阅读说明：本技术 一种黄芪配方制剂、其制备方法及其在用作类风湿病治疗药中的应用 (Astragalus formulation, its preparation method and its application in medicine for treating rheumatoid disease ) 是由 江玉娟 刘杰 许敏 高超 潘瑞雪 王莉 张亚欣 陈克欣 郝红慧 于 2020-07-28 设计创作，主要内容包括：本发明公开了一种黄芪配方制剂、其制备方法及其在用作类风湿病治疗药中的应用,黄芪配方制剂,由以下重量份的组分组成：黄芪30-40份,当归3-4份,钩藤5-10份,制何首乌6-8份,茯苓20-30份,川牛膝4-5份,鹿茸2-4份,骨碎补16-20份,阿胶9-10份,透骨草6-8份,葛根7-12份,川穹8-10份。该中药制剂中,以黄芪、川牛膝为君药,以川穹、葛根、骨碎补制何首乌为臣药,辅以当归、阿胶、鹿茸补血活血；钩藤清热凉血；茯苓益脾和胃；透骨草祛风除湿、活血通经,以祛风散寒、除湿行痹。(The invention discloses an astragalus formulation, a preparation method thereof and application thereof in treating rheumatoid diseases, wherein the astragalus formulation comprises the following components in parts by weight: 30-40 parts of astragalus membranaceus, 3-4 parts of angelica sinensis, 5-10 parts of uncaria, 6-8 parts of prepared polygonum multiflorum, 20-30 parts of poria cocos, 4-5 parts of radix cyathulae, 2-4 parts of cornu cervi pantotrichum, 16-20 parts of rhizoma drynariae, 9-10 parts of donkey-hide gelatin, 6-8 parts of garden balsam stem, 7-12 parts of radix puerariae and 8-10 parts of ligusticum chuanxiong hort. In the Chinese medicinal preparation, astragalus and medicinal cyathula root are taken as monarch drugs, ligusticum wallichii, kudzuvine root and tuber of drynaria rhizome-prepared tuber fleeceflower root are taken as ministerial drugs, and angelica, donkey-hide gelatin and pilose antler are taken as auxiliary drugs for enriching and activating blood; ramulus Uncariae cum uncis has effects of clearing heat and cooling blood; poria has effects in invigorating spleen and regulating stomach function; the garden balsam stem has the functions of expelling wind and removing dampness, promoting blood circulation and stimulating the menstrual flow, so as to expel wind and clear away cold, and remove dampness and arthralgia.)

1. An astragalus formulation preparation is characterized in that: the composition comprises the following components in parts by weight:

30-40 parts of astragalus membranaceus, 3-4 parts of angelica sinensis, 5-10 parts of uncaria, 6-8 parts of prepared polygonum multiflorum, 20-30 parts of poria cocos, 4-5 parts of radix cyathulae, 2-4 parts of cornu cervi pantotrichum, 16-20 parts of rhizoma drynariae, 9-10 parts of donkey-hide gelatin, 6-8 parts of garden balsam stem, 7-12 parts of radix puerariae and 8-10 parts of ligusticum chuanxiong hort.

2. The astragalus formulation of claim 1, wherein: the composition comprises the following components in parts by weight:

35-40 parts of astragalus membranaceus, 3-4 parts of angelica sinensis, 5-10 parts of uncaria, 6-8 parts of prepared polygonum multiflorum, 20-25 parts of poria cocos, 4-5 parts of radix cyathulae, 2-4 parts of cornu cervi pantotrichum, 16-18 parts of rhizoma drynariae, 9-10 parts of donkey-hide gelatin, 6-8 parts of garden balsam stem, 7-12 parts of radix puerariae and 8-10 parts of ligusticum chuanxiong hort.

3. The astragalus formulation of claim 2, wherein: the composition comprises the following components in parts by weight:

38-40 parts of astragalus membranaceus, 3-4 parts of angelica sinensis, 5-10 parts of uncaria, 6-8 parts of prepared polygonum multiflorum, 22-25 parts of poria cocos, 4-5 parts of radix cyathulae, 2-4 parts of cornu cervi pantotrichum, 16-18 parts of rhizoma drynariae, 9-10 parts of donkey-hide gelatin, 6-8 parts of garden balsam stem, 7-10 parts of radix puerariae and 8-10 parts of ligusticum chuanxiong hort.

4. The astragalus formulation of claim 3, wherein: the composition comprises the following components in parts by weight:

38-40 parts of astragalus membranaceus, 3-4 parts of angelica sinensis, 5-10 parts of uncaria, 6-8 parts of prepared polygonum multiflorum, 23-25 parts of poria cocos, 4-5 parts of radix cyathulae, 2-4 parts of cornu cervi pantotrichum, 16-18 parts of rhizoma drynariae, 9-10 parts of donkey-hide gelatin, 6-8 parts of garden balsam stem, 8-10 parts of radix puerariae and 8-9 parts of ligusticum chuanxiong hort.

5. The astragalus formulation of claim 4, wherein: the composition comprises the following components in parts by weight:

39 parts of astragalus membranaceus, 3 parts of angelica sinensis, 10 parts of uncaria, 6 parts of prepared polygonum multiflorum, 25 parts of poria cocos, 5 parts of medicinal cyathula root, 4 parts of pilose antler, 16 parts of rhizoma drynariae, 10 parts of donkey-hide gelatin, 6 parts of garden balsam stem, 10 parts of radix puerariae and 9 parts of ligusticum chuanxiong hort.

6. The method of preparing an astragalus formulation as claimed in any one of claims 1 to 5, wherein: the method comprises the following steps:

pulverizing radix astragali, radix Angelicae sinensis, radix Polygoni Multiflori Preparata, rhizoma Drynariae, ramulus Uncariae cum uncis, Poria, radix Cyathulae and herba Speranskiae Tuberculatae, decocting in water, and concentrating the filtrate to obtain paste;

drying the decocted residue, adding ethanol into the dried residue, extracting, and concentrating the extract to obtain a paste;

crushing radix Puerariae and rhizoma Ligustici Chuanxiong, extracting with ethanol, and concentrating the extractive solution to obtain paste;

mixing the three paste, drying, and pulverizing to obtain medicinal powder;

grinding colla Corii Asini and cornu Cervi Pantotrichum into fine powder, adding the fine powder into the above medicinal powder, and mixing to obtain preparation.

7. The method of claim 6, wherein: decocting in water for 1-2 hr.

8. The method of claim 6, wherein: the mass ratio of the medicine residue to the ethanol is 1: 2-4.

9. The method of claim 6, wherein: further comprising the step of sieving the mixed powder;

furthermore, the mesh number of the sieve is 100-200 meshes.

10. Use of the astragalus formulation of any one of claims 1 to 5 in the preparation of an anti-rheumatoid formulation.

Technical Field

The invention belongs to the field of medicines, and particularly relates to a radix astragali formula preparation, a preparation method thereof and application thereof in rheumatoid diseases.

Background

The information in this background section is only for enhancement of understanding of the general background of the invention and is not necessarily to be construed as an admission or any form of suggestion that this information forms the prior art that is already known to a person of ordinary skill in the art.

Rheumatoid arthritis is a common systemic autoimmune disease with chronic, symmetrical, erosive arthromeningitis as the main manifestation. The disease is well developed in joints of hands, wrists, feet, etc., and is distributed symmetrically. The main clinical manifestations are swelling and pain of joints, cartilage destruction and joint gap narrowing caused by the synovitis of the small joints, if the treatment is not performed in time, the disease condition will gradually develop and aggravate, resulting in joint stiffness, deformity and dysfunction. Can seriously affect the life of the patient, has higher disability rate and brings heavy burden to the life quality of the patient and family life.

In the field of traditional Chinese medicine, rheumatoid arthritis belongs to the category of arthralgia, and the book of Nei Jing (the internal classic) records: wind, cold and dampness are mixed to form arthralgia, wind, cold and dampness invade the skin and are not removed, so that qi and blood are stagnated, stagnation causes pain, qi and blood circulation is not smooth, channels are not nourished, joints are bent and stretched difficultly, dampness stays in the joints, swelling, stiffness, numbness and the like are caused, and if the disease is suffered for a long time, repeated attack causes liver and kidney deficiency and yang and qi weakness. As the etiology and pathogenesis of the disease are not completely clear, the effective measures for radically curing and preventing the disease are still lacking in clinic at present.

Clinically, the disease is mostly treated by antirheumatic drugs, nonsteroidal anti-inflammatory drugs, glucocorticoid and biological agents which are used as western medicines for improving the disease condition. The current therapeutic goals are to alleviate joint symptoms, delay disease progression, prevent and reduce joint destruction, protect joint function, and maximize the quality of life of the patient. Such as: the anti-rheumatism medicine for improving the disease controls the progress of the rheumatoid arthritis to a certain extent, but the effect is still unsatisfactory, the onset time is slow, and certain side effects and adverse reactions are accompanied. Nonsteroidal anti-inflammatory drugs, glucocorticoids of the adrenal gland, can alleviate the symptoms of the disease to some extent, but cannot prevent the progression of joint destruction. The biological agent is expensive and cannot be supported by common patients. Better curative effect can be obtained for treating rheumatoid arthritis from the dialectical treatment of the traditional Chinese medicine, and the adverse reaction is less. However, the existing traditional Chinese medicines for treating rheumatoid arthritis are few in types, and the treatment effect on rheumatoid arthritis is poor.

Disclosure of Invention

In order to solve the technical problems in the prior art, the invention aims to provide an astragalus formulation, a preparation method thereof and application thereof in serving as a rheumatoid disease treatment medicine.

To solve the above technical problem, one or more of the following embodiments of the present invention provide the following technical solutions:

in a first aspect, the invention provides an astragalus formulation which comprises the following components in parts by weight:

30-40 parts of astragalus membranaceus, 3-4 parts of angelica sinensis, 5-10 parts of uncaria, 6-8 parts of prepared polygonum multiflorum, 20-30 parts of poria cocos, 4-5 parts of radix cyathulae, 2-4 parts of cornu cervi pantotrichum, 16-20 parts of rhizoma drynariae, 9-10 parts of donkey-hide gelatin, 6-8 parts of garden balsam stem, 7-12 parts of radix puerariae and 8-10 parts of ligusticum chuanxiong hort.

The efficacy of each component in modern pharmacological studies is summarized as follows:

astragalus root: invigorating qi and raising yang: huang Qi is sweet and warm and enters spleen meridian, so it is a tonifying herb for spleen qi. It is often used to treat spleen qi deficiency, tiredness, asthenia, poor appetite, loose stool, etc. It is good at lifting yang and sinking, so it is often used to treat prolapse of anus and viscera due to sinking of qi of middle-jiao caused by spleen deficiency. In addition, the astragalus root can enter lung meridian and can tonify lung qi, and can be used for treating symptoms such as cough weakness, short breath, dyspnea, clear expectoration, low voice, laziness and the like caused by lung qi weakness; consolidating superficial resistance and arresting sweating: huang Qi can tonify qi of lung and spleen, strengthen defensive qi to strengthen exterior and check sweating, and is often combined with herbs that astringe sweating to check sweating, such as mu Li and Ma Huang Gen, etc. to treat spontaneous sweating due to exterior deficiency caused by qi deficiency of spleen and lung and insecurity of defensive qi.

Chinese angelica: has the functions of enriching the blood; promoting blood circulation; regulating menstruation and relieving pain; moistening dryness and smoothing intestine. It can be used for treating blood deficiency syndrome, menoxenia, amenorrhea, dysmenorrhea, abdominal mass, metrorrhagia, asthenia cold, abdominal pain, flaccidity arthralgia, numbness of skin, intestinal dryness, constipation, dysentery, carbuncle, skin ulcer, traumatic injury. The main components of the compound are organic acids and volatile oil, and the modern pharmacological research shows that the compound has the effects of resisting thrombus, improving blood circulation, improving coronary circulation, resisting inflammation, relieving pain, protecting liver, benefiting gallbladder, enriching blood and the like.

Uncaria: uncaria rhynchophylla is sweet in flavor and slightly cold in nature, and is attributed to liver and pericardium meridian. Ramulus Uncariae cum uncis has effects of calming endogenous wind, relieving spasm, clearing heat, and calming liver, and can be used for treating convulsion, headache, giddiness, etc. caused by liver wind stirring; can also be used for treating infantile convulsion, fever, unconsciousness, trismus, tetany, etc.; ramulus Uncariae cum uncis also has effects of cooling liver and relieving convulsion, and can be used with periostracum Cicadae and herba Menthae to treat nocturnal fretfulness in infants.

Preparing fleece-flower root: bitter, sweet and astringent taste, mild nature, and two kinds of radix Polygoni Multiflori Preparata and radix Polygoni Multiflori Preparata, the radix Polygoni Multiflori Preparata has effects of nourishing liver and kidney, replenishing essence and blood, blackening beard and hair, strengthening tendons and bones, eliminating turbid pathogen and reducing blood lipid, and can be used for treating blood deficiency sallow complexion, giddiness tinnitus, early white beard and hair, soreness of waist and knees, limb numbness, metrorrhagia leukorrhagia, hyperlipidemia, etc.

Tuckahoe, poria cocos: sweet and bland in nature, mild in nature, entering heart, spleen and lung meridians. Has the effects of excreting dampness and promoting diuresis, tonifying spleen and stomach, calming heart and tranquilizing mind. It can be used for treating difficulty in micturition, edema, abdominal distention, expectoration, emesis, diarrhea, spermatorrhea, stranguria with turbid urine, palpitation, and amnesia.

Radix cyathulae: has effects in dispelling blood stasis, dredging channels, promoting joint movement, and inducing diuresis for treating stranguria. Can be used for treating amenorrhea, abdominal mass, retained afterbirth, arthralgia, flaccidity of feet, spasm of tendons, stranguria with hematuria and blood, and traumatic injury. The composition mainly contains sterone and polysaccharide compounds, and the modern pharmacological research shows that the composition has the functions of regulating the immune system, protecting the cardiovascular and cerebrovascular systems and resisting tumors.

Pilose antler: sweet, salty and warm in nature, it enters kidney and liver meridians. Strengthening yang, invigorating qi and blood, nourishing marrow and essence, and strengthening tendons and bones. It is indicated for consumptive disease, emaciation, lassitude, deficiency-cold uterus, etc.

Rhizoma drynariae: rhizoma Drynariae is bitter in property and warm in nature, entering kidney and liver meridians. Has effects in invigorating kidney, strengthening bone, and treating fracture. It is commonly used for chronic arthralgia syndrome, liver and kidney deficiency, pain in waist and knees, and weakness of lower limbs.

Donkey-hide gelatin, sweet and neutral in flavor, enters lung, liver and kidney meridians, and has the effects of enriching blood, stopping bleeding, nourishing yin, moistening dryness, preventing miscarriage and the like. Can be used as both medicine and food, and has effects of replenishing blood and nourishing blood, whitening and caring skin, resisting aging, relieving fatigue, and improving immunity after long-term administration. Is suitable for a wide range of people, and can be used for treating blood deficiency, cough due to asthenia, hematemesis, hematochezia, menoxenia, metrorrhagia, and fetal leakage, and has effects of strengthening tendons and bones, and improving sub-health state. Is suitable for treating blood deficiency, sallow complexion, giddiness, cardiopalmus, vexation, insomnia, lung dryness and cough.

Garden balsam stem: nature and taste: bitter, pungent and warm; meridian tropism: enter lung and liver meridians. The functions are as follows: dispelling pathogenic wind, removing dampness, promoting blood circulation, dredging channels, removing blood stasis, and relieving swelling. Can be used for treating rheumatism osteodynia, traumatic injury, menorrhagia, carbuncle, furuncle, and tuberculosis of cervical lymph nodes.

Kudzu root: sweet and pungent in flavor and cool in nature; it enters spleen and stomach meridians, and has effects of expelling pathogenic factors from muscles, relieving fever, promoting eruption, promoting salivation, quenching thirst, invigorating yang, and relieving diarrhea. It can be used for treating fever, stiffness and pain of neck and back, measles without adequate eruption, thirst due to fever, diabetes due to yin deficiency, dysentery due to heat-purging, and diarrhea due to spleen deficiency.

Ligusticum wallichii: pungent taste and warm nature, entering liver, gallbladder and heart meridians; the powder with the smell of qi rising is mainly used for treating irregular menstruation, dysmenorrheal, amenorrhea, dystocia, persistent lochia, postpartum lochiorrhea and abdominal pain, lumps, pain in chest and hypochondrium, traumatic injury and swelling pain, headache, dizziness, dim eyesight, wind-cold-dampness arthralgia and other diseases.

In a second aspect, the invention provides a preparation method of the astragalus formulation, which comprises the following steps:

decocting radix astragali, radix Angelicae sinensis, radix Polygoni Multiflori Preparata, rhizoma Drynariae, ramulus Uncariae cum uncis, Poria, radix Cyathulae and herba Speranskiae Tuberculatae in water, and concentrating the filtrate to obtain paste;

crushing radix Puerariae and rhizoma Ligustici Chuanxiong, extracting with ethanol, and concentrating the extractive solution to obtain paste;

mixing the three paste, drying, and pulverizing to obtain medicinal powder;

grinding colla Corii Asini and cornu Cervi Pantotrichum into fine powder, adding the fine powder into the above medicinal powder, and mixing to obtain preparation.

In a third aspect, the invention provides an application of the astragalus formulation preparation in preparing an anti-rheumatoid preparation.

Compared with the prior art, one or more technical schemes of the invention have the following beneficial effects:

in the Chinese medicinal preparation, astragalus and medicinal cyathula root are taken as monarch drugs, ligusticum wallichii, kudzuvine root and tuber of drynaria rhizome-prepared tuber fleeceflower root are taken as ministerial drugs, and angelica, donkey-hide gelatin and pilose antler are taken as auxiliary drugs for enriching and activating blood; ramulus Uncariae cum uncis has effects of clearing heat and cooling blood; poria has effects in invigorating spleen and regulating stomach function; the garden balsam stem has the functions of expelling wind and removing dampness, promoting blood circulation and stimulating the menstrual flow, so as to expel wind and clear away cold, and remove dampness and arthralgia.

Detailed Description

It is to be understood that the following detailed description is exemplary and is intended to provide further explanation of the invention as claimed. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of exemplary embodiments according to the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.

In a first aspect, the invention provides an astragalus formulation which comprises the following components in parts by weight:

30-40 parts of astragalus membranaceus, 3-4 parts of angelica sinensis, 5-10 parts of uncaria, 6-8 parts of prepared polygonum multiflorum, 20-30 parts of poria cocos, 4-5 parts of radix cyathulae, 2-4 parts of cornu cervi pantotrichum, 16-20 parts of rhizoma drynariae, 9-10 parts of donkey-hide gelatin, 6-8 parts of garden balsam stem, 7-12 parts of radix puerariae and 8-10 parts of ligusticum chuanxiong hort.

The invention is further extended and applied on the basis of the application number of 011274778 and the patent name of a traditional Chinese medicine preparation for treating cervical spondylosis and a preparation method thereof. The patent describes that the preparation has a good inhibitory effect on mouse auricular swelling caused by xylene and rat toe swelling caused by carrageenan, so that the inventor tests the preparation on a model of rat rheumatoid arthritis, and the effect is poor although the preparation can achieve a certain treatment effect. Therefore, the inventor adjusts the composition and the proportion of the traditional Chinese medicine preparation, and obtains better effect in a rat rheumatoid arthritis model test.

In some embodiments, the astragalus formulation is composed of the following components in parts by weight:

35-40 parts of astragalus membranaceus, 3-4 parts of angelica sinensis, 5-10 parts of uncaria, 6-8 parts of prepared polygonum multiflorum, 20-25 parts of poria cocos, 4-5 parts of radix cyathulae, 2-4 parts of cornu cervi pantotrichum, 16-18 parts of rhizoma drynariae, 9-10 parts of donkey-hide gelatin, 6-8 parts of garden balsam stem, 7-12 parts of radix puerariae and 8-10 parts of ligusticum chuanxiong hort.

Further, the astragalus formulation preparation consists of the following components in parts by weight:

38-40 parts of astragalus membranaceus, 3-4 parts of angelica sinensis, 5-10 parts of uncaria, 6-8 parts of prepared polygonum multiflorum, 22-25 parts of poria cocos, 4-5 parts of radix cyathulae, 2-4 parts of cornu cervi pantotrichum, 16-18 parts of rhizoma drynariae, 9-10 parts of donkey-hide gelatin, 6-8 parts of garden balsam stem, 7-10 parts of radix puerariae and 8-10 parts of ligusticum chuanxiong hort.

Further, the astragalus formulation preparation consists of the following components in parts by weight:

38-40 parts of astragalus membranaceus, 3-4 parts of angelica sinensis, 5-10 parts of uncaria, 6-8 parts of prepared polygonum multiflorum, 23-25 parts of poria cocos, 4-5 parts of radix cyathulae, 2-4 parts of cornu cervi pantotrichum, 16-18 parts of rhizoma drynariae, 9-10 parts of donkey-hide gelatin, 6-8 parts of garden balsam stem, 8-10 parts of radix puerariae and 8-9 parts of ligusticum chuanxiong hort.

Furthermore, the astragalus formulation preparation consists of the following components in parts by weight:

39 parts of astragalus membranaceus, 3 parts of angelica sinensis, 10 parts of uncaria, 6 parts of prepared polygonum multiflorum, 25 parts of poria cocos, 5 parts of medicinal cyathula root, 4 parts of pilose antler, 16 parts of rhizoma drynariae, 10 parts of donkey-hide gelatin, 6 parts of garden balsam stem, 10 parts of radix puerariae and 9 parts of ligusticum chuanxiong hort.

In a second aspect, the invention provides a preparation method of the astragalus formulation, which comprises the following steps:

pulverizing radix astragali, radix Angelicae sinensis, radix Polygoni Multiflori Preparata, rhizoma Drynariae, ramulus Uncariae cum uncis, Poria, radix Cyathulae and herba Speranskiae Tuberculatae, decocting in water, and concentrating the filtrate to obtain paste;

drying the decocted residue, adding ethanol into the dried residue, extracting, and concentrating the extract to obtain a paste;

crushing radix Puerariae and rhizoma Ligustici Chuanxiong, extracting with ethanol, and concentrating the extractive solution to obtain paste;

mixing the three paste, drying, and pulverizing to obtain medicinal powder;

grinding colla Corii Asini and cornu Cervi Pantotrichum into fine powder, adding the fine powder into the above medicinal powder, and mixing to obtain preparation.

The active ingredients in the astragalus, the angelica, the prepared fleece-flower root, the rhizoma drynariae, the uncaria, the tuckahoe, the radix cyathulae and the garden balsam stem comprise water-soluble ingredients and oil-soluble ingredients, and the inventor finds that the oil-soluble active ingredients in the above components are difficult to extract when the active ingredients are decocted by water, and the oil-soluble active ingredients can be extracted when the dregs of a decoction are extracted by ethanol, so that the water-soluble ingredients and the oil-soluble ingredients are matched with each other, and the effect of treating the rheumatoid arthritis can be better achieved.

In addition, tests show that a certain amount of water remains in the dregs after simple filtration, the water can permeate into the crushed solid particles, and when ethanol is added for extraction, the water can hinder the permeation of the ethanol, so that the extraction of the ethanol on the oil-soluble active ingredients in each component is influenced. Therefore, the filtered residue is dried before extraction with ethanol.

In some embodiments, the time for decocting with water is 1-2 h.

In some embodiments, the mass ratio of the medicine residue to the ethanol is 1: 2-4. The ethanol is excessive to fully extract the oil-soluble active ingredients in the dregs.

In some embodiments, the method further comprises the step of sieving the mixed powder.

Furthermore, the mesh number of the sieve is 100-200 meshes.

In a third aspect, the invention provides an application of the astragalus formulation preparation in preparing an anti-rheumatoid preparation.