Traditional Chinese medicine composition for treating asthma as well as preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating asthma as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine, the traditional Chinese medicine composition comprises the following medicinal raw materials in parts by mass: 5-15 parts of ephedra, 10-30 parts of humulus scandens, 5-20 parts of radix sophorae flavescentis, 5-20 parts of earthworm, 10-30 parts of semen lepidii, 5-20 parts of rhizoma pinellinae praeparata, 3-9 parts of asarum, 10-30 parts of wild buckwheat, 5-20 parts of blackberry lily, 5-25 parts of raw almond, 5-20 parts of mangnolia officinalis and 5-20 parts of schisandra chinensis. The invention further discloses a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine has the beneficial effects that the traditional Chinese medicine treats asthma from dampness, has the core of clearing heat and eliminating phlegm, freeing lung and relieving asthma, and consolidating foundation and clearing damp, can improve the damp syndrome state of asthma patients, relieve clinical symptoms such as wheeze, shortness of breath, chest distress and cough, improve the life quality and improve the asthma control level, and has potential advantages of reducing acute attack of asthma.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular, to a traditional Chinese medicine composition for treating asthma, a preparation method thereof, and an application thereof. Background Art

[0002] Bronchial asthma (referred to as asthma for short) is a common chronic respiratory disease worldwide, and its prevalence has been increasing year by year in recent years. The treatment goal of asthma is to achieve good control of asthma symptoms, maintain normal activity levels, and at the same time minimize the risks of acute attacks and deaths, irreversible damage to lung function, and drug-related adverse reactions. Standardized western medicine treatment can effectively relieve the respiratory symptoms of patients, prevent acute attacks, and improve the quality of life. Inhaled glucocorticoids are the first-line drugs recommended in the guidelines for treating asthma, and severe cases require oral glucocorticoids.

[0003] Traditional Chinese medicine believes that asthma belongs to the category of "wheezing disorder". After thousands of years of development, a complete etiology, pathogenesis, and syndrome differentiation and treatment system has been established. Traditional Chinese medicine treats wheezing disorder adhering to the principle of "treating the symptoms in acute stage and treating the root cause in remission stage". Research has shown that traditional Chinese medicine has certain advantages in improving clinical symptoms, reducing acute attacks, and improving lung function. For example, the combination of Xiaoqinglong Decoction and western medicine can increase the effective rate of improving asthma symptoms and lung function, improve the asthma control level, and reduce the incidence of adverse reactions; Pingchuan Yiqi Granules can significantly reduce the clinical symptom score of asthma; the combination of Yupingfeng Granules and western medicine can significantly increase the treatment effective rate, shorten the time for cough to disappear, reduce the cough symptom score, and reduce the recurrence rate of cough within half a year; the combination of Guben Kechuan Capsules and western medicine can increase the treatment effective rate and improve asthma symptoms, etc.

[0004] Asthma is one of the allergic diseases caused and / or triggered by allergens. Since it is difficult to completely avoid allergen stimulation in the living or working environment, asthma is characterized by repeated attacks, progressive aggravation, and protracted and difficult to cure, seriously affecting the health and quality of life of patients. At the same time, damp pathogen is a common pathogenic factor of allergic diseases. Therefore, asthma is inseparable from "dampness". The generation of damp pathogen is related to the abnormal water metabolism of the body and is caused by the dysfunction of the three viscera of the lung, spleen, and kidney. Dampness is diffuse, widely pathogenic, intangible and turbid, blocking qi movement, remaining without leaving, and can gather into water, phlegm, and retained fluid. Therefore, dampness is the beginning of various diseases. For asthma patients, the body is inherently weak, and with the influence of factors such as climate and diet, the functions of the lung, spleen, and kidney are disordered, and body fluids cannot be distributed, transported, and evaporated, gathering into phlegm-dampness, which is latent in the lung and becomes a potential pathological factor. Its essence should be the disorder of the functions of the lung, spleen, and kidney affecting the transportation and transformation of body fluids. The origin of phlegm lies in the abnormal water metabolism, and dampness is the root of body fluids. As the severity of the disease increases, patients' dependence on western medicine and the dosage increase, and long-term maintenance medication is required. At the same time, some patients still cannot be well controlled and have repeated attacks even under the premise of standardized medication and good compliance. In terms of adverse reactions, maintaining hormone therapy is likely to cause adverse reactions such as oral infections and hoarseness. Oral hormone users often have side effects such as obesity, water and sodium retention, and hyperglycemia, breeding adverse emotions such as fear and anxiety, resulting in poor patient compliance and affecting the treatment effect. Therefore, the chronic disease prevention and control of asthma is still a huge challenge and major demand in our country.

[0005] Currently, the proprietary Chinese medicines for the clinical treatment of asthma mainly include Xiaoqinglong Granules, Hanchuan Zupa Granules, Danlong Oral Liquid, Zhichuanling Oral Liquid, etc. Among them, Xiaoqinglong Granules, Hanchuan Zupa Granules, Pingchuan Yiqi Granules, Yupingfeng Granules, Guben Kechuan Capsules, and San'ao Tablets are mainly beneficial to patients with cold syndromes and are not applicable to patients with heat-induced asthma; Danlong Oral Liquid has no function of strengthening the root; Zhichuanling Oral Liquid and Suhuang Zhike Capsules have no functions of strengthening the root, removing dampness, and clearing heat. The novelty search results show that the previously published patent No. CN102526674A discloses a set of drugs for the treatment of bronchitis and bronchial asthma in children aged 3 - 7, which consists of an oral traditional Chinese medicine decoction and acupoint injection medicine. The components of the traditional Chinese medicine decoction include 56 Chinese medicinal materials, mostly tonifying drugs such as American ginseng, wolfberry, Chinese yam, and Atractylodes macrocephala, and also added animal drugs such as gecko, black snake, and black ant. Overall, it pays more attention to tonifying and regulating. However, the medicine in this application has relatively fewer medicinal flavors, and the monarch, minister, assistant, and envoy are different from the previous formula, including drugs such as Sophora flavescens, Asarum, raw almond, and Fagopyrum dibotrys, and is more focused on clearing heat and removing dampness. Therefore, it is of great importance to develop a traditional Chinese medicine composition based on traditional Chinese medicine theory that can mainly treat asthma patients with poorly controlled symptoms of wheezing, shortness of breath, chest tightness, and cough with the main effects of clearing heat and resolving phlegm, dispersing the lung qi and relieving asthma, strengthening the root and removing dampness.

[0006] In view of this, the inventor of the present invention conducted in-depth research on this need, and thus this case was born. Summary of the Invention

[0007] Combining the understanding of allergic asthma and clinical practice, the inventor systematically sorted out and summarized the theory of "phlegm-dampness causing asthma", believing that allergic asthma is inseparable from "phlegm-dampness". Combining clinical epidemiological survey data shows that asthma patients are mainly divided into two types of phlegm-dampness syndromes: cold-dampness and damp-heat. At the same time, a more severe phlegm-dampness state is correlated with a worse asthma control level and the state of deficiency of the lung, spleen, and kidney. Its root cause should be phlegm-dampness lurking in the lung. Phlegm-dampness is the beginning of various diseases, taking phlegm-dampness as the root, and putting forward the academic view of "latent phlegm-dampness is the first root cause, and latent phlegm is the second root cause", advocating that "phlegm and dampness originate from the same source, cause diseases in common, and are both root causes". The core pathogenesis is "deficiency of the lung, spleen, and kidney, and obstruction of phlegm-dampness". For asthma patients with heat asthma syndrome or qi deficiency and damp-heat syndrome, the present invention focuses on clearing heat and resolving phlegm, dispersing the lung qi and relieving asthma, strengthening the body resistance and dispelling dampness, improving the phlegm-dampness state of asthma patients, alleviating clinical symptoms such as wheezing, shortness of breath, chest tightness, and cough, improving the quality of life, and enhancing the asthma control level. It provides a traditional Chinese medicine composition for treating asthma, its preparation method and application, which have potential advantages in reducing acute asthma attacks.

[0008] In order to achieve the above object, the present invention is solved by the following technical solutions:

[0009] A traditional Chinese medicine composition for treating asthma, comprising the following raw medicinal materials in parts by mass: 5-15 parts of Ephedrae Herba, 10-30 parts of Pentadactylopanax Root, 5-20 parts of Sophorae Flavescentis Radix, 5-20 parts of Pheretima, 10-30 parts of Lepidii Semen, 5-20 parts of Pinelliae Rhizoma Praeparatum, 3-9 parts of Asari Radix et Rhizoma, 10-30 parts of Fagopyri Cymosi Rhizoma, 5-20 parts of Belamcandae Rhizoma, 5-25 parts of Armeniacae Semen Amarum, 5-20 parts of Magnoliae Officinalis Cortex, 5-20 parts of Schisandrae Chinensis Fructus.

[0010] Preferably, it comprises the following raw medicinal materials in parts by mass: 7-13 parts of Ephedrae Herba, 10-25 parts of Pentadactylopanax Root, 5-15 parts of Sophorae Flavescentis Radix, 5-15 parts of Pheretima, 15-30 parts of Lepidii Semen, 5-15 parts of Pinelliae Rhizoma Praeparatum, 4-8 parts of Asari Radix et Rhizoma, 10-25 parts of Fagopyri Cymosi Rhizoma, 5-15 parts of Belamcandae Rhizoma, 10-25 parts of Armeniacae Semen Amarum, 5-15 parts of Magnoliae Officinalis Cortex, 5-15 parts of Schisandrae Chinensis Fructus.

[0011] Preferably, it comprises the following raw medicinal materials in parts by mass: 9-10 parts of Ephedrae Herba, 10-20 parts of Pentadactylopanax Root, 5-10 parts of Sophorae Flavescentis Radix, 5-10 parts of Pheretima, 15-25 parts of Lepidii Semen, 5-10 parts of Pinelliae Rhizoma Praeparatum, 5-6 parts of Asari Radix et Rhizoma, 10-20 parts of Fagopyri Cymosi Rhizoma, 5-15 parts of Belamcandae Rhizoma, 10-20 parts of Armeniacae Semen Amarum, 5-10 parts of Magnoliae Officinalis Cortex, 5-10 parts of Schisandrae Chinensis Fructus.

[0012] Preferably, it comprises the following raw medicinal materials in parts by mass: 9 parts of Ephedrae Herba, 15 parts of Pentadactylopanax Root, 10 parts of Sophorae Flavescentis Radix, 10 parts of Pheretima, 20 parts of Lepidii Semen, 10 parts of Pinelliae Rhizoma Praeparatum, 5 parts of Asari Radix et Rhizoma, 15 parts of Fagopyri Cymosi Rhizoma, 10 parts of Belamcandae Rhizoma, 15 parts of Armeniacae Semen Amarum, 10 parts of Magnoliae Officinalis Cortex, 10 parts of Schisandrae Chinensis Fructus.

[0013] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition for treating asthma in the preparation of drugs for treating asthma, especially in the preparation of drugs for treating patients with asthma of the heat asthma syndrome or the qi deficiency and damp-heat syndrome.

[0014] The present invention also provides a drug for treating asthma, comprising the above-mentioned traditional Chinese medicine composition for treating asthma and a pharmaceutically acceptable excipient.

[0015] Preferably, the dosage form of the drug is a granule, pill, capsule, traditional Chinese medicine decoction, decoction, tablet, tea, suspension, drop, powder, fruit juice or oral liquid.

[0016] The present invention also provides a preparation method of the above-mentioned drug for treating asthma, comprising the following steps:

[0017] Step 1, weigh the raw materials according to the weight ratio, perform cleaning, drying, cutting, pulverizing, and mixing evenly;

[0018] Step 2, add 6 to 7 times the amount of water to cover the raw materials and soak them sufficiently. First, bring to a boil over high heat, then change to low heat and continue to decoct for 1 to 2 hours, and filter to obtain the first filtrate; add 6 to 7 times the amount of water to cover the filter residue, bring to a boil over high heat, then change to low heat and continue to decoct for 1 to 2 hours, filter to remove the medicinal residues, and obtain the second filtrate;

[0019] Step 3, combine the first filtrate and the second filtrate, perform centrifugal filtration and decompression concentration to obtain a concentrated solution, which is the traditional Chinese medicine decoction;

[0020] Step 4, dry the concentrated solution to obtain the granule.

[0021] Preferably, add an excipient to the granule and mix to obtain one of a tablet, pill, drop, fruit juice or syrup, and the excipient is maltodextrin or magnesium stearate.

[0022] The beneficial effects of adopting the technical solution of the present invention are as follows:

[0023] The above traditional Chinese medicine composition uses Ephedra, Wuzhaolong, and Sophora flavescens as the monarch drugs. Ephedra disperses cold and relieves the exterior, and promotes the dispersing function of the lung to relieve asthma. Wuzhaolong supplements qi and strengthens the spleen, resolves dampness, and promotes qi movement. Sophora flavescens clears heat, dries dampness, and promotes diuresis. These three drugs as the monarch drugs work together to promote the dispersing function of the lung to relieve asthma, supplement qi and strengthen the spleen, clear heat, and remove dampness. And Earthworm, Lepidium apetalum, Pinellia ternata, Asarum, and Fagopyrum dibotrys are used as the minister drugs. Earthworm clears heat, dredges collaterals, and relieves asthma and promotes diuresis. Lepidium apetalum purges the lung to relieve asthma, promotes diuresis, and reduces swelling. Pinellia ternata dries dampness and resolves phlegm. Asarum relieves the exterior and dispels cold, dispels wind and opens orifices, warms the lung and resolves fluid-retention. Fagopyrum dibotrys clears heat and detoxifies, dispels stasis. The minister drugs can enhance the effects of the monarch drugs in promoting the dispersing function of the lung to relieve asthma and clearing heat and resolving phlegm. Further, Belamcanda chinensis, Apricot Kernel, and Magnolia officinalis are used as the assistant drugs. Belamcanda chinensis clears heat and eliminates phlegm, promotes qi downward to relieve asthma. Apricot Kernel lowers qi to relieve cough and asthma. Magnolia officinalis dries dampness, eliminates phlegm, promotes qi downward, and relieves fullness. The assistant drugs cooperate with the monarch drugs and the minister drugs to synergistically play the roles of lowering qi to relieve cough and resolving phlegm to relieve asthma, further alleviating symptoms such as asthma, cough, and excessive phlegm. At the same time, the dampness-drying and phlegm-eliminating effect of Magnolia officinalis can strengthen the overall effect of removing dampness. Schisandra chinensis is used as the guiding drug, which has the effects of regulating the pungent-dispersing properties of Ephedra and Asarum, and astringing qi to relieve asthma; the guiding drug regulates the properties of all the drugs, prevents the excessive pungent-dispersing of the monarch and minister drugs from consuming healthy qi, and at the same time enhances the anti-asthmatic effect of the whole formula, enabling the whole formula to take into account strengthening healthy qi while dispelling pathogenic factors. All the drugs are used in combination, clearing heat and resolving phlegm, promoting the dispersing function of the lung to relieve asthma, strengthening the root and removing dampness, and thus all symptoms are relieved.

[0024] The present invention treats asthma from the perspective of dampness, taking dampness as the root, and putting forward the academic view that "latent dampness is the first root cause, and latent phlegm is the second root cause", advocating that "phlegm and dampness share the same origin, have the same pathogenicity, and are both root causes". The core pathogenesis is "deficiency of the lung, spleen, and kidney, and obstruction of damp pathogen". Especially for asthma patients with heat asthma syndrome or qi-deficiency and damp-heat syndrome, with clearing heat and resolving phlegm, promoting the dispersing function of the lung to relieve asthma, strengthening the root and removing dampness as the core, it can improve the dampness syndrome state of asthma patients, relieve clinical symptoms such as wheezing, shortness of breath, chest tightness, and cough, improve the quality of life, enhance the asthma control level, and have potential advantages in reducing acute asthma attacks. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for description in the embodiments or the prior art. Obviously, the following described drawings are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0026] Figure 1 It is the ACT score chart before and after treatment;

[0027] Figure 2 It is the DSSCM score chart before and after treatment;

[0028] Figure 3 It is the VAS score chart of symptoms such as wheezing, shortness of breath, chest tightness, and cough before and after treatment;

[0029] Figure 4Mini-AQLQ score charts before and after treatment;

[0030] Figure 5 TCM syndrome integral score charts before and after treatment;

[0031] Figure 6 TCM syndrome curative effect evaluation chart after treatment. Specific implementation manners

[0032] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Apparently, the described embodiments are some but not all of the embodiments of the present invention. Therefore, the detailed description of the embodiments provided by the present invention is not intended to limit the scope of the claimed invention, but merely represents the selected embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts fall within the scope of protection of the present invention.

[0033] This embodiment fully analyzes the dampness syndrome state of asthma patients, including clinical symptoms such as wheezing, shortness of breath, chest tightness, cough, etc., treats asthma from the perspective of dampness, and aims at patients with heat asthma syndrome or qi deficiency and damp heat syndrome asthma. With clearing heat and resolving phlegm, dispersing the lung qi to relieve asthma, and strengthening the root and removing dampness as the core, a traditional Chinese medicine composition for treating asthma, its preparation method and application are invented. The specific implementation manners are as follows:

[0034] A traditional Chinese medicine composition for treating asthma, comprising the following raw medicinal materials in parts by mass: 5-15 parts of Ephedrae Herba, 10-30 parts of Pentadactylopanax Root, 5-20 parts of Sophorae Flavescentis Radix, 5-20 parts of Pheretima, 10-30 parts of Semen Lepidii, 5-20 parts of Pinelliae Rhizoma Praeparatum, 3-9 parts of Asari Radix et Rhizoma, 10-30 parts of Fagopyri Cymosi Rhizoma, 5-20 parts of Belamcandae Rhizoma, 5-25 parts of Armeniacae Semen Amarum, 5-20 parts of Magnoliae Officinalis Cortex, 5-20 parts of Schisandrae Chinensis Fructus.

[0035] The traditional Chinese medicine pharmacology of the traditional Chinese medicine preparation for treating asthma in the present invention is as follows:

[0036] Ephedrae Herba: The dried herbaceous stem of Ephedra sinica Stapf, Ephedra intermedia Schrenk et C. A. Mey. or Ephedra equisetina Bunge. It is pungent, slightly bitter, warm in nature, and belongs to the lung and bladder meridians. It is mainly used to treat cough and asthma, and also treats aversion to wind, aversion to cold, absence of sweating, body pain, joint pain, and general yellow swelling. It has the effects of inducing sweating and dispelling cold, dispersing the lung qi to relieve asthma, and promoting diuresis to reduce swelling. This product contains alkaloid components: ephedrine, pseudoephedrine, nor-ephedrine, nor-pseudoephedrine volatile oil, methylephedrine, methylpseudoephedrine, etc. It also contains components such as tannins and volatile oils.

[0037] Five-clawed Dragon: It is the root or branch of Ficus hirta Vahl of the genus Ficus in the Moraceae family. It tastes sweet and is of neutral nature, and enters the spleen and lung meridians. It is mainly used to treat rheumatic flaccidity and paralysis, low back and leg pain, dysentery, edema, leukorrhea, scrofula, traumatic injury, amenorrhea, and insufficient lactation. It has the effects of dispelling wind and dampness, removing stasis and reducing swelling. The root contains organic acids, amino acids, triterpenes, coumarins, alkaloids, etc.

[0038] Sophora flavescens: It is the dried root of Sophora flavescens Ait. of the Leguminosae family. It is bitter and cold in nature, and enters the heart, liver, stomach, large intestine, and bladder meridians. It is mainly used to treat damp-heat syndromes, dysentery with heat, hematochezia, jaundice with oliguria, leukorrhea with red and white discharge, swelling and itching of the vulva and vagina, eczema, moist sores, skin itching, scabies and leprosy; externally, it is used to treat trichomonas vaginitis. It has the effects of clearing heat and drying dampness, killing parasites, and promoting diuresis. This product contains alkaloids such as matrine, oxymatrine, isomatrine, sophocarpine, isosophocarpine, oxysophocarpine, and sophoramine. In addition, it also contains flavonoid compounds such as sophoranol, neosophoranol, kushenone, and isokushenone.

[0039] Earthworm: It is the dried body of Pheretima aspergillum (E. Perrier), Pheretima vulgaris Chen, Pheretima guillelmi (Michaelsen) or Pheretima pectinifera Michaelsen of the Megascolecidae family. It tastes salty and is cold in nature, and enters the liver, spleen, and bladder meridians. It is mainly used to treat high fever with coma, infantile convulsion, arthralgia, numbness of limbs, hemiplegia, cough and asthma due to lung heat, and edema with oliguria. It has the effects of clearing heat and relieving convulsion, dredging collaterals, relieving asthma, and promoting diuresis. Earthworms mainly contain lumbrofebrin, lumbrotoxin, 6-hydroxypurine, xanthine, adenine, guanine, choline, etc.; they also contain various amino acids, fatty acids, etc.

[0040] Semen Lepidii: It is the dried and mature seed of Descurainia sophia (L.) Webb. ex Prantl or Lepidium apetalum Willd. of the Brassicaceae family. It is better when the seeds are plump and brown. It tastes pungent and bitter, and is extremely cold; it enters the lung and bladder meridians. It is mainly used to treat phlegm congestion in the lungs, excessive cough and phlegm, fullness and distension in the chest and hypochondrium, inability to lie flat, abdominal and chest edema, and dysuria. It is mostly used for cough and asthma with dyspnea, abdominal distension with ascites, and has a strong effect of descending the lung qi. It has the effects of purging the lung to relieve asthma and promoting diuresis to reduce edema. This product mainly contains flavonoid components, volatile oils (mustard oil, benzyl isothiocyanate, allyl isothiocyanate, diallyl disulfide, etc.), fatty acid components (linoleic acid, linolenic acid, oleic acid, palmitostearic acid, erucic acid, etc.), and also contains alkaloids, etc.

[0041] Prepared Pinellia Rhizome: It is the processed product of purified Pinellia Rhizome. It is pungent and warm in nature, and enters the spleen, stomach, and lung meridians. It is mainly used to treat excessive phlegm with cough and asthma, dizziness and palpitations due to phlegm retention, wind-phlegm dizziness, headache due to phlegm syncope, and has the effect of drying dampness and resolving phlegm. This product mainly contains volatile oils: anethole, citral, 1-octene, β-elemene, etc. It also contains organic acids, etc.

[0042] Asarum: It is the dried root and rhizome of Asarum heterotropoides Fr. Schmidt var. mandshuricum (Maxim.) Kitag., Asarum sieboldii Miq. var. seoulense Nakai or Asarum sieboldii Miq. of the Aristolochiaceae family. It is pungent and warm in nature, and enters the heart, lung, and kidney meridians. It is mainly used to treat various pains caused by wind-cold and wind-dampness, as well as nasal congestion and headache in nasal sinusitis, toothache, nasal congestion with runny nose, rheumatic arthralgia, cough and asthma with phlegm retention. It has the effects of inducing sweating to dispel cold, dispelling wind and relieving pain, opening the orifices, and warming the lung to resolve fluid retention. This product contains lignan components, volatile oils, and also contains a trace amount of aristolochic acid I.

[0043] Fagopyrum dibotrys: The dried rhizome of Fagopyrum dibotrys, a plant of the family Polygonaceae. It is bitter in taste and neutral in nature, and acts on the lung, spleen, and liver meridians. It is a key herb for treating lung abscess and cough with lung heat, and also has the effects of promoting blood circulation to remove stasis, alleviating pain, and strengthening the spleen to eliminate dampness. It is mainly used to treat sore throat, dysentery, sores, scrofula, snake and insect bites, traumatic injuries, dysmenorrhea, and arthralgia. It can treat both internal and external abscesses, and is especially good at treating lung abscess, especially for those with spleen deficiency. It has the functions of clearing heat and detoxifying, removing phlegm and discharging pus, promoting blood circulation to remove stasis, and strengthening the spleen to eliminate dampness. This herb mainly contains flavanol derivatives such as epicatechin; flavonoid components such as dimeric procyanidins; organic acid components such as ferulic acid and chlorogenic acid.

[0044] Belamcanda chinensis: The dried rhizome of Belamcanda chinensis, a plant of the family Iridaceae. It is bitter in taste and cold in nature, and acts on the lung and liver meridians. It is mainly used to treat heat-toxin phlegm-fire stagnation, sore throat, excessive phlegm, cough, and asthma. It has the functions of clearing heat and detoxifying, eliminating phlegm, and relieving sore throat. This herb mainly contains flavonoid components such as irigenin, iridin, irigenin, tectoridin, tectorigenin, irilone, etc.; it also contains stilbene compounds, bicyclic triterpenoids and their derivatives, etc.

[0045] Bitter Apricot Kernels: The kernels of Prunus armeniaca or Prunus armeniaca var. ansu, deciduous arbor plants of the family Rosaceae. They are bitter in taste and warm in nature, and act on the lung and large intestine meridians. They are mainly used to treat cough and asthma, fullness in the chest with excessive phlegm, blood deficiency with dryness of body fluids, and constipation due to intestinal dryness. They have the functions of lowering qi to relieve cough and asthma, and moistening the intestine to promote defecation. This herb contains the active ingredient amygdalin, which can be decomposed into hydrocyanic acid and benzaldehyde in the body. Hydrocyanic acid can produce a certain inhibitory effect on the respiratory center, making the respiratory movement tend to be quiet to achieve the effect of relieving cough and asthma.

[0046] Magnolia officinalis: The dried bark, root bark, and twig bark of Magnolia officinalis or Magnolia officinalis var. biloba, plants of the family Magnoliaceae. It is bitter, pungent in taste and warm in nature, and acts on the spleen, stomach, lung, and large intestine meridians. It is mainly used to treat dampness stagnating in the middle energizer, stuffiness and vomiting and diarrhea in the epigastric region, food retention with qi stagnation, abdominal distension and constipation, and phlegm-fluid dyspnea and cough. It has the functions of drying dampness and eliminating phlegm, and lowering qi to relieve fullness. The bark and flowers of this herb contain chemical components such as lignans, volatile oils, and alkaloids. Lignans mainly include magnolol, honokiol, isomagnolol, etc.; volatile oils such as isolongifolene, elemene, caryophyllene, etc.; alkaloids mainly include magnocurarine, etc. Magnolol, honokiol, and magnocurarine are the active ingredients with muscle relaxation effects.

[0047] Schisandra chinensis: The dried ripe fruits of Schisandra chinensis, a plant of the family Magnoliaceae. It is sour, sweet in taste and warm in nature, and acts on the lung, heart, and kidney meridians. It is mainly used to treat chronic cough and asthma, spermatorrhea and premature ejaculation, enuresis and frequent urination, chronic diarrhea, spontaneous sweating and night sweating, thirst due to fluid impairment, internal heat with thirst, palpitation and insomnia. It can relieve cough and asthma by astringing the lung, astringe essence and stop diarrhea by nourishing the kidney, generate fluid and calm the mind by nourishing the interior, and astringe the exterior and stop sweating by consolidating the superficial resistance. It has the functions of astringing and astringing, replenishing qi and generating fluid, and tonifying the kidney and calming the mind. This herb mainly contains lignan components, volatile oils, and also contains polysaccharides, amino acids and other components.

[0048] As a preferred embodiment, it includes the following medicinal material raw materials in parts by mass: 7-13 parts of Ephedrae Herba, 10-25 parts of Wuzhaolong (Radix Pseudostellariae Heterophyllae), 5-15 parts of Sophorae Flavescentis Radix, 5-15 parts of Pheretima, 15-30 parts of Lepidii Semen, 5-15 parts of Pinelliae Rhizoma Praeparatum, 4-8 parts of Asari Radix et Rhizoma, 10-25 parts of Fagopyri Cymosi Rhizoma, 5-15 parts of Belamcandae Rhizoma, 10-25 parts of Armeniacae Semen Amarum, 5-15 parts of Magnoliae Officinalis Cortex, 5-15 parts of Schisandrae Chinensis Fructus.

[0049] As a preferred embodiment, it includes the following medicinal material raw materials in parts by mass: 9-10 parts of Ephedrae Herba, 10-20 parts of Wuzhaolong (Radix Pseudostellariae Heterophyllae), 5-10 parts of Sophorae Flavescentis Radix, 5-10 parts of Pheretima, 15-25 parts of Lepidii Semen, 5-10 parts of Pinelliae Rhizoma Praeparatum, 5-6 parts of Asari Radix et Rhizoma, 10-20 parts of Fagopyri Cymosi Rhizoma, 5-15 parts of Belamcandae Rhizoma, 10-20 parts of Armeniacae Semen Amarum, 5-10 parts of Magnoliae Officinalis Cortex, 5-10 parts of Schisandrae Chinensis Fructus.

[0050] As a preferred embodiment, it includes the following medicinal material raw materials in parts by mass: 9 parts of Ephedrae Herba, 15 parts of Wuzhaolong (Radix Pseudostellariae Heterophyllae), 10 parts of Sophorae Flavescentis Radix, 10 parts of Pheretima, 20 parts of Lepidii Semen, 10 parts of Pinelliae Rhizoma Praeparatum, 5 parts of Asari Radix et Rhizoma, 15 parts of Fagopyri Cymosi Rhizoma, 10 parts of Belamcandae Rhizoma, 15 parts of Armeniacae Semen Amarum, 10 parts of Magnoliae Officinalis Cortex, 10 parts of Schisandrae Chinensis Fructus.

[0051] The present invention also provides the application of the above traditional Chinese medicine composition for treating asthma in the preparation of drugs for treating asthma, especially in the preparation of drugs for treating patients with heat asthma syndrome or qi deficiency and damp-heat syndrome asthma.

[0052] The present invention also provides a drug for treating asthma, which includes the above traditional Chinese medicine composition for treating asthma and pharmaceutically acceptable excipients.

[0053] As a preferred embodiment, the dosage form of the drug is granule, pill, capsule, traditional Chinese medicine decoction, decoction, tablet, tea preparation, suspension, drops, powder, fruit juice preparation or oral liquid.

[0054] The present invention also provides a preparation method of the above drug for treating asthma, which includes the following steps:

[0055] Step 1, weigh the raw medicinal materials according to the weight ratio, perform cleaning and selection, drying, cutting, pulverization, and mix them evenly;

[0056] Step 2, add 6-7 times of water to cover the raw medicinal materials and soak them sufficiently. First, bring to a boil with strong fire, then change to slow fire and continue to decoct for 1-2 h, and filter to obtain the first filtrate; add 6-7 times of water to cover the residue, bring to a boil with strong fire, then change to slow fire and continue to decoct for 1-2 h, filter to remove the medicinal residues, and obtain the second filtrate;

[0057] Step 3, combine the first filtrate and the second filtrate, perform centrifugal filtration and vacuum concentration to obtain a concentrated solution, which is the traditional Chinese medicine decoction;

[0058] Step 4: Dry the concentrated solution to obtain the granule agent.

[0059] As a preferred embodiment, an excipient is added to the granule agent and mixed to obtain one of tablets, pills, drops, fruit juice agents or syrup agents, and the excipient is maltodextrin or magnesium stearate.

[0060] The present invention will be further described in detail below in conjunction with specific embodiments:

[0061] Example 1

[0062] A drug for treating asthma, the raw materials of the traditional Chinese medicine formula are taken according to the following parts by mass: 5 parts of ephedra, 10 parts of five-clawed dragon, 5 parts of sophora flavescens, 5 parts of earthworm, 10 parts of lepidium apetalum willd, 5 parts of pinellia ternata, 3 parts of asarum, 10 parts of fagopyrum dibotrys, 5 parts of belamcanda chinensis, 5 parts of raw almond, 5 parts of magnolia officinalis, 5 parts of schisandra chinensis. The drug for treating asthma in this Example 1 is a traditional Chinese medicine decoction, and its preparation method is as follows:

[0063] Step 1: Weigh the raw materials according to the parts by weight ratio, perform cleaning, drying, cutting, crushing, and mixing evenly;

[0064] Step 2: Add 7 times the amount of water to cover the raw materials and soak them sufficiently. First, bring to a boil over high heat, then change to low heat and continue to decoct for 2 hours, and filter to obtain the first filtrate; Add 6 times the amount of water to cover the residue, bring to a boil over high heat, then change to low heat and continue to decoct for 1 hour, filter out the medicinal residues, and obtain the second filtrate;

[0065] Step 3: Combine the first filtrate and the second filtrate, perform centrifugal filtration and vacuum concentration to obtain the concentrated solution, which is the traditional Chinese medicine decoction.

[0066] Example 2

[0067] A drug for treating asthma, the raw materials of the traditional Chinese medicine formula are taken according to the following parts by mass: 7 parts of ephedra, 10 parts of five-clawed dragon, 5 parts of sophora flavescens, 5 parts of earthworm, 15 parts of lepidium apetalum willd, 5 parts of pinellia ternata, 4 parts of asarum, 10 parts of fagopyrum dibotrys, 5 parts of belamcanda chinensis, 10 parts of raw almond, 5 parts of magnolia officinalis, 5 parts of schisandra chinensis. The drug for treating asthma in this Example 2 is a traditional Chinese medicine decoction, and its preparation method is the same as that of Example 1.

[0068] Example 3

[0069] A drug for treating asthma, the raw materials of the traditional Chinese medicine formula are taken according to the following parts by mass: 9 parts of ephedra, 15 parts of five-clawed dragon, 10 parts of sophora flavescens, 10 parts of earthworm, 20 parts of lepidium apetalum willd, 10 parts of pinellia ternata, 5 parts of asarum, 15 parts of fagopyrum dibotrys, 10 parts of belamcanda chinensis, 15 parts of raw almond, 10 parts of magnolia officinalis, 10 parts of schisandra chinensis. The drug for treating asthma in this Example 3 is a traditional Chinese medicine decoction, and its preparation method is the same as that of Example 1.

[0070] Example 4

[0071] A drug for treating asthma, the raw materials of the traditional Chinese medicine formula are taken according to the following parts by mass: 10 parts of Ephedrae Herba, 20 parts of Wuzhaolong (Herba Merremiae), 10 parts of Sophorae Flavescentis Radix, 10 parts of Pheretima, 25 parts of Lepidii Semen, 10 parts of Pinelliae Rhizoma Praeparatum, 6 parts of Asari Radix et Rhizoma, 20 parts of Fagopyri Dibotryis Herba, 15 parts of Belamcandae Rhizoma, 20 parts of Armeniacae Semen Amarum, 10 parts of Magnoliae Officinalis Cortex, 10 parts of Schisandrae Chinensis Fructus. The drug for treating asthma in this Example 4 is a traditional Chinese medicine decoction, and its preparation method is the same as that in Example 1.

[0072] Example 5

[0073] A drug for treating asthma, the raw materials of the traditional Chinese medicine formula are taken according to the following parts by mass: 13 parts of Ephedrae Herba, 25 parts of Wuzhaolong (Herba Merremiae), 15 parts of Sophorae Flavescentis Radix, 15 parts of Pheretima, 30 parts of Lepidii Semen, 15 parts of Pinelliae Rhizoma Praeparatum, 8 parts of Asari Radix et Rhizoma, 25 parts of Fagopyri Dibotryis Herba, 15 parts of Belamcandae Rhizoma, 25 parts of Armeniacae Semen Amarum, 15 parts of Magnoliae Officinalis Cortex, 15 parts of Schisandrae Chinensis Fructus. The drug for treating asthma in this Example 5 is a traditional Chinese medicine decoction, and its preparation method is the same as that in Example 1.

[0074] Example 6

[0075] A drug for treating asthma, the raw materials of the traditional Chinese medicine formula are taken according to the following parts by mass: 15 parts of Ephedrae Herba, 30 parts of Wuzhaolong (Herba Merremiae), 20 parts of Sophorae Flavescentis Radix, 20 parts of Pheretima, 30 parts of Lepidii Semen, 20 parts of Pinelliae Rhizoma Praeparatum, 9 parts of Asari Radix et Rhizoma, 30 parts of Fagopyri Dibotryis Herba, 20 parts of Belamcandae Rhizoma, 25 parts of Armeniacae Semen Amarum, 20 parts of Magnoliae Officinalis Cortex, 20 parts of Schisandrae Chinensis Fructus. The drug for treating asthma in this Example 6 is a traditional Chinese medicine decoction, and its preparation method is the same as that in Example 1.

[0076] In order to verify the efficacy of this application, the drug prepared in Preferred Example 3 was used for clinical research on the efficacy of this invention in asthma patients:

[0077] 1. Source of cases

[0078] All the cases included in this study were from the patients who visited the outpatient department of the Respiratory Department of Guangdong Provincial Hospital of Traditional Chinese Medicine from January 2024 to June 2024. A total of 30 cases of asthma patients who met the inclusion criteria were admitted for clinical observation and research. The male proportion was 43.33%, and the average age was (51.00 ± 16.60) years old.

[0079] 2. Inclusion criteria

[0080] (1) 18 years old ≤ age < 75 years old;

[0081] (2) Meeting the diagnostic criteria for asthma;

[0082] (3) Asthma Control Test (ACT) score ≤ 19 points, indicating that asthma is not controlled;

[0083] (4) Traditional Chinese medicine syndrome differentiation being heat asthma syndrome or qi deficiency and damp-heat syndrome;

[0084] (5) Signing the informed consent form.

[0085] 3. Exclusion Criteria

[0086] (1) Patients with severe asthma;

[0087] (2) Patients who had acute severe or critical asthma within the past month;

[0088] (3) Patients with comorbid respiratory diseases such as chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, active pulmonary tuberculosis, etc.;

[0089] (4) Patients with severe or uncontrolled underlying diseases: for example, liver insufficiency (ALT or AST ≥ 2 ULN, total bilirubin ≥ 2 ULN), renal insufficiency (serum creatinine > 177 μmol / L or 2 mg / dL), chronic congestive heart failure (NYHA class III-IV); immunodeficiency, such as malignant tumors, organ or bone marrow transplantation, HIV infection, or taking immunosuppressants in the past 3 months;

[0090] (5) Patients who are unwilling to accept observation measures or are unable to cooperate due to mental illness;

[0091] (6) Patients who are unable to cooperate to complete pulmonary function tests;

[0092] (7) Patients allergic to the drugs contained in the treatment plan;

[0093] (8) Pregnant, planning to be pregnant, and lactating patients;

[0094] (9) Patients who are receiving allergen-specific immunotherapy or biological agent targeted drugs (such as omalizumab, dupilumab, etc.);

[0095] (10) Patients who are participating in or preparing to participate in other clinical trials during the study period;

[0096] (11) Subjects considered by the researcher to have poor compliance and are difficult to complete or comply with the requirements of this trial.

[0097] 4. Treatment Plan

[0098] (1) Control group: Referring to the "Global Initiative for Asthma (GINA, 2023 Edition)" and the "Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 Edition)", conventional inhaled treatment was given.

[0099] (2) Treatment group: Take the water extract prepared in Example 3, 1 dose per day, divided into two times and taken half an hour after breakfast and dinner, about 250 - 300 mL each time.

[0100] 5. Treatment Course

[0101] 28 days.

[0102] 6. Observation Indicators

[0103] (1)Asthma Control Test Score (ACT): A total of 5 questions are scored, including daily activities, dyspnea, waking up at night, use of rescue medications, and self-evaluation of asthma control. The higher the score, the better the symptom control.

[0104] (2)Traditional Chinese Medicine Dampness Syndrome Assessment Scale (DSSCM): It consists of 30 items. Each item is graded as none, mild, moderate, severe, and extremely severe, with scores of 0, 1, 2, 3, and 4 respectively. The total score ranges from 0 to 120 points. The higher the score, the higher the severity of the dampness syndrome.

[0105] (3)VAS Scores for Wheezing, Shortness of Breath, Chest Tightness, and Cough

[0106] ① Visual Analogue Scale (VAS) for Wheezing: According to the patient's feeling, mark the corresponding scale on a line segment marked 0 - 10 cm to represent the severity of wheezing. 0 represents no wheezing, and 10 represents extremely severe wheezing.

[0107] ② Visual Analogue Scale (VAS) for Shortness of Breath: According to the patient's feeling, mark the corresponding scale on a line segment marked 0 - 10 cm to represent the severity of shortness of breath. 0 represents shortness of breath, and 10 represents extremely severe shortness of breath.

[0108] ③ Visual Analogue Scale (VAS) for Chest Tightness: According to the patient's feeling, mark the corresponding scale on a line segment marked 0 - 10 cm to represent the severity of chest tightness. 0 represents no chest tightness, and 10 represents extremely severe chest tightness.

[0109] ④ Visual Analogue Scale (VAS) for Cough: According to the patient's feeling, mark the corresponding scale on a line segment marked 0 - 10 cm to represent the severity of cough. 0 represents no cough, and 10 represents extremely severe cough.

[0110] (4)Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ): It is a specific quality of life questionnaire for asthma patients consisting of 15 items. There are four domains: environmental stimuli (3 items), symptoms (5 items), emotions (3 items), and activity limitations (4 items). The Likert 7-point scale is used, and each item is scored from 1 to 7. The lower the score, the more severe the impairment of quality of life. The score for each domain is the average of all items included in that domain. The total score is the average of the scores of each domain. The higher the score, the better the quality of life.

[0111] (5)TCM syndrome score: Referring to the results of the inventors' previous syndrome research and combining the symptom grading quantification tables in the "National Standard of the People's Republic of China - Diagnostic and Therapeutic Criteria for TCM Diseases and Syndromes" and the "Guiding Principles for Clinical Research of New Chinese Medicines (Trial)", a TCM syndrome score scale including the main clinical symptoms and signs was developed. Each syndrome was scored 0, 2, 4, and 6 points respectively for none, mild, moderate, and severe degrees. The higher the score, the higher the severity of the TCM syndrome.

[0112] (6)Judgment of TCM syndrome efficacy:

[0113] a. Clinical cure: The reduction rate of the total syndrome score ≥ 90%;

[0114] b. Marked effect: The reduction rate of the total syndrome score ≥ 70% and < 90%;

[0115] c. Effective: The reduction rate of the total syndrome score ≥ 30% and < 70%;

[0116] d. Ineffective: The reduction rate of the total syndrome score < 30%.

[0117] Total effective rate (%): The percentage of cured, markedly effective, and effective cases in the total number of cases.

[0118] Note: The reduction rate of the total syndrome score = [(total score sum before treatment - total score sum after treatment) / total score sum before treatment] × 100%.

[0119] The above indicators were evaluated before and after treatment and filled in and recorded in the clinical case observation form.

[0120] 7. Statistical methods

[0121] Epidata 3.1 was used for data management. SPSS 25.0 was used for statistical analysis. Measurement data were described as (x̄±s), and count data were described as rate or percentage. Paired sample t-test was used for comparison before and after treatment for measurement data with normal distribution, and Wilcoxon signed-rank test was used for data that did not conform to normal distribution; Chi-square test or Fisher's exact probability method was used for comparison before and after treatment for count data. P < 0.05 indicated statistical significance.

[0122] 8. Research results

[0123] (1)Comparison of ACT scores of patients before and after treatment

[0124] Table 1 Comparison of ACT scores of patients before and after treatment (x̄±s)

[0125]

[0126] Figure 1The figure shows the ACT scores before and after treatment. Combining with Table 1, it can be seen that the ACT score of asthma patients increased by 3.63 points after treatment compared with that before treatment (P<0.001). The above results suggest that the drug prepared by the present invention can improve the level of asthma control.

[0127] (2)Comparison of DSSCM scores of patients before and after treatment

[0128] Table 2 Comparison of DSSCM scores of patients before and after treatment (x̄±s)

[0129]

[0130] Figure 2 The figure shows the DSSCM scores before and after treatment. Combining with Table 2, it can be seen that the DSSCM score of asthma patients decreased by 5.70 points after treatment compared with that before treatment (P<0.001). The above results suggest that the drug prepared by the present invention can improve the damp syndrome state of asthma patients.

[0131] (3)Comparison of VAS scores of wheezing, shortness of breath, chest tightness and cough in patients before and after treatment

[0132] Table 3 Comparison of VAS scores of wheezing, shortness of breath, chest tightness and cough in patients before and after treatment (x̄±s)

[0133]

[0134] Figure 3 The figure shows the VAS scores of wheezing, shortness of breath, chest tightness and cough symptoms before and after treatment. Combining with Table 3, it can be seen that the VAS score of wheezing in asthma patients decreased by 1.23 points after treatment compared with that before treatment (P<0.001); the VAS score of shortness of breath decreased by 0.63 points (P<0.001); the VAS score of chest tightness decreased by 0.83 points (P<0.001); the VAS score of cough decreased by 2.83 points (P<0.001). The above results suggest that the drug prepared by the present invention can improve the clinical symptoms of wheezing, shortness of breath, chest tightness and cough in asthma patients.

[0135] (4)Comparison of Mini-AQLQ scores of patients before and after treatment

[0136] Table 4 Comparison of Mini-AQLQ scores of patients before and after treatment (x̄±s)

[0137]

[0138] Figure 4It is the Mini-AQLQ score chart before and after treatment. Combining with Table 4, it can be seen that the Mini-AQLQ score of asthma patients increased by 1.15 points compared with that before treatment (P<0.001); among them, the score of the activity limitation dimension increased by 0.68 points (P<0.001); the score of the environmental stimuli dimension increased by 0.57 points (P<0.001); the score of the symptom dimension increased by 1.72 points (P<0.001); the score of the emotional dimension increased by 1.64 points (P<0.001). The above results suggest that the drug prepared by the present invention can improve the quality of life of patients.

[0139] (5)Comparison of TCM syndrome scores of patients before and after treatment

[0140] Table 5 Comparison of TCM syndrome scores of patients before and after treatment (x̄±s)

[0141]

[0142] Figure 5 It is the TCM syndrome score chart before and after treatment. Combining with Table 5, it can be seen that the TCM syndrome score of patients after treatment decreased by 11.13 points compared with that before treatment (P<0.001). The above results suggest that the drug prepared by the present invention can effectively improve the TCM syndrome score of asthma patients.

[0143] (6)Evaluation of the curative effect of TCM syndrome in patients after treatment

[0144] Figure 6 It is the evaluation chart of the curative effect of TCM syndrome after treatment. From Figure 6 it can be seen that after 1 month of treatment, 3.33% of the patients' TCM syndrome scores reached the clinical cure standard; 23.33% of the patients reached the markedly effective standard, and the symptoms were significantly relieved; 70% of the patients reached the effective standard, and the symptoms were relieved to a certain extent; the total effective rate was 96.67%. The above results suggest that the drug prepared by the present invention can effectively improve the curative effect of TCM syndrome in asthma patients.

[0145] (7)Safety evaluation

[0146] No serious adverse events occurred during the trial. Only 1 adverse event occurred. One patient had an acute attack during the treatment, which was considered unrelated to the study drug.

[0147] In summary, the traditional Chinese medicine composition for treating asthma provided by the present invention treats asthma from the aspect of dampness, aiming to fundamentally treat the abnormal state of body fluids in patients, which is different from the traditional Chinese medicine concept of treating asthma from phlegm. The results of clinical application show that this formula can improve the dampness syndrome state of asthma patients, relieve symptoms such as wheezing, shortness of breath, chest tightness, and cough in patients, and can improve the quality of life, enhance the level of asthma control, and has potential advantages in reducing acute asthma attacks, with good therapeutic potential; it conforms to the traditional Chinese medicine syndrome characteristics of "heat-induced asthma" and "qi deficiency and dampness-heat" in asthma, has the effects of clearing heat and resolving phlegm, dispersing the lung and relieving asthma, strengthening the body and removing dampness, and has broad application prospects.

[0148] Typical cases:

[0149] Case 1: Patient Xu, male, 31 years old, had cough and shortness of breath for more than 10 months, with aggravation for 2 weeks. He came to our hospital for treatment in January 2024. The clinical manifestations were frequent cough, coughing day and night, sputum was yellowish-white, sticky in texture, shortness of breath after activities, dry mouth and bitter taste, loose stools, dark red tongue, yellow and greasy coating, and string-taut and slippery pulse. Traditional Chinese medicine diagnosis: Asthma, heat-induced asthma syndrome. Oral administration of the traditional Chinese medicine decoction containing Example 3 provided by the present invention, 1 dose per day, decocted twice, each time decocted to 250 - 300 mL with water, and taken warm after meals for 14 days. After treatment, the patient's cough was basically relieved, coughing occasionally in the morning, expectorating a small amount of white sticky sputum, shortness of breath disappeared, stools were formed, tongue was pale red, coating was thin, white and greasy, and pulse was string-taut. The results showed that this formula effectively improved the dampness syndrome state of asthma patients, relieved symptoms such as cough and shortness of breath in asthma patients, and had obvious curative effects on asthma patients with "heat-induced asthma" syndrome.

[0150] Case 2: Patient Zhong, female, 57 years old, had recurrent cough and shortness of breath for more than 8 years, with aggravation for 1 month. She came to our hospital for treatment in March 2024. The clinical manifestations were fatigue and drowsiness, shortness of breath, shortness of breath after activities, wheezing sound in the throat, frequent cough, less sputum, white, sticky in texture and difficult to expectorate, chest tightness, dry mouth and bitter taste, poor appetite, loose stools, pale tongue, yellow and thick greasy coating, and thready and slippery pulse. Traditional Chinese medicine diagnosis: Asthma, qi deficiency and dampness-heat syndrome. Oral administration of the traditional Chinese medicine decoction containing Example 4 provided by the present invention, 1 dose per day, decocted twice, each time decocted to 250 - 300 mL with water, and taken warm after meals for 28 days. After treatment, the patient's shortness of breath, shortness of breath, and chest tightness were relieved, coughing occasionally, expectorating a small amount of white sticky sputum, which could be expectorated, the sense of fatigue and drowsiness and poor appetite were reduced compared with before, stools were formed, tongue was pale red, coating was thin, white, and pulse was thready. The results showed that this formula effectively relieved symptoms such as cough, wheezing, shortness of breath, and chest tightness in asthma patients, and had obvious curative effects on asthma patients with "qi deficiency and dampness-heat" syndrome.

[0151] The above are only the preferred embodiments of the present invention and are not used to limit the present invention. For those skilled in the art, the present invention can have various changes and modifications. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating asthma, characterized in that, It comprises the following medicinal material raw materials in parts by mass: 5 - 15 parts of Ephedrae Herba, 10 - 30 parts of Pseudostellariae Herba, 5 - 20 parts of Sophorae Flavescentis Radix, 5 - 20 parts of Pheretima, 10 - 30 parts of Lepidii Semen, 5 - 20 parts of Pinelliae Rhizoma Praeparatum, 3 - 9 parts of Asari Radix et Rhizoma, 10 - 30 parts of Fagopyri Cymosi Rhizoma, 5 - 20 parts of Belamcandae Rhizoma, 5 - 25 parts of Armeniacae Semen Amarum, 5 - 20 parts of Magnoliae Officinalis Cortex, 5 - 20 parts of Schisandrae Chinensis Fructus.

2. The traditional Chinese medicine composition for treating asthma according to claim 1, wherein, It comprises the following medicinal material raw materials in parts by mass: 7 - 13 parts of Ephedrae Herba, 10 - 25 parts of Pseudostellariae Herba, 5 - 15 parts of Sophorae Flavescentis Radix, 5 - 15 parts of Pheretima, 15 - 30 parts of Lepidii Semen, 5 - 15 parts of Pinelliae Rhizoma Praeparatum, 4 - 8 parts of Asari Radix et Rhizoma, 10 - 25 parts of Fagopyri Cymosi Rhizoma, 5 - 15 parts of Belamcandae Rhizoma, 10 - 25 parts of Armeniacae Semen Amarum, 5 - 15 parts of Magnoliae Officinalis Cortex, 5 - 15 parts of Schisandrae Chinensis Fructus.

3. The traditional Chinese medicine composition for treating asthma according to claim 1, wherein, It comprises the following medicinal material raw materials in parts by mass: 9 - 10 parts of Ephedrae Herba, 10 - 20 parts of Pseudostellariae Herba, 5 - 10 parts of Sophorae Flavescentis Radix, 5 - 10 parts of Pheretima, 15 - 25 parts of Lepidii Semen, 5 - 10 parts of Pinelliae Rhizoma Praeparatum, 5 - 6 parts of Asari Radix et Rhizoma, 10 - 20 parts of Fagopyri Cymosi Rhizoma, 5 - 15 parts of Belamcandae Rhizoma, 10 - 20 parts of Armeniacae Semen Amarum, 5 - 10 parts of Magnoliae Officinalis Cortex, 5 - 10 parts of Schisandrae Chinensis Fructus.

4. Use of the traditional Chinese medicine composition for treating asthma according to any one of claims 1 - 3 in the preparation of a medicament for treating asthma.

5. A drug for treating asthma, characterized in that, It comprises the traditional Chinese medicine composition for treating asthma according to any one of claims 1 - 3 and a pharmaceutically acceptable excipient.

6. The drug for treating asthma according to claim 5, wherein, The dosage form of the medicament is granule, pill, capsule, traditional Chinese medicine decoction, decoction, tablet, tea, suspension, drop, powder, fruit juice or oral liquid.

7. A method for preparing a medicament for treating asthma according to claim 5 or 6, characterized in that, It comprises the following steps: Step 1: Weigh the raw medicinal materials according to the weight ratio, perform cleaning and selection, drying, cutting, pulverizing, and mix them evenly. Step 2: Add water to cover the raw medicinal materials and soak them sufficiently. First, bring to a boil over high heat, then change to low heat and continue to decoct for 1 - 2 h, and filter to obtain the first filtrate; Add water to cover the residue, bring to a boil over high heat, then change to low heat and continue to decoct for 1 - 2 h, filter to remove the medicinal residue, and obtain the second filtrate. Step 3: Combine the first filtrate and the second filtrate, perform centrifugal filtration and vacuum concentration to obtain a concentrated liquid, which is the traditional Chinese medicine decoction. Step 4: Dry the concentrated liquid to obtain granules.

8. The preparation method according to claim 7, characterized in that, Add an excipient to the granules and mix them to obtain one of tablet, pill, drop, fruit juice or syrup, and the excipient is maltodextrin or magnesium stearate.

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