A composition for preventing and treating new crown and a preparation method thereof

Abstract

The present application relates to a kind of composition for preventing and treating new crown and its preparation method.It is made of Huangqi, Baizhu, Wuweizi, Fangfeng, Jinyinhua, Lianqiao, Banlangen, Yuxingcao, Lugen, Tianhuafen, Jiegeng, Gancao, any dosage form is made using pharmaceutically acceptable carrier or excipient, such as formula granule, granule, decoction, tablet, capsule, soft capsule, drop pill or pill.It has the effect of benefiting qi and consolidating the exterior, clearing heat and detoxifying, clearing lung and benefiting throat.It is suitable for low immunity, weak or with other diseases of the body resistance decline susceptible population to prevent exogenous disease and or infectious disease, and new coronavirus infection population.Clinical studies show that new coronavirus infection patients treated by the present application, body temperature, sore throat, general soreness, sleep difficulty mostly in 6-8 hours improvement, generally in 20 hours symptom can basically disappear, indicating that the present application has exact curative effect on new coronavirus infection patients.

Description

I. Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to a composition for strengthening the body's resistance and preventing COVID-19, and its preparation method. II. Background Technology

[0002] With the shift in the disease spectrum, chronic non-communicable diseases have gradually decreased, becoming a significant factor in the disease burden and impacting economic development. However, infectious diseases remain a major public health issue. The continuous emergence of new infectious diseases poses new and serious threats to humanity. In the past 30 years, approximately 40 new infectious diseases have emerged globally, with one new type emerging each year. These diseases are characterized by their wide spread, rapid transmission, and significant social impact. Examples include SARS, MERS, H1N1 influenza, H7N9 avian influenza, Zika virus, and Ebola virus, which have become key and pressing issues in global public health.

[0003] Traditional Chinese medicine (TCM) has a long history of preventing and treating epidemics, accumulating rich experience. China has a history of epidemics spanning at least 3,500 years, with records of "epidemic" appearing as early as the Shang Dynasty in oracle bone inscriptions. TCM generally refers to infectious diseases as "epidemic disease," "plague," "typhoid fever," "external febrile disease," or "warm disease." Infectious diseases have existed in my country since ancient times and have caused considerable harm. Records show that since the Western Han Dynasty, my country has experienced more than 300 epidemics of infectious diseases. Looking back at the history of TCM, we find that in the thousands of years of combating epidemics, my country has developed a systematic theory of TCM epidemic prevention. From the records of the "five epidemics" in the *Huangdi Neijing* to Zhang Zhongjing's *Shanghan Lun* (Treatise on Cold Damage) summarizing the symptoms, pulse, signs, and treatment methods of "typhoid fever," to Ge Hong's *Zhouhou Beiji Fang* (Emergency Prescriptions to Keep Up One's Sleeve) in the Jin Dynasty explaining the cause of disease with "pestilential qi" and creatively proposing the use of artemisia annua to treat malaria, and Wu Youxing's *Wenyi Lun* (Treatise on Epidemic Febrile Diseases) in the Ming Dynasty, which made innovative contributions to the etiology, characteristics, and diagnostic and treatment methods of epidemic febrile diseases. Traditional Chinese medicine has continuously summarized its experience and innovated through repeated fights against epidemics, forming the TCM anti-epidemic theory that has been passed down to this day, and accumulating rich experience in the diagnosis and treatment of infectious diseases.

[0004] Traditional Chinese medicine (TCM) had a profound understanding of the onset of human exogenous diseases as early as 2,000 years ago. In "Discussion on Acupuncture Therapy in the Supplementary Writings of Plain Questions", it is stated that "if vital qi is stored internally, pathogenic factors cannot invade". This means that as long as the vital qi of the human body exists, pathogenic factors will not invade the body to cause diseases. In "Discussion on Heat Diseases in Plain Questions", it is stated that "where pathogenic factors lodge, the qi of that place must be deficient". This means that as long as a disease occurs, it indicates that the vital qi of the body is weak. Therefore, the basic principle for treating exogenous diseases is to strengthen the vital qi, consolidate the constitution and dispel pathogenic factors. By strengthening the vital qi and enhancing the body's disease resistance, pathogenic factors can be dispelled, promoting the recovery of physiological functions and thus achieving the purpose of curing diseases. The vital qi in TCM is closely related to immunity in modern medicine. Modern immunology believes that immunity is a function of the body to recognize and eliminate antigenic foreign substances, aiming to maintain the physiological balance of the body. The immune system has multiple functions such as immune defense, immune stability, and immune surveillance. The susceptible populations of exogenous diseases and / or infectious diseases are mostly those with low immunity, the elderly and the infirm, or those with poor body resistance accompanied by other diseases.

[0005] This invention is guided by the traditional Chinese medicine theories of "when the body's vital energy is abundant, pathogens cannot invade" and "where pathogens invade, the body's vital energy must be deficient." It proposes a treatment principle for susceptible populations of exogenous diseases and / or infectious diseases, focusing on strengthening the body's resistance and eliminating pathogens. The formula is prepared through modern pharmacological screening and optimization, and is used to prevent exogenous diseases and / or infectious diseases in susceptible populations with weakened immunity, the elderly, or those with other diseases. The originality of this invention lies in its focus on the fundamental pathogenesis of exogenous diseases and / or infectious diseases as a deficiency of vital energy. It combines this deficiency with immunity, using Astragalus membranaceus as the principal ingredient to tonify lung qi, strengthen the body's defensive qi, and prevent the invasion of pathogenic factors. Modern pharmacological research shows that Astragalus membranaceus can enhance and regulate the body's immune function, promote the interferon system, and improve the body's disease resistance; it also has an inhibitory effect on cell lesions caused by influenza virus and other viruses, and has a broad-spectrum antibacterial effect. The assistant herb, Atractylodes macrocephala, invigorates the spleen and replenishes qi. Modern pharmacological studies have shown that Atractylodes macrocephala can promote cellular immune function, increase white blood cell count, and has antibacterial and hepatoprotective effects. Schisandra chinensis tonifies the kidneys and replenishes qi. Modern pharmacological studies have shown that it can enhance the body's defense against non-specific stimuli, increase cellular immune function, improve immunity, and has antioxidant and anti-aging effects. It also has inhibitory effects on Staphylococcus aureus, Pneumococcus pneumoniae, Salmonella enterica, and Pseudomonas aeruginosa. Together, they assist the principal herb in replenishing qi, strengthening the defensive qi, and consolidating the exterior.The adjuvant drug Saposhnikoviae Radix dispels wind and relieves exterior syndrome, and defends against exogenous pathogens. Modern pharmacological studies have shown that Saposhnikoviae Radix has antipyretic, anti-inflammatory, and anti-allergic effects, and can enhance the phagocytic function of peritoneal macrophages in mice; Flos Lonicerae clears heat and detoxifies. Modern pharmacological studies have shown that Flos Lonicerae has a broad-spectrum antibacterial effect, can promote the phagocytosis of white blood cells, has obvious anti-inflammatory and antipyretic effects, has a strong inhibitory effect on pathogenic bacteria such as Staphylococcus aureus and Bacillus dysenteriae, and also has an inhibitory effect on various pathogenic microorganisms such as Leptospira interrogans, influenza virus, and pathogenic fungi; Fructus Forsythiae clears heat and detoxifies. Modern pharmacological studies have shown that Fructus Forsythiae has a broad-spectrum antibacterial effect, has a very strong inhibitory effect on Staphylococcus aureus and Bacillus dysenteriae, and also has a certain inhibitory effect on other pathogenic bacteria, influenza virus, and Leptospira interrogans, and has anti-inflammatory and antipyretic effects; Radix Isatidis clears heat and detoxifies, cools blood and relieves sore throat. Modern pharmacological studies have shown that Radix Isatidis has an inhibitory effect on a variety of Gram-positive bacteria, Gram-negative bacteria, influenza virus, arbovirus, and mumps virus, can enhance immune function, and has obvious antipyretic and antioxidant effects; Houttuyniae Herba clears heat and detoxifies. Modern pharmacological studies have shown that houttuynin has different degrees of inhibitory effects on a variety of Gram-positive and negative bacteria such as Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, Catarrhalis, Salmonella typhi, and Mycobacterium tuberculosis, can enhance the phagocytic ability of white blood cells, improve the body's immunity, and has an anti-inflammatory effect; Rhizoma Phragmitis clears heat and purges fire, and can clear and disperse lung heat and relieve cough. Modern pharmacological studies have shown that Rhizoma Phragmitis has antipyretic, sedative, analgesic, and antioxidant effects, and has an inhibitory effect on β-hemolytic streptococcus; Trichosanthis Radix clears heat and purges fire. It can purge fire to clear lung heat and promote the production of body fluid to moisten dryness in the lungs, and is used to treat dry cough with little phlegm, blood-streaked sputum and other lung heat dry cough syndromes caused by dryness-heat injuring the lungs. Modern pharmacological studies have shown that trichosanthin can inhibit the replication and reproduction of the AIDS virus (HIV) in infected immune cells, reduce the number of living cells infected by the virus in immune cells, and can inhibit the DNA replication and protein synthesis of HIV; Platycodonis Radix disperses the lung qi, eliminates phlegm, and relieves sore throat, protecting the upper respiratory tract. Modern pharmacological studies have shown that it can enhance the phagocytic function of macrophages, increase the activity of lysozyme, enhance the bactericidal power of neutrophils, and enhance anti-inflammatory and immune effects, and jointly assist the monarch drug to strengthen the healthy qi and eliminate pathogenic factors. The envoy drug Glycyrrhizae Radix et Rhizoma replenishes middle qi and benefits qi, clears heat and detoxifies, and harmonizes various drugs. Modern pharmacological studies have shown that Glycyrrhizae Radix et Rhizoma has antibacterial, antiviral, anti-inflammatory, and anti-allergic effects; it can protect the throat and tracheal mucosa. When all the drugs are used together, they jointly promote the effects of replenishing qi and consolidating the exterior, clearing heat and detoxifying, and clearing and benefiting the throat of the lung.

[0006] This invention is compared with existing patents related to strengthening the body's resistance. A search of the CNKI patent database using "strengthening the body's resistance" as the subject term revealed 31 patent applications related to the composition of strengthening the body's resistance composition. Excluding design patents and duplicate patents published multiple times, there are 22 patents. The formulations of these 22 patents are significantly different from those of this invention, as follows: (1) Application (patent) number: CN202210363648.X A traditional Chinese medicine composition that can strengthen the body's resistance and its preparation method, characterized in that it includes the following ingredients: Sophora flavescens, Ligustrum lucidum, Eclipta prostrata, raw dragon bone, raw oyster shell, Astragalus membranaceus, ginseng root, Ophiopogon japonicus, cardamom powder, Schisandra chinensis, and magnetite. (2) Application (Patent) No.: CN202010196388.2, a traditional Chinese medicine composition with the functions of strengthening the body, nourishing the liver and kidneys, and enhancing immunity, characterized in that: the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: Epimedium, Ligustrum lucidum, Astragalus membranaceus, Codonopsis pilosula, Angelica sinensis, processed Polygonum multiflorum, Salvia miltiorrhiza, processed Glycyrrhiza uralensis, Poria cocos, and Lycium barbarum. (3) Application (Patent) No.: CN201910653151.X, a traditional Chinese medicine composition for strengthening the body, characterized in that: it includes the following components in parts by weight: Astragalus membranaceus, Bupleurum chinense, Citrus aurantium, Paeonia lactiflora, Agrimonia pilosa, Ganoderma lucidum, Rhodiola rosea, Cordyceps sinensis, Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Poria cocos, Ligustrum lucidum, processed Glycyrrhiza uralensis, Ligusticum chuanxiong, Placenta hominis, Crataegus pinnatifida, and Hordeum vulgare. (4) Application (patent) number: CN201811064501.0, a traditional Chinese medicine preparation for strengthening the body and resisting cancer, characterized in that it is made from the following raw materials in parts by weight: Astragalus membranaceus, Angelica sinensis, Panax quinquefolius, stir-fried Atractylodes macrocephala, Paeonia lactiflora, Polygonatum sibiricum, Rehmannia glutinosa (processed), Rehmannia glutinosa (raw), Cornus officinalis, Dioscorea opposita, Poria cocos, Alisma plantago-aquatica, Paeonia suffruticosa, Paris polyphylla, Uncaria rhynchophylla, Cremastra appendiculata, Panax notoginseng, Hedyotis diffusa, Scutellaria barbata, Solanum lyratum, Solanum nigrum, Prunella vulgaris, Cervi cornu, Trionyx sinensis, Ostrea gigas, Cinnamomum cassia, Paeonia lactiflora, Prunus persica, Sparganium stoloniferum, Curcuma zedoaria, Bupleurum chinense, processed Pinellia ternata, Coptis chinensis, Scutellaria baicalensis, Glycyrrhiza uralensis, Taraxacum mongolicum. (5) Application (Patent) No.: CN201811632937.5, a food and medicine composition that nourishes both Qi and Yin and strengthens the body, characterized in that its effective ingredients are prepared from the following raw materials in parts by weight: longan, wolfberry, yam, polygonatum, rose, mulberry, jujube, and licorice. (6) Application (Patent) No.: CN201410117738.6, a compound fungal polysaccharide preparation, made from the following raw materials in weight percentage: maitake mushroom polysaccharide, hericium erinaceus polysaccharide, ganoderma lucidum polysaccharide, and poria cocos polysaccharide. (7) Application (patent) number: CN201410172346.X, a tonifying and strengthening granule for treating esophageal cancer, gastric cancer, lung cancer, breast cancer, ovarian cancer, cervical cancer, head and neck cancer, as well as enhancing the body's immunity and improving the quality of life of cancer patients, characterized in that it is made from the following raw materials in the following weight ratio: Scutellaria baicalensis, Epimedium, Ligustrum lucidum, Polygonum multiflorum, Rehmannia glutinosa, Rubia cordifolia, Polygonatum sibiricum, and Panax ginseng.(8) Application (Patent) No.: CN201410485800.7, a preparation for strengthening the body, invigorating qi, and calming the mind, characterized in that it is prepared from the following components in parts by weight: ginseng, Ganoderma lucidum, honey, and starch in appropriate amounts. (9) Application (Patent) No.: CN201210219176.7, a traditional Chinese medicine for strengthening the body, characterized in that it is prepared from the following medicinal materials in the following weight ratio: Cordyceps sinensis, Coix lacryma-jobi, Poria cocos, Angelica sinensis, Bupleurum chinense, Ganoderma lucidum, Rehmannia glutinosa, ginseng, Paeonia lactiflora, Dioscorea opposita, red adzuki bean, and jujube. (10) Application (Patent) No.: CN201310110672.3, a quality control method for strengthening the body granules, wherein the strengthening the body granules are prepared from the following raw materials: Scutellaria baicalensis, Ligustrum lucidum, Epimedium brevicornu, Polygonum multiflorum, Rehmannia glutinosa, Polygonatum sibiricum, Rubia cordifolia, and ginseng. (11) Application (Patent) No.: CN201210151089.2, A health drink suitable for diabetic patients, characterized in that it is made from the following raw materials in parts by weight: chickpeas, cordycepin, stevia, and purified water. (12) Application (Patent) No.: CN201110119811.X, A traditional Chinese medicine composition with the effects of strengthening the body, enhancing human immunity, anti-fatigue, anti-tumor, and delaying aging, characterized in that the raw materials of the composition are: *Paecilomyces hepiali* mycelium, Ganoderma lucidum, broken-cell wall Ganoderma lucidum spore powder, and American ginseng. (13) Application (Patent) No.: CN201110175461.9, A traditional Chinese medicine composition with the effects of strengthening the body, enhancing human immunity, anti-fatigue, anti-tumor, and delaying aging, characterized in that the composition is made by the following method: *Paecilomyces hepiali* mycelium, Ganoderma lucidum, broken-cell wall Ganoderma lucidum spore powder, and American ginseng. (14) Application (Patent) No.: CN201110386796.5, a tonifying and strengthening granule for treating esophageal cancer, gastric cancer, lung cancer, breast cancer, ovarian cancer, cervical cancer, head and neck cancer, as well as enhancing the body's immunity and improving the quality of life of cancer patients, characterized in that it is made from the following raw materials in the following weight ratio: Scutellaria baicalensis, Epimedium, Ligustrum lucidum, Polygonum multiflorum, Rehmannia glutinosa, Rubia cordifolia, Polygonatum sibiricum, and Panax ginseng. (15) Application (Patent) No.: CN200710090867.0, a drug for tonifying and strengthening the body during radiotherapy and chemotherapy for cancer patients, characterized in that it is made from the following raw materials in the following weight ratio: Astragalus membranaceus, Ophiopogon japonicus, Panax quinquefolius, Cornus officinalis (without pit), Lycium barbarum, and Cyperus rotundus (processed). (16) Application (patent) number: CN200810101889.7, a traditional Chinese medicine combination for strengthening the body and clearing heat and detoxifying, characterized by being composed of active ingredients and / or pharmaceutically acceptable carriers, wherein the active ingredients are made from the following raw materials: Smilax glabra, Isatis indigotica, Corydalis yanhusuo, prepared frankincense, myrrh, Lonicera japonica, Angelica sinensis, Salvia miltiorrhiza, prepared licorice, Bupleurum chinense, stir-fried Citrus aurantium, Taxillus chinensis, Cuscuta chinensis.(17) Application (Patent) No.: CN200810181011.9, a traditional Chinese medicine with the effects of tonifying the kidney and strengthening yang, and supporting the body's resistance and consolidating the foundation, characterized in that it is mainly made of the following raw materials in the following weight ratio: wolfberry, prepared rehmannia root, dodder seed, epimedium, cistanche, ginseng, ganoderma lucidum, black ant, and bee pollen. (18) Application (Patent) No.: CN200610065615.8, a traditional Chinese medicine compound preparation with the effects of detoxification, blood stasis removal, and supporting the body's resistance and consolidating the foundation, which can be used for combined chemotherapy of lung cancer, liver cancer, and gastric cancer, characterized in that it is made of the following traditional Chinese medicine raw materials in the following weight ratio: tiger eye evergreen, scutellaria barbata, cuspidatum, turmeric, white flower tongue grass, ginseng, salvia miltiorrhiza, astragalus, scorpion, and centipede. (19) Application (patent) number: CN200410062488.7, a composition for treating benign prostatic hyperplasia, prostatitis, decreased sexual function, menopausal syndrome, coronary heart disease, cerebral thrombosis, chronic fatigue syndrome, neurasthenia, memory loss, senile dementia and diseases caused by low or disordered immune function, made from the following raw materials in any dosage form: ginseng, astragalus, sea buckthorn, wolfberry, epimedium, notoginseng, schisandra, or the raw material composition may be varied in one of the following ways: (1) adding raspberry to the composition, with a dosage of 1-24g; (2) replacing ginseng with an equal amount of American ginseng; (3) replacing notoginseng with an equal amount of chuanxiong or danshen; or (4) replacing wolfberry with an equal amount of raspberry. (20) Application (Patent) No.: CN202010105076.6, A functional beverage for strengthening the body, enhancing immunity, and preventing and controlling infectious diseases, characterized in that: it is a product made from the following ingredients in parts by weight: a traditional Chinese medicine formula including ginseng, cordyceps militaris, donkey-hide gelatin, wolfberry, mulberry, yam, alpinia oxyphylla, polygonatum, longan pulp, poria cocos, lily, honeysuckle, sea buckthorn, tea tree flower, Japanese raisin tree fruit, malt, hawthorn, licorice, monk fruit, and acerola cherry. (21) Application (Patent) No.: CN202010105027.2, A functional flour for strengthening the body, enhancing immunity, and preventing and controlling infectious diseases, characterized in that: it is a product made from the following ingredients in parts by weight: whole wheat flour, corn germ powder, ginseng, cordyceps militaris, donkey-hide gelatin, wolfberry, mulberry, yam, polygonatum, poria cocos, lily, honeysuckle, sea buckthorn, tea tree flower, malt, and licorice. The invention is suitable for the elderly, weak, and immune-deficient people susceptible to epidemics, as well as those with chronic cough and asthma, excessive sweating, and frequent colds due to lung and kidney qi deficiency, or those with liver and kidney deficiency, premature graying of hair, dry hair, hair loss, intellectual decline or Alzheimer's disease, or those with insomnia due to overwork, eye strain from staying up late, eye cramps, flat and rough nails, and liver blood deficiency, or those who are physically weak, easily fatigued, and have spleen and stomach qi deficiency and blood deficiency. (22) Application (patent) number: CN201711377355.2, a food, health product or drug composition for strengthening the body and improving immunity, characterized in that: it is a preparation made from the following raw materials in the following weight ratio: ginseng, polygonatum, licorice and black tea.

[0007] A search of the CNKI patent database using "traditional Chinese medicine" and "COVID-19" as keywords revealed 10 patent applications related to traditional Chinese medicine compositions for the prevention and treatment of novel coronavirus infection. Among these 10 applications, 8 have formulations that are significantly different from the formulation of this invention. Specifically: (1) Application (patent) number: CN202210356124.8, a traditional Chinese medicine composition for the prevention of COVID-19, characterized in that it includes the following raw materials in parts by weight: realgar, Euonymus alatus, Salvia miltiorrhiza, red adzuki bean, black soybean, dried plum, Aster tataricus, peony root, Scutellaria baicalensis, Asarum heterotropoides, Anemarrhena asphodeloides and cinnamon bark. (2) Application (patent) number: CN202111630377.1, a traditional Chinese medicine combination with efficacy against COVID-19 and its preparation method, the key technical points of which are: including the following components: Angelica dahurica oil, Magnolia biondii oil, Magnolia officinalis oil, Citrus reticulata oil, Isatis indigotica root, Cimicifuga foetida, Pogostemon cablin oil, Coptis chinensis. (3) Application (Patent) No.: CN202110572543.0, A traditional Chinese medicine for preventing COVID-19 and its preparation method, characterized in that, by weight, it includes: Schizonepeta, Saposhnikovia, Bupleurum, Ligusticum chuanxiong, Dryopteris crassirhizoma, Notopterygium incisum, Coptis chinensis, Scutellaria baicalensis, Poria cocos, Chicken gizzard lining, Citrus aurantium, Pinellia ternata, Peucedanum praeruptorum, Mentha haplocalyx, Artemisia annua. (4) Application (Patent) No.: CN202110199971.3, A traditional Chinese medicine composition for treating COVID-19 wind-cold exterior deficiency syndrome and its preparation method, characterized in that it is prepared from the following materials in the following mass proportions: Cinnamomum cassia, Paeonia lactiflora, Glycyrrhiza uralensis, Artemisia annua powder, Gardenia jasminoides, Platycodon grandiflorus and Adenophora stricta. (5) Application (patent) No.: CN202011500278.7, a traditional Chinese medicine composition for preventing COVID-19 and its preparation method and application, characterized in that: the traditional Chinese medicine composition includes the following traditional Chinese medicine raw materials in parts by weight: Atractylodes lancea, Cinnamomum cassia, Amomum villosum, Artemisia argyi, Syzygium aromaticum, Ligusticum chuanxiong, Ephedra sinica, Lemongrass, Asarum heterotropoides, Atractylodes macrocephala, Amomum villosum, Acorus tatarinowii, Zingiber officinale, Hedyotis diffusa, Cnidium monnieri, Angelica dahurica, Saposhnikovia divaricata, Schizonepeta tenuifolia, Borneol, Isatis indigotica, Patchouli oil, and Eupatorium fortunei volatile oil. (6) Application (Patent) No.: CN202010372164.2, A traditional Chinese medicine composition for preventing and treating novel coronavirus infection and its preparation method and use, characterized in that the active pharmaceutical ingredients of the traditional Chinese medicine composition are a mixture of ephedra, coix seed, apricot kernel, aster, coltsfoot flower, gypsum, magnolia bark, anemarrhena rhizome, white peony root, scutellaria root, prepared licorice root, white mustard seed, perilla seed, radish seed, buckwheat, astragalus root, and lily bulb. (7) Application (Patent) No.: CN202010461885.0, A traditional Chinese medicine preparation for treating novel coronavirus and viral diseases and its preparation method, characterized in that the traditional Chinese medicine preparation includes the following traditional Chinese medicine raw materials by weight: prepared ephedra, apricot kernel, honeysuckle, gypsum, ginger, atractylodes rhizome, white flower snake grass, bitter orange peel, poria cocos, jujube, medicated leaven, saposhnikovia root, rhubarb, cinnamon twig, platycodon root, chuanxiong rhizome, schizonepeta, atractylodes rhizome, and prepared licorice root.(8) Application (patent) number: CN202110200022.2, Traditional Chinese medicine composition for treating COVID-19 invasion of the skin and the preparation method thereof, characterized in that it is composed of the following materials mixed in the following mass proportions: Platycodon grandiflorus, Lonicera japonica, Coix lacryma-jobi, Scutellaria baicalensis, Astragalus membranaceus (processed), Fritillaria cirrhosa, Citrus reticulata peel, Artemisia annua powder, Bletilla striata, stir-fried Lepidium apetalum and Glycyrrhiza uralensis.

[0008] Only two other patents contain more than five ingredients as described in this invention. The differences between these two patents and this invention are as follows: (1) Application (patent) number: CN202210361983.6, A traditional Chinese medicine composition for preventing novel coronavirus infection and its preparation method. The traditional Chinese medicine composition includes the following components: Astragalus membranaceus, Scutellaria baicalensis, Bupleurum chinense, Saposhnikovia divaricata, Morus alba leaf, Phragmites communis rhizome, Isatis indigotica root, Platycodon grandiflorus, Mentha haplocalyx, Forsythia suspensa, Atractylodes macrocephala, Poria cocos, and Glycyrrhiza uralensis. This invention application contains raw materials such as Astragalus membranaceus, Saposhnikovia divaricata, Phragmites communis, Isatis indigotica, Platycodon grandiflorus, Forsythia suspensa, Atractylodes macrocephala, and Glycyrrhiza uralensis. However, the invention application uses the principles of relieving exterior syndromes and dispelling cold, supporting the body's resistance and eliminating pathogens, tonifying qi and nourishing yin, and clearing the lungs and expelling pathogens. Its description states: "Astragalus membranaceus tonifies qi and strengthens the exterior, promotes the elimination of toxins and pus, and promotes diuresis and tissue regeneration; Saposhnikovia divaricata dispels wind, relieves exterior syndromes and eliminates dampness, allowing pathogens to have a way out; Bupleurum chinense soothes the liver and relieves depression, and raises yang qi; combined with Atractylodes macrocephala to strengthen the spleen and dry dampness, thereby enhancing the qi-tonifying and spleen-strengthening effects of Bupleurum chinense; combined with Mentha haplocalyx and Forsythia suspensa to clear heat, detoxify, and reduce swelling, thereby enhancing the effects of dispelling wind and relieving exterior syndromes; and as an adjuvant, Glycyrrhiza uralensis strengthens the spleen and harmonizes the middle jiao, moistens the lungs and detoxifies, and harmonizes the effects of the other herbs. It has the functions of supporting the body's resistance and eliminating epidemics, dispelling wind and moistening dryness, and clearing heat and detoxifying, and can effectively prevent novel coronavirus infection." However, its legislative principle is to primarily eliminate pathogens while also supporting the body's resistance. The distinction between the principal and assistant herbs is unclear, and the use of only Glycyrrhiza uralensis as an adjuvant is inappropriate. This invention addresses the root cause of deficiency, with Astragalus membranaceus as the principal ingredient to tonify lung qi, strengthen the defensive qi, and prevent the invasion of pathogenic factors. Atractylodes macrocephala is used as the assistant ingredient to invigorate the spleen and replenish qi; Schisandra chinensis tonifies the kidneys and replenishes qi, working together with the principal ingredient to tonify qi, strengthen the defensive qi, and consolidate the exterior. Saposhnikovia divaricata is used as the adjuvant ingredient to dispel wind and release the exterior, resisting external pathogens; Lonicera japonica clears heat and detoxifies; Forsythia suspensa clears heat and detoxifies; Isatis indigotica clears heat, detoxifies, cools the blood, and soothes the throat; Houttuynia cordata clears heat and detoxifies; Phragmites communis clears heat and drains fire, clearing lung heat and relieving cough; Trichosanthes kirilowii clears heat and drains fire, both clearing lung heat and generating fluids to moisten lung dryness, treating dry cough with little phlegm, blood-streaked sputum, and other symptoms of lung heat and dry cough; Platycodon grandiflorus promotes lung function, eliminates phlegm, soothes the throat, and protects the upper respiratory tract, working together with the principal ingredient to strengthen the body and expel pathogens. Glycyrrhiza uralensis is used as the guiding ingredient to tonify the middle jiao, replenish qi, clear heat and detoxify, and harmonize the other ingredients. The combined effects of these ingredients are to tonify qi, consolidate the exterior, clear heat and detoxify, clear the lungs, and soothe the throat. (2) Application (Patent) No.: CN202110952216.8, Application of a traditional Chinese medicine composition in the preparation of a drug that inhibits the increase of cytokines and chemokines in patients infected with the novel coronavirus, characterized in that the traditional Chinese medicine composition is made from the following raw materials in parts by weight: Forsythia suspensa, Lonicera japonica, Isatis indigotica, Rheum palmatum, Pogostemon cablin, Dryopteris crassirhizoma, Rhodiola rosea, Menthol, Ephedra sinica (processed), Prunus armeniaca (processed), Houttuynia cordata, Glycyrrhiza uralensis, and Gypsum. This invention application contains the raw materials of this invention, such as Forsythia suspensa, Lonicera japonica, Isatis indigotica, Houttuynia cordata, and Glycyrrhiza uralensis, but the specification of this invention application states that it is an innovative traditional Chinese medicine composition developed with the treatment method of "clearing heat and detoxifying, and relieving lung heat".This formula is based on the Ma Xing Shi Gan Tang from Zhang Zhongjing's *Treatise on Cold Damage* (Shang Han Lun) of the Han Dynasty, combined with the Yin Qiao San from Wu Jutong's *Treatise on Warm Diseases* (Wen Bing Tiao Bian) of the Qing Dynasty. It also incorporates the experience of using rhubarb in treating epidemic diseases from Wu Youke's *Treatise on Epidemic Diseases* (Wen Yi Lun) of the Ming Dynasty, adding Rhodiola rosea to clear the lungs, resolve blood stasis, and regulate immunity. The formula reflects the experience of traditional Chinese medicine in preventing and treating such epidemic diseases over two thousand years. Specifically, it adjusts the prescription and preparation method to address the pathogenesis and symptoms of the current novel coronavirus infection. Clinically, it is applicable to respiratory infectious diseases accompanied by fever, chills, cough, and muscle aches. This invention patent is based on the principle of "clearing heat and detoxifying, ventilating the lungs and relieving heat," focusing on eliminating pathogens while simultaneously supporting the body's resistance, which is significantly different from this invention. This invention addresses the deficiency of the body's resistance, with Astragalus membranaceus as the chief herb to tonify lung qi, strengthen the defensive qi, and prevent the invasion of pathogenic factors. Atractylodes macrocephala is used as an assistant herb to strengthen the spleen and replenish qi; Schisandra chinensis tonifies the kidneys and replenishes qi, assisting the chief herb in replenishing qi, strengthening the defensive qi, and consolidating the exterior. The adjuvant herbs, Fangfeng (Saposhnikovia divaricata), dispel wind and release the exterior, resisting external pathogens; Jinyinhua (Lonicera japonica) clears heat and detoxifies; Lianqiao (Forsythia suspensa) clears heat and detoxifies; Banlangen (Isatis indigotica) clears heat, detoxifies, cools the blood, and soothes the throat; Yuxingcao (Houttuynia cordata) clears heat and detoxifies; Lugen (Phragmites communis) clears heat and drains fire, clearing lung heat and relieving cough; Tianhuafen (Trichosanthes kirilowii) clears heat and drains fire, both clearing lung heat and generating fluids to moisten lung dryness, treating dry cough with little phlegm, blood-streaked sputum, and other lung heat and dry cough syndromes; Jiegeng (Platycodon grandiflorus) promotes lung function, eliminates phlegm, soothes the throat, protects the upper respiratory tract, and assists the principal herbs in supporting the body's resistance and expelling pathogens. The guiding herb, Gancao (Glycyrrhiza uralensis), tonifies the middle energizer, replenishes qi, clears heat and detoxifies, and harmonizes the other herbs. Together, these herbs work to tonify qi, strengthen the exterior, clear heat and detoxify, clear the lungs, and soothe the throat. III. Summary of the Invention

[0009] The purpose of this invention is to provide a composition for strengthening the body's resistance and preventing COVID-19, and its preparation method. It is suitable for susceptible populations with weakened immunity, the elderly, or those with other diseases whose resistance is reduced, in order to prevent exogenous diseases and / or infectious diseases, as well as for people infected with the novel coronavirus.

[0010] The technical solution of this invention: A composition for strengthening the body's resistance and preventing COVID-19, made from Astragalus membranaceus, Atractylodes macrocephala, Schisandra chinensis, Saposhnikovia divaricata, Lonicera japonica, Forsythia suspensa, Isatis indigotica, Houttuynia cordata, Phragmites communis, Trichosanthes kirilowii, Platycodon grandiflorus, and Glycyrrhiza uralensis, characterized in that it is prepared from the following raw materials in the following weight ratios: Astragalus membranaceus 3-27 parts, Atractylodes macrocephala 2-18 parts, Schisandra chinensis 2-18 parts, Saposhnikovia divaricata 2-18 parts, Lonicera japonica 2-18 parts, Forsythia suspensa 2-18 parts, Isatis indigotica 2-18 parts, Houttuynia cordata 2-18 parts, Phragmites communis 2-18 parts, Trichosanthes kirilowii 2-18 parts, Platycodon grandiflorus 2-18 parts, and Glycyrrhiza uralensis 1-9 parts. The preferred weight ratio range of this invention is: Astragalus membranaceus 5-18 parts, Atractylodes macrocephala 3-12 parts, Schisandra chinensis 3-12 parts, Saposhnikovia divaricata 3-12 parts, Lonicera japonica 3-12 parts, Forsythia suspensa 3-12 parts, Isatis indigotica 3-12 parts, Houttuynia cordata 3-12 parts, Phragmites communis 3-12 parts, Trichosanthes kirilowii 3-12 parts, Platycodon grandiflorus 3-12 parts, and Glycyrrhiza uralensis 2-6 parts. The optimal weight ratio range of this invention is: Astragalus membranaceus 9 parts, Atractylodes macrocephala 6 parts, Schisandra chinensis 6 parts, Saposhnikovia divaricata 6 parts, Lonicera japonica 6 parts, Forsythia suspensa 6 parts, Isatis indigotica 6 parts, Houttuynia cordata 6 parts, Phragmites communis 6 parts, Trichosanthes kirilowii 6 parts, Platycodon grandiflorus 6 parts, and Glycyrrhiza uralensis 3 parts.

[0011] A method for preparing a composition for strengthening the body's resistance and preventing COVID-19, characterized by using any dosage form made with a pharmaceutically acceptable carrier or excipient, such as formulated granules, granules, decoctions, tablets, capsules, soft capsules, drop pills or pills.

[0012] A method for preparing a composition for strengthening the body's resistance and preventing COVID-19, characterized in that the formula granules are prepared as follows: Astragalus membranaceus, Atractylodes macrocephala, Schisandra chinensis, Saposhnikovia divaricata, Lonicera japonica, Forsythia suspensa, Isatis indigotica, Houttuynia cordata, Phragmites communis, Trichosanthes kirilowii, Platycodon grandiflorus, and Glycyrrhiza uralensis are weighed according to the formula amount, converted into granules according to the national drug standard for traditional Chinese medicine formula granules promulgated by the National Medical Products Administration, mixed evenly, and packaged, with each bag containing 10 grams.

[0013] A method for preparing a composition for strengthening the body's resistance and preventing COVID-19, characterized in that the decoction is prepared according to the following steps:

[0014] (1) Weigh the raw materials: Weigh the raw materials of the composition according to the formula: Astragalus membranaceus, Atractylodes macrocephala, Schisandra chinensis, Saposhnikovia divaricata, Lonicera japonica, Forsythia suspensa, Isatis indigotica, Houttuynia cordata, Phragmites communis, Trichosanthes kirilowii, Platycodon grandiflorus and Glycyrrhiza uralen

[0015] (2) Soaking: Put the ingredients of the formula into a special container for decocting Chinese medicine, add 6 to 8 times the amount of cold water (drinking water that meets national health standards), and soak for 30 minutes in preparation for decoction.

[0016] (3) First decoction: Boil the soaked Chinese medicine and water over high heat until boiling, then reduce to low heat and simmer for 10-20 minutes. Turn off the heat and pour out the liquid completely while it is still hot. Filter the liquid to obtain 200ml of liquid. Store it in a sterilized container for later use.

[0017] (4) Second decoction: Add 6 to 8 times the amount of cold water (drinking water that meets national health standards) to the dregs from the first decoction. Bring to a boil over high heat, then reduce to low heat and continue to decoct for 10 to 20 minutes. Turn off the heat and pour out the liquid completely while it is still hot. Filter the liquid and press the dregs to filter the liquid. A total of 200ml of liquid is obtained.

[0018] (5) Mixing: Pour the second decoction into the container holding the first decoction and mix well to obtain the decoction. Package it into 200ml bags.

[0019] A method for preparing a composition for strengthening the body's resistance and preventing COVID-19, characterized in that 3-10 parts of inulin, 0.04-0.16 parts of sucralose, and isomaltitol are added to the granule preparation excipients to the total amount (small-scale test yield is about 20-25%), and the composition is prepared according to the following steps:

[0020] (1) Pretreatment: Take isomaltitol, crush it and pass it through an 80-mesh sieve for later use. If other materials are clumped, they can be passed through an 80-mesh sieve.

[0021] (2) Decoction: Weigh out Astragalus membranaceus, Atractylodes macrocephala, Schisandra chinensis, Saposhnikovia divaricata, Lonicera japonica, Forsythia suspensa, Isatis indigotica, Houttuynia cordata, Phragmites communis, Trichosanthes kirilowii, Platycodon grandiflorus and Glycyrrhiza uralensis according to the ingredient list, add 10 times the amount of water and decoct twice. The first decoction is 2 hours and the second decoction is 1 hour. Filter and set aside.

[0022] (3) Concentration: The filtrate is concentrated under reduced pressure (-0.06 to -0.10 MPa, ≤70℃) to a thick paste with a relative density of 1.15 to 1.25 (60±2℃);

[0023] (4) Drying: The thick paste is dried under reduced pressure (-0.06~-0.10Mpa, ≤70℃) until dry, then pulverized and passed through an 80-mesh sieve to obtain dry extract powder for later use;

[0024] (5) Granulation: Weigh isomalt, inulin and dry extract powder according to the formula and mix them together in a high-efficiency wet granulator for 5 minutes to obtain mixed powder; dissolve sucralose in 95% ethanol (about 18% of the total formula, the concentration and amount of ethanol can be adjusted according to the actual situation) as a wetting agent to make soft material, granulate it with 14 mesh, dry it at 55±5℃ (the moisture content of the particles is controlled below 5%), and granulate it with 14 mesh to obtain dry granules for later use;

[0025] (6) Inner packaging: Composite film packaging, 10g / bag;

[0026] (7) Outer packaging: label, box, pack, and put into warehouse after passing inspection;

[0027] (8) Inspection and warehousing: Finished products are put into storage after passing inspection.

[0028] The originality of this invention lies in its focus on the fundamental pathogenesis of exogenous diseases and / or infectious diseases, which stem from deficiency of vital energy. It combines this deficiency with immune function, using Astragalus membranaceus as the principal ingredient to tonify lung qi, strengthen the defensive qi, and prevent the invasion of pathogenic factors. Atractylodes macrocephala is used as the assistant ingredient to strengthen the spleen and replenish qi; Schisandra chinensis tonifies the kidneys and replenishes qi, working together with the principal ingredient to tonify qi, strengthen the defensive qi, and consolidate the exterior. Saposhnikovia divaricata is used as the adjuvant ingredient to dispel wind and release the exterior, resisting external pathogens; Lonicera japonica clears heat and detoxifies; Forsythia suspensa clears heat and detoxifies; Isatis indigotica clears heat, detoxifies, cools the blood, and soothes the throat; Houttuynia cordata clears heat and detoxifies; Phragmites communis clears heat and drains fire, clearing lung heat and relieving cough; Trichosanthes kirilowii clears heat and drains fire, both clearing lung heat and generating fluids to moisten lung dryness, treating dry cough with little phlegm, blood-streaked sputum, and other lung heat-related dry cough symptoms; Platycodon grandiflorus promotes lung function, eliminates phlegm, soothes the throat, and protects the upper respiratory tract, working together with the principal ingredient to strengthen the body and expel pathogens. Glycyrrhiza uralensis is used as the guiding ingredient to tonify the middle jiao, replenish qi, clear heat, detoxify, and harmonize the other ingredients. When used together, these herbs work synergistically to invigorate qi, strengthen the exterior, clear heat and detoxify, and soothe the lungs and throat.

[0029] A clinical observation of 32 patients with COVID-19 infection treated with the granule formulation of this invention.

[0030] 1. General Information: The 32 patients were from the isolation ward between November 1 and December 10, 2022. There were 24 males and 18 females. Their ages ranged from 18 to 59 years, and their illness duration was 1-2 days.

[0031] 2. Diagnostic criteria: Refer to the Diagnosis and Treatment Protocol for Novel Coronavirus Infection (Trial Version 9)

[0032] 3. Inclusion criteria: (1) Patients with symptoms such as fever, sore throat, body aches, and difficulty sleeping; (2) positive nucleic acid test or (3) positive COVID-19 antigen test.

[0033] 4. Test methods

[0034] (1) The formula granules of this invention (made from Astragalus membranaceus, Atractylodes macrocephala, Schisandra chinensis, Saposhnikovia divaricata, Lonicera japonica, Forsythia suspensa, Isatis indigotica, Houttuynia cordata, Phragmites communis, Trichosanthes kirilowii, Platycodon grandiflorus, and Glycyrrhiza uralensis, prepared by Kangrentang Pharmaceutical Co., Ltd., 10 grams per bag)

[0035] (2) Usage: Day 1: Take 2 packets for the first time, then take 2 packets 2 hours later, then take 2 packets 3 hours later, and then take 2 packets 4 hours later; Day 2: Take 1 packet at a time, 2-3 times a day; Day 3: Take 1 packet at a time, 2 times a day.

[0036] 5. Observation indicators: (1) body temperature, sore throat, body aches and pains, difficulty sleeping; (2) nucleic acid test; (3) COVID-19 antigen test.

[0037] 6. Test Results

[0038] (1) Changes in the patient's body temperature, sore throat, difficulty sleeping, and general body aches.

[0039] Table 1. Time for improvement in patients' body temperature, sore throat, difficulty sleeping, and general body aches.

[0040]

[0041] As shown in Table 1, after treatment with the granules formulated in this invention, most patients' body temperature, sore throat, body aches, and difficulty sleeping improved within 6-8 hours, and the symptoms generally disappeared within 20 hours.

[0042] (2) Nucleic acid and antigen detection

[0043] Due to quarantine zone management regulations, confirmed patients are no longer required to undergo repeat nucleic acid and antigen tests. Furthermore, recent policy changes have altered the implementation of nucleic acid and antigen testing, resulting in the lack of post-treatment systemic testing data. Follow-up was conducted on some patients who were released from quarantine after their symptoms disappeared; some of these patients tested negative for antigen after 5 days and for nucleic acid after 7 days.

[0044] 7. Conclusion

[0045] After treatment with the granules formulated according to this invention, most patients experienced improvement in body temperature, sore throat, body aches, and difficulty sleeping within 6-8 hours, and symptoms generally disappeared within 20 hours. This indicates that the granules formulated according to this invention are effective in treating COVID-19 patients. IV. Detailed Implementation

[0046] The present invention will be described in detail below with reference to specific embodiments:

[0047] Example 1: Formulation Granules

[0048] Weigh the ingredients according to the following proportions: Astragalus membranaceus 3 parts, Atractylodes macrocephala 2 parts, Schisandra chinensis 2 parts, Saposhnikovia divaricata 2 parts, Lonicera japonica 2 parts, Forsythia suspensa 2 parts, Isatis indigotica 2 parts, Houttuynia cordata 2 parts, Phragmites communis 2 parts, Trichosanthes kirilowii 2 parts, Platycodon grandiflorus 2 parts, Glycyrrhiza uralensis 1 part.

[0049] Preparation method: Convert the traditional Chinese medicine formula granules into granules according to the national drug standard for traditional Chinese medicine formula granules issued by the National Medical Products Administration, mix them well, and package them into 10-gram bags.

[0050] Example 2: Formulation Granules

[0051] Weigh the raw materials according to the following proportions: Astragalus membranaceus 27 parts, Atractylodes macrocephala 18 parts, Schisandra chinensis 18 parts, Saposhnikovia divaricata 18 parts, Lonicera japonica 18 parts, Forsythia suspensa 18 parts, Isatis indigotica 18 parts, Houttuynia cordata 18 parts, Phragmites communis 18 parts, Trichosanthes kirilowii 18 parts, Platycodon grandiflorus 18 parts, Glycyrrhiza uralensis 9 parts.

[0052] Preparation method: Convert the traditional Chinese medicine formula granules into granules according to the national drug standard for traditional Chinese medicine formula granules issued by the National Medical Products Administration, mix them well, and package them into 10-gram bags.

[0053] Example 3: Formulation Granules

[0054] Weigh the ingredients according to the following proportions: Astragalus membranaceus 9 parts, Atractylodes macrocephala 6 parts, Schisandra chinensis 6 parts, Saposhnikovia divaricata 6 parts, Lonicera japonica 6 parts, Forsythia suspensa 6 parts, Isatis indigotica 6 parts, Houttuynia cordata 6 parts, Phragmites communis 6 parts, Trichosanthes kirilowii 6 parts, Platycodon grandiflorus 6 parts, Glycyrrhiza uralensis 3 parts.

[0055] Preparation method: Convert the traditional Chinese medicine formula granules into granules according to the national drug standard for traditional Chinese medicine formula granules issued by the National Medical Products Administration, mix them well, and package them into 10-gram bags.

[0056] Example 4: Decoction

[0057] Weigh the ingredients according to the following proportions: Astragalus membranaceus 9 parts, Atractylodes macrocephala 6 parts, Schisandra chinensis 6 parts, Saposhnikovia divaricata 6 parts, Lonicera japonica 6 parts, Forsythia suspensa 6 parts, Isatis indigotica 6 parts, Houttuynia cordata 6 parts, Phragmites communis 6 parts, Trichosanthes kirilowii 6 parts, Platycodon grandiflorus 6 parts, Glycyrrhiza uralensis 3 parts.

[0058] Preparation method: (1) Weighing raw materials: Weigh the raw materials of the composition astragalus, atractylodes macrocephala, schisandra chinensis, saposhnikovia divaricata, honeysuckle, forsythia suspensa, isatis indigotica, houttuynia cordata, reed rhizome, trichosanthes kirilowii, platycodon grandiflorus, and licorice according to the formula amount; (2) Soaking: Put the raw materials of the formula amount into a special container for decocting Chinese medicine, add 6 to 8 times the amount of cold water (drinking water that meets the national health standards), soak for 30 minutes, and prepare for decoction; (3) First decoction: Boil the soaked Chinese medicine and water over high heat, then turn to low heat and simmer for 10 to 20 minutes. Turn off the heat and simmer the decoction while it is still hot. (3) Filter the entire contents to obtain 200ml of medicinal liquid. Store it in a sterilized container for later use. (4) Second decoction: Add 6 to 8 times the amount of cold water (drinking water that meets national health standards) to the dregs from the first decoction. Boil over high heat until boiling, then reduce to low heat and continue to decoct for 10 to 20 minutes. Turn off the heat and filter the medicinal liquid while it is still hot. Press the dregs to filter the liquid. A total of 200ml of medicinal liquid is obtained. (5) Mixing: Pour the second decoction into the container holding the first decoction and mix evenly to obtain the medicinal liquid. Pack it in two bags, each bag containing 200ml.

[0059] Example 5: Granules

[0060] Weigh the raw materials and excipients according to the following proportions: Astragalus membranaceus 9 parts, Atractylodes macrocephala 6 parts, Schisandra chinensis 6 parts, Saposhnikovia divaricata 6 parts, Lonicera japonica 6 parts, Forsythia suspensa 6 parts, Isatis indigotica 6 parts, Houttuynia cordata 6 parts, Phragmites communis 6 parts, Trichosanthes kirilowii 6 parts, Platycodon grandiflorus 6 parts, Glycyrrhiza uralensis 3 parts; Inulin 3-10 parts, Sucralose 0.04-0.16 parts, and Isomaltitol to the total amount (small-scale test yield is about 20-25%).

[0061] Preparation method: (1) Pretreatment: Take isomaltitol, pulverize it and pass it through an 80-mesh sieve for later use. If the other materials are clumped, they can be passed through an 80-mesh sieve. (2) Decoction: Weigh out Astragalus membranaceus, Atractylodes macrocephala, Schisandra chinensis, Saposhnikovia divaricata, Lonicera japonica, Forsythia suspensa, Isatis indigotica, Houttuynia cordata, Phragmites communis, Trichosanthes kirilowii, Platycodon grandiflorus, and Glycyrrhiza uralensis according to the ingredient list, add 10 times the amount of water and decoct twice. The first decoction is for 2 hours and the second decoction is for 1 hour. Filter and set aside. (3) Concentration: Concentrate the filtrate under reduced pressure (-0.06 to -0.10 MPa, ≤70℃) to a thick paste with a relative density of 1.15 to 1.25 (60±2℃). (4) Drying: Dry the thick paste under reduced pressure (-0.06 to -0.10 MPa, ≤70℃). As for, after crushing through an 80-mesh sieve, dry extract powder is obtained and set aside; (5) Granulation: weigh isomaltitol, inulin and dry extract powder according to the formula and mix them together in a high-efficiency wet granulator for 5 minutes to obtain mixed powder; dissolve sucralose in 95% ethanol (about 18% of the total formula, the ethanol concentration and amount can be adjusted according to the actual situation) as a wetting agent to make soft material, granulate at 14 mesh, dry at 55±5℃ (the moisture content of the particles is controlled below 5%), granulate at 14 mesh to obtain dry particles and set aside; (6) Inner packaging: composite film packaging, 10g / bag; (7) Outer packaging: label, box, pack, and put into storage after inspection and approval; (8) Inspection and storage: after the finished product is inspected and approved, it is put into storage.

Claims

1. A composition for strengthening the body's resistance and preventing COVID-19, characterized in that it is The medicine is prepared from the following raw materials in the following weight ratio: Radix Astragali 3-27 parts, Rhizoma Atractylodis Macrocephalae 2-18 parts, Schisandra Chinensis 2-18 parts, Saposhnikovia Divaricata 2-18 parts, Lonicera Japonica 2-18 parts, Forsythia Suspensa 2-18 parts, Radix Isatidis 2-18 parts, Houttuynia Cordata 2-18 parts, Phragmites Communis 2-18 parts, Radix Trichosanthis 2-18 parts, Platycodon Grandiflorum 2-18 parts, and Glycyrrhiza Uralensis 1-9 parts.

2. The composition for preventing and treating new crown in claim 1, wherein the raw materials are in the following weight ratio: Radix Astragali 5-18 parts, Rhizoma Atractylodis Macrocephalae 3-12 parts, Schisandra Chinensis 3-12 parts, Saposhnikovia Divaricata 3-12 parts, Lonicera Japonica 3-12 parts, Forsythia Suspensa 3-12 parts, Radix Isatidis 3-12 parts, Houttuynia Cordata 3-12 parts, Phragmites Communis 3-12 parts, Radix Trichosanthis 3-12 parts, Platycodon Grandiflorum 3-12 parts, and Glycyrrhiza Uralensis 2-6 parts.

3. The composition for preventing and treating new crown in any one of claims 1-2, wherein the raw materials are in the following weight ratio: Radix Astragali 9 parts, Rhizoma Atractylodis Macrocephalae 6 parts, Schisandra Chinensis 6 parts, Saposhnikovia Divaricata 6 parts, Lonicera Japonica 6 parts, Forsythia Suspensa 6 parts, Radix Isatidis 6 parts, Houttuynia Cordata 6 parts, Phragmites Communis 6 parts, Radix Trichosanthis 6 parts, Platycodon Grandiflorum 6 parts, and Glycyrrhiza Uralensis 3 parts.

4. The preparation method of the composition for preventing and treating COVID-19 according to any one of claims 1 to 3, characterized in that The preparation is prepared by using a pharmaceutically acceptable carrier or excipient, and the preparation is granules, decoction, tablets, capsules or pills.

5. The preparation method of the composition for preventing and treating COVID-19 according to claim 4, characterized in that The pills are drop pills.

6. The preparation method of the composition for preventing and treating COVID-19 according to claim 4, characterized in that The granules are formula granules, and the formula granules are prepared by weighing the raw materials of the composition, i.e., Radix Astragali, Rhizoma Atractylodis Macrocephalae, Schisandra Chinensis, Saposhnikovia Divaricata, Lonicera Japonica, Forsythia Suspensa, Radix Isatidis, Houttuynia Cordata, Phragmites Communis, Radix Trichosanthis, Platycodon Grandiflorum and Glycyrrhiza Uralensis, in the formula amount, respectively, converting them into granules according to the national medicine standard for Chinese medicine formula granules issued by the State Drug Administration, mixing them, and packaging 10 grams per bag.

7. The preparation method of the composition for preventing and treating COVID-19 according to claim 4, characterized in that The decoction is prepared by the following steps: (1) weighing the raw materials: weighing the raw materials of the composition, i.e., Radix Astragali, Rhizoma Atractylodis Macrocephalae, Schisandra Chinensis, Saposhnikovia Divaricata, Lonicera Japonica, Forsythia Suspensa, Radix Isatidis, Houttuynia Cordata, Phragmites Communis, Radix Trichosanthis, Platycodon Grandiflorum and Glycyrrhiza Uralensis, in the formula amount, respectively; (2) soaking: putting the raw materials in the formula amount into a special container for decocting Chinese medicine, adding 6-8 times the amount of cold water, and soaking for 30 minutes for decocting; (3) first decocting: putting the soaked medicine and water into a container, boiling them with a strong fire, then changing to a weak fire and decocting for 10-20 minutes, turning off the fire, and completely pouring out the hot filtrate to obtain 200 ml of filtrate, which is stored in a sterilized container for use; (4) second decocting: adding 6-8 times the amount of cold water to the medicine residue from the first decocting, boiling them with a strong fire, then changing to a weak fire and decocting for 10-20 minutes, turning off the fire, and completely pouring out the hot filtrate and squeezing the medicine residue to obtain 200 ml of filtrate; (5) mixing: pouring the second decocted filtrate into the container containing the first decocted filtrate and mixing them evenly to obtain the filtrate, which is packaged in bags, 200 ml per bag.

8. The preparation method of the composition for preventing and treating COVID-19 according to claim 4, characterized in that Granules preparation accessories add inulin 3-10 parts, sucralose 0.04-0.16 parts, isomalt to the total amount, prepared according to the following steps: (1) pretreatment: take isomalt powder through 80 mesh sieve, ready for use, the rest of the material, if there is caking, can be through 80 mesh sieve; (2) decoction: according to the ingredients single called radix astragali, atractylodes, schisandra chinensis, windproof, honeysuckle, forsythia, isatis root, fishy grass, sedge root, tianhuafen, platycodon, licorice root plus 10 times the amount of water decoct 2 times, the first decocting 2 hours, the second decocting 1 hour, filtration, ready for use; (3) concentration: filtrate-0.06~ -0.10MPa, ≤70 ℃ under reduced pressure concentration to the relative density of 60±2 ℃ 1.15-1.25 thick paste; (4) drying: thick paste-0.06~ -0.10Mpa, ≤70 ℃ under reduced pressure drying to dry, crushing through 80 mesh sieve, dry extract powder, ready for use; (5) granulation: according to the formula amount of isomalt, inulin and dry extract powder together in high efficiency wet granulator mixed 5 minutes, get mixed powder; sucralose dissolved in 95% ethanol as wetting agent to make soft material, 14 granulation, 55±5 ℃ temperature drying, granules water content control in 5% below, 14 whole grain, dry granules, ready for use; (6) inner packaging: composite film packaging, 10g / bag; (7) outer packaging: label, box, packing, after inspection qualified into warehouse; (8) inspection into warehouse: the finished product after inspection qualified, into warehouse.

9. Use of the composition of any one of claims 1-3 in the preparation of a drug for the treatment of COVID-19 infection.

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