Traditional Chinese medicine composition containing bighead atractylodes rhizome

文档序号:121237 发布日期:2021-10-22 浏览:38次 中文

阅读说明:本技术 一种含有白术的中药组合物 (Traditional Chinese medicine composition containing bighead atractylodes rhizome ) 是由 仝小林 闫凯境 于 2021-04-16 设计创作,主要内容包括:本发明公开了一种预防或治疗感冒和/或流行性感冒和/或新型冠状病毒肺炎的中药组合物,其特征在于其原料药组成为茯苓、白术、生姜等。本发明中药组合物具有补中益气,健脾燥湿、解表清热,凉血解毒之效。(The invention discloses a traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus pneumonia, which is characterized in that the raw medicines comprise tuckahoe, atractylodes, ginger and the like. The Chinese medicinal composition has the effects of tonifying middle-jiao and Qi, strengthening spleen and eliminating dampness, relieving exterior syndrome and clearing heat, and cooling blood and removing toxicity.)

1. A traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus pneumonia is characterized by comprising the raw medicines of astragalus, notopterygium root, kudzuvine root, wrinkled gianthyssop, heartleaf houttuynia herb, sweet wormwood herb, Chinese thorowax root, Indian buead, largehead atractylodes rhizome, tangerine peel and ginger.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: also comprises the raw materials of radix codonopsitis, perilla leaf, radix sileris and honeysuckle.

3. A traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus pneumonia is characterized in that the raw medicines comprise ephedra, gypsum, almond, notopterygium root, semen lepidii, cyrtomium rhizome, earthworm, paniculate swallowwort root, wrinkled gianthyssop herb, fortune eupatorium herb, rhizoma atractylodis, poria, raw bighead atractylodes rhizome, charred triplet, mangnolia officinalis, charred areca nut, simmered amomum fruit and ginger.

4. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight:

5-30 parts of raw astragalus membranaceus, 1-15 parts of notopterygium root, 1-20 parts of radix puerariae, 1-15 parts of agastache rugosus, 5-25 parts of houttuynia cordata, 1-15 parts of sweet wormwood herb, 1-10 parts of radix bupleuri, 5-30 parts of poria, 1-20 parts of fried bighead atractylodes rhizome, 1-15 parts of pericarpium citri reticulatae and 1-20 parts of ginger;

preference is given to

8-20 parts of raw astragalus membranaceus, 2-9 parts of notopterygium root, 5-12 parts of radix puerariae, 2-9 parts of agastache rugosus, 12-18 parts of houttuynia cordata, 2-9 parts of sweet wormwood herb, 1-5 parts of radix bupleuri, 8-20 parts of poria, 5-12 parts of fried bighead atractylodes rhizome, 2-9 parts of pericarpium citri reticulatae and 5-12 parts of ginger;

further has the option of

15 parts of raw astragalus, 6 parts of notopterygium root, 9 parts of kudzuvine root, 6 parts of wrinkled gianthyssop herb, 15 parts of heartleaf houttuynia herb, 6 parts of sweet wormwood herb, 3 parts of Chinese thorowax root, 15 parts of poria, 9 parts of fried largehead atractylodes rhizome, 6 parts of dried orange peel and 9 parts of ginger for later use.

5. The traditional Chinese medicine composition according to claim 2, which is prepared from the following raw materials in parts by weight:

5-30 parts of raw astragalus membranaceus, 1-20 parts of codonopsis pilosula, 1-20 parts of perilla leaves, 1-15 parts of notopterygium roots, 1-15 parts of divaricate saposhnikovia roots, 1-15 parts of wrinkled gianthyssop herbs, 1-20 parts of honeysuckle flowers, 5-30 parts of poria cocos, 1-20 parts of fried bighead atractylodes rhizomes, 1-15 parts of dried orange peels, 1-15 parts of ginger, 1-20 parts of kudzuvine roots, 5-30 parts of houttuynia cordata, 1-15 parts of sweet wormwood herbs and 1-10 parts of radix bupleuri;

preference is given to

8-20 parts of raw astragalus membranaceus, 5-12 parts of codonopsis pilosula, 5-12 parts of perilla leaves, 2-9 parts of notopterygium roots, 2-9 parts of divaricate saposhnikovia roots, 2-9 parts of wrinkled gianthyssop herbs, 5-12 parts of honeysuckle flowers, 8-20 parts of poria cocos, 5-12 parts of fried bighead atractylodes rhizomes, 2-8 parts of dried tangerine peels, 2-8 parts of ginger, 5-12 parts of kudzuvine roots, 8-20 parts of houttuynia cordata, 2-9 parts of sweet wormwood herbs and 1-5 parts of radix bupleuri;

more preferably

15 parts of raw astragalus membranaceus, 9 parts of codonopsis pilosula, 9 parts of perilla leaves, 6 parts of notopterygium roots, 6 parts of divaricate saposhnikovia roots, 6 parts of wrinkled gianthyssop herbs, 9 parts of honeysuckle flowers, 15 parts of poria cocos, 9 parts of fried bighead atractylodes rhizome, 6 parts of dried orange peels, 6 parts of ginger, 9 parts of kudzu roots, 15 parts of cordate houttuynia, 6 parts of sweet wormwood herbs and 3 parts of radix bupleuri.

6. The traditional Chinese medicine composition according to claim 3, which is prepared from the following raw material medicines in parts by weight:

1-20 parts of raw ephedra herb, 5-30 parts of gypsum, 1-20 parts of almond, 5-30 parts of notopterygium root, 5-30 parts of semen lepidii, 5-30 parts of cyrtomium rhizome, 5-30 parts of earthworm, 5-30 parts of cynanchum paniculatum, 5-30 parts of wrinkled gianthyssop, 1-20 parts of fortune eupatorium herb, 5-30 parts of rhizoma atractylodis, 20-80 parts of poria, 10-50 parts of raw bighead atractylodes rhizome, 1-20 parts of charred triplet, 5-30 parts of mangnolia officinalis, 1-20 parts of charred betel nut, 1-20 parts of simmered amomum fruit and 5-30 parts of ginger;

preference is given to

2-9 parts of raw ephedra herb, 8-20 parts of gypsum, 5-12 parts of almond, 8-20 parts of notopterygium root, 8-20 parts of semen lepidii, 8-20 parts of cyrtomium rhizome, 8-20 parts of earthworm, 8-20 parts of cynanchum paniculatum, 8-20 parts of wrinkled gianthyssop, 5-12 parts of fortune eupatorium herb, 8-20 parts of rhizoma atractylodis, 30-60 parts of poria, 20-40 parts of raw bighead atractylodes rhizome, 5-12 parts of charred triplet, 8-20 parts of mangnolia officinalis, 5-12 parts of charred betel nut, 5-12 parts of simmered amomum fruit and 8-20 parts of ginger;

more preferably

6 parts of raw ephedra herb, 15 parts of gypsum, 9 parts of almond, 15 parts of notopterygium root, 15 parts of semen lepidii, 15 parts of cyrtomium rhizome, 15 parts of earthworm, 15 parts of paniculate swallowwort root, 15 parts of wrinkled gianthyssop herb, 9 parts of fortune eupatorium herb, 15 parts of rhizoma atractylodis, 45 parts of poria, 30 parts of raw bighead atractylodes rhizome, 9 parts of charred triplet, 15 parts of mangnolia officinalis, 9 parts of charred areca seed, 9 parts of simmered amomum fruit and 15 parts of ginger.

7. A Chinese medicinal preparation for preventing or treating cold and/or influenza and/or novel coronavirus pneumonia, which is characterized by comprising the Chinese medicinal composition according to any one of claims 1-6, and further comprising pharmaceutically acceptable auxiliary materials and optional coating materials.

8. The traditional Chinese medicine preparation of claim 7, which is a tablet, granule, capsule, pill or syrup.

9. A method for preparing the Chinese medicinal composition or the preparation as claimed in any one of claims 1 to 8, wherein all the raw materials of the composition are extracted, concentrated and dried.

10. A process for preparing the Chinese-medicinal composition as claimed in claim 2, 5, 7 or 8,

taking all the raw materials of astragalus, codonopsis pilosula, perilla leaf, notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, honeysuckle flower, tuckahoe, largehead atractylodes rhizome, tangerine peel, ginger, kudzuvine root, heartleaf houttuynia herb, sweet wormwood herb and Chinese thorowax root, and then carrying out mass preparation on the raw materials

By any of the following methods

Preparation method 1

Decocting all the raw materials in water for 1-3 times, concentrating the extract into thick paste, and preparing into granules, capsules, pills, tablets and other preparations;

or

Decocting all the raw materials in water for 1-3 times, concentrating the extract, adding ethanol for alcohol precipitation, filtering, concentrating the alcohol precipitation solution to obtain thick paste, and preparing into pharmaceutically acceptable dosage forms;

preparation method II

Extracting volatile oil from all or part of the raw materials by a distillation method or an ultrasonic method or a cold soaking method, collecting the volatile oil and liquid medicine, decocting the residues after extracting the volatile oil with water for one time, mixing the liquid medicine and concentrating to obtain thick paste, and coating the volatile oil with 2-16 times of beta-cyclodextrin for later use. Decocting the other medicinal materials in the composition with water for 1-3 times, concentrating the liquid medicine to thick paste, and preparing the thick paste, the extract, the volatile oil inclusion compound and a proper amount of auxiliary materials into a pharmaceutically acceptable dosage form;

preparation method III

All raw materials are subjected to reflux extraction for 1-3 times by using 30-80% ethanol, and concentrated into thick paste to prepare a pharmaceutically acceptable preparation;

preparation method four

All the raw materials are subjected to reflux extraction for 1-3 times by using 70-90% ethanol, the dregs of a decoction are subjected to decoction and extraction for 1-3 times by adding water, and the decoction is concentrated into thick paste to prepare a pharmaceutically acceptable preparation;

preparation method five

Extracting radix codonopsitis, notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, largehead atractylodes rhizome, tangerine peel, ginger, kudzuvine root and Chinese thorowax root by 50-80 ethanol in a refluxing way for 1-3 times, recovering the ethanol, and concentrating to thick paste; decocting raw astragalus, perilla leaf, honeysuckle, poria, houttuynia cordata and sweet wormwood in water for 1-3 times, concentrating into thick paste, adding a proper amount of auxiliary materials into the thick paste and the ethanol extract, and preparing into a pharmaceutically acceptable dosage form;

preparation method VI

1) Preparing raw astragalus components: extracting with water, precipitating with ethanol, collecting precipitate, separating the supernatant with macroporous adsorbent resin, eluting with ethanol solution, concentrating the eluate, concentrating the precipitate, and drying to obtain saponin and polysaccharide components;

2) preparing a codonopsis pilosula component: soaking radix Codonopsis in 40-60% ethanol, adsorbing the soaking solution with macroporous resin, eluting, concentrating the eluate, and drying to obtain radix Codonopsis polysaccharide component; extracting lobetyolin components in the codonopsis pilosula by supercritical fluid with a banding agent to obtain codonopsis pilosula components;

3) preparing perilla leaf components: extracting volatile oil components and flavonoid components;

a, taking a proper amount of perilla leaves, extracting volatile oil components of the perilla leaves extracted in the step a by adopting a steam distillation method, a cold soaking method or an ultrasonic extraction method, and obtaining flavonoid components in the perilla leaves by adopting a microwave-assisted extraction method, wherein the microwave time is 30min, the microwave power is 268W, the liquid-material ratio is 15: 1ml/g, and the volume fraction of ethanol is 80%;

4) preparation of notopterygium component: extracting volatile oil by a steam distillation method or an ultrasonic method or a cold soaking method, collecting the volatile oil, and performing inclusion on the volatile oil by beta-cyclodextrin of which the amount is 2-16 times that of the volatile oil to obtain notopterygium root volatile oil components, or extracting notopterygium root by a supercritical extraction method, wherein the extract is included or not included to be used as the notopterygium root volatile oil components;

5) preparing a divaricate saposhnikovia root component: extracting radix Saposhnikoviae with 50-80% ethanol for 1-3 times, and performing ultrasonic extraction for 30min each time to obtain cimicifugae glycoside and 5-O-methylvisammioside glycoside; extracting volatile oil by a steam distillation method or an ultrasonic method or a cold soaking method, collecting the volatile oil, and performing inclusion on the volatile oil by beta-cyclodextrin of which the amount is 2-16 times that of the volatile oil to obtain a windproof volatile oil component, or extracting the windproof volatile oil by a supercritical extraction method, wherein the extract is included or not included to be used as the windproof volatile oil component;

6) preparing a wrinkled giant hyssop component: extracting volatile oil by a steam distillation method or an ultrasonic method or a cold soaking method, collecting the volatile oil, and performing inclusion on the volatile oil by beta-cyclodextrin of which the amount is 2-16 times that of the volatile oil to obtain a volatile oil component of the pogostemon cablin, or extracting the pogostemon cablin by a supercritical extraction method, wherein the extract is included or not included to be used as the volatile oil component of the pogostemon cablin;

7) preparing a honeysuckle component: taking a proper amount of honeysuckle, extracting with water, concentrating an extracting solution, adjusting the pH value of a concentrated solution to 2-4, eluting with macroporous resin, collecting an eluent, concentrating under reduced pressure, and drying to obtain an organic acid component; soaking flos Lonicerae in 50-80% ethanol for 8-16h, ultrasonic extracting to obtain flavone extract, concentrating and drying the extract, mixing with appropriate amount of polyamide powder, extracting and decolorizing, eluting with macroporous resin, collecting eluate, concentrating under reduced pressure, and drying to obtain flos Lonicerae total flavonoids component;

8) preparing the poria cocos components: extracting Poria with water or pulverizing into powder; pulverizing Poria, soaking in water, adding complex enzyme, extracting, precipitating with ethanol, washing with anhydrous ethanol, acetone and diethyl ether respectively to obtain pachyman crude product, purifying with deproteinized macroporous resin, concentrating eluate, dialyzing, concentrating dialysate, and freeze drying to obtain pachyman component;

9) preparing a bighead atractylodes rhizome component: extracting volatile oil by a steam distillation method (or an ultrasonic method or a cold soaking method), collecting the volatile oil, and performing inclusion on the volatile oil by beta-cyclodextrin of which the amount is 2-16 times that of the volatile oil to obtain a volatile oil component of the bighead atractylodes rhizome;

10) preparing dried orange peel components: extracting pericarpium Citri Tangerinae with 5-10 times of 50-80% ethanol for 1-3 times, adjusting p H value to 2-5, and recrystallizing the crude extract with 95% ethanol to obtain pericarpium Citri Tangerinae hesperidin extract; extracting volatile oil by a steam distillation method or an ultrasonic method or a cold soaking method, collecting the volatile oil, and performing inclusion on the volatile oil by beta-cyclodextrin of which the amount is 2-16 times that of the volatile oil to obtain a volatile oil component of the dried orange peel;

11) preparing a ginger component: extracting volatile oil by a steam distillation method or an ultrasonic method or a cold soaking method, collecting the volatile oil, and performing inclusion on the volatile oil by 2-16 times of beta-cyclodextrin to obtain a ginger volatile oil component, or extracting ginger by a supercritical extraction method, wherein the extract is included or not included to be used as the ginger volatile oil component;

12) preparation of a kudzu root component: extracting with 30-70% ethanol to obtain radix Puerariae total flavonoids; extracting with CO2 supercritical fluid to obtain radix Puerariae total flavonoids; purifying by polyamide column chromatography adsorption method with D101 resin and acetic acid crystallization method to obtain puerarin component;

13) preparing the houttuynia cordata component: extracting flavonoids from herba Houttuyniae with ethanol, ultrasonic-assisted ethanol, supercritical CO2 fluid extraction, and enzyme-assisted extraction to obtain flavonoids; extracting volatile oil of the houttuynia cordata by a steam distillation method, an ultrasonic method or a cold immersion method, collecting the volatile oil, and performing inclusion on the volatile oil by beta-cyclodextrin of which the amount is 2-16 times that of the volatile oil to obtain volatile oil components.

14) Preparing a sweet wormwood component: extracting with petroleum ether, concentrating and purifying to obtain artemisinin components, decocting the dregs in water for 1-3 times, concentrating to obtain a thin extract, adding ethanol until the ethanol concentration reaches 50-80%, standing, collecting supernatant, concentrating and drying the supernatant to obtain artemisia apiacea components;

15) the preparation of the bupleurum component: extracting triterpenoid saponin components in the radix bupleuri with 70% methanol; extracting under reflux with 80% ethanol to obtain ethanol solution of bupleuri radix total saponin, and purifying with AB-8 macroporous resin method to obtain bupleuri radix total saponin component; extracting the volatile oil of the Chinese thorowax root by a steam distillation method or an ultrasonic method or a cold soaking method, collecting the volatile oil, and clathrating the volatile oil with 2-16 times of beta-cyclodextrin to obtain volatile oil components;

adding auxiliary materials into all the components obtained in the steps 1) to 15) to prepare pharmaceutically acceptable dosage forms.

11. A process for preparing a Chinese medicinal composition or formulation as claimed in any one of claims 2, 5, 7 and 8,

taking all the raw materials of astragalus, codonopsis pilosula, perilla leaf, notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, honeysuckle flower, tuckahoe, bighead atractylodes rhizome, dried orange peel, ginger, kudzuvine root, heartleaf houttuynia herb, sweet wormwood herb and Chinese thorowax root, adding 3-10 times of water for reflux extraction for 1-3 times, merging water extracts, concentrating under reduced pressure until the specific gravity is 1.20-1.30 (60 ℃), adding auxiliary materials, and preparing into a pharmaceutically acceptable dosage form.

12. A process for preparing a Chinese medicinal composition or formulation as claimed in any one of claims 2, 5, 7 and 8,

taking all the raw materials of astragalus, codonopsis pilosula, perilla leaf, notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, honeysuckle flower, tuckahoe, bighead atractylodes rhizome, dried orange peel, ginger, kudzuvine root, heartleaf houttuynia herb, sweet wormwood herb and radix bupleuri;

adding 5-10 times of water into perilla leaf, notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, dried orange peel, ginger, heartleaf houttuynia herb and radix bupleuri, extracting volatile oil for hours by steam distillation to obtain volatile oil A and water solution B, adding raw astragalus, fried bighead atractylodes rhizome and sweet wormwood into medicinal residues, adding water, performing reflux extraction, mixing the obtained water extract and the water solution B, concentrating under reduced pressure until the specific gravity is 1.03-1.07 (60 ℃), and taking the mixture as water extract concentrated solution C;

extracting radix Codonopsis, flos Lonicerae, Poria and radix Puerariae with 50-95% ethanol under reflux, mixing extractive solutions, concentrating under reduced pressure to specific gravity of 1.03-1.07 (60 deg.C), mixing with the concentrated solution C, concentrating to specific gravity of 1.20-1.30 (60 deg.C), adding volatile oil A, mixing, adding adjuvants, and making into pharmaceutically acceptable dosage forms.

13. Use of a Chinese medicinal composition according to any one of claims 1 to 8 for the preparation of a medicament for the prevention or treatment of cold and/or influenza and or novel coronavirus pneumonia.

14. Use of a Chinese medicinal composition according to any one of claims 1 to 8 for the preparation of a medicament for anti-inflammatory and/or immune enhancement.

Technical Field

The invention belongs to the field of medicines, and relates to a traditional Chinese medicine composition containing bighead atractylodes rhizome, a preparation method and application thereof.

Background

From the perspective of traditional Chinese medicine, cold, influenza and novel coronavirus pneumonia (Corona Virus Disease 2019, COVID-19), referred to as "novel coronary pneumonia" for short, are caused by invasion of exogenous pathogens into lung channels. The new type coronavirus pneumonia belongs to cold-dampness epidemic disease, which is caused by the affection of cold-dampness epidemic toxin. The traditional Chinese medicine can integrally regulate the immune function of a human body, achieve the purposes of strengthening the body resistance and eliminating evil, dispel cold and remove dampness, avoid dirt and transform turbidity, protect lung and invigorate spleen. In Huangdi's classic on medicine, cold-shaped fluid can injure the lung, so the traditional Chinese medicine should regulate the spleen and stomach.

Therefore, a medicine capable of treating cold, influenza and new coronary pneumonia and well regulating spleen and stomach is needed.

The invention content is as follows:

the invention aims to provide a traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus pneumonia.

The composition can be made into tablet, granule, capsule, pill, syrup, etc. according to clinical requirement and experimental study practice.

The invention also aims to provide a method for preparing the traditional Chinese medicine composition or the preparation.

The invention also aims to provide application of the traditional Chinese medicine composition in the production of a medicine for preventing or treating diseases such as cold and/or influenza and/or novel coronavirus pneumonia.

In order to find an effective traditional Chinese medicine composition for preventing or treating cold and/or influenza virus and/or novel coronavirus pneumonia, the inventor of the invention reasonably combines the traditional Chinese medicine composition through long-term practice and performs antiviral experimental research, so that the traditional Chinese medicine composition is proved to have stronger antiviral effect.

Technical scheme

The inventor carries out extensive research and provides a traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus pneumonia, which is characterized in that the raw medicines comprise astragalus, notopterygium root, kudzuvine root, wrinkled gianthyssop herb, heartleaf houttuynia herb, sweet wormwood herb, Chinese thorowax root, Indian buead, largehead atractylodes rhizome, tangerine peel and ginger. The radix astragali is selected from radix astragali, radix astragali Preparata, parched radix astragali, radix astragali Preparata, and salted radix astragali, preferably radix astragali. Poria is preferably Poria. The Atractylodis rhizoma is selected from rhizoma Atractylodis Macrocephalae and parched Atractylodis rhizoma, preferably parched Atractylodis rhizoma.

A traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus pneumonia is prepared from the following raw materials in parts by weight: 5-30 parts of raw astragalus membranaceus, 1-15 parts of notopterygium root, 1-20 parts of radix puerariae, 1-15 parts of agastache rugosus, 5-25 parts of houttuynia cordata, 1-15 parts of sweet wormwood herb, 1-10 parts of radix bupleuri, 5-30 parts of poria, 1-20 parts of fried bighead atractylodes rhizome, 1-15 parts of pericarpium citri reticulatae and 1-20 parts of ginger for later use;

preferably, 8-20 parts of raw astragalus membranaceus, 2-9 parts of notopterygium root, 5-12 parts of radix puerariae, 2-9 parts of agastache rugosus, 12-18 parts of houttuynia cordata, 2-9 parts of sweet wormwood, 1-5 parts of radix bupleuri, 8-20 parts of poria, 5-12 parts of fried bighead atractylodes rhizome, 2-9 parts of pericarpium citri reticulatae and 5-12 parts of ginger for later use;

preferably, 15 parts of raw astragalus, 6 parts of notopterygium root, 9 parts of kudzuvine root, 6 parts of wrinkled gianthyssop herb, 15 parts of heartleaf houttuynia herb, 6 parts of sweet wormwood herb, 3 parts of Chinese thorowax root, 15 parts of poria, 9 parts of fried largehead atractylodes rhizome, 6 parts of dried orange peel and 9 parts of ginger for later use;

square solution: in the formula, astragalus and fried bighead atractylodes rhizome tonify qi and strengthen superficies; poria has effects of eliminating dampness and invigorating spleen, and parched Atractylodis rhizoma has effects of invigorating qi and invigorating spleen, eliminating dampness, and invigorating qi and invigorating spleen; the astragalus, the poria from Yunnan of China and the fried bighead atractylodes rhizome are monarch drugs, so that qi is tonified, the exterior is strengthened, the spleen is strengthened and the dampness is eliminated; the dried orange peel has the functions of regulating qi, strengthening spleen, eliminating dampness and phlegm, and the ginger warms middle energizer and stops vomiting, the dried orange peel and the ginger are used together, the wrinkled gianthyssop is added for warming middle energizer and eliminating phlegm, and the wrinkled gianthyssop is added for eliminating dampness and stopping vomiting, and the dried orange peel, the dried orange peel and the ginger are used as ministerial medicaments; the compatibility uses notopterygium root for relieving exterior syndrome and dispelling cold, kudzuvine root and bupleurum root for promoting the exterior syndrome, relieving muscles and fever, sweet wormwood for clearing heat and cooling blood, and the three are used as adjuvant medicines; the cordate houttuynia has the effect of clearing heat and removing toxicity, and is mainly used for clearing lung heat in lung meridian; used as adjuvant and guiding drugs; the medicines are combined to play the effects of tonifying qi and spleen, eliminating dampness and relieving exterior syndrome and clearing heat and detoxicating.

Technical scheme

In order to achieve better curative effect, the traditional Chinese medicine composition 1 can be combined with the raw medicines of radix codonopsitis, perilla leaf, radix sileris and honeysuckle to obtain a composition 2, namely a traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus pneumonia, wherein the raw medicines of the traditional Chinese medicine composition comprise radix astragali, radix codonopsitis, perilla leaf, notopterygium root, radix sileris, agastache rugosus, honeysuckle, tuckahoe, bighead atractylodes rhizome, dried orange peel, ginger, radix puerariae, houttuynia cordata, sweet wormwood and radix bupleuri.

A traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus pneumonia is prepared from the following raw materials in parts by weight: 5-30 parts of raw astragalus membranaceus, 1-20 parts of codonopsis pilosula, 1-20 parts of perilla leaves, 1-15 parts of notopterygium roots, 1-15 parts of divaricate saposhnikovia roots, 1-15 parts of wrinkled gianthyssop herbs, 1-20 parts of honeysuckle flowers, 5-30 parts of poria cocos, 1-20 parts of fried bighead atractylodes rhizomes, 1-15 parts of dried orange peels, 1-15 parts of ginger, 1-20 parts of kudzuvine roots, 5-30 parts of houttuynia cordata, 1-15 parts of sweet wormwood herbs and 1-10 parts of radix bupleuri;

8-20 parts of raw astragalus membranaceus, 5-12 parts of codonopsis pilosula, 5-12 parts of perilla leaves, 2-9 parts of notopterygium roots, 2-9 parts of divaricate saposhnikovia roots, 2-9 parts of wrinkled gianthyssop herbs, 5-12 parts of honeysuckle flowers, 8-20 parts of poria cocos, 5-12 parts of fried bighead atractylodes rhizomes, 2-8 parts of dried tangerine peels, 2-8 parts of ginger, 5-12 parts of kudzuvine roots, 8-20 parts of houttuynia cordata, 2-9 parts of sweet wormwood herbs and 1-5 parts of radix bupleuri;

preferably, 15 parts of raw astragalus, 9 parts of codonopsis pilosula, 9 parts of perilla leaves, 6 parts of notopterygium roots, 6 parts of divaricate saposhnikovia roots, 6 parts of wrinkled gianthyssop herbs, 9 parts of honeysuckle flowers, 15 parts of poria cocos, 9 parts of fried bighead atractylodes rhizome, 6 parts of dried orange peels, 6 parts of ginger, 9 parts of kudzuvine roots, 15 parts of cordate houttuynia, 6 parts of sweet wormwood herbs and 3 parts of radix bupleuri.

Square solution: in the formula, the astragalus and the codonopsis pilosula tonify middle-jiao and qi, and are used as monarch drugs; poria has effects of eliminating dampness and invigorating spleen, and parched Atractylodis rhizoma has effects of invigorating qi and invigorating spleen, eliminating dampness and eliminating phlegm, and is used as ministerial drug; the perilla leaves are added for dispelling cold and relieving exterior syndrome, promoting qi circulation and reducing phlegm, the wrinkled gianthyssop herb is used for eliminating dampness and arresting vomiting, the tangerine peel is used for regulating qi and strengthening spleen, eliminating dampness and reducing phlegm, the ginger is used for relieving exterior syndrome and dispelling cold, and warming middle-jiao and arresting vomiting, and the four medicines are used together and are also used as ministerial medicines; radix Puerariae, Notopterygii rhizoma, radix Saposhnikoviae, and bupleuri radix are used as adjuvant drugs for dispelling cold, relieving exterior syndrome, dispelling pathogenic wind and clearing heat; honeysuckle and houttuynia cordata are added for relieving exterior syndrome and clearing away heat and toxic materials, and the houttuynia cordata mainly enters lung meridian and excels in clearing lung heat; sweet wormwood herb has the efficacies of clearing deficiency heat and cooling blood, and is used together with other herbs. The medicines are combined to play the effects of tonifying middle-jiao and Qi, strengthening spleen and eliminating dampness, relieving exterior syndrome and clearing heat, and cooling blood and removing toxicity.

Technical scheme

The invention also provides a traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus pneumonia, which is characterized in that the raw medicines comprise ephedra, gypsum, almond, notopterygium root, semen lepidii, cyrtomium rhizome, earthworm, paniculate swallowwort root, wrinkled gianthyssop herb, fortune eupatorium herb, rhizoma atractylodis, tuckahoe, bighead atractylodes rhizome, charred triplet, mangnolia officinalis, charred areca seed, simmered amomum fruit and ginger. Poria is preferably Poria. The Atractylodis rhizoma is selected from rhizoma Atractylodis Macrocephalae and parched Atractylodis rhizoma, preferably parched Atractylodis rhizoma. The herba Ephedrae can be selected from raw herba Ephedrae and herba Ephedrae honey, preferably raw herba Ephedrae.

A traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus pneumonia is prepared from the following raw materials in parts by weight: 1-20 parts of raw ephedra herb, 5-30 parts of gypsum, 1-20 parts of almond, 5-30 parts of notopterygium root, 5-30 parts of semen lepidii, 5-30 parts of cyrtomium rhizome, 5-30 parts of earthworm, 5-30 parts of cynanchum paniculatum, 5-30 parts of wrinkled gianthyssop, 1-20 parts of fortune eupatorium herb, 5-30 parts of rhizoma atractylodis, 20-80 parts of poria, 10-50 parts of raw bighead atractylodes rhizome, 1-20 parts of charred triplet, 5-30 parts of mangnolia officinalis, 1-20 parts of charred betel nut, 1-20 parts of simmered amomum fruit and 5-30 parts of ginger;

2-9 parts of raw ephedra herb, 8-20 parts of gypsum, 5-12 parts of almond, 8-20 parts of notopterygium root, 8-20 parts of semen lepidii, 8-20 parts of cyrtomium rhizome, 8-20 parts of earthworm, 8-20 parts of cynanchum paniculatum, 8-20 parts of wrinkled gianthyssop, 5-12 parts of fortune eupatorium herb, 8-20 parts of rhizoma atractylodis, 30-60 parts of poria, 20-40 parts of raw bighead atractylodes rhizome, 5-12 parts of charred triplet, 8-20 parts of mangnolia officinalis, 5-12 parts of charred betel nut, 5-12 parts of simmered amomum fruit and 8-20 parts of ginger;

preferably, 6 parts of raw ephedra herb, 15 parts of gypsum, 9 parts of almond, 15 parts of notopterygium root, 15 parts of semen lepidii, 15 parts of cyrtomium rhizome, 15 parts of earthworm, 15 parts of paniculate swallowwort root, 15 parts of wrinkled gianthyssop herb, 9 parts of fortune eupatorium herb, 15 parts of rhizoma atractylodis, 45 parts of poria, 30 parts of raw bighead atractylodes rhizome, 9 parts of charred triplet, 15 parts of mangnolia officinalis, 9 parts of charred areca seed, 9 parts of simmered amomum fruit and 15 parts of ginger.

In the formula, the ephedra, the gypsum and the almond have the effects of ventilating lung and relieving cough and clearing lung heat; semen Lepidii with lung purging and diuresis promoting effects, rhizoma Osmundae with heat and toxic materials clearing away, and Lumbricus with collateral dredging and asthma relieving effects; notopterygii rhizoma and radix Cynanchi Paniculati for dispelling pathogenic wind and removing dampness, and optionally herba Agastaches, herba Eupatorii and rhizoma Atractylodis for eliminating dampness; cortex magnoliae officinalis, semen arecae preparatus and fructus zingiberis recens are three main medicines of Dayuan drink, and are capable of breaking warp and removing dirt and turbid; poria cocos and rhizoma Atractylodis Macrocephalae, charred triplet and ginger can strengthen spleen and remove dampness, and eliminate stagnation and harmonize stomach. The medicines are combined and the whole formula has the effects of freeing lung and expelling pathogenic factors, detoxifying and dredging collaterals, removing dirt and eliminating turbidity, and invigorating spleen and removing dampness.

Ventilating lung and expelling pathogenic factors, removing toxic substance and dredging collaterals, removing filth and eliminating turbid pathogen, invigorating spleen and removing dampness. It is applicable to patients suspected of new coronary pneumonia, those in close contact with each other, and those of mild type and those of ordinary type.

The traditional Chinese medicine composition 3 has the effects of ventilating the lung, resolving dampness, and ventilating and detoxifying, and can be used for treating new coronary pneumonia in clinical treatment period, common fever, heavy body, hypodynamia and serious dampness.

The invention also relates to a preparation method of the traditional Chinese medicine composition, which comprises the following steps:

composition 1 preparation method

Preparation method 1

Decocting all the medicinal materials of the composition with water for 1-3 times, extracting an extracting solution (or decocting the medicinal materials of the whole formula with water for 1-3 times, concentrating the extracting solution, adding ethanol for precipitating, filtering, precipitating the solution with ethanol) concentrating to obtain a thick paste, and preparing the thick paste into preparations such as granules, capsules, pills, tablets and the like.

Preparation method II

In the composition, all or part of notopterygium root, wrinkled gianthyssop herb, bighead atractylodes rhizome, dried orange peel, ginger, cordate houttuynia, radix bupleuri and other medicines are subjected to distillation (or ultrasonic method or cold soaking method) to extract volatile oil, the volatile oil and liquid medicine are collected, the residues after the volatile oil is extracted are decocted in water and extracted once, the liquid medicine is combined and concentrated into thick paste to obtain extract, and the volatile oil is coated by 2-16 times of beta-cyclodextrin for later use. The rest medicinal materials in the composition are decocted and extracted by adding water for 1-3 times, the liquid medicine is concentrated into thick paste, and the thick paste, the volatile oil inclusion compound and a proper amount of auxiliary materials are mixed to prepare granules, capsules, pills, tablets and other preparations.

Preparation method III

All the medicinal materials of the composition are extracted by 30 to 80 percent ethanol in a refluxing way for 1 to 3 times, concentrated into thick paste and prepared into preparations such as granules, capsules, pills, tablets and the like.

Preparation method four

All the medicinal materials of the composition are extracted by 70-90% ethanol under reflux for 1-3 times, the dregs of a decoction are extracted by adding water for 1-3 times, and the decoction is concentrated into thick paste to be prepared into preparations such as granules, capsules, pills, tablets and the like.

Composition 2 preparation method

The traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus pneumonia comprises astragalus, codonopsis pilosula, perilla leaf, notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, honeysuckle, poria cocos, bighead atractylodes rhizome, dried orange peel, ginger, kudzuvine root, heartleaf houttuynia herb, sweet wormwood herb and radix bupleuri.

Preparation method 1

Decocting all the medicinal materials of the composition with water for 1-3 times, concentrating the extracting solution into thick paste, and preparing into pharmaceutically acceptable dosage forms;

or decocting all the raw materials in water for 1-3 times, concentrating the extract, adding ethanol for alcohol precipitation, filtering, concentrating the alcohol precipitation solution to obtain thick paste, and preparing into pharmaceutically acceptable dosage forms;

preparation method II

Extracting volatile oil from all or part of the raw materials of the composition by a distillation method (or an ultrasonic method or a cold soaking method), collecting the volatile oil and liquid medicine, decocting the residues after extracting the volatile oil with water for one time, mixing the liquid medicine and concentrating to obtain thick paste to obtain extract, and clathrating the volatile oil with 2-16 times of beta-cyclodextrin for later use. The rest medicinal materials in the composition are decocted and extracted by adding water for 1-3 times, the liquid medicine is concentrated into thick paste, and the thick paste, the volatile oil inclusion compound and a proper amount of auxiliary materials are mixed to prepare granules, capsules, pills, tablets and other preparations.

Preparation method III

All the medicinal materials of the composition are extracted by 30 to 80 percent ethanol in a reflux way for 1 to 3 times, and the mixture is concentrated into thick paste to be prepared into a pharmaceutically acceptable preparation formulation.

Preparation method four

All the medicinal materials of the composition are extracted by 70-90% ethanol under reflux for 1-3 times, the dregs of a decoction are decocted by adding water for 1-3 times, and the decoction is concentrated into thick paste to be prepared into a pharmaceutically acceptable preparation formulation

Preparation method five

The codonopsis pilosula, notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, largehead atractylodes rhizome, tangerine peel, ginger, kudzuvine root and Chinese thorowax root in the composition are extracted by 50-80 ethanol in a refluxing way for 1-3 times, the ethanol is recycled, and the mixture is concentrated into thick paste; decocting raw astragalus, perilla leaf, honeysuckle, poria, houttuynia cordata and sweet wormwood in water for 1-3 times, concentrating into thick paste, adding a proper amount of auxiliary materials into the thick paste and the ethanol extract, and preparing into a pharmaceutically acceptable dosage form.

Preparation method VI

1. Preparing raw astragalus components: extracting with water, precipitating with ethanol, collecting precipitate, separating the supernatant with macroporous adsorbent resin, eluting with alcohol solution, concentrating the eluate, concentrating the precipitate, and drying to obtain saponin and polysaccharide components.

2. Preparing a codonopsis pilosula component: soaking radix Codonopsis in 40-60% ethanol, adsorbing the soaking solution with macroporous resin, eluting, concentrating the eluate, and drying to obtain radix Codonopsis polysaccharide component; the dangshen is used as dangshen component by supercritical fluid extraction with entrainer.

3. Preparing perilla leaf components: extracting volatile oil from folium Perillae by steam distillation, cold soaking or ultrasonic extraction. Extracting volatile oil by a steam distillation method: taking a proper amount of perilla leaves, adding water for extraction, measuring and extracting volatile oil according to a volatile oil measuring method (general rule 2204) in Chinese pharmacopoeia of 2015 edition, keeping slight boiling for 2-5h, collecting the volatile oil, and including the volatile oil with 2-16 times of beta-cyclodextrin for later use. ② an ultrasonic extraction method: taking appropriate amount of folium Perillae, adding petroleum ether, ultrasonic extracting for 2-5 times, mixing extractive solutions, volatilizing petroleum ether under reduced pressure, and collecting volatile oil. And (3) coating the volatile oil with 2-16 times of beta-cyclodextrin for later use. Cold dipping method: soaking appropriate amount of folium Perillae in diethyl ether at room temperature for 1-5 times for 12-48 h/time, mixing extractive solutions, volatilizing diethyl ether under reduced pressure, and collecting volatile oil. And (3) coating the volatile oil with 2-16 times of beta-cyclodextrin for later use. The flavonoid component is extracted by microwave-assisted extraction method with microwave time of 30min, microwave power of 268W, liquid-material ratio of 15: 1ml/g, and ethanol volume fraction of 80% to obtain flavonoid component in folium Perillae.

4. Preparation of notopterygium component: extracting volatile oil by a steam distillation method (or an ultrasonic method or a cold soaking method), collecting the volatile oil, and performing inclusion on the volatile oil by 2-16 times of beta-cyclodextrin to obtain notopterygium root volatile oil components, or extracting notopterygium root by a supercritical extraction method, wherein the extract is included or not included to be used as the notopterygium root volatile oil components.

5. Preparing a divaricate saposhnikovia root component: extracting radix Saposhnikoviae with 50-80% ethanol for 1-3 times, and performing ultrasonic extraction for 30min each time to obtain cimicifugae glycoside and 5-O-methylvisammioside glycoside; extracting volatile oil by a steam distillation method (or an ultrasonic method or a cold soaking method), collecting the volatile oil, and performing inclusion on the volatile oil by 2-16 times of beta-cyclodextrin to obtain a radix sileris volatile oil component, or extracting radix sileris by a supercritical extraction method, wherein the extract is included or not included to be used as the radix sileris volatile oil component.

6. Preparing a wrinkled giant hyssop component: extracting volatile oil by a steam distillation method (or an ultrasonic method or a cold soaking method), collecting the volatile oil, and performing inclusion on the volatile oil by 2-16 times of beta-cyclodextrin to obtain a volatile oil component of the pogostemon cablin, or extracting the pogostemon cablin by a supercritical extraction method, wherein the extract is included or not included to be used as the volatile oil component of the pogostemon cablin.

7. Preparing a honeysuckle component: taking a proper amount of honeysuckle, extracting with water, concentrating an extracting solution, adjusting the pH value of a concentrated solution to 2-4, eluting with macroporous resin, collecting an eluent, concentrating under reduced pressure, and drying to obtain an organic acid component; soaking flos Lonicerae in 50% -80% ethanol for 8-16h, and ultrasonic extracting to obtain flavone extractive solution. Concentrating and drying the extract, mixing with appropriate amount of polyamide powder, extracting and decolorizing, eluting with macroporous resin, collecting eluate, concentrating under reduced pressure, and drying to obtain flos Lonicerae total flavonoids.

8. Preparing the poria cocos components: extracting Poria with water or pulverizing into powder; pulverizing Poria, soaking in water, adding complex enzyme, extracting, precipitating with ethanol, washing with anhydrous ethanol, acetone and diethyl ether respectively to obtain pachyman crude product, purifying with deproteinized macroporous resin, concentrating the eluate, dialyzing, concentrating the dialysate, and freeze drying to obtain pachyman component.

9. Preparing a bighead atractylodes rhizome component: extracting volatile oil by a steam distillation method (or an ultrasonic method or a cold soaking method), collecting the volatile oil, and performing inclusion on the volatile oil by beta-cyclodextrin of which the amount is 2-16 times that of the volatile oil to obtain the components of the bighead atractylodes rhizome volatile oil.

10. Preparing dried orange peel components: extracting pericarpium Citri Tangerinae with 5-10 times of 50-80% ethanol for 1-3 times, adjusting p H value to 2-5, and recrystallizing the crude extract with 95% ethanol to obtain pericarpium Citri Tangerinae hesperidin extract; extracting volatile oil by a steam distillation method (or an ultrasonic method or a cold soaking method), collecting the volatile oil, and performing inclusion on the volatile oil by 2-16 times of beta-cyclodextrin to obtain the dried orange peel volatile oil component.

11. Preparing a ginger component: extracting volatile oil by a steam distillation method (or an ultrasonic method or a cold soaking method), collecting the volatile oil, and performing inclusion on the volatile oil by 2-16 times of beta-cyclodextrin to obtain a ginger volatile oil component, or extracting ginger by a supercritical extraction method, wherein the extract is included or not included to be used as the ginger volatile oil component.

12. Preparation of a kudzu root component: extracting with 30-70% ethanol (ultrasonic assisted extraction method or microwave assisted extraction method) to obtain radix Puerariae total flavonoids. Extracting with supercritical CO2 at 50 deg.C under 35MPa and material-liquid ratio of 280:330(m: V) to obtain radix Puerariae total flavonoids. The puerarin is obtained by purifying with polyamide column chromatography adsorption method by combining D101 resin with acetic acid crystallization method.

13. Preparing the houttuynia cordata component: the flavonoids component in herba Houttuyniae is obtained by ethanol extraction, ultrasonic assisted ethanol extraction, supercritical CO2 fluid extraction, and enzyme assisted extraction. Extracting volatile oil of the houttuynia cordata by a steam distillation method (or an ultrasonic method or a cold immersion method), collecting the volatile oil, and performing inclusion on the volatile oil by beta-cyclodextrin of which the amount is 2-16 times that of the volatile oil to obtain volatile oil components.

14. Preparing a sweet wormwood component: extracting with petroleum ether, concentrating and purifying to obtain artemisinin components, adding water into dregs of a decoction, decocting for 1-3 times, concentrating to obtain a thin extract, adding ethanol until the ethanol concentration reaches 50-80%, standing, collecting supernatant, concentrating and drying supernatant to obtain the sweet wormwood component.

15. The preparation of the bupleurum component: extracting triterpenoid saponin components in the radix bupleuri with 70% methanol; extracting with 80% ethanol under reflux to obtain ethanol solution of bupleuri radix total saponin, and purifying with AB-8 macroporous resin method to obtain bupleuri radix total saponin. Extracting the volatile oil of the Chinese thorowax root by a steam distillation method (or an ultrasonic method or a cold soaking method), collecting the volatile oil, and performing inclusion on the volatile oil by using beta-cyclodextrin of which the amount is 2-16 times that of the volatile oil to obtain volatile oil components.

Adding adjuvants into all the components obtained in steps 1-15, and making into pharmaceutically acceptable dosage forms.

Preparation method seven

Taking all the raw materials of astragalus, codonopsis pilosula, perilla leaf, notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, honeysuckle flower, tuckahoe, bighead atractylodes rhizome, dried orange peel, ginger, kudzuvine root, heartleaf houttuynia herb, sweet wormwood herb and Chinese thorowax root, adding 3-10 times of water for reflux extraction for 1-3 times, combining water extracts, concentrating under reduced pressure until the specific gravity is 1.20-1.30 (60 ℃), adding auxiliary materials, and preparing into a pharmaceutically acceptable dosage form.

Preparation method eight

Taking all the raw materials of astragalus, codonopsis pilosula, perilla leaf, notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, honeysuckle flower, tuckahoe, bighead atractylodes rhizome, dried orange peel, ginger, kudzuvine root, heartleaf houttuynia herb, sweet wormwood herb and radix bupleuri;

wherein perilla leaf, notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, dried orange peel, ginger, heartleaf houttuynia herb and radix bupleuri are added with 5-10 times of water, the volatile oil A and the water solution B are extracted by steam distillation for 5-10 hours, the herb residue is added with raw astragalus root, fried bighead atractylodes rhizome and sweet wormwood herb and is added with 5-10 times of water for reflux extraction for 1-3 times, each time for 1-3 hours, the obtained water extract and the water solution B are combined, and the mixture is subjected to reduced pressure concentration until the specific gravity is 1.03-1.07 (60 ℃), and is used as a water extraction concentrated solution C;

taking codonopsis pilosula, honeysuckle, poria cocos and radix puerariae, adding 50% -95% ethanol in an amount which is 5-10 times that of the codonopsis pilosula, the honeysuckle, the poria cocos and the radix puerariae, performing reflux extraction, combining extracting solutions, performing reduced pressure concentration until the specific gravity is 1.03-1.07 (60 ℃), combining the extracting solutions with a water-extracted concentrated solution C, continuing to concentrate until the specific gravity is 1.20-1.30 (60 ℃), adding the volatile oil A, uniformly mixing, adding auxiliary materials, and preparing into a pharmaceutically acceptable preparation.

Composition 3 preparation method

Preparation method 1

Decocting the whole formula of medicinal materials in water for 1-3 times, extracting an extracting solution (or decocting the whole formula of medicinal materials in water for 1-3 times, concentrating the extracting solution, adding ethanol for precipitating, filtering, precipitating the solution with ethanol) concentrating to obtain a thick paste, and preparing the thick paste into preparations such as granules, capsules, pills, tablets and the like. (the charred triplet can be added into the powder)

Preparation method II

Extracting volatile oil from all or part of the notopterygium root, wrinkled gianthyssop herb, rhizoma atractylodis, bighead atractylodes rhizome, tsaoko amomum fruit, ginger and the like by a distillation method (or an ultrasonic method or a cold soaking method), collecting the volatile oil and liquid medicine, decocting the residues after extracting the volatile oil in water for one time, mixing the liquid medicine and concentrating to obtain thick paste to obtain extract, and coating the volatile oil by 2-16 times of beta-cyclodextrin for later use. Decocting the other medicinal materials in water for 1-3 times, concentrating the liquid medicine to thick paste, mixing with the extract, the volatile oil inclusion compound and a proper amount of auxiliary materials, and preparing into granules, capsules, pills, tablets and other preparations. (the charred triplet can be added into the powder)

Preparation method III

The whole formula of the medicine is extracted by 30 to 80 percent ethanol under reflux for 1 to 3 times, concentrated into thick paste and prepared into granules or capsules, pills, tablets and other preparations. (the charred triplet can be added into the powder)

Preparation method four

The medicinal materials of the whole formula are extracted by 70 to 90 percent ethanol under reflux for 1 to 3 times, the dregs of a decoction are decocted and extracted by adding water for 1 to 3 times, and the decoction is concentrated into thick paste and prepared into granules, capsules, pills, tablets and other preparations. (the charred triplet can be added into the powder)

Preparation method five

In the formula, ephedra, notopterygium root, wrinkled gianthyssop herb, rhizoma atractylodis, bighead atractylodes rhizome, tsaoko amomum fruit and ginger are subjected to reflux extraction for 1-3 times by using 50-80% ethanol, the ethanol is recovered, and the extract is concentrated into thick paste; decocting the other medicines with water for 1-3 times, concentrating to obtain a thick paste, adding an appropriate amount of auxiliary materials into the thick paste and the ethanol extract, and preparing into preparations such as granules, capsules, pills, tablets and the like. (the charred triplet can be added into the powder)

Preparation method VI

1. The preparation of alkaloid components in the honey ephedra comprises the following steps: taking a proper amount of honey ephedra, carrying out reflux extraction for 3 times by water, combining filtrates, concentrating under reduced pressure, adding NaOH into an extracting solution to adjust the extracting solution to be alkaline, filling macroporous resin (D151) into a column, loading a sample, washing the eluting solution by water until the color of the eluting solution is extremely light, eluting by using 20-95% ethanol, collecting the eluting solution, concentrating under reduced pressure, and drying to obtain the alkaloid component.

2. Raw gypsum: extracting Gypsum Fibrosum with water or pulverizing into powder and adding into medicine.

3. The preparation of the amygdalin component in the almond comprises the following steps: water extraction: taking appropriate amount of crushed semen Armeniacae amarum, extracting with 5-10 times of water for 1-3 times, each time for 0.5-3 hr, filtering the extractive solution, and mixing filtrates; the filtrate is concentrated to a certain specific gravity and is used as a sample solution. Loading macroporous resin (HPD722, HPD720, AB-8, NKA-9, D101, HPD100, HPD400, etc.) into column, loading, washing with deionized water to remove impurities, eluting with 10% -50% ethanol, collecting eluate, concentrating under reduced pressure, and drying to obtain amygdalin component. Alcohol extraction: crushing bitter apricot seeds, inactivating enzyme, extracting 1-3 times by using 70-95% ethanol, concentrating, and recrystallizing to obtain the amygdalin component.

4. Preparation of notopterygium component: extracting volatile oil by a steam distillation method (or an ultrasonic method or a cold soaking method), collecting the volatile oil, and performing inclusion on the volatile oil by 2-16 times of beta-cyclodextrin to obtain notopterygium root volatile oil components, or extracting notopterygium root by a supercritical extraction method, wherein the extract is included or not included to be used as the notopterygium root volatile oil components.

5. Preparing a pepperweed seed cardiotonic glycoside component: decocting the medicinal materials, extracting with water for 2-3 times, concentrating the extractive solution to brown, loading on NKA-9 resin column, eluting with 80% ethanol, collecting eluate, concentrating under reduced pressure, and drying to obtain cardiac glycoside component.

6. Preparing phenolic components in the cyrtomium rhizome: taking a proper amount of cyrtomium rhizome, 70-90% ethanol, extracting for 1.5-2h according to the material-liquid ratio of 1:10-25, concentrating the extracting solution under reduced pressure, and drying to obtain the cyrtomium rhizome extract.

7. Water extraction preparation of earthworm: extracting Lumbricus with 10 times of water. Soaking Lumbricus with water, homogenizing at 37 deg.C to obtain homogenate, centrifuging to obtain supernatant, concentrating, and drying.

8. Preparing volatile oil components in paniculate swallowwort root: extracting volatile oil by steam distillation (ultrasonic wave/microwave assisted) at a ratio of 1:10-15, soaking for 3 hr, and collecting volatile oil components by steam distillation.

9. Preparing a wrinkled giant hyssop component: extracting volatile oil by a steam distillation method (or an ultrasonic method or a cold soaking method), collecting the volatile oil, and performing inclusion on the volatile oil by 2-16 times of beta-cyclodextrin to obtain a volatile oil component of the pogostemon cablin, or extracting the pogostemon cablin by a supercritical extraction method, wherein the extract is included or not included to be used as the volatile oil component of the pogostemon cablin.

10. Preparing volatile oil components in eupatorium fortunei: extracting volatile oil by steam distillation (ultrasonic wave/microwave assisted), collecting volatile oil, and clathrating with beta-cyclodextrin to obtain volatile oil components. And (3) preparing a flavonoid component: pulverizing appropriate amount of herba Eupatorii, adding water, ultrasonic extracting, concentrating the extractive solution under reduced pressure, and drying.

11. Preparing the volatile oil component in the rhizoma atractylodis: extracting volatile oil by steam distillation (ultrasonic wave/microwave assisted), collecting volatile oil, and clathrating with beta-cyclodextrin at 40 deg.C at a ratio of 1:6 to obtain volatile oil components. Or extracting rhizoma Atractylodis by supercritical extraction, and optionally clathrating the extract to obtain volatile oil component of rhizoma Atractylodis. The atractylodin can be extracted by microwave ultrasonic treatment with 75% ethanol as extraction solvent.

12. Preparing the poria cocos components: extracting Poria with water or pulverizing into powder; pulverizing Poria, soaking in water, adding complex enzyme, extracting, precipitating with ethanol, washing with anhydrous ethanol, acetone and diethyl ether respectively to obtain pachyman crude product, purifying with deproteinized macroporous resin, concentrating the eluate, dialyzing, concentrating the dialysate, and freeze drying to obtain pachyman component.

13. Preparation of raw white atractylodes rhizome (white atractylodes rhizome): extracting volatile oil by a steam distillation method (or an ultrasonic method or a cold soaking method), collecting the volatile oil, and performing inclusion on the volatile oil by beta-cyclodextrin of which the amount is 2-16 times that of the volatile oil to obtain the components of the bighead atractylodes rhizome volatile oil.

14. Preparing phenolic components in the magnolia officinalis: pulverizing appropriate amount of cortex Magnolia officinalis, adding 65% ethanol, adjusting pH to 9-10, extracting, concentrating the extractive solution under reduced pressure, and drying. Or extracting coarse powder with methanol, eluting with silica gel column chromatography at the volume ratio of petroleum ether to ethyl acetate of 1:1, concentrating the eluate, and drying.

15. Preparing alkaloid components in the burnt areca nuts: extracting appropriate amount of semen Arecae with water for 2-3 times, concentrating the extractive solution under reduced pressure, and drying.

16. Preparing volatile oil components in simmered tsaoko amomum fruits (tsaoko amomum fruits): crushing fructus Tsaoko, with granularity of 40 meshes and water-material ratio of 8:1, soaking for 1.5h, distilling for 6h by using a steam distiller, and collecting volatile oil components of fructus Tsaoko.

17. Preparing a ginger component: extracting volatile oil by a steam distillation method (or an ultrasonic method or a cold soaking method), collecting the volatile oil, and performing inclusion on the volatile oil by 2-16 times of beta-cyclodextrin to obtain a ginger volatile oil component, or extracting ginger by a supercritical extraction method, wherein the extract is included or not included to be used as the ginger volatile oil component.

Unless otherwise indicated, "double amount" of solvent in the present invention means volume to weight ratio, for example, L/kg, ml/g.

The pharmaceutically acceptable dosage forms comprise granules or preparations such as capsules, pills, tablets and the like.

The resin used in the present invention may be selected from the group consisting of XDA-6, XDA-8, XL-68M, AB-8, HPD722, HPD720, NKA-9, D101, HPD100, HPD400, HPD600, HPD700, DA201, DM130, DM-201, DM-301, DM-401, D4020, S-8, D3520, H1020 and other pharmaceutically acceptable conventional resin types.

Therefore, the invention also relates to the application of the traditional Chinese medicine composition in preparing a medicine for preventing or treating the cold and/or influenza and/or novel coronavirus pneumonia and other symptoms. The invention also relates to a method for preventing or treating diseases such as cold and/or influenza and/or novel coronavirus pneumonia by using the traditional Chinese medicine composition, which comprises the step of administering a preventive or therapeutic effective amount of the traditional Chinese medicine composition to a patient in need.

Another aspect of the present invention relates to the use of the above-mentioned Chinese medicinal composition for the preparation of a medicament for anti-inflammatory and/or enhancing immunity, comprising administering a prophylactically or therapeutically effective amount of the above-mentioned Chinese medicinal composition to a patient in need thereof.

The invention has the beneficial effects that:

the composition has the advantages of anti-inflammatory effect, high efficiency, safety and no toxicity, fully exerts the multi-path and multi-target treatment effect of the traditional Chinese medicine compound, and can be used for preventing and treating cold, influenza and novel coronavirus pneumonia. In addition, the composition of the invention also has the function of enhancing immunity. The invention fully exerts the advantages of the traditional Chinese medicine, regulates the physique, enhances the adaptability of an immune system to the outside, improves the capability of human bodies to resist virus infection and reduces the susceptibility. The traditional Chinese medicine composition has the effects of tonifying qi and spleen, eliminating dampness and relieving exterior syndrome, and clearing heat and removing toxicity, can be used for preventing and treating neocoronary pneumonia, and can also be used for preventing and treating cold and influenza. Is especially suitable for treating fever, body weight, hypodynamia and serious dampness in the clinical treatment period of the new coronary pneumonia. In addition, it can regulate spleen and stomach.

The specific implementation mode is as follows:

the invention is further illustrated by the following examples, which are not to be construed as limiting the invention thereto.

Example 1

15kg of raw astragalus membranaceus, 6kg of notopterygium root, 9kg of kudzuvine root, 6kg of wrinkled gianthyssop herb, 15kg of heartleaf houttuynia herb, 6kg of sweet wormwood herb, 3kg of radix bupleuri, 15kg of poria, 9kg of fried bighead atractylodes rhizome, 6kg of dried orange peel and 9kg of ginger for later use;

decocting all the medicinal materials of the composition with water for 1-3 times, extracting an extracting solution (or decocting the medicinal materials of the whole formula with water for 1-3 times, concentrating the extracting solution, adding ethanol for precipitating, filtering, precipitating the solution with ethanol) concentrating to obtain a thick paste, and preparing the thick paste into preparations such as granules, capsules, pills, tablets and the like.

Example 2

15kg of raw astragalus membranaceus, 6kg of notopterygium root, 9kg of kudzuvine root, 6kg of wrinkled gianthyssop herb, 15kg of heartleaf houttuynia herb, 6kg of sweet wormwood herb, 3kg of radix bupleuri, 15kg of poria, 9kg of fried bighead atractylodes rhizome, 6kg of dried orange peel and 9kg of ginger for later use;

in the composition, all or part of notopterygium root, wrinkled gianthyssop herb, bighead atractylodes rhizome, dried orange peel, ginger, cordate houttuynia, radix bupleuri and other medicines are subjected to distillation (or ultrasonic method or cold soaking method) to extract volatile oil, the volatile oil and liquid medicine are collected, the residues after the volatile oil is extracted are decocted in water and extracted once, the liquid medicine is combined and concentrated into thick paste to obtain extract, and the volatile oil is coated by 2-16 times of beta-cyclodextrin for later use. Decocting the other medicinal materials in the composition with water for 1-3 times, concentrating the liquid medicine to thick paste, mixing with the extract, the volatile oil inclusion compound and a proper amount of auxiliary materials, and preparing into granules, capsules or pills

Example 3

15 g of raw astragalus root, 9 g of codonopsis pilosula, 9 g of perilla leaf, 6g of notopterygium root, 6g of divaricate saposhnikovia root, 6g of wrinkled gianthyssop herb, 9 g of honeysuckle flower, 15 g of tuckahoe, 9 g of fried largehead atractylodes rhizome, 6g of dried orange peel, 6g of ginger, 9 g of kudzuvine root, 15 g of heartleaf houttuynia herb, 6g of sweet wormwood herb and 3 g of Chinese thorowax root

In the composition, all or part of notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, largehead atractylodes rhizome, tangerine peel, ginger, perilla leaf, heartleaf houttuynia herb, Chinese thorowax root and other medicines are subjected to distillation (or ultrasonic method or cold soaking) to extract volatile oil, the volatile oil and liquid medicine are collected, the volatile oil is extracted, the dregs are decocted in water for extraction once, the liquid medicine is combined and concentrated into thick paste, and extract is obtained, wherein the volatile oil is coated by 2-16 times of beta-cyclodextrin for later use. The rest medicinal materials in the composition are decocted and extracted by adding water for 1-3 times, the liquid medicine is concentrated into thick paste, and the thick paste, the volatile oil inclusion compound and a proper amount of auxiliary materials are mixed to prepare granules, capsules, pills, tablets and other preparations.

Example 4

6kg of raw ephedra herb, 15kg of gypsum, 9kg of almond, 15kg of notopterygium root, 15kg of semen lepidii, 15kg of cyrtomium rhizome, 15kg of earthworm, 15kg of paniculate swallowwort root, 15kg of wrinkled gianthyssop herb, 9kg of fortune eupatorium herb, 15kg of rhizoma atractylodis, 45kg of poria, 30kg of raw bighead atractylodes rhizome, 9kg of charred triplet, 15kg of officinal magnolia bark, 9kg of charred areca seed, 9kg of stewed amomum fruit and 15kg of ginger.

Extracting volatile oil from all or part of the notopterygium root, wrinkled gianthyssop herb, rhizoma atractylodis, bighead atractylodes rhizome, tsaoko amomum fruit, ginger and the like by a distillation method (or an ultrasonic method or a cold soaking method), collecting the volatile oil and liquid medicine, decocting the residues after extracting the volatile oil in water for one time, mixing the liquid medicine and concentrating to obtain thick paste to obtain extract, and coating the volatile oil by 2-16 times of beta-cyclodextrin for later use. Decocting the other medicinal materials in water for 1-3 times, concentrating the liquid medicine to thick paste, mixing with the extract, the volatile oil inclusion compound and a proper amount of auxiliary materials, and preparing into granules, capsules, pills, tablets and other preparations. (the charred triplet can be added into the powder)

Example 5

15kg of raw astragalus root, 9kg of codonopsis pilosula, 9kg of perilla leaf, 6kg of notopterygium root, 6kg of divaricate saposhnikovia root, 6kg of wrinkled gianthyssop herb, 9kg of honeysuckle flower,

15kg of poria cocos, 9kg of fried bighead atractylodes rhizome, 6kg of dried orange peel, 6kg of ginger, 9kg of kudzu root, 15kg of houttuynia cordata, 6kg of sweet wormwood and 3kg of radix bupleuri

Adding 6 times of water into fifteen medicines, carrying out reflux extraction for 2 times, wherein each time lasts for 1 hour, combining water extracts, concentrating under reduced pressure until the specific gravity is 1.20-1.30 (60 ℃), and obtaining an extract

Example 6

15kg of raw astragalus root, 9kg of codonopsis pilosula, 9kg of perilla leaf, 6kg of notopterygium root, 6kg of divaricate saposhnikovia root, 6kg of wrinkled gianthyssop herb, 9kg of honeysuckle flower,

15kg of poria cocos, 9kg of fried bighead atractylodes rhizome, 6kg of dried orange peel, 6kg of ginger, 9kg of kudzu root, 15kg of houttuynia cordata, 6kg of sweet wormwood and 3kg of radix bupleuri

Adding 8 times of water into fifteen-component perilla leaves, notopterygium roots, divaricate saposhnikovia roots, wrinkled gianthyssop herbs, dried tangerine peels, ginger, heartleaf houttuynia herbs and radix bupleuri, extracting volatile oil for 6 hours by steam distillation, using the volatile oil A and water solution B for later use, adding 6 times of water into dregs of a decoction, adding raw astragalus roots, fried bighead atractylodes rhizome and sweet wormwood herbs, performing reflux extraction for 2 times, using 1 hour each time, combining the obtained water extract and the water solution B, concentrating under reduced pressure until the specific gravity is 1.03-1.07 (60 ℃), and using the mixture as a water extract concentrated solution C for later use; reflux-extracting radix Codonopsis, flos Lonicerae, Poria and radix Puerariae with 6 times of 75% ethanol for 2 times, each for 1 hr, mixing extractive solutions, concentrating under reduced pressure to specific gravity of 1.03-1.07 (60 deg.C), mixing with the concentrated water extractive solution C, concentrating to specific gravity of 1.20-1.30 (60 deg.C), adding volatile oil A, and mixing to obtain extract

Example 7

8kg of raw astragalus, 5kg of codonopsis pilosula, 5kg of perilla leaf, 2kg of notopterygium root, 2kg of divaricate saposhnikovia root, 2kg of wrinkled gianthyssop herb, 5kg of honeysuckle flower, 8kg of poria cocos, 5kg of fried bighead atractylodes rhizome, 2kg of dried orange peel, 2kg of ginger, 5kg of kudzuvine root, 8kg of heartleaf houttuynia herb, 2kg of sweet wormwood herb and 1kg of Chinese thorowax root

Extracting all the raw materials with 3 times of water under reflux for 3 times, each time for 1 hour, mixing the water extracts, concentrating under reduced pressure until the specific gravity is 1.20-1.30 (60 deg.C), adding adjuvants, drying, and making into pill.

Example 8

20kg of raw astragalus, 12kg of codonopsis pilosula, 12kg of perilla leaf, 9kg of notopterygium root, 9kg of divaricate saposhnikovia root, 9kg of wrinkled gianthyssop herb, 12kg of honeysuckle, 20kg of poria cocos, 12kg of fried bighead atractylodes rhizome, 8kg of dried orange peel, 8kg of ginger, 12kg of kudzuvine root, 20kg of heartleaf houttuynia herb, 9kg of sweet wormwood herb and 5kg of Chinese thorowax root

Extracting all the raw materials with 10 times of water under reflux for 1 time, each time for 2 hours, mixing the water extracts, concentrating under reduced pressure until the specific gravity is 1.20-1.30 (60 ℃), adding adjuvants, drying, and making into granule.

Example 10

8kg of raw astragalus, 12kg of codonopsis pilosula, 5kg of perilla leaf, 9kg of notopterygium root, 2kg of divaricate saposhnikovia root, 2kg of wrinkled gianthyssop herb, 12kg of honeysuckle, 20kg of poria cocos, 12kg of fried bighead atractylodes rhizome, 8kg of dried orange peel, 8kg of ginger, 12kg of kudzuvine root, 20kg of heartleaf houttuynia herb, 9kg of sweet wormwood herb and 5kg of Chinese thorowax root

Adding 5 times of water into perilla leaves, notopterygium roots, divaricate saposhnikovia roots, wrinkled gianthyssop herbs, dried orange peels, ginger, heartleaf houttuynia herbs and radix bupleuri, extracting volatile oil for 5 hours by steam distillation to obtain volatile oil A and water liquid B, adding 5 times of water into dregs of a decoction, performing reflux extraction on the dregs of the decoction and the raw astragalus roots, the fried bighead atractylodes rhizome and the sweet wormwood herbs, extracting for 3 times for 1 hour each time, combining the obtained water extract and the water liquid B, and concentrating under reduced pressure until the specific gravity is 1.03-1.07 (60 ℃) to obtain water extraction concentrated solution C;

reflux-extracting radix Codonopsis, flos Lonicerae, Poria and radix Puerariae with 50% ethanol for 3 times, each for 1 hr, mixing extractive solutions, concentrating under reduced pressure to specific gravity of 1.03-1.07 (60 deg.C), mixing with the concentrated water extract C, concentrating to specific gravity of 1.20-1.30 (60 deg.C), adding volatile oil A, mixing, adding adjuvants, and making into capsule.

Example 11

5kg of raw astragalus, 1kg of codonopsis pilosula, 1kg of perilla leaf, 1kg of notopterygium root, 1kg of divaricate saposhnikovia root, 1kg of wrinkled gianthyssop herb, 1kg of honeysuckle, 5kg of poria cocos, 1kg of fried bighead atractylodes rhizome, 1kg of dried orange peel, 1kg of ginger, 1kg of kudzuvine root, 5kg of heartleaf houttuynia herb, 1kg of sweet wormwood herb and 1kg of Chinese thorowax root;

wherein perilla leaf, notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, dried orange peel, ginger, heartleaf houttuynia herb and Chinese thorowax root are added with 8 times of water, the volatile oil is extracted for 10 hours by steam distillation to obtain volatile oil A and water solution B, the dregs of a decoction are added with raw astragalus root, fried bighead atractylodes rhizome and sweet wormwood herb and are added with 5 times of water for reflux extraction for 3 times, the obtained water extract and the water solution B are combined, the mixture is concentrated under reduced pressure until the specific gravity is 1.03-1.07 (60 ℃), and the concentrated water extract C is obtained;

taking radix codonopsitis, honeysuckle, tuckahoe and radix puerariae, adding 10 times of 50% ethanol for reflux extraction, combining extracting solutions, concentrating under reduced pressure until the specific gravity is 1.03-1.07 (60 ℃), combining the extracting solutions with the water-extracted concentrated solution C, continuing to concentrate until the specific gravity is 1.20-1.30 (60 ℃), adding the volatile oil A, mixing uniformly, adding auxiliary materials, and preparing into tablets.

Example 12

30kg of raw astragalus, 20kg of codonopsis pilosula, 20kg of perilla leaf, 15kg of notopterygium root, 15kg of divaricate saposhnikovia root, 15kg of wrinkled gianthyssop herb, 20kg of honeysuckle, 30kg of poria cocos, 20kg of fried bighead atractylodes rhizome, 15kg of dried orange peel, 15kg of ginger, 20kg of kudzuvine root, 30kg of heartleaf houttuynia herb, 15kg of sweet wormwood herb and 10kg of Chinese thorowax root;

adding 10 times of water into perilla leaves, notopterygium roots, divaricate saposhnikovia roots, wrinkled gianthyssop herbs, dried tangerine peels, ginger, houttuynia cordata and radix bupleuri, extracting volatile oil for 8 hours by steam distillation to obtain volatile oil A and water liquid B, adding 10 times of water into dregs of a decoction, performing reflux extraction for 1 time and 3 hours each time, combining the obtained water extract and the water liquid B, and performing reduced pressure concentration until the specific gravity is 1.03-1.07 (60 ℃), so as to obtain water extraction concentrated solution C;

taking codonopsis pilosula, honeysuckle, poria cocos and radix puerariae, adding 95% ethanol in an amount which is 5 times that of the codonopsis pilosula, the honeysuckle, the poria cocos and the radix puerariae, performing reflux extraction, combining extracting solutions, performing reduced pressure concentration until the specific gravity is 1.03-1.07 (60 ℃), combining the extracting solutions with a water-extracted concentrated solution C, continuing to concentrate until the specific gravity is 1.20-1.30 (60 ℃), adding the volatile oil A, uniformly mixing, adding auxiliary materials, and preparing into a pharmaceutically acceptable preparation.

The beneficial effects of the present invention are further illustrated by experimental data as follows:

in the following experiments, the experimental samples were derived from the extracts obtained according to examples 5 and 6

Firstly, toxicity test:

the purpose is as follows: after the extractum obtained in examples 5 and 6 is administrated to experimental mice by a gastric lavage way, the toxic reaction of the mice is observed to obtain the maximum tolerance amount and/or the minimum lethal amount, and a reference basis is provided for the research and development of the invention.

The method comprises the following steps: 50 SPF-grade ICR mice were randomly divided into 5 groups, namely a control group (equal volume of deionized water), an extract-L group (57.6g of extract/kg/day) in example 5, an extract-H group (72.0g of extract/kg/day) in example 5, an extract-L group (57.6g of extract/kg/day) in example 6, an extract-H group (72.0g of extract/kg/day) in example 6, and hermaphrodite groups. Experiment Each group of animals was administered the corresponding test substance by gavage at 40 mL/kg/time, 2 times at intervals of 4h within 24 h. The administration was observed for 1 hour after the day of administration, and thereafter, 1 time per day while weighing the body weight regularly, and gross anatomy examination was conducted on all animals 14 days after the observation was resumed.

As a result: the control mice were not abnormal. On the day of administration, mice in the extract-L group of example 5, the extract-H group of example 5, the extract-L group of example 6, and the extract-H group of example 6 began to exhibit decreased autonomic activity about 5 minutes after administration; in example 5, the individual mice in the extract-L group and the mice in the extract-H group in example 6 have loose stool 0.5 to 1 hour after administration. And (4) after 1-2 hours of administration, the mice of each administration group recover to be normal. The body weight of mice in each group is steadily increased compared with the control group within the observation period of 1-14 days after administration, and the mice are not statistically different from the control group (P > 0.05). Meanwhile, the mice in each group did not die in the test period, and the visceral organs and tissues of the mice are dissected in a large body and have no obvious abnormal change visible to naked eyes 14 days after the drug is applied.

And (4) conclusion: under the experimental conditions, the Maximum Tolerance (MTD) of the extract in example 5 and the extract in example 6 to single-time gastric lavage of mice is 72.0g of extract/kg/day, which is equivalent to 146.9 g of crude drug/kg/day and 145.4g of crude drug/kg/day respectively, and is 68 times of the clinical planned dosage.

Second, drug effect experiment

1. A xylene-induced mouse acute ear swelling model is adopted to evaluate the anti-inflammatory effect of the medicament

The purpose is that the research adopts a xylene-induced mouse acute ear swelling model to evaluate the anti-inflammatory effect of the invention.

The method comprises the following steps that after the adaptation period of 70 ICR mice is finished, the ICR mice are randomly divided into 7 groups according to body weight: normal group, model group, positive drug group, two dosage groups of high and low extract in example 5, and two dosage groups of high and low extract in example 6. The mice of each group were separately gazed with corresponding test substances, and the normal group and the model group were gazed with distilled water and administered continuously for 7 days. 30min after the 7 th intragastric administration, the front and back of the right ear of each mouse were evenly coated with 30ul of xylene as an inflammation-causing agent, and the left ear was not treated. And (3) after 30min of modeling, dislocating and killing the cervical vertebra of the mouse, shearing off double ears along the auricle base line of the mouse, punching off round ear pieces at the same positions of the left ear and the right ear by using a puncher with the diameter of 6mm, immediately accurately weighing the weight of the left ear and the right ear by using an analytical balance, and calculating the ear swelling inhibition rate.

Effect of swelling of mouse ear by Paraxylene (x. + -.s, n ═ 10)

Group of Body weight (g) Left ear weight (mg) Right ear weight (mg) Swelling Rate (%) Inhibition ratio (%)
Normal group 30.5±1.2 8.5±0.8 8.4±1.4 -0.2±14.9 ---
Model set 29.0±1.2 8.4±1.3 19.6±2.1 142.5±17.5## ---
Positive drug group (Aspirin) 29.4±1.9 8.6±1.1 18.6±2.1 120.5±43.5 15.4
EXAMPLE 5 extract (Low dose) 30.0±2.2 7.4±0.9 18.6±0.7 156.6±35.7 -9.9
EXAMPLE 5 extract (high dose) 29.1±1.9 7.6±0.8 16.3±4.7 114.0±56.1 20.0
EXAMPLE 6 extract (Low dose) 30.6±2.0 8.5±1.0 17.4±1.5 105.9±23.7** 25.7
EXAMPLE 6 extract (high dose) 29.3±1.8 7.8±0.6 15.4±2.4 96.9±30.4** 32.0

Note: in comparison with the normal group,#P<0.05,##P<0.01; comparison with model group<0.05,**P<0.01

The result shows that the average swelling rate of the model group is 142.5 percent, which indicates that the xylene-induced mouse ear swelling model is successful. Example 6 the high dose group (26.2g extract/kg) and the low dose group (13.1g extract/kg) of the extract can inhibit mouse ear swelling caused by xylene (P <0.05vs model group), and the swelling inhibition rates are 32.0% and 25.7% respectively.

The conclusion is that the extract in the example 6 can inhibit mouse ear swelling caused by dimethylbenzene, and has obvious anti-inflammatory effect.

2. The medicine of the invention has the function of regulating immunity by adopting a cyclophosphamide-induced mouse model with low immune function

The research adopts a cyclophosphamide-induced mouse model with low immune function to evaluate the function of the invention in regulating immunity.

The method comprises the following steps that after the adaptation period of 60 ICR mice is finished, the ICR mice are randomly divided into 6 groups according to body weight: normal group, model group, two dosage groups of high extract and low extract in example 5, and two dosage groups of high extract and low extract in example 6. The low dose of each administration group is clinical equivalent dose, and the high dose is 2 times of clinical equivalent dose. The mice of each group were separately gazed with the corresponding test substance, and the mice of the normal group were gazed with distilled water and administered for 14 days continuously. Starting from experiment 11d, except for the normal group, each mouse of the other groups was injected with 0.2ml of cyclophosphamide at 80mg/kg intraperitoneally and continuously molded for 3 d. The day before the end of the experiment, all mice were fasted without water deprivation. On the experiment day, after 30min after each group of mice is perfused with corresponding test substances, blood is collected from eyeballs, cervical vertebrae of the mice are killed, thymus and spleen of the mice are dissected and taken and weighed, and thymus index and spleen index are calculated. Mouse whole blood is centrifuged at 3500r/min for 10min to obtain serum, and the content of immunoglobulin G (IgG) and interferon gamma (INF-gamma) in the serum is measured.

Influence on thymus index, spleen index, serum IgG and IFN-gamma of mice with low immune function (x +/-s, n 10)

Group of Body weight (g) Index of thymus Spleen index IgG(mg/ml) IFN-γ(pg/ml)
Normal group 29.6±1.4 1.77±0.45 3.53±0.41 15.68±1.00 651.2±42.4
Model set 30.1±1.2 0.72±0.19## 2.05±0.29## 14.37±1.53# 634.2±51.0
EXAMPLE 5 extract (Low dose) 29.0±2.3 0.77±0.17 2.24±0.25 15.51±0.90 609.0±39.3
EXAMPLE 5 extract (high dose) 31.2±2.0 0.96±0.22* 2.17±0.30 15.30±1.4 633.8±55.3
EXAMPLE 6 extract (Low dose) 30.9±1.4 0.90±0.16* 2.06±0.26 15.82±1.24* 690.2±52.3*
EXAMPLE 6 extract (high dose) 30.3±1.5 0.81±0.20 2.13±0.36 15.05±0.86 639.3±44.3

Note: in comparison with the normal group,#P<0.05,##P<0.01; comparison with model group<0.05,**P<0.01

As a result, the thymus and spleen indices: the high-dose group (26.0g of extract/kg) of the extract in the example 5 and the low-dose group (13.1g of extract/kg) of the extract in the example 6 can increase the thymus index and the spleen index of the mice (P <0.05 or P <0.01vs model group). ② immunoglobulin G: example 6 the low dose group of extract (13.1g extract/kg) increased serum IgG levels in mice (P <0.05 or P <0.01vs model group). ③ interferon gamma: example 6 the low dose group of extract (13.1g extract/kg) all increased the mouse serum IFN-. gamma.content (P <0.05 or P <0.01vs model group).

And (4) conclusion:

example 6 the extract can increase thymus index and spleen index of mice, increase serum IgG and IFN-gamma content of mice, and has obvious effect of increasing immunity.

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