formulation for (i) the treatment of gout and hyperuricemia; and/or (ii) reduce the total amount and frequency of use of uric acid lowering western medicines.

5. The use according to claim 4, wherein the medicament or formulation is further for one or more uses selected from the group consisting of:

(iii) Reducing blood uric acid and promoting blood uric acid to reach the standard; and

(iv) Protecting kidney function and improving glomerular filtration rate.