A traditional Chinese medicine composition for relieving asthma, preparation and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for relieving asthma, which comprises fried ephedra, asarum, inula flower, rhodiola, bitter apricot kernel, euphorbia, lonicera, earthworm, oldenlandia and licorice. The traditional Chinese medicine composition has the characteristics of ascending and descending combination, yin and yang combination, cold and warm combination and treatment of symptoms and root causes, and is suitable for children with asthma caused by latent pathogen, phlegm, blood stasis and air retention. The traditional Chinese medicine composition can improve the lung function, cough, expectoration and other symptoms of the children, effectively reduce the recurrence rate of bronchial asthma of the children with wind-phlegm-latent-lung type, and has no obvious adverse reactions and side effects. The application also protects an oral dose prepared from the traditional Chinese medicine composition and application thereof.

Description

Technical Field

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

[0002] Bronchial asthma (BA) is a heterogeneous disease mediated by various inflammatory cells, structural cells, and their components, characterized by chronic airway inflammation, airway hyperresponsiveness, and airway remodeling. It is recognized as one of the most serious lung diseases. Asthma is the most common chronic airway disease in children, characterized by recurrent attacks and difficulty in complete cure, posing a serious threat to children's health. Currently, there are 300 million asthma patients worldwide. The WHO states that the comprehensive economic burden of asthma each year is comparable to that of diseases such as diabetes and arteriosclerosis, making it a global public health problem.

[0003] Asthma has complex etiologies and diverse clinical phenotypes, and its pathogenesis remains incompletely understood. The 2023 GINA guidelines still recommend "inhaled corticosteroids (ICS) as the primary anti-inflammatory drug combined with β2-receptor agonists (SABA or LABA) as the main symptom-relieving agent" as first-line treatment. However, the potential negative impacts of long-term steroid use on children's growth and development are of great concern. Furthermore, even with existing drug treatments, 5-10% of patients still fail to achieve clinical control, developing refractory asthma characterized by airway remodeling, which is a major cause of treatment difficulties and increased mortality. Therefore, further research and continuous optimization of asthma prevention and treatment strategies to improve airway remodeling and airway inflammation, and enhance patients' quality of life, have significant clinical importance and practical value.

[0004] Asthma falls under the category of "asthma disease" in Traditional Chinese Medicine (TCM). Its location is in the lungs, and it is closely related to the dysfunction of the spleen and kidneys. TCM believes that the difficulty in curing asthma stems from its "long-standing root cause," and its onset is closely related to "latent phlegm, blood stasis, and qi stagnation." These three pathogenic factors, under the combined influence of internal and external factors such as "untimely illness" and "inherent deficiency," lead to a complex imbalance of deficiency and excess in the body and an imbalance of yin and yang, which is the basic pathological state of asthma.

[0005] The inventor holds a Doctor of Medicine degree and is a Master's degree supervisor. He has been selected for several prestigious programs, including the "Rising Talents of Yunnan," the "Ten Thousand Talents Program for Young Outstanding Talents," and the "Yunnan High-Level Traditional Chinese Medicine Talents Program." With over 15 years of clinical experience, he sees over 10,000 outpatients annually. His clinical and basic research focuses on pediatric respiratory diseases, with particular expertise in treating bronchial asthma and allergic rhinitis. He enjoys a high reputation among patients in Yunnan Province and surrounding areas, with over 70% of his patients coming from outside the region. Through long-term clinical practice, the inventor emphasizes the etiology and pathogenesis of asthma, focusing on "phlegm-dampness, qi stagnation, blood stasis, and latent pathogens." He has summarized and refined clinically effective formulas, aiming to leverage the unique advantages of traditional Chinese medicine in treating asthma and enrich effective TCM treatment strategies for the condition. Summary of the Invention

[0006] The present invention provides a traditional Chinese medicine composition for preparing a drug for the prevention / treatment of respiratory diseases, comprising processed ephedra, asarum, inula, rhodiola rosea, bitter almond, lepidium seed, magnolia flower, earthworm, oldenlandia diffusa, and licorice.

[0007] Prepared ephedra 3-9 parts, Asarum 1-3 parts, Inula 6-15 parts, Rhodiola rosea 3-9 parts, bitter apricot kernel 3-9 parts, Lepidium apetalum 3-9 parts, Magnolia biondii 6-12 parts, Pheretima aspergillum 6-12 parts, Hedyotis diffusa 3-9 parts, Glycyrrhiza uralensis 3-6 parts.

[0008] The preferred ingredients are: 6 parts processed ephedra, 3 parts asarum, 9 parts inula flower, 6 parts rhodiola rosea, 6 parts bitter almond, 9 parts lepidium seed, 9 parts magnolia flower, 9 parts earthworm, 6 parts oldenlandia diffusa, and 6 parts licorice.

[0009] The method for preparing the decoction according to the present invention is as follows: Each medicinal herb is washed and drained, and a clean earthenware pot is prepared; all medicinal herbs are placed in the earthenware pot and water is added, ensuring the water level covers the herbs, with water added once during the process; the decoction is heated to a boil for 30 minutes (the decoction time should not exceed half an hour), filtered twice, and finally the decoction of this prescription is obtained.

[0010] Application of this traditional Chinese medicine composition in the preparation of drugs for the prevention and / or treatment of respiratory diseases.

[0011] Respiratory diseases are chronic airway diseases in children.

[0012] The respiratory disease is childhood asthma.

[0013] The respiratory disease is childhood bronchial asthma.

[0014] The respiratory disease is childhood bronchial asthma of the wind-phlegm-lurking lung type.

[0015] Preparations of traditional Chinese medicine compositions also include pharmaceutically acceptable excipients.

[0016] Ephedra (processed), Asarum, Inula japonica, Rhodiola rosea, bitter apricot kernel, Lepidium apetalum, Magnolia biondii, earthworm, Hedyotis diffusa, and licorice are included in the 2020 edition of the Chinese Pharmacopoeia.

[0017] "Prepared ephedra and asarum" are the principal herbs:

[0018] Ephedra has the effects of inducing sweating, opening the orifices, relieving asthma, and promoting diuresis. It is an essential medicine for treating lung diseases and has a significant effect on relieving asthma. The "Treatise on Asthma" in Volume 3 of the "Collection of Infant Formulas" states, "Asthma is caused by stubborn phlegm obstructing the lung orifices. Without ephedra, it is impossible to open the lung orifices. Use it boldly, and it will be effective every time." Asarum is pungent and warm, which can open the orifices, warm the lungs, and resolve phlegm. It can treat nasal congestion, cough, and wheezing. The combination of the two medicines can not only open the lungs and relieve asthma but also relieve the exterior and open the orifices, implying the simultaneous treatment of the lungs and nose.

[0019] "Rhodiola rosea and Inula japonica", "Bitter almond and Lepidium apetalum"—these four herbs serve as assistant herbs:

[0020] ① Rhodiola rosea: Cold, sweet, and astringent. It enters the lung meridian and has the functions of tonifying qi and promoting blood circulation, dispersing blood stasis and unblocking collaterals. Previous basic and modern medical research have shown that it has a significant effect on improving airway remodeling in early asthma. Moreover, the use of this product to support the body's resistance and eliminate pathogens, remove blood stasis without harming the body's resistance, and tonify qi without causing stagnation, is especially suitable for asthma with deficiency in the root and excess in the branch, playing an important role in strengthening immunity and improving airway remodeling.

[0021] ②Inula japonica: Bitter, pungent, and slightly warm in nature, it has the effects of lowering qi, resolving phlegm, promoting diuresis, and stopping vomiting. This herb is pungent and bitter, slightly warm and descending, primarily entering the lung and stomach meridians. It is good at lowering qi, resolving phlegm, and relieving asthma, and also eliminates phlegm and promotes diuresis to relieve abdominal distension. Studies have shown that this herb can effectively improve the pathological characteristics of airway hyperresponsiveness, making it an essential medicine for treating phlegm stagnation and upward reversal of lung qi.

[0022] ③ Bitter Almond and Lepidium Seed: Bitter almond is bitter and slightly warm in nature, and is good at lowering qi, relieving cough and asthma, and moistening the intestines to promote bowel movement. It is used to treat cough and asthma, chest fullness and excessive phlegm, implying "the lung and large intestine are connected". Lepidium seed is bitter and cold, and can strongly purge phlegm and blood stasis in the lungs and promote urination. The combination of the two herbs has the effect of lowering qi, relieving asthma, and expelling phlegm and blood stasis. When combined with ephedra and asarum, it strengthens the function of lowering lung qi, helps ephedra and asarum to purge the lungs, remove phlegm and promote urination, so that phlegm and blood stasis can be transformed or go out through the large intestine.

[0023] "Magnolia biondii, earthworm, and Hedyotis diffusa" - these three herbs are used as adjuvants.

[0024] ① Magnolia flower and earthworm: Magnolia flower is pungent and warm, and enters the lung and stomach meridians. It has the function of dispersing wind and cold and clearing the nasal passages. It is known as the "holy medicine of rhinology". Earthworm is salty and cold, and clears heat, unblocks the meridians and removes blood stasis. The combination of the two medicines can not only clear the nasal passages, but also remove blood stasis in the lungs. It is a manifestation of the theory of "treating the lungs and nose at the same time, and treating asthma by first treating the nose".

[0025] ② "Hedyotis diffusa" is bitter and bland in taste, and cold in nature. It has the functions of clearing heat and detoxifying, relieving pain and dissipating nodules, and promoting diuresis and removing dampness. It is a common medicine in southern Yunnan. Modern pharmacological studies show that it has significant anti-inflammatory, immune-boosting, and cough-relieving effects, and is especially good at treating various types of inflammation. It has a good effect of clearing heat and benefiting the lungs for lung heat cough caused by latent pathogens and infections. At the same time, it can also help to counteract the warm and drying nature of other medicines in the prescription, so that phlegm and dampness can be resolved without damaging yin fluids.

[0026] Licorice is used as an adjuvant.

[0027] It has a sweet taste and neutral properties, and can invigorate qi, replenish the middle jiao, eliminate phlegm, stop cough, and detoxify; it also has the meaning of protecting the middle jiao.

[0028] Usage: Soak the above-mentioned herbs in warm water for 30 minutes, then boil for 20 minutes. Collect the decoction as required and take it orally half an hour after meals, reheating it. One dose every two days. The specific dosage is as follows:

[0029] 1. 6 months to 1 year: 10ml / dose, three times a day;

[0030] 2.1-3 years old: 30ml / dose, three times a day;

[0031] 3.3-5 years old: 40ml / dose, three times a day;

[0032] 4. Children aged 5-7: 50ml / dose, three times a day;

[0033] 5. Ages 8-12: 70ml / dose, three times a day;

[0034] 6. Ages 12-18: 100ml / dose, three times a day;

[0035] 7. Adults >18 years of age: 150ml / dose, three times a day;

[0036] Treatment should proceed in a step-down manner, addressing asthma patients in the three stages: acute exacerbation (stage 1), chronic persistent asthma (stage 2), and clinical remission (stage 3). Once the patient completes stage 3, a standard treatment course is completed, typically lasting 3 months. The initial "step" in the treatment course is not strictly adhered to and should be determined based on the initial assessment. Treatment for refractory or severe asthma often requires several standard courses.

[0037] The following points should be noted in the third stage of treatment: If the child's condition is stable during clinical practice, treatment should not be stopped immediately. The patient should be advised to be careful about their daily life. Treatment should only be stopped after the condition has not recurred for at least one month during the third stage of treatment. This is to treat the root cause of the disease, aiming to eradicate the underlying causes, phlegm, blood stasis, and latent pathogens, and to solve the fundamental problem of asthma recurrence from the source.

[0038] This invention combines the effects of both ascending and descending qi, yin and yang, cold and heat, and addresses both the root cause and symptoms. It eliminates external pathogens, resolves phlegm and blood stasis, and rapidly controls clinical symptoms while also regulating the child's constitution. It treats the disease from its essence, thereby achieving the goal of long-term disease control.

[0039] The inventor has come to understand several key points in the treatment of asthma through long-term clinical work: (1) Treating asthma from the perspective of "phlegm and dampness": Zhu Danxi said that "asthma is mainly caused by phlegm"; children's lung, spleen and kidney functions are disordered or insufficient, which leads to abnormal body fluid regulation and the pathological state of "water and dampness accumulation and phlegm retention", forming the "root cause" of repeated asthma attacks. Therefore, the treatment of asthma from the perspective of phlegm and dampness has been highly valued by physicians throughout history. When airway inflammation occurs, the amount of phlegm secretion increases significantly, which is "tangible phlegm"; chronic airway inflammation leads to mucosal congestion and edema, bronchial gland hypertrophy, goblet cell increase, etc., which are airway inflammations located in the lumen, glands, mucosa and cells. The disease location is deeper and the degree is more serious, which can be regarded as "intangible phlegm". The meaning of "phlegm and dampness" in traditional Chinese medicine is highly consistent with the essence of airway inflammation. "Resolving phlegm and dampness" should be an important link in the treatment of asthma. (2) Treating asthma from the perspective of "blood stasis": "Blood stasis invades the lungs, causing cough and wheezing." The academic view that blood stasis causes asthma has a long history. In clinical practice, combining blood-activating and stasis-removing drugs with phlegm-removing and qi-regulating drugs can achieve satisfactory results. From the perspective of the relationship between phlegm and blood stasis, "phlegm mixed with blood stasis, thus forming a nest" is the pathological essence of the "root cause". "Phlegm and blood stasis mutually binding internally" is the fundamental reason for the recurrence and protracted nature of asthma. Therefore, "resolving phlegm and dampness" and "removing blood stasis" cannot be treated separately and must be treated together. (3) Treating asthma from the perspective of "qi stagnation": The Suwen says, "All qi stagnation belongs to the lungs." Asthma is located in the lungs. The lungs govern qi and can disperse and descend. The failure of the lungs to disperse and descend and the upward reversal of lung qi caused by internal and external factors are the core symptoms of asthma. "Qi stagnation" is intrinsically related to airway hyperresponsiveness. "Regulating qi" is beneficial to clear the qi stagnation, phlegm obstruction and blood stasis during asthma attacks. Therefore, it runs through the entire process of asthma treatment. (4) Treating Asthma from the Perspective of "Lurking Evil": The human body's defense against external evils depends on the lung's function of governing qi. Children's lungs are often deficient, resulting in insufficient defensive qi and a weak barrier, making the body susceptible to invasion by external evils. The *Miscellaneous Diseases: Origins and Development* states, "When wind evil attacks a person, it inevitably returns to the lungs." In reality, children with asthma often have a history of recurrent respiratory infections, or many wheezing episodes are often triggered by external evils. This is a manifestation of evil qi remaining dormant in the body, easily triggering asthma. Therefore, the onset of this disease is closely related to "latent evil." Children with asthma are often first affected by nasal passages, subsequently exhibiting nasal congestion, runny nose, and other nasal-related symptoms. As latent evil penetrates deeper, further invading the lungs, causing the lung qi to fail to descend properly, leading to the interaction of qi and phlegm, ultimately resulting in asthma symptoms such as coughing and wheezing. Therefore, treating asthma by first addressing the nose, treating both the lungs and nose simultaneously, and focusing on eliminating infectious factors are also key points in the treatment of this disease.

[0040] Therefore, based on a grasp of the etiology and pathogenesis of asthma, focusing on the treatment methods and prescriptions of "regulating qi stagnation, resolving phlegm and dampness, removing blood stasis, and clearing latent pathogens" is an effective clinical strategy for treating asthma with traditional Chinese medicine.

[0041] The present invention has the following beneficial effects:

[0042] 1. This invention targets the etiology of asthma as "phlegm-dampness, qi stagnation, blood stasis, and latent pathogens," and treats asthma from the aspects of "regulating qi stagnation, resolving phlegm-dampness, removing blood stasis, and clearing latent pathogens." It creates Xuanhong Dingchuan Decoction, which has the effects of relieving asthma by clearing the lungs, resolving phlegm and removing blood stasis, regulating qi and relieving adverse qi flow, and clearing latent pathogens. It balances the body's qi mechanism, harmonizes yin and yang, and treats both the symptoms and the root cause, treating the disease from its essence, reducing the incidence of airway remodeling, and improving airway inflammation.

[0043] 2. The present invention has the advantages of convenient operation, few side effects, low price, definite curative effect and easy acceptance by children in treating asthma. It can effectively improve the clinical compliance of patients with standardized treatment, reduce the number of asthma attacks in children and reduce the economic burden on children's families.

[0044] 3. Due to external pathogenic factors, coupled with the physiological characteristics of children's lungs, spleen, and kidneys being often deficient, the body's fluid metabolism is disordered, phlegm and fluid retention occur, and prolonged illness leads to qi stagnation, blood stasis, and phlegm and blood stasis, resulting in recurrent and persistent asthma. The present invention has significant advantages in treating this disease and improving the symptoms of traditional Chinese medicine, and can improve the symptoms of wheezing, coughing, rapid breathing, chest tightness, and difficulty breathing in children.

[0045] Advantages of this invention:

[0046] This invention provides a traditional Chinese medicine composition for the prevention / treatment of respiratory diseases, which improves lung function and symptoms such as cough, sputum, and runny nose in children, effectively reduces the recurrence rate of bronchial asthma (non-acute exacerbation) in children with wind-phlegm-laden lung type, and has no obvious adverse reactions or side effects. Attached Figure Description

[0047] Figure 1 This is a comparison chart of overall effectiveness. Detailed Implementation

[0048] The present invention will be further described below, but this is not intended to limit the invention in any way. Any modifications made based on the present invention are within the scope of protection of the present invention.

[0049] Example 1

[0050] (Dosage for children aged 3-12)

[0051] Prepared ephedra 6g, Asarum 3g, Inula japonica 9g, Rhodiola rosea 6g, bitter apricot kernel 6g, Lepidium apetalum 9g, Magnolia biondii 9g, earthworm 9g, Hedyotis diffusa 6g, licorice 6g.

[0052] Example 2

[0053] (Dosage for children around 1-2 years old)

[0054] Prepared ephedra 3g, Asarum 1g, Inula japonica 6g, Rhodiola rosea 3g, bitter apricot kernel 3g, Hedyotis diffusa 3g, Magnolia biondii 6g, earthworm 6g, Lepidium apetalum 6g, licorice 3g.

[0055] Example 3

[0056] (For children aged 16-18, or adult dosage)

[0057] Prepared ephedra 8g, Asarum 6g, Inula japonica 12g, Rhodiola rosea 9g, bitter apricot kernel 9g, Hedyotis diffusa 9g, Magnolia biondii 12g, earthworm 12g, Lepidium apetalum 9g, licorice 9g.

[0058] Case:

[0059] (1) Case 1:

[0060] Shao XX, male, 7 years and 6 months old. Presented on February 24, 2022. Previously diagnosed with cough-variant asthma at a local hospital for over two months. He is prone to colds and has recurrent coughs, often experiencing runny nose, sneezing, and nasal congestion upon waking. In the past two weeks, his cough, nasal congestion, and runny nose worsened after catching a cold. His parents, concerned about the side effects of long-term hormone use, sought systematic TCM treatment at our hospital. Presenting symptoms: paroxysmal cough with difficult-to-expectorate phlegm, worsening after activity and at night, accompanied by nasal congestion, clear runny nose, frequent nose rubbing, fair appetite, poor sleep, slightly dry stools (once every two days), normal urination. History of dust mite allergy. Physical examination: Fair mental state, pale complexion, nasal congestion, slightly red pharynx, coarse breath sounds in both lungs, no rales heard, other physical examination unremarkable, pale tongue with a white, greasy coating, and a wiry, slippery pulse. The diagnosis was cough variant asthma (CVA), with wind-phlegm lurking in the lungs. The general treatment principle was to dispel wind and open the orifices, resolve phlegm and relieve asthma, and promote blood circulation and remove blood stasis.

[0061] First prescription: Original formula of Xuanhong Dingchuan Decoction, 1 dose every 2 days, 3 times a day, decocted in water and taken orally. Instructed to stay away from flowers, plants, cats, and dogs in daily life, and to change bed sheets and blankets frequently. Two weeks later, the cough was significantly relieved; nasal congestion and runny nose occurred upon waking and exposure to cold air, but other symptoms subsided.

[0062] Second prescription: The original formula of Xuanhong Dingchuan Decoction, plus 6g of Magnolia officinalis and 6g of stir-fried Xanthium sibiricum, 1 dose every 2 days, 3 times a day, decocted in water and taken orally. After 2 weeks, there were no obvious symptoms.

[0063] The third prescription was: the original formula of Xuanhong Dingchuan Decoction plus 9g of ginkgo seeds, one dose every two days, three times a day, decocted in water and taken orally to consolidate the therapeutic effect. Three months after stopping the medication, the patient returned for a follow-up visit, and the cough-variant asthma had not recurred.

[0064] (2) Case 2:

[0065] Yang XX, male, 13 years and 10 months old. Presented on July 16, 2022. He had a history of being diagnosed with asthma, allergic rhinitis, and allergic conjunctivitis for over two years. He received standard ICS treatment for six months and systematic treatment with related Western medicines such as mometasone furoate nasal spray and montelukast sodium for over one year. During this period, he did not experience any asthma attacks. His parents, concerned about the side effects of long-term steroid use, discontinued the medication on their own. The child had a persistent cough, which worsened with exertion, and paroxysmal rattling in the throat. Seeking systematic treatment with Traditional Chinese Medicine, he came to our hospital. Presenting symptoms: cough, expectoration of yellow-white sputum, worse at night and after exercise, accompanied by nasal congestion, runny nose, sneezing, and itchy throat. No wheezing, shortness of breath, or chest tightness. Appetite and sleep are fair, and bowel movements are normal. History of dust mite allergy. Physical examination: The patient's mental state was fair, but her complexion was pale. She had bruising under her eyes, nasal congestion, a red throat, and coarse breath sounds in both lungs, with occasional dry rales. Other physical examinations were unremarkable. Her tongue was red with a thick, greasy white coating, and her pulse was wiry and slippery. The diagnosis was allergic asthma (wind-phlegm lurking in the lungs). The general treatment principle was to dispel wind, clear the nasal passages, resolve phlegm, relieve asthma, and promote blood circulation and remove blood stasis.

[0066] First prescription: The original formula of Xuanhong Dingchuan Decoction plus 9g of Belamcanda chinensis. One dose every two days, three times a day, decocted in water. The patient was instructed to stay away from flowers, plants, cats, and dogs in daily life, and to change bed sheets and blankets frequently. Two weeks later, the cough, nasal congestion, and itchy throat symptoms were all relieved.

[0067] Second prescription: The original formula of Xuanhong Dingchuan Decoction with the addition of 9g of Magnolia officinalis, one dose every two days, three times a day, decocted in water. Acupuncture was continued. After two weeks, there were no obvious symptoms, and the bruising under the eyes lessened.

[0068] The third prescription was the original formula of Xuanhong Dingchuan Decoction, one dose every two days, three times a day, decocted in water and taken orally. Treatment with the decoction continued for one month to consolidate the therapeutic effect. Three months after stopping the medication, a follow-up visit revealed that the asthma and rhinitis symptoms had not recurred.

[0069] (3) Case 3:

[0070] Li XX, male, 2 years and 8 months old. Presented on April 5, 2022. Previously diagnosed with asthma for over six months and allergic rhinitis for over one year, but had not received systematic Western medical treatment. Four days prior, the child developed a cough after catching a cold, which worsened with shortness of breath and rattling sounds in the throat. Seeking systematic TCM treatment, he came to our hospital. Presenting symptoms: cough, rattling sounds in the throat, slight wheezing, mainly at night and after exercise, accompanied by nasal congestion, runny nose, and sneezing. Appetite and sleep are fair, bowel movements are normal. Allergic to dust mites and soybeans. Physical examination: Spirits are fair, complexion is pale, under-eye bruising, nasal congestion, slightly red throat, coarse breath sounds in both lungs, no obvious wheezing, other physical examinations are unremarkable, tongue is red with a thick, greasy white coating, pulse is wiry and slippery. Diagnosed as bronchial asthma, wind-phlegm lurking in the lungs syndrome. The general treatment principle is to dispel wind and open the nasal passages, resolve phlegm and relieve asthma, and promote blood circulation and remove blood stasis.

[0071] The initial prescription was: Xuanhong Dingchuan Decoction (original formula) plus 6g of ginkgo seeds, 6g of honey-processed mulberry bark, 12g of chlorite, 6g of dandelion, and 6g of prepared pinellia. One dose every two days, three times a day, decocted in water. The child was instructed to stay away from flowers, plants, cats, and dogs, and to change bed sheets and blankets frequently. They were also advised to prepare budesonide nebulizer solution and salbutamol sulfate nebulizer solution, and to seek immediate medical attention after nebulization as prescribed. A follow-up visit was scheduled one week later. The parents reported that the child had no wheezing, the cough had lessened, but there was still phlegm in the throat, and nasal congestion and runny nose upon waking. No nebulization treatment was given during the home treatment period.

[0072] Second prescription: Continue the above treatment, one dose every two days, three times a day, decocted in water and taken orally to consolidate the therapeutic effect. Two weeks later, there was no shortness of breath, no obvious cough, little sputum, and the nasal congestion and runny nose were reduced.

[0073] Third consultation prescription: The parents reported that the child was sweating excessively. The original prescription of Xuanhong Dingchuan Decoction was given with the addition of 9g of Ephedra root, one dose every two days, three times a day, decocted in water and taken orally. After two weeks, there were no obvious symptoms, and the under-eye bruising had lessened. Fourth consultation prescription: The prescription remained unchanged, one dose every two days, three times a day, decocted in water and taken orally. This was to consolidate the therapeutic effect. Three months after stopping the medication, a follow-up visit was conducted, and the asthma and rhinitis symptoms had not recurred.

[0074] Clinical efficacy:

[0075] Between October 2021 and November 2023, this project collected 72 children who met the inclusion criteria from the pediatric outpatient department of the First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine. They were randomly divided into two groups for clinical observation using a random number table.

[0076] The treatment group was given oral "Xuanhong Dingchuan Decoction", which is the prescription in Examples 1 to 3 of this invention.

[0077] Usage: Soak the medicinal materials from Examples 1-3 of this invention in warm water for 30 minutes, then decoct and boil for 20 minutes. Collect the decoction as required and take it orally half an hour after meals, one dose every two days. The specific dosage is as follows:

[0078] 1. 6 months to 1 year: 10ml / dose, three times a day;

[0079] 2. Children aged 1-3 years: 30ml / dose, three times a day;

[0080] 3. Children aged 3 to 5 years: 40ml / dose, three times a day;

[0081] 4. Children aged 5-7: 50ml / dose, three times a day;

[0082] 5. Ages 8-12: 70ml / dose, three times a day;

[0083] 6. Ages 12-18: 100ml / dose, three times a day;

[0084] The control group received "fluticasone propionate inhalation aerosol (50ug / spray, 50ug / dose, twice a day)".

[0085] Both groups of children received treatment for 8 weeks. Changes in clinical symptoms before and after treatment were compared between the two groups to assess the efficacy of TCM syndrome differentiation. Follow-up was conducted 3 months after the completion of the treatment course. The clinical efficacy of Xuanhong Dingchuan Decoction was objectively evaluated using TCM syndrome scores, the effective rate of disease treatment, and the recurrence rate.

[0086] result:

[0087] 1. In terms of overall efficacy: the total effective rate of the treatment group was 90.00%, while that of the control group was 96.77%. Both groups showed significant efficacy before and after treatment, with the effective rate of the traditional Chinese medicine treatment group being slightly lower than that of the control group.

[0088] 2. Regarding symptom relief:

[0089] (1) After comparison, the total TCM syndrome score, main symptom score and some secondary symptom score of the two groups of children decreased significantly after treatment. P <0.05), indicating that both groups of drugs have significant effects in relieving the clinical symptoms of bronchial asthma in children with wind-phlegm-lung invasion (non-acute exacerbation phase);

[0090] (2) After treatment, the total score of TCM syndrome, the score of major symptoms, the score of minor symptoms, and the individual scores of the four symptoms "cough, runny nose, expectoration, and complexion" in the TCM treatment group were all lower than those in the control group. P <0.05), indicating that the traditional Chinese medicine treatment group has certain advantages in improving the overall clinical symptoms and signs of the children and the symptoms and signs of "cough, runny nose, sputum, and complexion".

[0091] 3. Regarding the reduction of recurrence: Among the children followed up, the recurrence rate in the Xuanhong Dingchuan Decoction treatment group was 3.22%, while it was 13.33% in the control group. P <0.05, meaning that the Xuanhong Dingchuan Decoction treatment group can effectively reduce the recurrence rate of childhood bronchial asthma (non-acute exacerbation period) of wind-phlegm-latent lung type.

[0092] 4. In addition to improving symptoms, it also has a certain effect on improving the lung function of children with this disease, and has no obvious adverse reactions or side effects. It is a safe and effective method for treating this disease.

[0093] (I) Comparison of syndrome scores between the two groups of children before treatment

[0094] 1. Comparison of main symptom scores between the two groups before treatment

[0095] Statistical analysis was performed on the individual scores of the main symptoms between the two groups before treatment. Since the data distribution did not conform to a normal distribution, the M(P) method was used. 25，P 75 The description was performed, and the rank-sum test was used for analysis. The individual scores of the main symptoms before treatment were compared between the two groups. P The values ​​were all >0.05, indicating that there was no statistically significant difference in the individual scores of the main symptoms between the two groups before treatment, and they were comparable. See Table 1 for details.

[0096] Table 1 Comparison of main symptom scores before treatment

[0097]

[0098] 2. Comparison of symptom scores between the two groups before treatment

[0099] The individual scores of the two groups of children before treatment did not conform to a normal distribution, so M(P) was used. 25， P 75 The description was performed, and the rank-sum test was used for analysis. After the test, the individual scores of secondary symptoms before treatment in the two groups were compared. P All values ​​> 0.05, indicating that there was no statistically significant difference in the individual scores of secondary symptoms between the treatment group and the control group before treatment, and they were comparable. See Table 2 for details.

[0100] Table 2 Comparison of symptom scores before treatment

[0101]

[0102] 3. Comparison of total scores between the two groups before treatment

[0103] Analysis revealed that the quantitative data did not conform to a normal distribution; therefore, M(P) was adopted. 25， P 75 The description was performed, and the rank-sum test was used for analysis. After the test, the total scores of the main symptoms, secondary symptoms, and syndromes in the two groups before treatment were analyzed. P All values ​​> 0.05, indicating that there were no statistically significant differences between the treatment group and the control group in terms of total score of primary symptom, total score of secondary symptom, and total score before treatment, and they were comparable. See Table 3 for details.

[0104] Table 3 Comparison of total scores before treatment

[0105]

[0106] (II) Comparison of syndrome scores before and after treatment in the two groups of children

[0107] 1. Comparison of main symptom scores before and after treatment

[0108] According to the rank-sum test, the scores of all individual items of the main symptoms in both groups of children decreased compared with those before treatment, and P The value <0.05 indicates a statistically significant difference, suggesting that both groups of drugs can improve the TCM syndrome scores of the primary symptom in children. See Table 4 for details.

[0109] Table 4 Comparison of main symptom scores before and after treatment

[0110]

[0111] 2. Comparison of secondary symptom scores before and after treatment

[0112] Tests showed that after treatment, the scores for the single symptom items "sputum production and facial complexion" decreased in the treatment group, and... P <0.05, the difference was statistically significant, indicating that the medication in the treatment group improved the symptoms of "sputum production and facial color" in the children, but had no significant effect on the improvement of other symptom scores. In the control group, the scores of the individual symptom items "facial color and palpitations" decreased, and P <0.05, the difference is statistically significant, indicating that the drug in the control group can improve the symptoms of "facial complexion and palpitations" in children, but has no significant effect on improving the scores of other secondary symptoms. See Table 5 for details.

[0113] Table 5 Comparison of secondary symptom scores before and after treatment

[0114]

[0115] 3. Comparison of total TCM syndrome scores before and after treatment

[0116] According to the rank-sum test, the total scores of primary symptoms, secondary symptoms, and syndromes in both groups of children were significantly lower than before, and P <0.05, the difference is statistically significant. This indicates that both groups of drugs can significantly improve the overall clinical symptoms and signs of the children. See Table 6 for details.

[0117] Table 6 Comparison of total TCM syndrome scores before and after treatment

[0118]

[0119] (III) Comparison of syndrome scores between the two groups of children after treatment

[0120] 1. Comparison of main symptom scores between groups after treatment

[0121] According to the rank-sum test, the treatment group had lower scores than the control group in the two main symptoms of "cough and runny nose". P The value <0.05 indicates a statistically significant difference, suggesting that the treatment group's medication was superior to the control group's medication in improving the children's symptoms of cough and runny nose. See Table 7 for details.

[0122] Table 7 Comparison of main symptom scores between groups after treatment

[0123]

[0124] 2. Comparison of symptom scores between groups after treatment

[0125] According to the rank-sum test, the treatment group had lower scores than the control group in the two secondary symptoms of "sputum production" and "facial complexion".P The value <0.05 indicates a statistically significant difference, suggesting that the treatment group's medication was superior to the control group's medication in improving the children's symptoms of "sputum production and facial pallor." See Table 8 for details.

[0126] Table 8 Comparison of secondary symptom scores between groups after treatment

[0127]

[0128] 3. Comparison of total scores between groups after treatment

[0129] The tests showed that the total TCM syndrome score, main symptom score, and secondary symptom score of the children in the treatment group were all lower than those in the control group. P <0.05 indicates that the treatment group's medication was superior to the control group in improving the overall clinical symptoms and signs of the children. See Table 9 for details.

[0130] Table 9 Comparison of main symptom scores between groups after treatment

[0131]

[0132] (iv) Comparison of overall therapeutic effects

[0133] The total effective rate in the treatment group was 96.77%, and the total effective rate in the control group was 90.00%. The results were analyzed using the rank-sum test. Z =-2.619, P =0.009 < 0.05, indicating that the overall efficacy of the treatment group was better than that of the control group. See Table 10 for details. Figure 1 .

[0134] Table 10 Comparison of Overall Effectiveness

[0135]

[0136] (v) Comparison of recurrence rates after 3 months of follow-up

[0137] The recurrence rate in the treatment group was 3.22%, while the recurrence rate in the control group was 13.30%. According to the rank-sum test... P <0.05 indicates that the treatment group's medication was superior to the control group's medication in preventing acute relapses of childhood bronchial asthma. See Table 11 for details.

[0138] Table 11 Comparison of Recurrence Rates

[0139]

[0140] (vi) Observation of adverse reactions

[0141] No adverse reactions occurred in any of the 61 children during the medication period. See Table 12 for details.

[0142] Table 12 Adverse Reaction Observation Table

[0143] Group Number of examples None (example) Yes (example) Treatment group 31 31 0 control group 30 30 0

Claims

1. A traditional Chinese medicine composition for relieving asthma, characterized in that, It is made from 3-9 parts of processed ephedra, 1-3 parts of asarum, 6-15 parts of inula, 3-9 parts of rhodiola rosea, 3-9 parts of bitter apricot kernel, 3-9 parts of lepidium seed, 6-12 parts of magnolia flower, 6-12 parts of earthworm, 3-9 parts of oldenlandia diffusa, and 3-6 parts of licorice.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, It is made from 6 parts of processed ephedra, 3 parts of asarum, 9 parts of inula flower, 6 parts of rhodiola rosea, 6 parts of bitter almond, 9 parts of lepidium seed, 9 parts of magnolia flower, 9 parts of earthworm, 6 parts of oldenlandia diffusa, and 6 parts of licorice.

3. A formulation based on the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The decoction is prepared as follows: it is prepared by boiling according to traditional methods. Each herb is washed and drained, and a clean earthenware pot is prepared. All herbs are put into the earthenware pot and water is added, with the water level covering the herbs. Water is added once in the middle. It is heated to a boil for 30 minutes, filtered twice, and finally the decoction of this prescription is obtained.

4. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for the prevention and / or treatment of asthma.

5. The application as described in claim 4, characterized in that, The asthma mentioned refers to childhood asthma.

6. The application as described in claim 5, characterized in that, The asthma mentioned refers to childhood bronchial asthma.

7. The application as described in claim 6, characterized in that, The asthma described is childhood bronchial asthma of the wind-phlegm-lurking lung type.

8. A formulation based on the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, It also includes pharmaceutically acceptable excipients.

Images