A traditional Chinese medicine composition, a traditional Chinese medicine preparation, a preparation method thereof and application

Abstract

This invention belongs to the field of pharmaceutical technology. Addressing the problem that current TCM treatments for allergic rhinitis-asthma syndrome primarily rely on literature review and the experience of renowned practitioners, lacking clinically validated and fixed-composition TCM formulas, this invention proposes a TCM composition, a TCM preparation, its preparation method, and its application. The TCM composition provided by this invention is made from the following raw materials in parts by weight: Bupleurum chinense 3-10 parts, Angelica sinensis 6-15 parts, Paeonia lactiflora 6-15 parts, Magnolia biondii 6-15 parts, Cicadae periostracum 3-12 parts, Perilla frutescens 6-15 parts, Citrus reticulata 6-15 parts, Fritillaria cirrhosa 2-10 parts, Astragalus membranaceus 10-30 parts, Atractylodes macrocephala 10-30 parts, Saposhnikovia divaricata 6-12 parts, and Glycyrrhiza uralensis 3-12 parts. This invention can effectively improve the disease control level of CARAS patients, increase asthma control test scores, significantly reduce allergic rhinitis control symptom scores, significantly improve quality of life, and significantly alleviate clinical symptoms. Specifically, it promotes the recovery of disease and lung function by regulating immunity, increasing IFN-γ levels, reducing eosinophil infiltration, and improving chronic airway inflammation.

Description

Technical Field

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

[0002] Allergic rhinitis-asthma syndrome (CARAS) refers to a syndrome in which allergic rhinitis and asthma occur simultaneously. The allergies in the upper and lower respiratory tracts interact, exacerbating disease progression and severely impacting quality of life. Epidemiological studies show that 60%-78% of asthma patients also have allergic rhinitis, 5-7 times higher than the general population, while 20%-38% of allergic rhinitis patients also have asthma. CARAS is characterized by high incidence, low control rate, and frequent relapses, highlighting its challenging treatment. Currently, clinical diagnosis and treatment of this disease are often conducted separately in respiratory or otolaryngology departments, lacking an integrated upper and lower respiratory tract treatment plan. Therefore, patients often experience misdiagnosis, mistreatment, or duplicate medication due to interdisciplinary treatment. With the concept of "one airway, one disease," CARAS is receiving increasing attention. Multiple studies show a close relationship between CARAS and chronic asthma management; poor control of CARAS often leads to a significantly increased risk of acute asthma exacerbations and a marked increase in asthma severity. Therefore, in-depth research on CARAS has significant clinical value and application prospects.

[0003] Currently, the treatment of CARAS (Allergic Rhinitis-Asthma Syndrome) still largely follows the same methods used for allergic rhinitis and asthma. While leukotriene receptor antagonists have anti-chronic inflammatory effects on both the upper and lower airways, they also have adverse neurological and psychological effects. Inhaled corticosteroids increase the risk of mucosal damage and pneumonia, and the disease often recurs after discontinuation, easily leading to steroid dependence. Therefore, finding safe and effective drugs to prevent and treat CARAS is a pressing clinical problem. Traditional Chinese medicine (TCM) treatment of allergic rhinitis-asthma syndrome has the unique advantage of "holistic treatment," but current methods mainly rely on literature review and the experience of renowned practitioners, lacking clinically validated and fixed-formula TCM prescriptions. Summary of the Invention

[0004] The purpose of this invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine composition, a traditional Chinese medicine preparation, its preparation method and application.

[0005] The first aspect of this invention provides a traditional Chinese medicine composition made from the following raw materials in parts by weight: Bupleurum chinense 3-10 parts, Angelica sinensis 6-15 parts, Paeonia lactiflora 6-15 parts, Magnolia biondii 6-15 parts, Cicadae periostracum 3-12 parts, Perilla frutescens 6-15 parts, Citrus reticulata 6-15 parts, Fritillaria cirrhosa 2-10 parts, Astragalus membranaceus 10-30 parts, Atractylodes macrocephala 10-30 parts, Saposhnikovia divaricata 6-12 parts, Glycyrrhiza uralensis 3-12 parts.

[0006] Furthermore, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: Bupleurum chinense 6 parts, Angelica sinensis 12 parts, raw Paeonia lactiflora 10 parts, Magnolia biondii 10 parts, Cicadae periostracum 10 parts, Perilla frutescens 12 parts, Citrus reticulata 12 parts, Fritillaria cirrhosa 6 parts, raw Astragalus membranaceus 15 parts, stir-fried Atractylodes macrocephala 15 parts, Saposhnikovia divaricata 10 parts, raw Glycyrrhiza uralensis 6 parts.

[0007] Furthermore, the dosage form of the traditional Chinese medicine composition is a decoction.

[0008] The rationale for the raw materials used in the traditional Chinese medicine composition provided by this invention is as follows: The principal herbs in this formula are Bupleurum chinense, which soothes the liver and relieves depression, and Paeonia lactiflora and Angelica sinensis, which nourish the blood and soften the liver. These three herbs work together to promote the smooth flow of Qi while minimizing the risk of "damaging the liver Yin". The assistant herbs in this formula are: raw astragalus to invigorate qi and strengthen the exterior, stir-fried atractylodes macrocephala to strengthen the spleen and strengthen the interior, and saposhnikovia divaricata to ward off external pathogens. These three herbs together invigorate qi and strengthen the body's foundation, thus achieving the effect of strengthening the body's foundation and protecting the body's defenses. Adjuvant herbs: Perilla leaf in this formula promotes lung function and relieves chest congestion, tangerine peel resolves phlegm and regulates qi, one promotes lung function and the other resolves phlegm and regulates qi, fritillaria enhances lung function and relieves cough; magnolia flower and cicada slough open the orifices and benefit the throat; the five herbs together serve as adjuvant herbs, which not only open the orifices and relieve cough, but also guide the medicine to the meridians, so that the effect reaches the lungs and nose.

[0009] Guiding herb: Raw licorice root, known as "the elder of the state," is sweet and neutral in nature. It enters all twelve meridians and is good at harmonizing various herbs, relieving spasms and pain, and also invigorating qi, harmonizing the middle jiao, replenishing deficiency and detoxifying. It is used as a guiding herb.

[0010] When used together, the formula works synergistically to relieve depression, clear the orifices, strengthen the body's foundation, and support healthy function.

[0011] The traditional Chinese medicine composition provided by this invention targets the TCM pathogenesis of allergic rhinitis-asthma syndrome, characterized by "stagnation of pathogenic factors in the lungs and nose, and deficiency of lung and spleen qi." The principal herb resolves stagnation of qi and blood, while the assistant herb tonifies the deficiency of lung and spleen qi. The principal and assistant herbs work synergistically to resolve stagnation without harming the body's vital energy, and to tonify the body's vital energy without causing excessive tonification. This achieves a mutually beneficial effect. Furthermore, targeting the disease location—the lungs and nose—the adjuvant herbs are selected to direct the effects of the principal and assistant herbs to the affected areas. This makes the effects of resolving stagnation and tonifying the body more targeted to the lungs and nose, while also allowing the adjuvant herbs to exert their own effects of clearing the lungs, moistening the lungs, relieving cough, opening the nasal passages, soothing the throat, and resolving phlegm, thus alleviating clinical symptoms. Finally, the adjuvant herb, raw licorice root, soothes the throat, detoxifies, and harmonizes the other herbs, relieving throat discomfort and making the overall formula mild, reducing gastrointestinal irritation.

[0012] In summary, the traditional Chinese medicine composition provided by this invention has the effects of relieving depression and clearing the orifices, strengthening the body's resistance and boosting the body's morale. It not only improves symptoms such as chest tightness, shortness of breath, cough, phlegm, and nasal congestion caused by qi stagnation, but also strengthens the body's resistance, regulates the body's immune function, improves disease control, and enhances the patient's quality of life.

[0013] A second aspect of the present invention provides a traditional Chinese medicine preparation comprising the above-mentioned traditional Chinese medicine composition.

[0014] Furthermore, the traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients.

[0015] Pharmaceutically acceptable excipients include, but are not limited to, one or more of fillers, binders, disintegrants, lubricants, surfactants, or flavoring agents.

[0016] Furthermore, the dosage form of the traditional Chinese medicine preparation is decoction, pill, lozenge, tablet, granule, powder, ointment or capsule.

[0017] Furthermore, the dosage form of the traditional Chinese medicine preparation is a decoction.

[0018] A third aspect of the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising: weighing and mixing each raw material according to the proportion of raw materials in the above-mentioned traditional Chinese medicine composition, soaking for 30 minutes, adding water and decocting twice, each time for 30 minutes, combining the two decoction filtrates to obtain the traditional Chinese medicine composition.

[0019] Furthermore, the amount of water added in both decoctions was 4 to 6 times the total amount of each raw material.

[0020] A fourth aspect of the present invention provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating allergic rhinitis-asthma syndrome.

[0021] A fourth aspect of the present invention provides the application of the above-mentioned traditional Chinese medicine preparation in the preparation of a medicament for treating allergic rhinitis-asthma syndrome.

[0022] Compared with the prior art, the advantages of this invention are as follows: (1) The traditional Chinese medicine composition provided by the present invention corresponds to the complex pathogenesis of CARAS from the aspects of "evil stagnation in the lungs and nose, and deficiency of lung and spleen qi". It not only includes the idea of ​​"prevention before disease" and "prevention of disease progression", but also covers the pathological products of wind, phlegm and blood stasis, as well as the unique pathogenesis of "stagnation" in respiratory allergic diseases. It has the therapeutic advantage of overall regulation for CARAS, and can effectively improve the disease control level of CARAS patients, improve the asthma control test score, significantly reduce the allergic rhinitis control symptom score, significantly improve the quality of life, and significantly relieve clinical symptoms (such as wheezing, chest tightness and shortness of breath, cough, runny nose, phlegm, itching, fatigue and cyanosis).

[0023] (2) The traditional Chinese medicine composition provided by the present invention promotes disease recovery and improves the quality of life of patients by regulating immunity, increasing IFN-γ levels, reducing eosinophil infiltration, and improving chronic airway inflammation. Attached Figure Description

[0024] Figure 1 This is a technical roadmap for the research of this invention; Figure 2A bar chart showing the proportion of CARAS disease control grading. Figure 3 Violin plot for asthma control test scores; Figure 4 Violin plot for allergic rhinitis symptom control score; Figure 5 Violin plot for assessing quality of life in adults with asthma; Figure 6 Violin diagram for quantitative scoring of TCM syndromes; Figure 7 Violin diagram for quantifying TCM symptoms (dyspnea); Figure 8 Violin chart for quantifying TCM symptoms (chest tightness and shortness of breath); Figure 9 Violin chart for quantifying TCM symptoms (cough); Figure 10 Violin chart for quantifying TCM symptoms (runny nose with clear discharge); Figure 11 Violin chart for quantitative scoring of TCM symptoms (coughing and phlegm); Figure 12 Violin plot for quantifying symptoms (itching) in Traditional Chinese Medicine; Figure 13 Violin plot for quantitative scoring of TCM symptoms (fatigue and weakness); Figure 14 A violin diagram for quantifying and scoring symptoms in Traditional Chinese Medicine (cyanosis / purple discoloration); Figure 15 A violin plot showing the results of FEV1 lung function tests. Figure 16 A violin plot showing the results of the FVC (French VC) test for lung function. Figure 17 A violin plot showing the results of FEV1 / FVC lung function measurements; Figure 18 A violin plot showing the results of PEF (pulmonary function) measurements. Figure 19 A violin diagram showing the results of nitric oxide measurements in exhaled breath; Figure 20 A violin plot showing the results of nasal exhaled nitric oxide measurement; Figure 21 Violin plot of blood eosinophil count; Figure 22 A violin plot of the immunoglobulin E assay results; Figure 23 A violin plot showing the results of interleukin-4 assay; Figure 24 A violin plot of the interferon-γ assay results; Figure 25 Asthma control test score; Figure 26 The score for allergic rhinitis symptom control; Figure 27 Quantitative scoring of TCM syndromes; Figure 28 A questionnaire on the quality of life of asthma patients. Detailed Implementation

[0025] The following will be described in conjunction with embodiments of the present invention. Figures 1 to 28 The technical solutions in the embodiments of the present invention are clearly and completely described herein. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0026] Example 1 This invention provides a traditional Chinese medicine composition (i.e., a formula for relieving depression and strengthening the body), made from the following raw materials in parts by weight: Bupleurum chinense 6 parts, Angelica sinensis 12 parts, raw Paeonia lactiflora 10 parts, Magnolia biondii 10 parts, Cicadae periostracum 10 parts, Perilla frutescens 12 parts, Citrus reticulata 12 parts, Fritillaria cirrhosa 6 parts, raw Astragalus membranaceus 15 parts, stir-fried Atractylodes macrocephala 15 parts, Saposhnikovia divaricata 10 parts, raw Glycyrrhiza uralensis 6 parts.

[0027] In this embodiment, one portion of Chinese medicinal materials specifically refers to 1g.

[0028] In this embodiment of the invention, the dosage form of the traditional Chinese medicine composition is a decoction.

[0029] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising: weighing and mixing each raw material according to the raw material ratio of the above-mentioned traditional Chinese medicine composition, soaking for 30 minutes, adding water and decocting twice, each time for 30 minutes, combining the two decoction filtrates to obtain the traditional Chinese medicine composition.

[0030] Specifically, the amount of water added in both decoctions is 4 to 6 times the total amount of each raw material.

[0031] Example 2 This invention provides a traditional Chinese medicine composition (i.e., a formula for relieving depression and strengthening the body), made from the following raw materials in parts by weight: Bupleurum chinense 10 parts, Angelica sinensis 15 parts, raw Paeonia lactiflora 15 parts, Magnolia biondii 6 parts, Cicadae periostracum 3 parts, Perilla frutescens 6 parts, Citrus reticulata 15 parts, Fritillaria cirrhosa 2 parts, raw Astragalus membranaceus 30 parts, stir-fried Atractylodes macrocephala 10 parts, Saposhnikovia divaricata 12 parts, raw Glycyrrhiza uralensis 3 parts In this embodiment, one portion of Chinese medicinal materials specifically refers to 1g.

[0032] In this embodiment of the invention, the dosage form of the traditional Chinese medicine composition is a decoction.

[0033] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising: weighing and mixing each raw material according to the raw material ratio of the above-mentioned traditional Chinese medicine composition, soaking for 30 minutes, adding water and decocting twice, each time for 30 minutes, combining the two decoction filtrates to obtain the traditional Chinese medicine composition.

[0034] Specifically, the amount of water added in both decoctions is 4 to 6 times the total amount of each raw material.

[0035] Example 3 This invention provides a traditional Chinese medicine composition (i.e., a formula for relieving depression and strengthening the body), made from the following raw materials in parts by weight: Bupleurum chinense 3 parts, Angelica sinensis 6 parts, raw Paeonia lactiflora 6 parts, Magnolia biondii 15 parts, Cicadae periostracum 12 parts, Perilla frutescens 15 parts, Citrus reticulata 6 parts, Fritillaria cirrhosa 10 parts, raw Astragalus membranaceus 10 parts, stir-fried Atractylodes macrocephala 30 parts, Saposhnikovia divaricata 6 parts, raw Glycyrrhiza uralensis 12 parts In this embodiment, one portion of Chinese medicinal materials specifically refers to 1g.

[0036] In this embodiment of the invention, the dosage form of the traditional Chinese medicine composition is a decoction.

[0037] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising: weighing and mixing each raw material according to the raw material ratio of the above-mentioned traditional Chinese medicine composition, soaking for 30 minutes, adding water and decocting twice, each time for 30 minutes, combining the two decoction filtrates to obtain the traditional Chinese medicine composition.

[0038] Specifically, the amount of water added in both decoctions is 4 to 6 times the total amount of each raw material.

[0039] Example 4 This invention provides a traditional Chinese medicine preparation, which includes the traditional Chinese medicine composition of Example 1.

[0040] In this embodiment of the invention, the traditional Chinese medicine preparation further includes pharmaceutically acceptable excipients.

[0041] Pharmaceutically acceptable excipients include, but are not limited to, one or more of fillers, binders, disintegrants, lubricants, surfactants, or flavoring agents.

[0042] In this embodiment of the invention, the dosage form of the traditional Chinese medicine preparation is decoction, pill, lozenge, tablet, granule, powder, paste or capsule.

[0043] In this embodiment of the invention, the dosage form of the traditional Chinese medicine preparation is a decoction.

[0044] Since the traditional Chinese medicine compositions provided in Examples 1-3 of this invention have basically the same efficacy in treating allergic rhinitis-asthma syndrome, the efficacy of the traditional Chinese medicine composition provided in Example 1 of this invention in treating allergic rhinitis-asthma syndrome will be described below.

[0045] 1. Research Methods 1.1 Research Approach like Figure 1 As shown, 66 CARAS patients meeting the inclusion and exclusion criteria were collected and randomly assigned to an experimental group (Jieyu Guben group) and a Western medicine control group using Excel software. After 4 weeks of medication, the efficacy of Jieyu Guben was evaluated by CARAS disease control grading, asthma control test scores, asthma quality of life scores, allergic rhinitis symptom control scores, lung function, FeNO, serum EOS, IgE, IL-4, and IFN-γ. Safety was evaluated using blood, urine, liver and kidney function tests, and electrocardiogram. The mechanisms of action of Jieyu Guben in regulating immune function, influencing chronic airway inflammation, and restoring lung function were explored using IL-4, IFN-γ, serum EOS, IgE, lung function, and FeNO.

[0046] 1.2 Research Subjects 1.2.1 Source of Subjects Cases were drawn from respiratory outpatient clinics and wards, and CARAS patients meeting the inclusion and exclusion criteria were selected. The study followed the requirements of regulations such as the Declaration of Helsinki, Good Clinical Practice for Drug Clinical Trials, and Ethical Review Management Guidelines for Clinical Research in Traditional Chinese Medicine, and has been reviewed and approved by the Medical Ethics Committee (ethics approval number: 2023XLA051-2); it has also been registered and approved in the National Health Security Information Platform - Medical Research Registration and Filing Information System (registration number: MR-11-24-026984).

[0047] 1.2.2 Informed Consent of Subjects Before each participant joins this study, the researchers will provide them with a complete and written explanation of the study's purpose, nature, methods, procedures, potential benefits, and risks, and inform them of their right to withdraw from the study at any time. Each participant must obtain a written informed consent form before enrollment; only after understanding, agreeing, and voluntarily signing the form can they be enrolled in the clinical trial. The informed consent form should be properly kept for future reference and will become part of the original data of the clinical trial. To protect the privacy of the participants, the case report form should not contain their names or identification information; instead, their identity will be confirmed and recorded using codes.

[0048] 1.2.3 Sample Size Calculation The sample size was determined based on the following criteria: The sample size for this trial was estimated according to literature review, expert panel experience, previous research conclusions, the study type, and reference to clinical epidemiology monographs, using the effective rate as a parameter. The calculation formula is as follows: (1) In the formula, n1 is the experimental group, n2 is the control group; π is the efficacy rate of the control group, δ is the superiority threshold, δ=Δ / 2, Δ is the effect difference in the placebo-controlled superiority trial; α is the probability of a Type I error (false alarm), and α=0.10, μ α μ is the critical value of α. α =1.645; β is the probability of a Type II error (false negative), β=0.10, μ β μ is the critical value of β. β =1.282.

[0049] Based on the meta-analysis of the efficacy of montelukast in patients with asthma and allergic rhinitis, the average overall effective rate of Western medicine treatment is expected to be 71%. Therefore, according to formula (1), the required sample size for the control group is 27.8 (cases).

[0050] Based on the design principles of clinical epidemiology, rounding up is used, so each group should have no fewer than 28 cases.

[0051] Using the efficacy rate as a parameter, the total sample size required for the clinical implementation study is 28 × 2 = 56 (cases). Considering a 15% dropout rate for outpatient and inpatient patients, and rounding to an even number, the sample size should be increased by 10 cases. Therefore, the total sample size is: 56 + 10 = 66 (cases).

[0052] Therefore, there were 33 cases in the experimental group and 33 cases in the control group.

[0053] 1.2.4 Grouping Method A block randomization method was used, with 66 subjects selected using Excel software. The experimental and control groups were randomly assigned in a 1:1 ratio, with drug serial numbers 01-66 corresponding to the treatment allocations. Subjects could be inpatients or outpatients, and medication was administered sequentially. Based on the half-life of montelukast sodium, a 3-day pre-enrollment washout period was stipulated.

[0054] 1.3 Various Standards 1.3.1 Diagnostic Criteria 1.3.1.1 Western Medicine Diagnostic Criteria CARAS is described as "same airway, same disease" or "single airway disease," meaning a combined diagnosis of two diseases. Diagnosis relies primarily on medical history, clinical symptoms, and immunological tests, and must meet the diagnostic criteria for both allergic rhinitis and asthma. The diagnostic criteria are based on the 2024 Expert Consensus on the Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Allergic Rhinitis-Asthma Syndrome, the 2016 Guidelines for the Prevention and Treatment of Bronchial Asthma, and the 2016 Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (English Version).

[0055] 1.3.1.1.1 Diagnostic criteria for bronchial asthma (1) Recurrent episodes of wheezing, chest tightness, cough, shortness of breath, etc. are often related to exposure to cold air, allergens, physical and chemical irritants, respiratory infections, exercise, etc. (2) Wheezing, predominantly expiratory, can be heard in both lungs, and is either scattered or diffuse. (3) The above symptoms and signs can be relieved on their own or relieved by treatment; (4) Excluding wheezing, coughing, chest tightness, and shortness of breath caused by other diseases; (5) For patients with atypical clinical manifestations, the following examinations can be completed. If any of the results are positive, it can help diagnose bronchial asthma: positive airway dilatation test, and intraday variation rate of maximum expiratory flow measured by a simple peak flow meter ≥20%.

[0056] Those who meet the criteria (1)-(4) or (4) and (5) can be diagnosed with bronchial asthma.

[0057] 1.3.1.1.2 Diagnostic criteria for allergic rhinitis (1) Scoring criteria: ① Perennial onset of the disease, with a cumulative number of days of illness exceeding 6 months within 1 year, a cumulative duration of illness exceeding 0.5 hours within 1 day, and 3 typical manifestations of sneezing (≥3 consecutive sneezes each time), runny nose, and nasal mucosal swelling. ② Disease duration ≥ 1 year.

[0058] (2) Scoring criteria: 1 point for each of the following: clear clues of inhaled allergens, history of allergic diseases (personal and / or family history), and typical symptoms and signs during an attack. 2 points for each of the following: positive skin test for allergens (at least ≥1 type marked "++" or above), positive specific IgE antibody or positive nasal provocation test for allergens (consistent with medical history and skin test). 1 point for each of the following: positive EOS in nasal secretion smear or positive mast cells in nasal mucosal scraping.

[0059] (3) Diagnostic criteria: 0-8 points in total. A score of 6-8 points is diagnosed as "perennial allergic rhinitis", 3-5 points is diagnosed as "suspected allergic rhinitis", and 0-2 points is considered as "non-allergic rhinitis".

[0060] 1.3.1.1.3 CARAS Diagnostic Criteria Patients who meet the diagnostic criteria for both allergic rhinitis and bronchial asthma.

[0061] 1.3.1.2 Traditional Chinese Medicine Diagnostic Criteria This document was formulated with reference to the 2024 Expert Consensus on the Diagnosis and Treatment of Allergic Rhinitis and Asthma Syndrome with Integrated Traditional Chinese and Western Medicine, the 2016 Diagnostic Criteria for Traditional Chinese Medicine Syndromes of Bronchial Asthma, the Diagnostic Criteria for Traditional Chinese Medicine Syndromes of Allergic Rhinitis, the 2002 Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs (Trial Implementation), and the Guiding Principles for Clinical Research of Traditional Chinese Medicine Syndromes, and in combination with the clinical characteristics of this disease.

[0062] Syndrome of pathogenic factors affecting the lungs and nose, and deficiency of lung and spleen qi: chest tightness, shortness of breath, wheezing, paroxysmal cough, symptoms worsened by irritating odors, itchy nose, runny nose with clear discharge, itchy throat, rattling in the throat or difficulty expectorating phlegm, fatigue, pale complexion, dark lower eyelids, cyanosis of the lips and fingertips, poor appetite, loose stools, spontaneous sweating, prone to recurrent external infections, pale tongue with a thin white or greasy coating, and a slow or slippery pulse.

[0063] 1.3.2 Inclusion criteria for cases (1) Patients who meet the criteria for chronic persistent CARAS (mild to moderate persistent CARAS); (2) Those diagnosed by traditional Chinese medicine as having pathogenic factors stagnating in the lungs and nose, and deficiency of lung and spleen qi; (3) No acute exacerbation of the disease in the week prior to enrollment; (4) Age: 18-75 years old; (5) Voluntarily join the group and sign the informed consent form.

[0064] 1.3.3 Exclusion criteria (1) Patients with serious underlying diseases such as heart, brain, respiratory, digestive, liver, kidney, blood, or tumors; (2) Those whose liver function (ALT or AST) or kidney function (BUN or CREA) exceeds twice or more the upper limit of normal; (3) Women who are breastfeeding, pregnant, or in the preconception period (within 3 months); (4) History of drug abuse or chronic alcoholism; (5) Mentally ill patients, those unable to cooperate with the test, or those whose compliance is affected by other factors; (6) Those who are allergic to the medication used, such as the Jieyu Gubenfang formula or montelukast sodium; (7) Those who participated in other trials within 1 month; (8) Other situations in which the researchers believe that the candidate is not suitable for inclusion.

[0065] 1.4 Intervention Measures 1.4.1 Investigational Drug (1) Western medicine control group: conventional Western medicine treatment was adopted: the treatment measures were in accordance with the treatment methods for non-acute exacerbations of bronchial asthma proposed in the Global Strategy for Asthma (GINA, 2022 revised edition): Montelukast sodium 10mg was taken orally before bedtime.

[0066] (2) Experimental group: The Chinese medicine composition (concentrated 100ml / bag) provided in Example 1 of this invention was used for treatment, 1 bag / time, twice a day.

[0067] (3) Combined medication: Budesonide formoterol (160 / 4.5ug) can be used as needed, 1-2 sprays / time, 1-2 times a day by oral inhalation; or salbutamol aerosol (100ug / spray) can be used as needed, 1-2 sprays / time, 0-4 times a day by oral inhalation.

[0068] (4) Treatment course: 4 weeks.

[0069] (5) Follow-up: Follow up for six months, and record the patient’s medication use truthfully during the follow-up period.

[0070] (6) Quality control: The Chinese herbal decoction (concentrated 100ml / bag) provided in Example 1 of this invention is processed by the hospital's decoction room.

[0071] 1.5 Observation Items 1.5.1 General Information Subject's name, pinyin initials, gender, age, contact number, trial start date, etc.

[0072] 1.5.2 Biological Indicators Height, weight, vital signs (body temperature, heart rate, respiration, blood pressure), and any abnormalities detected during physical examination.

[0073] 1.5.3. Efficacy indicators and observation time points (1) Main therapeutic indicators ①CARAS Disease Control Grading: CARAS disease control was graded based on symptoms, onset time, nocturnal symptoms, and lung function level. The CARAS disease control grading table is shown in Table 1 below. Observations and records were made once before treatment, once at the visit, and once after treatment. Records were made every 3 months during the follow-up period, for a total of 5 times.

[0074] Table 1. CARAS Disease Control Grading Table ②Asthma Control Test (ACT) score: Observations and records were made once before treatment, once at the first visit, and once after treatment. Recordings were also made every 3 months during the follow-up period, for a total of 5 times. The ACT score chart is shown below. Figure 25 As shown.

[0075] ③ Allergic rhinitis symptom control score (AS score): Observations and records were made once before treatment, once during the initial visit, and once after treatment. Recordings were also made every 3 months during the follow-up period, for a total of 5 times. The AS score chart is shown below. Figure 26 As shown.

[0076] (2) Secondary therapeutic indicators ① Quantitative scoring of TCM syndromes (see Figure 27 ): Observations and records were made once before and once after the trial treatment, for a total of 2 times.

[0077] ②Asthma Quality of Life Scale (see Figure 28 ): Observations and records were made once before and once after the trial treatment, for a total of 2 times.

[0078] ③ Lung function (FEV1, FVC, FEV1 / FVC, PEF): Record the results once before and once after the trial treatment, for a total of 2 times.

[0079] ④ Exhaled nitric oxide measurement (oral exhaled nitric oxide, nasal exhaled nitric oxide): Record the results once before and once after the trial treatment, for a total of 2 times.

[0080] ⑤ Serum inflammatory markers (eosinophils, immunoglobulin E, interleukin-4, interferon-γ): Detected and recorded once before and after the trial treatment, for a total of 2 times.

[0081] (3) Safety observation indicators: ① Blood routine and urine routine tests: Record the results once before and once after the trial treatment, for a total of 2 times.

[0082] ② Liver and kidney function tests and electrocardiogram: Record the results once before and once after the trial treatment, for a total of 2 times.

[0083] 1.5.4 Follow-up Plan Follow-up was conducted for six months, with follow-up calls every three months via phone or WeChat, for a total of two times. The number of acute exacerbations of allergic rhinitis-asthma syndrome during the follow-up period was recorded. If an acute exacerbation occurred, the time of occurrence, triggering factor, medication used, duration of relief, whether outpatient or hospitalization was required, and whether inhaled, oral, or intravenous corticosteroids were used were recorded.

[0084] 1.6 Criteria for Evaluating Therapeutic Effect (1) Assessment of efficacy of key indicators ①CARAS disease control grading: The changes in allergic rhinitis-asthma control grading before and after treatment and during follow-up were compared between the two groups, and inter-group comparisons were made.

[0085] ②ACT score: Compare the changes in ACT scores before and after treatment in the two groups, and make inter-group comparisons.

[0086] ③ Allergic rhinitis symptom control score: The changes in allergic rhinitis symptom control scores before and after treatment were compared between the two groups, and inter-group comparisons were made.

[0087] (2) Secondary indicators for efficacy assessment Traditional Chinese medicine syndrome quantitative scoring, asthma quality of life score, lung function (FEV1, FVC, FEV1 / FVC, PEF), exhaled nitric oxide measurement, and serum inflammatory markers (EOS, IgE, CRP, IL-4, IFN-γ): changes before and after treatment were compared between the two groups, and then inter-group comparisons were performed to determine the efficacy.

[0088] (3) Safety observation indicators The safety of the drug was assessed based on changes in blood, urine, liver and kidney function, and electrocardiogram before and after treatment.

[0089] (4) Adverse event evaluation Adverse events are identified based on the following indicators: ①Is there a reasonable chronological relationship between the occurrence of suspected adverse reactions and the start of medication? ② Whether the suspected adverse reaction is consistent with the known adverse reactions of the drug; ③ Can the suspected adverse reaction be explained by the subject's condition, concomitant medications, or other interventions? ④ After reducing the dosage or stopping the medication, can the suspected adverse reactions be reduced or disappear? ⑤ After using the suspected drug again, did the same or similar adverse reactions occur again?

[0090] Based on the judgment indicators ①-⑤, determine the cause and effect.

[0091] 1.7 Statistical Methods 1.7.1 Analyzing Dataset Selection Full Analysis Set (FAS): This set includes all randomized cases who received at least one dose of medication. Data from cases where the entire treatment course could not be observed are carried over to the final results using data from the last observation. This data is used for intention-to-treat analysis of efficacy and adverse event rates. The FAS was used for efficacy and safety analyses in this study.

[0092] The Protocol Compliance Set (PPS) is a group of cases that meet the inclusion criteria and complete the treatment protocol, namely, cases that comply with the trial protocol, have good adherence, are not taking prohibited drugs, and have completed the CRF (Clinical Review Letter) requirements. The PSS was also used for efficacy evaluation in this study.

[0093] Safety dataset (SS): Actual data from patients who received at least one treatment and whose safety observation indicators were recorded; no data transfer was made for withdrawn cases. The safety analysis in this study used the SS dataset.

[0094] 1.7.2 Statistical Analysis Methods This study used R 4.3.3 (http: / / www.R-project.org, The R Foundation). Normality was tested using the Shapiro-Wilk test. Continuous and categorical variables were described using mean ± standard deviation and frequency / percentage, respectively. Between-group comparisons were performed using the independent t-test (for normally distributed continuous variables), the Wilcoxon test (for skewed continuous variables), and the chi-square test (for categorical variables), with corresponding statistics of t, w, and , respectively. The functions t.test, wilcox.test, and chisq.test are used respectively.

[0095] For comparisons within a group, paired t-tests are used for continuous variables with normally distributed differences, and paired Wilcoxon tests are used for continuous variables with skewed differences. For categorical variables, which are ordinal variables, paired Wilcoxon signed-rank tests are also used. The corresponding statistics are t and w, respectively, using the t.test(paired = TRUE) and wilcox.test(paired = TRUE) functions.

[0096] 1.7.3 Statistical Description (1) Whether it conforms to a normal distribution: If it does not conform, modify the statistical method or perform data transformation.

[0097] (2) Whether there are outliers: Conduct statistical and professional analysis to decide whether to include or exclude them.

[0098] (3) Missing values: When a certain data of an individual subject is not measured, it is decided from a statistical and professional perspective whether to classify it as a dropout or to transfer the data.

[0099] (4) The proportion of dropout cases should not exceed 20%; otherwise, it should be analyzed and explained.

[0100] (5) Descriptive statistical analysis: indicate the mean, standard deviation, maximum value, minimum value, median, confidence interval, frequency, etc.

[0101] 1.7.4 Statistical Expression The report primarily uses tables and graphs. Tables are self-explanatory, including titles, footnotes, and examples. Violin plots and scale bar charts are used to visualize continuous and categorical variables, respectively. A violin plot is a statistical chart used to visualize data distribution. It combines box plots and kernel density estimation plots to simultaneously display the mean, standard deviation, distribution shape, and data density, showing the data distribution. The black dot in the center of the plot represents the mean, and the upper and lower ends of the black vertical line represent the standard deviation.

[0102] All hypothesis tests were two-tailed, with confidence intervals set at 95%, and P < 0.05 was considered statistically significant.

[0103] 2. Research Results 2.1 Research Completion Status This study included 66 participants, with 33 in the experimental group and 33 in the Western medicine control group. Ultimately, 65 participants completed the trial, including 33 in the experimental group and 32 in the Western medicine control group (one participant withdrew due to inconvenience of returning to Beijing from another location). There was no statistically significant difference in patient compliance between the two groups (P > 0.05).

[0104] 2.2 Baseline Data Analysis There were no statistically significant differences in gender and age between the two groups of subjects included in this study (P > 0.05).

[0105] Before treatment, there were no statistically significant differences between the two groups in CARAS classification, ACT, AS score, syndrome, AQLQ, FEV1, FVC, FEV1, FVC, PEF, FeNO, FnNO, EOS, IgE, IL-4, IFN-γ, wheezing, chest tightness and shortness of breath, cough, runny nose, sputum, itching, fatigue and weakness, and cyanosis. The baselines of the two groups were the same.

[0106] 2.3. Main therapeutic indicators 2.3.1 CARAS Disease Control Classification CARAS level grading is based on indicators such as patient symptom frequency, lung function, and medication use, classifying CARAS control status into three levels: complete control, partial control, and no control, to guide treatment adjustments and long-term management. In this invention, levels 1, 2, and 3 represent complete control, partial control, and no control, respectively. Specific data and proportional bar charts for CARAS disease control grading in the Jieyu Guben group and the Western medicine control group are shown in Table 2 and [Table 2 not provided]. Figure 2 .

[0107] Table 2. CARAS Disease Control Classification Note: Compared with the pre-treatment level in this group , Compared with the control group after treatment △△ P < 0.01.

[0108] Through Table 2 and Figure 2The results showed that the disease control grading in both groups was significantly improved compared with that before treatment (P<0.001 in the Jieyu Guben group, P=0.015 in the Western medicine control group), and the improvement in grading in the Jieyu Guben group was significantly better than that in the Western medicine control group (P<0.001). This suggests that both drugs can improve the CARAS disease grading level, but the Jieyu Guben formula of this invention has a better improvement effect.

[0109] 2.3.2 ACT Scoring The ACT (Acute Antidepressant) is the most widely used assessment system in clinical practice. It quantifies the level of control through five questions, with 25 points indicating complete control, 20-24 points indicating partial control, and below 20 points indicating no control. Specific data on the ACT scores of the antidepressant and detoxifying group and the Western medicine control group, as well as the violin plots, are shown in Table 3 and [Table data missing]. Figure 3 .

[0110] Table 3 ACT Scores Note: Compared with the pre-treatment level in this group .

[0111] Through Table 3 and Figure 3 The results showed that the ACT score in the Jieyugu group improved significantly after treatment compared to before treatment (P=0.017<0.05); the ACT score in the Western medicine control group also improved significantly after treatment compared to before treatment (P=0.018<0.05); no statistically significant difference was found between the two groups. This suggests that both groups were effective in improving ACT, and the effects were comparable.

[0112] 2.3.3 AS Scoring The AS score is a nasal symptom assessment for allergic rhinitis, including four symptoms: nasal congestion, runny nose, nasal itching, and sneezing. Each symptom is scored from 0 to 3, for a total score of 0 to 12. Higher scores indicate more severe symptoms. Specific data on AS scores and violin plots for the anti-inflammatory and detoxifying group and the Western medicine control group are shown in Table 4 and [Table 5]. Figure 4 .

[0113] Table 4 AS Scores Note: Compared with the pre-treatment level in this group Compared with the control group after treatment △△ P < 0.01.

[0114] Through Table 4 and Figure 4 The results showed that the AS score in the Jieyu Guben group was significantly lower after treatment than before, with a statistically significant difference (P < 0.01), and also significantly lower than that in the Western medicine control group (P < 0.01). In contrast, there was no statistically significant difference in AS score between the Western medicine control group before and after treatment (P > 0.05). This suggests that the Jieyu Guben group was significantly more effective than the Western medicine control group in terms of AS score.

[0115] 2.4 Secondary therapeutic indicators 2.4.1 Adult Asthma Quality of Life Score (AQLQ) The AQLQ measures five aspects of adult activity level, asthma control, mental state, allergic reactions, and health concerns, consisting of 35 questions scored on a 5-point scale (5 being the best and 1 the worst). Higher scores indicate better quality of life for asthma patients. Specific data on AQLQ scores for the anti-depression and anti-inflammatory group and the Western medicine control group, along with violin plots, are shown in Tables 5 and 5, respectively. Figure 5 .

[0116] Table 5 AQLQ Scores Note: Compared with the pre-treatment level in this group Compared with the control group after treatment △△ P < 0.01.

[0117] Through Table 5 and Figure 5 The results showed that the AQLQ score of the Jieyu Guben group was significantly higher after treatment than before treatment (P<0.01), and the AQLQ score after treatment was significantly different from that of the Western medicine control group (P<0.01). Although the Western medicine control group showed a slight increase after treatment, there was no statistical difference (P>0.05).

[0118] 2.4.2 Quantitative Scoring of Traditional Chinese Medicine Syndromes Based on the CARAS syndrome of lung and nose stagnation and lung and spleen qi deficiency, quantitative indicators for syndrome differentiation were established: the primary symptoms were wheezing, chest tightness, shortness of breath, cough, and clear nasal discharge, scored from 0 to 8 points; secondary symptoms included sputum production, itching, fatigue, and cyanosis, scored from 0 to 4 points; tongue and pulse were recorded but not scored. Higher scores indicated more severe related symptoms and more prominent syndrome characteristics. Specific data on the quantitative TCM syndrome differentiation scores for the relieving stagnation and consolidating the body group and the Western medicine control group, as well as violin plots, are shown in Tables 6 and 6, respectively. Figure 6 The specific data on the quantitative scores of TCM symptoms in the antidepressant and tonifying group and the Western medicine control group, as well as the violin diagrams, are shown in Table 7 and 8, respectively. Figures 7-14 .

[0119] Table 6 Quantitative Scoring of Traditional Chinese Medicine Syndromes Note: Compared with the pre-treatment level in this group Compared with the control group after treatment △△ P < 0.01.

[0120] Through Table 6 and Figure 6The results showed that the TCM syndrome quantitative score of the Jieyu Guben group decreased significantly after treatment compared with that before treatment (P<0.01), and the improvement in score was significantly better than that of the Western medicine control group, with a statistically significant difference (P<0.01). In contrast, there was no significant difference in the TCM syndrome quantitative score before and after treatment in the Western medicine control group. This suggests that the Jieyu Guben formula is more effective than the Western medicine control group in treating related syndromes based on syndrome differentiation.

[0121] Table 7 Quantitative Scoring of Traditional Chinese Medicine Symptoms Note: Compared with the pre-treatment level in this group Compared with the control group after treatment △△ P < 0.01.

[0122] Through Table 7 and Figures 7-14 The results showed that after treatment with Jieyugu, the symptoms of wheezing, chest tightness, shortness of breath, cough, runny nose, sputum, itching, fatigue, and cyanosis were significantly reduced compared with those before treatment (P<0.01). There was no statistically significant difference in runny nose between the two groups after treatment (P>0.05). The scores of other symptoms in Jieyugu were significantly lower than those in the Western medicine control group (P<0.01). There were no significant differences in any TCM symptoms before and after treatment in the Western medicine control group (P>0.05).

[0123] 2.4.3 Lung function test The pulmonary function test results of the antidepressant and tonifying group and the Western medicine control group are shown in Table 8. Figures 15-18 As shown.

[0124] Table 8. Results of Lung Function Tests Through Table 8 and Figures 15-18 The results showed that FEV1, FVC, FEV1 / FVC, and PEF in the antidepressant group were slightly higher than before treatment. In the western medicine control group, FVC and PEF were slightly higher than before treatment, while FEV1 and FEV1 / FVC were slightly lower. There were no statistically significant differences in FEV1, FVC, FEV1 / FVC, and PEF between the two groups before and after treatment (P>0.05), and there were also no statistically significant differences between the two groups after treatment (P>0.05).

[0125] 2.4.4 Exhaled Nitric Oxide Test (1) Exhaled nitric oxide (FeNO) test The FeNO test results of the antidepressant and antibacterial group and the Western medicine control group are shown in Table 9. Figure 19 As shown.

[0126] Table 9 Results of Nitric Oxide Measurement in Exhaled Breath Through Table 9 and Figure 19 The results showed that although FeNO levels tended to decrease before and after treatment in the Jieyu Guben group and the Western medicine control group, there were no statistically significant differences (P>0.05). There were also no significant differences between the two groups after treatment (P>0.05).

[0127] (2) Nasal exhaled nitric oxide (FnNO) test The FnNO test results of the antidepressant and antibacterial group and the Western medicine control group are shown in Table 10 and Figure 20 As shown.

[0128] Table 10 Results of nasal exhaled nitric oxide measurement Through Table 10 and Figure 20 The results showed no statistically significant difference in FnNO levels before and after treatment in the Jieyu Guben group and the Western medicine control group (P>0.05). There were also no significant differences between the two groups after treatment (P>0.05).

[0129] 2.4.5. Blood eosinophil (EOS) count The EOS test results of the antidepressant and tonifying group and the Western medicine control group are shown in Table 11 and Figure 21 As shown.

[0130] Table 11 Blood eosinophil count Note: Compared with the pre-treatment level in this group .

[0131] Through Table 11 and Figure 21 The results showed that the EOS count in the Jieyu Guben group was significantly lower after treatment than before treatment, with a statistically significant difference (P < 0.05); in the Western medicine control group, there was no statistically significant difference in EOS count before and after treatment (P > 0.05). There was no statistically significant difference in EOS count between the two groups after treatment (P > 0.05).

[0132] 2.4.6 Immunoglobulin E (IgE) The IgE test results of the antidepressant and antibacterial group and the Western medicine control group are shown in Table 12 and 12. Figure 22 As shown.

[0133] Table 12 IgE Determination Through Table 12 and Figure 22 The results showed no statistically significant difference between the two groups before and after IgE treatment (P>0.05), and there was also no statistically significant difference between the two groups after treatment (P>0.05).

[0134] 2.4.7 Interleukin-4 (IL-4) The IL-4 test results of the antidepressant and tonifying group and the Western medicine control group are shown in Table 13 and Figure 23 As shown.

[0135] Table 13 IL-4 Measurement Through Table 13 and Figure 23 The results showed no statistically significant difference in IL-4 levels before and after treatment in either group (P>0.05), and no statistically significant difference between the two groups after treatment (P>0.05).

[0136] 2.4.8 Interferon-γ (IFN-γ) The IFN-γ test results of the antidepressant and tonifying group and the Western medicine control group are shown in Table 14 and Figure 24 As shown.

[0137] Table 14 IFN-γ Measurement Through Table 14 and Figure 24 The results showed that the IFN-γ test results in the Jieyugu group were significantly higher after treatment than before treatment, with a statistically significant difference (P < 0.05); while there was no statistically significant difference in the IFN-γ test results before and after treatment in the Western medicine control group (P > 0.05). The IFN-γ value after treatment in the Jieyugu group was significantly higher than that in the Western medicine control group after treatment, and the difference between the two groups after treatment was statistically significant (P < 0.05).

[0138] 2.5 Safety Assessment and Adverse Events No serious adverse reactions were observed in either group. In the group receiving the antidepressant, one patient experienced loose, sticky stools, which they attributed to a potentially oily diet. No specific treatment was given, and the symptoms resolved spontaneously after 3 days; this was determined to be unrelated to the experimental intervention. In the Western medicine treatment group, one patient experienced insomnia, which resolved spontaneously after 2 days; this was determined to be unrelated to the experimental intervention. Another patient experienced abdominal distension, which resolved spontaneously after 3 days; this was also determined to be unrelated to the experimental intervention. During the trial, no significant abnormalities were observed in liver and kidney function, urinalysis, or electrocardiogram in either group. Mild gastrointestinal symptoms occurred in both groups, but these resolved spontaneously, and no further gastrointestinal discomfort occurred with continued medication; therefore, it was preliminarily determined that these symptoms were likely unrelated to the experimental drug.

[0139] 3. Research Summary and Discussion of Treatment Mechanisms 3.1 Understanding the Pathogenesis of Allergic Rhinitis-Asthma Syndrome from the Perspective of "Evil Qi Stagnation in the Lungs and Nose, and Deficiency of Lung and Spleen Qi" Allergic rhinitis-asthma syndrome falls under the category of "lung and nose as one disease" in Traditional Chinese Medicine (TCM). The nose is the orifice of the lungs, and the lungs are the root of the nose. When lung qi is abundant, pathogens cannot invade, and the nasal passages remain clear; a clear and sensitive nasal passage allows for the distinguishing of fragrances and odors and the defense against external pathogens. Conversely, when lung qi is deficient, the clear orifices cannot be opened, and the nose becomes weak, allowing pathogens to penetrate deeper. These two factors influence each other, creating a vicious cycle that ultimately leads to disease of both the root and the orifices. The lungs are the master of qi, and the spleen is the source of qi. When qi is deficient, the lungs fail to govern qi, resulting in respiratory dysfunction; the spleen fails to ascend clear qi, leading to the internal generation of phlegm and dampness. Over time, blood circulation becomes sluggish, phlegm and blood stasis accumulate, obstructing the airways, hindering qi flow, and gradually causing cough, wheezing, and nasal congestion. Therefore, the root cause of this disease is deficiency of the body's vital energy, with the primary location of the disease being the lungs and nose. In the early stages of the disease, lung qi deficiency is the primary symptom; in the chronic, persistent stage, lung and spleen qi deficiency is most common.

[0140] The deficiency in this disease differs from other diseases; it is always mixed with excess symptoms within the deficiency pattern. This is closely related to the "special constitution" of these patients. Individuals with a special constitution, while having congenital deficiencies, often have latent pathogenic factors lurking in the meridians. They appear normal most of the time, but are triggered by external factors. Because their symptoms are "frequent and changeable," "sticky phlegm in the diaphragm," and dark complexion of the lips, nails, and eyelids, the latent pathogenic factor is identified as "wind-phlegm-blood stasis." Initially, this latent pathogenic factor does not cause organic damage but lies dormant in the airways. When triggered by external factors, it often flares up, and the condition often resolves spontaneously or improves easily, leaving the patient feeling normal after recovery. However, with each flare-up or prolonged illness, the latent pathogenic factor gradually invades the lung meridians, causing qi stagnation. Prolonged airway spasm increases airway sensitivity; if treated promptly and effectively at this point, recovery is still possible. But if the condition repeatedly worsens, and the wind-phlegm-blood stasis pathogenic factors penetrate deeper, entering the blood and meridians, they erode and destroy the foundation of the airways, causing airway remodeling. In such cases, the disease becomes difficult to recover from, and respiratory function significantly declines. This progression from superficial to deep, from the surface to the core, and from easy recovery to deep-rooted symptoms, is precisely related to the concept of "stagnation" in Traditional Chinese Medicine (TCM). When pathogenic factors stagnate in the lungs and nose, the focus is on qi stagnation during acute attacks, phlegm stagnation during chronic episodes, and blood stagnation during the recovery period. Simultaneously, the presence of lung and spleen qi deficiency weakens the patient's immune function, often leading to recurrent attacks due to external pathogenic factors and weakened defensive qi.

[0141] Based on the above characteristics, the pathogenesis of chronic persistent allergic rhinitis-asthma syndrome is mainly characterized by "evil stagnation in the lungs and nose, and deficiency of lung and spleen qi".

[0142] 3.2 Clinical exploration of the antidepressant and root-strengthening formula in the treatment of allergic rhinitis-asthma syndrome This invention is based on the pathogenesis of chronic persistent allergic rhinitis-asthma syndrome (CARAS) caused by "evil stagnation in the lungs and nose, and deficiency of lung and spleen qi." Treatment focuses on relieving stagnation, clearing the nasal passages, and strengthening the body's resistance. A formula for relieving stagnation and strengthening the body's resistance has been developed. Unlike general phlegm-resolving and tonifying herbs, this formula addresses the complex pathogenesis of CARAS from multiple aspects, including "simultaneous lung and nose disease" and "deficiency-stagnation-phlegm-stasis." It encompasses the concept of "prevention before disease" and "preventing disease progression," covers the pathological products of wind, phlegm, and blood stasis, and targets the unique pathogenesis of "stagnation" in respiratory allergic diseases. The formula consists of four herbal pairs: Bupleurum, White Peony Root, and Angelica Root (from Xiaoyao San); Astragalus Root, Fried Atractylodes Rhizome, and Saposhnikovia Root (from Yupingfeng San); Perilla Leaf, Tangerine Peel, and Fritillaria Root (from Jiawei Xingsu San); and Magnolia Flower, Cicada Slough, and Raw Licorice Root (from Jiawei Cang'erzi San). This approach simultaneously strengthens the body's resistance and eliminates pathogenic factors, regulating both the root and the orifices.

[0143] The Xiaoyao San formula, originating from the Song Dynasty's *Taiping Huimin Heji Jufang*, uses Bupleurum as its principal ingredient to soothe the liver and relieve depression, and Angelica sinensis and Paeonia lactiflora as assistant ingredients to nourish the blood and soften the liver. Bupleurum is used in small doses, while Angelica sinensis and Paeonia lactiflora are used in slightly larger doses, aiming to "regulate Qi within the blood," thus minimizing the risk of "damaging liver Yin" while smoothing the flow of Qi. The Yupingfeng San formula, from *Jiuyuan Fang*, uses Astragalus membranaceus to tonify Qi and strengthen the exterior, Atractylodes macrocephala (fried) to strengthen the spleen and solidify the interior, and Saposhnikovia divaricata to ward off external pathogens, achieving the effect of strengthening the body's foundation and protecting the body's defenses. The Xingsu San formula, from *Wenbing Tiaobian*, uses Perilla frutescens to open the lungs and widen the chest, and Apricot kernel to lower Qi and resolve phlegm, one astringing and the other dispersing to regulate the flow of Qi. The original formula did not include Fritillaria cirrhosa, but later physicians often added it to enhance its lung-moistening and cough-relieving effects. Xanthium Fruit Powder originates from *Jisheng Fang*. It uses pungent and aromatic herbs to open the nasal passages. The original formula primarily used Xanthium Fruit and Magnolia Flower as the main ingredients, supplemented by Angelica dahurica, Mentha haplocalyx, and Glycyrrhiza uralensis. However, considering the slight toxicity of Xanthium Fruit, and the fact that later physicians often used Cicada Slough to open the nasal passages and soothe the throat, it was substituted. In this four-herb formula, Xiaoyao Powder is the chief herb, focusing on relieving stagnation; Yupingfeng Powder is the assistant herb, tonifying Qi and strengthening the body's foundation; and Jiawei Xanthium Fruit Powder and Jiawei Xingsu Powder are the adjuvant herbs, both opening the nasal passages and stopping coughs, and guiding the medicine to the lungs and nose. The entire formula works synergistically to relieve stagnation, open the nasal passages, strengthen the body's foundation, and support the body's vital energy.

[0144] 3.3. A prospective, randomized controlled clinical study has preliminarily confirmed that the present invention's antidepressant and tonifying formula has good safety and efficacy against CARAS.

[0145] The preliminary results of the aforementioned prospective, randomized controlled study confirm that the Jieyu Guben formula has a holistic therapeutic advantage in regulating CARAS, effectively improving disease control levels, increasing ACT scores, significantly reducing AS scores, significantly improving quality of life, and significantly alleviating clinical symptoms such as wheezing, chest tightness, shortness of breath, cough, runny nose, sputum production, itching, fatigue, and cyanosis. While the Western medicine control group also showed some improvement in CARAS control and quality of life, it did not significantly improve TCM syndromes and related symptoms. The Jieyu Guben formula proposed in this invention has significant efficacy in treating TCM-related lung and nose stagnation and lung and spleen qi deficiency, significantly alleviating related symptoms and demonstrating the unique advantages of TCM syndrome differentiation and treatment for CARAS.

[0146] In terms of mechanism, the IFN-γ value of the Jieyu Gubenfang group was significantly increased compared with that before treatment, and there was a significant difference in treatment compared with the Western medicine control group. The eosinophil count was improved compared with that before treatment, suggesting that the mechanism of action of Jieyu Gubenfang may be related to regulating immunity, increasing IFN-γ level, reducing eosinophil infiltration, and improving chronic airway inflammation, thereby promoting the recovery of patients and improving their quality of life.

[0147] Although embodiments of the invention have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A traditional Chinese medicine composition, characterized in that, Made from the following parts by weight of active pharmaceutical ingredient: Bupleurum chinense 3-10 parts, Angelica sinensis 6-15 parts, Paeonia lactiflora 6-15 parts, Magnolia biondii 6-15 parts, Cicadae periostracum 3-12 parts, Perilla frutescens 6-15 parts, Citrus reticulata 6-15 parts, Fritillaria cirrhosa 2-10 parts, Astragalus membranaceus 10-30 parts, Atractylodes macrocephala 10-30 parts, Saposhnikovia divaricata 6-12 parts, Glycyrrhiza uralensis 3-12 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, Made from the following parts by weight of active pharmaceutical ingredient: Bupleurum chinense 6 parts, Angelica sinensis 12 parts, raw Paeonia lactiflora 10 parts, Magnolia biondii 10 parts, Cicadae periostracum 10 parts, Perilla frutescens 12 parts, Citrus reticulata 12 parts, Fritillaria cirrhosa 6 parts, raw Astragalus membranaceus 15 parts, stir-fried Atractylodes macrocephala 15 parts, Saposhnikovia divaricata 10 parts, raw Glycyrrhiza uralensis 6 parts.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The dosage form of the traditional Chinese medicine composition is a decoction.

4. A traditional Chinese medicine preparation, characterized in that, The traditional Chinese medicine preparation includes the traditional Chinese medicine composition according to any one of claims 1-3.

5. The traditional Chinese medicine preparation according to claim 4, characterized in that, The traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients.

6. The traditional Chinese medicine preparation according to claim 5, characterized in that, The dosage forms of the traditional Chinese medicine preparations are decoctions, pills, lozenges, tablets, granules, powders, ointments, or capsules.

7. The traditional Chinese medicine preparation according to claim 6, characterized in that, The dosage form of the traditional Chinese medicine preparation is a decoction.

8. A method for preparing a traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, include: According to the proportion of raw materials in the traditional Chinese medicine composition, weigh each raw material and mix them. Soak for 30 minutes, then add water and decoct twice, each time for 30 minutes. Combine the filtrates from the two decoctions to obtain the traditional Chinese medicine composition.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for treating allergic rhinitis-asthma syndrome.

10. The use of the traditional Chinese medicine preparation according to any one of claims 4-7 in the preparation of a medicament for treating allergic rhinitis-asthma syndrome.

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