A traditional Chinese medicine composition, its preparation method and application

Abstract

This invention provides a traditional Chinese medicine composition, characterized in that the composition comprises: 0.5-1 parts by weight of honey-processed ephedra, 0.5-1.5 parts by weight of bitter almond, 0.5-1 parts by weight of perilla seed, 1.5-3 parts by weight of mulberry bark, 1.5-2 parts by weight of scutellaria, 0.5-1.5 parts by weight of cicada slough, 0.5-1.5 parts by weight of silkworm, 1.5-3 parts by weight of earthworm, 0.5-1.5 parts by weight of angelica root, 0.5-1.5 parts by weight of belamcanda rhizome, 1.5-3 parts by weight of coltsfoot flower, 0.5-1.5 parts by weight of prepared pinellia tuber, and 0.5-1 parts by weight of licorice root. This invention provides a traditional Chinese medicine composition that works synergistically to relieve lung congestion and asthma, suppress cough, clear heat, and resolve phlegm. Modern pharmacological experiments have shown that this composition can be used to treat bronchial asthma or its chronic persistent phase, bronchitis with cough, and pharyngitis.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition, its preparation method, and its application. Background Technology

[0002] Bronchial asthma (or simply asthma) is a chronic inflammatory disease of the airways involving various cells (eosinophils, mast cells, T cells, neutrophils, airway epithelial cells, etc.) and cellular components. Asthma often manifests as paroxysmal cough, chest tightness, and difficulty breathing. It is mainly caused by chronic inflammation, leading to increased airway hyperresponsiveness and resulting in recurrent episodes of wheezing, shortness of breath, chest tightness, and cough, especially at night and in the early morning. Some patients cough up sputum, which is more abundant when the attack is subsiding. If there is no concurrent infection, the sputum is usually white and sticky, firm, and sometimes appears as rice grains or mucus columns. The severity and duration of attacks vary greatly from person to person. Mild cases may only experience chest tightness lasting several minutes, and symptoms are usually paroxysmal; most patients can recover spontaneously or with treatment. Severe cases involve extreme shortness of breath that can last for weeks or longer. If a severe acute asthma attack is not treated promptly, it can be fatal.

[0003] Traditional Chinese medicine (TCM) considers asthma to fall under the categories of "asthma syndrome" or "asthma disease." It is often caused by improper or untreated pathogenic factors, which remain in the lung channels, stagnating and transforming into heat, which scorches body fluids and forms phlegm. Prolonged obstruction of lung qi affects the circulation of qi and blood, leading to blood stasis, which in turn interacts with phlegm and fluid retention. Therefore, internal obstruction of phlegm and heat, and stagnation of blood stasis are the basic pathological changes in asthma, persisting throughout both acute and remission periods. When external pathogens invade, or improper diet, overexertion, or emotional distress triggers the attack of phlegm and qi, resulting in wind-heat, spasms, and symptoms such as shortness of breath, wheezing, and rattling in the throat.

[0004] Eliminating airway inflammation and supplementing with bronchodilators is currently the best treatment option in modern medicine. Clinically, glucocorticoids and β2-receptor agonists are mainly used. However, even with hormone therapy lasting up to three years, it can only temporarily suppress airway inflammation and reduce airway responsiveness, but it is difficult to completely reduce airway responsiveness to normal, let alone cure asthma. Furthermore, it can cause various side effects such as metabolic imbalance. β2-receptor agonists, on the other hand, can cause rapid desensitization, decreased lung function, paradoxical bronchospasm, and increased airway responsiveness, all of which are harmful to asthma patients. Traditional Chinese medicine's treatment of asthma can be traced back to the Spring and Autumn and Warring States periods. The *Suwen* (Plain Questions) records, "When Yin contends internally and Yang disturbs externally, the *po* (spirit) sweat is not stored, and the four *qi* (four *qi*) rise up, which then stagnates the lungs, causing wheezing," indicating a wealth of experience in treating this disease. With continuous advancements in clinical practice, traditional Chinese medicine has demonstrated unique efficacy and significant advantages in the treatment of bronchial asthma. Treatment methods vary depending on the etiology, pathogenesis, and clinical manifestations of asthma. These methods include internal treatment, acupuncture, nebulized Chinese medicine therapy, enema therapy, and dietary therapy. However, no definitively effective Chinese medicine prescription has been found yet.

[0005] Acute pharyngitis is an acute inflammation of the pharyngeal mucosa, submucosa, and lymphoid tissue. Its main causative factors are bacterial infection, viral infection, and physical and chemical irritants. It is a common and frequently occurring clinical disease, and can also be a local manifestation of systemic diseases or a prodromal manifestation of acute infectious diseases. In recent years, environmental and climatic factors have led to a sharp increase in the incidence of acute pharyngitis. In traditional Chinese medicine, acute pharyngitis falls under the category of "throat obstruction," accounting for 7% to 17% of throat diseases. If left untreated, acute pharyngitis often recurs and becomes chronic, making treatment difficult. Currently, there are no highly effective drugs in both traditional Chinese and Western medicine for treating acute pharyngitis. Summary of the Invention

[0006] To solve the above-mentioned technical problems, the present invention provides a traditional Chinese medicine composition, characterized in that the composition comprises: 0.5-1 parts by weight of honey-processed ephedra, 0.5-1.5 parts by weight of bitter almond, 0.5-1 parts by weight of perilla seed, 1.5-3 parts by weight of mulberry bark, 1.5-2 parts by weight of scutellaria, 0.5-1.5 parts by weight of cicada slough, 0.5-1.5 parts by weight of silkworm, 1.5-3 parts by weight of earthworm, 0.5-1.5 parts by weight of angelica root, 0.5-1.5 parts by weight of belamcanda rhizome, 1.5-3 parts by weight of coltsfoot flower, 0.5-1.5 parts by weight of prepared pinellia tuber, and 0.5-1 parts by weight of licorice root. The use of the composition can be any method beneficial to improving the corresponding symptoms of the patient, including treatment or prevention.

[0007] Furthermore, the traditional Chinese medicine composition includes: 0.6-0.7 parts by weight of honey-processed ephedra, 0.9-1.1 parts by weight of bitter almond, 0.6-0.7 parts by weight of perilla seed, 1.8-2.2 parts by weight of mulberry bark, 1.5-1.7 parts by weight of scutellaria, 0.9-1.1 parts by weight of cicada slough, 0.9-1.1 parts by weight of silkworm, 1.8-2.2 parts by weight of earthworm, 0.9-1.1 parts by weight of angelica root, 0.9-1.1 parts by weight of belamcanda rhizome, 1.8-2.2 parts by weight of coltsfoot flower, 0.9-1.1 parts by weight of prepared pinellia tuber, and 0.6-0.7 parts by weight of licorice root.

[0008] Preferably, the traditional Chinese medicine composition comprises: 0.61 parts by weight of honey-processed ephedra, 1 part by weight of bitter almond, 0.61 parts by weight of perilla seed, 2 parts by weight of mulberry bark, 1.6 parts by weight of scutellaria, 1 part by weight of cicada slough, 1 part by weight of silkworm, 2 parts by weight of earthworm, 1 part by weight of angelica dahurica, 1 part by weight of belamcanda chinensis, 2 parts by weight of coltsfoot flower, 1 part by weight of prepared pinellia, and 0.61 parts by weight of licorice.

[0009] The above-mentioned composition can be made by directly grinding raw materials into powder, or it can be an extract or other form obtained by conventional means.

[0010] The present invention also provides a method for preparing any of the aforementioned traditional Chinese medicine compositions, characterized in that the preparation method comprises the following steps:

[0011] Take five medicinal materials: honey-processed ephedra, bitter almond, perilla seed, prepared pinellia, and licorice. Add water and decoct. Filter. Concentrate the filtrate under reduced pressure to an extract with a relative density of 1.05-1.10 (60℃). Cool to room temperature. Add ethanol to the concentrate to make the alcohol content reach 50-80%. Let stand for more than 24 hours. Take the supernatant and concentrate under reduced pressure until there is no alcohol taste to obtain extract 1.

[0012] Five medicinal materials, namely Scutellaria baicalensis, Peucedanum praeruptorum, Belamcanda chinensis, Tussilago farfara, and Morus alba root bark, were extracted by reflux with 60-80% ethanol, filtered, and the filtrate was concentrated under reduced pressure to obtain extract 2.

[0013] Take three medicinal materials: cicada molting, silkworm pupa, and earthworm, add water and decoct, filter, and concentrate the filtrate under reduced pressure to obtain extract 3;

[0014] Combine extracts 1, 2 and 3, concentrate under reduced pressure to a wet extract with a relative density of 1.10 to 1.25 (60°C), and dry under reduced pressure to obtain the final product.

[0015] Specifically, the preparation method described above involves the following steps:

[0016] Take five medicinal materials: honey-processed ephedra, bitter almond, perilla seed, prepared pinellia, and licorice. Add 6 to 12 times the amount of water and decoct 1 to 3 times, each time for 1 to 3 hours. Filter and concentrate the filtrate under reduced pressure to an extract with a relative density of 1.05 to 1.10 (60℃). Cool to room temperature, add ethanol to make the alcohol content reach 70 to 80%, let stand for more than 24 hours, take the supernatant, and concentrate under reduced pressure to an extract without alcohol odor.

[0017] Take five medicinal materials: Scutellaria baicalensis, Peucedanum praeruptorum, Belamcanda chinensis, Tussilago farfara, and Morus alba root bark. Add 6-12 times the amount of 60-80% ethanol and reflux extract 1-3 times, 0.5-3 hours each time. Filter and concentrate the filtrate under reduced pressure to obtain extract 2.

[0018] Take cicada molting, silkworm pupa, and earthworm, add 6 to 12 times the amount of water and decoct 1 to 3 times, each time for 1 to 3 hours. Filter and concentrate the filtrate under reduced pressure to an extract with a relative density of 1.05 to 1.10 (60℃).

[0019] Combine extracts 1, 2 and 3, concentrate under reduced pressure to a wet extract with a relative density of 1.23 to 1.25 (60°C), and dry under reduced pressure to obtain the final product.

[0020] Preferably, the preparation method described above includes the following steps:

[0021] Weigh out 120-200g of honey-processed ephedra, 180-330g of bitter apricot kernel, 120-200g of perilla seed, 360-660g of mulberry bark, 240-528g of scutellaria, 180-330g of cicada slough, 180-330g of silkworm pupa, 360-660g of earthworm, 180-330g of angelica dahurica, 180-330g of belamcanda chinensis, 360-660g of coltsfoot flower, 180-330g of prepared pinellia, and 120-200g of licorice. Add 10 times the amount of water to the five herbs (honey-processed ephedra, bitter apricot kernel, perilla seed, prepared pinellia, and licorice) and decoct twice, 1.5 hours each time. Filter the decoction, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.05-1.10 (60℃), and cool to room temperature. Add ethanol to make the alcohol content reach 75%, let stand for more than 24 hours, take the supernatant, concentrate under reduced pressure until there is no alcohol taste, and obtain extract 1 for later use; take five medicinal materials, Scutellaria baicalensis, Peucedanum praeruptorum, Belamcanda chinensis, Tussilago farfara, and Morus alba root bark, add 8 times the amount of 70% ethanol and reflux extract twice, each time for 1.0 hour, filter, concentrate the filtrate under reduced pressure until there is no alcohol taste, and obtain extract 2 for later use; take three medicinal materials, Cicadae periostracum, Bombyx mori, and Pheretima aspergillum, add 8 times the amount of water and decoct twice, each time for 1.5 hours, filter, concentrate the filtrate under reduced pressure to extract 3 with a relative density of 1.08-1.10 (60℃), and keep it for later use; combine extract 1, extract 2 and extract 3, concentrate under reduced pressure to a wet paste with a relative density of 1.23-1.25 (60℃), and dry under reduced pressure (70℃) to obtain the final product.

[0022] Optionally, the preparation method described above includes the following steps:

[0023] 200g of honey-processed ephedra, 330g of bitter almond, 200g of perilla seed, 660g of mulberry bark, 528g of scutellaria, 330g of cicada slough, 330g of silkworm, 660g of earthworm, 330g of angelica dahurica, 330g of belamcanda chinensis, 660g of coltsfoot flower, 330g of prepared pinellia, and 200g of licorice. Take the five medicinal materials (honey-processed ephedra, bitter almond, perilla seed, prepared pinellia, and licorice) and add 10 times the amount of water to decoct twice, 1.5 hours each time. Filter, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.05–1.10 (60℃), cool to room temperature, add ethanol to achieve an alcohol content of 75%, let stand for at least 24 hours, take the supernatant, concentrate under reduced pressure until there is no alcohol taste, and obtain extract 1 for later use. Five medicinal materials—Scutellaria baicalensis, Peucedanum praeruptorum, Belamcanda chinensis, Tussilago farfara, and Morus alba—were extracted twice with 8 times the amount of 70% ethanol, each time for 1.0 hour. The extract was filtered, and the filtrate was concentrated under reduced pressure until no alcohol odor remained, yielding extract 2 for later use. Three medicinal materials—Cicada slough, Bombyx mori, and Pheretima aspergillum—were decocted twice with 8 times the amount of water, each time for 1.5 hours. The extract was filtered, and the filtrate was concentrated under reduced pressure to an extract with a relative density of 1.08–1.10 (60℃), yielding extract 3 for later use. Extracts 1, 2, and 3 were combined and concentrated under reduced pressure to a wet extract with a relative density of 1.23–1.25 (60℃), and then dried under reduced pressure (70℃) to obtain a dry extract powder.

[0024] Optionally, the preparation method described above includes the following steps:

[0025] 120g of honey-processed ephedra, 180g of bitter almond, 120g of perilla seed, 360g of mulberry bark, 240g of scutellaria, 180g of cicada slough, 180g of silkworm, 360g of earthworm, 180g of angelica dahurica, 180g of belamcanda chinensis, 360g of coltsfoot flower, 180g of prepared pinellia, and 120g of licorice. Take the five medicinal materials (honey-processed ephedra, bitter almond, perilla seed, prepared pinellia, and licorice) and add 10 times the amount of water to decoct twice, 1.5 hours each time. Filter, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.05–1.10 (60℃), cool to room temperature, add ethanol to achieve an alcohol content of 75%, let stand for at least 24 hours, take the supernatant, and concentrate under reduced pressure until there is no alcohol odor, obtaining extract 1 for later use. Five medicinal materials—Scutellaria baicalensis, Peucedanum praeruptorum, Belamcanda chinensis, Tussilago farfara, and Morus alba—were extracted twice with 8 times the amount of 70% ethanol, each time for 1.0 hour. The extract was filtered, and the filtrate was concentrated under reduced pressure until no alcohol odor remained, yielding extract 2 for later use. Three medicinal materials—Cicada slough, Bombyx mori, and Pheretima aspergillum—were decocted twice with 8 times the amount of water, each time for 1.5 hours. The extract was filtered, and the filtrate was concentrated under reduced pressure to an extract with a relative density of 1.08–1.10 (60℃), yielding extract 3 for later use. Extracts 1, 2, and 3 were combined and concentrated under reduced pressure to a wet extract with a relative density of 1.23–1.25 (60℃), and then dried under reduced pressure (70℃).

[0026] The present invention also proposes a traditional Chinese medicine composition prepared by any of the above preparation methods.

[0027] This invention also proposes the application of any of the aforementioned traditional Chinese medicine compositions or traditional Chinese medicine compositions prepared by any of the above preparation methods in the preparation of medicaments for asthma, pharyngitis, or cough. The pharyngitis or cough may be caused by asthma or bronchitis.

[0028] The traditional Chinese medicine composition of the present invention can be used to prepare drugs for relieving lung congestion and asthma, clearing heat and resolving phlegm, or for chronic persistent bronchial asthma.

[0029] The present invention also proposes a drug, characterized in that the drug comprises any of the aforementioned traditional Chinese medicine compositions or traditional Chinese medicine compositions prepared by any of the aforementioned preparation methods and pharmaceutically acceptable excipients or additives.

[0030] Furthermore, the drug is selected from tablets, capsules, granules, pills, injections, decoctions, suspensions, dispersants, syrups, suppositories, gels, aerosols, patches, or oral liquids.

[0031] In the traditional Chinese medicine composition described in this invention:

[0032] Honey-processed ephedra has a pungent and slightly bitter nature, and enters the lung and bladder meridians. It can open up blockages in the skin and hair to allow lung qi to flow freely; internally, it can descend rebellious qi to restore the lung's normal function of descending qi. Therefore, it is good at relieving cough and asthma, and is an essential medicine for treating cough and asthma caused by lung qi stagnation. Bitter almond stops cough, moistens the lungs, relieves asthma, promotes body fluid production, and stimulates appetite. It treats cough and asthma due to deficiency, and constipation due to intestinal dryness. Perilla seed descends qi, relieves asthma, eliminates phlegm, and stops cough; it assists honey-processed ephedra in clearing the lungs and relieving asthma. Scutellaria baicalensis, Belamcanda chinensis, Morus alba root bark, Pinellia ternata, Tussilago farfara, Peucedanum praeruptorum, Cicadae periostracum, Pheretima aspergillum, and Bombyx mori. Scutellaria baicalensis clears heat and dries dampness, drains fire and detoxifies. The "Ben Cao Jing Shu" records: Scutellaria baicalensis, its nature is clear and astringent, so it removes evil; its taste is bitter, so it dries dampness; its yin and cold nature overcomes heat, so it treats various heat-related conditions. Belamcanda chinensis clears heat and detoxifies, eliminates phlegm, and soothes the throat; it can both clear and descend, functioning to reduce fire and detoxify, disperse blood stasis, and soothe the throat. It can also clear the lungs and disperse nodules, making it an essential medicine for sore throat and cough with excessive phlegm. When combined with Scutellaria baicalensis, it clears lung fire and soothes the throat, treating lung abscess with sore throat and hoarseness. Morus alba root bark clears the lungs and relieves asthma, promotes diuresis and reduces swelling, used for lung heat cough and asthma, facial edema, and difficulty urinating. Pinellia ternata dries dampness and resolves phlegm, mainly used for cough and asthma with excessive phlegm, phlegm-induced dizziness and palpitations, wind-phlegm dizziness, and phlegm-induced headache. Tussilago farfara flower is pungent, sweet, and warm, entering the lung meridian, which is suitable for the blood aspect of the lungs. It is mainly used to treat lung stagnation and hemoptysis, chronic cough with blood in sputum, as well as pulmonary atrophy, phlegm-induced asthma, and diabetes, making the lung orifices feel cool and moist. Peucedanum praeruptorum is pungent and bitter, its pungent nature dispersing wind-heat and its bitterness descending lung qi causing cough and asthma. Therefore, it is best for treating cough and asthma caused by wind-heat stagnation in the lungs. When combined with bitter apricot kernel, one is slightly cold and the other slightly hot, both having the effect of dispersing lung qi, relieving cough and asthma. Cicada slough is light and buoyant, entering the lung and liver meridians. When combined with ephedra and earthworm, it strengthens the dispersing of internal wind. Bombyx mori extinguishes wind and relieves spasms, disperses wind-heat, resolves phlegm and dissipates nodules, with the effect of dispelling wind and resolving phlegm being superior. When combined with earthworm, it has a stronger effect of extinguishing wind, stopping spasms, activating blood circulation and relieving pain. Licorice tonifies the spleen and replenishes qi, relieves cough and moistens the lungs, relieves spasms and detoxifies, and harmonizes all medicines. "Ben Cao Tong Xuan" says it enters the spleen and stomach; "Bie Lu" says it warms the middle and lowers qi, relieves restlessness and shortness of breath, cough caused by internal injury, quenches thirst, unblocks meridians, promotes blood circulation and qi, and detoxifies all medicines.

[0033] The main functions and indications of this formula are: to relieve lung congestion and asthma, clear heat and resolve phlegm. It is used to treat chronic persistent bronchial asthma, bronchitis cough, and pharyngitis.

[0034] The advantages of this invention compared with the prior art are as follows:

[0035] 1. The traditional Chinese medicine composition provided by this invention for the treatment of bronchial asthma or its chronic persistent phase, bronchitis with cough, and pharyngitis, works synergistically to relieve lung congestion, asthma, cough, and phlegm. Animal experimental results show that the composition of this invention significantly improves acute asthma symptoms and airway inflammation, and significantly reduces the production and release of allergenic substance IgE, reduces local eosinophil infiltration in lung tissue, and has a significant anti-allergic effect; it also significantly improves chronic asthma symptoms and airway inflammation, and significantly reduces the production and release of allergenic substance IgE, reduces local eosinophil infiltration in lung tissue, and has a significant anti-allergic effect, and can be used for the treatment of chronic asthma and variant cough; it also significantly improves acute pharyngitis symptoms and reduces inflammatory reactions, and can be used to treat pharyngitis with symptoms such as pharyngeal congestion and swelling. Furthermore, the efficacy of the composition of this invention in treating asthma, cough, and pharyngitis is superior to that of the traditional Chinese medicine composition in the comparative example.

[0036] 2. This invention also proposes a preferred preparation method for the above-mentioned traditional Chinese medicine composition. Based on the pharmacodynamic properties of the drugs, the five medicinal materials—honey-processed ephedra, bitter almond, perilla seed, prepared pinellia, and licorice—are extracted by water extraction and alcohol precipitation to obtain the effective components and remove ineffective components. The five medicinal materials—scutellaria, angelica, belamcanda, coltsfoot flower, and mulberry bark—have their main pharmacodynamic components that are alcohol-soluble. To better obtain these components, the effective components are directly extracted by alcohol extraction, thus yielding superior pharmacodynamic components. Detailed Implementation

[0037] Unless otherwise specified, all experiments in the following experiments were conducted under standard conditions or conditions recommended by the manufacturer. Active pharmaceutical ingredients (APIs) or excipients, as well as reagents or instruments whose manufacturers are not specified, are all commercially available products. Unless otherwise stated, all percentages, ratios, proportions, or parts are by weight.

[0038] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as are familiar to those skilled in the art. Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to this invention.

[0039] The following methods for preparing the compositions or formulations of the present invention are merely examples of the methods proposed in the present invention, and should not be construed as limiting the preparation methods of the present invention to the methods listed above.

[0040] Example 1: Preparation of the composition granules

[0041] 200g of honey-processed ephedra, 330g of bitter almond, 200g of perilla seed, 660g of mulberry bark, 528g of scutellaria, 330g of cicada slough, 330g of silkworm, 660g of earthworm, 330g of angelica dahurica, 330g of belamcanda chinensis, 660g of coltsfoot flower, 330g of prepared pinellia, and 200g of licorice.

[0042] Take five medicinal herbs: honey-processed ephedra, bitter almond, perilla seed, prepared pinellia, and licorice root. Add 10 times the amount of water and decoct twice, 1.5 hours each time. Filter, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.05–1.10 (60℃). Cool to room temperature, add ethanol to achieve an alcohol content of 75%, let stand for at least 24 hours, collect the supernatant, and concentrate under reduced pressure until no alcohol odor remains, obtaining extract 1 for later use. Take five medicinal herbs: scutellaria root, angelica root, belamcanda rhizome, coltsfoot flower, and mulberry bark. Add 8 times the amount of 70% ethanol and reflux extract twice, 1.0 hour each time. Filter, concentrate the filtrate under reduced pressure until no alcohol odor remains, obtaining extract 2 for later use. Take three medicinal herbs: cicada slough, silkworm, and earthworm. Add 8 times the amount of water and decoct twice, 1.5 hours each time. Filter, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.08–1.10 (60℃), obtaining extract 3 for later use. Combine the above-mentioned extracts 1, 2 and 3, concentrate under reduced pressure to a wet paste with a relative density of 1.23 to 1.25 (60°C), dry under reduced pressure (70°C) to obtain a dry paste powder, pulverize to obtain composite granules, add an appropriate amount of dextrin, mix evenly, wet granulate, spray dry to prepare granules.

[0043] Example 2: Preparation of the composition capsule

[0044] 100g of honey-processed ephedra, 100g of bitter almond, 100g of perilla seed, 300g of mulberry bark, 300g of scutellaria, 100g of cicada slough, 100g of silkworm, 300g of earthworm, 100g of angelica dahurica, 100g of belamcanda chinensis, 300g of coltsfoot flower, 100g of prepared pinellia, and 100g of licorice.

[0045] Take five medicinal herbs: honey-processed ephedra, bitter almond, perilla seed, prepared pinellia, and licorice root. Add 10 times the amount of water and decoct twice, 1.5 hours each time. Filter, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.05–1.10 (60℃). Cool to room temperature, add ethanol to achieve an alcohol content of 75%, let stand for at least 24 hours, collect the supernatant, and concentrate under reduced pressure until no alcohol odor remains, obtaining extract 1 for later use. Take five medicinal herbs: scutellaria root, angelica root, belamcanda rhizome, coltsfoot flower, and mulberry bark. Add 8 times the amount of 70% ethanol and reflux extract twice, 1.0 hour each time. Filter, concentrate the filtrate under reduced pressure until no alcohol odor remains, obtaining extract 2 for later use. Take three medicinal herbs: cicada slough, silkworm, and earthworm. Add 8 times the amount of water and decoct twice, 1.5 hours each time. Filter, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.08–1.10 (60℃), obtaining extract 3 for later use. Combine the above-mentioned extracts 1, 2, and 3, concentrate under reduced pressure to a wet extract with a relative density of 1.23–1.25 (60°C), dry under reduced pressure (70°C), pulverize, and prepare into oral capsules according to conventional processes.

[0046] Example 3: Preparation of the composition tablet

[0047] Honey-processed ephedra 120g, bitter almond 180g, perilla seed 120g, mulberry bark 360g, scutellaria baicalensis 240g, cicada slough 180g, silkworm 180g, earthworm 360g, angelica dahurica 180g, belamcanda chinensis 180g, coltsfoot flower 360g, prepared pinellia ternata 180g, licorice root 120g.

[0048] Take five medicinal herbs: honey-processed ephedra, bitter almond, perilla seed, prepared pinellia, and licorice root. Add 10 times the amount of water and decoct twice, 1.5 hours each time. Filter, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.05–1.10 (60℃). Cool to room temperature, add ethanol to achieve an alcohol content of 75%, let stand for at least 24 hours, collect the supernatant, and concentrate under reduced pressure until no alcohol odor remains, obtaining extract 1 for later use. Take five medicinal herbs: scutellaria root, angelica root, belamcanda rhizome, coltsfoot flower, and mulberry bark. Add 8 times the amount of 70% ethanol and reflux extract twice, 1.0 hour each time. Filter, concentrate the filtrate under reduced pressure until no alcohol odor remains, obtaining extract 2 for later use. Take three medicinal herbs: cicada slough, silkworm, and earthworm. Add 8 times the amount of water and decoct twice, 1.5 hours each time. Filter, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.08–1.10 (60℃), obtaining extract 3 for later use. Combine the above-mentioned extracts 1, 2, and 3, concentrate under reduced pressure to a wet extract with a relative density of 1.23–1.25 (60°C), dry under reduced pressure (70°C), pulverize, and prepare oral tablets according to conventional processes.

[0049] Example 4: Preparation of the Composition Pill

[0050] Honey-processed ephedra 60g, bitter almond 80g, perilla seed 60g, mulberry bark 150g, scutellaria baicalensis 150g, cicada slough 80g, silkworm 80g, earthworm 150g, angelica dahurica 80g, belamcanda chinensis 80g, coltsfoot flower 150g, prepared pinellia ternata 80g, licorice 60g.

[0051] Take five medicinal herbs: honey-processed ephedra, bitter almond, perilla seed, prepared pinellia, and licorice root. Add 10 times the amount of water and decoct twice, 1.5 hours each time. Filter, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.05–1.10 (60℃). Cool to room temperature, add ethanol to achieve an alcohol content of 75%, let stand for at least 24 hours, collect the supernatant, and concentrate under reduced pressure until no alcohol odor remains, obtaining extract 1 for later use. Take five medicinal herbs: scutellaria root, angelica root, belamcanda rhizome, coltsfoot flower, and mulberry bark. Add 8 times the amount of 70% ethanol and reflux extract twice, 1.0 hour each time. Filter, concentrate the filtrate under reduced pressure until no alcohol odor remains, obtaining extract 2 for later use. Take three medicinal herbs: cicada slough, silkworm, and earthworm. Add 8 times the amount of water and decoct twice, 1.5 hours each time. Filter, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.08–1.10 (60℃), obtaining extract 3 for later use. Combine the above-mentioned extracts 1, 2, and 3, concentrate under reduced pressure to a wet paste with a relative density of 1.23–1.25 (60°C), dry under reduced pressure (70°C), pulverize, and prepare oral pills according to conventional processes.

[0052] Example 5: Preparation of the oral liquid composition

[0053] 100g of honey-processed ephedra, 150g of bitter almond, 100g of perilla seed, 250g of mulberry bark, 200g of scutellaria, 150g of cicada slough, 150g of silkworm, 250g of earthworm, 150g of angelica dahurica, 150g of belamcanda chinensis, 250g of coltsfoot flower, 150g of prepared pinellia, and 100g of licorice.

[0054] Take five medicinal herbs: honey-processed ephedra, bitter almond, perilla seed, prepared pinellia, and licorice root. Add 10 times the amount of water and decoct twice, 1.5 hours each time. Filter, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.05–1.10 (60℃). Cool to room temperature, add ethanol to achieve an alcohol content of 75%, let stand for at least 24 hours, collect the supernatant, and concentrate under reduced pressure until no alcohol odor remains, obtaining extract 1 for later use. Take five medicinal herbs: scutellaria root, angelica root, belamcanda rhizome, coltsfoot flower, and mulberry bark. Add 8 times the amount of 70% ethanol and reflux extract twice, 1.0 hour each time. Filter, concentrate the filtrate under reduced pressure until no alcohol odor remains, obtaining extract 2 for later use. Take three medicinal herbs: cicada slough, silkworm, and earthworm. Add 8 times the amount of water and decoct twice, 1.5 hours each time. Filter, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.08–1.10 (60℃), obtaining extract 3 for later use. Combine the above-mentioned extracts 1, 2, and 3, concentrate under reduced pressure to a wet extract with a relative density of 1.23–1.25 (60°C), dry under reduced pressure (70°C), pulverize, and prepare an oral liquid according to conventional processes.

[0055] Pharmacological test

[0056] The granules of the composition of the present invention, as well as the comparative granules, were prepared by Jiangsu Kangyuan Pharmaceutical Co., Ltd., as detailed below:

[0057] Preparation method of the composition granules of the present invention: Take 8 kg of honey-processed ephedra, 13.2 kg of bitter almond, 8 kg of perilla seed, 26.4 kg of mulberry bark, 21.2 kg of scutellaria, 13.2 kg of cicada slough, 13.2 kg of silkworm, 26.4 kg of earthworm, 13.2 kg of angelica dahurica, 13.2 kg of belamcanda chinensis, 26.4 kg of coltsfoot flower, 13.2 kg of prepared pinellia, and 8 kg of licorice. Prepare the dry paste according to the process of Example 1 of the present invention. The pulverized sample is the composition granules of the present invention.

[0058] Preparation method of comparative granules: Take 8 kg of processed ephedra, 10 kg of apricot kernel, 20 kg of mulberry bark, 16 kg of scutellaria, 10 kg of cicada molting, 10 kg of silkworm, 20 kg of earthworm, 10 kg of ginkgo, 10 kg of angelica dahurica, 10 kg of belamcanda chinensis, 20 kg of aster, 10 kg of pinellia ternata, and 6 kg of licorice. Boil and extract twice with 10 times the amount of water, 2 hours each time. Combine the two extracts, concentrate, vacuum dry, and pulverize to obtain comparative granules.

[0059] The composition particles and comparative particles in the following experimental examples were all prepared using the above method.

[0060] Effect of Experiment 1 on OVA-induced acute bronchial asthma model in guinea pigs

[0061] Experimental materials

[0062] Animals: Guinea pigs, common grade, half male and half female, 100 in total, weighing 180-200g. Provided by Nanjing Pukou District Laifu Breeding Farm, License No.: SCXK(Su)2014-0004.

[0063] Drugs: Terbutaline Sulfate Tablets: AstraZeneca Pharmaceutical Co., Ltd., Production Batch No.: 1611098; Chuan Sou Ning Tablets: Xiuzheng Pharmaceutical Group Co., Ltd., Batch No.: 160201.

[0064] Reagents: Ovalbumin: OVA, Shanghai Yuanye Biotechnology Co., Ltd., Lot. No. AN1121GA14; Rapid Wright's stain: Nanjing Jiancheng Technology Co., Ltd., Lot. No. 20170323; Eosinophil direct counting solution: Nanjing Jiancheng Bioengineering Institute, Lot. No. 20170223.

[0065] Instruments and consumables: Ultra-low temperature freezer (Haier, model: DW-86L728); Electronic balance (Sartorius Scientific Instruments, model: BSA224S-CW); Refrigerator (SIEMENS, model: BCD-254); Centrifuge (XiangYi, model: L420); 402AI ultrasonic nebulizer (Jiangsu Yuyue Medical Equipment Co., Ltd., model: 140408832); Glass slides (Sailboat brand glass slides Cat.No.7101); Syringes (Shanghai Kangdelai KDL Enterprise Development Group Co., Ltd., specifications: 1ml, 2ml).

[0066] Experimental methods

[0067] The experiment began after 7 days of acclimatization. On day 1, each group of guinea pigs was intraperitoneally injected with 1 ml of 10% OVA (prepared with physiological saline). Behavioral signs of the guinea pigs were observed and scored according to the following criteria: trembling or head nodding was 1 point, coughing or deepening of breathing was 2 points, rhythmic contraction-like panting was 3 points, and falling was 6 points, with the most severe behavioral sign recorded. Those scoring 3 points or higher were randomly assigned to a model group, a terbutaline sulfate tablet group, a terbutaline tablet group, a combination group (low, medium, and high doses), and a control group (low, medium, and high doses) (the dosage for the combination and control groups was calculated based on the amount of raw drug administered). Each treatment group began receiving the corresponding drug on day 8, with the model group receiving 1 ml / 100g of physiological saline for 7 consecutive days. On day 15, 60 minutes after the last administration, the guinea pigs in the model group and all treatment groups were placed in a sealed glass nebulizer for 100 seconds to induce panting with 1% OVA. The latency period for induced asthma in guinea pigs was recorded (the time from the start of inhalation to the onset of asthma, the appearance of rhythmic contraction-like panting, and finally to convulsions and collapse). If the above manifestations did not appear within 6 minutes, the latency period was calculated as 360 seconds. After the test, the guinea pigs were anesthetized, euthanized by exsanguination, and the trachea was separated. The chest was opened, the right lung was ligated, and the left lung was lavaged with phosphate-buffered saline (PBS, pH 7.4). Bronchoalveolar lavage fluid (BALF) was collected, and the levels of cytokines IL-4, IFN-γ, IgE, and EOS in the BALF were measured. The right lung tissue was fixed in 10% formaldehyde solution, dehydrated, embedded in paraffin, and prepared into 4 μm sections. Hematoxylin-eosin (HE) staining was performed, and the pathological changes of the lung tissue were observed under a light microscope. Pathological damage was scored according to the following criteria: lesions were graded from mild to severe, ranging from 0.5 to 4 points. The scoring standards were as follows: slight or very minor lesions received 0.5 points; mild lesions or a small amount received 1 point; moderate lesions or a moderate amount received 2 points; severe lesions or a large amount received 3 points; and extremely severe lesions or a large amount received 4 points. No lesions received 0 points. All scores were added together to calculate the average lesion score for each group of animals.

[0068] The results showed that, compared with the model group, administration of the composition and the comparative granules significantly prolonged the latency period of OVA-induced asthma in guinea pigs (P<0.05). The low, medium, and high doses of the composition all showed significant effects in delaying asthma attacks, with better results than the comparative group. Compared with the model group, the levels of IL-4 and IgE in the BALF of the medium and high dose groups of the comparative group showed significant differences (P<0.05), and the levels of IFN-γ in the BALF of the low, medium, and high dose groups of the comparative group showed significant differences (P<0.01). The EOS count level in the BALF of the high dose group of the comparative group was significantly reduced. The levels of IL-4 and IFN-γ in the BALF of the low, medium, and high dose groups of the composition all showed significant differences (P<0.01), and the levels of IgE and EOS in the BALF of the medium and high dose groups of the composition were significantly reduced (P<0.05, P<0.01). Regarding pathological damage to lung tissue, both the comparative ratio (medium and high doses) and the composition (low, medium, and high doses) significantly reduced inflammatory lesions and the degree of emphysema (P<0.01, P<0.05), with the composition showing the best effect. Results are detailed in Tables 1, 2, and 3. The above indicators suggest that the composition of this invention significantly improves acute asthma symptoms and airway inflammation, significantly reduces the production and release of the allergenic substance IgE, and reduces local eosinophil infiltration in lung tissue, exhibiting a significant anti-allergic effect. It can be used to treat acute asthma and variant cough, with better efficacy than the comparative ratio.

[0069] Table 1: Effect of OVA on the latency of asthma in an OVA-induced acute asthma model in guinea pigs

[0070]

[0071] Note: Compared with the model group, *P<0.05, **P<0.01.

[0072] Table 2: Effects of IL-4, IFN-γ, IgE, and EOS on BALF in an OVA-induced acute asthma model in guinea pigs.

[0073]

[0074]

[0075] Note: Compared with the model group, *P<0.05, **P<0.01.

[0076] Table 3: Effects on lung tissue pathological scores in an OVA-induced acute asthma model in guinea pigs

[0077]

[0078] Note: Compared with the model group, *P<0.05, **P<0.01.

[0079] Effect of Experiment Example 2 on Histamine-Induced Chronic Bronchial Asthma Model in Guinea Pigs

[0080] Experimental materials

[0081] Animals: Guinea pigs, common grade, half male and half female, 100 in total, weighing 220-250g. Provided by Nanjing Pukou District Laifu Breeding Farm, License No.: SCXK(Su)2014-0004.

[0082] Drugs: Terbutaline Sulfate Tablets: AstraZeneca Pharmaceutical Co., Ltd., Production Batch No.: 1611098; Chuan Sou Ning Tablets: Xiuzheng Pharmaceutical Group Co., Ltd., Batch No.: 160201; Comparative Granules and Composite Granules, prepared by Jiangsu Kangyuan Pharmaceutical Co., Ltd.

[0083] Reagents: Histamine phosphate: Shanghai Yuanye Biotechnology Co., Ltd., batch number: A17O7D22934; Acetylcholine chloride: Shanghai Yuanye Biotechnology Co., Ltd., batch number: D05M8B35414; Rapid Wright stain solution: Nanjing Jiancheng Technology Co., Ltd., Lot. No. 20170323; Eosinophil direct counting solution: Nanjing Jiancheng Institute of Biotechnology, Lot. No. 20170223.

[0084] Instruments and consumables: Ultra-low temperature freezer (Haier, model: DW-86L728); Electronic balance (Sartorius Scientific Instruments, model: BSA224S-CW); Refrigerator (SIEMENS, model: BCD-254); Centrifuge (XiangYi, model: L420); 402AI ultrasonic nebulizer (Jiangsu Yuyue Medical Equipment Co., Ltd., model: 140408832); Glass slides (Sailboat brand glass slides Cat.No.7101); Syringes (Shanghai Kangdelai KDL Enterprise Development Group Co., Ltd., specifications: 1ml, 2ml).

[0085] Experimental methods

[0086] After 7 days of acclimatization, several guinea pigs were pre-selected and placed in spray boxes. A mixture of 2% acetylcholine chloride (10g acetylcholine chloride dissolved in 500mL physiological saline) and 0.05% histamine phosphate (0.25g histamine phosphate dissolved in 500mL physiological saline) was sprayed for 15 seconds to induce asthma. The latency period of asthma induction (i.e., the time from the start of spraying to the guinea pig convulsing and falling) was observed and recorded. Pigs exceeding 150 seconds were considered insensitive and not selected. The pre-selected guinea pigs were randomly divided into a model group, a terbutaline sulfate tablet group, a bronchodilator tablet group, a control group (low, medium, and high doses), and a combination group (low, medium, and high doses). All groups continued to be induced with the above-mentioned asthma-inducing solution, sprayed for 10 seconds daily for 21 days. Simultaneously with chronic asthma induction, each treatment group received the corresponding medication, while the model group received physiological saline at 1ml / 100g for 21 consecutive days. Sixty minutes after the last administration, guinea pigs underwent a repeat asphyxiation experiment using the screening method described above, and the latency period for asphyxiation was recorded. After the test, guinea pigs were anesthetized, euthanized by exsanguination, and their trachea was separated. The chest was opened, the right lung was ligated, and the left lung was lavaged with phosphate-buffered saline (PBS, pH 7.4). Bronchoalveolar lavage fluid (BALF) was collected, and the levels of cytokines IL-4, IFN-γ, IgE, and EOS in the BALF were measured. Right lung tissue was fixed in 10% formaldehyde solution, dehydrated, embedded in paraffin, and prepared into 4μm sections. Hematoxylin-eosin (HE) staining was performed, and the pathological changes in the lung tissue were observed under a light microscope. Pathological damage was scored according to the following criteria: lesions were scored from 0.5 to 4 points, ranging from mild to severe. The scoring criteria were: 0.5 points for slight or very minor lesions; 1 point for mild or minor lesions; 2 points for moderate lesions; 3 points for severe or major lesions; and 4 points for extremely severe or major lesions. Animals without lesions are scored as 0. All scores are added together to calculate the average score for lesions in each group of animals.

[0087] The results showed that, compared with the model group, the latency period of OVA-induced asthma in guinea pigs was significantly prolonged after administration of the composition and the comparative granules (P<0.05, P<0.01). The low, medium, and high doses of the composition all showed significant effects in delaying asthma attacks, with better results than the comparative group. Compared with the model group, the levels of IL-4 and IgE in the BALF of the medium and high dose groups of the comparative group showed significant differences (P<0.05, P<0.01), and the levels of IFN-γ and EOS counts in the BALF of the high dose group of the comparative group showed significant differences (P<0.05, P<0.01). The low, medium, and high dose groups of the composition all showed significant differences in IgE levels in the BALF (P<0.05), and the medium and high dose groups of the composition showed significant differences in IL-4 and EOS counts in the BALF (P<0.01, P<0.05). The IFN-γ level in the BALF of the high dose group of the composition was significantly increased (P<0.01). Regarding pathological damage to lung tissue, both the comparative ratio (medium and high doses) and the composition (low, medium, and high doses) significantly reduced inflammatory lesions and the degree of emphysema (P<0.01, P<0.05), with the composition showing the best effect. Results are shown in Tables 4, 5, and 6. The above indicators suggest that the composition of this invention significantly improves symptoms of chronic asthma and airway inflammation, and significantly reduces the production and release of the allergenic substance IgE, reduces local eosinophil infiltration in lung tissue, and has a significant anti-allergic effect. It can be used to treat chronic asthma and variant cough, and its effect is superior to that of the comparative ratio.

[0088] Table 4: Effects of histamine on the latency of asthma in a guinea pig model of chronic asthma.

[0089]

[0090]

[0091] Note: Compared with the model group, *P<0.05, **P<0.01.

[0092] Table 5: Effects of IL-4, IFN-γ, IgE, and EOS on histamine-induced chronic asthma model in balf-alcoholic fluid (BALF)

[0093]

[0094] Note: Compared with the model group, *P<0.05, **P<0.01.

[0095] Table 6: Effects of histamine on lung tissue pathological scores in a guinea pig model of chronic asthma

[0096]

[0097] Note: Compared with the model group, *P<0.05, **P<0.01.

[0098] Effect of Experiment Example 3 on the guinea pig ammonia-induced cough model

[0099] Experimental materials

[0100] Animals: Guinea pigs, common grade, half male and half female, 100 in total, weighing 220-250g. Provided by Nanjing Pukou District Laifu Breeding Farm, License No.: SCXK(Su)2014-0004.

[0101] Drugs: Terbutaline Sulfate Tablets: AstraZeneca Pharmaceutical Co., Ltd., Production Batch No.: 1611098; Chuan Sou Ning Tablets: Xiuzheng Pharmaceutical Group Co., Ltd., Batch No.: 160201; Comparative Granules and Composite Granules, prepared by Jiangsu Kangyuan Pharmaceutical Co., Ltd.

[0102] Reagent: Ammonia solution: 28% NH4OH, Sinopharm Chemical Reagent Co., Ltd., batch number: 20150106

[0103] Instrument: YLS-8A Multifunctional Cough and Asthma Induction Device, Jinan Yiyan Technology Development Co., Ltd.

[0104] Experimental methods

[0105] The experiment began after 7 days of acclimatization. On the first day, ammonia water (28% NH4OH) was sprayed for 5 seconds using a cough-inducing device. Forty-eight guinea pigs with a positive cough reflex (coughing more than 10 times within 3 minutes) were selected (coughing criteria: abdominal muscle contraction, simultaneous wide-open mouth, sometimes accompanied by coughing sounds). They were randomly divided into 9 groups according to body weight: a model group, a terbutaline sulfate tablet group, a cough-inducing tablet group, a control group (low, medium, and high doses), and a combination group (low, medium, and high doses). Males and females were housed separately, and the groups were marked with picric acid. Twenty-four hours after grouping, each group was administered the drug according to the prescribed dosage. The model group was given 1 ml / 100g of physiological saline. The drug was administered for 7 consecutive days. Sixty minutes after the last administration, the guinea pigs were stimulated in the same way. The latency period of cough induction and the number of coughs within 5 minutes were recorded. The percentage of prolonged latency period and the percentage of reduced cough were calculated as evaluation indicators.

[0106] Experimental results showed that, compared with the model group, the medium and high dose groups of the comparative group reduced the number of coughs and the cough latency period within 5 minutes in guinea pigs (p<0.05, p<0.01); the low, medium, and high doses of the composition reduced the cough latency period within 5 minutes in guinea pigs (p<0.05, p<0.01), and the medium and high doses of the composition reduced the number of coughs within 5 minutes in guinea pigs (p<0.05). The results are shown in Table 7. Compared with the comparative group, the composition of the present invention has a significant effect in alleviating cough symptoms and can be used to treat coughs caused by asthma, bronchitis, etc., with better efficacy than the comparative group.

[0107] Table 7: Effects on cough latency and cough frequency in the guinea pig model induced by ammonia water

[0108]

[0109] Note: Compared with the model group, *P < 0.05, **P < 0.01.

[0110] Effect of Experimental Example 4 on the acute rat pharyngitis model

[0111] Experimental materials

[0112] Animals: 90 SD rats, half male and half female, 200 - 220 g; SPF grade, provided by Beijing Vital River Laboratory Animal Technology Co., Ltd., license number: SCXK(Beijing)2012 - 0001.

[0113] Drugs: Pudilan Xiaoyan Tablets (0.6 g / tablet, batch number: 20150306, Guangdong Xinbao Pharmaceutical Co., Ltd.); control granules for comparative example, composition granules, prepared by Jiangsu Kanion Pharmaceutical Co., Ltd.

[0114] Reagents: Ammonia water: 28% NH4OH, Sinopharm Chemical Reagent Co., Ltd., batch number: 20150106

[0115] Instruments and consumables: Electronic balance (Sartorius Scientific Instruments Co., Ltd. model: BSA224S - CW); automatic hematology analyzer (Siemens, Germany: ADVIA 2120 type); throat nebulizer, produced by Shanghai Jiading Medical Equipment Factory.

[0116] Experimental method

[0117] The animals started the experiment after 7 days of adaptive feeding. The rats' mouths were opened wide. Except for the blank group that was nebulized with normal saline in the throat, the other groups were nebulized with 25% ammonia water using a throat nebulizer, twice a day, 3 presses each time, for a total of 3 days of model establishment. During the operation, ensure that no liquid droplets flow into the trachea. The experiment was set up with a normal group, a model group, a Pudilan Xiaoyan Tablets control group, a comparative example (low, medium, high dose) group, and a composition (low, medium, high dose) group. Each group had 10 rats. Each administration group started to administer the corresponding drug on the 4th day of the experiment. Among them, the model group and the normal group were given normal saline at 1 ml / 100 g for 7 consecutive days. Observe the diet, activity, and other states of the animals during drug administration and model establishment. One hour after the last administration of each group of rats, observe the pharyngeal conditions of each group of rats with the naked eye. And record according to the following judgment criteria: score 3, frequently scratching the mouth, drinking water, and showing pharyngeal congestion, swelling, and bright red mucosa; score 2, pharyngeal swelling, partial congestion; score 1, pharyngeal swelling, no congestion; score 0, no above - mentioned conditions. After the rats were anesthetized, the abdominal aorta blood was anticoagulated for white blood cell count.

[0118] Experimental results showed that compared with the model group, the medium and high dose groups of the comparative sample could alleviate symptoms such as pharyngeal congestion and swelling (p<0.05, p<0.01), and the low, medium, and high doses of the composition could alleviate symptoms such as pharyngeal congestion and swelling (p<0.05, p<0.01). The composition was more effective than the comparative sample. There was no significant difference between the comparative sample and the medium and high dose groups of the composition in reducing white blood cell count and differential count to varying degrees (see Tables 8 and 9). Based on these results, the composition of this invention is considered to have a significant effect in improving acute pharyngitis symptoms and reducing inflammatory response. It can be used to treat pharyngitis with symptoms such as pharyngeal congestion and swelling, and its effect is superior to that of the comparative sample.

[0119] Table 8: Effects of the composition on local pharyngeal symptoms in rats with acute pharyngitis

[0120]

[0121] Table 9: Effects of the composition on white blood cell count and differential in rats with acute pharyngitis

[0122]

[0123]

[0124] The composition proposed in this invention not only has the effect of preventing or treating asthma and cough, but also has a good effect of improving pathological changes in the throat. This pharmacological effect has also been verified by relevant experiments.

[0125] This prescription consists of 13 medicinal herbs: honey-processed ephedra, bitter almond, perilla seed, mulberry bark, scutellaria, cicada slough, silkworm, earthworm, angelica root, belamcanda rhizome, coltsfoot flower, prepared pinellia tuber, and licorice root. Compared to the control prescription, this prescription omits ginkgo, which has astringent properties, to avoid hindering the smooth flow of qi in the lungs and intestines, and to prevent its slight toxicity from harming the body's vital energy. Perilla seed is added, as it has a strong effect in lowering qi, relieving asthma, and eliminating phlegm and cough. Coltsfoot flower is added; its bitter taste and fragrant aroma have a dispersing effect, moistening the lungs, lowering qi, resolving phlegm, and stopping cough. Combined with pinellia tuber's ability to dry dampness and resolve phlegm, and the addition of almond to lower qi and stop cough, it eliminates phlegm and moistens the lungs, thus enhancing the phlegm-resolving effect. The entire prescription has the effects of clearing the lungs, relieving spasms and asthma, clearing heat, lowering qi, and resolving phlegm.

[0126] The above embodiments of the present invention are merely examples to clearly illustrate the present invention and are not intended to limit the implementation of the present invention. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. The application of a traditional Chinese medicine composition in the preparation of a medicament for pharyngeal congestion and swelling, characterized in that, This traditional Chinese medicine composition is made from the following raw materials in parts by weight: 0.5-1 parts ephedra (honey-processed), 0.5-1.5 parts bitter almond, 0.5-1 parts perilla seed, 1.5-3 parts mulberry bark, 1.5-2 parts scutellaria, 0.5-1.5 parts cicada slough, 0.5-1.5 parts silkworm, 1.5-3 parts earthworm, 0.5-1.5 parts angelica, 0.5-1.5 parts belamcanda, 1.5-3 parts coltsfoot flower, 0.5-1.5 parts prepared pinellia, and 0.5-1 parts licorice; wherein, the preparation method of the traditional Chinese medicine composition is as follows: Take five medicinal materials: honey-processed ephedra, bitter almond, perilla seed, prepared pinellia, and licorice. Add water and decoct. Filter. Concentrate the filtrate under reduced pressure to an extract with a relative density of 1.05-1.10 at 60°C. Cool to room temperature. Add ethanol to the concentrate to make the alcohol content reach 50-80%. Let stand for more than 24 hours. Take the supernatant and concentrate under reduced pressure until there is no alcohol taste to obtain extract 1. Five medicinal materials, namely Scutellaria baicalensis, Peucedanum praeruptorum, Belamcanda chinensis, Tussilago farfara, and Morus alba root bark, were extracted by reflux with 60-80% ethanol, filtered, and the filtrate was concentrated under reduced pressure to obtain extract 2. Take three medicinal materials: cicada molting, silkworm pupa, and earthworm, add water and decoct, filter, and concentrate the filtrate under reduced pressure to obtain extract 3; Combine extracts 1, 2, and 3, concentrate under reduced pressure to a wet extract with a relative density of 1.10–1.25 at 60°C, and dry under reduced pressure to obtain the final product.

2. The application according to claim 1, characterized in that, This traditional Chinese medicine composition is made from the following raw materials in parts by weight: 0.6-0.7 parts of honey-processed ephedra, 0.9-1.1 parts of bitter almond, 0.6-0.7 parts of perilla seed, 1.8-2.2 parts of mulberry bark, 1.5-1.7 parts of scutellaria, 0.9-1.1 parts of cicada slough, 0.9-1.1 parts of silkworm, 1.8-2.2 parts of earthworm, 0.9-1.1 parts of angelica root, 0.9-1.1 parts of belamcanda rhizome, 1.8-2.2 parts of coltsfoot flower, 0.9-1.1 parts of prepared pinellia tuber, and 0.6-0.7 parts of licorice root.

3. The application according to claim 2, characterized in that, This traditional Chinese medicine composition is made from the following raw materials in parts by weight: 0.61 parts ephedra, 1 part bitter almond, 0.61 parts perilla seed, 2 parts mulberry bark, 1.6 parts scutellaria, 1 part cicada slough, 1 part silkworm, 2 parts earthworm, 1 part angelica, 1 part belamcanda, 2 parts coltsfoot flower, 1 part prepared pinellia, and 0.61 parts licorice.

4. A traditional Chinese medicine composition, characterized in that, The preparation method of this traditional Chinese medicine composition is as follows: Weigh out 0.5–1 part by weight of honey-processed ephedra, 0.5–1.5 parts by weight of bitter almond, 0.5–1 part by weight of perilla seed, 1.5–3 parts by weight of mulberry bark, 1.5–2 parts by weight of scutellaria, 0.5–1.5 parts by weight of cicada slough, 0.5–1.5 parts by weight of silkworm, 1.5–3 parts by weight of earthworm, 0.5–1.5 parts by weight of angelica root, 0.5–1.5 parts by weight of belamcanda rhizome, 1.5–3 parts by weight of coltsfoot flower, and 0.5 parts by weight of prepared pinellia tuber. ~1.5 parts by weight, 0.5 to 1 part by weight of licorice; take honey ephedra, bitter almond, perilla seed, prepared pinellia, and licorice, add 6 to 12 times the amount of water and decoct 1 to 3 times, each time for 1 to 3 hours, filter, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.05 to 1.10 at 60°C, cool to room temperature, add ethanol to make the alcohol content reach 70 to 80%, let stand for more than 24 hours, take the supernatant, concentrate under reduced pressure to an extract without alcohol taste 1; Take five medicinal materials: Scutellaria baicalensis, Peucedanum praeruptorum, Belamcanda chinensis, Tussilago farfara, and Morus alba root bark. Add 6-12 times the amount of 60-80% ethanol and reflux extract 1-3 times, each time for 0.5-3 hours. Filter and concentrate the filtrate under reduced pressure to obtain extract 2. Take cicada molting, silkworm pupa, and earthworm, add 6 to 12 times the amount of water and decoct 1 to 3 times, each time for 1 to 3 hours. Filter and concentrate the filtrate under reduced pressure to an extract with a relative density of 1.05 to 1.10 at 60°C. Combine extracts 1, 2, and 3, concentrate under reduced pressure to a wet extract with a relative density of 1.23–1.25 at 60°C, and dry under reduced pressure to obtain the final product.

5. The traditional Chinese medicine composition as described in claim 4, characterized in that, The preparation method steps are as follows: Take five medicinal herbs: honey-processed ephedra, bitter almond, perilla seed, prepared pinellia, and licorice root. Add 10 times the amount of water and decoct twice, 1.5 hours each time. Filter the decoction, concentrate the filtrate under reduced pressure to an extract with a relative density of 1.05-1.10 at 60°C, cool to room temperature, add ethanol to make the alcohol content reach 75%, let stand for more than 24 hours, take the supernatant, concentrate under reduced pressure until there is no alcohol odor, and obtain extract 1 for later use; take five medicinal herbs: scutellaria root, angelica root, belamcanda rhizome, coltsfoot flower, and mulberry bark, add 8 times the amount of 70% ethanol and reflux. Extract twice, 1.0 hour each time, filter, concentrate the filtrate under reduced pressure until no alcohol odor remains, to obtain extract 2 for later use; take cicada slough, silkworm, and earthworm, add 8 times the amount of water and decoct twice, 1.5 hours each time, filter, concentrate the filtrate under reduced pressure to extract 3 with a relative density of 1.08-1.10 at 60℃, for later use; combine extract 1, extract 2 and extract 3, concentrate under reduced pressure to a wet extract with a relative density of 1.23-1.25 at 60℃, and dry under reduced pressure at 70℃ to obtain the final product.

6. The use of the traditional Chinese medicine composition as described in claim 4 or 5 in the preparation of a medicament for asthma, pharyngitis or cough.

7. A drug, characterized in that, The drug is composed of the traditional Chinese medicine composition as described in claim 4 or 5 and pharmaceutically acceptable excipients.

8. The medicament according to claim 7, characterized in that, The drug is selected from tablets, capsules, granules, pills, injections, decoctions, suspensions, dispersants, syrups, suppositories, gels, aerosols, patches, or oral liquids.

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