CN113521232B - A Chinese medicinal composition containing Atractylodis rhizoma - Google Patents
A Chinese medicinal composition containing Atractylodis rhizoma Download PDFInfo
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- CN113521232B CN113521232B CN202110412731.7A CN202110412731A CN113521232B CN 113521232 B CN113521232 B CN 113521232B CN 202110412731 A CN202110412731 A CN 202110412731A CN 113521232 B CN113521232 B CN 113521232B
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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Abstract
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 material medicines comprise poria cocos, bighead atractylodes rhizome, ginger and the like. The traditional Chinese medicine composition has the effects of tonifying middle-jiao and Qi, strengthening spleen and eliminating dampness, relieving exterior syndrome and clearing heat, cooling blood and detoxifying.
Description
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 traditional Chinese medicine perspective, cold, influenza and novel coronavirus infection (Corona Virus Disease 2019, covd-19), abbreviated as "novel coronavirus infection", are caused by invasion of exogenous evil into lung channel. The novel coronavirus infection belongs to cold-dampness epidemic disease and is caused by cold-dampness epidemic disease virus. The traditional Chinese medicine can regulate the immune function of the human body as a whole, achieve the purposes of strengthening body resistance and eliminating pathogenic factors, dispelling cold and eliminating dampness, avoiding dirt and eliminating turbid urine, protecting lung and strengthening spleen. The Huangdi's interior channel says "cold-cold drink hurts the lung", so the treatment of traditional Chinese medicine should be to regulate the spleen and stomach.
Therefore, a medicine which can treat cold, influenza and new crown infection and can well regulate spleen and stomach is needed.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus infection.
According to clinical needs and experimental study practices, the composition can be prepared into dosage forms such as tablets, granules, capsules, pills, syrups and the like.
The invention also aims at providing a method for preparing the traditional Chinese medicine composition or the preparation.
The invention also aims to provide the application of the traditional Chinese medicine composition in the production of a medicine for preventing or treating cold and/or influenza and/or novel coronavirus infection and other diseases.
In order to find an effective traditional Chinese medicine composition for preventing or treating cold and/or influenza virus and/or novel coronavirus infection, the inventor of the invention reasonably combines through long-term practice and performs antiviral experimental study, thereby proving that the traditional Chinese medicine composition has stronger antiviral effect.
A technical scheme
The inventor conducts extensive research and provides a traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus infection, which is characterized in that the raw material 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, mel radix astragali, parched radix astragali, radix astragali Preparata, sal 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 infection is prepared from the following raw materials in parts by weight: 5-30 parts of raw astragalus root, 1-15 parts of notopterygium root, 1-20 parts of kudzuvine root, 1-15 parts of wrinkled gianthyssop herb, 5-25 parts of heartleaf houttuynia herb, 1-15 parts of sweet wormwood herb, 1-10 parts of Chinese thorowax root, 5-30 parts of poria, 1-20 parts of stir-fried largehead atractylodes rhizome, 1-15 parts of dried orange peel and 1-20 parts of ginger for standby;
Preferably, 8-20 parts of raw astragalus root, 2-9 parts of notopterygium root, 5-12 parts of kudzuvine root, 2-9 parts of wrinkled gianthyssop herb, 12-18 parts of heartleaf houttuynia herb, 2-9 parts of sweet wormwood herb, 1-5 parts of Chinese thorowax root, 8-20 parts of poria, 5-12 parts of stir-fried largehead atractylodes rhizome, 2-9 parts of dried orange peel and 5-12 parts of ginger for standby;
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 cocos, 9 parts of stir-fried largehead atractylodes rhizome, 6 parts of dried orange peel and 9 parts of ginger for standby;
And (3) square solution: in the formula, astragalus root is mixed with stir-fried bighead atractylodes rhizome to tonify qi and strengthen superficies; poria has effects of eliminating dampness and invigorating spleen, and parched Atractylodis rhizoma has effects of invigorating qi and spleen, and eliminating dampness, and both can be used together; astragalus, poria cocos and fried bighead atractylodes rhizome are monarch drugs, and are used for tonifying qi, strengthening exterior, strengthening spleen and eliminating dampness; the dried orange peel has the functions of regulating qi and strengthening spleen, eliminating dampness and resolving phlegm, and the ginger warms and middle energizes and prevents vomiting, and the dried orange peel and the ginger are combined to warm the middle energizer and resolve phlegm, and the wrinkled giant hyssop is added to resolve dampness and prevent vomiting, so that the dried orange peel, the dried orange peel and the ginger are all ministerial drugs; the notopterygium root is used for relieving exterior syndrome and dispelling cold, the kudzuvine root is used as an adjuvant drug for combining with the bupleurum root for penetrating exterior syndrome, relieving muscle and fever, and the sweet wormwood is used for clearing heat and cooling blood; yu xing Cao has the actions of clearing heat and removing toxicity, so it mainly enters lung meridian to clear lung heat; is used as an adjuvant drug; the medicines are combined together to play roles of tonifying qi and strengthening spleen, resolving dampness and relieving exterior syndrome, and clearing heat and detoxicating.
A technical scheme
In order to achieve better curative effect, the traditional Chinese medicine composition 1 can be combined with codonopsis pilosula, perilla leaf, divaricate saposhnikovia root and honeysuckle to obtain the composition 2, namely the traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus infection, wherein the composition comprises astragalus membranaceus, codonopsis pilosula, perilla leaf, notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, honeysuckle, poria cocos, bighead atractylodes rhizome, dried orange peel, ginger, kudzuvine root, houttuynia cordata, sweet wormwood herb and bupleurum.
A traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus infection is prepared from the following raw materials in parts by weight: 5-30 parts of raw astragalus, 1-20 parts of dangshen, 1-20 parts of perilla leaf, 1-15 parts of notopterygium root, 1-15 parts of divaricate saposhnikovia root, 1-15 parts of wrinkled gianthyssop herb, 1-20 parts of honeysuckle, 5-30 parts of Indian buead, 1-20 parts of stir-fried largehead atractylodes rhizome, 1-15 parts of tangerine peel, 1-15 parts of ginger, 1-20 parts of kudzuvine root, 5-30 parts of heartleaf houttuynia herb, 1-15 parts of sweet wormwood herb and 1-10 parts of Chinese thorowax root;
8-20 parts of raw astragalus, 5-12 parts of dangshen, 5-12 parts of perilla leaf, 2-9 parts of notopterygium root, 2-9 parts of divaricate saposhnikovia root, 2-9 parts of wrinkled gianthyssop herb, 5-12 parts of honeysuckle, 8-20 parts of Indian buead, 5-12 parts of stir-fried largehead atractylodes rhizome, 2-8 parts of tangerine peel, 2-8 parts of ginger, 5-12 parts of kudzuvine root, 8-20 parts of heartleaf houttuynia herb, 2-9 parts of sweet wormwood herb and 1-5 parts of Chinese thorowax root;
Preferably, 15 parts of raw astragalus, 9 parts of codonopsis pilosula, 9 parts of perilla leaf, 6 parts of notopterygium root, 6 parts of divaricate saposhnikovia root, 6 parts of wrinkled gianthyssop herb, 9 parts of honeysuckle, 15 parts of poria cocos, 9 parts of stir-fried bighead atractylodes rhizome, 6 parts of dried orange peel, 6 parts of ginger, 9 parts of kudzuvine root, 15 parts of heartleaf houttuynia herb, 6 parts of sweet wormwood herb and 3 parts of Chinese thorowax root.
And (3) square solution: in the recipe, astragalus root and pilose asiabell root are used as monarch drugs for strengthening the middle warmer and replenishing qi; poria cocos excretes dampness and invigorates spleen, and rhizoma atractylodis macrocephalae is stir-fried to invigorate qi and invigorate spleen, and dry dampness and phlegm are combined to invigorate qi and invigorate spleen and dry dampness and serve as ministerial drugs; adding Perilla leaf for dispelling cold, relieving exterior syndrome, activating qi-flowing, resolving phlegm, herba Agastaches for resolving dampness, relieving vomiting, pericarpium Citri Tangerinae for regulating qi-flowing, invigorating spleen, eliminating dampness, resolving phlegm, rhizoma Zingiberis recens for relieving exterior syndrome, dispelling cold, warming middle-jiao, relieving vomiting, and combining the four medicines to relieve exterior syndrome, dispelling cold, warming middle-jiao, and resolving phlegm; 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; flos Lonicerae and herba Houttuyniae are added to relieve exterior syndrome, clear heat and remove toxic substances, and herba Houttuyniae enters lung meridian and has good effects of clearing lung heat; qing Hao has the actions of clearing and removing deficiency heat and cooling blood, and is combined with side effect. The medicines are combined to play the roles of tonifying middle-jiao and Qi, strengthening spleen and eliminating dampness, relieving exterior syndrome and clearing heat, cooling blood and detoxifying.
A technical scheme
The invention also provides a traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus infection, which is characterized in that the traditional Chinese medicine composition comprises ephedra, gypsum, almond, notopterygium root, pepperweed seed, cyrtomium rhizome, earthworm, paniculate swallowwort root, wrinkled gianthyssop herb, eupatorium, rhizoma atractylodis, poria cocos, bighead atractylodes rhizome, charred triplet, magnolia officinalis, charred areca nut, roasted tsaoko cardamom 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 is selected from herba Ephedrae, preferably herba Ephedrae.
A traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus infection is prepared from the following raw materials in parts by weight: 1-20 parts of raw ephedra, 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 fortunei, 5-30 parts of earthworm, 5-30 parts of paniculate swallowwort root, 5-30 parts of wrinkled gianthyssop herb, 1-20 parts of eupatorium, 5-30 parts of rhizoma atractylodis, 20-80 parts of poria cocos, 10-50 parts of raw bighead atractylodes rhizome, 1-20 parts of charred triplet, 5-30 parts of magnolia officinalis, 1-20 parts of charred areca seed, 1-20 parts of roasted fructus tsaoko and 5-30 parts of ginger;
2-9 parts of raw ephedra, 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 fortunei, 8-20 parts of earthworm, 8-20 parts of paniculate swallowwort root, 8-20 parts of wrinkled gianthyssop herb, 5-12 parts of eupatorium, 8-20 parts of rhizoma atractylodis, 30-60 parts of poria cocos, 20-40 parts of raw bighead atractylodes rhizome, 5-12 parts of charred triplet, 8-20 parts of magnolia officinalis, 5-12 parts of charred areca seed, 5-12 parts of roasted fructus tsaoko and 8-20 parts of ginger;
preferably, 6 parts of raw ephedra, 15 parts of gypsum, 9 parts of almond, 15 parts of notopterygium root, 15 parts of pepperweed seed, 15 parts of cyrtomium rhizome, 15 parts of earthworm, 15 parts of paniculate swallowwort root, 15 parts of wrinkled giant hyssop, 9 parts of eupatorium, 15 parts of rhizoma atractylodis, 45 parts of poria cocos, 30 parts of raw bighead atractylodes rhizome, 9 parts of charred triplet, 15 parts of magnolia officinalis, 9 parts of charred betelnut, 9 parts of roasted amomum tsao-ko and 15 parts of ginger.
Herba Ephedrae, gypsum Fibrosum, and semen Armeniacae amarum in the recipe can ventilate lung to relieve cough, and clear away lung heat; semen Lepidii is added to purge lung and promote diuresis, rhizoma cyrtomii Falcati to clear away heat and toxic materials, and Lumbricus to dredge collaterals and relieve asthma; notopterygii rhizoma and radix Cynanchi Paniculati for dispelling pathogenic wind and removing dampness, and herba Agastaches, herba Eupatorii and rhizoma Atractylodis for eliminating dampness; the magnolia bark, the charred betel nut and Jiang Caoguo are three main medicines for original drinking, break the warp and remove dirt and turbid materials; poria cocos and rhizoma atractylodis macrocephalae invigorate spleen and remove dampness, charred triplet and raw Jiang Xiao and stomach. The medicines are combined together, and the whole prescription has the effects of dispersing lung qi, eliminating pathogenic factors, removing toxic materials, dredging collaterals, removing dirt, eliminating turbid pathogen, strengthening spleen and removing dampness.
Dispersing lung qi, eliminating pathogenic factors, removing toxic substances, dredging collaterals, eliminating turbid pathogen, invigorating spleen, and removing dampness. Is suitable for suspected people with new crown infection, intimate contact people, light and common type.
The traditional Chinese medicine composition 3 disclosed by the invention can disperse lung, eliminate dampness, disperse toxin and can be used for treating clinical treatment period type of new crown infection, common type fever, heavy body weight, weakness and serious dampness.
The invention also relates to a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
Process for the preparation of composition 1
Preparation method one
Decocting all the medicinal materials in water for 1-3 times, concentrating the extractive solution (or decocting all the medicinal materials in water for 1-3 times, concentrating the extractive solution, precipitating with ethanol, filtering, precipitating with ethanol), concentrating to obtain soft extract, and making into granule, capsule, pill, tablet, etc.
Preparation method II
Extracting volatile oil from all or part of the herbs such as notopterygium root, wrinkled giant hyssop, white atractylodes rhizome, dried orange peel, ginger, cordate houttuynia, bupleurum and the like by distillation (or ultrasonic method and cold leaching method), collecting volatile oil and liquid medicine, decocting residues after extracting the volatile oil with water for one time, merging the liquid medicine, concentrating the liquid medicine into thick paste to obtain extract, and clathrating the volatile oil with beta-cyclodextrin of 2-16 times for later use. Decocting other materials in water for 1-3 times, concentrating the liquid medicine into soft extract, mixing with the above extract, volatile oil clathrate and adjuvant, and making into granule, capsule, pill, tablet, etc.
Preparation method III
Reflux extracting all the medicinal materials with 30-80% alcohol for 1-3 times, concentrating to obtain soft extract, and making into granule, capsule, pill, tablet, etc.
Preparation method IV
Reflux-extracting all the medicinal materials with 70-90% ethanol for 1-3 times, decocting the residue with water for 1-3 times, concentrating to obtain soft extract, and making into granule, capsule, pill, tablet, etc.
Process for preparing composition 2
The traditional Chinese medicine composition for preventing or treating cold and/or influenza and/or novel coronavirus infection comprises the following raw materials of astragalus, codonopsis pilosula, perilla leaf, notopterygium root, radix sileris, wrinkled gianthyssop, honeysuckle, poria cocos, bighead atractylodes rhizome, dried orange peel, ginger, kudzuvine root, cordate houttuynia, sweet wormwood herb and radix bupleuri.
Preparation method one
Decocting all the medicinal materials of the composition in water for 1-3 times, concentrating the extract to thick paste, and preparing pharmaceutically acceptable dosage forms;
Or decocting all the raw materials in water for 1-3 times, concentrating the extract, precipitating with ethanol, filtering, concentrating the ethanol precipitation solution to obtain soft extract, and making into pharmaceutically acceptable dosage form;
Preparation method II
Extracting volatile oil from all or part of the crude drugs of the composition by distillation (or ultrasonic method or cold soaking method), collecting volatile oil and medicinal liquid, extracting the residue after extracting the volatile oil by decocting with water for one time, merging the medicinal liquid, concentrating to obtain thick paste, and clathrating the volatile oil with 2-16 times of beta-cyclodextrin for later use. Decocting other materials in water for 1-3 times, concentrating the liquid medicine into soft extract, mixing with the above extract, volatile oil clathrate and adjuvant, and making into granule, capsule, pill, tablet, etc.
Preparation method III
Reflux extracting all the medicinal materials of the composition with 30-80% ethanol for 1-3 times, concentrating to thick paste, and preparing into pharmaceutically acceptable dosage forms.
Preparation method IV
Reflux-extracting all the medicinal materials with 70-90% ethanol for 1-3 times, decocting the residue with water for 1-3 times, concentrating to obtain soft extract, and making into pharmaceutically acceptable dosage form
Fifth preparation method
Reflux-extracting radix codonopsis pilosulae, notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, bighead atractylodes rhizome, dried orange peel, ginger, kudzuvine root and bupleurum root in the composition with 50-80 ethanol for 1-3 times, recovering ethanol, and concentrating into thick paste; decocting radix astragali, folium Perillae, flos Lonicerae, poria, herba Houttuyniae, herba Artemisiae Annuae and water for 1-3 times, concentrating to soft extract, mixing with above ethanol extract, adding adjuvant, and making into pharmaceutically acceptable dosage form.
Preparation method six
1. The raw astragalus component is prepared by the following steps: extracting with water, precipitating with ethanol, collecting precipitate, separating supernatant with macroporous adsorbent resin, eluting with ethanol solution, concentrating eluate, concentrating, and drying to obtain saponin and polysaccharide components.
2. The preparation of the codonopsis pilosula component: soaking radix Codonopsis in 40% -60% ethanol, adsorbing with macroporous resin, eluting, concentrating the eluate, and drying to obtain radix Codonopsis polysaccharide component; the radix Codonopsis is used for extracting radix Codonopsis acetylenic glycoside component from radix Codonopsis with supercritical fluid with entrainer as radix Codonopsis component.
3. Preparing a perilla leaf component: extracting volatile oil from appropriate amount of folium Perillae by steam distillation, cold soaking or ultrasonic extraction. ① Extracting volatile oil by steam distillation: extracting appropriate amount of folium Perillae with water, extracting volatile oil according to 2015 edition Chinese pharmacopoeia volatile oil assay (general rule 2204), keeping micro-boiling for 2-5 hr, collecting volatile oil, and clathrating volatile oil with 2-16 times of beta-cyclodextrin. ② Ultrasonic extraction: extracting folium Perillae with petroleum ether for 2-5 times under ultrasonic, mixing extractive solutions, volatilizing petroleum ether under reduced pressure, and collecting volatile oil. The volatile oil is clathrated by beta-cyclodextrin with the concentration of 2-16 times for standby. ③ cold dipping method: soaking folium Perillae in diethyl ether for 12-48 hr for 1-5 times at room temperature, mixing extractive solutions, volatilizing diethyl ether under reduced pressure, and collecting volatile oil. The volatile oil is clathrated by beta-cyclodextrin with the concentration of 2-16 times for standby. The flavonoid component is extracted by adopting a microwave auxiliary extraction method, the microwave time is 30min, the microwave power is 268W, the liquid-material ratio is 15:1 ml/g, and the volume fraction of ethanol is 80%, so that the flavonoid component in the perilla leaf is obtained.
4. Preparing a notopterygium root component: extracting volatile oil by steam distillation (or ultrasonic method or cold soaking method), collecting volatile oil, clathrating with 2-16 times of beta-cyclodextrin to obtain volatile oil component of Notopterygii rhizoma, or extracting Notopterygium incisum by supercritical extraction method, wherein the volatile oil component of Notopterygium incisum is the clathrate or not clathrate of the extract.
5. Preparation of a wind-proof component: extracting radix Saposhnikoviae with 50-80% ethanol for 1-3 times, and ultrasonic extracting for 30 min each time to obtain cimicifugae rhizoma glycoside and 5-O-methyl-Weisi amiloride effective components; extracting volatile oil by steam distillation (or ultrasonic method or cold soaking method), collecting volatile oil, clathrating with 2-16 times of beta-cyclodextrin to obtain radix Saposhnikoviae volatile oil component, or extracting radix Saposhnikoviae by supercritical extraction method, wherein the extract can be clathrated or not clathrated to obtain radix Saposhnikoviae volatile oil component.
6. The preparation of the agastache rugosus component: extracting volatile oil by steam distillation (or ultrasonic method or cold soaking method), collecting volatile oil, clathrating with 2-16 times of beta-cyclodextrin to obtain herba Agastaches volatile oil component, or extracting herba Agastaches by supercritical extraction method, wherein the extract clathrates or not clathrates as herba Agastaches volatile oil component.
7. Preparing honeysuckle components: extracting proper amount of honeysuckle with water, concentrating the extracting solution, regulating the pH value of the concentrated solution to 2-4, eluting with macroporous resin, collecting the eluent, concentrating under reduced pressure, and drying to obtain an organic acid component; soaking flos Lonicerae in 50% -80% ethanol for 8-16 hr, and ultrasonic extracting to obtain flavone extractive solution. Concentrating and drying the extract, mixing with 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 poria cocos component: extracting Poria with water or pulverizing to powder; pulverizing Poria, soaking in water, adding complex enzyme, leaching, precipitating with ethanol, washing with absolute ethanol, acetone, and diethyl ether respectively to obtain pachyman crude product, adsorbing and purifying with deproteinized macroporous resin, concentrating the eluate, dialyzing, concentrating the dialysate, and lyophilizing to obtain pachyman component.
9. The preparation of the bighead atractylodes rhizome component: extracting volatile oil by steam distillation (or ultrasonic method or cold soaking method), collecting volatile oil, and clathrating with 2-16 times of beta-cyclodextrin to obtain volatile oil component of Atractylodis rhizoma.
10. And (3) preparing a dried orange peel component: extracting pericarpium Citri Tangerinae with 50-80% ethanol 5-10 times of the amount of the extract for 1-3 times, adjusting p H to 2-5, and recrystallizing the crude extract with 95% ethanol to obtain pericarpium Citri Tangerinae hesperidin extract; extracting volatile oil by steam distillation (or ultrasonic method or cold soaking method), collecting volatile oil, and clathrating with 2-16 times of beta-cyclodextrin to obtain pericarpium Citri Tangerinae volatile oil component.
11. The ginger component is prepared by the following steps: extracting volatile oil by steam distillation (or ultrasonic method or cold soaking method), collecting volatile oil, clathrating with 2-16 times of beta-cyclodextrin to obtain volatile oil component of rhizoma Zingiberis recens, or extracting rhizoma Zingiberis recens by supercritical extraction method, wherein the volatile oil component of rhizoma Zingiberis recens is obtained by clathrating or not clathrating the extract.
12. The preparation of the kudzuvine root components: extracting with 30% -70% ethanol (ultrasonic assisted extraction method and microwave assisted extraction method) to obtain radix Puerariae total flavonoids. CO2 supercritical fluid extraction at 50deg.C under 35MPa with feed-liquid ratio of 280:330 (m: V) to obtain radix Puerariae total flavonoids. And purifying by adopting a method combining D101 resin and an acetic acid crystallization method and a polyamide column chromatography adsorption method to obtain puerarin.
13. The cordate houttuynia component preparation: the flavonoid component in herba Houttuyniae is obtained by ethanol extraction, ultrasonic assisted ethanol extraction, supercritical CO2 fluid extraction, and enzyme assisted extraction. Extracting cordate houttuynia volatile oil by steam distillation (or ultrasonic method or cold soaking method), collecting volatile oil, and clathrating with 2-16 times of beta-cyclodextrin to obtain volatile oil component.
14. Preparing sweet wormwood components: extracting with petroleum ether, concentrating and purifying to obtain arteannuin component, decocting the residue with water for 1-3 times, concentrating to obtain dilute extract, adding ethanol to ethanol concentration of 50-80%, standing, collecting supernatant, concentrating and drying supernatant to obtain arteannuin component.
15. The bupleurum components are prepared: extracting triterpenoid saponins from bupleurum with 70% methanol; reflux extracting with 80% ethanol to obtain ethanol solution of total saponins of radix bupleuri, and purifying with AB-8 macroporous resin method to obtain total saponins of radix bupleuri. Extracting bupleurum volatile oil by steam distillation (or ultrasonic method or cold soaking method), collecting volatile oil, clathrating with 2-16 times beta-cyclodextrin to obtain volatile oil component.
Adding auxiliary materials into all the components obtained in the steps 1-15, and preparing a pharmaceutically acceptable dosage form.
Preparation method seven
Taking all raw materials of astragalus, codonopsis pilosula, perilla leaf, notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, honeysuckle flower, indian buead, largehead atractylodes rhizome, tangerine 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 to a specific gravity of 1.20-1.30 (60 ℃), adding auxiliary materials, and preparing a pharmaceutically acceptable dosage form.
Eight preparation methods
Taking all the raw materials of astragalus, codonopsis pilosula, perilla leaf, notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, honeysuckle flower, indian buead, largehead atractylodes rhizome, tangerine peel, ginger, kudzuvine root, heartleaf houttuynia herb, sweet wormwood herb and Chinese thorowax root;
wherein, adding 5-10 times of water into perilla leaf, notopterygium root, divaricate saposhnikovia root, agastache rugosus, dried orange peel, ginger, cordate houttuynia and bupleurum, extracting volatile oil by steam distillation for 5-10 hours to obtain volatile oil A and water solution B, adding 5-10 times of water into dregs, adding raw astragalus root, stir-fried largehead atractylodes rhizome and sweet wormwood herb, extracting for 1-3 times by reflux, each time for 1-3 hours, combining the obtained water extract and water solution B, concentrating under reduced pressure until the specific gravity is 1.03-1.07 (60 ℃), and taking the mixture as water extract concentrate C;
Reflux extracting radix Codonopsis, flos Lonicerae, poria, and radix Puerariae with 5-10 times of 50% -95% ethanol, mixing the extractive solutions, concentrating under reduced pressure to specific gravity of 1.03-1.07 (60deg.C), mixing with water concentrate C, concentrating to specific gravity of 1.20-1.30 (60deg.C), adding volatile oil A, mixing, adding adjuvants, and making into pharmaceutically acceptable dosage forms.
Process for preparing composition 3
Preparation method one
Decocting the whole medicinal materials in water for 1-3 times, concentrating the extractive solution (or decocting the whole medicinal materials in water for 1-3 times, concentrating the extractive solution, precipitating with ethanol, filtering, precipitating with ethanol), concentrating to obtain soft extract, and making into granule, capsule, pill, tablet, etc. (adding the Coke Sanxian beaten powder)
Preparation method II
Extracting volatile oil from all or part of the herbs including notopterygium root, agastache rugosus, rhizoma atractylodis, bighead atractylodes rhizome, tsaoko cardamom, ginger and the like by distillation (or ultrasonic method and cold soaking method), collecting volatile oil and liquid medicine, extracting the residues after extracting the volatile oil by adding water, decocting the liquid medicine once, merging the liquid medicine, concentrating the liquid medicine into thick paste to obtain extract, and clathrating the volatile oil by beta-cyclodextrin of 2-16 times for standby. Decocting the other materials in water for 1-3 times, concentrating the liquid medicine into soft extract, mixing with the above extract, volatile oil clathrate and adjuvant, and making into granule, capsule, pill, tablet, etc. (adding the Coke Sanxian beaten powder)
Preparation method III
Reflux extracting the whole medicinal materials with 30-80% ethanol for 1-3 times, concentrating to obtain soft extract, and making into granule, capsule, pill, tablet, etc. (adding the Coke Sanxian beaten powder)
Preparation method IV
Reflux-extracting the whole medicinal materials with 70-90% ethanol for 1-3 times, decocting the residues with water for 1-3 times, concentrating to obtain soft extract, and making into granule, capsule, pill, tablet, etc. (adding the Coke Sanxian beaten powder)
Fifth preparation method
In the formula, ephedra, notopterygium root, wrinkled gianthyssop herb, rhizoma atractylodis, bighead atractylodes rhizome, tsaoko cardamom and ginger are extracted with 50-80 ethanol under reflux for 1-3 times, ethanol is recovered, and concentrated into thick paste; decocting the other materials with water for 1-3 times, concentrating to obtain soft extract, mixing with above ethanol extract, adding adjuvant, and making into granule, capsule, pill, tablet, etc. (adding the Coke Sanxian beaten powder)
Preparation method six
1. Alkaloid components in the ephedra herb are prepared: reflux extracting herba Ephedrae with water for 3 times, mixing filtrates, concentrating under reduced pressure, adding NaOH to the extractive solution to alkaline, loading into macroporous resin (D151), loading into column, washing with water until the color of the eluate is very light, eluting with 20% -95% ethanol, collecting eluate, concentrating under reduced pressure, and drying to obtain alkaloid component.
2. Gypsum: extracting Gypsum Fibrosum with water or pulverizing to powder.
3. The amygdalin component in the almond is prepared by the following steps: ① water extraction method: taking a proper amount of crushed bitter almonds, extracting with 5-10 times of water for 1-3 times, each time for 0.5-3 hours, filtering the extracting solution, and combining the filtrates; concentrating the filtrate to a certain specific gravity to obtain the sample liquid. Loading macroporous resin (HPD 722, 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. ② alcohol extraction method: crushing bitter almond, inactivating enzyme, extracting with 70-95% alcohol for 1-3 times, concentrating, recrystallizing to obtain amygdalin component.
4. Preparing a notopterygium root component: extracting volatile oil by steam distillation (or ultrasonic method or cold soaking method), collecting volatile oil, clathrating with 2-16 times of beta-cyclodextrin to obtain volatile oil component of Notopterygii rhizoma, or extracting Notopterygium incisum by supercritical extraction method, wherein the volatile oil component of Notopterygium incisum is the clathrate or not clathrate of the extract.
5. Preparing a cardiac glycoside component in semen lepidii: decocting the medicinal materials in bag, extracting with water for 2-3 times, concentrating the extractive solution to brown, loading on NKA-9 resin column, loading on sample, eluting with 80% ethanol, collecting eluate, concentrating under reduced pressure, and drying to obtain cardiac glycoside component.
6. Preparing phenolic components in cyrtomium fortunei: extracting rhizoma Osmundae with 70-90% ethanol at a feed-liquid ratio of 1:10-25 for 1.5-2 hr, concentrating under reduced pressure, and drying.
7. Extracting Lumbricus with water: extracting Lumbricus with 10 times of water. Soaking Lumbricus in water, homogenizing at 37deg.C until homogenization is complete, centrifuging to obtain supernatant, concentrating, and drying.
8. Preparing volatile oil in paniculate swallowwort root: extracting volatile oil by steam distillation (ultrasonic/microwave assisted) with a feed-liquid ratio of 1:10-15, soaking for 3 hr, and collecting volatile oil component by steam distillation.
9. The preparation of the agastache rugosus component: extracting volatile oil by steam distillation (or ultrasonic method or cold soaking method), collecting volatile oil, clathrating with 2-16 times of beta-cyclodextrin to obtain herba Agastaches volatile oil component, or extracting herba Agastaches by supercritical extraction method, wherein the extract clathrates or not clathrates as herba Agastaches volatile oil component.
10. Preparing volatile oil components in eupatorium: extracting volatile oil by steam distillation (ultrasonic/microwave assisted), collecting volatile oil, and clathrating with beta-cyclodextrin to obtain volatile oil component. The flavonoid component is prepared: pulverizing herba Eupatorii, adding water, ultrasonic extracting, concentrating under reduced pressure, and drying.
11. The volatile oil component in rhizoma atractylodis is prepared by: extracting volatile oil by steam distillation (ultrasonic/microwave assisted), collecting volatile oil, and clathrating with beta-cyclodextrin at 40 deg.C at a ratio of 1:6 to obtain volatile oil component. Or extracting rhizoma Atractylodis by supercritical extraction, and clathrating or not clathrating the extract to obtain volatile oil component of rhizoma Atractylodis. The atractylin can be extracted by adopting 75% ethanol as an extraction solvent through microwave ultrasonic treatment.
12. Preparing poria cocos component: extracting Poria with water or pulverizing to powder; pulverizing Poria, soaking in water, adding complex enzyme, leaching, precipitating with ethanol, washing with absolute ethanol, acetone, and diethyl ether respectively to obtain pachyman crude product, adsorbing and purifying with deproteinized macroporous resin, concentrating the eluate, dialyzing, concentrating the dialysate, and lyophilizing to obtain pachyman component.
13. Raw white atractylodes rhizome (white atractylodes rhizome) components are prepared: extracting volatile oil by steam distillation (or ultrasonic method or cold soaking method), collecting volatile oil, and clathrating with 2-16 times of beta-cyclodextrin to obtain volatile oil component of Atractylodis rhizoma.
14. The phenolic components in magnolia officinalis are prepared by the following steps: pulverizing cortex Magnolia officinalis, adding 65% ethanol, adjusting pH to 9-10, extracting, concentrating under reduced pressure, and drying. Or extracting coarse powder with methanol, eluting with silica gel column chromatography with petroleum ether and ethyl acetate at a volume ratio of 1:1, concentrating the eluate, and drying.
15. The alkaloid component in the scorched betel nut is prepared by the following steps: extracting appropriate amount of semen Arecae with water for 2-3 times, concentrating the extractive solution under reduced pressure, and drying.
16. The volatile oil component of the roasted fructus tsaoko (fructus tsaoko) is prepared by: pulverizing fructus Tsaoko, sieving with 40 mesh sieve, soaking with water-material ratio of 8:1 for 1.5 hr, distilling with steam distillation for 6 hr, and collecting volatile oil components.
17. The ginger component is prepared by the following steps: extracting volatile oil by steam distillation (or ultrasonic method or cold soaking method), collecting volatile oil, clathrating with 2-16 times of beta-cyclodextrin to obtain volatile oil component of rhizoma Zingiberis recens, or extracting rhizoma Zingiberis recens by supercritical extraction method, wherein the volatile oil component of rhizoma Zingiberis recens is obtained by clathrating or not clathrating the extract.
The term "double" of the solvent in the present invention refers to the volume to weight ratio, e.g., L/kg, ml/g, unless otherwise indicated.
The pharmaceutically acceptable dosage forms of the invention comprise granules or capsules, pills, tablets and other preparations.
The resin used in the present invention may be selected from the pharmaceutically acceptable common resin types such as 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.
Therefore, another aspect of the invention relates to the use of the above-mentioned Chinese medicinal composition for preparing a medicament for preventing or treating the above-mentioned cold and/or influenza and/or novel coronavirus infection and other diseases. The invention also relates to a method for preventing or treating cold and/or influenza and/or novel coronavirus infection and other diseases by using the traditional Chinese medicine composition, which comprises the step of applying the traditional Chinese medicine composition with the effective preventing or treating amount to patients in need.
In another aspect the present invention relates to the use of the above-mentioned Chinese medicinal composition for the preparation of an anti-inflammatory and/or immune enhancing medicament comprising administering to a patient in need thereof a prophylactically or therapeutically effective amount of the above-mentioned Chinese medicinal composition.
The invention has the beneficial effects that:
The composition has the advantages of anti-inflammatory, high efficiency, safety and innocuity, fully plays the multi-path and multi-target treatment role of the traditional Chinese medicine compound, and can be used for preventing and treating cold, influenza and novel coronavirus infection. In addition, the composition of the invention has the function of enhancing immunity. The invention fully plays the advantages of strengthening body resistance of the traditional Chinese medicine, adjusts physique, enhances the adaptability of the immune system to the outside, improves the capability of resisting virus infection of human body and reduces susceptibility. The traditional Chinese medicine composition has the effects of tonifying qi and strengthening spleen, resolving dampness and relieving exterior syndrome, and clearing heat and detoxicating, and can be used for preventing and treating new crown infection and also can be used for preventing and treating cold and influenza. Is especially suitable for treating the clinical treatment stage type, common type fever, heavy body weight, debilitation and serious damp evils of the new crown infection. In addition, it can also regulate spleen and stomach.
Detailed Description
The invention is further illustrated by the following examples, which are not intended to be limiting.
Example 1
15Kg of raw astragalus root, 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 Chinese thorowax root, 15kg of poria cocos, 9kg of stir-fried largehead atractylodes rhizome, 6kg of dried orange peel and 9kg of ginger for standby;
Decocting all the medicinal materials in water for 1-3 times, concentrating the extractive solution (or decocting all the medicinal materials in water for 1-3 times, concentrating the extractive solution, precipitating with ethanol, filtering, precipitating with ethanol), concentrating to obtain soft extract, and making into granule, capsule, pill, tablet, etc.
Example 2
15Kg of raw astragalus root, 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 Chinese thorowax root, 15kg of poria cocos, 9kg of stir-fried largehead atractylodes rhizome, 6kg of dried orange peel and 9kg of ginger for standby;
Extracting volatile oil from all or part of the herbs such as notopterygium root, wrinkled giant hyssop, white atractylodes rhizome, dried orange peel, ginger, cordate houttuynia, bupleurum and the like by distillation (or ultrasonic method and cold leaching method), collecting volatile oil and liquid medicine, decocting residues after extracting the volatile oil with water for one time, merging the liquid medicine, concentrating the liquid medicine into thick paste to obtain extract, and clathrating the volatile oil with beta-cyclodextrin of 2-16 times for later use. Decocting the other materials in water for 1-3 times, concentrating the liquid medicine to obtain soft extract, mixing with the above extract, volatile oil clathrate and adjuvant, and making into granule, capsule, or pill
Example 3
15 G of raw astragalus, 9 g of codonopsis pilosula, 9 g of perilla leaf, 6 g of notopterygium root, 6 g of divaricate saposhnikovia root, 6 g of wrinkled gianthyssop herb, 9 g of honeysuckle, 15 g of poria cocos, 9 g of stir-fried bighead atractylodes rhizome, 6 g of dried orange peel, 6 g of ginger, 9 g of kudzuvine root, 15 g of heartleaf houttuynia herb, 6 g of sweet wormwood herb and 3 g of Chinese thorowax root
Extracting volatile oil from all or part of the medicinal herbs such as notopterygium root, ledebouriella root, agastache rugosus, white atractylodes rhizome, dried orange peel, ginger, perilla leaf, houttuynia cordata, bupleurum and the like by distillation (or ultrasonic method or cold soaking method), collecting volatile oil and medicinal liquid, extracting the residue after extracting the volatile oil by adding water, decocting the medicinal liquid once, merging the medicinal liquid, concentrating into thick paste to obtain extract, and clathrating the volatile oil with beta-cyclodextrin of 2-16 times for later use. Decocting other materials in water for 1-3 times, concentrating the liquid medicine into soft extract, mixing with the above extract, volatile oil clathrate and adjuvant, and making into granule, capsule, pill, tablet, etc.
Example 4
6Kg of raw ephedra, 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 giant hyssop, 9kg of eupatorium, 15kg of rhizoma atractylodis, 45kg of poria, 30kg of raw bighead atractylodes rhizome, 9kg of charred triplet, 15kg of magnolia officinalis, 9kg of charred areca nut, 9kg of roasted tsaoko cardamom and 15kg of ginger.
Extracting volatile oil from all or part of the herbs including notopterygium root, agastache rugosus, rhizoma atractylodis, bighead atractylodes rhizome, tsaoko cardamom, ginger and the like by distillation (or ultrasonic method and cold soaking method), collecting volatile oil and liquid medicine, extracting the residues after extracting the volatile oil by adding water, decocting the liquid medicine once, merging the liquid medicine, concentrating the liquid medicine into thick paste to obtain extract, and clathrating the volatile oil by beta-cyclodextrin of 2-16 times for standby. Decocting the other materials in water for 1-3 times, concentrating the liquid medicine into soft extract, mixing with the above extract, volatile oil clathrate and adjuvant, and making into granule, capsule, pill, tablet, etc. (adding the Coke Sanxian beaten powder)
Example 5
15Kg of raw astragalus, 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 kudzuvine root, 15kg of cordate houttuynia, 6kg of sweet wormwood herb and 3kg of radix bupleuri
Reflux extracting the fifteen materials with 6 times of water for 2 times (1 hr each time), mixing the water extractive solutions, concentrating under reduced pressure to specific gravity of 1.20-1.30 (60deg.C) to obtain extract
Example 6
15Kg of raw astragalus, 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 kudzuvine root, 15kg of cordate houttuynia, 6kg of sweet wormwood herb and 3kg of radix bupleuri
Extracting volatile oil from fifteen materials including folium Perillae, notopterygii rhizoma, radix Saposhnikoviae, herba Agastaches, pericarpium Citri Tangerinae, rhizoma Zingiberis recens, herba Houttuyniae and bupleuri radix by steam distillation for 6 hr, collecting volatile oil A and water solution B, reflux extracting residues with radix astragali, parched Atractylodis rhizoma and herba Artemisiae Annuae with 6 times of water for 2 times, each time for 1 hr, mixing the obtained water extractive solution and water solution B, concentrating under reduced pressure to specific gravity of 1.03-1.07 (60deg.C), and collecting water extractive concentrated solution C; reflux-extracting radix Codonopsis, flos Lonicerae, poria and radix Puerariae with 6 times of 75% ethanol for 2 times (each for 1 hr), mixing the extractive solutions, concentrating under reduced pressure to specific gravity of 1.03-1.07 (60deg.C), mixing with water extract concentrate C, concentrating to specific gravity of 1.20-1.30 (60deg.C), adding volatile oil A, and mixing to obtain extract
Example 7
Raw astragalus 8, pilose asiabell root 5, perilla leaf 5, notopterygium root 2, ledebouriella root 2, wrinkled gianthyssop herb 2, honeysuckle flower 5, poria cocos 8, stir-fried white atractylodes rhizome 5, dried orange peel 2, ginger 2, kudzuvine root 5, cordate houttuynia 8, sweet wormwood 2 and bupleurum 1kg
Reflux extracting all above materials with 3 times of water for 3 times (each for 1 hr), mixing the water extracts, concentrating under reduced pressure to specific gravity of 1.20-1.30 (60deg.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 stir-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 radix bupleuri
Reflux extracting all above materials with 10 times of water for 1 time and 2 hr each time, mixing the water extractive solutions, concentrating under reduced pressure to specific gravity of 1.20-1.30 (60deg.C), adding adjuvants, drying, and making into granule.
Example 10
Raw astragalus root 8, pilose asiabell root 12, perilla leaf 5, notopterygium root 9, ledebouriella root 2, wrinkled gianthyssop herb 2, honeysuckle flower 12, poria cocos 20, white atractylodes rhizome 12, dried orange peel 8, ginger 8, kudzuvine root 12, cordate houttuynia 20, sweet wormwood 9 and bupleurum root 5kg
In the raw material medicines, perilla leaf, notopterygium root, divaricate saposhnikovia root, wrinkled gianthyssop herb, dried orange peel, ginger, cordate houttuynia and bupleurum are added with 5 times of water, volatile oil is extracted by steam distillation for 5 hours, so as to obtain volatile oil A and water liquid B, dregs are added with raw astragalus root, stir-fried largehead atractylodes rhizome and sweet wormwood herb, 5 times of water are added for reflux extraction for 3 times, each time for 1 hour, the obtained water extract and water liquid B are combined, and the mixture is decompressed and concentrated to have the specific gravity of 1.03-1.07 (60 ℃) and is taken as water extract concentrated solution C;
reflux extracting radix Codonopsis, flos Lonicerae, poria, and radix Puerariae with 50% ethanol for 3 times each for 1 hr, mixing the extractive solutions, concentrating under reduced pressure to specific gravity of 1.03-1.07 (60deg.C), mixing with water concentrate C, concentrating to specific gravity of 1.20-1.30 (60deg.C), adding volatile oil A, mixing, adding adjuvants, and making into capsule.
Example 11
Raw astragalus 5kg, codonopsis pilosula 1kg, perilla leaf 1kg, notopterygium root 1kg, ledebouriella root 1kg, agastache rugosus 1kg, honeysuckle 1kg, poria cocos 5kg, stir-fried bighead atractylodes rhizome 1kg, dried orange peel 1kg, ginger 1kg, kudzuvine root 1kg, cordate houttuynia 5kg, sweet wormwood 1kg and bupleurum 1kg;
Extracting volatile oil from folium Perillae, notopterygii rhizoma, radix Saposhnikoviae, herba Agastaches, pericarpium Citri Tangerinae, rhizoma Zingiberis recens, herba Houttuyniae and bupleuri radix by steam distillation for 10 hr to obtain volatile oil A and water solution B, reflux extracting the residue with radix astragali, parched Atractylodis rhizoma and herba Artemisiae Annuae with 5 times of water for 3 times each for 1 hr, mixing the obtained water extractive solution and water solution B, concentrating under reduced pressure to specific gravity of 1.03-1.07 (60deg.C) to obtain water extractive concentrated solution C;
Reflux extracting radix Codonopsis, flos Lonicerae, poria, and radix Puerariae with 10 times of 50% ethanol, mixing the extractive solutions, concentrating under reduced pressure to specific gravity of 1.03-1.07 (60deg.C), mixing with water concentrate C, concentrating to specific gravity of 1.20-1.30 (60deg.C), adding volatile oil A, mixing, adding adjuvants, and making into tablet.
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 stir-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 radix bupleuri;
Extracting volatile oil from folium Perillae, notopterygii rhizoma, radix Saposhnikoviae, herba Agastaches, pericarpium Citri Tangerinae, rhizoma Zingiberis recens, herba Houttuyniae and bupleuri radix with 10 times of water by steam distillation for 8 hr to obtain volatile oil A and water solution B, reflux extracting the residue with 10 times of water for 1 time and 3 hr each time, mixing the obtained water extractive solution and water solution B, concentrating under reduced pressure to specific gravity of 1.03-1.07 (60deg.C) to obtain water extractive concentrated solution C;
Reflux extracting radix Codonopsis, flos Lonicerae, poria, and radix Puerariae with 5 times of 95% ethanol, mixing the extractive solutions, concentrating under reduced pressure to specific gravity of 1.03-1.07 (60deg.C), mixing with water concentrate C, concentrating to specific gravity of 1.20-1.30 (60deg.C), adding volatile oil A, mixing, adding adjuvants, and making into pharmaceutically acceptable dosage forms.
The beneficial effects of the invention are further illustrated by experimental data as follows:
The following experiments were conducted, with experimental samples derived from the extracts obtained according to example 5 and example 6
1. Toxicity experiment:
The purpose is as follows: after the extract obtained in example 5 and example 6 is administered to experimental mice by the gastric lavage route, the toxic reaction of the mice is observed to obtain the maximum tolerance and/or the minimum lethal dose of the mice, 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 assigned to 5 groups, each of control (equal volume of deionized water), example 5 extract-L (57.6 g extract/kg/day), example 5 extract-H (72.0 g extract/kg/day), example 6 extract-L (57.6 g extract/kg/day), and example 6 extract-H (72.0 g extract/kg/day), and the male and female halves. Each group of animals was dosed with the corresponding test subjects at 40 mL/kg/lavage for 2 doses at 4h intervals over 24 h. The day of dosing was followed by 1 hour post-dosing, 1 post-day, while body weights were periodically weighed and after 14 days of resumption of the observations, all animals were subjected to gross anatomical examination.
Results: the control mice were not abnormal. On the day of dosing, mice from the example 5 extract-L, example 5 extract-H, example 6 extract-L and example 6 extract-H fractions began to develop reduced voluntary activity at about 5 minutes post-dosing; individual mice of the extract-L group of example 5 and partial mice of the extract-H group of example 6 showed loose stool at 0.5-1 hour after administration. And after 1-2 hours of administration, the mice in each group are recovered to be normal. The mice in each group dosed had steadily increased body weight compared to the control group during the observation period of 1-14 days after dosing, and were not statistically different from the control group (P > 0.05). Meanwhile, each group of mice did not die during the test, and the organ tissues were dissected substantially 14 days after the drug without visible obvious abnormal changes.
Conclusion: under the experimental conditions, the Maximum Tolerance (MTD) of the extract of the example 5 and the extract of the example 6 on the single gastric lavage administration of mice is 72.0g extract/kg/day, which is equivalent to 146.9 g crude drug/kg/day and 145.4g crude drug/kg/day respectively, and is 68 times of the clinical planned dosage.
2. Experiment of drug efficacy
1. Evaluation of the anti-inflammatory action of the drug of the present invention Using the xylene-induced acute ear swelling model in mice
Purpose this study used a model of xylene-induced acute ear swelling in mice to evaluate the anti-inflammatory effect of the present invention.
The method comprises the following steps of randomly dividing 70 ICR mice into 7 groups according to body weight after the adaptation period is ended, wherein the groups are as follows: normal group, model group, positive drug group, example 5 extract high and low two dose groups, example 6 extract high and low two dose groups. The mice of each group were respectively perfused with the corresponding test subjects, and the normal group and model group were perfused with distilled water, and were continuously dosed for 7d. 30min after the 7d gastric lavage administration, 30ul of the inflammatory agent xylene was uniformly smeared on the front and back of the right ear of each mouse, and the left ear was not treated. After 30min of modeling, the cervical dislocation of the mice is killed, ears are cut off along the auricle baseline of the mice, round lugs are respectively punched at the same positions of the left ear and the right ear by using a puncher with the diameter of 6mm, the weight of the left ear and the right ear is accurately weighed by using an analytical balance immediately, and the swelling inhibition rate of the lugs is calculated.
Effect of ear swelling in mice due to 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 group | 29.0±1.2 | 8.4±1.3 | 19.6±2.1 | 142.5±17.5## | --- |
| Positive medicine group (Aspirin) | 29.4±1.9 | 8.6±1.1 | 18.6±2.1 | 120.5±43.5 | 15.4 |
| Example 5 extractum (Low dose) | 30.0±2.2 | 7.4±0.9 | 18.6±0.7 | 156.6±35.7 | -9.9 |
| Example 5 extractum (high dosage) | 29.1±1.9 | 7.6±0.8 | 16.3±4.7 | 114.0±56.1 | 20.0 |
| Example 6 extractum (Low dose) | 30.6±2.0 | 8.5±1.0 | 17.4±1.5 | 105.9±23.7** | 25.7 |
| Example 6 extractum (high dosage) | 29.3±1.8 | 7.8±0.6 | 15.4±2.4 | 96.9±30.4** | 32.0 |
Note that: #P<0.05,## P <0.01 compared to normal group; p <0.05, P <0.01 compared to model group
As a result, the average swelling rate of the model group was 142.5%, indicating that the model of swelling of the mouse ear caused by xylene was successful. Example 6 the extract high dose group (26.2 g extract/kg) and the extract low dose group (13.1 g extract/kg) can inhibit the mouse ear swelling caused by the xylene (P <0.05vs model group), and the swelling inhibition rates are 32.0% and 25.7% respectively.
Conclusion the extract of example 6 can inhibit mice ear swelling caused by xylene, and has obvious anti-inflammatory effect.
2. The cyclophosphamide induced mouse model with low immune function is adopted, and the medicine of the invention has the function of regulating immunity
The present study uses cyclophosphamide-induced hypoimmunity mouse model to evaluate the effect of the invention on regulating immunity.
The method comprises the following steps of after the adaptation period of 60 ICR mice is ended, randomly dividing the mice into 6 groups according to the weight, wherein the groups are respectively as follows: normal group, model group, example 5 extract high and low two dose groups, example 6 extract high and low two dose groups. The low dose of each administration group is the clinically equivalent dose, and the high dose is 2 times the clinically equivalent dose. The mice of each group were respectively perfused with the corresponding test substance, and the normal group was perfused with distilled water, and continuously dosed for 14d. Experiment 11d was started, and each mouse of the remaining groups except the normal group was intraperitoneally injected with 0.2ml of cyclophosphamide at 80mg/kg, and continuous molding was performed for 3d. All mice fasted and did not lose water the day before the end of the experiment. After the mice of each group perfuse the stomach for 30min on the day of the experiment, the eyeballs are used for blood collection, the thymus and spleen of the mice are taken by the cervical vertebra sacrifice dissection and weighed, and the thymus index and spleen index are calculated. The whole blood of the mice is centrifuged for 10min at 3500r/min to obtain serum, and the content of immunoglobulin G (IgG) and interferon gamma (INF-gamma) in the serum is measured.
Effects on the thymus index, spleen index and serum IgG, IFN- γ of immunocompromised mice (x±s, n=10)
| Group of | Body weight (g) | Thymus index | 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 group | 30.1±1.2 | 0.72±0.19## | 2.05±0.29## | 14.37±1.53# | 634.2±51.0 |
| Example 5 extractum (Low dose) | 29.0±2.3 | 0.77±0.17 | 2.24±0.25 | 15.51±0.90 | 609.0±39.3 |
| Example 5 extractum (high dosage) | 31.2±2.0 | 0.96±0.22* | 2.17±0.30 | 15.30±1.4 | 633.8±55.3 |
| Example 6 extractum (Low dose) | 30.9±1.4 | 0.90±0.16* | 2.06±0.26 | 15.82±1.24* | 690.2±52.3* |
| Example 6 extractum (high dosage) | 30.3±1.5 | 0.81±0.20 | 2.13±0.36 | 15.05±0.86 | 639.3±44.3 |
Note that: #P<0.05,## P <0.01 compared to normal group; p <0.05, P <0.01 compared to model group
Results ① thymus, spleen index: example 5 extract high dose group (26.0 g extract/kg), example 6 extract low dose group (13.1 g extract/kg), can increase thymus index and spleen index of mice (P <0.05 or P <0.01vs model group). ② Immunoglobulin G: example 6 extract low dose group (13.1 g extract/kg) increased serum IgG levels in mice (P <0.05 or P <0.01vs model group). ③ Interferon gamma: example 6 extract low dose groups (13.1 g extract/kg) each increased the serum IFN-gamma content of mice (P <0.05 or P <0.01vs model group).
Conclusion:
The extract of example 6 can increase thymus index and spleen index of mice, increase the content of IgG and IFN-gamma in serum of mice, and has obvious effect of increasing immunity.
Claims (4)
1. An anti-inflammatory and immunity-enhancing traditional Chinese medicine composition is characterized by being prepared from the following raw materials in parts by weight:
15kg of raw astragalus, 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 kudzuvine root, 15kg of heartleaf houttuynia herb, 6kg of sweet wormwood herb and 3kg of radix bupleuri;
The preparation method comprises the following steps:
Extracting volatile oil from fifteen materials including folium Perillae, notopterygii rhizoma, radix Saposhnikoviae, herba Agastaches, pericarpium Citri Tangerinae, rhizoma Zingiberis recens, herba Houttuyniae and bupleuri radix by steam distillation for 6 hr, collecting volatile oil A and water solution B, reflux extracting residues with radix astragali, parched Atractylodis rhizoma and herba Artemisiae Annuae with 6 times of water for 2 times, each time for 1 hr, mixing the obtained water extractive solution and water solution B, concentrating under reduced pressure to specific gravity of 1.03-1.07, and measuring at 60deg.C to obtain water concentrated solution C; reflux extracting radix Codonopsis, flos Lonicerae, poria and radix Puerariae with 6 times of 75% ethanol for 2 times each for 1 hr, mixing the extractive solutions, concentrating under reduced pressure to specific gravity 1.03-1.07, measuring at 60deg.C, concentrating with water concentrate C, concentrating to specific gravity 1.20-1.30, measuring at 60deg.C, adding volatile oil A, and mixing.
2. An anti-inflammatory and immunity-enhancing traditional Chinese medicine preparation, characterized in that it comprises the traditional Chinese medicine composition according to claim 1, and further comprises pharmaceutically acceptable auxiliary materials and optional coating materials; the Chinese medicinal preparation is tablet, granule, capsule, pill or syrup.
3. A method for preparing the Chinese medicinal preparation according to claim 2, characterized in that,
Extracting volatile oil from fifteen materials including folium Perillae, notopterygii rhizoma, radix Saposhnikoviae, herba Agastaches, pericarpium Citri Tangerinae, rhizoma Zingiberis recens, herba Houttuyniae and bupleuri radix by steam distillation for 6 hr, collecting volatile oil A and water solution B, reflux extracting residues with radix astragali, parched Atractylodis rhizoma and herba Artemisiae Annuae with 6 times of water for 2 times, each time for 1 hr, mixing the obtained water extractive solution and water solution B, concentrating under reduced pressure to specific gravity of 1.03-1.07, and measuring at 60deg.C to obtain water concentrated solution C; reflux-extracting radix Codonopsis, flos Lonicerae, poria and radix Puerariae with 6 times of 75% ethanol for 2 times (each for 1 hr), mixing the extractive solutions, concentrating under reduced pressure to specific gravity of 1.03-1.07, measuring at 60deg.C, concentrating with water to concentrate C, concentrating to specific gravity of 1.20-1.30, measuring at 60deg.C, adding volatile oil A, mixing, adding adjuvants, and making into pharmaceutically acceptable dosage forms.
4. Use of a traditional Chinese medicine composition according to claim 1 for preparing anti-inflammatory and immunity-enhancing medicines.
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