Pharmaceutical composition for treating post-infection cough and preparation method thereof

Abstract

The invention discloses a pharmaceutical composition for treating post-infection cough and a preparation method thereof. The traditional Chinese medicine composition provided by the invention dispels wind and freezes lung to relieve exterior syndrome, eliminates dampness and strengthens spleen to treat middle energizer and depresses qi and reduces phlegm to relieve cough, and the whole formula combines dredging and tonifying and orderly freeing and descending, and embodies the formula characteristics of simultaneous regulation of lung and spleen and simultaneous treatment of principal and subordinate symptoms. The medicines are matched to dispel lung channel wind to stop spasm, and also can dissipate dampness with aromatics, invigorate the spleen to eliminate phlegm sources, tonify qi to strengthen superficies to tonify deficiency, and achieve the effects of dispelling wind and ventilating lung, eliminating dampness and phlegm, depressing qi and relieving cough. The traditional Chinese medicine composition directly focuses on the pathogenesis of cough with wind evil with dampness and adverse rising of lung qi after infection, and can be used for treating the symptoms of cough with exuberant wind and dampness obstruction after infection, such as throat itching and cough, frequent and severe cough, sticky expectoration, chest distress, epigastric fullness, fatigue and the like. The invention provides a new treatment strategy for the post-infection cough, and has a wide clinical application prospect.

Description

Pharmaceutical composition for treating post-infectious cough and its preparation method Technical Field

[0001] This invention relates to the field of biomedical technology, specifically to a pharmaceutical composition for treating post-infectious cough and its preparation method. Background Technology

[0002] Post-infectious cough (PIC) is a common clinical symptom in respiratory diseases, referring to a persistent cough that persists for 3 to 8 weeks after the acute symptoms of a respiratory infection have subsided. It falls under the category of "cough" in Traditional Chinese Medicine (TCM). Although chest X-rays usually show no obvious abnormalities, the persistent, irritating cough severely impacts patients' sleep, work, and quality of life, making it a common and difficult-to-treat condition in respiratory clinics. Studies have shown that the pathogenesis of PIC is complex and closely related to factors such as airway mucosal damage, airway inflammation, airway hyperresponsiveness, and increased cough reflex sensitivity. With increasing air pollution and the prevalence of respiratory infectious diseases, the incidence of PIC is on the rise. Current Western medicine treatments for PIC have certain limitations: conventional anti-infective drugs are often ineffective, and while corticosteroids and centrally acting antitussives can control symptoms, they carry potential adverse reactions and addiction risks. Therefore, seeking safe and effective TCM treatment options is particularly necessary.

[0003] While existing technologies offer various traditional Chinese medicine (TCM) remedies for post-infectious cough, most emphasize only pathological factors such as wind-evil, phlegm-dampness, and yin deficiency, paying little attention to the spleen deficiency and dampness accumulation symptoms, particularly fatigue, prevalent in the later stages of infection, especially viral infections. Furthermore, the use of various heat-clearing herbs over long periods can easily damage the body's vital energy and affect the spleen and stomach, further hindering their ability to alleviate the pathological changes of spleen deficiency in the later stages of infection. Therefore, developing novel TCM preparations that combine the effects of dispelling wind and clearing the lungs with strengthening the spleen, resolving dampness, and replenishing qi, providing rapid symptom relief with minimal side effects, is of significant clinical importance. Summary of the Invention

[0004] To overcome the shortcomings of the prior art, the purpose of this invention is to provide a traditional Chinese medicine composition that combines the effects of dispelling wind and ventilating the lungs with strengthening the spleen, resolving dampness, and replenishing qi, and is also low in cost.

[0005] To achieve the above objectives, the present invention adopts the following technical solution: The first aspect of the present invention provides a traditional Chinese medicine composition for treating post-infectious cough.

[0006] Furthermore, the traditional Chinese medicine composition is prepared from honey-processed ephedra, stir-fried Atractylodes lancea, Citrus reticulata peel, bitter almond, Perilla leaf, stir-fried burdock seed, stir-fried perilla seed, Peucedanum praeruptorum, ginger-processed Magnolia officinalis, Pogostemon cablin, Astragalus membranaceus and Glycyrrhiza uralensis.

[0007] The inventive concept of this invention lies in addressing the wind-dampness obstruction syndrome manifested in post-infectious cough. The core pathogenesis of this syndrome is wind-evil invading the lungs, accompanied by internal dampness, leading to impaired lung qi circulation, combined with lung and spleen qi deficiency, and weakened defensive qi, constituting a mixed deficiency-excess pattern. Therefore, this invention proposes a treatment method that gently promotes lung qi circulation, aromatically resolves dampness, and tonifies qi and strengthens the body's resistance to fundamentally correct this pathogenesis. Based on this inventive concept, we designed and screened the following traditional Chinese medicine composition: honey-processed ephedra, bran-fried atractylodes lancea, tangerine peel, bitter almond, perilla leaf, fried burdock seed, fried perilla seed, angelica dahurica, ginger-processed magnolia bark, patchouli, astragalus, and licorice. This composition is suitable for the protracted stage where pathogenic factors have not been completely eliminated and the body's resistance is gradually weakening, or for patients with inherent lung and spleen qi deficiency who are recurrently susceptible to infection.

[0008] The closest formula to this invention is: 8 g of processed ephedra, 9 g of stir-fried bitter apricot kernel, 9 g of cicada slough, 12 g of stir-fried perilla seed, 9 g of raw angelica root, 9 g of stir-fried burdock seed, 9 g of stemona root, 9 g of acorus tatarinowii rhizome, 12 g of ginger-processed magnolia bark, 6 g of tangerine peel, 9 g of raw atractylodes rhizome, and 6 g of raw licorice root. However, this formula targets the phlegm-dampness syndrome manifested in post-infectious cough, the pathogenesis of which is wind-evil binding the lungs, phlegm and qi obstruction, and impaired lung function, with the pathogenic factor being the main focus. The treatment principle is to promote lung function, relieve stagnation, and resolve phlegm, with the main focus on eliminating pathogenic factors. It is suitable for the acute attack stage when the body's resistance is still sufficient and the pathogenic factor is prominent. At the same time, this invention has demonstrated through comparative experiments that the formula of this application is superior to this formula in treating cough and reducing lung inflammation. It is evident that this application and this formula represent two different inventive concepts, with no technical inspiration between them, and this invention represents a significant advancement in treating cough and reducing lung inflammation compared to the prior art.

[0009] The traditional Chinese medicine composition provided by this invention is named the Wind-Dispelling, Dampness-Resolving, and Cough-Relieving Formula. In the embodiments of this invention, the terms "traditional Chinese medicine composition," "traditional Chinese medicine," and "Wind-Dispelling, Dampness-Resolving, and Cough-Relieving Formula" have the same meaning and can be used interchangeably.

[0010] In the herbal composition of this invention, honey-processed ephedra and bran-fried Atractylodes lancea are used together as the principal herbs. Honey-processed ephedra is pungent and slightly bitter, warm in nature, and enters the lung and bladder meridians; bran-fried Atractylodes lancea is pungent and bitter, warm in nature, and enters the spleen and stomach meridians. Citrus reticulata peel, bitter apricot kernel, and perilla leaf are used together as the assistant herbs. Citrus reticulata peel is pungent and bitter, warm in nature, and enters the lung and spleen meridians; bitter apricot kernel is bitter, slightly warm in nature, slightly toxic, and enters the lung and large intestine meridians; perilla leaf is pungent and warm in nature, and enters the lung and spleen meridians. Burdock seed, perilla seed, angelica root, magnolia bark, patchouli, and astragalus are used as adjuvant herbs. Burdock seed is pungent and bitter, cold in nature, and enters the lung and stomach meridians; perilla seed is pungent and warm in nature, and enters the lung and large intestine meridians; angelica root is bitter and pungent, slightly cold in nature, and enters the lung meridian; magnolia bark, after processing, is bitter and pungent, warm in nature, and enters the spleen, stomach, lung, and large intestine meridians; patchouli is pungent and slightly warm in nature, and enters the spleen, stomach, and lung meridians; astragalus is sweet and slightly warm in nature, and enters the spleen and lung meridians. Licorice is used as the guiding herb, sweet in taste, neutral in nature, and enters the spleen, stomach, lung, and heart meridians.

[0011] Furthermore, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 6 parts honey-processed ephedra, 9 parts stir-fried Atractylodes lancea, 6 parts Citrus reticulata peel, 6 parts bitter almond, 6 parts perilla leaf, 6 parts stir-fried burdock seed, 6 parts stir-fried perilla seed, 6 parts Peucedanum praeruptorum, 6 parts Magnolia officinalis, 6 parts Pogostemon cablin, 9 parts Astragalus membranaceus, and 3 parts licorice.

[0012] In this invention, part by weight refers to any unit of weight, such as gram (g), kilogram (kg), etc.

[0013] In the above composition, the weight of the medicine is calculated based on the raw medicinal materials, and the proportions are based on weight parts. During production, the proportions can be increased or decreased proportionally. For example, large-scale production can be measured in kilograms or tons, while small-scale production can be measured in grams or milligrams. The weight can be increased or decreased, but the weight ratio of the raw medicinal materials among the components remains unchanged. The above weight ratios are obtained through scientific screening. For special patients, such as those with severe or mild illnesses, or obese or underweight patients, the proportions of the components can be adjusted accordingly, with increases or decreases not exceeding 100%, without changing the efficacy.

[0014] Furthermore, the types of raw materials include dried medicinal materials, fresh medicinal materials, raw medicinal materials, processed medicinal materials, whole plant of medicinal materials, effective parts of whole plant of medicinal materials, or combinations thereof.

[0015] In this invention, "raw material" is synonymous with "active pharmaceutical ingredient," referring to the traditional Chinese medicinal materials that enable the invention to exert its active function. These materials include various forms, specifically dried, fresh, raw, processed, or prepared medicinal materials, the whole plant of the medicinal material, the effective parts of the whole plant of the medicinal material, or combinations thereof, but are not limited thereto. In some embodiments, the raw material further comprises the main active ingredients extracted from the raw material, all of which are components proven in the prior art.

[0016] Furthermore, the traditional Chinese medicine composition also includes pharmaceutically acceptable excipients.

[0017] Furthermore, the excipients include binders, surfactants, flavoring agents, osmotic pressure regulators, antibacterial agents, stabilizers, and / or solubilizers.

[0018] In some embodiments, the excipients include excipients, gliding agents, sweeteners, diluents, preservatives, dyes / colorants, flavor enhancers, surfactants, wetting agents, dispersants, suspending agents, stabilizers, isotonic agents, pH adjusters and / or buffers, solubilizers, lubricants, fillers, and disintegrants.

[0019] In some implementations, diluents include lactose, sodium chloride, glucose, urea, starch, and water; binders include starch, pregelatinized starch, dextrin, maltodextrin, sucrose, gum arabic, gelatin, methylcellulose, carboxymethylcellulose, ethylcellulose, polyvinyl alcohol, polyethylene glycol, polyvinylpyrrolidone, alginate and alginates, xanthan gum, hydroxypropyl cellulose, and hydroxypropyl methylcellulose; surfactants include polyethylene oxide sorbitan fatty acid esters, sodium lauryl sulfate, glyceryl monostearate, and hexadecyl alcohol; wetting agents include glycerin and starch; and lubricants include zinc stearate, glyceryl monostearate, and polyethylene glycol. Talc, calcium and magnesium stearate, polyethylene glycol, boric acid powder, hydrogenated vegetable oil, sodium stearate fumarate, polyoxyethylene monostearate, monolaurate, sodium lauryl sulfate, magnesium lauryl sulfate, magnesium dodecyl sulfate, etc.; fillers such as mannitol (granular or powdered), xylitol, sorbitol, maltose, erythrose, microcrystalline cellulose, polysaccharides, coupled sugars, glucose, lactose, sucrose, dextrin, starch, sodium alginate, kelp polysaccharide powder, agar powder, calcium carbonate and sodium bicarbonate, etc.; disintegrants such as crosylvinylpyrrolidone, sodium carboxymethyl starch, low-substituted hydroxypropyl methyl, crosylcarboxymethyl cellulose sodium, soybean polysaccharides, etc.

[0020] Furthermore, the dosage forms of the traditional Chinese medicine composition include ointments, powders, decoctions, tinctures, oils, powders, granules, blocks, tablets, capsules, pills, gel candies, and water pills.

[0021] Furthermore, the traditional Chinese medicine composition can be administered orally, via non-gastrointestinal means, via inhalation spray, via topical administration, via rectal administration, via nasal administration, via buccal administration, or via an implanted drug storage device.

[0022] In some implementation schemes, when administering the traditional Chinese medicine composition of the present invention to a specific individual subject, the effective therapeutic dose and specific treatment plan for that individual subject can be affected by many factors, including the pharmacodynamic activity of the drug used, the age, weight, general condition, gender, diet, administration time, disease susceptibility, disease progression, and the judgment of the attending physician. In addition, those skilled in the art know that the administration method, dosage form, and dosage of the drug are affected by many factors such as the patient's age, weight, gender, pathological condition, diet, administration time, excretion rate, and responsiveness. Therefore, the dosage of the traditional Chinese medicine composition described in the present invention is not limited to the dosage in the embodiments of the present invention, and the administration method and dosage form are similar.

[0023] Any traditional Chinese medicine composition covered by this invention can be delivered orally, for example, via any acceptable and suitable oral formulation. Exemplary oral formulations include (but are not limited to, for example) tablets, sugar lozenges, tablets, aqueous and oily suspensions, dispersible powders or granules, emulsions, hard capsules and soft capsules, liquid capsules, syrups, and elixirs. Pharmaceutical compositions intended for oral administration can be prepared according to any method known in the art for manufacturing pharmaceutical compositions intended for oral administration.

[0024] Furthermore, the traditional Chinese medicine composition also includes a pharmaceutically acceptable salt of the active pharmaceutical ingredient.

[0025] Furthermore, the pharmaceutically usable salts include acid addition salts and alkali addition salts.

[0026] The term "medicinal salt" as used herein includes ammonium phosphates, metal salts, salts formed with amino acids, salts formed with amines, and salts formed with other bases such as piperidine or morpholine. The term "medicinal salt" includes monosalts or disalts. Specific embodiments include ammonium, sodium, calcium, magnesium, cesium, lithium, potassium, barium, zinc, aluminum, lysine, arginine, histidine, methylamine, ethylamine, tert-butylamine, cyclohexylamine, and N. Methylglucosamine, ethylenediamine, glycine, procaine, benzathine, diethanolamine, triethanolamine, piperidine, and morpholine.

[0027] In some embodiments, the term "medicinal salt" may also include hydrates of the pharmaceutical salts containing the active ingredient of the present invention. Examples of salts include, but are not limited to, sulfates, citrates, acetates, oxalates, chlorides, hydrochlorides, bromides, hydrobromides, iodides, nitrates, hydrogen sulfates, phosphates, acid phosphates, isonicotinate, lactate, salicylates, acid citrates, tartrates, oleates, tannates, pantothenates, hydrogen tartrates, ascorbic acid salts, gentisinates, gluconates, glucuronides, glycosides, formates, benzoates, glutamates, methanesulfonates, ethanesulfonates, benzenesulfonates, p-toluenesulfonates, camphorsulfonates, naphthalenesulfonates, propionates, succinates, fumarates, maleates, malonates, mandelates, malates, palmitates, aspartate salts, phthalates, and pyrates. Preferred pharmaceutically acceptable salts include succinate, acetate, mesylate, maleate, fumarate, tartrate, citrate, benzenesulfonate, and L. Aspartate, R ( ) Mandelates, sulfates, or palmitates; and each of the salts mentioned above may be anhydrous or hydrated. The term "medicinal salt" as used herein also refers to salts formed by the active ingredient of the medicinal materials of this invention with an acidic functional group, such as a carboxylic acid functional group, and an alkali. Examples of alkalis include, but are not limited to: hydroxides of alkali metals including sodium, potassium, and lithium; hydroxides of alkaline earth metals such as calcium and magnesium; hydroxides of other metals such as aluminum and zinc; ammonia; and organic amines, such as unsubstituted or hydroxylated monoamines. ,two Or trialkylamine, dicyclohexylamine; tributylamine; pyridine; N Methyl, N Ethylamine; diethylamine; triethylamine; monoethylamine ,two Or three (2 OH (C1 C6) Alkylamines), such as N, N dimethyl N (2 Hydroxyethylamine or trihydroxyethylamine (2 Hydroxyethylamine; N methyl D Glucosamine; morpholine; thiomorpholine; piperidine; pyrrolidine; and amino acids such as arginine and lysine.

[0028] The second aspect of the present invention provides a method for preparing a traditional Chinese medicine composition for treating post-infectious cough.

[0029] Furthermore, the preparation method includes the following steps: extracting or processing the raw materials of the traditional Chinese medicine composition described in the first aspect of the present invention to obtain its effective components, and then using the effective components as raw materials, adding pharmaceutically acceptable excipients as needed, and preparing the required dosage form according to conventional pharmaceutical techniques.

[0030] Furthermore, the preparation method includes the following steps: soaking the raw materials of the traditional Chinese medicine composition described in the first aspect of the present invention in water, decocting and extracting, filtering to obtain the extract, concentrating under reduced pressure and adding excipients to prepare a decoction.

[0031] Furthermore, pharmaceutically acceptable excipients may additionally contain liquids such as water, physiological saline, glycerin, and ethanol. Additionally, auxiliary substances such as wetting agents, emulsifiers, or pH buffers may be present in the pharmaceutical composition. These carriers enable the pharmaceutical composition to be formulated into dosage forms such as granules, tablets, pills, capsules, injections, oral liquids, tinctures, mixtures, powders, lotions, films, and drops for patient ingestion.

[0032] As a non-limiting example, the dosage form of the pharmaceutical preparation is prepared as follows: Granules: Using the traditional Chinese medicine composition described in the first aspect of the present invention as the active ingredient, pharmaceutical excipients are added, mixed, granulated, dried, and packaged to obtain traditional Chinese medicine granules containing the traditional Chinese medicine composition described in the first aspect of the present invention.

[0033] Tablets: Using the traditional Chinese medicine composition described in the first aspect of the present invention as the active ingredient, the ingredients are dried, pharmaceutical excipients are added, mixed, granulated, dried, compressed, and coated to obtain traditional Chinese medicine tablets containing the traditional Chinese medicine composition described in the first aspect of the present invention. The tablets can be plain tablets or coated tablets, such as sugar-coated, gastric-coated, or enteric-coated tablets.

[0034] Capsules: Using the traditional Chinese medicine composition described in the first aspect of the present invention as the active ingredient, the ingredients are dried, then pharmaceutical excipients are added, mixed, granulated, dried, and encapsulated to obtain a traditional Chinese medicine capsule containing the traditional Chinese medicine composition described in the first aspect of the present invention. The capsule can be a hard capsule or a soft capsule.

[0035] Oral liquid: Using the traditional Chinese medicine composition described in the first aspect of the present invention as the active ingredient, water is added and stirred until homogeneous, then pharmaceutical excipients are added, stirred until homogeneous, filtered, filled, sterilized, and packaged to obtain a traditional Chinese medicine oral liquid containing the traditional Chinese medicine composition described in the first aspect of the present invention.

[0036] Pills: Using the traditional Chinese medicine composition described in the first aspect of the present invention as the active ingredient, after drying and pulverizing, pharmaceutical excipients are added, the mixture is placed in a sugar coating pan, a polar solvent is added while rotating the sugar coating machine, the mixture is stirred, formed into pills, dried, coated, and packaged to obtain traditional Chinese medicine pills containing the traditional Chinese medicine composition described in the first aspect of the present invention.

[0037] Droplets: Using the traditional Chinese medicine composition described in the first aspect of this invention as the active ingredient, after drying and pulverizing, pharmaceutical excipients are added, mixed evenly, heated and melted, stirred evenly, made into pills, washed, dried, and packaged to obtain traditional Chinese medicine droplets containing the traditional Chinese medicine composition described in the first aspect of this invention.

[0038] The third aspect of this invention provides the use of the traditional Chinese medicine composition described in the first aspect of this invention in the preparation of a medicament for the prevention and / or treatment of cough.

[0039] Furthermore, the cough mentioned is a post-infectious cough.

[0040] Furthermore, the syndrome of post-infection cough is classified as wind-dampness obstruction syndrome.

[0041] The fourth aspect of this invention provides the application of the traditional Chinese medicine composition described in the first aspect of this invention in the preparation of a medicine that dispels wind and clears the lungs, strengthens the spleen and resolves dampness, and invigorates qi.

[0042] Advantages and beneficial effects of this invention: This invention provides a novel traditional Chinese medicine composition for post-infectious cough with wind-dampness obstruction syndrome. It innovatively employs methods of gently dispersing lung qi, aromatically resolving dampness, and tonifying qi to fundamentally correct the pathogenesis of this syndrome. The traditional Chinese medicine composition provided by this invention dispels wind and disperses lung qi to relieve exterior symptoms, dries dampness and strengthens the spleen to treat the middle jiao, and descends qi to resolve phlegm to stop coughing. The entire formula combines tonification and purgation, with orderly dispersing and descending actions, reflecting the characteristics of simultaneous regulation of the lung and spleen and treating both the root cause and the symptoms. The combined effects of the various herbs not only disperse latent wind in the lung meridian to stop spasms, but also aromatically resolve dampness, strengthen the spleen to eliminate the source of phlegm, and tonify qi to consolidate the exterior to replenish deficiency, thus achieving the effects of dispelling wind and dispersing lung qi, drying dampness and resolving phlegm, and descending qi to stop coughing. It precisely addresses the pathogenesis of post-infectious cough with wind-dampness and upward reversal of lung qi, and can be used for post-infectious cough with wind-dampness obstruction syndrome, characterized by itchy throat followed by coughing, frequent and severe coughing, thick sputum, chest tightness and epigastric fullness, fatigue, etc., showing broad clinical application prospects. Attached Figure Description

[0043] Figure 1 shows the number of coughs in mice within 3 minutes after capsaicin stimulation; Figure 2 shows the results of HE staining of lung tissue. Detailed Implementation

[0044] To make the objectives, technical solutions, and beneficial effects of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. Reagents or instruments used, where the manufacturer is not specified, are all conventional products that can be purchased commercially.

[0045] Example: Composition and efficacy of the wind-dispelling, dampness-resolving, and cough-relieving formula of the present invention 1. Experimental materials The traditional Chinese medicine composition of the present invention, also known as the wind-dispelling, dampness-resolving, and cough-relieving formula, is composed of 6g of honey-processed ephedra, 9g of bran-fried Atractylodes lancea, 6g of Citrus reticulata peel, 6g of bitter almond, 6g of Perilla leaf, 6g of fried Arctium lappa, 6g of fried Perilla frutescens, 6g of Peucedanum praeruptorum, 6g of ginger-processed Magnolia officinalis, 6g of Pogostemon cablin, 9g of Astragalus membranaceus, and 3g of Glycyrrhiza uralensis.

[0046] 2. Experimental Methods (1) Preparation of the formula for dispelling wind, resolving dampness, and relieving cough: Weigh the above raw materials, soak them in 10 times their volume of distilled water for 1 hour, bring to a boil over high heat, then simmer over low heat for 30 minutes, and filter the decoction through gauze; soak the residue in 8 times their volume of distilled water, bring to a boil over high heat, then simmer over low heat for 30 minutes, and filter again through gauze. Combine the two decoctions and concentrate them to a concentration of 1.54 g / mL of raw herbs, then store at 4°C.

[0047] (2) Study subjects: 20 male SPF grade C57 / 6J mice aged 6-8 weeks, purchased from Vital River.

[0048] (3) PIC model construction: Mice were placed in a smoke chamber (0.5m) 3Mice were exposed to 50g of sawdust and the smoke of 10 cigarettes for 30 minutes daily, with free access to food and water for the remaining time, for a total of 10 days. On days 11, 14, and 17, mice were anesthetized with ether, and 250μL of phosphate-buffered saline (PBS) containing 20μg of lipopolysaccharide (LPS) was instilled into their nasal cavity. On days 12, 13, 15, 16, and 18, mice were placed in a transparent chamber and treated daily with capsaicin aerosol (1×10⁻⁶). -4 Treatment with LPS (mol / L) once, lasting 3 minutes each time. During the fumigation process, mice showed sparse and dry fur, loss of appetite, and poor mental state; during LPS nasal drops and capsaicin nebulization, nasal secretions appeared and frequent coughing occurred; if the number of coughs within 3 minutes induced by capsaicin was not less than 10, the model was considered successfully established.

[0049] (4) Grouping and administration: Mice were randomly divided into a control group, a model group, a decoction for dispelling wind and dampness and relieving cough, and a compound methoxyphenamine (positive control drug, also known as Asma) group, with 5 mice in each group. Except for the control group, the other groups were used to construct the PIC model. The administration started on day 18. The decoction for dispelling wind and dampness and relieving cough was administered by gavage at a dose of 1.54 g / ml, the compound methoxyphenamine was administered by gavage at a dose of 5.73 mg / ml, and the control group and the model group were administered physiological saline by gavage once a day for 7 consecutive days.

[0050] (5) Specimen collection: The number of coughs in mice within 3 minutes after capsaicin stimulation was recorded 2 hours after drug administration. After euthanizing the mice, the left lung was taken, fixed by immersion in 4% paraformaldehyde, embedded in paraffin, and cut into 4μm sections. Each section was stained with hematoxylin and eosin (HE) to observe the lesions and inflammatory cell infiltration in the mouse lung tissue.

[0051] 3. Experimental Results: The number of coughs in mice within 3 minutes after capsaicin stimulation is shown in Figure 1. Compared with the model group, the herbal medicine group of this invention significantly reduced the number of coughs in mice and was superior to the positive control drug compound methoxyphenamine (Asma). The pathological results of lung tissue HE staining are shown in Figure 2. In the blank group, the alveolar structure of the lung tissue of mice was clear, the septa were normal, and there was less inflammatory cell infiltration; the pathological manifestations were basically normal. In the model group, the alveolar structure disappeared, the alveolar septa widened, and there was a large amount of inflammatory cell infiltration in the bronchi and surrounding areas. After treatment with the herbal medicine of this invention or compound methoxyphenamine (Asma), the pathological manifestations of the lung tissue of mice were improved to a certain extent, and the herbal medicine group of this invention was superior to the compound methoxyphenamine (Asma) treatment group.

[0052] In summary, the traditional Chinese medicine composition provided by this invention can significantly reduce the frequency of coughing and clearly improve the pathological characteristics of lung tissue. It has obvious advantages over compound methoxyphenamine (Asma), a positive control drug commonly used in clinical practice to treat post-infectious cough, and has no obvious adverse reactions, demonstrating good safety.

[0053] The above description of the embodiments is only for understanding the method and core ideas of the present invention. It should be noted that those skilled in the art can make various modifications and changes to the present invention without departing from its principles, and these modifications and changes will also fall within the protection scope of the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating post-infectious cough, characterized in that, The traditional Chinese medicine composition is prepared from honey-processed ephedra, stir-fried Atractylodes lancea, Citrus reticulata peel, bitter almond, Perilla leaf, stir-fried burdock seed, stir-fried perilla seed, Peucedanum praeruptorum, ginger-processed Magnolia officinalis, Pogostemon cablin, Astragalus membranaceus and Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 6 parts honey-processed ephedra, 9 parts stir-fried Atractylodes lancea, 6 parts Citrus reticulata peel, 6 parts bitter almond, 6 parts perilla leaf, 6 parts stir-fried burdock seed, 6 parts stir-fried perilla seed, 6 parts Peucedanum praeruptorum, 6 parts Magnolia officinalis, 6 parts Pogostemon cablin, 9 parts Astragalus membranaceus, and 3 parts licorice.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The types of raw materials include dried medicinal materials, fresh medicinal materials, raw medicinal materials, processed medicinal materials, whole plant of medicinal materials, effective parts of whole plant of medicinal materials, or combinations thereof.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition further includes pharmaceutically acceptable excipients; preferably, the excipients include binders, surfactants, flavoring agents, osmotic pressure regulators, antibacterial agents, stabilizers, and / or solubilizers.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, The dosage forms of the traditional Chinese medicine composition include ointments, powders, decoctions, tinctures, oils, powders, granules, blocks, tablets, capsules, pills, gel candies, and water pills; preferably, the traditional Chinese medicine composition is administered orally, via non-gastrointestinal administration, inhalation spray, local administration, rectal administration, nasal administration, buccal administration, or via an implanted drug storage device.

6. A method for preparing a traditional Chinese medicine composition for treating post-infectious cough, characterized in that, The preparation method includes the following steps: extracting or processing the raw materials of the traditional Chinese medicine composition according to any one of claims 1-5 to obtain its effective components, and then using the effective components as raw materials, adding pharmaceutically acceptable excipients as needed, and preparing the required dosage form according to conventional pharmaceutical techniques.

7. The preparation method according to claim 6, characterized in that, The preparation method includes the following steps: soaking the raw materials of the traditional Chinese medicine composition according to any one of claims 1-5 in water, decocting and extracting, filtering to obtain the extract, concentrating under reduced pressure and adding excipients to prepare a decoction.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-5 in the preparation of a medicament for the prevention and / or treatment of cough.

9. The application according to claim 8, characterized in that, The cough is a post-infectious cough; preferably, the syndrome of the post-infectious cough is wind-dampness obstruction syndrome.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-5 in the preparation of a medicine for dispelling wind and ventilating the lungs, strengthening the spleen and resolving dampness, and replenishing qi.

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