Traditional Chinese medicine composition for treating interstitial lung disease with fibrosis as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating interstitial lung disease with fibrosis and a preparation method and application thereof.The traditional Chinese medicine composition is prepared from, by weight, 5-15 parts of ginseng, 8-15 parts of radix asparagi, 10-20 parts of radix rehmanniae recen, 15-25 parts of astragalus membranaceus, 5-15 parts of schisandra chinensis, 15-25 parts of honey-fried radix asteris, 15-25 parts of honey-fried flos farfarae, 8-15 parts of curcuma zedoary, 8-15 parts of peach kernels and 8-15 parts of herba epimedii. , 15-30 parts of semen lepidii, 10-20 parts of fructus liquidambaris, and 10-20 parts of semen sinapis. The traditional Chinese medicine composition provided by the invention has the effects of strengthening vitality, reducing phlegm, activating blood, removing blood stasis and dredging collaterals, and can improve clinical symptoms of patients with interstitial lung diseases and fibrosis, improve life quality and delay disease progression.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating interstitial lung disease with fibrosis and a preparation method and application thereof. BACKGROUND

[0002] Interstitial lung disease (ILD) is a group of heterogeneous non-tumor and non-infectious lung diseases mainly involving the lung interstitium, alveoli, and or bronchioles, with diffuse lung parenchyma, alveolar inflammation and interstitial fibrosis as the basic pathological changes. The core mechanism of the disease is the persistent damage and abnormal repair of alveolar epithelium, leading to excessive deposition of extracellular matrix, and eventually forming irreversible pulmonary fibrosis scars. This process causes serious obstacles to gas exchange, and patients with respiratory difficulty show progressive aggravation. Most patients develop respiratory failure and die due to repeated or continuous progression of the disease. Globally, the incidence of ILD is increasing year by year, and it has become one of the important public health problems leading to respiratory disability and death.

[0003] Currently, the treatment of western medicine mainly focuses on anti-inflammatory and anti-fibrosis therapy. Anti-fibrosis drugs such as nintedanib and pirfenidone have been approved for marketing, but their efficacy is limited to delaying the decline in lung function, and there are significant gastrointestinal and light hypersensitivity side effects, and poor patient tolerance. In addition, these drugs cannot reverse the formed fibrosis lesions, and long-term use may cause abnormal liver and kidney function, making it difficult to improve the quality of life, and the disease burden is heavy, there is a large unmet medical need, and the prevention and control situation is becoming increasingly severe.

[0004] Traditional Chinese medicine shows unique advantages in the treatment of ILD. ILD can be attributed to "pulmonary obstruction", "pulmonary atrophy" and "cough and upper gas" in the theory of traditional Chinese medicine. Its etiology and pathogenesis are complex, mainly related to "deficiency", "phlegm" and "stasis", and traditional Chinese medicine has unique advantages in treating multiple targets and synergistic intervention, avoiding the liver and kidney toxicity and hormone-dependent risk of western medicine, and improving the safety of long-term medication. Therefore, it is essential to develop drugs for interstitial lung disease with fibrosis. SUMMARY

[0005] Therefore, the present application aims to provide a traditional Chinese medicine composition for treating interstitial lung disease with fibrosis and a preparation method and application thereof, to solve the liver and kidney toxicity and hormone-dependent risk of western medicine in the treatment of interstitial lung disease in the prior art.

[0006] To achieve the above-mentioned purpose, the technical scheme adopted by the present application is as follows.

[0007] The application provides a traditional Chinese medicine composition for treating interstitial lung disease with fibrosis, which comprises the following raw medicinal materials in parts by weight: 5-15 parts of ginseng, 8-15 parts of asparagus, 10-20 parts of radix rehmanniae, 15-25 parts of astragalus, 5-15 parts of schisandra chinensis, 15-25 parts of honeyed lily, 15-25 parts of honeyed comfrey, 8-15 parts of curcuma zedoaria, 8-15 parts of persicae semen, 8-15 parts of herba epimedii, 15-30 parts of semen lepidii, 10-20 parts of radix aconiti, and 10-20 parts of semen brassicae.

[0008] Interstitial lung disease is an advantage disease in TCM treatment, and TCM classifies ILD into "pulmonary obstruction", "pulmonary atrophy" and "cough and upper air" categories, the etiology and pathogenesis of which are complex, mainly due to deficiency of the essence of the kidney, and accumulation of phlegm and blood stasis, which is often manifested as shortness of breath, wheezing, especially when moving, and is often accompanied by cough, chest tightness and other symptoms. From the perspective of "lungs governing qi" and "essence of the kidney accumulating in the chest", when the lung loses the function of promoting and descending, and the essence of the kidney is not fixed, the external evil is easy to invade, and the disease is easy to relapse, the blood circulation is blocked, the pathological state of qi stagnation and phlegm obstruction and collateral stasis is formed, and the disease condition of ILD is repeated, the essence of the kidney is deficient throughout the whole process. TCM can play a unique advantage in the treatment of ILD. On the one hand, it can intervene in multiple targets, improve clinical symptoms, improve the quality of life, prevent disease progression and repeated exacerbation, on the other hand, it can avoid the risk of liver and kidney toxicity and hormone dependence of western medicine, improve the safety of long-term medication, and is easy to be accepted and adhered to by patients, and can provide a safer and more effective treatment option for patients.

[0009] In some embodiments of the application, the traditional Chinese medicine composition comprises the following raw medicinal materials in parts by weight: 5-12 parts of ginseng, 8-12 parts of asparagus, 12-18 parts of radix rehmanniae, 15-20 parts of astragalus, 5-10 parts of schisandra chinensis, 15-20 parts of honeyed lily, 15-20 parts of honeyed comfrey, 8-12 parts of curcuma zedoaria, 8-12 parts of persicae semen, 8-12 parts of herba epimedii, 15-20 parts of semen lepidii, 12-18 parts of radix aconiti, and 12-18 parts of semen brassicae.

[0010] In some embodiments of the application, the traditional Chinese medicine composition comprises the following raw medicinal materials in parts by weight: 10 parts of ginseng, 10 parts of asparagus, 15 parts of radix rehmanniae, 20 parts of astragalus, 10 parts of schisandra chinensis, 20 parts of honeyed lily, 15 parts of honeyed comfrey, 10 parts of curcuma zedoaria, 10 parts of persicae semen, 10 parts of herba epimedii, 20 parts of semen lepidii, 15 parts of radix aconiti, and 15 parts of semen brassicae.

[0011] The application further provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps: weighing raw medicinal materials of ginseng, asparagus, radix rehmanniae, astragalus, schisandra chinensis, honeyed lily, honeyed comfrey, curcuma zedoaria, persicae semen, herba epimedii, semen lepidii, radix aconiti and semen brassicae according to the proportion, extracting with water, and obtaining the traditional Chinese medicine composition.

[0012] In some embodiments of the application, the water is 5-8 times the amount of the raw medicinal materials.

[0013] In some embodiments of the present application, the extraction method is selected from any one of decoction, water heating reflux extraction or ultrasonic extraction.

[0014] In some embodiments of the present application, the extraction is performed for 1-3 times.

[0015] In some embodiments of the present application, each extraction is performed for 0.5-1 h.

[0016] In some embodiments of the present application, when the decoction method is used for extraction, each extraction is performed by first boiling with strong fire and then decocting with weak fire; the boiling time with strong fire is 0.3-0.5 h, and the decocting time with weak fire is 0.1-0.5 h.

[0017] The present application also provides a medicine for treating interstitial lung disease with fibrosis, wherein the Chinese medicinal composition is used as an active ingredient.

[0018] In some embodiments of the present application, the medicine further comprises a pharmaceutically acceptable excipient.

[0019] In some embodiments of the present application, the pharmaceutically acceptable excipient comprises at least one of an excipient, a filler, a diluent, a lubricant, a disintegrant, a colorant, a flavoring agent, a humectant, a suspending agent, an emulsifying agent and a preservative.

[0020] In some embodiments of the present application, one or more of maltodextrin, honey, stearic acid or sodium carboxymethyl cellulose is used.

[0021] In some embodiments of the present application, the medicine is in the form of decoction, granules, pills, capsules, tablets, powder or oral liquid.

[0022] In some embodiments of the present application, an excipient is added to the Chinese medicinal composition to prepare the Chinese medicinal composition into pills, capsules, tablets, granules or powder.

[0023] The present application also provides use of the Chinese medicinal composition in the preparation of a medicine for treating interstitial lung disease with fibrosis.

[0024] The Chinese medicinal composition provided by the present application is a self-formulated prescription established by Professor Lin Lin, a famous TCM doctor in Guangdong Province, based on his experience and the pathogenesis characteristics of patients with interstitial lung disease with fibrosis, and based on the TCM pathogenesis characteristics of "deficiency of Zong Yuan and mutual knotting of phlegm and blood stasis".

[0025] The monarch drug: ginseng, radix asparagi and radix rehmanniae.

[0026] Ginseng is sweet and slightly bitter in taste, and warm in nature, and is good at tonifying the primordial qi, benefiting the lung and invigorating the spleen, generating saliva and astringing.

[0027] Radix asparagi is sweet and bitter in taste, and cold in nature, and is good at nourishing yin and reducing fire, moistening dryness and generating saliva.

[0028] Rehmanniae Radix tastes sweet and bitter, and is cold in nature, which can clear heat and cool blood, nourish yin and generate fluid.

[0029] The three herbs are used together, with Ginseng tonifying qi to build up the vital essence, Rehmanniae Radix clearing heat to nourish yin, and Radix Asparagi nourishing yin to moisten dryness. The three herbs are used together to tonify qi and nourish yin, and to moisten the lung, spleen and kidney. When the qi is sufficient, the yin fluid is abundant, and the yang qi is attached to the yin, the effect of building up the vital essence and consolidating the foundation is achieved.

[0030] Minors: Astragalus, Schisandra, honeyed Tuber Fleeceflower, honeyed Radix Ilicis Rotundae, Rhizoma Curcumae and Semen Persicae.

[0031] Astragalus tastes sweet and is warm in nature, which is the source of the vital essence, and has the function of tonifying the vital essence, benefiting the defensive aspect and consolidating the exterior; Schisandra tastes sour and sweet, and is warm in nature, which can astringe the lung to stop cough, benefit qi and generate fluid, and tonify the kidney to calm the heart. The two herbs are used together to tonify the lung and kidney, and to make the vital essence abundant, which can absorb qi and relieve asthma.

[0032] Honeyed Tuber Fleeceflower tastes bitter and is warm in nature, and its moistening property is enhanced after honeyed processing, which can moisten the lung, resolve phlegm, stop cough and relieve asthma; honeyed Radix Ilicis Rotundae tastes bitter and is warm in nature, which has the function of moistening the lung, relieving cough and resolving phlegm. The two herbs are used together to moisten the lung, resolve phlegm, stop cough and relieve asthma, and when the phlegm is resolved, the qi is smooth.

[0033] Rhizoma Curcumae tastes bitter and is warm in nature, which is good at resolving the lung collaterals and blood stasis, and promoting the flow of qi; Semen Persicae tastes bitter and sweet, and is neutral in nature, which has the function of activating blood and resolving stasis, and moistening the intestines to promote defecation. The two herbs are used together to resolve stasis and promote the flow of qi, activate blood and resolve collaterals, and when the stasis is resolved, the new blood is generated, the flow of qi and blood is smooth, and the lung collaterals are moistened and nourished.

[0034] Overall, honeyed Tuber Fleeceflower and honeyed Radix Ilicis Rotundae are used to regulate the upper jiao, Astragalus is used to regulate the middle jiao, Schisandra is used to consolidate the lower jiao, and Rhizoma Curcumae and Semen Persicae are used to resolve stasis and promote the flow of qi, which runs through the three jiaos, coordinates the flow of qi and blood, and smoothens the lung collaterals.

[0035] Adjuvants: Herba Epimedii, Semen Platycladi and Lapis Lapis Lazuli.

[0036] Herba Epimedii tastes bitter and is warm in nature, which tonifies kidney yang and helps to invigorate the vital essence in the kidney, and promote the circulation of the vital essence;

[0037] Semen Platycladi tastes bitter and is cold in nature, which is good at resolving phlegm and relieving asthma, and enhances the function of stopping cough and relieving asthma;

[0038] Lapis Lapis Lazuli tastes bitter and is neutral in nature, which promotes the flow of collaterals, especially the flow of the twelve meridians, and regulates the qi movement of the five zang organs and six fu organs, which has the effect of tonifying by promoting the flow, and helps the vital essence and the vital essence to circulate smoothly, and the vital essence and the vital essence to recover.

[0039] Minors: Semen Raphani.

[0040] Mustard seeds are pungent and warm in nature, and they penetrate into the lungs, warming the lungs and resolving phlegm, promoting qi circulation and dispersing stagnation, and clearing the meridians and relieving pain. They are good at removing phlegm and blood stasis, and restoring the circulation of qi. Ye Tianshi said in "Clinical Guide to Medical Cases": "Without pungent and fragrant herbs, nothing can enter the meridians." Mustard seeds can guide other medicines directly to the lung meridians and exert their function of guiding and clearing the meridians.

[0041] Furthermore, clinical trials of the aforementioned traditional Chinese medicine composition have shown that it can effectively improve the clinical symptoms of patients with interstitial lung disease and fibrosis, enhance their quality of life, and slow disease progression.

[0042] Based on the technical solution of this invention, compared with the prior art, this invention has the following beneficial effects: The traditional Chinese medicine composition of this invention has the effects of nourishing the body's vital energy, resolving phlegm and promoting blood circulation, and removing blood stasis and unblocking the meridians. Clinical trials show that this composition can improve the clinical symptoms of patients with interstitial lung disease and fibrosis, improve their quality of life, and delay disease progression. Attached Figure Description

[0043] Figure 1 A bar chart comparing VAS scores for cough before and after treatment.

[0044] Figure 2 A bar chart comparing the VAS scores for cough and sputum before and after treatment.

[0045] Figure 3 A bar chart comparing the VAS scores for asthma before and after treatment.

[0046] Figure 4 A bar chart comparing VAS scores for chest tightness before and after treatment.

[0047] Figure 5 A bar chart comparing CAT scores before and after treatment.

[0048] Figure 6 A bar chart comparing SGRQ scores before and after treatment; where, Figure 6 In the figure, A represents the bar chart of the statistical results of respiratory symptom scores; Figure 6 B in the chart represents the bar chart of the scoring statistics for activity restrictions; Figure 6 C in the figure represents the bar chart of the statistical results of the disease impact score; Figure 6 D in the chart represents the total score in a bar chart.

[0049] Figure 7 A bar chart comparing anxiety and depression scores before and after treatment; among them, Figure 7 In the figure, A represents the statistical results of the anxiety score in a bar chart; Figure 7 B in the figure represents the bar chart of the statistical results of the depression score. Detailed Implementation

[0050] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the embodiments in the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art without creative effort belong to the protection scope of the present application.

[0051] The present application will be described below with reference to specific embodiments.

[0052] Embodiment 1: A traditional Chinese medicine composition for treating interstitial lung disease with fibrosis and a preparation method thereof

[0053] A traditional Chinese medicine composition for treating interstitial lung disease with fibrosis, which is composed of the following raw medicinal materials by weight: 10g of ginseng, 10g of asparagus, 15g of radix rehmanniae, 20g of astragalus, 10g of schisandra, 20g of honeyed radix trichosanthis, 15g of honeyed flos callicarpae, 10g of curcuma, 10g of persica, 10g of epimedium, 20g of semen lepidii, 15g of lycium, and 15g of semen brassicae.

[0054] The preparation method of the traditional Chinese medicine composition for treating interstitial lung disease with fibrosis described above comprises the following steps:

[0055] The ginseng, asparagus, radix rehmanniae, astragalus, schisandra, honeyed radix trichosanthis, honeyed flos callicarpae, curcuma, persica, epimedium, semen lepidii, semen lycii, and semen brassicae are weighed according to the proportion, and then boiled twice with water. The filtrates are combined to obtain the traditional Chinese medicine composition for treating interstitial lung disease with fibrosis. 5 times the amount of water by weight of the raw medicinal materials is added each time for boiling, and the water is boiled for 0.5h with a strong fire, and then boiled for 0.5h with a weak fire. Filtration is performed to obtain the filtrate.

[0056] Embodiment 2: A traditional Chinese medicine composition for treating interstitial lung disease with fibrosis and a preparation method thereof

[0057] A traditional Chinese medicine composition for treating interstitial lung disease with fibrosis, which is composed of the following raw medicinal materials by weight: 5g of ginseng, 8g of asparagus, 10g of radix rehmanniae, 15g of astragalus, 5g of schisandra, 15g of honeyed radix trichosanthis, 15g of honeyed flos callicarpae, 8g of curcuma, 8g of persica, 8g of epimedium, 15g of semen lepidii, 10g of lycium, and 10g of semen brassicae.

[0058] The preparation method of the traditional Chinese medicine composition for treating interstitial lung disease with fibrosis described above comprises the following steps:

[0059] The ginseng, asparagus, radix rehmanniae, astragalus, schisandra, honeyed radix trichosanthis, honeyed flos callicarpae, curcuma, persica, epimedium, semen lepidii, semen lycii, and semen brassicae are weighed according to the proportion, and then boiled twice with water. The filtrates are combined to obtain the traditional Chinese medicine composition for treating interstitial lung disease with fibrosis. 6 times the amount of water by weight of the raw medicinal materials is added each time for boiling, and the water is boiled for 0.3h with a strong fire, and then boiled for 0.2h with a weak fire. Filtration is performed to obtain the filtrate.

[0060] Example 3: A traditional Chinese medicine composition for treating interstitial lung disease with fibrosis and a preparation method thereof

[0061] A traditional Chinese medicine composition for treating interstitial lung disease with fibrosis, which is composed of the following raw medicinal materials by weight: 12g of ginseng, 12g of asparagus, 18g of radix rehmanniae, 20g of astragalus, 10g of schisandra, 20g of honeyed radix trichosanthis, 20g of honeyed flos callicephalae, 12g of curcuma, 12g of persica, 12g of herba epimedii, 20g of semen platycladi, 18g of lycopodium, and 18g of semen brassicae.

[0062] The preparation method of the traditional Chinese medicine composition for treating interstitial lung disease with fibrosis described above comprises the following steps:

[0063] The ginseng, asparagus, radix rehmanniae, astragalus, schisandra, honeyed radix trichosanthis, honeyed flos callicephalae, curcuma, persica, herba epimedii, semen platycladi, lycopodium, and semen brassicae are weighed according to the proportion, and then boiled twice with water. The filtrates are combined to obtain the traditional Chinese medicine composition for treating interstitial lung disease with fibrosis. 8 times the amount of water of the raw medicinal materials is added each time, and boiled for 0.4h with a strong fire, then changed to a weak fire for 0.1h, and filtered to obtain the filtrate.

[0064] Example 4: A traditional Chinese medicine composition for treating interstitial lung disease with fibrosis and a preparation method thereof

[0065] A traditional Chinese medicine composition for treating interstitial lung disease with fibrosis, which is composed of the following raw medicinal materials by weight: 15g of ginseng, 15g of asparagus, 20g of radix rehmanniae, 25g of astragalus, 15g of schisandra, 25g of honeyed radix trichosanthis, 25g of honeyed flos callicephalae, 15g of curcuma, 15g of persica, 15g of herba epimedii, 30g of semen platycladi, 20g of lycopodium, and 20g of semen brassicae.

[0066] The preparation method of the traditional Chinese medicine composition for treating interstitial lung disease with fibrosis described above comprises the following steps:

[0067] The ginseng, asparagus, radix rehmanniae, astragalus, schisandra, honeyed radix trichosanthis, honeyed flos callicephalae, curcuma, persica, herba epimedii, semen platycladi, lycopodium, and semen brassicae are weighed according to the proportion, and then boiled twice with water. The filtrates are combined to obtain the traditional Chinese medicine composition for treating interstitial lung disease with fibrosis. 8 times the amount of water of the raw medicinal materials is added each time, and boiled for 0.4h with a strong fire, then changed to a weak fire for 0.1h, and filtered to obtain the filtrate.

[0068] Efficacy verification of the traditional Chinese medicine composition for treating interstitial lung disease with fibrosis:

[0069] 1. Clinical data

[0070] 1.1 Diagnostic criteria

[0071] The diagnosis of interstitial lung disease with fibrosis refers to the 2002 American Thoracic Society (ATS) and European Respiratory Society (ERS) expert consensus, the 2015 ERS / ATS official research consensus: interstitial pneumonia with autoimmune features (IPAF), the 2018 Chinese expert consensus on the diagnosis and treatment of connective tissue disease-related interstitial lung disease, and the 2022 version of adult idiopathic pulmonary fibrosis (update) and progressive pulmonary fibrosis: ATS / ERS / JRS / ALAT clinical practice guidelines.

[0072] 1.2 Inclusion criteria

[0073] ①No gender limit, age ≥18 years old;

[0074] ②Meet the diagnostic criteria for interstitial lung disease with fibrosis; TCM syndrome differentiation is Zongyuan deficiency and phlegm and blood stasis;

[0075] ③Volunteer to participate, can provide detailed and effective contact information, and willing to cooperate with follow-up.

[0076] 1.3 Exclusion criteria

[0077] ①Combined with severe cardiovascular, hematological, liver and kidney dysfunction, etc.

[0078] ②Patients with mental illness who cannot cooperate with the study;

[0079] ③Acute infectious diseases;

[0080] ④Allergic to drugs contained in the treatment plan;

[0081] ⑤Pregnant, planning to get pregnant and lactating patients.

[0082] 1.4 Withdrawal criteria

[0083] ①Dropouts / lost to follow-up during the study;

[0084] ②Cases meeting the inclusion criteria who developed serious adverse events during the trial;

[0085] ③Patients with poor compliance, who did not return for follow-up or did not take medication as required, with a cumulative medication time of less than 8 weeks.

[0086] 1.5 Case source

[0087] From September 2024 to April 2025, interstitial lung disease with fibrosis patients who visited the respiratory department of Guangdong Provincial Hospital of Traditional Chinese Medicine.

[0088] 1.6 Clinical data

[0089] 32 cases of interstitial lung disease with fibrosis patients who met the inclusion criteria were included in the prospective case study.

[0090] 2. Method

[0091] 2.1 Treatment method

[0092] In this application, the traditional Chinese medicine compositions provided in Examples 1-4 can achieve the effect of treating interstitial lung disease with fibrosis. In this efficacy verification, the enrolled patients were treated with the traditional Chinese medicine composition in Example 1, and the drug dosage form was Guangdong Provincial Hospital of Traditional Chinese Medicine Herbal Medicine, decocted with water, 1 dose per day, taken twice a day before and after lunch, about 250-300 mL each time.

[0093] 2.2 Treatment course

[0094] The treatment cycle is 3 months. Patients who are not convenient to regularly visit the hospital can make an appointment through the hospital internet platform. According to the situation, fill in the inquiry table and clinical case observation table, and add or subtract drugs according to the symptoms.

[0095] 2.3 Follow-up

[0096] All patients are followed up from the beginning of treatment. In the early stage, patients with interstitial lung disease with fibrosis are popularized about the knowledge of this disease, so that patients can fully understand the characteristics of the disease, and be informed of the importance of regular review and follow-up. The follow-up method is mainly outpatient follow-up. For patients who are in other places or inconvenient to come to the hospital, follow-up is carried out through telephone, WeChat, network platform and other forms. Review data is followed up by clear photography or through mailing. All patients need to fill in the clinical case observation table.

[0097] 2.4 Observation index

[0098] 2.4.1 General information

[0099] Gender, age, occupation history, smoking history, allergy history, foreign body contact history, disease duration, past medical history, family history, and past treatment history, etc.

[0100] 2.4.2 Visual analogue scale (VAS)

[0101] The subjects are required to describe the severity of the four items of cough, sputum, asthma and chest tightness in the past 48 hours. Each subject marks the corresponding scale on the line segment marked 0-10 cm according to their own feelings to represent the severity of cough, sputum, asthma and chest tightness. Among them, 0 represents no symptoms at all, and 10 represents unbearable severe symptoms. The distance between the left end of the line segment and the mark is the severity of the patient's cough, sputum, asthma and chest tightness.

[0102] The improvement of cough, sputum, asthma and chest tightness before and after treatment was evaluated before and after treatment, and the scale was filled in for self-evaluation.

[0103] 2.4.3 COPD Assessment Test score (CAT)

[0104] A comprehensive assessment of the respiratory symptoms of the subject, mainly used to evaluate the health status of patients with chronic respiratory diseases, mainly including 8 items of cough, expectoration, chest tightness, activity capacity, daily life ability, going-out ability, sleep and energy. Each item is scored by a 6-point scale (0 for no impact, 5 for extremely severe impact), with a total score ranging from 0 to 40, of which 0-10 is mild impact, 11-20 is moderate impact, 21-30 is severe impact, and 31-40 is very severe impact.

[0105] 2.4.4 Modified British Medical Research Council (mMRC) Dyspnea Questionnaire

[0106] Modified from the British Medical Research Council, it is a 5-point scale used to evaluate dyspnea, which is simple and practical. According to the activity level of the patient when shortness of breath occurs, it is divided into 0-4 grades, 0 grade means no symptoms, and 4 grade means dyspnea even at the slightest activity.

[0107] 2.4.5 St. George's Respiratory Questionnaire (SGRQ)

[0108] Designed by four scholars from the Medical School of St. George's University in the UK in 1991, it is used to measure the impact of chronic airflow limitation diseases on the quality of life of patients, which is divided into 3 dimensions of respiratory symptoms, activity limitation and disease impact. The respiratory symptom dimension assesses the frequency, severity and interference of respiratory symptoms on life, with a total of 12 items. The activity limitation dimension assesses the decline in daily activity capacity caused by the disease, with a total of 8 items. The disease impact dimension assesses the comprehensive impact of the disease on the patient's psychological state, social function and overall quality of life, with a total of 30 items, which is the most comprehensive dimension. Each item selects the corresponding option according to the actual situation of the patient (such as "never / occasionally / often / always"), and different options correspond to different weight scores. The scores of each dimension and the total score are converted into standard scores of 0-100, and the higher the score, the greater the impact on daily life and the worse the quality of life.

[0109] 2.4.6 Generalized Anxiety Disorder 7-item scale (GAD-7)

[0110] The GAD-7 consists of seven items designed to assess how often patients have experienced anxiety over the past two weeks. These seven items are: 1. Feeling tense, anxious, or restless; 2. Inability to stop or control worry; 3. Excessive worry about various things; 4. Difficulty relaxing; 5. Difficulty sitting still due to restlessness; 6. Becoming easily irritable or impatient; and 7. Feeling afraid, as if something terrible is about to happen. Each item is rated on a 4-point scale from 0 to 3. The scores for all seven items are added together, resulting in a total score of 0 to 21. A score of 5 to 9 indicates mild anxiety, 10 to 14 indicates moderate anxiety, and 15 to 21 indicates severe anxiety.

[0111] 2.4.7 Depression Rating Scale (PHQ-9)

[0112] The PHQ-9 consists of nine items and aims to understand how often a patient has been troubled by the following nine issues over the past two weeks: 1. Lack of motivation or interest in activities; 2. Feeling depressed, frustrated, or hopeless; 3. Difficulty speaking, restless sleep, or excessive sleep; 4. Feeling tired or lacking energy; 5. Loss of appetite or overeating; 6. Feeling inadequate or disappointing oneself or family; 7. Difficulty concentrating, such as when reading or watching television; 8. Slowed movement or speech to the point that others notice, or conversely, more restless or fidgety than usual; 9. Thoughts of dying or harming oneself. Each item is rated on a 4-point scale from 0 to 3. The total score is 0 to 27, with 5-9 indicating mild depression, 10-14 indicating moderate depression, 15-19 indicating moderate to severe depression, and 20-27 indicating severe depression.

[0113] 2.5. Statistical Analysis

[0114] Quantitative data are expressed as mean ± standard deviation. Data were described using mean ± standard deviation (±s), and count data were described using rates or percentages. Normality was tested for all variables. For normally distributed continuous data, paired-samples t-tests were used to compare pre- and post-treatment data; for non-normally distributed data, Wilcoxon signed-rank test was used. For count data, chi-square test or Fisher's exact test was used to compare pre- and post-treatment data. A p-value < 0.05 was considered statistically significant.

[0115] 3. Results

[0116] 3.1 Baseline Data

[0117] Thirty-two patients were included, of whom 18 were male (56.25%) and 14 were female (43.75%). Baseline characteristics showed that the mean age of the included patients was 65.19 ± 10.54 years.

[0118] 3.2 Effectiveness Results

[0119] 3.2.1 VAS Scores

[0120] 3.2.1.1 Cough VAS Scores

[0121] Results are shown in Table 1 and Figure 1 As shown in Table 1 and

[0122] Table 1. Comparison of Cough VAS Scores Before and After Treatment (n=32)

[0123]

[0124] Note: Wilcoxon signed rank test was used for comparison before and after.

[0125] 3.2.1.2 Sputum VAS Scores

[0126] Results are shown in Table 2 and Figure 2 As shown in Table 2 and

[0127] Table 2. Comparison of Sputum VAS Scores Before and After Treatment (n=32)

[0128]

[0129] Note: Wilcoxon signed rank test was used for comparison before and after.

[0130] 3.2.1.3 Breathlessness VAS Scores

[0131] Results are shown in Table 3 and Figure 3 As shown in Table 3 and

[0132] Table 3. Comparison of Breathlessness VAS Scores Before and After Treatment (n=32)

[0133]

[0134] Note: Wilcoxon signed rank test was used for comparison before and after.

[0135] 3.2.1.4 Chest Tightness VAS Scores

[0136] Results Table 4 and Figure 4 The VAS score of chest tightness of 32 patients with interstitial lung disease with fibrosis was significantly decreased after treatment (1.28±0.96) compared with that before treatment (1.78±1.31) (P<0.01), and the difference was statistically significant.

[0137] Table 4 Comparison of VAS scores of chest tightness before and after treatment (n=32)

[0138]

[0139] Note: Wilcoxon signed rank test was used for comparison before and after treatment.

[0140] 3.2.2 CAT score

[0141] Results Table 5 and Figure 5 The CAT score of 32 patients with interstitial lung disease with fibrosis was significantly decreased after treatment (6.50±3.46) compared with that before treatment (9.97±4.63) (P<0.01), and the difference was statistically significant.

[0142] Table 5 Comparison of CAT scores before and after treatment (n=32)

[0143]

[0144] Note: Wilcoxon signed rank test was used for comparison before and after treatment.

[0145] 3.2.3 SGRQ score

[0146] Results Table 6 and Figure 6 A~D show that the SGRQ respiratory symptom score of 32 patients with interstitial lung disease with fibrosis was significantly decreased after treatment (27.50±14.34) compared with that before treatment (35.97±17.06) (P<0.01), the SGRQ activity limitation score after treatment (26.75±21.45) was significantly lower than that before treatment (30.34±21.77) (P<0.01), the SGRQ disease impact score after treatment (20.59±17.01) was significantly lower than that before treatment (27.56±19.45) (P<0.01), the SGRQ total score after treatment (23.41±17.18) was significantly lower than that before treatment (29.69±18.90) (P<0.01), and the differences were statistically significant.

[0147] Table 6 Comparison of SGRQ scores before and after treatment (n=32)

[0148]

[0149] Note: Wilcoxon signed rank test was used for comparison before and after treatment

[0150] 3.2.4 Anxiety and depression scores

[0151] Results A and B in Table 7 and Figure 7 show that the anxiety score of 32 patients with interstitial lung disease with fibrosis after treatment (2.75±2.60) was significantly lower than that before treatment (3.41±2.96) (P<0.01), and the depression score after treatment (2.91±1.99) was significantly lower than that before treatment (4.38±2.88) (P<0.01), and the difference was statistically significant.

[0152] Table 7 Comparison of anxiety and depression scores before and after treatment (n=32)

[0153]

[0154] Note: Wilcoxon signed rank test was used for comparison before and after treatment.

[0155] 4. Discussion

[0156] Interstitial lung disease is a general term for diffuse "interstitial- parenchymal" lesions in the lung caused by various causes, with more than 200 causes. Most ILD patients are accompanied by pulmonary fibrosis, and the lung interstitial tissue loses its original diastolic function, resulting in restrictive ventilation dysfunction and diffusion dysfunction. Pulmonary function declines progressively, and dyspnea worsens progressively. Ultimately, patients will die of respiratory failure due to repeated or aggravated progression of the disease. The global incidence of ILD is on the rise, and its diagnosis and treatment will be a major challenge in the field of respiratory system.

[0157] ILD has no specific clinical manifestations, diverse imaging characteristics, and lacks precise indicators for diagnosis and treatment, which is a difficult point in the diagnosis and treatment of respiratory diseases. Currently, the treatment of Western medicine mainly focuses on anti-inflammatory and anti-fibrosis therapy. Nintedanib and pirfenidone, anti-fibrosis drugs, have been approved for marketing, but their efficacy is limited to delaying the decline in pulmonary function, and they have significant gastrointestinal and light hypersensitivity side effects. Patients often stop taking the drugs due to intolerance of drug side effects, affecting the overall treatment effect. In addition, these drugs cannot reverse the already formed fibrotic lesions, and long-term use may cause abnormal liver and kidney function, making it difficult to improve the quality of life, and the disease burden is heavy. There is a large unmet medical need, and the prevention and control situation is becoming increasingly severe. Therefore, it is crucial to develop drugs for interstitial lung disease with fibrosis.

[0158] Chinese medicine classifies ILD into "pulmonary obstruction", "pulmonary atrophy" and "cough and upper respiratory" categories, and its etiology and pathogenesis are complex, often manifested as shortness of breath and wheezing, especially when moving, which can be accompanied by cough, chest tightness and other symptoms. From the perspective of "lungs governing qi" and "qi accumulating in the chest", when the lung fails to promote, descend and fix the qi, the external pathogen is easy to invade, the qi and blood circulation is blocked, and the pathological state of qi stagnation and phlegm obstruction is formed. Moreover, ILD is recurrent, and the vital qi is consumed in long-term illness, and the deficiency of the root and the source is throughout. Chinese medicine can play a unique advantage in the treatment of ILD. On the one hand, it can intervene in multiple targets to improve clinical symptoms, improve quality of life, prevent disease progression and repeated exacerbation. On the other hand, it can avoid the risk of liver and kidney toxicity and hormone dependence of western medicine, improve the safety of long-term medication, and is easy for patients to accept and adhere to, providing a safer and more effective treatment option for patients.

[0159] Chinese medicine believes that the pathogenesis of ILD is mainly deficiency of the root and the source, and phlegm and blood stasis are combined. The treatment of chronic respiratory diseases represented by ILD needs to be based on the method of "cultivating and supporting the root and the source". While eliminating evil and regulating qi, the root qi is supplemented to strengthen the center, and the original qi is warmed to fix the root. From the whole, the physical fitness, lung function and immune defense ability of the patient are improved, the disease progression is effectively delayed, and the risk of acute exacerbation is reduced. The traditional Chinese medicine compound of the present application is an experienced prescription developed by Professor Lin Lin through clinical observation of patients and combined with the physiological and pathological basis of ILD disease. It is targeted to treat patients with interstitial lung disease with fibrosis.

[0160] The results show that the traditional Chinese medicine compound aiming at the core pathogenesis of "deficiency of the root and the source, and phlegm and blood stasis in the collateral" can improve clinical symptoms, improve quality of life, delay disease progression, and patients have no obvious adverse reactions during treatment, so it is worth further research and promotion.

[0161] Each technical feature of the above-described embodiments can be combined arbitrarily, and to make the description concise, each technical feature in the above embodiments is not described in all possible combinations, but as long as the combination of these technical features does not exist contradictory, it should be considered as the scope of the present application.

[0162] The above-described embodiments only express several implementation manners of the present application, and the description is more specific and detailed, but it should not be understood as a limitation on the scope of the present application. It should be pointed out that for ordinary skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which are all within the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the appended claims.

Claims

1. A traditional Chinese medicine composition for treating interstitial lung disease with fibrosis, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: ginseng 5-15 parts, asparagus root 8-15 parts, rehmannia root 10-20 parts, astragalus root 15-25 parts, schisandra fruit 5-15 parts, honey-processed aster root 15-25 parts, honey-processed coltsfoot flower 15-25 parts, turmeric root 8-15 parts, peach kernel 8-15 parts, epimedium root 8-15 parts, lepidium seed 15-30 parts, luffa fruit 10-20 parts, and mustard seed 10-20 parts.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: ginseng 5-12 parts, asparagus root 8-12 parts, rehmannia root 12-18 parts, astragalus root 15-20 parts, schisandra fruit 5-10 parts, honey-processed aster root 15-20 parts, honey-processed coltsfoot flower 15-20 parts, turmeric root 8-12 parts, peach kernel 8-12 parts, epimedium root 8-12 parts, lepidium seed 15-20 parts, luffa fruit 12-18 parts, and mustard seed 12-18 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts ginseng, 10 parts asparagus root, 15 parts rehmannia root, 20 parts astragalus root, 10 parts schisandra fruit, 20 parts honey-processed aster root, 15 parts honey-processed coltsfoot flower, 10 parts turmeric root, 10 parts peach kernel, 10 parts epimedium root, 20 parts lepidium seed, 15 parts luffa fruit, and 15 parts mustard seed.

4. The method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, include: Weigh out the raw materials ginseng, asparagus root, rehmannia root, astragalus root, schisandra fruit, honey-processed aster root, honey-processed coltsfoot flower, turmeric root, peach kernel, epimedium root, lepidium seed, luffa fruit, and mustard seed according to the specified ratio, and extract with water to obtain the final product.

5. The preparation method according to claim 4, characterized in that, The amount of water is 5 to 8 times the weight of the raw drug.

6. The preparation method according to claim 4, characterized in that, The extraction method can be selected from any one of the following: decoction, water heating and reflux, or ultrasonic extraction.

7. The preparation method according to claim 6, characterized in that, The number of extractions is 1 to 3.

8. A drug for treating interstitial lung disease with fibrosis, characterized in that, The drug comprises the traditional Chinese medicine composition according to any one of claims 1 to 3 as the active ingredient and pharmaceutically acceptable excipients.

9. The medicament as described in claim 8, characterized in that, The dosage form of the drug is decoction, granules, pills, capsules, tablets, powders, or oral liquid.

10. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating interstitial lung disease with fibrosis.

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