Traditional Chinese medicine composition and traditional Chinese medicine preparation for treating cough and expectoration

Abstract

The invention provides a traditional Chinese medicine composition for treating cough and expectoration. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 6-15 parts of radix scutellariae, 5-10 parts of rhizoma pinellinae praeparata, 10-20 parts of herba houttuyniae, 5-15 parts of bulbus fritillariae cirrhosae, 10-20 parts of rhizoma phragmitis, 6-10 parts of radix platycodonis, 6-10 parts of liquorice root, 10-20 parts of radix astragali, 10-20 parts of radix codonopsis and 10-20 parts of semen coicis. The traditional Chinese medicine composition for treating cough and expectoration provided by the invention is simple in medicine flavor and has a relatively good treatment effect on cough and expectoration caused by phlegm-heat obstructing lung. Based on the traditional Chinese medicine composition, the invention also provides a traditional Chinese medicine preparation taking the traditional Chinese medicine composition as a medicinal active component.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition and a traditional Chinese medicine preparation for treating cough and expectoration. Background Art

[0002] Cough is a protective respiratory reflex action of the human body. Expectoration is an action in which the pathological secretions in the respiratory tract are expelled from the oral cavity by means of the ciliary movement of the bronchial mucosal epithelial cells, the contraction of the bronchial smooth muscle, and the airflow impulse during coughing. Cough and expectoration are common clinical manifestations of respiratory diseases, and the two often occur together. Various physical (including foreign bodies), chemical, and allergic factors that stimulate the trachea and bronchi, as well as infections by bacteria, tuberculosis bacteria, fungi, viruses, mycoplasmas, parasites, and lung tumors, can all cause cough and expectoration. And respiratory tract infection is the most common cause of cough and expectoration. Although cough and expectoration are a protective reflex action, they can also spread tracheal lesions to adjacent small bronchi, exacerbating the condition. In addition, persistent and severe cough will affect the patient's rest, consume physical strength, and cause damage to the elastic tissue of the alveolar wall, and even induce emphysema, etc. At present, Western medicine uses symptomatic treatments such as anti-infection, cough suppression, expectoration reduction, and anti-asthma, but there are problems such as drug resistance, easy recurrence of symptoms, and poor long-term curative effects.

[0003] Traditional Chinese medicine believes that cough is a disease syndrome caused by external or internal factors, resulting in the failure of the lungs to disperse and descend properly, and the upward reversal of lung qi, characterized by the emission of a cough sound or accompanied by expectoration. In previous dynasties, a cough without phlegm was called "ke", expectoration without a cough sound was called "sou", and a cough with phlegm and a cough sound was called "kesou". Clinically, the sound of phlegm and cough are often seen together and it is difficult to clearly distinguish them, so they are collectively referred to as "cough". Cough is not only one of the main syndromes of lung diseases but also an independent disease. The research on cough in traditional Chinese medicine has a long history, and a relatively complete system of syndrome differentiation and treatment has been formed in the development process of previous dynasties. The treatment of cough has significant advantages and definite curative effects, and can greatly reduce the disadvantages such as drug resistance and side effects of Western medicine treatment.

[0004] However, there are problems such as a complex taste, poor pertinence, and uncertain curative effects in the current numerous proprietary Chinese medicines and traditional Chinese medicine compound prescriptions.

[0005] In view of this, the purpose of the present invention is to provide a traditional Chinese medicine composition with a good therapeutic effect on cough and expectoration caused by phlegm-heat obstructing the lungs. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine formula for treating cough and expectoration, with concise ingredients and a good therapeutic effect on cough and expectoration caused by phlegm-heat obstructing the lungs.

[0007] The first aspect of the present invention is to provide a traditional Chinese medicine composition for treating cough and expectoration, comprising the following components in parts by weight:

[0008] 6 - 15 parts of Scutellaria baicalensis, 5 - 10 parts of Pinellia ternata processed with Rhizoma Zingiberis Recens, 10 - 20 parts of Houttuynia cordata, 5 - 15 parts of Fritillaria cirrhosa, 10 - 20 parts of Phragmites australis, 6 - 10 parts of Platycodon grandiflorum, 6 - 10 parts of Glycyrrhiza uralensis, 10 - 20 parts of Astragalus membranaceus, 10 - 20 parts of Codonopsis pilosula, 10 - 20 parts of Coix lacryma-jobi.

[0009] Furthermore, the traditional Chinese medicine composition for treating cough with expectoration includes the following components in parts by weight:

[0010] 10 parts of Scutellaria baicalensis, 10 parts of Pinellia ternata processed with Rhizoma Zingiberis Recens, 15 parts of Houttuynia cordata, 6 parts of Fritillaria cirrhosa, 20 parts of Phragmites australis, 10 parts of Platycodon grandiflorum, 10 parts of Glycyrrhiza uralensis, 15 parts of Astragalus membranaceus, 10 parts of Codonopsis pilosula, 20 parts of Coix lacryma-jobi.

[0011] Furthermore, the traditional Chinese medicine composition is used for treating cough with expectoration caused by phlegm-heat blocking the lung.

[0012] Furthermore, the cough with expectoration caused by phlegm-heat blocking the lung is caused by cold, acute or chronic tracheo-bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchiectasis, lung abscess, pulmonary nodule, lung cancer, or novel coronavirus infection.

[0013] The second aspect of the present invention is to provide a traditional Chinese medicine preparation for treating cough with expectoration, which contains a pharmaceutically active ingredient and a pharmaceutically acceptable excipient, wherein the pharmaceutically active ingredient is the powder of the traditional Chinese medicine composition described in the first aspect, or the water or organic solvent extract of the traditional Chinese medicine composition.

[0014] Furthermore, the traditional Chinese medicine preparation is an oral preparation, and the oral preparation is a solution, granule, pill, tablet or paste.

[0015] Furthermore, the traditional Chinese medicine composition is used for treating cough with expectoration caused by phlegm-heat blocking the lung.

[0016] Furthermore, the cough with expectoration caused by phlegm-heat blocking the lung is caused by cold, acute or chronic tracheo-bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchiectasis, lung abscess, pulmonary nodule, lung cancer, or novel coronavirus infection.

[0017] The traditional Chinese medicine composition for treating cough and expectoration of the present invention mainly aims at cough and expectoration caused by phlegm-heat obstructing the lung. External contraction or internal injury leads to the failure of the lung to disperse and descend properly, and the upward reversal of lung qi causes cough. The main organ involved in the pathological change of cough is the lung, and the pathological factors are mainly phlegm, heat and deficiency clinically. The vital qi is insufficient and the body's defensive qi is weak, so the pathogenic factors of the six exogenous evils invade the lung system from the outside and cause cough. As the saying goes, "where pathogenic factors gather, the vital qi must be deficient". The normal exercise of the function of the defensive qi in resisting pathogenic factors depends on the lungs and the spleen. The defensive qi is derived from food and water. When the spleen and stomach function healthily and transport the essence of food and water, the defensive qi can be generated. When the lung qi disperses, the defensive qi can be distributed to the body surface, skin and hair. Therefore, patients with cough often have deficiency of both the lung and spleen qi. The spleen is the mother of the lung and the source of phlegm production. Improper diet and internal injury to the spleen lead to the failure of the spleen to transport and transform, resulting in the endogenous production of phlegm turbidity, which accumulates in the lung and causes the lung to fail to disperse and descend and reverse upward, leading to cough. The lung is the upper source of water and is responsible for regulating water passages. When the lung fails to disperse and descend, the water fluid cannot be regulated, the metabolism of body fluids is abnormal, endogenous phlegm turbidity is produced, and it stagnates and transforms into heat, resulting in the combination of phlegm and heat. Phlegm and fire can cause each other. Prolonged stagnation of phlegm transforms into fire, and fire boils body fluids and consumes body fluids to form phlegm. Prolonged accumulation of phlegm and heat cannot be resolved, resulting in repeated and protracted symptoms. The treatment should be to clear heat and resolve phlegm, disperse the lung and relieve cough, and supplement qi and strengthen the spleen. The traditional Chinese medicine composition of the present invention is formulated based on the etiology and pathogenesis of this disease. Among them, Fritillaria cirrhosa is bitter, sweet, and slightly cold in nature, and belongs to the lung and heart meridians. It is moistening, dispersing, descending and slightly ascending. It is good at resolving phlegm and relieving cough to restore the function of the lung in dispersing and descending. Astragalus membranaceus is sweet and warm, and belongs to the spleen and lung meridians. It supplements the qi of the lung and spleen, and can assist the vital qi to expel pathogenic factors, expel pathogenic factors without damaging the vital qi, and prevent the recurrence of pathogenic factors. The two herbs are combined as the monarch drugs. Scutellaria baicalensis is bitter and cold, and enters the lung, stomach, gallbladder and large intestine meridians. It is good at clearing away lung heat, drying dampness and detoxifying. Pinellia ternata is pungent, warm, and belongs to the lung, spleen and stomach meridians. It is good at resolving phlegm and dissipating nodules. "Compendium of Materia Medica" states: "Pinellia ternata can treat phlegm retention... When dampness is removed, the soil becomes dry and phlegm and saliva are no longer produced." Prepared Pinellia ternata has a milder drying property. When combined with Scutellaria baicalensis, it resolves phlegm and dissipates nodules without the drawback of promoting heat due to its warm nature. The two herbs are combined as the minister drugs. Houttuynia cordata is pungent, cold, and belongs to the lung meridian. It is a food and medicine homologous product, clearing heat without causing cold stagnation. Reed rhizome is sweet, cold, and enters the lung and stomach meridians. It is sweet, cold and floating in nature, and is good at clearing lung heat. Its stem is hollow and specializes in promoting diuresis, and is good at treating lung abscess with foul-smelling and purulent sputum. Platycodon grandiflorum is pungent, dispersing and bitter, discharging. It disperses the lung qi and benefits the chest, diaphragm, throat, and can also resolve phlegm and expel pus. Codonopsis pilosula is sweet and flat, and belongs to the spleen and lung meridians. It supplements qi and strengthens the spleen. Coix lacryma-jobi is sweet, cool, and belongs to the spleen, stomach and lung meridians. It strengthens the spleen and promotes diuresis to remove dampness, targeting the source of phlegm production. The five herbs are combined as the assistant drugs. Licorice is used as the envoy drug to harmonize various herbs, and together with Platycodon grandiflorum, it forms the Platycodon Decoction, which is a good prescription for treating lung abscess by Zhang Zhongjing. The compatibility of each herb is precise, and together they achieve the effects of clearing heat and resolving phlegm, dispersing the lung and relieving cough, and supplementing qi and strengthening the spleen.

[0018] Compared with the prior art, the beneficial effects of the traditional Chinese medicine composition for treating cough and expectoration provided by the present invention are as follows:

[0019] The traditional Chinese medicine composition for treating cough and expectoration provided by the present invention has concise ingredients, precise compatibility of each herb, and together they achieve the effects of clearing heat and resolving phlegm, dispersing the lung and relieving cough, and supplementing qi and strengthening the spleen, and has a significant effect on cough caused by phlegm-heat obstructing the lung. Detailed implementation mode

[0020] To enable those skilled in the art to better understand the technical solutions in the embodiments of the present invention and make the above-mentioned objects, features, and advantages of the present invention more obvious and understandable, the following further describes the specific embodiments of the present invention.

[0021] In the ranges disclosed herein, the endpoints and any values are not limited to the exact ranges or values. These ranges or values should be understood to include values close to these ranges or values. For numerical ranges, between the endpoint values of each range, between the endpoint values of each range and individual point values, and between individual point values, they can be combined with each other to obtain one or more new numerical ranges, and these numerical ranges should be regarded as specifically disclosed herein.

[0022] The traditional Chinese medicine composition for treating cough and expectoration of the present invention, the nature, flavor, meridian tropism, and pharmacological effects of each drug are as follows:

[0023] Scutellaria baicalensis: Bitter, cold. It belongs to the lung, gallbladder, spleen, large intestine, and small intestine meridians. It clears heat and dries dampness, purges fire and detoxifies, and stops bleeding. It is used for treating diseases such as cough due to lung heat, high fever and restlessness, damp-warm summer heat, chest distress and nausea. Its main chemical components include flavonoids, terpenoids, volatile oils, phenolic acids, polysaccharides, and trace elements, etc. Baicalein, wogonin, baicalin, and wogonoside are the main active components of flavonoids. Modern pharmacological studies show that Scutellaria baicalensis has effects such as anti-inflammatory, antitussive and antiasthmatic, diuretic, antimicrobial, antitumor, antioxidant, antifibrotic, protecting the cardiovascular and nervous systems, etc. Its active ingredients can treat respiratory diseases by inhibiting airway or lung inflammation, improving oxidative stress, and reducing pulmonary fibrosis.

[0024] Pinellia ternata: Pungent, warm. It belongs to the spleen, stomach, and lung meridians. It dries dampness and resolves phlegm, and reduces adverse qi and stops vomiting. It is used for treating diseases such as cough and excessive phlegm, dizziness due to phlegm retention, wind-phlegm dizziness, headache due to phlegm syncope, vomiting and nausea, and stuffiness and discomfort in the chest and epigastrium. Its main chemical components include alkaloids, amino acids, flavonoids, volatile oils, organic acids, pinellin, and various trace elements, etc. Modern pharmacological studies have found that Pinellia ternata has effects such as antibacterial, anti-inflammatory, antitussive and expectorant, antioxidant, antitumor, etc.

[0025] Houttuynia cordata: Pungent, slightly cold. It belongs to the lung meridian. It clears heat and detoxifies, and eliminates carbuncles and discharges pus. It is used for treating diseases such as lung abscess with expectoration of pus, cough and asthma due to phlegm-heat. Its main chemical components include volatile oils, flavonoids, alkaloids, phenylpropanoids, and steroids and other compounds. Modern pharmacological studies have found that Houttuynia cordata has significant pharmacological effects such as anti-inflammatory, antibacterial, and antiviral activities.

[0026] Fritillaria cirrhosa: Bitter, sweet, slightly cold. It belongs to the lung and heart meridians. It clears heat and moistens the lung, reduces phlegm and stops cough, and disperses nodules and eliminates carbuncles. It is used for treating diseases such as dry cough due to lung heat, dry cough with little phlegm, consumptive cough due to yin deficiency, and blood streaks in phlegm. Its chemical components are mainly alkaloids. Modern pharmacological studies have found that Fritillaria cirrhosa has effects such as antitussive, antiasthmatic, expectorant, and anti-inflammatory, and it has an obvious relaxing effect on bronchial smooth muscle.

[0027] Rhizoma Phragmitis: Sweet, cold. Acting on the lung and stomach meridians. Clearing heat and purging fire, promoting the production of body fluid to quench thirst, removing vexation, and stopping vomiting. Indicated for such syndromes as feverish vexation, cough due to lung heat, vomiting due to stomach heat, etc. Its main chemical constituents include inorganic elements, proteins, fats, carbohydrates, crude fiber, organic acids, vitamins, sterols, etc. Modern pharmacological studies have found that it has antibacterial, antiviral, anti-inflammatory and immunomodulatory effects. It has good antibacterial activity against Staphylococcus aureus, Bacillus subtilis and Escherichia coli.

[0028] Radix Platycodonis: Bitter, pungent, neutral. Acting on the lung meridian. Dispelling lung qi, resolving phlegm, alleviating sore throat, and discharging pus. Indicated for such syndromes as profuse sputum, difficult expectoration, chest distress, sore throat with hoarse voice, lung abscess with expectoration of pus, etc. Its main chemical constituents include triterpenoid saponins, flavonoids, phenolic acids, phytosterols and polysaccharides, etc., among which triterpenoid saponin components are its main active ingredients. Modern pharmacological studies have found that it has antitussive, antioxidant, antitumor, anti-inflammatory, immunomodulatory, cardiovascular protective and liver protective effects.

[0029] Radix Glycyrrhizae: Sweet, neutral. Acting on the heart, lung, spleen and stomach meridians. Tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, alleviating spasm and pain, and coordinating the actions of various medicinal herbs. Indicated for such syndromes as cough with profuse sputum, weakness of the spleen and stomach, lassitude and weakness, sore throat, etc. Its main active ingredients mainly include flavonoids, triterpenoid saponins, coumarins, polysaccharides, organic acids and alkaloids, etc. Modern pharmacological studies have found that it has antitussive and antiasthmatic, antiviral, antitumor, anti-inflammatory, immune enhancing and other effects.

[0030] Radix Astragali: Sweet, slightly warm. Acting on the spleen and lung meridians. Tonifying qi and lifting yang, strengthening the exterior and consolidating the superficial resistance, promoting diuresis to alleviate edema, and promoting the production of body fluid and nourishing blood. Indicated for such syndromes as weakness of the lung qi, cough and dyspnea, spontaneous sweating due to superficial deficiency, qi deficiency and fatigue, poor appetite and loose stools, sallow complexion due to blood deficiency, etc. Its main chemical constituents include astragalus polysaccharides, astragaloside IV, etc., and it has a variety of pharmacological effects such as antioxidant, anti-inflammatory, anti-fibrotic, antiviral, hypoglycemic, blood pressure regulation, anti-cancer and immunomodulatory effects.

[0031] Radix Codonopsis: Sweet, neutral. Acting on the spleen and lung meridians. Tonifying the spleen and lung, nourishing blood and promoting the production of body fluid. Indicated for such syndromes as qi deficiency of the spleen and lung, anorexia and lassitude, cough with deficiency asthma, qi and blood deficiency, sallow complexion, dizziness and fatigue, etc. Its main chemical constituents include codonopsis polysaccharides, codonopsosides, phytosterols, codonolactone, flavonoids, phenolic acids, alkaloids, etc. It has pharmacological effects such as antitumor, anti-aging, intelligence enhancing, analgesic, expectorant, antitussive and improving microcirculation disorders.

[0032] Semen Coicis: Sweet, bland, cool. Acting on the spleen, stomach and lung meridians. Promoting diuresis and percolating dampness, strengthening the spleen and stopping diarrhea, relieving impediment, discharging pus, detoxifying and dissipating nodules. Indicated for such syndromes as lung abscess, edema, diarrhea due to spleen deficiency, cancer, etc. Its main components mainly include esters and fatty acids, polysaccharides, proteins, etc., and it has pharmacological effects such as anti-cancer, hypoglycemic, regulating blood lipid metabolism, antiviral, anti-inflammatory, enhancing immunity, regulating intestinal microbiota, etc.

[0033] The Chinese medicine composition for treating cough and sputum of the present invention comprises the following components by weight:

[0034] 6-15 parts of Scutellaria baicalensis, 5-10 parts of Pinellia ternata, 10-20 parts of Houttuynia cordata, 5-15 parts of Fritillaria cirrhosa, 10-20 parts of Phragmites australis, 6-10 parts of Platycodon grandiflorum, 6-10 parts of Licorice root, 10-20 parts of Astragalus membranaceus, 10-20 parts of Codonopsis pilosula, and 10-20 parts of Coix seeds.

[0035] The Chinese medicine preparation for treating cough and sputum of the present invention comprises active pharmaceutical ingredients and pharmaceutically acceptable excipients. The active pharmaceutical ingredients include the following ingredients by weight:

[0036] 6-15 parts of Scutellaria baicalensis, 5-10 parts of Pinellia ternata, 10-20 parts of Houttuynia cordata, 5-15 parts of Fritillaria cirrhosa, 10-20 parts of Phragmites australis, 6-10 parts of Platycodon grandiflorum, 6-10 parts of Licorice root, 10-20 parts of Astragalus membranaceus, 10-20 parts of Codonopsis pilosula, and 10-20 parts of Coix seeds.

[0037] The active ingredient is the powder of the above-mentioned Chinese medicine composition, or the water or organic solvent extract of the Chinese medicine composition, and the organic solvent is an alcohol organic solvent, such as ethanol. Pharmaceutically acceptable excipients include starch, dextrin, lactose, etc.

[0038] The Chinese medicine preparation is an oral preparation, such as a solution, granules, pills, tablets or paste.

[0039] The Chinese medicine composition and Chinese medicine preparation for treating cough and sputum of the present invention are described in detail below through specific examples.

[0040] Example 1

[0041] A Chinese medicine preparation for treating cough and sputum, wherein the active ingredients of the medicine include the following raw materials:

[0042] 10 grams of Scutellaria baicalensis, 10 grams of Pinellia ternata, 15 grams of Houttuynia cordata, 6 grams of Fritillaria cirrhosa, 20 grams of Phragmites australis, 10 grams of Platycodon grandiflorum, 10 grams of Licorice, 15 grams of Astragalus membranaceus, 10 grams of Codonopsis pilosula, and 20 grams of Coix seed.

[0043] The Chinese medicine preparation of this embodiment is prepared as follows:

[0044] Weigh the above raw materials according to the ratio, add 10 times the volume of water to soak for 30 minutes, heat to boiling, then boil for 20 to 30 minutes, filter and extract the medicinal liquid; add 10 times the volume of water to the residue, repeat the boiling and filtering extraction once, combine the two filtrates, heat and concentrate to 400 ml at normal pressure to obtain the product.

[0045] Example 2

[0046] A Chinese medicine preparation for treating cough and sputum, wherein the active ingredients of the medicine include the following raw materials:

[0047] 10 g of Scutellaria baicalensis, 10 g of Pinellia ternata (processed), 15 g of Houttuynia cordata, 6 g of Fritillaria cirrhosa, 20 g of Phragmites australis, 10 g of Platycodon grandiflorum, 10 g of Glycyrrhiza uralensis, 10 g of Astragalus membranaceus, 10 g of Codonopsis pilosula, 20 g of Coix lacryma-jobi

[0048] The traditional Chinese medicine preparation of this example is prepared as follows:

[0049] Weigh the above raw materials according to the ratio, soak them in 20 times the amount of water for 30 min, then decoct for 1 h, filter, add 20 times the amount of water to the medicinal residues, repeat decocting and filtering once, combine the two filtrates, concentrate under normal pressure to 400 ml, and add the commonly used excipients in pharmaceuticals to make tablets.

[0050] Example 3

[0051] A traditional Chinese medicine preparation for treating cough with expectoration, the active pharmaceutical ingredients of which include the following raw materials:

[0052] 15 g of Scutellaria baicalensis, 10 g of Pinellia ternata (processed), 20 g of Houttuynia cordata, 10 g of Fritillaria cirrhosa, 20 g of Phragmites australis, 10 g of Platycodon grandiflorum, 10 g of Glycyrrhiza uralensis, 20 g of Astragalus membranaceus, 15 g of Codonopsis pilosula, 20 g of Coix lacryma-jobi

[0053] The traditional Chinese medicine preparation of this example is prepared as follows:

[0054] Weigh the above raw materials according to the ratio, soak them in 8 times the amount of water for 30 min, then decoct for 1 h, filter, add 8 times the amount of water to the medicinal residues, repeat decocting and filtering once, combine the two filtrates, concentrate under normal pressure to 400 ml, and add the commonly used excipients in pharmaceuticals to make granules.

[0055] Clinical trials:

[0056] 1. Research method: Select patients who meet the inclusion criteria for cough with expectoration of phlegm-heat obstructing the lung within the past year, and use the pharmaceutical composition of the present invention for treatment, and observe its clinical efficacy and adverse reactions.

[0057] 2. Research subjects: All the cases in this study were patients with cough and expectoration in Changsha City, Hunan Province. All patients were followed up completely, with a total of 60 cases.

[0058] 3. Diagnostic criteria

[0059] Inclusion criteria for cases: ① Meet the diagnostic criteria of traditional Chinese medicine symptomatology: main symptoms are cough, expectoration, yellow or white sputum; secondary symptoms are chest tightness, shortness of breath, wheezing, restlessness, fever, thirst, dry throat, sore throat, constipation, short and red urine. The tip and edges of the tongue are red, the tongue coating is thin yellow or yellow and greasy, and the pulse is slippery and rapid. The syndrome belongs to phlegm-heat obstructing the lung. ② The patient's age is between 18 and 80 years old, regardless of gender. ③ The patient is informed and consents to participate.

[0060] Exclusion criteria for cases: ① Patients with severe primary diseases such as severe heart, liver, kidney and hematopoietic systems, and psychiatric patients. ② Pregnant women. ③ Psychiatric patients. ④ Patients allergic to the study drug. ⑤ Those who do not meet the inclusion criteria, do not take the medicine as prescribed, and whose curative effect cannot be judged or whose data are incomplete, etc., affecting the judgment of curative effect or safety.

[0061] 4. Treatment methods

[0062] Test drug: The preparation method of the traditional Chinese medicine preparation in Example 1 is adopted, and the formula of the traditional Chinese medicine composition is appropriately adjusted within the formula range of the present invention according to the patient's condition.

[0063] Medication method: Administer the traditional Chinese medicine preparation, 200 ml each time, twice a day, warm orally in the morning and evening.

[0064] 5. Overall curative effect judgment criteria

[0065] The curative effect scoring criteria for traditional Chinese medicine syndromes refer to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines".

[0066] (1) Clinical cure: The syndromes of phlegm-heat obstructing the lung disappear or basically disappear, cough and expectoration disappear, N≥95%;

[0067] (2) Marked effect: The syndromes of phlegm-heat accumulating in the lung are significantly improved, cough and expectoration are reduced, 95%>N≥70%;

[0068] (3) Effective: The syndromes of phlegm-heat accumulating in the lung are all improved, cough and expectoration are reduced, 70%>N≥30%;

[0069] (4) Ineffective: The syndromes of phlegm-heat accumulating in the lung are not significantly improved or even aggravated, cough and expectoration are not improved, N<30%.

[0070] The curative effect is judged by the Nimodipine method: Curative effect index (N)=[(total score before treatment - total score after treatment) / total score before treatment]*100%.

[0071] Total effective rate=(clinical cure + marked effect + effective) / total number of cases×100%

[0072] 6. Summary of clinical curative effect

[0073] For 60 patients with cough and expectoration, after observing one treatment course (7 days), 12 cases (20%) were cured, 31 cases (51.7%) had a marked effect, 13 cases (21.7%) were effective, and 4 cases (6.7%) were ineffective. After one treatment course, the total effective rate of the 60 patients was 93.3%. The clinical research observation items are shown in Statistical Table - Table 1.

[0074] Table 1: Statistical table of clinical curative effect

[0075] Treatment situation Number of people Proportion Clinical cure 12 20％ Marked effect 31 51.7％ Effective 13 21.7％ Ineffective 4 6.7％ Total effective 56 93.3％

[0076] 7. Adverse Reactions

[0077] Clinical applications have shown no toxic or side effects and no adverse reactions.

[0078] 8. Conclusion

[0079] Based on the above curative effect results, the traditional Chinese medicine composition of the present invention can significantly improve the symptoms of cough and expectoration in patients with phlegm-heat obstructing the lung.

[0080] Typical Cases

[0081] Case 1

[0082] Patient Xiao, female, 30 years old, visited on June 15, 2024. Chief complaint: Cough for 5 days. The patient had fever, nasal congestion, and runny nose 5 days ago due to getting cold. She took ibuprofen sustained-release tablets by herself. After the fever subsided, she had cough and expectoration, and the symptoms were not significantly relieved after taking antibiotics and traditional Chinese patent medicines for relieving cough and resolving phlegm. Current symptoms: Cough, expectoration of yellow phlegm, nasal congestion, runny turbid nose, poor appetite, normal stools, yellow urine, and average sleep. The tip and edges of the tongue were red, the tongue coating was yellow, and the pulse was thready. After dialectical differentiation, it was diagnosed as cough with phlegm-heat obstructing the lung syndrome. After being treated with the traditional Chinese medicine preparation of the present invention (prepared by the preparation method of Example 1) for 1 week, the patient achieved clinical cure.

[0083] Case 2

[0084] Child Liu, female, 6 years old, visited on April 23, 2024. Chief complaint: Cough for half a month. The family members of the patient reported that the child had cough half a month ago due to getting cold. The local clinic treated her with antibiotics, cough-relieving and phlegm-resolving drugs, but the cough was not significantly relieved. She was diagnosed with mycoplasma pneumonia in the People's Hospital 3 days ago. Current symptoms: Cough, gurgling in the throat with phlegm, nasal congestion and runny nose, good appetite, and usually dry stools. The tip of the tongue was red, the tongue coating was slightly yellow, and the fingerprint was purple. After dialectical differentiation, it was diagnosed as cough with phlegm-heat obstructing the lung syndrome. After being treated with the traditional Chinese medicine preparation of the present invention (prepared by the preparation method of Example 1) for 2 weeks, the child achieved clinical cure.

[0085] Case 3

[0086] Patient Zhou, female, 57 years old, visited on June 23, 2024. Chief complaint: Intermittent cough for 8 years, aggravated for 10 days. The patient had intermittent cough and expectoration in the past 8 years, with repeated attacks. She was diagnosed with bronchiectasis by Western medicine. The symptoms were aggravated 10 days ago due to being greedy for cold. Current symptoms: Cough, less phlegm, chest tightness, palpitation, dry mouth, poor appetite, yellowish-red urine, dry stools, and average sleep. The tip and edges of the tongue were red, the tongue coating was yellow and greasy, and the pulse was stringy and rapid. After dialectical differentiation, it was diagnosed as cough with phlegm-heat obstructing the lung syndrome. After being treated with the traditional Chinese medicine preparation of the present invention (prepared by the preparation method of Example 1) for 4 weeks, the patient achieved clinical cure.

[0087] Case 4

[0088] Patient Hou, male, 45 years old, visited the hospital on March 28, 2024. Main complaint: cough for 1 month. The patient had nasal congestion, runny nose, and fever after catching a cold 1 month ago. The fever subsided after taking the granules, but cough, sputum, and throat itching soon appeared. Taking cough and expectorant Chinese patent medicines and antibiotics was ineffective. The symptoms of taking Jinsuozi throat treasure were slightly relieved, but they recurred soon. Current symptoms: cough, yellow sputum that is difficult to cough, throat itching, dry mouth, normal diet, general sleep, yellow urine, loose and sticky stools. The tip of the tongue is red, the tongue coating is slightly greasy, and the pulse is stringy. Chest X-ray shows: the texture of both lungs is thickened and disordered. After syndrome differentiation, it belongs to cough due to phlegm-heat blocking the lungs. After 2 weeks of treatment with the Chinese medicine preparation of the present invention (using the preparation method of Example 1), the patient achieved clinical cure.

[0089] Case 5

[0090] Patient Zhang, female, 29 years old, visited the hospital on October 12, 2023. Chief complaint: cough for 10 days. The patient had cough, nasal congestion, runny nose, sore throat, and fever 10 days ago due to greed for cold drinks. The highest body temperature was 38.8°C. He was treated with intravenous antibiotics in the community hospital. After 2 days, the fever subsided, and the cough, sputum and sore throat were not relieved significantly. Self-medication with cough and phlegm-reducing Chinese patent medicine was ineffective, so he came for Chinese medicine treatment. Current symptoms: cough, yellow and thick sputum, sore throat, dry mouth, upset, normal diet, normal sleep, yellow urine, and normal bowel movements. The tip of the tongue is red, the tongue coating is yellow, and the pulse is thin and rapid. History of chronic pharyngitis. The syndrome differentiation is a cough caused by phlegm-heat blocking the lungs. After 2 weeks of treatment with the Chinese medicine preparation of the present invention (using the preparation method of Example 1), the patient was clinically cured.

[0091] Case 6

[0092] Patient Zhang, male, 72 years old, visited the hospital on December 9, 2023. Main complaint: cough and sputum for more than one month. The patient occasionally caught a cold and had cough and fever one month ago. After comprehensive treatment in a certain hospital, the body temperature dropped to normal, but cough and asthma were still seen. Current symptoms: cough, sticky sputum and difficult cough, chest tightness, fatigue, loss of appetite, poor sleep, normal urination, constipation, and bowel movements 3-4 days / time. The tip of the tongue is red, the tongue coating is yellow and greasy, and the pulse is deep and slippery. The history of chronic bronchitis is more than 10 years. The syndrome differentiation is phlegm-heat blocking the lung syndrome cough. After 6 weeks of treatment with the Chinese medicine preparation of the present invention (using the preparation method of Example 1), the patient was clinically cured.

[0093] Example 7

[0094] Ms. Xie, female, 35 years old, visited on April 16, 2023. Chief complaint: Repeated cough and expectoration for more than 3 months. More than 3 months ago, after being infected with the novel coronavirus, the patient developed cough and expectoration. The sputum was thick, yellowish, small in amount, difficult to expectorate, and occasionally had blood streaks. She also had chest tightness and shortness of breath. She visited a local hospital, and after taking oral cough-relieving and phlegm-reducing drugs, the symptoms were slightly relieved, but recurred after stopping the drugs. The current symptoms are: less sputum in cough, mainly dry cough, aggravated by talking or exposure to wind, itchy throat, foreign body sensation in the pharynx, dry mouth, and chest tightness. The diet is okay, but the sleep at night is poor and it is difficult to fall asleep. The tongue is red, the tongue coating is thin and yellow, and the pulse is stringy. Blood routine and chest CT showed no abnormalities. Pulmonary function test indicated a positive bronchial provocation test. After syndrome differentiation, it belongs to cough with syndrome of phlegm-heat obstructing the lung. After being treated with the traditional Chinese medicine preparation of the present invention (using the preparation method of Example 1) for 3 weeks, the patient achieved clinical cure.

[0095] The above cases are only part of the cases in clinical observation. In actual clinical use, the dosage of specific drugs in the pharmaceutical composition can be selected within the scope of the present invention according to different clinical symptoms of patients. At the same time, in clinical practice, the prescription can be adjusted for different patients as follows:

[0096] (1) When affected by the pathogenic qi of the four seasons, it can be added or subtracted seasonally after syndrome differentiation. For those with cough and expectoration and affected by wind-warmth, 6 - 10 grams of Saposhnikovia divaricata, 10 grams of Schizonepeta tenuifolia, and 6 grams of Mentha haplocalyx can be added; for those affected by summer heat, 6 - 15 grams of Lonicera japonica, 6 - 15 grams of Forsythia suspensa, and 6 grams of Mentha haplocalyx can be added; for those affected by autumn dryness, 6 - 15 grams of Morus alba leaf, 6 - 15 grams of Chrysanthemum morifolium can be added; for those affected by cold pathogen, 3 - 10 grams of Ephedra sinica, 6 - 10 grams of Cinnamomum cassia can be added.

[0097] (2) If there are symptoms of yin injury such as less tongue coating in addition to cough and expectoration, 10 - 20 grams of Rehmannia glutinosa, 10 - 20 grams of Ophiopogon japonicus, 10 - 20 grams of Lilium brownii, and 10 - 15 grams of Glehnia littoralis can be added to nourish yin and moisten the lung.

[0098] (3) If a long-term cough damages qi and blood, with symptoms such as fatigue and shortness of breath, 6 - 20 grams of Panax ginseng and 10 - 20 grams of Angelica sinensis can be added to tonify qi and nourish blood.

[0099] (4) If there is a saw-like sore throat in addition to cough and expectoration, 10 - 15 grams of Belamcanda chinensis, 6 grams of Cryptotympana pustulata, and 10 - 15 grams of Scrophularia ningpoensis can be added to clear heat and relieve sore throat.

[0100] (5) If there is blood in the sputum in addition to cough and expectoration, 10 - 15 grams of Prunus persica, 10 - 20 grams of Benincasa hispida seed, and 10 - 20 grams of Imperata cylindrica can be added to cool blood for hemostasis and promote blood circulation to expel pus.

[0101] In summary, the traditional Chinese medicine composition and traditional Chinese medicine preparation of the present invention have concise medicinal properties and definite curative effects, and can be used as a basic prescription for cough and expectoration caused by diseases such as cold, acute and chronic tracheo-bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchiectasis, lung abscess, lung nodules, lung cancer, and novel coronavirus infection.

[0102] The embodiments of the present invention have been described in detail above, but the present invention is not limited to the described embodiments. For those skilled in the art, various changes, modifications, substitutions, and variations made to these embodiments without departing from the principle and spirit of the present invention still fall within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating cough and sputum, characterized in that: The composition comprises the following components by weight: 6-15 parts of Scutellaria baicalensis, 5-10 parts of Pinellia ternata, 10-20 parts of Houttuynia cordata, 5-15 parts of Fritillaria cirrhosa, 10-20 parts of Phragmites australis, 6-10 parts of Platycodon grandiflorum, 6-10 parts of Licorice root, 10-20 parts of Astragalus membranaceus, 10-20 parts of Codonopsis pilosula, and 10-20 parts of Coix seeds.

2. The Chinese medicine composition for treating cough and sputum according to claim 1, characterized in that: The composition includes the following components by weight: 10 parts of Scutellaria baicalensis, 10 parts of Pinellia ternata, 15 parts of Houttuynia cordata, 6 parts of Fritillaria cirrhosa, 20 parts of Rhizoma Phragmites, 10 parts of Platycodon grandiflorum, 10 parts of Licorice, 15 parts of Astragalus, 10 parts of Codonopsis pilosula, and 20 parts of Semen Coicis.

3. The Chinese medicine composition for treating cough and sputum according to claim 1 or 2, characterized in that: The Chinese medicine composition is used for treating cough and sputum caused by phlegm-heat blocking the lungs.

4. The Chinese medicine composition for treating cough and sputum according to claim 3, characterized in that: Cough and sputum caused by phlegm-heat blocking the lungs are caused by colds, acute and chronic tracheobronchitis, pneumonia, chronic obstructive pulmonary disease, bronchiectasis, lung abscess, lung nodules, lung cancer, or new coronavirus infection.

5. A Chinese medicine preparation for treating cough and sputum, characterized in that: The composition comprises active pharmaceutical ingredients and pharmaceutically acceptable excipients, wherein the active pharmaceutical ingredients are the powder of the traditional Chinese medicine composition according to claim 1, or the water or organic solvent extract of the traditional Chinese medicine composition.

6. The Chinese medicinal preparation for treating cough and sputum according to claim 5, characterized in that: The Chinese medicine preparation is an oral preparation, and the oral preparation is a solution, granules, pills, tablets or paste.

7. The Chinese medicinal preparation for treating cough and sputum according to claim 5 or 6, characterized in that: The Chinese medicine composition is used for treating cough and sputum caused by phlegm-heat blocking the lungs.

8. The Chinese medicinal preparation for treating cough and sputum according to claim 7, characterized in that: Cough and sputum caused by phlegm-heat blocking the lungs are caused by colds, acute and chronic tracheobronchitis, pneumonia, chronic obstructive pulmonary disease, bronchiectasis, lung abscess, lung nodules, lung cancer, or new coronavirus infection.