Traditional Chinese medicine composition for treating children asthma migration as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition with an effect of treating children asthma migration and delay and a preparation method thereof. Through a large number of clinical practices, the traditional Chinese medicine composition is prepared from raw materials including raw radix astragali, radix ephedrae, fructus perillae, radix paeoniae rubra, rhizoma belamcandae, bulbus lilii, honey-fried radix stemonae, flos magnoliae, herba schizonepetae and fructus mume. The traditional Chinese medicine composition has the effects of tonifying qi, strengthening superficies, depressing qi, reducing phlegm, dispelling wind and preventing asthma, and is used for treating qi deficiency and phlegm lingering in asthma of children. Clinical verifications prove that the traditional Chinese medicine composition can obviously improve the clinical symptoms of asthma, wheeze, chest distress, cough and the like of asthma migrant and delay children, and reduce the incidence frequency. Animal experiment research shows that the traditional Chinese medicine composition can effectively improve lung functions of asthma migrant and delay model mice, reduce airway resistance and relieve airway hyperresponse; the traditional Chinese medicine composition can relieve inflammation, reduce airway mucus hypersecretion, reduce airway collagen deposition, delay airway remodeling and improve anaphylaxis. The traditional Chinese medicine composition can be used for filling the market blank of treating children asthma migration and delay based on the theories of qi regulation, qi depressing and wind phlegm, and has a very good development prospect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a drug for treating chronic asthma in children made from Chinese herbal medicines, its preparation method, and its application. Background Technology

[0002] Childhood asthma is a common, recurrent wheezing and coughing respiratory disease in children. The Global Asthma Network (GAN) 2018 Global Asthma Report indicates that approximately 339 million people worldwide are affected by asthma. Because children's respiratory systems are not fully developed and their immune systems are not yet fully mature, the incidence of asthma is higher than in adults. Despite significant progress in the understanding and treatment of asthma in Western medicine, data from the Standardized Diagnosis and Treatment Guidelines for Childhood Bronchial Asthma (2020 Edition) shows that approximately 30% of urban children with asthma are not diagnosed in a timely manner, and more than 20% of children with asthma are not well controlled. Recurrent and prolonged asthma attacks severely affect children's growth, development, and daily life, placing a heavy psychological and economic burden on families and society. Traditional Chinese medicine (TCM) has unique characteristics and advantages in the diagnosis and treatment of childhood asthma, offering advantages such as fewer side effects and comprehensive conditioning and control compared to conventional Western anti-inflammatory and bronchodilator drugs.

[0003] Developing a traditional Chinese medicine compound for treating the chronic stage of childhood asthma is of great significance for the prevention and treatment of childhood asthma. Currently, drug treatment generally uses chemical drugs and traditional Chinese medicine. Chemical drugs are fast-acting, but their adverse reactions and unknown effects on children's growth and development lead to parental resistance and low compliance. Traditional Chinese medicine treatment can address both the symptoms and the root cause, and is safe and effective.

[0004] Currently, there are no traditional Chinese medicine drugs specifically for treating the chronic stage of childhood asthma on the market. This invention is based on the theories of "regulating qi," "descending qi," and "wind-phlegm" in traditional Chinese medicine, and treats the chronic stage of childhood asthma from the perspectives of qi, phlegm, and wind. It is a summary of many years of clinical experience and can better make up for the lack of similar products currently on the market. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine compound that effectively controls the condition, reduces the frequency and severity of asthma attacks, improves the quality of life of children with chronic asthma due to qi deficiency and phlegm retention, and has good safety profile. Another objective of this invention is to provide a method for preparing and applying this traditional Chinese medicine compound.

[0006] Childhood asthma is generally considered to be related to allergens, infections, diet, family history, medication use, and excessive exercise. Clinically, it is mainly characterized by recurrent episodes of wheezing, shortness of breath, cough, and chest tightness, often occurring or worsening at night and / or in the early morning. Internal causes of asthma attacks are attributed to deficiencies in the lungs, spleen, and kidneys, leading to the retention of phlegm and fluid retention, which becomes the root cause of asthma. External causes are attributed to exposure to external pathogens, often wind as the initiator, with wind-phlegm lingering in the lungs, leading to prolonged and recurrent asthma; exposure to unusual airways, a diet high in fatty and sweet foods, fatigue, and emotional changes. The saying goes, "Internal stagnation of qi, external untimely exposure, and solidified phlegm in the diaphragm combine to obstruct the airways, resulting in asthma." The chronic phase is a crucial stage in asthma treatment, referring to the appearance of wheezing, cough, shortness of breath, and chest tightness of varying frequency and severity within the past three months, equivalent to the chronic persistent phase in Western medicine. This phase is often overlooked because the symptoms are less severe than in acute attacks. In the continuation stage, children still exhibit airway hyperresponsiveness, and attacks can be triggered by minor external stimuli, exercise, or dietary indiscretions. Improper or neglected treatment at this stage can lead to long-term damage such as airway remodeling and impaired lung function, increasing the difficulty and risk of treatment. Among these, the syndrome of Qi deficiency and phlegm retention (lung and spleen Qi deficiency, with wind-phlegm lingering in the lungs) is the most common syndrome in the continuation stage of childhood asthma.

[0007] Western medicine currently primarily treats chronic persistent asthma in children using combinations of inhaled corticosteroids and long-acting β2 receptor agonists, inhaled corticosteroids alone, or oral leukotriene receptor antagonists. Treatment cycles are lengthy, and young children often struggle to master inhalation techniques, leading to poor adherence. This invention, however, employs a holistic approach, addressing the root causes of asthma by regulating qi, phlegm, and wind. This effectively prevents recurrent asthma attacks, eliminates the underlying causes, and offers unique advantages with minimal side effects and safety.

[0008] The technical solution of this invention is based on the theories of "regulating Qi," "descending Qi," and "treating wind-phlegm," grounded in the understanding and treatment principles of the chronic stage of childhood asthma in Traditional Chinese Medicine. It was developed through repeated screening and careful research, combined with years of clinical experience in treating this disease. Asthma primarily affects the lungs, which reside in the chest and act as the "ministerial organ," the "canopy" of the five viscera and six bowels, and the body's Qi. The smooth flow of Qi is achieved through its dispersing and descending movements, distributing Qi and body fluids, and influencing the functions of other organs. Therefore, all lung diseases originate from Qi, and regulating Qi is key to treatment. Asthma has many causes, with latent phlegm being the root cause. The key pathogenesis involves the upward flow of lung Qi, the lingering of wind-phlegm in the lungs, and the obstruction of Qi by phlegm. "Tonifying Qi" and "descending Qi" are important treatment methods for consolidating the exterior, relieving the upward flow of lung Qi, and eliminating latent phlegm; "dispelling wind" is the main means of eliminating external wind and latent wind, and regulating allergic constitution. When lung Qi flows smoothly, cough and wheezing subside, body fluids are distributed normally, and phlegm dissipates with the Qi; descending Qi can resolve phlegm. Furthermore, children's internal organs are delicate, and their physical constitution is underdeveloped, exhibiting immature Yin and Yang. Children with asthma repeatedly suffer from external pathogens, which over time weakens their lung Qi, affecting their dominant Qi and regulatory functions, leading to recurrent and persistent asthma attacks. The treatment principle of this invention is based on "regulating Qi" (tonifying and lowering Qi) and "dispelling wind and resolving phlegm" throughout the entire process. When Qi is abundant, the exterior is strengthened and pathogens are eliminated; when Qi is lowered, coughing and wheezing subside; when Qi flows smoothly, phlegm and fluid retention are resolved; dispelling wind reduces sensitivity and eliminates triggering factors. Ultimately, it achieves the effects of tonifying Qi and strengthening the exterior, lowering Qi and resolving phlegm, and dispelling wind and preventing asthma, and is used to treat persistent childhood asthma.

[0009] To achieve the above objectives, the specific technical solution adopted by the present invention is as follows: A traditional Chinese medicine composition effective in treating chronic asthma in children, made from the following raw materials: Raw Astragalus, Ephedra Root, Belamcanda Rhizome, Red Peony Root, Perilla Seed, Lily Bulb, Honey-processed Stemona Root, Magnolia Flower, Schizonepeta, and Dried Plum.

[0010] As a preferred embodiment, a traditional Chinese medicine composition for treating chronic asthma in children is made from the following raw materials in the indicated weight ratios: Raw Astragalus membranaceus 6-18g, Ephedra root 2-8g, Perilla seed 4-14g, Red peony root 4-14g, Belamcanda chinensis 4-14g, Lilium brownii 4-14g, Honey-processed Stemona japonica 2-10g, Magnolia biondii 2-10g, Schizonepeta tenuifolia 2-10g, Prunus mume 2-10g.

[0011] As a more preferred embodiment, the traditional Chinese medicine composition for treating chronic asthma in children is made from the following raw materials in the preferred weight ratio: Raw Astragalus 8-16g, Ephedra root 4-6g, Perilla seed 6-12g, Red peony root 6-12g, Belamcanda chinensis 6-12g, Lilium brownii 6-12g, Honey-processed Stemona japonica 4-8g, Magnolia biondii 4-8g, Schizonepeta tenuifolia 4-8g, Mume 4-8g.

[0012] As a particularly preferred embodiment, the traditional Chinese medicine composition for treating chronic asthma in children is made from the following raw materials in the optimal weight ratio: Raw Astragalus 12g, Ephedra root 5g, Perilla seed 9g, Red peony root 9g, Belamcanda chinensis 9g, Lilium brownii 9g, Honey-processed Stemona japonica 6g, Magnolia biondii 6g, Schizonepeta tenuifolia 6g, Mume 6g.

[0013] The TCM syndrome differentiation and prescription rules of the traditional Chinese medicine composition provided by this invention are as follows: The prescription consists of 10 herbs: raw astragalus, ephedra root, perilla seed, red peony root, belamcanda rhizome, lily bulb, honey-processed stemona root, magnolia flower, schizonepeta, and dried plum.

[0014] Raw Astragalus: Sweet in taste, slightly warm in nature. It enters the Lung and Spleen meridians. Its functions include tonifying Qi and raising Yang, consolidating the exterior and stopping sweating. The *Ben Cao Chong Yuan* states, "Tonifying deficiency means tonifying the deficiency of vital Qi, thus harmonizing the meridians and strengthening the muscles." Children with asthma are repeatedly exposed to external pathogens, which inevitably attack the lungs first, leading to lung Qi deficiency over time. Therefore, raw Astragalus is used to tonify lung Qi, directly reaching the affected area, and also has the effect of consolidating the exterior. Raw Astragalus tonifies Qi without generating heat, making it most suitable for children with a pure Yang constitution. Ephedra Root: Sweet and astringent in taste, neutral in nature. It enters the Heart and Lung meridians, and its function is to consolidate the exterior and stop sweating. Combined with raw Astragalus, it forms the principal herb, tonifying Qi and consolidating the exterior. The two herbs used together can restore the lung's ability to regulate Qi and enhance the body's defense functions.

[0015] Stir-fried Perilla Seeds: pungent and warm in nature, entering the lung and spleen meridians. Functions include lowering qi, resolving phlegm, moistening the lungs, and relieving asthma. Red Peony Root: bitter and slightly cold in nature, entering the liver meridian. Functions include clearing heat and cooling the blood, dispersing blood stasis, and relieving pain. In chronic illnesses, pathogenic factors often transform into heat and enter the collaterals to form blood stasis, leading to prolonged asthma. Red peony root disperses blood stasis, relieves asthma, clears heat, and resolves phlegm. Belamcanda Rhizome: bitter and cold in nature, entering the lung meridian. Functions include clearing heat and detoxifying, eliminating phlegm, and benefiting the throat. The throat is the gateway to the lungs and stomach. Recurrent and prolonged asthma attacks in children are often caused by external pathogens that directly reach the airways through the throat. Belamcanda Rhizome prevents and dispels these pathogens, acting as a gatekeeper. These three herbs, pungent and bitter, act as assistant herbs, restoring the lung's function of "descending qi," focusing on lowering qi and resolving phlegm.

[0016] Lily bulb: Sweet and cold in nature. It enters the heart and lung meridians. Its functions include nourishing yin and moistening the lungs, clearing the heart and calming the mind. Honey-processed stemona root: Sweet and bitter in nature, slightly warm in nature. It enters the lung meridian. Its functions include moistening the lungs, lowering qi, and relieving cough. The combination of these two herbs restores yin fluids, enhancing their lung-moistening and phlegm-resolving effects, thus relieving the lingering, difficult-to-cure "latent phlegm" root cause in children with asthma.

[0017] Magnolia flower bud: pungent in taste, warm in nature, enters the lung and stomach meridians. Its function is to dispel wind-cold and clear nasal passages. "The same airway, the same disease," as asthmatic children often also have rhinitis. Adding magnolia flower bud aims to dispel wind and clear nasal passages, calming latent wind within the child's body. Schizonepeta tenuifolia: pungent in taste, slightly warm. Enters the lung and liver meridians. Its function is to relieve exterior wind, promote rash eruption, and eliminate sores. It has a clear fragrance, is light and floating, excelling at relieving exterior wind, and is mildly warm without being harsh, with a gentle medicinal nature. Prunus mume: sour and astringent in taste, neutral. Enters the liver, spleen, lung, and large intestine meridians. Its function is to astringe the lungs and intestines, generate fluids, and expel roundworms. Used for chronic cough due to lung deficiency, it astringes the dissipated lung qi, combining dispersing and astringing effects, while also having anti-allergic effects. The three herbs complement each other, making this formula both descending and dispersing, tonifying and dispersing, dispersing and astringing, harmonizing the ascending and descending of qi, eliminating latent wind, preventing external wind, and dispelling wind-phlegm.

[0018] The combined use of these herbs aims to regulate Qi throughout the entire process, combining downward movement with upward movement, tonification without hindering the elimination of pathogens, and dispersion with astringency. The goal is to ensure that when Qi is abundant, the exterior is strengthened and pathogens are eliminated; when Qi is lowered, cough and asthma subside; and when Qi flows smoothly, phlegm and fluid retention are resolved. Ultimately, this achieves the effects of tonifying Qi and strengthening the exterior, lowering Qi and resolving phlegm, and dispelling wind and preventing asthma.

[0019] The method for preparing the traditional Chinese medicine composition provided by the present invention includes the following steps: (1) First, place raw Astragalus membranaceus, Ephedra root, Perilla seed, Red peony root, Belamcanda chinensis, Lilium brownii, Honey Stemona japonica, Magnolia biondii (wrapped and decocted), Schizonepeta tenuifolia and Prunus mume in an extraction tank, first soak them in water, then heat and extract, filter, then add water to extract again, filter, combine the filtrates, concentrate, and obtain concentrated liquid. (2) Add an appropriate amount of ethanol to the concentrate in step (1), stir well, let stand, filter, take the supernatant, recover the ethanol until there is no alcohol smell, concentrate, and obtain the concentrate for the preparation of various preparations.

[0020] As a preferred embodiment, the preparation method of the traditional Chinese medicine composition of the present invention comprises the following steps: According to the weight ratio, soak raw Astragalus membranaceus, Ephedra sinica root, Perilla frutescens seed, Paeonia lactiflora, Belamcanda chinensis, Lilium brownii, Stemona japonica (honey-processed), Magnolia biondii (wrapped and decocted), Schizonepeta tenuifolia, and Prunus mume in 8-12 times the weight of the herbs in water for 30 minutes. Then heat the soaking liquid and decoct or reflux extract for 1-3 hours, filter, add 6-10 times the amount of water to the filtrate and decoct or reflux extract 1-2 times, each time for 1-2 hours, filter, combine the filtrates, and concentrate to a 2:1 ratio (herbs: liquid). (2) Add 95% ethanol to the drug solution until the alcohol content reaches 70% to 80%, let it stand for 24 to 48 hours, filter, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.1 to 1.3, refrigerate, and use it to prepare various preparations.

[0021] Pharmaceutically acceptable excipients can be added to the concentrated extract obtained by this invention, and then it can be prepared into commonly used oral and external dosage forms, such as oral liquids, granules, tablets, mixtures, powders, capsules, soft capsules, pills, and other oral preparations or throat sprays, using conventional Chinese medicine preparation methods.

[0022] Beneficial effects: The traditional Chinese medicine composition provided by this invention, which has the effect of treating the persistent stage of childhood asthma, has the following advantages: This invention screened the composition and optimal weight ratio of each medicinal ingredient through extensive clinical trials. Clinical trials have shown that the traditional Chinese medicine composition (Qi-regulating and asthma-preventing formula) provided by this invention has the effects of tonifying Qi and strengthening the exterior, lowering Qi and resolving phlegm, and dispelling wind and preventing asthma. When used to treat chronic asthma in children, it can significantly improve clinical symptoms such as wheezing, cough, shortness of breath, and chest tightness, reducing the frequency of attacks. It is especially suitable for Qi deficiency and phlegm retention syndrome, with significant efficacy, no toxic side effects, and good safety.

[0023] Furthermore, animal experiments have shown that the traditional Chinese medicine composition provided by this invention can improve the mental state of mice in the chronic stage of asthma and improve behavioral manifestations such as nose scratching, sneezing, and head nodding during breathing. It can also improve lung function in mice in the chronic stage of asthma, reduce airway resistance, alleviate airway hyperresponsiveness, reduce chronic inflammation of lung tissue and airways, improve airway mucus hypersecretion, reduce airway collagen deposition and delay airway remodeling, and alleviate IgE-mediated allergic reactions. Attached Figure Description

[0024] Figure 1 To investigate the effect of the Qi-regulating and anti-asthmatic formula on lung function in mice with persistent asthma, note: Control: normal group, Model: model group, TQFXF-L; low-dose Qi-regulating and anti-asthmatic formula group, TQFXFM: medium-dose Qi-regulating and anti-asthmatic formula group, TQFXF-H: high-dose Qi-regulating and anti-asthmatic formula group; Mont: montelukast sodium group, n=3~4. Comparison with the blank group: # p < 0.05; compared with the model group, * p <0.05,** p < 0.01.

[0025] Figure 2 To investigate the effects of the Qi-regulating and anti-asthmatic formula on lung pathology in mice with persistent asthma, note: Control: normal group, Model: model group, TQFXF-L; low-dose Qi-regulating and anti-asthmatic formula group, TQFXF-M: medium-dose Qi-regulating and anti-asthmatic formula group, TQFXFF-H: high-dose Qi-regulating and anti-asthmatic formula group; Mont: montelukast sodium group.

[0026] Figure 3 To investigate the effect of Tiaoqi Fangxiao Formula on pulmonary mucus secretion levels in mice with chronic asthma, note: Control: normal group, Model: model group, TQFXF-L; low-dose Tiaoqi Fangxiao Formula group, TQFXF-M: medium-dose Tiaoqi Fangxiao Formula group, TQFXF-H: high-dose Tiaoqi Fangxiao Formula group; Mont: montelukast sodium group.

[0027] Figure 4To investigate the effect of Tiaoqi Fangxiao Formula on pulmonary collagen deposition in mice with chronic asthma, note: Control: normal group, Model: model group, TQFXF-L; low-dose Tiaoqi Fangxiao Formula group, TQFXF-M: medium-dose Tiaoqi Fangxiao Formula group, TQFXF-H: high-dose Tiaoqi Fangxiao Formula group; Mont: montelukast sodium group.

[0028] Figure 5 This study analyzed the results of HE staining, AB-PAS staining, and Masson staining, and investigated the effects of the Tiaoqi Fangxiao formula on the levels of IL-4, IL-13, and serum OVA-sIgE in lung tissue of mice in the asthma continuation phase. Note: Control group: normal group; Model group: model group; TQFXF-L: low-dose Tiaoqi Fangxiao formula group; TQFXF-M: medium-dose Tiaoqi Fangxiao formula group; TQFXF-H: high-dose Tiaoqi Fangxiao formula group; Mont: montelukast sodium group; n=4. Comparison with the blank group: ## p < 0.01, ### p < 0.001; compared with the model group, * p < 0.05,** p < 0.01, *** p < 0.001. Detailed Implementation

[0029] The present invention can be better understood from the following embodiments. However, those skilled in the art will readily understand that the specific material ratios, process conditions, and results described in the embodiments are for illustrative purposes only and should not, and will not, limit the invention as described in detail in the claims.

[0030] Example 1 A traditional Chinese medicine oral liquid for treating chronic asthma in children is made from the following raw materials in the indicated weight ratios: Raw Astragalus 12g, Ephedra root 5g, Perilla seed 9g, Red peony root 9g, Belamcanda chinensis 9g, Lilium brownii 9g, Honey-processed Stemona japonica 6g, Magnolia biondii 6g (wrapped and decocted), Schizonepeta tenuifolia 6g, Prunus mume 6g.

[0031] 2. A method for preparing an oral liquid for treating persistent asthma in children, comprising the following steps: (1) Take 12g of raw Astragalus membranaceus, 5g of Ephedra sinica root, 9g of Perilla frutescens seed, 9g of Paeonia lactiflora, 9g of Belamcanda chinensis, 9g of Lilium brownii, 6g of Stemona japonica (honey-processed), 6g of Magnolia biondii (wrapped and decocted), 6g of Schizonepeta tenuifolia, and 6g of Prunus mume. Place them in an extraction tank and add 8 times the weight of the herbs in drinking water to soak for 30 minutes. Then heat and decoct the soaking liquid of the Chinese herbal raw materials for 2 hours, filter, take the filtrate, add 8 times the amount of water to the residue and decoct for 1.5 hours, filter, combine the two filtrates, and concentrate to 2:1 (herbal material: liquid). (2) Take the concentrated medicine solution from step (1), add 95% ethanol to the concentrated medicine solution to make the ethanol content reach 80%, let it stand for 24 hours, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.2, add distilled water to the specified volume, add an appropriate amount of flavoring agent and other excipients, mix well, let it stand for 12 to 24 hours, filter, bottle, sterilize, and the traditional Chinese medicine oral liquid is made.

[0032] Example 2: Preparation of a traditional Chinese medicine capsule for treating the persistent stage of childhood asthma, comprising the following steps: (1) Take 12g of raw Astragalus membranaceus, 5g of Ephedra sinica root, 9g of Perilla frutescens seed, 9g of Paeonia lactiflora, 9g of Belamcanda chinensis, 9g of Lilium brownii, 6g of Stemona japonica (honey-processed), 6g of Magnolia biondii (wrapped and decocted), 6g of Schizonepeta tenuifolia, and 6g of Prunus mume. Place them in an extraction tank, add 10 times the weight of the herbs in drinking water and soak for 30 minutes. Then heat and decoct the soaking liquid for 2 hours, filter, take the filtrate, add 8 times the amount of water to the residue and extract for 1.5 hours, filter, add 8 times the amount of water to the residue and extract for 1 hour, filter, combine the three filtrates, and concentrate to 2:1 (herb: liquid). (2) Add 95% ethanol to the drug solution in step (1) until the alcohol content reaches 75%, let stand for 48 hours, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.3, add dextrin, mix well, vacuum dry, pulverize, granulate, dry, granulate, and encapsulate to make capsules.

[0033] Example 3: Preparation of a traditional Chinese medicine tablet for treating the persistent stage of childhood asthma, comprising the following steps: (1) Take 16g of raw Astragalus membranaceus, 6g of Ephedra sinica root, 12g of Perilla frutescens seed, 12g of Paeonia lactiflora, 12g of Belamcanda chinensis, 12g of Lilium brownii, 8g of Stemona japonica (honey-processed), 8g of Magnolia biondii (wrapped and decocted), 8g of Schizonepeta tenuifolia, and 8g of Prunus mume. Place them in an extraction tank and add 10 times the weight of the herbs in drinking water to soak for 30 minutes. Then heat and decoct the soaking liquid for 2 hours, filter it, add 10 times the amount of water to extract for 1.5 hours, filter it, combine the filtrates, and concentrate to 2:1 (herb: liquid). (2) Add 95% ethanol to the drug solution in step (1) until the alcohol content reaches 78%, let stand for 48 hours, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.3, add dextrin, mix well, vacuum dry, pulverize, granulate, dry, granulate, compress, and coat to make tablets.

[0034] Example 4: Preparation of a traditional Chinese medicine granule for treating the persistent stage of childhood asthma, comprising the following steps: (1) Take 16g of raw Astragalus membranaceus, 6g of Ephedra sinica root, 12g of Perilla frutescens seed, 12g of Paeonia lactiflora, 12g of Belamcanda chinensis, 12g of Lilium brownii, 8g of Stemona japonica (honey-processed), 8g of Magnolia biondii (wrapped and decocted), 8g of Schizonepeta tenuifolia, and 8g of Prunus mume. Place them in an extraction tank and add 10 times the weight of the herbs in drinking water to soak for 30 minutes. Then decoct the soaking liquid, heat and extract for 2 hours, filter, add 8 times the amount of water to extract for 1.5 hours, filter, combine the filtrates, and concentrate to 2:1 (herb: liquid). (2) Add 95% ethanol to the drug solution in step (1) until the alcohol content reaches 70%, let stand for 48 hours, filter, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.1 to 1.2, granulate in one step, granulate, and package to make granules.

[0035] Example 5: Preparation of a traditional Chinese medicine soft capsule for treating chronic asthma in children, comprising the following steps: (1) Take 12g of raw Astragalus membranaceus, 5g of Ephedra sinica root, 9g of Perilla frutescens seed, 9g of Paeonia lactiflora, 9g of Belamcanda chinensis, 9g of Lilium brownii, 6g of Stemona japonica (honey-processed), 6g of Magnolia biondii (wrapped and decocted), 6g of Schizonepeta tenuifolia, and 6g of Prunus mume. Place them in an extraction tank and add 10 times the weight of the herbs in drinking water to soak for 30 minutes. Then decoct the soaking liquid, heat and extract for 2 hours, filter, add 10 times the amount of water to extract for 1.5 hours, filter, combine the filtrates, and concentrate to 2:1 (herb: liquid). (2) Add 95% ethanol to the drug solution in step (1) until the alcohol content reaches 75%, let stand for 24 hours, filter, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.1, dry, add an appropriate amount of glycerin, mix well, drip or press into soft capsules, and package to make soft capsules.

[0036] Example 6: Preparation of a traditional Chinese medicine external throat spray for treating the persistent stage of childhood asthma, comprising the following steps: Take 12g of raw Astragalus membranaceus, 5g of Ephedra sinica root, 9g of Perilla frutescens seed, 9g of Paeonia lactiflora, 9g of Belamcanda chinensis, 9g of Lilium brownii, 6g of Stemona japonica (honey-processed), 6g of Magnolia biondii (wrapped and decocted), 6g of Schizonepeta tenuifolia, and 6g of Prunus mume. Place them in an extraction tank and add 10 times the weight of the herbs in drinking water to soak for 30 minutes. Then decoct the soaking liquid and heat to extract for 2 hours. Filter the liquid, add 10 times the amount of water to extract for 1.5 hours, filter the liquid, combine the filtrates, and concentrate to a ratio of 2:1 (herbs: liquid). Take the medicine solution from step (1), add 95% ethanol to the concentrate to make the ethanol content reach 80%, let it stand for 24 hours, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.2, add distilled water to the specified volume, mix well, let it stand for 12 to 24 hours, filter, bottle, sterilize, and the throat spray is made.

[0037] Example 7: Clinical trial of a traditional Chinese medicine composition for treating chronic asthma in children with qi deficiency and phlegm retention. Case selection: All cases were children diagnosed with bronchial asthma who visited the pediatric outpatient department of Nanjing University of Chinese Medicine Affiliated Hospital (Jiangsu Provincial Hospital of Traditional Chinese Medicine) between October 2024 and October 2025. Ninety cases were selected, including 59 males and 31 females. The youngest patient was 3 years old, the oldest was 11 years old, and the mean age was 6.34 (±2.30) years. The treatment course was one month. Inclusion criteria: ① Meeting the Western medicine diagnostic criteria for chronic persistent bronchial asthma and the TCM diagnostic criteria for persistent phase with qi deficiency and phlegm retention; ② Age between 3 and 14 years. Exclusion criteria: ① Concurrent structural lung injury, pulmonary embolism, acute upper airway inflammation, or respiratory decompensation; ② Presence of bronchial malformations; ③ Concurrent primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, and hematopoietic systems; ④ Allergy to this drug.

[0038] (2) Treatment drugs and dosage: The sample was prepared by boiling water according to step (1) of Example 1. For children aged 3-5, the dosage was 100 mL; for children aged 6-10, it was 150 mL; and for children aged 11-14, it was 200 mL. The sample was taken orally twice daily, morning and evening. One course of treatment lasted two weeks, and two courses were observed.

[0039] (3) Observation of treatment effect: 1) Overall effective rate before and after treatment In this invention, a traditional Chinese medicine composition (Qi-regulating and asthma-preventing formula) was used to treat 90 children with bronchial asthma due to Qi deficiency and phlegm retention. After treatment, 8 cases achieved clinical control, 48 cases showed significant improvement, 29 cases showed improvement, and 5 cases showed no improvement, with a total effective rate of 94.44%. This was verified by chi-square test. p <0.05, which is statistically significant, indicating that this formula can significantly improve the clinical symptoms of Qi deficiency and phlegm retention in children with chronic bronchial asthma (see Table 1 for details).

[0040] Table 1. Statistics on the efficacy of the Qi-regulating and Asthma-preventing Formula in treating cases over one month.

[0041] .

[0042] 2) Main symptom scores, treatment efficacy, and improvement rate The main symptoms of chronic asthma in children include wheezing, cough, shortness of breath, and chest tightness. Nonparametric rank-sum analysis of clinically collected case data showed that the scores of all these main symptoms decreased during treatment. Furthermore, statistical analysis revealed that wheezing and shortness of breath achieved clinical control levels after treatment, with significant improvements in scores before and after treatment. Wilcoxon test results confirmed this improvement. p<0.05 was statistically significant. Of the 14 patients with wheezing symptoms before treatment, all 14 showed improvement, a 100% improvement rate. Of the 23 patients with wheezing symptoms before treatment, all 23 showed improvement, a 100% improvement rate. Chest tightness was also clinically controlled after one month of treatment, with significant improvement in scores before and after treatment, as confirmed by the Wilcoxon test. p <0.05 was statistically significant. Of the 15 children initially diagnosed with chest tightness, all 15 showed improvement, resulting in an improvement rate of 100%. Cough symptoms improved significantly after one month of treatment, as indicated by the Wilcoxon test. p <0.05 is statistically significant. Of the 85 patients with cough symptoms before treatment, 78 showed improvement, resulting in an improvement rate of 91.76%. In summary, this suggests that taking the Qi-regulating and asthma-preventing formula can effectively improve the main clinical symptoms such as wheezing, shortness of breath, chest tightness, and cough in children with continuation-stage asthma, with statistically significant differences (see Tables 2-5 for details).

[0043] Table 2. Scoring table for wheezing before and after treatment

[0044] Table 3. Scoring table for wheezing and shortness of breath before and after treatment.

[0045] Table 4. Scoring Table for Chest Tightness Before and After Treatment

[0046] Table 5. Cough Treatment Evaluation Table

[0047] 3) Efficacy and improvement rate of secondary symptoms and TCM syndrome scores The efficacy of treatment for secondary symptoms and TCM syndromes of Qi deficiency and phlegm retention in children with chronic asthma was evaluated. Nonparametric analysis using the rank-sum test showed that the scores for symptoms such as fatigue, sweating, nasal symptoms (sneezing, nasal congestion, runny nose), complexion, and appetite all decreased during treatment. Wilcoxon analysis confirmed this. p <0.05, the difference was statistically significant. According to statistics, 17 children presented with fatigue and weakness at initial diagnosis; after one month of treatment, 10 children showed improvement, an improvement rate of 58.82%. Wilcoxon test results showed... p The value is 0.002 ( p <0.05), the difference was statistically significant. 63 patients presented with excessive sweating at initial diagnosis; after one month of treatment, 45 patients showed symptom improvement, an improvement rate of 71.43%. p<0.05. Regarding nasal symptoms, 68 patients had symptoms before treatment, and 59 patients showed improvement after one month of treatment, an improvement rate of 86.76%. Regarding appetite, 38 patients had symptoms before treatment, and 30 patients showed improvement after one month of treatment, an improvement rate of 78.95%. Facial complexion improved somewhat after treatment, but the improvement was not significant compared to other secondary symptoms. 88 patients initially presented with a pale or sallow complexion; after one month of treatment with the Qi-regulating and asthma-preventing formula, 13 patients showed improvement, an improvement rate of 6.77%. p The value is 0.005 ( p <0.05), the difference is statistically significant. (See Tables 6-10 for details).

[0048] Table 6. Fatigue and weakness scoring table before and after treatment

[0049] Table 7 Sweating Treatment Rating Table

[0050] Table 8. Nasal Symptoms Before and After Treatment Scoring Table

[0051] Table 9. Feeding Therapy Pre- and Post-Treatment Scoring Table

[0052] Table 10 Facial Complexion Rating Table Before and After Treatment

[0053] Example 8: Therapeutic Mechanism and Effects of Traditional Chinese Medicine Composition Reagents and experimental drugs The Chinese herbal composition administration group (hereinafter referred to as the Qi-regulating and asthma-preventing formula): The Chinese herbal decoction pieces of this invention were purchased from Jiangsu Provincial Hospital of Traditional Chinese Medicine and prepared according to the method of Example 1.

[0054] Montelukast Sodium Group: Montelukast Sodium Tablets, CSPC Ouyi Pharmaceutical Co., Ltd., H20203046.

[0055] Dosage: The conversion formula between experimental animal and human clinical drug dosage proposed in "Methodology of Pharmacological Research of Traditional Chinese Medicine" was used. dB = dA * RB / RA *

[0056] Note: dB is the dose per kilogram of animal B to be calculated; dA is the dose per kilogram of animal A known; WA and WB are the known weights of animals A and B; RA and RB are the body size coefficients of animals A and B.

[0057] (2) Laboratory animals Forty-eight healthy female BALB / c mice, SPF grade, 4 weeks old, weighing 14±2 g, were purchased from Hangzhou Medical College. Animal qualification certificate number: A202506300923.

[0058] (3) Experimental methods 1) Animal model of asthma in its protracted stage Forty-eight female BALB / c mice were acclimatized for one week. Except for eight randomly selected control mice, the other five groups of mice were sensitized by intraperitoneal injection of 0.2 mL of sensitizing solution (100 μg OVA, 1 mg aluminum hydroxide dissolved in physiological saline) on days 1 and 8. Starting on day 21, mice were sensitized by nebulization of 2% OVA (OVA Grade V) dissolved in physiological saline for 30 min for 3 consecutive days each week for 5 weeks, for a total of 15 times. The normal control group received the same volume of physiological saline instead of the OVA solution.

[0059] 2) Administration Starting from day 29 of the modeling period, the model mice were randomly divided into a model group, low-, medium-, and high-dose Tiaoqi Fangxiao Fang groups, and a montelukast sodium group, with 8 mice in each group. The mice were administered the formula via gavage for 4 consecutive weeks. The control group and model group were administered 1.0 ml / 100 g of physiological saline. The low-, medium-, and high-dose Tiaoqi Fangxiao Fang groups were administered the formula via gavage at concentrations of 10.23 g / kg, 20.47 g / kg (clinically equivalent dose), and 40.94 g / kg, respectively. The montelukast sodium group was administered the formula via gavage at a concentration of 1.328 mg / kg (clinically equivalent dose), once daily.

[0060] 3) Specimen Collection Lung function testing: After the modeling and drug administration, four mice were taken from each group. The lung function of the mice was tested using a multifunctional animal lung function testing system. The mice were placed in a whole-body scanning chamber and nebulized with methacholine chloride (Mch) at concentrations of 0, 3.125, 6.25, 12.5, 25, and 50 mg / ml for 1 min. The changes in the enhanced pause (Penh) value of the bronchial contraction parameter after stimulation were measured to determine the airway hyperresponsiveness of the mice.

[0061] Blood collection: 16 hours after the last administration, mice were fasted. After 8 hours of fasting, they were anesthetized by intraperitoneal injection of 0.2 mL / 10 g of 0.3% sodium pentobarbital. After intraperitoneal anesthesia, blood was collected by fundus puncture of all mice. The blood was allowed to stand for 1 hour, then centrifuged at 3000 r / min for 10 minutes at 4°C. The serum was aliquoted and stored at -80°C for later use.

[0062] Lung tissue was harvested: lung tissue was washed with phosphate buffer, fixed with 4% paraformaldehyde at room temperature, dehydrated with ethanol at gradient concentrations, and embedded in paraffin. 4 µm thick tissue sections were stained with hematoxylin and eosin (HE), PAS, and Masson staining to observe inflammatory cell infiltration, mucus secretion, smooth muscle hyperplasia, and collagen deposition levels in the lung tissue.

[0063] Preparation of lung homogenate and determination of protein concentration: Take an appropriate amount of lung tissue (20 mg), wipe off surface foreign matter with absorbent paper, and weigh. Place the lung tissue in a 1.5 ml EP tube, add 200 µl PBS and a grinding ball, seal the tube, and homogenize the tissue using a ball mill at 25 rpm for 5 min. Then, centrifuge at 12000 rpm for 30 min in a pre-cooled 4℃ high-speed centrifuge and collect the supernatant. Add the sample and working solution according to the BCA protein quantification kit instructions, calculate the total protein concentration in the tissue based on the standard concentration curve, mix with double-distilled water, and dilute the total protein to a final concentration of 3.5 µg / μl.

[0064] Experimental results 1) General situation During the modeling period, the mice in the asthma continuation stage model showed slightly poor mental state, preferred to lie down and had reduced activity, and occasionally exhibited restlessness, scratching their ears and cheeks, frequent nose scratching, frequent sneezing, and head nodding breathing. After 28 days of drug administration, the mental state of mice in all drug treatment groups improved to varying degrees, with slightly increased activity and reduced nose scratching, sneezing, and head nodding breathing.

[0065] 2) Lung function test Children in the continuation phase of asthma often experience symptoms of airway spasm and narrowing, such as wheezing, stridor, and coughing, after exposure to external stimuli. Airway resistance can be assessed by pulmonary function tests. Some children in the continuation phase often exhibit abnormal pulmonary function, presenting as a state of "upward reversal of airflow." Increased airway resistance and abnormal pulmonary function are important manifestations of airway hyperresponsiveness in asthma. This study used whole-volume phlometry (WBP) in mice to obtain Penh values ​​for each group to quantify airway resistance and assess airway hyperresponsiveness. Figure 1 As shown, after nebulization provocation with 0, 3.125, 6.25, 12.5, 25, and 50 mg / mL Mch, compared with the normal group, the airway reactivity of mice after asthma prolongation modeling was significantly increased at concentrations of 6.25–50 mg / mL. p < 0.05, p <0.05, p < 0.05, p < 0.05), while the administration of the Qi-regulating and anti-asthmatic formula can improve airway hyperresponsiveness in asthma model mice. Among them, the low-dose groups at 6.25, 12.5 and 50 mg / mL can significantly reduce airway hyperresponsiveness ( p < 0.05, p< 0.05, p < 0.05), the medium-dose group showed a significant reduction in airway hyperresponsiveness at challenge doses of 6.25, 12.5, 25, and 50 mg / mL. p < 0.05, p <0.05, p < 0.05, p < 0.01), and the high-dose group also showed a significant reduction in airway hyperresponsiveness at challenge levels of 6.25, 12.5, 25, and 50 mg / mL. p < 0.05, p < 0.05, p < 0.05, p < 0.05). Meanwhile, montelukast sodium intervention significantly reduced airway hyperresponsiveness at challenge levels of 6.25, 12.5, and 50 mg / mL ( p < 0.05, p < 0.01, p < 0.05), indicating that the Qi-regulating and anti-asthmatic formula can improve lung function and reduce airway hyperresponsiveness in mice in the chronic asthma stage, thereby exerting the effects of "regulating Qi" and "reducing Qi".

[0066] 3) HE staining of lung tissue The study results indicate that chronic airway inflammation is prevalent during the chronic phase of asthma. HE staining was used to observe the extent of airway inflammation. Figure 2 As shown, compared with the normal group, the peri-airway inflammation was significantly increased after modeling, the airway and blood vessel walls were thickened, local inflammatory infiltration of lung tissue was observed, and the pathological score was significantly elevated. p < 0.001). After intervention with low, medium, and high doses of the Qi-regulating and anti-asthmatic formula and montelukast sodium, airway and perivascular inflammation were significantly reduced, alveolar morphology became regular, and airway inflammation pathology scores were significantly lower. p <0.01, p < 0.001, p < 0.001, p < 0.001). This shows that the Qi-regulating and asthma-preventing formula can improve chronic airway inflammation in mice with a prolonged asthma stage.

[0067] 4) PAS staining of lung tissue Mucus hypersecretion is an important pathological mechanism in the development and progression of asthma. For example... Figure 3 As shown, compared with the normal group, the model group showed a large number of dark red glycogen secretions in the airways, an increased number of AB PAS-positive cells indicating goblet cell hyperplasia, and increased mucus secretion. The differences were statistically significant. p< 0.001, low, medium, and high doses of the Qi-regulating and anti-asthmatic formula, as well as intervention with montelukast sodium, significantly reduced airway mucus secretion, mucus plug dissolution, goblet cell proliferation, and the number of ABPAS-positive cells, with statistically significant differences. p < 0.001, p < 0.001, p < 0.001, p <0.001). Jiangqi Pingxiao Formula can achieve the effect of "reducing qi and resolving phlegm" by reducing the high mucus secretion in the airways during the chronic stage of asthma.

[0068] 5) Masson staining of lung tissue Chronic airway inflammation can lead to changes in airway structure, known as airway remodeling. Airway remodeling is considered a key pathological change causing irreversible airflow limitation and airway hyperresponsiveness. For example... Figure 4 Masson staining results showed that, compared with the normal group, the model group had a large amount of blue collagen deposition in the lung tissue and around the airways, and the difference was statistically significant. p < 0.01), after low, medium, and high doses of the Qi-regulating and anti-asthmatic formula, airway collagen deposition was significantly alleviated ( p < 0.05, p < 0.05, p <0.05 indicates that the Qi-regulating and anti-asthmatic formula can improve airway remodeling in mice with a prolonged asthma stage.

[0069] 6) Detection of inflammatory factors in lung tissue homogenate like Figure 5 As shown, compared with the normal control group, the levels of IL-4 and IL-13 in the lung tissue homogenate of the model group mice were significantly increased ( p < 0.01, p < 0.001). Compared with the model group, the IL-4 level in the lung tissue of mice in the medium and high dose groups of the Qi-regulating and anti-asthmatic formula was significantly reduced, and the difference was statistically significant. p < 0.01, p < 0.05, the IL-13 level in the lung tissue of mice in the low, medium and high dose groups of the Qi-regulating and anti-asthmatic formula and the montelukast sodium group was decreased, and the difference was statistically significant. p < 0.001, p < 0.001, p The value <0.001 indicates that the Qi-regulating and asthma-preventing formula can improve the level of chronic inflammation in lung tissue and has a good anti-inflammatory effect.

[0070] 7) Serum OVA-sIgE detection IgE, as an initiator of allergic reactions, binds to high-affinity receptors (FcεRI) on the surface of mast cells and basophils, triggering degranulation and the release of mediators such as histamine, leukotrienes, and cytokines (e.g., IL-4, IL-5, IL-13), leading to bronchoconstriction and increased mucus secretion. Figure 5 As shown, compared with the normal control group, the serum OVA-sIgE level in the model group mice was significantly increased ( p < 0.001). Compared with the model group, the serum OVA-sIgE levels in mice in the low, medium, and high dose groups of the Qi-regulating and anti-asthmatic formula and the montelukast sodium group were significantly reduced, and the differences were statistically significant. p <0.001, p <0.001, p <0.001), indicating that the Qi-regulating and anti-asthmatic formula can improve IgE-mediated allergic reactions.

[0071] Case 1 Li Moumou, male, 7 years old First visit on May 8, 2025 Chief complaint: Recurrent cough and wheezing for 2 years.

[0072] Present Illness: The child has experienced recurrent cough, wheezing, shortness of breath, and chest tightness for the past two years, often triggered by colds or external pathogens. In March 2025, after a cold, the child experienced a recurrence of cough and wheezing. At another hospital, the child received nebulized inhalation treatment for one week, including budesonide suspension (2ml twice daily), ipratropium bromide solution (2ml twice daily), and salbutamol sulfate solution (2ml twice daily). After this treatment, the cough and wheezing largely disappeared. For the past two months, the child has experienced occasional coughing after exercise and occasional wheezing at night. Current Symptoms: The child occasionally coughs upon waking and at night, with phlegm in the throat that is difficult to expectorate. There is no significant wheezing, chest tightness, or shortness of breath. Nasal itching, runny nose, and sneezing occur intermittently. The child is generally prone to colds, fatigue, and weakness, with slight aversion to wind, spontaneous sweating, poor appetite, mild halitosis, good sleep, and normal bowel movements.

[0073] Physical examination: The patient's complexion was pale, the pharynx was slightly congested, and auscultation revealed slightly coarse breath sounds in both lungs, but no wheezing was heard. The tongue was dark red with a slightly greasy white coating.

[0074] Diagnosis: Traditional Chinese Medicine: Asthma (protracted stage); Syndrome type: Qi deficiency with phlegm retention; Western Medicine: Bronchial asthma Prescription: Astragalus membranaceus 12g, Ephedra sinica root 5g, Belamcanda chinensis 9g, Paeonia lactiflora 9g, Perilla frutescens seed (fried) 9g, Lilium brownii 9g, Stemona japonica (honey-processed) 6g, Magnolia biondii (wrapped and decocted) 6g, Schizonepeta tenuifolia 6g, Prunus mume 6g. 14 doses in total, one dose daily, decocted in water, 150mL, taken warm twice daily, morning and evening.

[0075] Second visit on May 21, 2025: The child's symptoms were well controlled during medication, with a significant reduction in cough frequency, improved runny nose, occasional nasal itching and sneezing, and improved spontaneous sweating. Appetite was still slightly poor. The child's symptoms improved, and the original prescription was continued for another 14 doses to consolidate the treatment.

[0076] Third visit on June 4, 2025: The child's symptoms have gradually subsided. Asthma did not flare up during medication, with occasional sneezing. Appetite has improved, bad breath has disappeared, and there is slight spontaneous sweating. The child's symptoms have subsided, and the patient has entered the remission phase. A self-prescribed spleen-strengthening and asthma-preventing formula will continue to be used for treatment. The family was instructed to pay attention to their health, reduce exposure to colds, and follow up with the doctor if any discomfort occurs.

[0077] Follow-up on August 5, 2025: The child experienced one bout of external infection during medication, presenting with a mild cough but no obvious asthma symptoms. The cough disappeared after 3 days of treatment with a pediatric antiasthmatic compound. A repeat pulmonary function test showed normal pulmonary ventilation; FeNO (oral): 23 ppb. The child's condition is currently stable, and there have been no recurrences of cough and wheezing in the past 3 months. The family was instructed to discontinue medication and observe the child, paying attention to their health and seeking medical attention if any discomfort arises.

[0078] Case 2 Chen, female, 9 years old First visit on June 14, 2025 Chief complaint: Recurrent cough and wheezing for 4 years Present Illness: The child has experienced recurrent cough, wheezing, shortness of breath, and chest tightness for the past four years, often triggered by colds or strenuous exercise. On May 5, 2025, after a cold, the child developed cough and wheezing. At another hospital, the child was given procaterol hydrochloride tablets 25mg once daily, montelukast sodium chewable tablets 5mg once daily, and loratadine tablets 5mg once daily. The cough and wheezing significantly improved, but the cough has recurred since then. Current Symptoms: The child occasionally coughs upon waking and at night, and occasionally experiences chest tightness and shortness of breath after strenuous exercise. There is phlegm in the throat, but no wheezing or stridor. There is also nasal itching and sneezing, but no nasal congestion or runny nose. The child is usually easily fatigued, slightly averse to wind, experiences intermittent dizziness, excessive night sweats, poor appetite, restless sleep, occasional teeth grinding and talking in the sleep, normal urination, and loose stools.

[0079] Physical examination: The patient's complexion was pale, the pharynx was slightly congested, and auscultation revealed slightly coarse breath sounds in both lungs, but no wheezing was heard. The tongue was dark red with a white coating.

[0080] Auxiliary examinations: Pulmonary function test in March 2025 showed normal pulmonary ventilation function; FeNO (oral): 25 ppb.

[0081] Diagnosis: Traditional Chinese Medicine: Asthma (protracted stage); Syndrome type: Qi deficiency with phlegm retention; Western Medicine: Bronchial asthma Prescription: Astragalus membranaceus 12g, Ephedra root 5g, Belamcanda chinensis 9g, Paeonia lactiflora 9g, Perilla frutescens seed 9g, Lilium brownii 9g, Stemona japonica (honey-processed) 6g, Magnolia biondii (wrapped and decocted) 6g, Schizonepeta tenuifolia 6g, Prunus mume 6

[0082] 14 doses, one dose per day, decocted in water to 150mL, taken warm twice a day, morning and evening.

[0083] Second visit on June 28, 2025: The child's symptoms were well controlled after taking the medication; cough and night sweats disappeared, and appetite improved. The child now occasionally experiences mild chest tightness after exercise, accompanied by nasal itching, occasional sneezing, itchy skin prone to developing red rashes, and restless sleep. With all symptoms improving, the original prescription was continued with the addition of 10g of Dictamnus dasycarpus root bark for 14 more doses.

[0084] Third consultation on July 12, 2025: The child's symptoms are gradually subsiding. During the medication period, the asthma did not flare up, chest tightness disappeared, itching improved, and the rash subsided. Currently, there is occasional nasal itching. The child's symptoms are gradually subsiding, with occasional nasal itching. Continue the original prescription for another 14 doses to consolidate the treatment.

[0085] On July 26, 2025, the fourth consultation revealed that the child's symptoms had subsided, and the cough and wheezing had not recurred for nearly three months, now entering a remission phase. A self-prescribed spleen-strengthening and asthma-preventing formula was prescribed for continued treatment. The family was instructed to pay attention to their child's health, reduce exposure to colds, and seek medical attention if any discomfort was observed.

[0086] Follow-up on August 30, 2025: The child had one cold during the medication period, with only mild nasal congestion and runny nose, and no other discomfort. The child and family were instructed to stop the medication and observe, and to pay attention to the child's daily care and take care of themselves. If any discomfort occurs, seek medical attention in time.

Claims

1. A traditional Chinese medicine composition for treating chronic asthma in children, characterized in that, It is made from the following raw materials: Raw Astragalus, Ephedra Root, Perilla Seed, Red Peony Root, Belamcanda Rhizome, Lily Bulb, Honey-processed Stemona Root, Magnolia Flower, Schizonepeta, and Dried Plum.

2. The traditional Chinese medicine composition according to claim 1, which has the effect of treating the persistent stage of childhood asthma, is characterized in that, It is made from the following raw materials in the indicated weight ratios: Raw Astragalus membranaceus 6-18g, Ephedra root 2-8g, Perilla seed 4-14g, Red peony root 4-14g, Belamcanda chinensis 4-14g, Lilium brownii 4-14g, Honey-processed Stemona japonica 2-10g, Magnolia biondii 2-10g, Schizonepeta tenuifolia 2-10g, Prunus mume 2-10g.

3. The traditional Chinese medicine composition for treating chronic asthma in children according to claim 2, characterized in that, It is made from the following raw materials in the indicated weight ratios: Raw Astragalus 8-16g, Ephedra root 4-6g, Perilla seed 6-12g, Red peony root 6-12g, Belamcanda chinensis 6-12g, Lilium brownii 6-12g, Honey-processed Stemona japonica 4-8g, Magnolia biondii 4-8g, Schizonepeta tenuifolia 4-8g, Mume 4-8g.

4. The traditional Chinese medicine composition for treating chronic asthma in children according to claim 3, characterized in that, It is made from the following raw materials in the indicated weight ratios: Raw Astragalus 12g, Ephedra root 5g, Perilla seed 9g, Red peony root 9g, Belamcanda chinensis 9g, Lilium brownii 9g, Honey-processed Stemona japonica 6g, Magnolia biondii 6g, Schizonepeta tenuifolia 6g, Mume 6g.

5. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that, Includes the following steps: (1) Take any one of the raw Astragalus membranaceus, Ephedra root, Perilla seed, Red peony root, Belamcanda chinensis, Lilium brownii, Honey Stemona japonica, Magnolia biondii (wrapped and decocted), Schizonepeta tenuifolia and Prunus mume as described in any one of claims 1 to 4 and place them in an extraction tank. First, soak them in water, then heat and extract them, filter them, then add water and extract them multiple times, filter them, combine the filtrates, concentrate them, and obtain a concentrated solution. (2) Add an appropriate amount of ethanol to the concentrate in step (1), stir well, let stand, filter, take the supernatant, recover the ethanol until there is no alcohol smell, concentrate, and obtain the concentrate.

6. The method for preparing the traditional Chinese medicine composition according to claim 5, characterized in that, In step (1), add 8 to 12 times the weight of the raw material with water, soak for 30 minutes, then heat and decoct or reflux extract for 1 to 3 hours, filter, and obtain filtrate. Add 6 to 10 times the amount of water to the residue, heat and decoct or reflux and extract 1 to 2 times, each time for 1 to 2 hours, filter, combine the filtrates, and concentrate to a ratio of 2:1 between the raw material and the liquid.

7. The method for preparing the traditional Chinese medicine composition according to claim 5, characterized in that, The ethanol added in step (2) has a concentration of 95%, so that the alcohol content in the concentrate is 70% to 80%. After standing for 24 to 48 hours, it is concentrated to a relative density of 1.1 to 1.

3.

8. The method for preparing the traditional Chinese medicine composition according to claim 5, characterized in that, The concentrate from step (2) is combined with pharmaceutically acceptable excipients to form oral liquids, capsules, tablets, granules, mixtures, powders, pills, oral preparations, or external throat sprays.

9. The use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for preventing and treating chronic asthma in children.

10. The use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicine for preventing and treating the prolonged stage of childhood asthma due to qi deficiency and phlegm retention.

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