Ethnic pharmaceutical composition for treating cough as well as preparation and application of ethnic pharmaceutical composition

Abstract

The invention discloses an ethnic pharmaceutical composition for treating cough and a preparation and application thereof, and the ethnic pharmaceutical composition is composed of ginseng, semen armeniacae amarae, stemona yunnanensis, honey ephedra, pericarpium citri reticulatae, pink reineckea herb, honey tussilago farfara, honey aster, astragalus membranaceus, bighead atractylodes rhizome, divaricate saposhnikovia root, schizonepeta, folia perillae acutae and liquorice. The ethnic pharmaceutical composition for treating cough is prepared into a preparation by adding pharmaceutically acceptable auxiliary materials. The ethnic pharmaceutical composition for treating cough and the preparation thereof can be used for preparing medicines for treating cough and cough variant asthma.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of medicine, and particularly relates to a national medicine composition for treating cough, and a preparation and application thereof, in particular to a national medicine composition for treating cough of wind invading lung syndrome, and a preparation and application thereof. BACKGROUND

[0002] Cough of wind invading lung syndrome is common in clinical cough, with the increasing of allergens in the environment and frequent climate change, its incidence is rising year by year, which seriously affects the quality of life of patients. The typical feature of the syndrome is irritating cough, and the cough symptoms will be significantly aggravated when the patient is in contact with cold air, dust mites and other inducements after a cold, and has the characteristics of repeated and prolonged course. At present, for such cough, the conventional cough medicine, antihistamine and bronchodilator are often used in clinical treatment. Although the conventional cough medicine can relieve cough to a certain extent, it cannot block the invasion of wind, and the cough is easy to recur; the antihistamine has a certain effect on the cough caused by contact with dust mites and other allergens, but it is difficult to improve the pathological state of the whole wind invading lung; the bronchodilator mainly acts on airway spasm, and has limited effect on the cough caused by wind invading lung. These existing treatment methods can only temporarily relieve symptoms, and cannot effectively intervene in the core pathogenesis of wind invading lung, so it is difficult to cure the disease fundamentally, and long-term use may cause drowsiness, palpitation and other adverse reactions. Therefore, it is urgent to develop a medicine composition which can effectively treat cough of wind invading lung syndrome, block the pathogenic factors, relieve the symptoms of irritating cough, improve the pathological state from the root and reduce the risk of recurrence. SUMMARY

[0003] In view of the deficiencies in the prior art, the present application aims to provide a national medicine composition for treating cough and a preparation and application thereof. The medicine composition for treating cough has the effects of dispelling wind and evil, relieving cough, and strengthening the body resistance, and is safe and has no side effects.

[0004] The purpose of the present application is achieved by the following technical solutions: A national medicine composition for treating cough, which is composed of the following components in parts by weight: Radix Lamiophloma violaceum 9-15 parts, bitter apricot kernel 5-10 parts, Yunnan Radix Stachys 10-20 parts, honey Ephedra 5-15 parts, dried tangerine or orange peel 5-15 parts, Herba Lysimachiae 5-20 parts, honey Syringa 5-20 parts, honey Aster 5-20 parts, Radix Astragali 10-30 parts, Atractylodes 5-20 parts, Radix Saposhnikoviae 5-20 parts, Schizonepeta 5-20 parts, Perilla leaf 5-20 parts, and Radix Glycyrrhizae 3-10 parts.

[0005] Preferably, the ethnic medicine composition for treating cough consists of the following components in parts by weight: Luanhuaxian 10-15 parts, bitter apricot kernel 5-10 parts, Dianbaibu 5-20 parts, honey ephedra 5-10 parts, dried tangerine or orange peel 5-10 parts, Jixiangcao 10-20 parts, honey Lonicera japonica 10-20 parts, honey Asiatic lily 10-20 parts, Huangqi 15-30 parts, Baizhu 10-20 parts, Fangfeng 10-20 parts, Jingjie 5-20 parts, Zixu Ye 10-20 parts, Gancao 3-10 parts.

[0006] More preferably, the ethnic medicine composition for treating cough consists of the following components in parts by weight: Luanhuaxian 10-15 parts, bitter apricot kernel 8-10 parts, Dianbaibu 10-15 parts, honey ephedra 5-10 parts, dried tangerine or orange peel 8-10 parts, Jixiangcao 10-15 parts, honey Lonicera japonica 10-15 parts, honey Asiatic lily 10-15 parts, Huangqi 20-25 parts, Baizhu 12-15 parts, Fangfeng 10-15 parts, Jingjie 10-15 parts, Zixu Ye 10-15 parts, Gancao 3-6 parts.

[0007] According to traditional Chinese medicine theory, the lung is the Huagai Zang, opens the nose and is combined with the skin and hair, has the physiological functions of promoting and descending, and regulating water passages. Wind evil is the first of the six evils, and is light and easy to change, easy to enter from the mouth, nose, skin and hair, and directly attack the lung to cause disease. Wind evil can cause disease alone, forming simple wind evil invading the lung syndrome, or combined with cold, heat and wet evil to cause complex and diverse conditions. When the wind evil binds the table, the lung and the lung lose their normal function, leading to the accumulation of dampness and the formation of sputum. At the same time, the lung loses its descending function, and the lung qi rises, which together causes cough, wheezing, and sputum. If the patient is weak, or the cough is prolonged, the lung and spleen qi are easily consumed, so the wind evil stays and the healthy qi is not strong enough to resist evil, which can cause repeated cough, worsening with wind, and self-haemorrhage and weakness. According to the above pathogenesis, the application is guided by the theory of syndrome differentiation and treatment, and the idea of "dispelling wind and evil, promoting the lung to stop cough, and strengthening the body" is used to balance the symptoms and the root cause.

[0008] In the formula: The monarch drug Luanhuaxian, bitter apricot kernel and Dianbaibu together promote the lung, stop cough and asthma, and moisten the lung to reduce sputum. Luanhuaxian is sweet and slightly bitter, neutral, and belongs to the lung and spleen meridians, and is good for tonifying qi and invigorating the spleen, and eliminating phlegm and relieving cough. It is a "boat and oar" drug that can carry drugs up to the lung, regulate lung qi stagnation, and treat cough and phlegm. Bitter apricot kernel is bitter and slightly warm, and belongs to the lung and large intestine meridians, and is good for descending qi to stop cough and asthma, and moistening the intestine to promote defecation. It promotes and descends with Luanhuaxian, regulates the lung qi, and enhances the effect of stopping cough and asthma. Dianbaibu is sweet and bitter, slightly warm, and belongs to the lung meridian, and is good for moistening the lung to stop cough and killing insects and lice, especially for treating acute and chronic cough and whooping cough. Its warm and moist nature can prevent excessive promotion and descent from damaging the lung, and is the main drug for treating cough. The three drugs together promote and descend lung qi, moisten the lung and reduce sputum, and are the monarch drugs for treating cough and asthma.

[0009] Assistant herbs: Honey-processed ephedra: dispels lung heat and cold, relieves asthma and promotes urination, assisting the principal herb in alleviating cough and asthma caused by wind-cold binding the lungs. Tangerine peel: regulates qi and strengthens the spleen, dries dampness and resolves phlegm, regulating spleen and stomach qi stagnation, eliminating the source of phlegm production, and enhancing the phlegm-resolving effect when combined with the principal herb. Auspicious herb: detoxifies and soothes the throat, cools the blood and stops bleeding, nourishes yin and moistens the lungs, assisting the principal herb in lowering qi and resolving phlegm, and also clearing wind-heat in the lung meridian, suitable for cough and asthma with phlegm-heat or external wind-heat with phlegm, balancing the warming and drying nature of the entire formula. Honey-processed coltsfoot flower and honey-processed aster: both enter the lung meridian, and the honey-processing enhances their lung-moistening and cough-relieving effects. These five herbs assist the principal herb, working synergistically from multiple angles—dispersing lung heat, lowering qi, resolving phlegm, clearing heat, and moistening dryness—to address complex pathogenesis such as cough with phlegm, cold, or heat, and together serve as assistant herbs.

[0010] Adjuvant herbs: Astragalus: Tonifies Qi and strengthens the exterior, raises Yang and lifts prolapse, replenishes the Qi of the lungs and spleen, enhances the body's defensive function, prevents external pathogens from invading, and addresses the underlying deficiency pathogenesis of wind-cold cough. Atractylodes macrocephala: Bitter and sweet in taste, strengthens the spleen, dries dampness, tonifies Qi and strengthens the exterior. When combined with Astragalus, it strengthens the spleen to eliminate the source of phlegm, replenishes the acquired constitution to replenish lung Qi, and assists the principal herb in treating the root cause. Saposhnikovia divaricata: Dispels wind and releases the exterior, eliminates dampness and relieves pain, disperses external pathogens, and harmonizes Ying and Wei. The three herbs together tonify the lungs and strengthen the spleen, strengthen the exterior and dispel wind, both supporting the body's vital energy to treat the root cause and restraining the Qi-depleting tendencies of the principal and assistant herbs. Together, they serve as adjuvant herbs, embodying the principle of "treating both the root cause and the symptoms."

[0011] Guiding herbs: Schizonepeta, Perilla leaf, and Licorice root; these guide the other herbs to their respective meridians and harmonize the effects of the other herbs.

[0012] Overall, the formula employs both ascending and descending methods: ginseng promotes lung function, while apricot kernel and ephedra descend qi, restoring the lung's qi-regulating function; it addresses both the root cause and the symptoms: the principal and assistant herbs stop coughing and relieve asthma, while the adjuvant herbs tonify qi and strengthen the spleen, addressing the root cause, suitable for coughs with mixed deficiency and excess (such as chronic bronchitis, recurrent cough and asthma due to weakness, etc.); it combines warming and clearing: ephedra and tangerine peel warm and disperse wind-cold phlegm and dampness, auspicious grass clears and drains stagnant heat in the lung meridian, and honey coltsfoot flower and honey aster warm and moisten to stop coughing, the entire formula addresses both cold and heat, suitable for various syndrome types; it combines dispersing and tonifying: astragalus and atractylodes macrocephala tonify qi and strengthen the exterior, while saposhnikovia, schizonepeta, and perilla leaf relieve exterior symptoms and dispel pathogens, tonifying without stagnation and dispersing without harming the body's vital energy, embodying the principle of "supporting the body's vital energy and eliminating pathogens." The combination of all the herbs in this formula eliminates pathogens without harming the body's vital energy, and supports the body's vital energy without lingering on pathogens. Together, they work to dispel wind and pathogens, clear the lungs and stop coughing, and strengthen the body's vital energy. This formula addresses both the etiology, pathogenesis, and clinical symptoms of cough caused by wind-evil invading the lungs, treating both the symptoms and the root cause.

[0013] The ethnic medicine composition for treating cough can also be formulated with pharmaceutically acceptable excipients to produce decoctions, oral liquids, pills, tablets, granules, etc.

[0014] The ethnic medicine composition and its preparation for treating cough have the effects of dispelling wind and evil, clearing the lungs and relieving cough, and strengthening the body's resistance. They can be used to prepare medicines for treating cough, especially for treating cough caused by wind-evil invading the lungs, and can also effectively relieve the symptoms of cough variant asthma.

[0015] Compared with the prior art, the present invention has the following beneficial effects: 1. The ethnic medicine composition and its preparation described in this invention are specifically targeted at the key syndrome of wind-evil invading the lungs. Through the synergistic effect of dispelling wind and evil and relieving cough, it intervenes from the pathological link triggered by the inducing factors, and achieves precise treatment of specific types of irritative cough.

[0016] 2. The ethnic medicine composition and its preparation described in this invention use wind-dispelling drugs as the lead to quickly eliminate external pathogens; simultaneously, it is combined with lung-clearing and cough-relieving drugs to unblock the flow of qi and stop coughing; and more innovatively, it adds tonifying and strengthening drugs to form a combination logic of "eliminating pathogens without harming the body's resistance, and tonifying the body's resistance to eliminate pathogens", breaking the limitations of the existing technology of "single target and single effect".

[0017] 3. This invention targets irritant coughs triggered by exposure to cold air, dust mites, and other factors. Compared to existing single-drug cough suppressants or anti-allergy medications, it significantly reduces the frequency, severity, and duration of coughs. Regarding syndrome differentiation suitability, existing medications have an overall improvement rate of 75% for the wind-cold invading the lung syndrome, while this invention, through its "treating both the symptoms and the root cause" formulation design, achieves a total clinical efficacy rate of over 90% for this syndrome. It not only quickly relieves coughs but also improves accompanying symptoms such as phlegm, itchy throat, and chest tightness, achieving comprehensive intervention for the disease.

[0018] 4. Existing medications can only control symptoms in the short term, and relapse is common after discontinuation. The ethnic medicine composition and its preparations described in this invention not only relieve symptoms but also enhance the body's resistance to inducing factors such as wind-evil. Clinical data show that this approach upgrades from "symptomatic treatment" to a comprehensive conditioning that addresses both the cause and the symptoms, effectively overcoming the core defects of existing medications that "treat the symptoms but not the root cause and are prone to relapse."

[0019] 5. Through rigorous formulation and quality control, this invention has not shown any significant adverse reactions in clinical applications. Its safety profile is significantly higher than that of some existing drugs containing irritating ingredients, achieving the dual advantages of "high efficiency and safety".

[0020] 6. The ethnic medicine composition described in this invention is a Hani ethnic medicine formula, which follows the traditional concept of "treating the root cause of the disease and addressing both the symptoms and the root cause". Through precise formulation, it achieves multi-dimensional synergy of "cough relief, phlegm reduction, asthma relief, strengthening the exterior and invigorating the spleen". It not only fits the pathogenesis of cough in Southwest China, but also takes into account the advantages of mild medicinal properties and wide applicability. It reflects the core wisdom of Hani medicine of "adapting to local conditions, treating according to syndrome differentiation, and combining prevention and treatment", and is especially suitable for acute cough caused by wind-evil invading the lungs or acute exacerbation of chronic cough. Attached Figure Description

[0021] Figure 1 The disease scores of rats in each group in Example 1 are shown.

[0022] Figure 2The images show a comparison of the lung conditions of rats in each group in Example 1. A is a photograph of the lung, B is a microscopic image of a pathological section (100X), and C is an immunofluorescence microscopic image (100X). (F4 / 80 is a marker for macrophages; DAPI is used to label all cell nuclei and show the cell distribution in the tissue; Merge is an overlay image of F4 / 80 and DAPI, which visually shows the distribution of macrophages in the tissue.)

[0023] Figure 3 The serum IL-1β levels of rats in each group in Example 1 are shown in the figure (**). P <0.01).

[0024] Figure 4 The serum IL-6 levels of rats in each group in Example 1 are shown in the figure (*). P <0.05).

[0025] Figure 5 The serum TNF-α levels of rats in each group in Example 1 were used. Detailed Implementation

[0026] The present invention will be further described below with reference to the embodiments, but the present invention is not limited to the embodiments. Example 1

[0027] A traditional Chinese medicine composition for treating cough comprises the following components: 15g of Panax quinquefolius, 12g of bitter apricot kernel, 18g of Stemona japonica, 6g of honey-processed ephedra, 10g of dried tangerine peel, 12g of Auspicious Grass, 15g of honey-processed Tussilago farfara, 15g of honey-processed Aster tataricus, 20g of Astragalus membranaceus, 15g of Atractylodes macrocephala, 12g of Saposhnikovia divaricata, 10g of Schizonepeta tenuifolia, 10g of Perilla frutescens leaf, and 6g of licorice. Example 2

[0028] A traditional Chinese medicine composition for treating cough comprises the following components: 12g of Panax quinquefolius, 10g of bitter apricot kernel, 15g of Stemona japonica, 5g of honey-processed ephedra, 8g of dried tangerine peel, 10g of Auspicious Grass, 12g of honey-processed Tussilago farfara, 12g of honey-processed Aster tataricus, 18g of Astragalus membranaceus, 12g of Atractylodes macrocephala, 10g of Saposhnikovia divaricata, 8g of Schizonepeta tenuifolia, 8g of Perilla frutescens leaf, and 5g of Glycyrrhiza uralensis. Example 3

[0029] A traditional Chinese medicine composition for treating cough comprises the following components: 10g of Panax quinquefolius, 8g of bitter apricot kernel, 12g of Stemona japonica, 4g of honey-processed ephedra, 6g of dried tangerine peel, 8g of Auspicious Grass, 10g of honey-processed coltsfoot flower, 10g of honey-processed Aster tataricus, 15g of Astragalus membranaceus, 10g of Atractylodes macrocephala, 8g of Saposhnikovia divaricata, 6g of Schizonepeta tenuifolia, 6g of Perilla frutescens leaf, and 4g of licorice. Example 4

[0030] A traditional Chinese medicine composition for treating cough comprises the following components: 13g of Panax quinquefolius, 11g of bitter apricot kernel, 16g of Stemona japonica, 5g of honey-processed ephedra, 9g of dried tangerine peel, 11g of Auspicious Grass, 13g of honey-processed Tussilago farfara, 13g of honey-processed Aster tataricus, 17g of Astragalus membranaceus, 13g of Atractylodes macrocephala, 11g of Saposhnikovia divaricata, 9g of Schizonepeta tenuifolia, 9g of Perilla frutescens leaf, and 5g of licorice. Example 5

[0031] A traditional Chinese medicine composition for treating cough comprises the following components: 14g of Panax quinquefolius, 12g of bitter apricot kernel, 17g of Stemona japonica, 6g of honey-processed ephedra, 10g of dried tangerine peel, 12g of Auspicious Grass, 14g of honey-processed Tussilago farfara, 14g of honey-processed Aster tataricus, 19g of Astragalus membranaceus, 14g of Atractylodes macrocephala, 12g of Saposhnikovia divaricata, 10g of Schizonepeta tenuifolia, 10g of Perilla frutescens leaf, and 6g of licorice. Example 6

[0032] A traditional Chinese medicine composition for treating cough comprises the following components: 16g of Panax quinquefolius, 13g of bitter apricot kernel, 19g of Stemona japonica, 7g of honey-processed ephedra, 11g of dried tangerine peel, 13g of Auspicious Grass, 15g of honey-processed Tussilago farfara, 15g of honey-processed Aster tataricus, 21g of Astragalus membranaceus, 16g of Atractylodes macrocephala, 13g of Saposhnikovia divaricata, 11g of Schizonepeta tenuifolia, 11g of Perilla frutescens leaf, and 7g of licorice. Example 7

[0033] A traditional Chinese medicine composition for treating cough comprises the following components: 11g of Panax quinquefolius, 9g of bitter apricot kernel, 13g of Stemona japonica, 4g of honey-processed ephedra, 7g of dried tangerine peel, 9g of Auspicious Grass, 11g of honey-processed Tussilago farfara, 11g of honey-processed Aster tataricus, 16g of Astragalus membranaceus, 11g of Atractylodes macrocephala, 9g of Saposhnikovia divaricata, 7g of Schizonepeta tenuifolia, 7g of Perilla frutescens leaf, and 4g of Glycyrrhiza uralensis. Example 8

[0034] A traditional Chinese medicine composition for treating cough comprises the following components: 12g of Panax quinquefolius, 10g of bitter apricot kernel, 14g of Stemona japonica, 5g of honey-processed ephedra, 8g of dried tangerine peel, 10g of Auspicious Grass, 12g of honey-processed Tussilago farfara, 12g of honey-processed Aster tataricus, 17g of Astragalus membranaceus, 12g of Atractylodes macrocephala, 10g of Saposhnikovia divaricata, 8g of Schizonepeta tenuifolia, 8g of Perilla frutescens leaf, and 5g of Glycyrrhiza uralensis. Example 9

[0035] A traditional Chinese medicine composition for treating cough comprises the following components: 15g of Panax quinquefolius, 12g of bitter apricot kernel, 18g of Stemona japonica, 6g of honey-processed ephedra, 10g of dried tangerine peel, 12g of Auspicious Grass, 15g of honey-processed Tussilago farfara, 15g of honey-processed Aster tataricus, 20g of Astragalus membranaceus, 15g of Atractylodes macrocephala, 12g of Saposhnikovia divaricata, 10g of Schizonepeta tenuifolia, 10g of Perilla frutescens leaf, and 6g of licorice. Example 10

[0036] A traditional Chinese medicine composition for treating cough comprises the following components: 17g of Panax quinquefolius, 14g of bitter apricot kernel, 20g of Stemona japonica, 7g of honey-processed ephedra, 12g of dried tangerine peel, 14g of Auspicious Grass, 16g of honey-processed Tussilago farfara, 16g of honey-processed Aster tataricus, 22g of Astragalus membranaceus, 17g of Atractylodes macrocephala, 14g of Saposhnikovia divaricata, 12g of Schizonepeta tenuifolia, 12g of Perilla frutescens leaf, and 7g of licorice. Example 11

[0037] A traditional Chinese medicine composition for treating cough comprises the following components: 15g of Panax quinquefolius, 10g of bitter apricot kernel, 12g of Stemona japonica, 6g of honey-processed ephedra, 9g of dried tangerine peel, 15g of Auspicious Grass, 10g of honey-processed Tussilago farfara, 10g of honey-processed Aster tataricus, 20g of Astragalus membranaceus, 12g of Atractylodes macrocephala, 10g of Saposhnikovia divaricata, 10g of Schizonepeta tenuifolia, 10g of Perilla frutescens leaf, and 6g of licorice. Example 12

[0038] A formulation of a traditional Chinese medicine composition for treating cough is prepared by weighing medicinal materials according to the weight of any one of the traditional Chinese medicine compositions described in Examples 1-11, and following the steps below: (1) Extract volatile oil from the leaves of catnip and perilla. Collect the aqueous solution after extracting the volatile oil separately and keep the residue for later use. (2) Mix the dregs from step (1) with Panax ginseng, bitter almond, Stemona japonica, ephedra, tangerine peel, auspicious grass, coltsfoot, aster, astragalus, atractylodes macrocephala, saposhnikovia divaricata, and licorice. Decoct twice with water: first, add 10 times the amount of water and decoct for 1 hour; second, add 8 times the amount of water and decoct for 1 hour. Filter, combine the decoctions, let stand for 24 hours, and filter out the precipitate. It is preferable to use a 180-200 mesh sieve for filtration. (3) Combine the decoction obtained in step (2) with the aqueous solution in step (1) and concentrate under reduced pressure to a thick paste with a relative density of 1.30-1.35 (50℃); (4) Add an appropriate amount of dextrin to the thick paste obtained in step (3), dry, pulverize, mix with 0.2wt% sucralose powder, make granules with 70wt%-80wt% ethanol as a wetting agent, dry, granulate, sieve to make granules, and dry. (5) Add the dried granules to the volatile oil extracted in step (1), mix well, and you will get the product. Application Example 1 – Animal Experiments on the Improvement of Cough Due to Wind-Evil Invading the Lungs by the Ethnic Medicine Composition of the Present Invention for Treating Cough 1. Materials and Instruments Male SD rats: SPF grade, 8 weeks old, weighing 210-220g, housed at the Experimental Animal Center of Pu'er Traditional Chinese Medicine Hospital; Interleukin-6 (IL-6) and Tumor Necrosis Factor-α (TNF-α) detection kits: Kunming Runsheng Company; Lung tissue pathological section staining reagents: Shanghai Keshun Biotechnology Co., Ltd.; Ultrasonic cleaner: JM-03D-40 model, Shenzhen Jiemeng Cleaning Equipment Co., Ltd.; Microplate reader: Epoch model, BioTek Corporation, USA; Electronic analytical balance: FA2004 model, Shanghai Precision Instruments Co., Ltd.; Pathological section microscope: BX53 model, Olympus (China) Co., Ltd.

[0039] 2 Experimental Methods 2.1 Animal grouping, model establishment, and drug administration 2.1.1 Grouping Forty-eight healthy SD rats were selected and acclimatized for one week in a standard experimental animal environment. The rats were randomly divided into three groups according to their weight. Twelve rats were randomly selected as the normal control group, and the remaining 36 rats were used for modeling. After successful modeling, the rats were randomly divided into a model control group, a positive control group, and the drug group of this invention, with 12 rats in each group.

[0040] 2.1.2 Modeling Method After the rats were acclimatized, except for the normal control group, the rats in the other groups were given 10 μL of house dust mite extract (concentration 200 μg / mL) via micropipette and dripped into each nostril (total 20 μL / rabbit / day) once a day for 3-5 consecutive days.

[0041] Simultaneously, airflow stimulation at room temperature (8-10℃, humidity 70%-80%, dampness) and fan blowing (wind speed 0.5-1.5m / s) for 2-4 hours daily can enhance the "wind evil" characteristics. The model should be established for 5-7 days, with adjustments made based on the rats' responses.

[0042] Modeling screening indicators and symptom scores: ① Observe the frequency of rat coughing. Record the number of times rats cough per unit time. If the number of coughs is significantly higher than that of the control group, it is considered as one of the indicators of successful modeling; ② Observe the respiratory status of rats. If symptoms such as rapid breathing and wheezing appear; ③ In the observation of pathological sections of rat lungs, if pathological changes such as inflammatory cell infiltration and bronchial mucosal congestion and edema are found, it can better reflect the pathological symptoms of cough. 2.1.3 Administration method After successful modeling, the positive control group was given Xuanfei Zhike Mixture (Gansu Puan Pharmaceutical Co., Ltd.); the drug group of this invention was given the drug composition described in Example 9, which was soaked in 8 times the amount of water for 30 minutes, brought to a boil over high heat, then simmered over low heat for 40 minutes, and the liquid was filtered out; the residue was then simmered in 6 times the amount of distilled water for 30 minutes, the decoctions were combined, and concentrated to a concentration of 1.0g of raw drug per 1mL; the normal control group and the model control group were given an equal volume of physiological saline. All four groups were administered the drug by gavage at a dose of 0.5mL / kg, once a day, for 14 consecutive days.

[0043] 2.2 Experimental Procedure 2.2.1 Conduct model evaluation index checks (1) Observation of behavioral indicators: ① Cough frequency: The number of coughs within 30 minutes after daily stimulation was significantly higher in the model group than in the saline control group (usually 2-3 times higher).

[0044] ② Traditional Chinese Medicine symptom scores: including cough (0-3 points, based on frequency), nasal itching (0-2 points, based on the number of scratches), runny nose (0-2 points, based on the amount of secretions), and aversion to wind (0-2 points, based on whether the wind is avoided). The total score was significantly higher in the model group.

[0045] Starting 1 hour before administration each day, rats were observed for 60 minutes, recording their cough frequency, respiratory status, mental state, and diet. Cough frequency was manually counted. Respiratory status was observed for signs of rapid breathing or wheezing. Mental state was assessed by reduced activity levels, generalized or partial muscle tension, and abnormal licking behaviors, reflecting the rats' activity level. The scoring rules are shown in Table 1, with scores ranging from 5 to 0, indicating a gradual increase from normal to severe.

[0046]

[0047] 2.2.2 Collection of materials Four groups of rats were observed for 14 days. After the observation period, the rats were anesthetized by intraperitoneal injection of ether. After anesthesia, lung tissue was quickly removed from the rats and placed in test tubes containing 4% paraformaldehyde for subsequent testing. 2.2.3 Pathological and histological examination Fresh lung tissue from rats was obtained and quickly fixed in 4% formalin solution for over 48 hours. After dehydration and paraffin embedding, 4μm sections were continuously cut using a paraffin microtome, spread in a 42℃ water bath, retrieved onto glass slides, and dried at 60℃ for 2 hours before staining and observation. Pathological changes in the lung tissue were examined under a microscope.

[0048] 2.2.4 Hematoxylin-eosin (HE) staining Paraffin sections were dewaxed with xylene and hydrated with a gradient of ethanol to distilled water. Then, the hematoxylin and eosin (HE) staining kit instructions were strictly followed: hematoxylin staining for 10 min, differentiation with 1% hydrochloric acid alcohol for a few seconds, blue reversion with running water, and eosin staining for 5 min. The sections were again dehydrated with a gradient of ethanol, cleared with xylene, and finally mounted with neutral resin. Images were acquired and observed under an optical microscope to assess the basic morphology and structure of the lung tissue. HE-stained sections were observed and images acquired under a Nikon upright optical microscope. HE staining observations included airway mucosal epithelial damage, submucosal edema, and eosinophil / lymphocyte infiltration. Pathological sections were prepared, and pathological changes in the lung tissue, including the degree of inflammatory cell infiltration and bronchial mucosal damage, were observed under a microscope and scored.

[0049] 2.2.5 Detection of immune indicators Bronchoalveolar lavage fluid (BALF): After centrifugation, the total cell count and classification were determined (eosinophil percentage >5% was considered positive). The expression of inflammation-related genes or proteins in lung tissue, such as inflammatory factors (IL-1β, IL-6, TNF-α, etc.), was detected using techniques such as PCR and ELISA to assess the degree and type of lung inflammation.

[0050] 2.2.6 RNA Extraction After obtaining lung tissue, the procedure was strictly followed according to the instructions. The tissue was first flash-frozen in liquid nitrogen, then cut into small pieces and placed in a homogenizer. A homogenate was obtained by rinsing, mincing, and grinding the tissue. 1 mL of Trizol reagent was added to every 30-50 mg of tissue, and the homogenate was thoroughly homogenized. The homogenate was then aspirated and allowed to stand at room temperature for 5 min. The mixture was centrifuged at 12000 rpm for 10 min, and the supernatant was transferred to a new 1.5 mL centrifuge tube. Total RNA was extracted using Trizol reagent, and then 1 μg of RNA was reverse transcribed using an RNA reverse transcription kit to prepare cDNA. Finally, real-time quantitative polymerase chain reaction (RT-QPCR) was performed to detect the expression levels of inflammatory factors such as IL-1β, IL-6, and TNF-α. 2.2.7 ELISA Detection After obtaining lung tissue, the tissue was homogenized and centrifuged at 13,000 rpm for 5 min. The supernatant was then collected into centrifuge tubes. The expression of IL-1β, IL-6, and TNF-α in the lung tissue was detected by ELISA. 2.3 Statistical Methods Statistical analysis of the data was performed using GraphPad Prism 8.0 data analysis software. For quantitative data, the average value at each time point of each group was taken, expressed as mean ± standard error. Repeated measures ANOVA was used to compare the means between groups. For data that conformed to a normal distribution and had homogeneous variances, independent samples were used for comparisons between two groups. t For comparisons among multiple groups, one-way ANOVA is used. P <0.05 indicates a significant difference. 3 Results and Analysis 3.1 General Situation The changes in the four groups of rats were statistically analyzed according to the scoring rules, and the results are as follows: Figure 1 As shown in the figure. The results indicate that in the normal control group, the box line was concentrated around 0, indicating that this group had almost no disease symptoms. In the model control group, the box line shifted significantly upward, indicating that this group had significant disease symptoms. In the positive control group, the box line was significantly lower than that of the model control group, showing that the positive drug had a certain ameliorative effect on the disease. In the drug group of this invention, the box line was the lowest, indicating that the ethnic medicine composition of this invention not only reduced the disease score but also had a more stable therapeutic effect. Furthermore, the median and quartile range of the disease score in the drug group of this invention were better than those in the positive control group, indicating that the ethnic medicine composition of this invention can effectively alleviate the cough symptoms, improve the respiratory status and mental state of rats, and its effect is better than that of the positive drug.

[0051] 3.2 Pathological changes in the lungs Compared with the normal control group, the model control group, the positive control group, and the drug group of this invention all showed significant pathological changes in the lungs after modeling, indicating that the modeling was successful (e.g. Figure 2 (As shown in A).

[0052] The pathological sections revealed the morphology of different lung regions. The normal control group showed intact tissue structure with no obvious pathological changes; the model control group showed extensive inflammatory cell infiltration, tissue necrosis, and structural damage; the positive control group showed less pathological changes than the model control group; the drug group of this invention showed near-normal tissue morphology and the mildest degree of inflammation and necrosis. Therefore, compared with the model control group, the drug group of this invention showed reduced inflammatory cell infiltration in the lungs of rats, repaired bronchial mucosal damage, and reduced alveolar structural damage. P <0.05) (e.g. Figure 2 (As shown in B).

[0053] Immunofluorescence results as follows Figure 2As shown in Figure C, in the normal control group, the red fluorescence was weak and sparse, indicating a low number of macrophages. In the model control group, the red fluorescence was significantly enhanced and densely distributed, indicating that the model successfully induced a large number of macrophages to infiltrate. In the positive control group, the red fluorescence was significantly reduced compared to the model control group, indicating that the positive control had an inhibitory effect on macrophage infiltration. In the drug group of this invention, the red fluorescence was further reduced, even lower than that in the positive control group, indicating that the drug was more effective in inhibiting macrophage infiltration. Compared with the model control group, the drug group of this invention significantly reduced the infiltration of F4 / 80 positive macrophages, and its effect was better than that of the positive drug group, suggesting that the drug has a good anti-inflammatory effect.

[0054] 3.3 Comparison of serum IL-1β, IL-6, and TNF-α levels in different groups of rats On day 14, lung tissue samples were collected from four groups of rats, and enzyme-linked immunosorbent assay (ELISA) was used to detect inflammation-related genes (IL-1β, IL-6, TNF-α, etc.) in the lung tissue. The results showed that, compared with the model control group, the levels of inflammatory factors IL-1β and IL-6 in the positive control group and the drug group of this invention were significantly reduced, while TNF-α showed no significant reduction. Figures 3-5 As shown. 4. Conclusion This experiment simulated the pathological state of cough using a specific modeling method to verify the efficacy of the ethnic medicine composition described in this invention. The experimental results show that the medicine composition significantly improves cough symptoms and lung pathological changes in the animal model, and can significantly inhibit lung inflammation. This indicates that the medicine composition described in this invention can effectively alleviate cough symptoms and reduce lung inflammation in rats, demonstrating a good therapeutic effect on cough.

[0055] Application Example 2 – Clinical observation of the use of the ethnic medicine composition of the present invention for the treatment of cough 1. General Information We collected data from 120 patients with cough treated at the outpatient and inpatient departments of the Respiratory Department of Pu'er Traditional Chinese Medicine Hospital between January 1, 2023 and December 31, 2023. Inclusion criteria were: patients meeting the diagnostic criteria for cough due to wind-evil invading the lungs in Traditional Chinese Medicine (primary symptoms: cough, itchy throat; secondary symptoms: nasal congestion, runny nose, aversion to wind, thin white tongue coating, floating pulse), with a course of illness exceeding one week, and those who had been ruled out for serious organic lesions (such as pneumonia, lung cancer, bronchiectasis, etc.) by routine Western medical examinations. Patients were randomly divided into a control group and a treatment group, with 60 patients in each group.

[0056] The control group consisted of 32 males and 28 females, aged 18-65 years, with a mean age of (38.5±10.2) years; the duration of cough ranged from 7 to 30 days, with a mean duration of (14.5±5.3) days; and the mean severity of cough (using the Visual Analogue Scale (VAS), with 0 points indicating no cough and 10 points indicating severe and persistent cough) was (6.8±1.5). The treatment group consisted of 35 males and 25 females, aged 20-62 years, with a mean age of (37.8±9.8) years; the duration of cough ranged from 8 to 28 days, with a mean duration of (13.8±4.9) days; and the mean severity of cough was (6.6±1.3) points. Statistical analysis showed no statistically significant differences in general characteristics such as gender, age, duration of cough, and severity of cough between the two groups of patients. P (>0.05), making them comparable. Control group: The control group was treated with the existing clinically common TCM treatment plan, and was given Xuanfei Zhike Mixture (National Drug Approval Number Z20050288, Gansu Puan Pharmaceutical Co., Ltd.), 20mL orally, 3 times a day, half an hour after meals, for a course of 7 days, for a total of 2 courses of treatment.

[0057] Treatment group: The drug composition described in Example 11 was used for treatment. The decoction was prepared by decocting and concentrating the herbs. The specific process was as follows: After washing the above-mentioned herbs, they were soaked in 8 times the amount of purified water for 30 minutes. After boiling over high heat, the decoction was simmered over low heat for 40 minutes. The decoction was then filtered out. The dregs were then decocted in 6 times the amount of distilled water for 30 minutes. The two decoctions were combined and concentrated until each 1 mL contained 0.8 g of raw herbs. Dosage and administration: 150 mL three times a day, taken warm half an hour after meals. One course of treatment lasted seven days, and two courses were administered in total.

[0058] During treatment, both groups of patients discontinued other cough suppressants, anti-allergy medications, and antibiotics, avoided exposure to cold air, dust mites, and other known triggers, and maintained a light diet and regular sleep schedule.

[0059] 2. Observation indicators 2.1 Clinical efficacy The cough syndrome score was calculated according to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs (Trial Implementation)". The primary symptoms (cough frequency, cough severity, sputum volume) were scored as follows: 0, 2, 4, and 6 points for absence, mild, moderate, and severe, respectively. Secondary symptoms (itchy throat, shortness of breath, chills, tongue coating, pulse, etc.) were scored as follows: 0, 1, 2, and 3 points for absence, mild, moderate, and severe, respectively. The TCM syndrome score was the sum of the scores for the primary and secondary symptoms, and the efficacy was assessed in conjunction with the cough relief. Clinical cure: The TCM syndrome score decreased by ≥95%, and the cough and related symptoms completely disappeared. Significant effect: The TCM syndrome score decreased by ≥70%, but did not meet the clinical cure standard, and the cough and related symptoms were significantly relieved. Effective: The TCM syndrome score decreased by ≥30%, but did not reach the standard of significant effect; cough and related symptoms improved. Invalid: Does not meet any of the above criteria. Overall effective rate = (number of clinically cured cases + number of cases with significant effect + number of effective cases) / total number of cases × 100%.

[0060] 2.2 Inflammatory markers Five mL of fasting venous blood was drawn from the elbow veins of both groups of patients before and after treatment. The blood was centrifuged at a rate of 3000 r / min, a radius of 10 cm, and a time of 15 min. Serum was separated and the levels of interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) in the serum were measured using an enzyme-linked immunosorbent assay (ELISA). The kit was purchased from Kunming Runsheng Company. 2.3 Adverse Reactions During the treatment, the occurrence of adverse reactions (nausea, vomiting, rash, etc.) in both groups of patients was recorded.

[0061] 3. Statistical methods Data were analyzed using SPSS 26.0 software. Categorical data were expressed as percentages and analyzed using the χ² test; continuous data were expressed as mean ± standard deviation (mean ± standard deviation). ) indicates that the following is adopted t test, P <0.05 indicates that the difference is statistically significant. 4. Results 4.1 Comparison of clinical efficacy between the two groups The total effective rate in the treatment group was 93.33% (56 / 60), which was significantly higher than that in the control group (75.00%, 45 / 60), and the difference was statistically significant. P <0.05). See Table 2 for details.

[0062]

[0063] 4.2 Comparison of inflammatory marker levels before and after treatment Before treatment, there was no statistically significant difference in serum IL-6 and TNF-α levels between the two groups. P The values ​​were >0.05, indicating comparability. After treatment, the levels of the above-mentioned inflammatory markers in both groups decreased compared to before treatment, and the differences were statistically significant. P <0.05), and the treatment group showed a more significant decrease in IL-6 and TNF-α, with statistically significant differences. P <0.05). See Table 3 for details.

[0064]

[0065] 4.3 Adverse Reactions No significant adverse reactions were observed in the treatment group during the observation period; 3 cases in the control group experienced mild gastrointestinal discomfort.

[0066] 5. Conclusion Based on the above results, it can be seen that the ethnic medicine composition of the present invention has a significant effect on improving the symptoms and inflammatory indicators of cough caused by wind-evil invading the lungs. The improvement effect and efficacy rate are better than those of the commonly used cough medicine Xuanfei Zhike Mixture, indicating that the medicine composition of the present invention has a good therapeutic effect on cough caused by wind-evil invading the lungs.

[0067] Application Example 3 – Clinical observation of the use of the ethnic medicine composition of the present invention in the treatment of cough variant asthma (wind-evil invading the lungs syndrome). 1. General Information Eighty patients with cough-variant asthma treated at the outpatient and inpatient departments of the Department of Respiratory Medicine of Pu'er Traditional Chinese Medicine Hospital from January 1, 2023 to December 31, 2023 were included. The inclusion criteria were: (1) meeting the diagnostic criteria for cough-variant asthma in the "Guidelines for the Diagnosis and Treatment of Cough (2021 Edition)" (main manifestations include irritating dry cough, which worsens at night and in the early morning, and is induced or aggravated by exposure to cold air, fumes, dust mites, etc., with a positive bronchial provocation test or a positive bronchodilator test); (2) meeting the diagnostic criteria for wind-evil invading the lung syndrome in traditional Chinese medicine (main symptoms: cough, itchy throat; secondary symptoms: nasal congestion and runny nose, aversion to wind, thin white tongue coating, floating pulse); (3) the course of the disease was more than 4 weeks; (4) pneumonia, lung cancer, bronchiectasis, gastroesophageal reflux disease and other diseases that cause chronic cough were excluded by routine Western medicine examinations (chest CT, blood routine, pulmonary function, etc.). They were randomly divided into a control group and a treatment group, with 40 cases in each group.

[0068] The control group consisted of 18 males and 22 females, aged 18-65 years (mean 38.2 ± 10.5 years), with a disease duration of 4-24 weeks (mean 10.5 ± 4.8 weeks). The mean cough severity (using the Visual Analogue Scale (VAS), with 0 indicating no cough and 10 indicating severe and persistent cough) was 6.9 ± 1.4. The mean percentage of predicted forced expiratory volume in one second (FEV1) was 82.5 ± 6.3%.

[0069] The treatment group consisted of 16 males and 24 females, aged 20-62 years (mean 37.6 ± 9.6 years), with a disease duration of 4-22 weeks (mean 10.2 ± 4.5 weeks), a cough severity score of 6.7 ± 1.2, and a FEV1 percentage of predicted value of 83.1 ± 5.9%.

[0070] Statistical analysis showed no statistically significant differences between the two groups in general characteristics such as gender, age, disease duration, cough severity, and FEV1 percentage of predicted value. P (>0.05), making them comparable.

[0071] Control group: Received standard Western medicine treatment, including montelukast sodium tablets (National Drug Approval Number HJ20181187, Hangzhou Merck & Co., Ltd.) combined with a lung-clearing and cough-relieving mixture (National Drug Approval Number Z20050288, Gansu Puan Pharmaceutical Co., Ltd.). Montelukast sodium tablets were taken orally, 10 mg once daily before bedtime; the lung-clearing and cough-relieving mixture was taken orally, 20 mL three times daily, half an hour after meals. One course of treatment lasted fourteen days.

[0072] Treatment group: The drug composition described in Example 10 was used for treatment. The decoction was prepared by decocting and concentrating the herbs. The specific process was as follows: After washing the above-mentioned herbs, they were soaked in 8 times the amount of purified water for 30 minutes. After boiling over high heat, the decoction was simmered over low heat for 40 minutes. The decoction was then filtered out. The dregs were then decocted in 6 times the amount of distilled water for 30 minutes. The two decoctions were combined and concentrated until each 1 mL contained 1.0 g of raw herbs. Dosage and administration: 150 mL three times a day, taken warm half an hour after meals. One course of treatment lasted fourteen days.

[0073] During treatment, both groups of patients discontinued other cough suppressants, anti-allergy medications, bronchodilators, and antibiotics, avoided exposure to specific triggers such as cold air, dust mites, and cooking fumes, maintained a light diet and regular sleep schedule, and avoided strenuous exercise.

[0074] 2. Observation indicators 2.1 Clinical efficacy Referring to the relevant standards in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine (Trial)" and the "Guidelines for the Diagnosis and Treatment of Cough (2021 Edition)," and combining the characteristics of cough-variant asthma, efficacy evaluation criteria were formulated, using a combination of TCM syndrome scores and pulmonary function indicators for assessment. TCM syndrome scores: Primary symptoms (cough frequency, cough severity, and sore throat severity) were scored as follows: none, mild, moderate, and severe, respectively, with scores of 0, 2, 4, and 6. Secondary symptoms (nasal congestion, runny nose, aversion to wind, shortness of breath, tongue coating, and pulse, etc.) were scored as follows: none, mild, moderate, and severe, respectively, with scores of 0, 1, 2, and 3. The TCM syndrome score is the sum of the scores for primary and secondary symptoms. Pulmonary function indicators: The percentage of FEV1 relative to predicted value was measured before and after treatment.

[0075] Clinical cure: TCM syndrome score decreased by ≥95%, cough and related symptoms completely disappeared, FEV1 accounted for ≥90% of the predicted value, and there was no recurrence during a 1-month follow-up.

[0076] Significant effect: The TCM syndrome score decreased by ≥70% but did not reach the clinical cure standard; cough and related symptoms were significantly relieved; and the percentage of FEV1 to predicted value increased by ≥15% compared with before treatment.

[0077] Effective: The TCM syndrome score decreased by ≥30% but did not reach the standard of significant effect; cough and related symptoms improved; and the percentage of FEV1 to predicted value increased by 5%-14% compared with before treatment.

[0078] Ineffective: If any of the above criteria are not met, symptoms and lung function do not improve or even worsen.

[0079] Overall effective rate = (number of clinically cured cases + number of cases with significant effect + number of effective cases) / total number of cases × 100%.

[0080] 2.2 Inflammatory markers and pulmonary function indicators 2.2.1 Inflammatory markers: 5 mL of fasting venous blood was drawn from both groups of patients before and after treatment and centrifuged at a speed of 3000 r / min, a radius of 10 cm, and a time of 15 min. Serum was separated and the levels of interleukin-6 (IL-6) and eosinophil cationic protein (ECP) in the serum were measured by enzyme-linked immunosorbent assay (ELISA). The kit was purchased from Kunming Runsheng Company.

[0081] 2.2.2 Lung function indicators: The percentage of FEV1 to predicted value and the forced expiratory volume in one second / forced vital capacity (FEV1 / FVC) were measured before and after treatment using a pulmonary function testing instrument.

[0082] 2.3 Adverse Reactions During treatment, the occurrence time, severity, and outcome of adverse reactions (nausea, vomiting, diarrhea, rash, dizziness, dry mouth, etc.) in both groups of patients were closely observed and recorded to assess drug safety.

[0083] 3. Statistical methods Data were analyzed using SPSS 26.0 software. Categorical data were expressed as percentages (%) and analyzed using the χ² test; continuous data were expressed as mean ± standard deviation (%). ) indicates that the following is adopted t The test, and the comparison of pre- and post-treatment results within the group, were performed using paired methods. t Tests and comparisons between groups use independent samples. t test. P <0.05 indicates that the difference is statistically significant.

[0084] 4. Results 4.1 Comparison of clinical efficacy between the two groups The total effective rate in the treatment group was 92.5% (37 / 40), significantly higher than that in the control group (75.0%, 30 / 40), and the difference was statistically significant. P <0.05). Among them, in the treatment group, 12 cases were clinically cured, 19 cases showed significant improvement, 6 cases were effective, and 3 cases were ineffective; in the control group, 6 cases were clinically cured, 14 cases showed significant improvement, 10 cases were effective, and 10 cases were ineffective. See Table 4 for details.

[0085]

[0086] 4.2 Comparison of inflammatory markers and pulmonary function markers before and after treatment Before treatment, there were no statistically significant differences in serum IL-6, ECP levels, FEV1 percentage of predicted value, and FEV1 / FVC between the two groups. P >0.05, indicating comparability. After treatment, the levels of the above-mentioned inflammatory markers in both groups were significantly lower than before treatment, and the pulmonary function indicators were significantly improved, with statistically significant differences. P <0.05; and the treatment group showed significantly greater reductions in IL-6 and ECP, as well as significantly greater increases in FEV1 percentage of predicted value and FEV1 / FVC compared to the control group, with statistically significant differences. P <0.05). See Table 5 for details.

[0087]

[0088] 4.3 Adverse Reactions During the observation period, no significant adverse reactions occurred in the treatment group; in the control group, 4 cases experienced mild adverse reactions, including 2 cases of gastrointestinal discomfort (nausea and abdominal distension) and 2 cases of dizziness. None of them discontinued the medication, and the symptoms were relieved after symptomatic treatment, without affecting the treatment.

[0089] 5. Conclusion Based on the above results, the ethnic medicine composition of this invention can significantly improve the clinical symptoms of patients with cough-variant asthma (wind-evil invading the lungs syndrome), reduce serum inflammatory markers such as IL-6 and ECP, and improve lung function. The overall clinical effective rate is significantly higher than the conventional treatment regimen of montelukast sodium tablets combined with a lung-clearing and cough-relieving compound, and the composition has good safety with no significant adverse reactions. This indicates that the drug composition of this invention has a definite therapeutic effect on cough-variant asthma of the wind-evil invading the lungs syndrome type, providing a new and effective treatment option for the clinical treatment of this disease.

Claims

1. A traditional medicine composition for treating cough, characterized in that, By weight parts, consisting of: blue flower 9-15 parts, bitter almond 5-10 parts, Yunnan 10-20 parts, honey Ephedra 5-15 parts, dried orange 5-15 parts, lucky grass 5-20 parts, honey 5-20 parts, honey 5-20 parts, honey 5-20 parts, 10-30 parts of Huangqi, 5-20 parts of Baizhu, 5-20 parts of Fangfeng, 5-20 parts of Jingjie, 5-20 parts of Zixu Ye, 3-10 parts of Gancao.

2. The ethnic medicinal composition for treating cough according to claim 1, characterized in that, By weight parts, consisting of: blue flower 9-15 parts, bitter almond 5-10 parts, Yunnan 10-20 parts, honey Ephedra 5-15 parts, dried orange 5-10 parts, lucky grass 10-20 parts, honey 10-20 parts, honey 10-20 parts, honey 10-20 parts, 15-30 parts of Huangqi, 10-20 parts of Baizhu, 10-20 parts of Fangfeng, 5-20 parts of Jingjie, 10-20 parts of Zixu Ye, 3-10 parts of Gancao.

3. The ethnic medicinal composition for treating cough as claimed in claim 2 wherein, By weight parts, consisting of: blue flower 9-15 parts, bitter almond 5-10 parts, Yunnan 10-20 parts, honey Ephedra 5-15 parts, dried orange 5-10 parts, lucky grass 10-20 parts, honey 10-20 parts, honey 10-20 parts, honey 10-20 parts, 15-30 parts of Huangqi, 10-20 parts of Baizhu, 10-20 parts of Fangfeng, 5-20 parts of Jingjie, 10-20 parts of Zixu Ye, 3-10 parts of Gancao.

4. The preparation of the ethnic medicine composition for treating cough according to any one of claims 1 to 3, characterized in that, The preparation is prepared by adding pharmaceutically acceptable adjuvant to the national medicine composition for treating cough.

5. The preparation of the ethnic medicinal composition for treating cough according to claim 4, characterized in that, The preparation is decoction, oral liquid, pill, tablet, granules.

6. The preparation method of the ethnic medicine composition for treating cough according to claim 5, characterized in that, The preparation method of the granules comprises the following steps: (1) extract volatile oil from Jingjie and Zixu Ye, collect the water solution after extracting volatile oil in another device, and reserve the residue for use; (2) mix the residue in step (1) with bitter almond, Yunnan, honey Ephedra, dried orange, lucky grass, honey 10-20 parts, honey 10-20 parts, honey 10-20 parts, 15-30 parts of Huangqi, 10-20 parts of Baizhu, 10-20 parts of Fangfeng, 5-20 parts of Jingjie, 10-20 parts of Zixu Ye, 3-10 parts of Gancao, and add water to decoct, filter out the precipitate to obtain decoction; (3) combine the decoction prepared in step (2) with the water solution in step (1), and concentrate under reduced pressure to a thick paste; (4) add dextrin to the thick paste obtained in step (3), dry, crush, add flavoring agent and wetting agent to prepare granules; (5) add the dried granules to the volatile oil extracted in step (1) and mix evenly.

7. Use of the national medicine composition for treating cough according to any one of claims 1 to 3 in the preparation of a medicine for treating cough or cough variant asthma.

8. Use of the preparation of the national medicine composition for treating cough according to claim 4 in the preparation of a medicine for treating cough or cough variant asthma.

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