Traditional Chinese medicine composition and application thereof

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials: pericarpium citri reticulatae, mulberries, dandelions, fructus lycii, rhizoma zingiberis, longan and liquorice. The traditional Chinese medicine composition disclosed by the invention can exert the overall regulation advantage of the compound traditional Chinese medicine, organically combines the functions of removing pathogenic factors, relieving symptoms and regulating immunity, realizes multi-target treatment, and has a remarkable curative effect on preventing and / or treating respiratory infectious diseases such as novel coronavirus infection and severe influenza according to clinical experiments. And the effect is obviously better than that of the selected similar control drug.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition and its uses. In particular, it relates to a traditional Chinese medicine composition for preventing and / or treating respiratory infectious diseases, especially diseases caused by the novel coronavirus, and its uses. Background Art

[0002] Corona Virus Disease 2019 (COVID-19) refers to pneumonia caused by the novel coronavirus infection in 2019.

[0003] The clinical manifestations of patients with pneumonia caused by the novel coronavirus infection are mainly fever, fatigue, and dry cough. Upper respiratory symptoms such as nasal congestion and runny nose are rare, and hypoxic and low-oxygen states will occur. Approximately half of the patients will develop dyspnea after about one week, and severe cases will rapidly progress to acute respiratory distress syndrome, septic shock, difficult-to-correct metabolic acidosis, and coagulation dysfunction. It should be noted that critically ill patients may have moderate or low fever during the course of the disease, or even no obvious fever. Some patients have mild onset symptoms and may not have fever, and mostly recover after 1 week. Most patients have a good prognosis, and a few patients have severe illness and even die.

[0004] The disease caused by the novel coronavirus infection is a newly emerging disease, and medical experts' understanding and knowledge of this disease are not yet comprehensive and profound enough. In the prior art, Lianhua Qingwen has a good therapeutic effect on the inflammation of patients with pneumonia caused by the novel coronavirus, but its direct inhibitory effect on the virus is relatively weak.

[0005] There are many symptoms of the novel coronavirus infection, especially white lung. Although traditional Chinese medicine has irreplaceable advantages in the treatment of diseases caused by the novel coronavirus infection, existing traditional Chinese medicines generally have disadvantages such as low efficacy and long medication time.

[0006] Therefore, there is still a huge demand for traditional Chinese medicines that are effective, have a rapid onset, and are safe in the treatment of diseases caused by the novel coronavirus. Summary of the Invention

[0007] In view of the deficiencies of the prior art, based on long-term clinical practice and multiple improvements, the present inventor provides a traditional Chinese medicine composition that can reverse novel coronavirus infection or other respiratory infectious diseases. The characteristics of the composition of the present invention are that the raw materials are composed of natural plants, all of which are included in the catalog of homologous medicines and foods released by the State Administration of Traditional Chinese Medicine, and are natural plants that can be used both as medicine and food. The main efficacy is to prevent and / or treat novel coronavirus infection (pneumonia caused by the novel coronavirus) and other various respiratory infectious diseases such as colds. For the post-infection symptoms such as dizziness, shortness of breath, sore throat, soreness of the muscles and bones of the spine and limbs, thick and yellowish phlegm and runny nose, nausea and vomiting, loss of appetite, difficult urination and defecation, tinnitus, palpitations, restlessness and insomnia, soreness of the waist and knees, premature whitening of hair, polydipsia, dry mouth, dry and itchy eyes, dry and scaly skin, etc., it can significantly relieve and ultimately cure them. At the same time, it can significantly improve the aggravation of underlying diseases caused by infection.

[0008] Therefore, an object of the present invention is to provide a traditional Chinese medicine composition, the raw materials of which include: dried tangerine peel, mulberry, dandelion, wolfberry fruit, dried ginger, longan, liquorice.

[0009] Preferably, the raw materials of the traditional Chinese medicine composition include: dried tangerine peel, mulberry, dandelion, wolfberry fruit, jujube, rose, dried ginger, longan, liquorice.

[0010] More preferably, the raw materials of the traditional Chinese medicine composition include: dried tangerine peel, mulberry, dandelion, wolfberry fruit, jujube, rose, dried ginger, longan, liquorice, roselle, mint.

[0011] Preferably, in terms of parts by weight, the dosage of the raw materials is:

[0012]

[0013] Further preferably, in terms of parts by weight, the dosage of the raw materials is:

[0014]

[0015]

[0016] Further preferably, in terms of parts by weight, the dosage of the raw materials is:

[0017]

[0018] In a specific embodiment, in terms of parts by weight, the dosage of the raw materials is:

[0019]

[0020] Preferably, the liquorice is raw liquorice.

[0021] Preferably, the mint is mint leaves; more preferably, fresh mint leaves are used.

[0022] Another object of the present invention is to provide a method for preparing the Chinese medicine composition, which comprises the following steps:

[0023] Take tangerine peel and mint, add water, and steam distill to obtain volatile oil; filter the water extract and optionally concentrate to obtain extract 1;

[0024] Take mulberry, dandelion, wolfberry, jujube, rose, dried ginger, longan, licorice, and roselle, add water, heat, filter the water extract, and optionally concentrate to obtain extract 2;

[0025] The volatile oil, extract 1 and extract 2 are mixed to obtain the product.

[0026] Preferably, the amount of water added is 5-8 times the weight of the raw materials.

[0027] Preferably, the water extraction adopts a decoction method, each time for 10-20 minutes, and the number of extractions is 4-6 times.

[0028] Preferably, the water extraction adopts a decoction method, each time for 15 minutes, and the number of extractions is 5 times.

[0029] Another object of the present invention is to provide the use of the traditional Chinese medicine composition in the preparation of medicines for preventing and / or treating respiratory infectious diseases (such as colds).

[0030] In particular, the present invention provides the use of the traditional Chinese medicine composition in the preparation of a drug for preventing and / or treating diseases caused by novel coronavirus infection (e.g., pneumonia caused by novel coronavirus).

[0031] In particular, the Chinese medicine composition of the present invention is used to relieve or cure one or more of the following symptoms: fever, cough, fatigue, sore throat, cough, shortness of breath and sputum, bone and joint pain, muscle aches, difficulty in defecation and urination, and white lung.

[0032] In particular, the Chinese medicine composition of the present invention is used to relieve or cure one or more of the following symptoms: dizziness, shortness of breath, fatigue, sore throat, soreness of the spine, limbs, muscles and bones, excessive phlegm and yellow-green mucus, nausea and vomiting, poor appetite, difficulty in defecation and urination, tinnitus, palpitations, irritability and insomnia, soreness of the waist and knees, premature graying of hair, thirst, dry mouth, dry and itchy eyes, dry skin, and white lungs.

[0033] The Chinese medicine composition of the present invention can give play to the overall regulatory advantages of compound Chinese medicine, organically combine the elimination of pathogens, relief of symptoms, and immune regulation to achieve multi-target treatment. Clinical experiments have confirmed that it has significant therapeutic effects on the prevention and / or treatment of respiratory infectious diseases such as pneumonia and severe influenza caused by new coronavirus infection, and its effect is significantly better than that of the selected similar control drugs. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 For the antigen test results of the nasal and pharyngeal swabs of the patient.

[0035] Figure 2 For the lung CT images before and after treatment in the clinical treatment group. Detailed implementation manners

[0036] The present invention will be described below by way of examples, but the present invention is not limited thereto. The experimental methods shown in the following examples are all conventional methods unless otherwise specified. The reagents and materials shown are all commercially available products.

[0037] First, the traditional Chinese medicine composition of the present invention is explained from the perspectives of traditional medicine and modern phytochemistry.

[0038] Tangerine peel

[0039] From the perspective of the inheritance records in the classics of traditional medicine, tangerine peel is warm in nature, pungent and bitter in taste, enters the spleen meridian, stomach meridian and lung meridian, can regulate qi and strengthen the spleen, regulate the middle, dry dampness and resolve phlegm. It is mainly used for treating abdominal distension or pain caused by qi stagnation in the spleen and stomach, indigestion. Chest and abdominal distension, poor appetite and loose stools caused by damp turbidity blocking the middle. Cough and asthma caused by phlegm-dampness congesting the lung. It is used for chest and epigastric fullness, anorexia, vomiting and diarrhea, and cough with profuse phlegm. "Compendium of Materia Medica" states: Its main function is to regulate qi and dry dampness. When combined with tonics, it tonifies; when combined with laxatives, it purges; when combined with ascending drugs, it ascends; when combined with descending drugs, it descends. The spleen is the mother of the vital energy, and the lung is the key to controlling qi. Therefore, tangerine peel is an important drug for the qi of the two meridians, but its effects of tonifying, purging, ascending and descending vary according to the combination. "Daily Use Materia Medica" states: It can disperse, purge, warm and tonify, eliminate diaphragmatic qi, resolve phlegm, harmonize the spleen and stop cough, and dredge the five types of stranguria. "Explanation of the Compendium of Materia Medica" states: Pungency can disperse, bitterness can purge, and warmth can promote qi movement, so the adverse qi can descend, vomiting and cough can stop, and the chest mass and heat can be eliminated. "Collection of Remarks on Materia Medica" states: It is pungent and good at dispersing, so it can promote qi; it is bitter and can promote the discharge of fluid, so it can resolve phlegm; its nature is mild and it is good at promoting qi movement, so it can stop vomiting, stop cough, strengthen the spleen and harmonize the stomach. Li Dongyuan said: People take the spleen and stomach as the main, and treat diseases by regulating qi first. If you want to regulate qi and strengthen the spleen, tangerine peel ranks first in its effects. Warmth can promote qi movement, pungency can disperse, and bitterness can discharge water.

[0040] From the perspective of modern phytochemistry, the main component of the volatile oil extracted from tangerine peel by this method is limonene (molecular formula: C 10 H 16)。Limonene is a monoterpene compound with good antitussive, expectorant, and antibacterial effects. Compound limonene can be used clinically for choleresis, litholysis, promoting the secretion of digestive juices, and expelling intestinal gas. The main component of the water extract of tangerine peel is hesperidin. Hesperidin is a flavonoid compound with definite pharmacological activity and a wide range of functions. Hesperidin is a drug for treating hypertension and myocardial infarction, with anti-lipid oxidation, scavenging of oxygen free radicals, anti-inflammatory, antiviral, and antibacterial effects. Long-term use can delay aging and prevent cancer. At the same time, hesperidin can also enhance the toughness of capillaries, shorten bleeding time, and reduce cholesterol. In addition, hesperidin has a broad-spectrum antibacterial effect on common food contaminating bacteria, and has significant inhibitory effects on Bacillus subtilis, Salmonella typhimurium, Shigella flexneri, Streptococcus hemolyticus, and Vibrio cholerae, etc. Clinically, it also has a definite effect of alleviating and anti-inflammatory on vascular diseases such as hemorrhoids, varicose veins, poor circulation, and venous stasis.

[0041] Mulberry

[0042] From the perspective of the inheritance and records in ancient medical classics of traditional medicine, mulberry (sang shen) tastes sweet, sour, and slightly cold, enters the heart, liver, and kidney meridians, and is an excellent fruit for nourishing and strengthening the body and nourishing the heart and enhancing intelligence. It has the effects of enriching blood and nourishing yin, promoting the production of body fluids to quench thirst, and moistening the intestines and relieving constipation, etc. It is mainly used to treat dizziness, tinnitus, palpitation, restlessness, insomnia, soreness and weakness of the waist and knees, early whitening of hair, thirst, dry mouth, constipation caused by insufficient yin and blood, tonifying the liver and kidney, calming endogenous wind, and nourishing body fluids, treating consumptive thirst, constipation, dim vision, tinnitus, scrofula, and joint discomfort due to deficiency of the liver and kidney yin. "Tang Materia Medica" states that eating it alone can treat consumptive thirst. "Supplementary Materia Medica" states that it benefits the five zang-organs, joints, and promotes qi and blood circulation; "Yanyi of Materia Medica" states that it can treat febrile thirst, generate spirit, and clear the heat of the small intestine. "Compendium of Materia Medica in Yunnan" states that it benefits the kidneys and consolidates essence, and long-term use can blacken hair and improve eyesight. "Compendium of Materia Medica" states that drinking its juice can relieve alcohol poisoning, and brewing and taking it can promote diuresis and reduce swelling. "Yuqiao's Explanation of Materia Medica" states that it can treat stranguria, scrofula, and bald sores. "Truth Seeking of Materia Medica" states that it can clear heat, nourish yin, and relieve diarrhea. "Dietetic Recipes for Health Preservation" states that it nourishes the liver and kidneys, enriches the blood, dispels wind-dampness, strengthens the steps, calms endogenous wind, and clears deficiency-fire.

[0043] From the perspective of modern phytochemistry, the main components of mulberry are polyphenols and polysaccharides, which are functional components with diverse physiological activities. Polyphenols have the effects of antioxidant, anti-tumor, hypoglycemic and hypolipidemic, anti-atherosclerotic, antibacterial, promoting bone marrow hematopoiesis function, and whitening, etc. Polysaccharides have the effects of protecting the liver, reducing blood lipids, regulating intestinal flora, anti-aging, immune protection, and anti-inflammatory.

[0044] Dandelion

[0045] From the perspective of traditional medicine, dandelion is sweet, slightly bitter, and cold in nature. It belongs to the liver and stomach meridians. It has the effects of diuresis, laxation, reducing jaundice, and promoting gallbladder function. It can treat heat toxins, carbuncles, sores, internal abscesses, red and swollen eyes, damp-heat, jaundice, painful and difficult urination, furuncles, breast abscess, scrofula, toothache, red eyes, sore throat, lung abscess, intestinal abscess, damp-heat jaundice, and painful and difficult strangury. It can treat acute mastitis, lymphadenitis, scrofula, furunculosis, acute conjunctivitis, fever due to cold, acute tonsillitis, acute bronchitis, gastritis, hepatitis, cholecystitis, urinary tract infection, etc. It has a significant inhibitory effect on Escherichia coli, Shigella flexneri, hemolytic streptococcus, and Vibrio cholerae, etc.

[0046] From the perspective of modern phytochemistry, it mainly contains various healthy nutritional components such as taraxasterol, taraxacin, choline, organic acids, and inulin. In addition, it also contains a large amount of carbohydrates, proteins, as well as trace elements and vitamins. Taraxasterol, etc. have the effects of antibacterial, anti-tumor, protecting the liver and gallbladder, and anti-ulcer, the effects of regulating the stomach and relieving pain, clearing heat and promoting diuresis, promoting blood circulation and detumescence, and can improve the body's immunity, relieve the patient's loss of appetite, with small side effects and significant curative effects, and can prolong the survival time and improve the quality of life of gastric cancer patients. The presence of choline can correct and repair DNA, liver cells, and nerve cells. Since the most direct damage caused by the invasion of the novel coronavirus into the body is the misrecognition between the internal organs and the human body system, the application of choline in dandelion can exactly correct the misrecognition problem of the immune system caused by the infection.

[0047] Wolfberry

[0048] From the perspective of traditional medicine, wolfberry is sweet and flat in nature and belongs to the liver and kidney meridians. It tonifies the liver and kidney gently and has a tonic and strengthening effect. It can be applied to all syndromes of liver and kidney yin deficiency, such as dizziness due to liver and kidney deficiency and blood essence deficiency, decreased vision, or soreness and weakness of the waist and knees, spermatorrhea, deficiency of essence and qi due to liver and kidney yin deficiency, soreness and pain of the waist and knees, dizziness and tinnitus, internal heat and thirst, blood deficiency and sallow complexion, blurred vision, etc. The traditional classic "Shennong Ben Cao Jing" records: "Taking wolfberry for a long time can strengthen the muscles and bones, withstand cold and heat, make the body light and never grow old, and it is the top-grade among traditional Chinese medicines." "Compendium of Materia Medica" records: "Wolfberry is sweet, flat and moist, and its nature is nourishing... It can tonify the kidney, moisten the lungs, produce essence, and benefit qi. This is a mild tonic medicine." As is well known, Ningxia wolfberry is a traditional precious Chinese medicinal material in China, with the effects of tonifying the kidney and liver, moistening the lungs and improving eyesight, and has received great attention from Chinese and foreign medical experts and dietotherapy and health preservation experts.

[0049] From the perspective of modern phytochemistry, the main chemical components of wolfberry fruits are wolfberry polysaccharides, and it also contains betaine, atropine, and hyoscyamine; it also contains zeaxanthin, physalein, cryptoxanthin, scopoletin, carotene, riboflavin, niacin, vitamin B1, B2, and C. The seeds contain amino acids: aspartic acid, proline, alanine, leucine, etc. Wolfberry polysaccharide is a water-soluble polysaccharide composed of 6 monosaccharide components: arabinose, glucose, galactose, mannose, xylose, and rhamnose. It has physiological activity, can enhance non-specific immune function, improve disease resistance, and inhibit tumor growth and cell mutation. Intraperitoneal injection of wolfberry polysaccharide can significantly increase the value of 3H-TdR incorporation into splenic T cells under the induction of ConA. Wolfberry polysaccharide has an obvious inhibitory effect on the transformation reaction of splenic T cells.

[0050] Jujube

[0051] From the perspective of traditional medicine, jujube is sweet in taste and warm in nature. It acts on the spleen and stomach meridians. It can invigorate the middle energizer and replenish qi, nourish blood and soothe the nerves. It is used for less appetite due to spleen deficiency, fatigue and loose stools, and restlessness of women. "Shennong Ben Cao Jing": "It can treat pathogenic factors in the heart and abdomen, soothe the spleen in the middle, and assist the twelve meridians. It can regulate the stomach qi, open the nine orifices, tonify qi deficiency and fluid deficiency, relieve the deficiency in the body, relieve severe fright, relieve heaviness of the limbs, and harmonize various herbs." "Bencao Jizhu": "It can neutralize the toxicity of aconite." "Bie Lu": "It can invigorate the middle energizer and replenish qi, strengthen the body, relieve restlessness, and treat the condition of stuffiness in the heart and diarrhea." Meng Shen: "It can mainly tonify body fluids, wash away pathogenic factors in the heart and abdomen, neutralize the toxicity of various herbs, open the nine orifices, tonify qi deficiency, cook and eat to nourish the stomach and intestines, and it is the best for tonifying qi in the middle. For children suffering from autumn dysentery, eating it with insect jujube is good." "Rihuazi Bencao": "It can moisten the heart and lungs, relieve cough. Tonify the five zang-organs, treat deficiency and fatigue, and eliminate the qi stagnation in the stomach and intestines." "Zhenzhunang": "It can warm the stomach." Li Gao: "It can warm to tonify the deficiency of the spleen meridian, soothe the yin blood with sweetness, harmonize yin and yang, regulate nutrient qi and defensive qi, and promote the production of body fluids." "Yaopin Huayi": "It can nourish blood and soothe the liver." "Bencao Zaixin": "It can invigorate the middle energizer and replenish qi, nourish the kidney and warm the stomach, and treat yin deficiency." "Chinese Medicinal Herb Illustrations": "It can treat allergic purpura, anemia and hypertension." "Bencao Xinbian": "It can open the nine orifices, harmonize various herbs, nourish the lungs and stomach, replenish qi, moisten the heart and lungs, promote the production of body fluids, assist various meridians, and tonify the five zang-organs. However, it should not be eaten by those with abdominal fullness and heat diseases, and should not be tasted by those with toothache and wind diseases. It is a harmonizing herb, not a tonifying herb." What "Shennong Ben Cao Jing" said about its tonifying effect is also due to its harmonizing property.

[0052] Rose

[0053] From the perspective of traditional medical classics, roses are sweet with a slight bitterness, slightly warm in nature, and belong to the liver, spleen, and stomach meridians. In "Compendium of Materia Medica", it is stated that: "Roses are clear without being turbid, harmonious without being violent, soothing the liver and awakening the stomach, regulating qi and activating blood circulation, dredging stagnation without any disadvantages of being pungent, warm, and rigid. It is undoubtedly the most effective and gentle among qi-regulating herbs, and there is hardly any match among fragrant herbs." Lu He in the Ming Dynasty said in "Food Materia Medica": "Eating roses is fragrant, sweet, and delicious, making people feel refreshed." "Supplementary Records to Compendium of Materia Medica" records that roses harmonize blood, promote blood circulation, regulate qi, and can be used as medicine to treat wind arthralgia, liver and stomach qi pain, chest and abdominal distension, irregular menstruation and other diseases.

[0054] From the perspective of modern phytochemistry, roses contain more than 300 chemical components, such as aromatic alcohols, aldehydes, fatty acids, phenols, and oils and fats containing fragrances. Regular consumption of rose products can soothe the liver and awaken the stomach, regulate qi and activate blood circulation, beautify the face and nourish the skin, and make people feel refreshed. The newly opened flowers of roses can be used as medicine, with the effects of regulating qi, activating blood circulation, and astringing. It is mainly used to treat irregular menstruation, traumatic injuries, liver qi stomach pain, breast swelling and pain, etc.

[0055] Dry ginger

[0056] From the perspective of the inheritance level of traditional medicine, dried ginger has a pungent taste and a hot nature. It belongs to the spleen, stomach, heart, and lung meridians. In traditional Chinese medicine, it is mainly used clinically for warming the middle-jiao to dispel cold, strengthening the spleen-yang, restoring yang and promoting blood circulation, drying dampness and resolving phlegm, and warming the lungs to resolve fluid-retention. Therefore, it is used for vomiting and diarrhea caused by cold pain in the epigastrium and abdomen, syncope due to yang collapse, cold-fluid dyspnea and cough, and cold-damp arthralgia. Due to its function of restoring yang, it is used to treat syncope and reversal of qi due to heart and kidney yang deficiency and internal exuberance of yin cold, with a faint pulse on the verge of exhaustion, cold body and cold back, and profuse and clear phlegm. In addition, it can also treat traumatic suppurative infections and enuresis. "Supplementary Records of the Divine Husbandman's Classic of Materia Medica": "Great heat, non-toxic." "Materia Medica Compendium for Compatibility": "Dried ginger enters the qi aspect of the hand-shaoyin and foot-taiyin meridians; prepared ginger enters the blood aspect of the foot-taiyin meridian." "Shennong's Classic of Materia Medica": "It is mainly used for fullness in the chest, cough with reversed qi, warming the middle-jiao, stopping bleeding, promoting sweating, expelling wind-damp arthralgia, and diarrhea due to intestinal obstruction. The raw one is especially good." "Supplementary Records of the Divine Husbandman's Classic of Materia Medica": "It treats cold pain in the abdomen, sudden syncope, cholera, distension, various wind toxins, qi stagnation in the skin, and stops spitting blood." "Treatise on Medicinal Properties": "It treats cold pain in the waist and kidneys, cold qi, promoting blood circulation, expelling wind, dredging the joints of the four limbs, opening the five zang-organs and six fu-organs, dispelling wind-toxin and cold arthralgia, and frequent urination at night. It treats cough, mainly for warming the middle-jiao, continuous cholera, abdominal pain, relieving distension and cold diarrhea, and treating blood stasis obstruction. For patients who are weak and cold, it is advisable to add it." "Newly Revised Materia Medica": "It treats wind, lowers qi, stops bleeding, dredges all the collaterals, and causes slight sweating." "Materia Medica of Ri Hua Zi": "It resolves phlegm and lowers qi, treats cramps, vomiting and diarrhea, cold in the abdomen and viscera, nausea and vomiting due to inversion of the stomach, blood stasis, contusions and strains, stops epistaxis, relieves cold and heat toxins, promotes appetite, and eliminates retained food." "Medical Origins": "According to 'The Essentials of Treatment', it promotes the flow of heart qi, helps yang, dispels the profound cold in the zang-fu organs, releases the cold qi in all the meridians, and treats abdominal pain due to cold contraction." Wang Haogu: "It is mainly used for cold and stuffy feeling in the epigastrium, and long-term eye pain." "After being prepared, it warms the spleen and dries the stomach." "Introduction to Medicine": "Prepared ginger warms the spleen and stomach, treats diarrhea due to internal cold, dysentery, chronic malaria, cholera; cold pain and distension in the abdomen and chest, stops epistaxis, spitting blood, bloody dysentery, and metrorrhagia." "Interpretation of the Properties of Medicinal Herbs": "Prepared ginger reduces deficiency heat." "Explanation of Medicinal Herbs in Treatise on Febrile Diseases Caused by Cold": "It dries dampness and warms the middle-jiao, promotes qi movement and reduces turbidity, descends adverse qi, relieves cough, lifts sunken qi, and stops slippery diarrhea." "Collection and Annotation of the Classic of Materia Medica": "It is used in combination with Chinese prickly ash. It is incompatible with Coptis chinensis, Scutellaria baicalensis, and feces of bats. It can detoxify Pinellia ternata and Hyoscyamus niger." "Explanation of the Classic of Materia Medica": "Taking it for a long time will damage yin and harm the eyes. It is contraindicated for those with yin deficiency and internal heat, yin deficiency with cough and vomiting blood, exterior deficiency with heat and sweating, spontaneous sweating and night sweating, internal hemorrhoids with bloody stools, vomiting and nausea due to heat, and hot abdominal pain."

[0057] From the perspective of modern phytochemistry, dried ginger contains a large amount of gingerenone, a small amount of gingerol, and a trace amount of gingerone; fresh ginger contains a large amount of gingerol, a small amount of gingerenone, and no gingerone. Its water extract has a definite analgesic effect. The dried ginger infusion has an inhibitory tendency on the spontaneous movement of mice and can prolong the sleeping time of hexobarbital. When the dried ginger infusion (0.25 g / kg) was intravenously injected into rats, a transient increase in blood pressure occurred first, followed by a decrease in blood pressure, and it could enhance the atrial autonomous activity. Regarding the effect on the digestive system, the dried ginger infusion has an inhibitory effect on stress ulcers. The dried ginger infusion can inhibit gastric juice acidity and gastric juice secretion, and its inhibitory effect on stress ulcers is related to this. Both the ether extract and water extract of dried ginger have obvious anti-inflammatory effects. The dried ginger infusion and gingerenone by gavage have no obvious effect on carrageenan-induced paw swelling in rats. When the dose of gingerenone is doubled, it has an obvious anti-inflammatory effect, and its strength is weaker than that of indomethacin (5 mg / kg). The ether extract of dried ginger has an anti-hypoxia effect and can prolong the survival time of mice under normal pressure hypoxia and potassium cyanide poisoning hypoxia; it can also prolong the respiratory maintenance time after acute cerebral ischemia and hypoxia caused by decapitated mice, but only has a tendency to prolong the survival time of mice poisoned by sodium nitrite and has no effect on the low-temperature survival time of mice. The water extract of dried ginger and the volatile oil of dried ginger by gavage can significantly prevent the formation of experimental thrombosis in rats. The decoction of dried ginger has the effect of prolonging the coagulation time and partially dissolving fibrin. The dried ginger infusion has an obvious inhibitory effect on the vomiting of frogs induced by the peripheral emetic copper sulfate; the decoction of dried ginger has no inhibitory effect on the vomiting of pigeons induced by the central emetic apomorphine and digitalis. The dried ginger infusion can inhibit vascular permeability, and gingerol and gingerenone have a significant effect on killing snails.

[0058] Longan

[0059] From the perspective of traditional medicine, longan is of neutral nature and sweet taste; it enters the heart, liver, spleen, and kidney meridians. "Shennong Ben Cao Jing" states that it is also called "Yi Zhi Zi" because the sweet taste enters the spleen and can improve intelligence, which is not the current "Yi Zhi Zi". "Shennong Ben Cao Jing": "It can treat the pathogenic qi of the five zang-organs, calm the mind, reduce anorexia. Long-term use can strengthen the soul, enhance intelligence." "Kaibao Ben Cao": "Entering the spleen and being able to improve intelligence." "Diannan Ben Cao": "Nourish blood and soothe the nerves, improve intelligence and reduce sweating, promote appetite and benefit the spleen." "Depei Ben Cao": "Benefit the spleen and stomach, nourish the heart blood, moisten the five zang-organs, and treat palpitations." "Quanzhou Ben Cao": "Strengthen yang and replenish qi, tonify the spleen and stomach, treat postpartum edema in women, qi deficiency edema, and spleen deficiency diarrhea."

[0060] From the perspective of modern phytochemistry and modern medical research, longan pulp contains protein, fat, carbohydrates, organic acids, crude fiber, and various vitamins and minerals, etc. It can inhibit lipid peroxidation and increase the activity of antioxidant enzymes, suggesting that it has a certain anti-aging effect, and has the effects of enhancing the body's immune function, inhibiting tumor cells, reducing blood lipid, increasing coronary blood flow, and strengthening the body's quality.

[0061] Licorice

[0062] From the perspective of traditional medicine, licorice is of neutral nature, sweet in taste, and belongs to the twelve meridians. It has pharmacological effects such as detoxification, expectoration, pain relief, spasmolysis, diuresis, and even anti-cancer effects. In traditional Chinese medicine, licorice invigorates the spleen and replenishes qi, nourishes the lungs to relieve cough, relieves spasm and detoxifies, and harmonizes all kinds of medicines. When used raw, it is mainly used to treat sore throat, carbuncles and ulcers, gastrointestinal ulcers, as well as to relieve drug poisoning and food poisoning. It is also commonly used in the treatment of heart qi deficiency, palpitations, uneven pulse, as well as spleen and stomach qi deficiency, lassitude and weakness, and the treatment of painful urination due to heat strangury. It can be used to treat asthma and cough without distinguishing between wind-heat cough, wind-cold cough, and heat-phlegm cough. It is also used for stomachache, abdominal pain, and acute pain of gastrocnemius muscle spasm. It is also a commonly used agent to reconcile the potency of certain drugs, so-called harmonizing all kinds of medicines. Tao Hongjing, a medical scientist in the Southern Dynasties, honored licorice as the "national elder" and said: "This herb is the king of all herbs, and there are few classical prescriptions that do not use it." "National elder" means the title of the emperor's teacher. The reason for respecting licorice as the "emperor's teacher" of herbs is as explained by Li Shizhen in "Compendium of Materia Medica": "Licorice is the monarch among all herbs. It can treat 72 kinds of milk and stone poisons, relieve 1,200 kinds of herbal poisons, and has the merit of harmonizing all kinds of medicines, so it has the title of 'national elder'."

[0063] It has been found from modern phytochemistry and western pharmacology research that licorice preparations have anti-inflammatory and anti-allergic functions. Therefore, in western clinical medicine, it is mainly used as a demulcent. It can relieve cough, expectorate phlegm, and treat pharyngitis and laryngitis; Licorice or glycyrrhetinic acid has the effects of desoxycorticosterone, and has good efficacy for chronic adrenocortical hypofunction; Licorice preparations can promote the formation and secretion of gastric mucus, prolong the lifespan of epithelial cells, and have anti-inflammatory activity, and are commonly used in the treatment of chronic ulcers and duodenal ulcers; The flavonoids of licorice have anti-inflammatory, spasmolytic, and anti-acid effects.

[0064] Roselle

[0065] From the perspective of traditional medicine, roselle is pungent in flavor, slightly cool in nature, enters the kidney meridian, and is mainly used for diuresis, clearing heat and relieving summer heat, beautifying the face, removing freckles, and relieving alcoholism. It was first recorded in "Lingnan Agricultural Journal". The calyx and seed oil have curative effects on cardiovascular diseases, arteriosclerosis, hypertension, fractures, poor growth of children, indigestion in the elderly, and lack of gastric acid. The calyx (fresh or dried) has the medicinal effects of lowering blood pressure, anti-scurvy, and diuresis, and has a relieving effect on bronchitis and cough.

[0066] From the perspective of modern phytochemistry, Roselle has a faint fragrance and a sour taste, containing nutrients such as vitamin C, sambunigrin, and citric acid. The calyx of Roselle is a fleshy structure, juicy, rich in protein, organic acids, vitamin C, various amino acids, a large amount of natural vitamins, and minerals required by the human body, such as iron, calcium, and phosphorus. Roselle contains seventeen kinds of amino acids essential for the human body, such as aspartic acid, glutamic acid, proline, glycine, alanine, lysine, and arginine, as well as anthocyanins, polyphenols, furfural, and hydroxymethylfurfural with significant antioxidant functions, especially high in Vc - ascorbic acid. These components have the effects of calming the liver and reducing fire, clearing heat and inflammation, promoting fluid production to quench thirst, reducing blood pressure and fat, refreshing the mind and calming the nerves, and scavenging free radicals. Among them, hibiscus acid is considered to have certain curative effects on treating heart diseases, hypertension, arteriosclerosis, etc., and can reduce cholesterol and triglycerides. Some other components also have spasmolytic effects on the intestines and uterine muscles, and at the same time have anthelmintic effects, can promote juice secretion, reduce blood concentration, and stimulate intestinal wall peristalsis. Roselle not only has the above - mentioned medical and health - care effects, but also is a food with excellent color, fragrance, and taste. The pure - natural healthy drink produced from it is a rare natural beverage. The calyx of Roselle can also be used medicinally. It tastes sour and is cold in nature, with the effects of clearing heat and relieving summer heat, diuretic and antihypertensive, beautifying and removing freckles, detoxifying, and relieving hangover. Modern research shows that Roselle contains flavonoids, protocatechuic acid, anthocyanins, isoflavones, as well as rich amino acids, vitamins, sugars, organic acids, inorganic salts and other chemical components, which can reduce cholesterol and triglycerides, inhibit the oxidation of low - density lipoprotein, inhibit platelet aggregation, reduce the formation of thrombus, and reduce atherosclerosis, and can effectively prevent the occurrence of cardiovascular diseases. The calyx and seed oil of Roselle have curative effects on cardiovascular diseases, arteriosclerosis, hypertension, fractures, poor growth in children, indigestion in the elderly, and lack of gastric acid. Roselle has the effects of relieving summer heat, reducing blood pressure, and strengthening blood vessel elasticity, and can treat hypertension, heatstroke, cough, and drunkenness. It can clear heat and detoxify, has the effects of helping digestion and promoting fluid production to quench thirst, and also has the effect of detoxifying all poisons. Research results in the medical field show that: Roselle protocatechuic acid (PCA) can promote the apoptosis of blood cancer cells; Roselle extract (Rs) can inhibit the carcinogenic effect of chemical substance (AOM) on colon cancer; Roselle polyphenol (HPE) can promote the apoptosis of gastric cancer cells; Roselle anthocyanin (HAc) can promote the apoptosis and death of blood cancer cells; The extract of Roselle can increase the role of glutathione (GSH) in protecting liver function; Roselle anthocyanin (HAc) can also inhibit drug - induced liver oxidative damage. The extract of Roselle can also regulate blood pressure and improve sleep.

[0067] Mint

[0068] According to traditional medical records, mint is pungent and cool in nature, and is a diaphoretic and antipyretic drug. It is good at dispelling wind, dissipating heat, warding off filth, and detoxifying. It can treat exogenous wind-heat, headache, red eyes, sore throat, food stagnation and bloating, mouth sores, toothache, scabies, and eczema. "Yao Xing Lun": "Removes anger, induces toxic sweat, stops blood and stops dysentery, and clears joints." "Qian Jin·Shi Zhi": "Removes kidney qi, makes people's breath fragrant and clean. Mainly wards off evil spirits and poisons, and eliminates fatigue." Sun Siyao: "Boil the soup to wash lacquer sores." "Tang Materia Medica": "It treats evil wind and sweats. (Cure) bad breath and abdominal distension. Cholera. Indigestion, and relieves gas." "Shi Liao Materia Medica": "Pound the juice and take it to remove wind and heat from the heart." "Shi Xing Materia Medica": "It can lead all medicines into the Yingwei. Treat yin and yang poisons, typhoid fever and headache." "Rihuazi Materia Medica": "Treats aphonia and spitting caused by stroke. Eliminates evil wind. Treats abdominal distension. Lowers gas, eliminates stagnation and headache, etc." "Compendium of Materia Medica": "Treats colds, head winds, Tongguan grid, and wind saliva in children." "Compendium of Materia Medica": "Children's convulsions, high fever, must This is the lead medicine; it treats bone steaming and fatigue fever, and its juice is used with other medicines as an ointment. "Li Gao: "It is mainly used to clear the head and eyes." Wang Haogu: "It can search for liver qi. It also treats lung excess, shoulder and back pain, and wind-cold sweating." "Southern Yunnan Materia Medica": "It treats all typhoid headaches, cholera vomiting and diarrhea, carbuncle, ulcer, scabies, epilepsy and other sores." Also: "Wild mint clears the head and eyes, stops headaches, dizziness, fever, removes wind phlegm, treats colds and coughs, brain leakage and runny nose, and reduces fever due to consumptive tuberculosis." "Compendium of Materia Medica": "It benefits the throat and mouth and teeth. It treats scrofula, sores and scabies, wind itching and urinary rashes." "Compendium of Materia Medica": "It treats stroke, epilepsy, and injury caused by dryness and heat." "Medical Collection": "It cures toothache, hot cough, relieves depression and heat, stops thirst, stops bloody diarrhea, and promotes urination." "New Materia Medica": "It eliminates eye opacity."

[0069] Modern phytochemical research has shown that fresh mint leaves contain 0.8-1% volatile oil, and dry stems and leaves contain 1.3-2%. The main component of the oil is menthol, with a content of about 77-78%, followed by menthone, with a content of 8-12%. It also contains menthyl acetate, camphene, limonene, isomenthone, pinene, menthyl ketone, resin and a small amount of tannin and rosmarinic acid. Topical application of menthol can treat headaches, neuralgia, itching, etc. When applied to the skin, there is a cool feeling at first, followed by a slight burning sensation. This cool feeling is not caused by a decrease in skin temperature, but is caused by stimulating the cold receptors of nerve endings. Menthol and menthone have an inhibitory effect on isolated rabbit intestines, and the latter has a stronger effect. In experiments with mice, mint essential oil has an antispasmodic (anti-acetylcholine) effect on isolated small intestines; but it has no significant effect on the propulsion speed of the small intestinal contents of whole mice, and even has an inhibitory tendency. Therefore, it is speculated that its gastric effect may be caused by the secondary nature of its olfactory and taste sensations. Menthol alcohol solution has an antiseptic effect. It has some therapeutic effects on respiratory inflammation, probably because it promotes secretion and removes mucus attached to the mucous membrane. Menthone is more irritating than menthol. The total flavonoids in the same plant, peppermint, have a choleretic effect.

[0070] The compatibility and combination principle of the Chinese medicine composition of the present invention is as follows:

[0071] In terms of the logical relationship of traditional Chinese medicine, among the raw materials of the traditional Chinese medicine composition of the present invention:

[0072] The sovereign drugs: tangerine peel, mulberry, dandelion, wolfberry fruit, dried ginger, longan, liquorice;

[0073] The ministerial drugs: jujube, rose, liquorice;

[0074] The adjuvant drugs: roselle, liquorice, mint;

[0075] The guiding drug: dried ginger, mint.

[0076] In terms of the mutual generation and restriction relationship of traditional food and medicine: Explained according to the principle of the balance of cold, heat, yin and yang of traditional food and medicine, in the traditional Chinese medicine composition of the present invention that is both food and medicine, dried ginger can relieve the adverse effects of such drugs as mulberry and dandelion on spleen and kidney deficiency with damp cold, and is also used to relieve the epistaxis problem caused by long-term use of mulberry. At the same time, the combined effect of dried ginger with jujube and rose can relieve the harm to people with spleen and stomach deficiency cold and difficult transportation of spleen dampness. The combination of liquorice and jujube can relieve the toxicity of all drugs. Jujube can also relieve the problems such as easy swelling, allergy caused by liquorice, and ultimately lead to reduced sexual desire and other forms of sexual impotence in men, inhibit the conversion of cortisol, resulting in increased blood pressure, hypokalemia and gastrointestinal discomfort. Roselle can dredge the edema and urinary retention of the above-mentioned food and medicine homologous substances, and accelerate diuresis.

[0077] Preparation Example 1

[0078]

[0079] Take tangerine peel and freeze-dried mint (fresh leaves), add 6 times the weight of water, and perform steam distillation 5 times, 15 minutes each time, to obtain volatile oil; Combine the water extracts from multiple times, filter, and obtain Extract 1;

[0080] Take mulberry, dandelion, wolfberry fruit, jujube, rose, dried ginger, longan, raw liquorice, roselle, add 6 times the weight of water, heat and decoct 5 times, 15 minutes each time, combine the water extracts from multiple times, filter, and obtain Extract 2;

[0081] Combine the volatile oil, Extract 1 and Extract 2 to obtain the traditional Chinese medicine composition of the present invention. Pack it into 100 bags.

[0082] The purpose of freeze-drying (lyophilization) the fresh mint leaves is to lock in freshness and maximize the retention of the nutritional components of mint. The freeze-drying is carried out by conventional techniques in the art.

[0083] Preparation Example 2

[0084] Extraction was carried out in the same manner as in Preparation Example 1. After combining Extract 1 and Extract 2, they were concentrated to a fluid extract with a relative density of 1.20 - 1.25 (60 °C), dried under reduced pressure (70 °C, 0.08 Mpa), pulverized, passed through an 80-mesh sieve, an appropriate amount of starch was added, hydrated, dried at 60 °C, granulated, volatile oil was added, mixed evenly, granulated, and the traditional Chinese medicine composition (granules) of the present invention was obtained.

[0085] The present invention can be made into any solid dosage form by existing food or traditional Chinese medicine preparation technologies and process methods, including capsules, tablets, granules, pills, etc.

[0086] Preparation Example 3

[0087] Extraction was carried out in the same manner as in Preparation Example 1. The volatile oil, Extract 1 and Extract 2 were combined, distilled water was added, and the taste was appropriately adjusted to obtain the traditional Chinese medicine composition (oral liquid, syrup or daily drink) of the present invention.

[0088] Experimental Example: Acute oral animal toxicity experiment (hereinafter referred to as LD50)

[0089] The toxicity reaction of the traditional Chinese medicine composition of the present invention was determined by the LD50 method for rats. This experiment was entrusted to the cooperative experimental center of Tianjin Zhongchuang Jiayun Technology Co., Ltd.

[0090] 1. Materials

[0091] ① Experimental animals: 100 SD rats, half male and half female, with a body weight of 200 ± 10 g. All experimental animals were in good health and were numbered one by one.

[0092] ② Experimental drug: The traditional Chinese medicine composition of the present invention obtained in Preparation Example 1.

[0093] ③ Experimental design: The experimental drug was administered by oral gavage. Highest dose group: 600 g / kg (equivalent to 100 times the human dose, calculated based on a human body weight of 60 kg); High dose group: 360 g / kg (equivalent to 60 times the human dose); Medium dose group: 180 g / kg (equivalent to 63 times the human dose); Low dose group: 90 g / kg (equivalent to 15 times the human dose); The blank control group was given an equal volume of distilled water.

[0094] 2. Experimental method:

[0095] Acute toxicity test: The safety of food and drugs is generally directly proportional to the magnitude of their LD50 and inversely proportional to the magnitude of their ED50. Therefore, the safety of drugs is often expressed by the ratio of LD50 to ED50.

[0096] After pre-experiment, the median lethal dose (LD50) of the traditional Chinese medicine composition of the present invention was not detected, so the maximum tolerance test was carried out.

[0097] Twenty healthy SPF-grade SD rats, 10 males and 10 females, were fasted for 24 hours, and then given the maximum dose of the traditional Chinese medicine composition of the present invention by oral gavage once a day for 60 consecutive days. The animals were weighed once a day to observe the changes in general condition, hair color, body weight, diet, activity and other indicators after administration. After stopping the drug for 60 days, half of the animals were taken for relevant determinations.

[0098] Hematological measurement indicators include: red blood cell count (RBC), platelet count, white blood cell count (WBC) and classification, hemoglobin content (Hb); liver function measurement indicators include: serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST), total protein (TP); renal function measurement indicators include: blood urea nitrogen (BUN), creatinine (Cr), etc.

[0099] After 60 days, the animals were sacrificed after stopping the drug. The brain, heart, liver, spleen, lung, kidney, thymus, adrenal gland and other organs were taken for tissue examination, weighed, the organ coefficients were calculated, and pathological examinations were performed.

[0100] 3. Statistical analysis

[0101] All statistical tests were two-sided tests, and P≤0.05 was considered to indicate a statistically significant difference. Descriptive analysis: Count data were described by the number of cases and the constituent ratio, and measurement data were described by the mean ± standard deviation. The t-test was used for comparison between groups of quantitative data, and the chi-square test or exact probability method was used for categorical data.

[0102] 4. Conclusions of acute toxicity experiments:

[0103] After the animals were given the traditional Chinese medicine composition of the present invention, they were continuously observed for 60 days. The observation contents included: appearance, physical signs, behavioral activities, mental state, diet, urine and feces, etc. It was found that: except for a slight decrease in body weight, a slight increase in urine volume, more regular urine and feces, and a better mental state than before taking the drug, there were no abnormal changes in the above indicators of all animals. There were no abnormal secretions in the mouth, eyes, nose, etc. All animals given the traditional Chinese medicine composition of the present invention did not die. After sacrificing the animals, no pathological morphological changes were observed in the organs by naked eye. The maximum tolerated dose of the animals was measured to be 600 g / kg, which is 100 times the daily oral dose of an adult weighing 60 kg. The results are shown in Table 1 and Table 2.

[0104] Table 1 Results of hematological indicators in acute toxicity experiments

[0105]

[0106] Table 2 Results of liver and kidney function indicators in acute toxicity experiments

[0107]

[0108] Clinical examples

[0109] To confirm the efficacy of the traditional Chinese medicine composition of the present invention in preventing and treating diseases caused by novel coronavirus infection and other respiratory infectious diseases (including colds), the following clinical trial studies were conducted using the traditional Chinese medicine composition of the present invention prepared according to Preparation Examples 1 to 3 above.

[0110] Patients who met the diagnostic criteria for pneumonia caused by novel coronavirus infection and were determined to be positive for novel coronavirus nucleic acid through nucleic acid testing of specimens such as sputum, throat swabs, and lower respiratory tract secretions were collected. Inclusion criteria: Patients aged 8 years or older who met the diagnostic criteria for novel coronavirus infection: positive antigen detection of nasal and throat swabs (see Figure 1 . Figure 1 for the antigen detection results of the patients' nasal and throat swabs).

[0111] Exclusions: (1) Patients with severe or critical novel coronavirus infection; (2) Acute respiratory diseases not caused by 2019-nCoV; (3) Any other chronic respiratory diseases, respiratory system bacterial infections such as suppurative tonsillitis, acute tracheo-bronchitis, sinusitis, otitis media, and other respiratory diseases that affect the clinical trial evaluation; (4) Patients with asthma that requires daily treatment, patients with basic lung diseases such as severe pulmonary interstitial lesions and bronchiectasis confirmed by chest CT; (5) Patients with novel coronavirus infection who have a history of old respiratory diseases and underlying diseases.

[0112] Exclusion items: Basic diseases such as severe primary immunodeficiency diseases, acquired immunodeficiency syndrome, congenital respiratory malformations, congenital heart diseases, and abnormal lung development.

[0113] Grouping criteria:

[0114] (1) Those who can only provide positive novel coronavirus antigen;

[0115] (2) Those who provide positive novel coronavirus antigen and have white lungs on CT images;

[0116] (3) Those with a history of old respiratory diseases and underlying diseases and positive novel coronavirus antigen;

[0117] (4) Those who only have the same main symptoms as novel coronavirus infection but cannot provide a positive novel coronavirus antigen certificate and CT images.

[0118] One hundred patients aged over 8 years who met the diagnostic criteria for novel coronavirus infection were divided into four groups according to the above (1) to (4) items to take the traditional Chinese medicine composition of the present invention for testing, 1 bag each time, 3 times a day; using age and body temperature as covariates, the propensity score value was calculated using a logistic regression model and matched in a 1:1 ratio.

[0119] One hundred matched patients were used as the control group. The treatment plan was the antiviral treatment plan in the "Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (Ninth Edition)" issued by the National Health Commission. At the same time, 30 mg of PF-07321332 and 100 mg of ritonavir were taken every 12 hours for 5 consecutive days.

[0120] Evaluation indicators: Compare the cure rates of the main symptoms (fever, fatigue, sore throat, cough, phlegm congestion, muscle soreness, joint pain, difficulty in defecation and urination, etc.), the time to disappearance of fever, and the cure rates of other single symptoms between the treatment group and the control group.

[0121] Statistical methods: All statistical tests were two-sided tests. A P value ≤ 0.05 was considered to indicate a statistically significant difference in the test. Descriptive analysis: Count data were described by the number of cases and the constituent ratio, and measurement data were described by the mean and standard deviation. The between-group comparison of quantitative data used the t-test or, and categorical data used the chi-square test or the exact probability method.

[0122] Results

[0123] Baseline data: A total of 200 confirmed patients with ordinary type of novel coronavirus pneumonia who met the requirements were included. Treatment group: 46 males (46%), 54 females (54%), with an average age of (57.1 ± 14.0) years old; Control group: 47 males (57%), 53 females (53%), with an average age of (55.4 ± 12.3) years old. There were no statistically significant differences in the baseline data between the two groups of patients, such as age, gender, body temperature, blood pressure, heart rate, respiration, past medical history, and time from onset to diagnosis (P > 0.05), and they were comparable.

[0124] Comparison of main symptoms:

[0125] There were 100 cases in the treatment group, among which: 100 cases had fever, 91 cases had cough, 98 cases had fatigue, 100 cases had sore throat, 100 cases had cough, 91 cases had shortness of breath and phlegm congestion, 9 cases had joint pain, 90 cases had muscle soreness, 70 cases had difficulty in defecation and urination, 100 cases had positive antigen, and 65 cases had white lungs on CT images;

[0126] There were 100 cases in the control group, among which: 100 cases had fever, 91 cases had cough, 98 cases had fatigue, 100 cases had sore throat, 100 cases had cough, 91 cases had shortness of breath and phlegm congestion, 9 cases had joint pain, 90 cases had muscle soreness, 70 cases had difficulty in defecation and urination, 100 cases had positive antigen, and 70 cases had white lungs on CT images;

[0127] There was no statistically significant difference in the comparison of symptoms between the treatment group and the control group (P > 0.05), and they were comparable.

[0128] Treatment results (cure rate):

[0129] There were 100 cases in the treatment group (taking the traditional Chinese medicine composition of the present invention). Among them, the fever disappeared in 100 cases (cure rate 100%), cough disappeared in 91 cases (cure rate 100%), fatigue disappeared in 98 cases (cure rate 100%), sore throat disappeared in 100 cases (cure rate 100%), cough disappeared in 100 cases (cure rate 100%), shortness of breath with phlegm congestion disappeared in 91 cases (cure rate 100%), joint and bone pain disappeared in 9 cases (cure rate 100%), muscle soreness disappeared in 90 cases (cure rate 100%), difficulty in urination and defecation disappeared in 70 cases (cure rate 100%), antigen positive turned negative in 100 cases (cure rate 100%), and white lung shown in CT images disappeared in 60 cases (cure rate 92.3%); After taking the traditional Chinese medicine composition of the present invention, the cure rate of the fever symptom reached 100%, and it only took 1 to 3 days; the cure rate of the fatigue symptom reached 100% and it could be relieved immediately; the cure rate of the sore throat symptom reached 100% and it could be relieved immediately; the cure rate of the cough symptom reached 100% and the symptom could be relieved immediately; the cure rate of the shortness of breath with phlegm congestion symptom reached 100% and the symptom could be relieved immediately; the joint and bone pain symptom could be relieved immediately and the cure rate reached 100%; the muscle soreness symptom could be relieved immediately and the cure rate reached 100%; the difficulty in urination and defecation symptom could be relieved on the same day and the cure rate reached 100%, the nucleic acid positive turned negative, and for those who could provide lung CT images, it could be clearly seen that the reversal rate of the area of white lung (fibrotic lung cells) could reach 97%, reaching the standard of basically normal lungs. The results are shown in Figure 2 . Figure 2 are the lung CT images of the clinical treatment group before and after treatment.

[0130] There were 100 cases in the control group (using the conventional treatment method and taking antiviral drugs). Among them, the fever disappeared in 91 cases (cure rate 91%), cough disappeared in 27 cases (cure rate 30%), fatigue disappeared in 0 cases (cure rate 0), sore throat disappeared in 47 cases (cure rate 47%), cough disappeared in 26 cases (cure rate 26%), shortness of breath with phlegm congestion disappeared in 2 cases (cure rate 2.2%), joint and bone pain disappeared in 0 cases (cure rate 0), muscle soreness disappeared in 2 cases (cure rate 2.2%), difficulty in urination and defecation disappeared in 0 cases (cure rate 0), antigen positive turned negative in 100 cases (cure rate 100%), and white lung shown in CT images disappeared in 0 cases (cure rate 0); Using the conventional treatment method and taking antiviral drugs, it took 3 to 7 days to improve the fever state to achieve fever reduction, at least 3 to 7 months for the fatigue symptom to subside, 3 to 7 days for the sore throat symptom to subside, 7 days to 7 months for the cough symptom to subside, 7 to 7 months for the shortness of breath with phlegm congestion symptom to subside, 7 days to 7 months for the joint and bone pain symptom to subside, 7 days to 7 months for the muscle soreness symptom to subside, there was no solution for the difficulty in urination and defecation symptom, the nucleic acid positive turned negative, and the area of white lung (fibrotic lung cells) could not be reversed.

[0131] There was a statistically significant difference between the control group and the treatment group (P < 0.05). The results are shown in Table 3 - 6.

[0132] Table 3 can only provide the treatment results of those who are positive for COVID-19 antigen

[0133]

[0134] Table 4 provides the treatment results of those who are antigen-positive and have white lungs on CT images

[0135]

[0136] Table 5 shows the treatment results of those with a history of old respiratory diseases and underlying diseases who are positive for COVID-19 antigen

[0137]

[0138] Table 6 shows the treatment results of those whose main symptoms are the same as those of COVID-19 infection but who cannot provide positive proof and CT images

[0139]

[0140] Clinical results show that the traditional Chinese medicine composition of the present invention can immediately relieve the symptoms of COVID-19 infection such as fatigue, sore throat, cough, shortness of breath with phlegm, joint pain, muscle soreness, and difficulty in defecation and urination, and the cure rate can reach 100%; it can clearly relieve and ultimately cure the post-infection symptoms such as dizziness, shortness of breath and fatigue, sore throat, soreness of the bones and muscles of the spine and limbs, phlegm and runny nose that are yellowish-green, nausea and vomiting, poor appetite, difficulty in defecation and urination, tinnitus, palpitations, irritability and insomnia, weakness in the waist and knees, premature whitening of hair, diabetes, dry mouth, itchy and dry eyes, dry and peeling skin, etc. At the same time, it can clearly improve the condition of the aggravated underlying diseases caused by the infection. It can fundamentally reverse the fibrotic lung tissue (white lung) caused by the virus infection and prevent the formation of long COVID-19.

[0141] In addition, it was unexpectedly found in clinical practice that the present invention also has significant effects on reducing the mean pulmonary artery pressure of hypoxic pulmonary hypertension, alleviating and delaying the pathological processes such as pulmonary vascular remodeling and ventricular hypertrophy, and terminating the damage caused by myocardial hypoxia. At the same time, it can also effectively inhibit the activity of PLA and its inflammatory mediators.

[0142] Based on the above description of the invention content, those skilled in the art can comprehensively apply the present invention, and all modifications based on the same principle or similar ones should be considered as included within the scope of the present invention.

Claims

1. A traditional Chinese medicine composition, the raw materials of which include: Dried tangerine peel, mulberry, dandelion, wolfberry fruit, dried ginger, longan, liquorice.

2. The traditional Chinese medicine composition according to claim 1, the raw materials of which include: Dried tangerine peel, mulberry, dandelion, wolfberry fruit, jujube, rose flower, dried ginger, longan, liquorice; Preferably, the raw materials include: dried tangerine peel, mulberry, dandelion, wolfberry fruit, jujube, rose flower, dried ginger, longan, liquorice, roselle, mint.

3. The traditional Chinese medicine composition according to claim 2, wherein, by weight, the dosage of the raw materials is: Preferably, by weight, the dosage of the raw materials is:

4. The traditional Chinese medicine composition according to claim 2, wherein, by weight, the dosage of the raw materials is: Preferably, by weight, the dosage of the raw materials is:

5. The traditional Chinese medicine composition according to any one of claims 1-4, wherein, the liquorice is raw liquorice; the mint is fresh mint leaves, preferably fresh mint leaves.

6. The preparation method of the traditional Chinese medicine composition according to claim 2, comprising the following steps: Take dried tangerine peel and mint, add water, and steam distill to obtain volatile oil; filter the water extract and optionally concentrate it to obtain extract 1; Take mulberry, dandelion, wolfberry fruit, jujube, rose flower, dried ginger, longan, liquorice, roselle, add water, heat, filter the water extract and optionally concentrate it to obtain extract 2; Mix the above-mentioned volatile oil, extract 1 and extract 2 to obtain the product.

7. The preparation method according to claim 6, wherein: The amount of water added is 5-8 times the weight of the raw materials; the water extraction is carried out by decoction method, each time for 10-20 minutes, and the extraction times are 4-6 times; preferably, the water extraction is carried out by decoction method, each time for 15 minutes, and the extraction times are 5 times.

8. Use of the traditional Chinese medicine composition according to any one of claims 1-6 in the preparation of a drug for preventing and / or treating respiratory infectious diseases (such as cold).

9. Use of the traditional Chinese medicine composition according to any one of claims 1-6 in the preparation of a drug for preventing and / or treating diseases caused by novel coronavirus infection (such as pneumonia).

10. The use according to claim 8 or 9, wherein, the traditional Chinese medicine composition is used to relieve or cure one or more of the following symptoms: fever, cough, fatigue, sore throat, cough, shortness of breath with phlegm, joint pain, muscle soreness, difficulty in defecation and urination, white lung; or the traditional Chinese medicine composition is used to relieve or cure one or more of the following symptoms: dizziness, shortness of breath and fatigue, sore throat, soreness of the spine, limbs and bones, excessive phlegm and runny nose that are yellow and green, nausea and vomiting, poor appetite, difficulty in defecation and urination, tinnitus, palpitation, restlessness and insomnia, soreness and weakness of the waist and knees, premature whitening of hair, diabetes, dry mouth, itchy and dry eyes, dry and peeling skin, white lung.

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