A traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, and its preparation method and application

Abstract

The present invention discloses a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, comprising the following raw materials in parts by weight: 6-12 parts of roasted ephedra, 6-12 parts of scutellaria baicalensis seeds, 6-12 parts of perilla seeds, 6-12 parts of peucedanum peucedanum, 20-30 parts of pyrrosia odoratum, 20-30 parts of cyperus rotundus, 9-15 parts of pumice, 6-12 parts of sophora flavescens, 9-15 parts of geranium herb, 6-10 parts of earthworm, 6-12 parts of uncaria, 6-12 parts of thunbergia thunbergii, and 3-9 parts of liquorice. The present invention, through the combination of the above components and proportions, in combination with a specific extraction method, provides a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, with the technical advantages of simple formulation, rapid effect, strong efficacy, and no toxic side effects.

Description

Technical field:

[0001] The present invention belongs to the technical field of traditional Chinese medicine formulas, and particularly relates to a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, and a preparation method and application thereof. Background technology:

[0002] Chronic obstructive pulmonary disease (COPD) is a common chronic disease characterized by chronic bronchitis and / or emphysema with airflow obstruction, which can further develop into cor pulmonale and respiratory failure. It is associated with an abnormal inflammatory response to harmful gases and particles, resulting in high disability and mortality rates. The global incidence rate in people over 40 years old has reached 9% to 10%. The Global Initiative for Chronic Obstructive Pulmonary Disease (GIOPD) 2023 defines AECOPD as follows: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an acute event in which COPD patients experience worsening dyspnea and / or cough and sputum production. Symptom worsening occurs within 14 days and may be accompanied by shortness of breath and / or tachycardia. It is often caused by respiratory infections, air pollution that exacerbates local or systemic inflammatory responses, or other causes of airway damage. Symptoms include coughing, expectoration, shortness of breath, chest tightness, and dyspnea, along with increased sputum production that is purulent or mucopurulent, fever, general fatigue, abdominal distension, and poor appetite. Some patients even experience sitting up for breath and are unable to lie flat. Treatment options include terbutaline, formoterol, ipratropium bromide, and theophylline sustained-release tablets. Sometimes, nebulized budesonide can be used to help with expectoration, or oxygen therapy can be used. However, if care is not taken, the condition can worsen, even leading to respiratory failure. Western medications can also cause adverse reactions such as palpitations, dry mouth, and hand tremors.

[0003] The information disclosed in this background technology section is only intended to enhance understanding of the overall background of the invention and should not be regarded as an admission or any form of suggestion that the information constitutes the prior art already known to a person skilled in the art. Summary of the invention:

[0004] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, thereby overcoming the defects in the above-mentioned prior art.

[0005] To achieve the above object, the present invention provides a Chinese medicine composition for treating acute exacerbation of COPD, comprising the following raw materials in parts by weight:

[0006] 6-12 parts of roasted ephedra, 6-12 parts of scutellaria baicalensis seeds, 6-12 parts of perilla seeds, 6-12 parts of peucedanum, 20-30 parts of pyrrosia, 20-30 parts of cyperus rotundus, 9-15 parts of pumice, 6-12 parts of sophora flavescens, 9-15 parts of geranium, 6-10 parts of earthworms, 6-12 parts of uncaria rhynchophylla, 6-12 parts of thunbergia thunbergii, and 3-9 parts of liquorice.

[0007] Preferably, the traditional Chinese medicine composition for treating acute exacerbation of COPD comprises the following raw materials in parts by weight:

[0008] 6 parts of roasted ephedra, 6 parts of scutellaria baicalensis seeds, 6 parts of perilla seeds, 6 parts of peucedanum, 20 parts of pyrrosia, 20 parts of plankton, 9 parts of pumice, 6 parts of sophora flavescens, 9 parts of geranium, 6 parts of earthworms, 6 parts of uncaria, 6 parts of fritillaria thunbergii, 6 parts of licorice.

[0009] Preferably, the traditional Chinese medicine composition for treating acute exacerbation of COPD comprises the following raw materials in parts by weight:

[0010] 9 parts of roasted ephedra, 9 parts of scutellaria baicalensis, 9 parts of perilla seeds, 9 parts of peucedanum, 25 parts of pyrrosia, 25 parts of plankton, 12 parts of pumice, 9 parts of sophora flavescens, 12 parts of geranium, 8 parts of earthworms, 9 parts of uncaria rhynchophylla, 9 parts of thunbergia bulbs, and 6 parts of liquorice.

[0011] Preferably, the traditional Chinese medicine composition for treating acute exacerbation of COPD comprises the following raw materials in parts by weight:

[0012] 12 parts of roasted ephedra, 12 parts of scutellaria baicalensis seeds, 12 parts of perilla seeds, 12 parts of peucedanum, 30 parts of pyrrosia, 30 parts of plankton, 15 parts of pumice, 12 parts of sophora flavescens, 15 parts of geranium, 10 parts of earthworms, 12 parts of uncaria rhynchophylla, 12 parts of thunbergia bulbs, and 9 parts of liquorice.

[0013] The present invention provides the use of any one of the above-mentioned traditional Chinese medicine compositions in the preparation of a product for treating acute exacerbation of chronic obstructive pulmonary disease.

[0014] The present invention provides a product for treating acute exacerbation of chronic obstructive pulmonary disease, comprising the traditional Chinese medicine composition described in any one of the above technical solutions.

[0015] Preferably, the dosage form of the product is decoction, tablet, capsule, granule or pill.

[0016] The present invention provides a method for preparing a decoction for treating acute exacerbation of chronic obstructive pulmonary disease, comprising the following steps:

[0017] Mix roasted ephedra, scutellaria baicalensis seeds, perilla seeds, peucedanum chinense, pyrrosia sinensis, plantain truncatum, pumice stone, sophora flavescens, geranium, earthworm, thunbergia thunbergii, and licorice, soak in water, heat and decoct for the first time, add Uncaria rhynchophylla after boiling to obtain the first medicinal liquid, decoct again, and combine the medicinal liquids to obtain the product.

[0018] Preferably, the mass ratio of the roasted ephedra, scutellaria baicalensis seed, perilla seed, peucedanum peucedanum, pyrrosia azedarach, plantain cyperus, pumice stone, sophora flavescens, geranium herb, earthworm, Uncaria rhynchophylla, fritillaria thunbergii, and liquorice is (6-12): (6-12): (6-12): (6-12): (20-30): (20-30): (9-15): (6-12): (9-15): (6-10): (6-12): (6-12): (3-9);

[0019] The mass ratio of the total amount of roasted ephedra, scutellaria baicalensis seed, perilla seed, peucedanum peucedanum, pyrrosia sinensis, plantain twig, pumice stone, sophora flavescens, geranium herb, earthworm, Uncaria rhynchophylla, fritillaria thunbergii and liquorice to water is 1:5.

[0020] The present invention provides a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease. The composition comprises the following raw materials in parts by weight: 6-12 parts of roasted ephedra, 6-12 parts of scutellaria baicalensis seeds, 6-12 parts of perilla seeds, 6-12 parts of peucedanum chinense, 20-30 parts of pyrrosia odoratum, 20-30 parts of scutellaria baicalensis, 9-15 parts of pumice, 6-12 parts of sophora flavescens, 9-15 parts of geranium herb, 6-10 parts of earthworm, 6-12 parts of Uncaria rhynchophylla, 6-12 parts of Fritillaria thunbergii, and 3-9 parts of liquorice.

[0021] The present invention combines the above-mentioned components and proportions with a specific extraction method to produce a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, which has the technical effects of simple prescription, rapid effect, strong efficacy and no toxic side effects. Specific implementation method:

[0022] The specific embodiments of the present invention are described in detail below, but it should be understood that the protection scope of the present invention is not limited by the specific embodiments.

[0023] Unless expressly stated otherwise, throughout the specification and claims, the term "comprise" or variations such as "include" or "comprising", etc., will be understood to include the stated elements or components but not to exclude other elements or other components.

[0024] The present invention provides a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease. The preparation method and application thereof can be achieved by those skilled in the art by referring to the contents of this article and appropriately improving the process parameters. It should be pointed out in particular that all similar replacements and modifications are obvious to those skilled in the art and they all fall within the scope of protection of the present invention. The methods and applications of the present invention have been described through preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the methods and applications herein without departing from the content, spirit and scope of the present invention to implement and apply the technology of the present invention.

[0025] The present invention provides a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, comprising the following raw materials in parts by weight:

[0026] 6-12 parts of roasted ephedra, 6-12 parts of scutellaria baicalensis seeds, 6-12 parts of perilla seeds, 6-12 parts of peucedanum, 20-30 parts of pyrrosia, 20-30 parts of cyperus rotundus, 9-15 parts of pumice, 6-12 parts of sophora flavescens, 9-15 parts of geranium, 6-10 parts of earthworms, 6-12 parts of uncaria rhynchophylla, 6-12 parts of thunbergia thunbergii, and 3-9 parts of liquorice.

[0027] In some preferred embodiments of the present invention, the Chinese medicine composition for treating allergic asthma comprises the following raw materials in parts by weight:

[0028] In some preferred embodiments of the present invention, the traditional Chinese medicine composition for treating acute exacerbation of COPD comprises the following raw materials in parts by weight:

[0029] 6 parts of roasted ephedra, 6 parts of scutellaria baicalensis seeds, 6 parts of perilla seeds, 6 parts of peucedanum, 20 parts of pyrrosia, 20 parts of plankton, 9 parts of pumice, 6 parts of sophora flavescens, 9 parts of geranium, 6 parts of earthworms, 6 parts of uncaria, 6 parts of fritillaria thunbergii, 6 parts of licorice.

[0030] In some preferred embodiments of the present invention, the traditional Chinese medicine composition for treating acute exacerbation of COPD comprises the following raw materials in parts by weight:

[0031] 9 parts of roasted ephedra, 9 parts of scutellaria baicalensis, 9 parts of perilla seeds, 9 parts of peucedanum, 25 parts of pyrrosia, 25 parts of plankton, 12 parts of pumice, 9 parts of sophora flavescens, 12 parts of geranium, 8 parts of earthworms, 9 parts of uncaria rhynchophylla, 9 parts of thunbergia bulbs, and 6 parts of liquorice.

[0032] In some preferred embodiments of the present invention, the traditional Chinese medicine composition for treating acute exacerbation of COPD comprises the following raw materials in parts by weight:

[0033] 12 parts of roasted ephedra, 12 parts of scutellaria baicalensis seeds, 12 parts of perilla seeds, 12 parts of peucedanum, 30 parts of pyrrosia, 30 parts of plankton, 15 parts of pumice, 12 parts of sophora flavescens, 15 parts of geranium, 10 parts of earthworms, 12 parts of uncaria rhynchophylla, 12 parts of thunbergia bulbs, and 9 parts of liquorice.

[0034] Roasted Ephedra: Pungent and bitter in flavor, warm in nature, enters the Lung and Bladder meridians. It has the effects of dispelling cold, relieving cough and asthma, and promoting diuresis and reducing swelling. It is primarily used to treat wind-cold exterior syndrome, characterized by aversion to cold, fever, anorexia, headache and body aches; asthma and cough due to wind-cold externalization and internal stagnation of lung qi; cough and asthma caused by cold phlegm and fluid retention; and edema caused by wind-dampness and dysuria. It is the main herb in this prescription.

[0035] Tenglizi (Scutellaria baicalensis) is bitter and pungent in flavor, cold in nature, and enters the lung and bladder meridians. It has the effects of purging the lungs and relieving asthma, promoting diuresis and reducing swelling. It is used for phlegm-filled lungs, wheezing, coughing with excessive sputum, chest and flank distension, inability to lie flat, chest and abdominal edema, and difficulty urinating. It is the main ingredient in this prescription.

[0036] Perilla seed: Pungent, warm in nature, enters the Lung meridian. It has the effects of lowering Qi and resolving phlegm, relieving cough and asthma, and moistening the intestines and promoting bowel movements. It is used for cough, asthma, difficulty in expectorating, chest tightness, and constipation caused by dry intestines. It is the main ingredient in this prescription.

[0037] Peucedanum chinense: Bitter and pungent in flavor, slightly cold in nature, enters the Lung meridian. It has the effects of descending Qi, resolving phlegm, dispersing wind and clearing heat. It is mainly used to treat wheezing due to phlegm-heat, coughing up thick yellow phlegm, and coughing with excessive phlegm due to wind-heat. It serves as the adjuvant in this prescription.

[0038] Selaginella: Sweet and bitter in flavor, slightly cold in nature, it enters the lung and bladder meridians. It clears the lungs and relieves cough, promotes diuresis and relieves stranguria, and cools the blood and stops bleeding. It is primarily used to treat stranguria caused by heat, hematuria, stranguria with stones, urinary obstruction, painful and dribbling urine, asthma and cough due to lung heat, hematemesis, epistaxis, hematuria, and metrorrhagia. It serves as the adjuvant in this prescription.

[0039] Pinellia ternata: Slightly bitter in flavor, neutral in nature, it enters the Lung and Liver meridians. It has the effects of resolving phlegm and relieving cough, promoting dampness, and promoting blood circulation. It is primarily used to treat new and chronic coughs; blood in sputum; jaundice; edema; stranguria; leucorrhea; amenorrhea and dysmenorrhea; rheumatic pain; and traumatic injuries. It serves as the adjuvant in this prescription.

[0040] Sea Pumice: Salty in flavor, cold in nature, enters the Lung and Kidney meridians. It clears lung heat, resolves old phlegm, softens hard masses, and relieves stranguria. It is used to treat wheezing and coughing due to phlegm-heat, old phlegm accumulation, goiters, gonorrhea, hernias, scabies, and eye opacities. It serves as the adjuvant in this prescription.

[0041] Sophora flavescens: Bitter in flavor, cold in nature, it enters the Heart, Liver, Stomach, Large Intestine, and Bladder meridians. It clears heat and dampness, kills parasites, and acts as a diuretic. It is used for heat dysentery, blood in the stool, jaundice, urinary retention, vaginal discharge, vaginal swelling and itching, eczema, eczema, itchy skin, scabies, leprosy, and external treatment of trichomonas vaginitis. It serves as an adjuvant in this prescription.

[0042] Geranium Herba: Bitter, slightly pungent, neutral in nature, it enters the Liver and Large Intestine meridians. It dispels wind and dredges the meridians, promotes blood circulation, and clears heat and dampness. It is primarily used to treat rheumatic pain, numbness of the skin, soreness of the tendons and bones, injuries from falls, diarrhea, dysentery, and sores. It serves as an adjuvant in this prescription.

[0043] Earthworm: Salty in flavor, cold in nature, it enters the liver, spleen, and bladder meridians. It clears heat and calms convulsions, dredges the meridians, relieves asthma, and acts as a diuretic. It is primarily used to treat high fever, coma, epilepsy, joint pain, limb numbness, hemiplegia, asthma and cough due to lung heat, oliguria, edema, and hypertension. It serves as an adjuvant in this prescription.

[0044] Uncaria rhynchophylla: Sweet in flavor, cooling in nature, enters the Liver and Pericardium meridians. It calms wind and convulsions, clears heat and soothes the liver. It is used for internal liver wind disturbances, epilepsy and convulsions, high fever convulsions, colds and convulsions, crying infants, eclampsia during pregnancy, and headaches and dizziness. It serves as an adjuvant in this prescription.

[0045] Fritillaria thunbergii: Bitter in flavor, cold in nature, enters the Lung and Heart meridians. It clears heat, resolves phlegm, and relieves cough, detoxifies, and dissipates carbuncle. It is primarily used to treat coughs due to wind-heat, phlegm-fire, lung abscesses, mastitis, scrofula, and sores. It serves as an adjuvant in this prescription.

[0046] Licorice: Sweet in flavor, neutral in nature, it enters the Heart, Lung, Spleen, and Stomach meridians. It tonifies the spleen and replenishes Qi, clears away heat and detoxifies, eliminates phlegm and relieves cough, relieves pain, and harmonizes various medicinal properties. It is primarily used to treat spleen and stomach deficiency, fatigue, palpitations and shortness of breath, cough with excessive sputum, acute pain in the abdomen and limbs, carbuncles, sores, and alleviates drug toxicity and potency. It serves as the guiding ingredient in this prescription.

[0047] The invention uses roasted ephedra, scutellaria baicalensis seeds and perilla seeds as main medicines, peucedanum chinense, scutellaria baicalensis, plantain twig and pumice as assistant medicines, sophora flavescens, geranium, earthworm, Uncaria rhynchophylla and fritillaria thunbergii as adjuvant medicines, and liquorice to harmonize the medicines, so that the traditional Chinese medicine has the functions of fast effect, high cure rate and low recurrence, and at the same time plays the effects of clearing the lungs, relieving cough, promoting lung function and relieving asthma.

[0048] The inventors have scientifically combined Chinese medicinal raw materials to effectively control the lung symptoms during acute exacerbation of COPD, relieve asthma and cough, and at the same time regulate the spleen and stomach, ventilate and regulate qi, thereby achieving a comprehensive treatment of the symptoms and root causes of COPD without toxic side effects. In terms of treating COPD, the invention has many advantages such as good efficacy, rapid results, strong efficacy, and low recurrence rate.

[0049] The present invention provides a method for preparing a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, comprising the following steps:

[0050] Mix roasted ephedra, scutellaria baicalensis seeds, perilla seeds, peucedanum chinense, pyrrosia sinensis, plantain truncatum, pumice stone, sophora flavescens, geranium herb, earthworm, thunbergia thunbergii, and liquorice, soak in water, heat and decoct for the first time, add Uncaria rhynchophylla after boiling to obtain the first medicinal liquid, decoct again, and combine the medicinal liquids to obtain the product.

[0051] The decoction is preferably performed 1 to 2 times; the soaking time is 15 to 20 minutes.

[0052] According to international guidelines, the diagnosis of COPD should be determined based on a comprehensive analysis of clinical manifestations, history of exposure to risk factors, physical signs, and laboratory tests. Pulmonary function tests are the gold standard for diagnosing COPD. An FEV1 / FVC ratio <70% after bronchodilator use is considered incompletely reversible airflow limitation. Mild airflow limitation in the early stages of COPD may or may not be clinically symptomatic. Acute exacerbations are primarily manifested by worsening respiratory symptoms, such as cough, sputum production, shortness of breath, and / or wheezing, increased sputum volume, often purulent or mucous, and fever.

[0053] The present invention provides a product for treating acute exacerbation of chronic obstructive pulmonary disease, comprising the traditional Chinese medicine composition described in any one of the above technical solutions.

[0054] Preferably, the dosage form of the product is decoction, tablet, capsule, granule or pill.

[0055] The Chinese medicine composition of the present invention can be prepared into specific Chinese medicine preparations such as decoctions, tablets, capsules, granules, or dripping pills using conventional pharmaceutical preparation methods. Pharmaceutically acceptable excipients, including but not limited to fillers, emulsifiers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and bases, may be added as needed during the preparation of these dosage forms.

[0056] The present invention provides a method for preparing a decoction for treating acute exacerbation of chronic obstructive pulmonary disease, comprising the following steps:

[0057] Mix roasted ephedra, scutellaria baicalensis seeds, perilla seeds, peucedanum chinense, pyrrosia sinensis, plantain truncatum, pumice stone, sophora flavescens, geranium herb, earthworm, thunbergia thunbergii, and liquorice, soak in water, heat and decoct for the first time, add Uncaria rhynchophylla after boiling to obtain the first medicinal liquid, decoct again, and combine the medicinal liquids to obtain the product.

[0058] The mass ratio of the combined ingredients of roasted ephedra, scutellaria baicalensis, perilla seed, peucedanum peucedanum, scutellaria baicalensis, pumice stonecrop, sophora flavescens, geranium herb, earthworm, Uncaria rhynchophylla, Fritillaria thunbergii, and liquorice to water is 1:5. The soaking time is 15-20 minutes. The first decoction is specifically performed by boiling over high heat, then adding Uncaria rhynchophylla, and heating over low heat for 20-25 minutes. The second decoction is performed by boiling over low heat, then heating over low heat for 10-15 minutes. In the present invention, low heat refers to a low and slow heat for decocting the medicine, while high heat refers to a high and rapid heat for decocting the medicine. The low heat in the present invention is 160-170°C; high heat is 220-230°C.

[0059] Decoction again and combine the medicinal liquid to obtain the product.

[0060] Use the above method to decoct the medicine for the second time. Use hot water directly to boil the medicine. After boiling, heat it over low heat for 10 to 15 minutes. Put the two boiled medicine liquids into the same container.

[0061] The present invention provides a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, comprising the following raw materials in parts by weight:

[0062] 6-12 parts of roasted ephedra, 6-12 parts of scutellaria baicalensis seeds, 6-12 parts of perilla seeds, 6-12 parts of peucedanum peucedanum, 20-30 parts of pyrrosia, 20-30 parts of cyperus rotundus, 9-15 parts of pumice, 6-12 parts of sophora flavescens, 9-15 parts of geranium, 6-10 parts of earthworm, 6-12 parts of Uncaria rhynchophylla, 6-12 parts of thunbergii bulbs, and 3-9 parts of liquorice. The present invention combines the above components and proportions with a specific extraction method to produce a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, which has the technical effects of simple formula, quick effect, strong efficacy, and no toxic side effects.

[0063] To further illustrate the present invention, a traditional Chinese medicine composition for treating acute exacerbation of COPD provided by the present invention, as well as its preparation method and application are described in detail below in conjunction with examples.

[0064] Example 1

[0065] A traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease is composed of the following raw materials: 6 parts of roasted ephedra, 6 parts of scutellaria baicalensis seeds, 6 parts of perilla seeds, 6 parts of peucedanum peucedanum, 20 parts of pyrrosia, 20 parts of plankton, 9 parts of pumice, 6 parts of sophora flavescens, 9 parts of geranium, 6 parts of earthworm, 6 parts of Uncaria rhynchophylla, 6 parts of Fritillaria thunbergii, and 3 parts of liquorice.

[0066] Example 2

[0067] A traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease is composed of the following raw materials: 9 parts of roasted ephedra, 9 parts of scutellaria baicalensis, 9 parts of perilla seeds, 9 parts of peucedanum, 25 parts of pyrrosia, 25 parts of plankton, 12 parts of pumice, 9 parts of sophora flavescens, 12 parts of geranium, 8 parts of earthworm, 9 parts of Uncaria rhynchophylla, 9 parts of Fritillaria thunbergii, and 6 parts of liquorice.

[0068] Example 3

[0069] A traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease is composed of the following raw materials: 12 parts of roasted ephedra, 12 parts of scutellaria baicalensis seeds, 12 parts of perilla seeds, 12 parts of peucedanum peucedanum, 30 parts of pyrrosia, 30 parts of cyperus rotundus, 15 parts of pumice, 12 parts of sophora flavescens, 15 parts of geranium, 10 parts of earthworm, 12 parts of Uncaria rhynchophylla, 12 parts of Fritillaria thunbergii, and 9 parts of liquorice.

[0070] Control group: The control group received conventional Western medicine treatment without the addition of the Chinese medicine composition.

[0071] Preparation method:

[0072] Prepare a decoction: Take the above-mentioned Chinese medicinal components by weight and place them in a casserole; add 1000ml of water to the casserole and soak for 20 minutes; boil over high heat, then simmer for 25 minutes. After the temperature drops slightly, pour it into a container to obtain the first medicinal solution; continue with the above method, decoct the medicine a second time. The second time, you can directly boil the medicine with hot water. After boiling, simmer for about 15 minutes. Put the two decoctions into the same container, totaling about 400ml. Take it twice a day. Alternatively, decoct the medicine for two days at a time, sterilize the resulting medicinal solution, seal it, refrigerate it, and slightly heat it before taking.

[0073] Example 4

[0074] Typical Cases

[0075] Case 1: Mr. Wang, a 78-year-old male from Qixia District, Nanjing. He had a smoking history of over 40 years, smoking approximately 20 cigarettes per day, and had quit smoking five years earlier. Since 2013, he had experienced recurrent cough and sputum production, as well as shortness of breath after exertion. These symptoms were often exacerbated by seasonal changes and exposure to cold. He had been admitted to our hospital both as an outpatient and as an inpatient. Pulmonary function tests revealed: 1. Moderate obstructive ventilatory dysfunction; 2. Mild diffusion impairment; 3. Negative diastolic function test. He was diagnosed with chronic obstructive pulmonary disease (COPD) and was managed with inhaled Seretide. One week prior to admission, he developed cough and sputum production, with copious amounts of yellow sputum, chest tightness and shortness of breath after exposure to cold. These symptoms worsened with exertion, accompanied by a fever, with a temperature of 38.3°C. He self-treated at home with cefixime, Feining mixture, and Day and Night Baifuning, but the fever did not recur. However, he continued to cough, produce copious amounts of yellow sputum, and experience significant chest tightness and shortness of breath after exertion. He sought further treatment in our respiratory department and was admitted to the outpatient department with symptoms of acute exacerbation of COPD. Admission symptoms: The patient had cough, yellow sputum that was difficult to cough up, chest tightness and shortness of breath, which was more obvious after activity, no fever, no chest pain, good appetite, poor sleep, and normal bowel movements. Physical examination: clear consciousness, good spirits, auscultation of both lungs revealed coarse breath sounds, obvious wheezing, and no moist rales. Auxiliary examinations: Pulmonary function: 1. Severe obstructive ventilation dysfunction; 2. Mild diffusion dysfunction; 3. Negative diastolic test. Electrocardiogram: Complete right bundle branch block. Chest CT: Changes of chronic bronchitis and emphysema, and bullae formation in the right upper lung. Blood routine: White blood cell count 13.87×10 9 / L, neutrophil count 12.19×10 9 / L, neutrophil ratio 87.9%, high-sensitivity C-reactive protein 87.41mg / L. Diagnosis: Traditional Chinese Medicine: Asthma (phlegm-heat stagnation in the lungs); Western Medicine: Acute exacerbation of chronic obstructive pulmonary disease. Conventional treatment plus the present invention was used for treatment. Dosage: decoction in water, one dose of 400ml per day, taken twice a day, for two consecutive courses. The patient's symptoms of cough, sputum, chest tightness and asthma were significantly relieved. Blood routine examination showed a white blood cell count of 6.56×10 9 / L, neutrophil count 4.80×10 9 / L, neutrophil count 73.2%, and high-sensitivity C-reactive protein 5.46 mg / L. After 3 months of follow-up, the patient's condition remained stable with no relapse. Outpatient pulmonary function test revealed: 1. Moderate obstructive ventilatory dysfunction; 2. Mild diffusion dysfunction.

[0076] Case 2: Xu, male, 82 years old, from Xuanwu District, Nanjing. He had a smoking history of over 50 years, smoking approximately 15 cigarettes per day, and had quit smoking eight years earlier. Since 2000, he had experienced recurrent cough and sputum production, as well as wheezing after exertion. He also had a more pronounced cough in the morning, producing sticky, white sputum. These symptoms worsened with seasonal changes and exposure to cold. He had been treated at the Second Affiliated Hospital of Nanjing Medical University, Jiangsu Provincial Hospital of Traditional Chinese Medicine, and our hospital. His pulmonary function test results were: 1. Severe obstructive ventilatory dysfunction; 2. Mild diffusion impairment; 3. Negative diastolic function test. He was diagnosed with chronic obstructive pulmonary disease and was treated with inhaled seretide and tiotropium bromide. His condition had worsened in recent years. Three days before admission, the patient developed a cough and expectoration after catching a cold. The cough produced large amounts of yellow sputum, and she experienced chest tightness, shortness of breath, and dyspnea with the slightest movement, but no fever. She was treated with intravenous infusions of ceftizoxime and ambroxol at a community clinic for two days without improvement. She sought further treatment at our respiratory department and was admitted to the outpatient department with symptoms of "acute exacerbation of chronic obstructive pulmonary disease." Admission symptoms: The patient had a cough, a large amount of yellow, sticky sputum that was easily coughed up, chest tightness, shortness of breath, and dyspnea with movement, but no fever or chest pain. She also had poor diet and sleep, dry stools, and yellow urine. Physical examination: The patient was alert but not very energetic. Auscultation revealed low breath sounds in both lungs, with noticeable wheezing but no moist rales. Auxiliary examinations: Pulmonary function tests: 1. Extremely severe obstructive ventilatory dysfunction; 2. Mild diffusion dysfunction; 3. Negative diastolic test. Electrocardiogram: Complete right bundle branch block. Chest CT revealed chronic bronchitis and emphysema with bullae; old subpleural lesions in the left upper lobe; small nodules in both lungs; and atherosclerosis of the aorta and coronary arteries. Blood count: white blood cell count 15.38 × 10 9 / L, neutrophil count 13.16×10 9 / L, neutrophil ratio 85.6%, high-sensitivity C-reactive protein 5764mg / L. Diagnosis: Traditional Chinese Medicine: Asthma (phlegm-heat stagnation in the lungs); Western Medicine: Acute exacerbation of chronic obstructive pulmonary disease. Conventional treatment plus the present invention was used for treatment. Dosage: decoction in water, one dose of 400ml per day, taken twice a day, for two consecutive courses of treatment. The patient's cough, sputum, chest tightness and asthma symptoms were significantly relieved. Blood routine examination showed a white blood cell count of 5.89×10 9 / L, neutrophil count 4.14×10 9 / L, neutrophil count 70.3%, and high-sensitivity C-reactive protein 7.35 mg / L. After 3 months of follow-up, the patient's condition remained stable with no relapse. Outpatient pulmonary function test revealed: 1. Severe obstructive ventilatory dysfunction; 2. Mild diffusion dysfunction.

[0077] Case 3: Zhang XX, male, 68 years old, from Qixia District, Nanjing. He has a history of smoking for more than 40 years, about 40 cigarettes a day, and has not quit smoking. The patient has had repeated coughs and sputum since 2018, and shortness of breath after activities. The symptoms worsened after seasonal changes and cold. He was treated in Jiangsu Provincial People's Hospital. Pulmonary function: 1. Moderate obstructive ventilation dysfunction; 2. Negative diastolic test. Diagnosed with "chronic obstructive pulmonary disease", "usually irregular inhalation of "Symbico" to control the condition. Five days before admission, the patient coughed again after taking a cold bath, coughed up yellow sputum, chest tightness and shortness of breath, which worsened after activities, accompanied by fever, nasal congestion, runny nose, sore throat, and self-measured body temperature of 37.8℃. After taking "Moxifloxacin, Kechuanning Oral Liquid, and Xinkangtai" at home, the symptoms did not improve. He still had fever, cough, yellow sputum, chest tightness and shortness of breath. For further treatment, he came to the respiratory department of our hospital and was admitted to the outpatient department with "acute exacerbation of chronic obstructive pulmonary disease". Admission symptoms: The patient coughed, The patient has yellow sputum, which is easy to cough up. He has chest tightness and shortness of breath, which is more obvious after exercise. He has fever, no aversion to cold, no chest pain, a good appetite, poor sleep, and normal bowel movements. Physical examination: The patient is alert and mentally fit. Auscultation reveals coarse breath sounds in both lungs, scattered wheezing sounds, but no moist rales. Auxiliary examinations: Pulmonary function: 1. Moderate obstructive ventilatory dysfunction; 2. Negative diastolic test. Electrocardiogram: Sinus tachycardia. Chest CT: consistent with changes in chronic bronchiolitis and emphysema, with slight inflammation in the lower lobes of both lungs. Aortic atherosclerosis. Liver cyst. Blood routine: White blood cell count: 10.85×10 9 / L, neutrophil count 10.44×10 9 / L, neutrophil ratio 85.7%, high-sensitivity C-reactive protein 106.57mg / L. Diagnosis: Traditional Chinese Medicine: Asthma (Syndrome of Phlegm-Heat Stagnation in the Lungs); Western Medicine: Acute Exacerbation of Chronic Obstructive Pulmonary Disease. Conventional treatment plus the present invention was used for treatment. Dosage: Decoction in water, one dose of 400ml per day, divided into two doses, for two consecutive courses. The patient's cough, sputum, chest tightness and asthma symptoms were significantly relieved. Blood routine examination showed a white blood cell count of 7.34×10 9 / L, neutrophil count 5.02×10 9 / L, neutrophil count 68.5%, and high-sensitivity C-reactive protein 5.46 mg / L. After 3 months of follow-up, the patient's condition remained stable with no relapse. Outpatient pulmonary function test revealed: 1. Moderate obstructive ventilatory dysfunction; 2. Mild diffusion dysfunction.

[0078] Example 5

[0079] The present invention is further described based on the clinical data from the Department of Respiratory Medicine of our hospital, the Affiliated Hospital of Integrated Traditional Chinese and Western Medicine of Nanjing University of Chinese Medicine:

[0080] 5.1 Case Source

[0081] According to the 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for the diagnosis of AECOPD and COPD;

[0082] Diagnostic criteria: 2020 GOLD Global Initiative for Chronic Obstructive Pulmonary Disease

[0083] symptom Risk factors shortness of breath Host Factor: Tobacco chronic cough Objective factors: indoor and outdoor air pollution Coughing up phlegm Family history of COPD

[0084] 1. The diagnosis of COPD should be considered in patients older than 40 years who have shortness of breath, chronic cough, and sputum production, with or without known risk factors and with or without a family history of COPD.

[0085] 2. Pulmonary function is necessary for the diagnosis of COPD: after inhalation of bronchodilators, FEV1 / FVC < 0.70, and there is irreversible airflow limitation; 3 Differential diagnosis.

[0086] AECOPD is defined as an acute exacerbation of respiratory symptoms in patients with COPD who are not receiving conventional treatment and can be categorized as mild (receiving SABA alone), moderate (receiving SABA plus antibiotics, and or no corticosteroids), or severe (requiring hospitalization or intensive care unit admission).

[0087] 5.2 Case Grouping and Treatment Plan

[0088] Two hundred patients were randomly divided into an experimental group and a control group, with 50 patients in each group. Experimental groups 1-3 were treated with conventional Western medicine combined with the preparations described in Examples 1-3 of the present invention, combining traditional Chinese and Western medicine. The control group received conventional Western medicine. The dosing regimen for each of the different groups was: 400 ml of the drug per day, taken in two divided doses, for a five-day course of treatment, generally for three consecutive courses.

[0089] 5.3 Efficacy evaluation criteria

[0090] 5.3.1 Safety evaluation

[0091] Monitor the following indicators before and after treatment: vital signs (blood pressure, respiration, heart rate, pulse); routine urine and stool examinations; blood tests; electrocardiograms; liver and kidney function; adverse events, including dizziness, chest tightness, and abdominal distension. Record the time of occurrence, severity, frequency, duration, measures taken, and outcomes of adverse events. Simultaneously monitor patients for adverse reactions during medication. If a severe adverse reaction of grade 3 or above occurs, discontinue medication immediately.

[0092] 5.3.2 Observation and evaluation of therapeutic efficacy

[0093] Main efficacy indicators: Effective rate: The sum of clinical control rate, marked effective rate and effective rate is the total effective rate.

[0094] 1) Clinical control: The patient's clinical symptoms completely disappear and lung function indicators return to normal;

[0095] 2) Significant effect: The clinical symptoms are significantly alleviated and the lung function indicators tend to be normal.

[0096] 3) Effective: The patient's clinical symptoms improved and lung function indicators improved;

[0097] 4) Invalid: Patients who do not meet the above requirements are considered invalid.

[0098] Secondary efficacy indicators:

[0099] 1) Time of onset: Observe and record in detail the time it takes for the condition to stabilize.

[0100] 2) Inflammatory indicators: Observe the changes in CRP values after 7 days of treatment.

[0101] 3) Pulmonary function: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1 as a percentage of predicted value (FEV1%), and FEV1 / FVC.

[0102] 5.3.3 Statistical Analysis: SPSS 20.0 statistical software was used. Measurement data were expressed as mean ± standard deviation; one-way analysis of variance was used to compare different groups; paired t-test was used to compare the same group before and after treatment; chi-square test was used for enumeration data, and nonparametric tests of multiple independent samples were used for comparisons between multiple groups; the significance level was set at α = 0.05.

[0103] 5.4 Clinical trial results

[0104] 5.4.1 Safety evaluation

[0105] During the period of medication, the patient's vital signs, urine and stool routine examinations, blood routine, electrocardiogram, and liver and kidney function tests before and after treatment showed no obvious abnormalities.

[0106] 5.4.2 Observation and evaluation of therapeutic efficacy

[0107] (1) Efficiency

[0108] As shown in Table 1, the clinical effective rates of Examples 1-3 of the invention were 96%, 98%, and 98%, respectively, which were higher than 88% of the control group.

[0109] Table 1 Comparison of clinical efficacy

[0110] Group Number of cases invalid efficient Significantly effective Clinical control Efficiency Implementation Group 1 50 2 8 37 3 96％ Implementation Group 2 50 1 9 38 2 98％ Implementation Group 3 50 1 9 36 4 98％ control group 50 6 15 28 1 88％

[0111] (2) Onset time

[0112] Table 2 Clinical onset time

[0113] Group Number of people Onset time Implementation Group 1 50 <![CDATA[4.78±2.11 * ]]> Implementation Group 2 50 <![CDATA[4.52±2.07 * ]]> Implementation Group 3 50 <![CDATA[4.29±1.78 * ]]> control group 50 7.14±2.93

[0114] *Compared with the control group, P < 0.05

[0115] As shown in Table 2, the clinical onset time of the invention implementation groups 1-3 was significantly higher than that of the control group, and the difference was statistically significant (P < 0.05).

[0116] (3) Changes in inflammatory indicators

[0117] Table 3 Changes of CRP before and after treatment

[0118] Group time CRP P Implementation Group 1 Before treatment 61.21±12.17 P＜0.05 After treatment 6.24±7.33 Implementation Group 2 Before treatment 60.57±15.24 P＜0.05 After treatment 6.13±7.16 Implementation Group 3 Before treatment 62.39±16.22 P＜0.05 After treatment 5.99±8.15 control group Before treatment 60.89±17.38 P＜0.05 After treatment 10.33±15.64

[0119] There was no statistical difference in serum CRP levels among the four groups before treatment (P>0.05). After treatment, CRP levels in the four groups decreased compared with those before treatment (P<0.01). Among them, the decrease levels in the implementation groups 1-3 were significantly higher than those in the control group, and the differences were statistically significant (P<0.05).

[0120] (4) Changes in lung function before and after treatment

[0121] Group time FEV1 / FVC% FEV1 / pred% P Implementation Group 1 Before treatment 61.27±2.34 73.90±0.89 P＜0.05 After treatment 67.71±2.68 80.45±3.70 Implementation Group 2 Before treatment 61.16±2.39 73.75±0.91 P＜0.05 After treatment 67.82±2.91 80.93±3.77 Implementation Group 3 Before treatment 61.57±3.10 73.01±0.81 P＜0.05 After treatment 68.05±2.59 80.83±3.57 control group Before treatment 61.39±2.44 73.72±0.84 P＜0.05 After treatment 65.75±3.21 78.32±3.04

[0122] There was no statistical difference in the levels of lung function FEV1 / FVC% and FEV1 / pred% among the four groups before treatment (P>0.05). After treatment, the levels of FEV1 / FVC% and FEV1 / pred% in the four groups were higher than those before treatment (P<0.05). Among them, the increased levels in the implementation groups 1-3 were significantly higher than those in the control group, and the differences were statistically significant (P<0.05).

[0123] The foregoing descriptions of specific exemplary embodiments of the present invention are for purposes of illustration and description. These descriptions are not intended to limit the invention to the precise forms disclosed, and it is apparent that many variations and modifications are possible in light of the foregoing teachings. The exemplary embodiments have been selected and described for the purpose of explaining the specific principles of the invention and their practical application, thereby enabling those skilled in the art to realize and utilize a variety of exemplary embodiments of the invention and various options and modifications. The scope of the invention is intended to be defined by the claims and their equivalents.

Claims

1. A Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, characterized in that: The invention is composed of the following raw materials in parts by mass: 6-12 parts of roasted ephedra, 6-12 parts of scutellaria baicalensis seeds, 6-12 parts of perilla seeds, 6-12 parts of peucedanum, 20-30 parts of pyrrosia, 20-30 parts of scutellaria baicalensis, 9-15 parts of pumice, 6-12 parts of sophora flavescens, 9-15 parts of geranium, 6-10 parts of earthworms, 6-12 parts of Uncaria rhynchophylla, 6-12 parts of Fritillaria thunbergii, and 3-9 parts of liquorice.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition for treating acute exacerbation of COPD is composed of the following raw materials in parts by weight: 6 parts of roasted ephedra, 6 parts of scutellaria baicalensis seeds, 6 parts of perilla seeds, 6 parts of peucedanum, 20 parts of pyrrosia, 20 parts of plankton, 9 parts of pumice, 6 parts of sophora flavescens, 9 parts of geranium, 6 parts of earthworms, 6 parts of uncaria, 6 parts of fritillaria thunbergii, 6 parts of licorice.

3. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition for treating acute exacerbation of COPD is composed of the following raw materials in parts by weight: 9 parts of roasted ephedra, 9 parts of scutellaria baicalensis, 9 parts of perilla seeds, 9 parts of peucedanum, 25 parts of pyrrosia, 25 parts of plankton, 12 parts of pumice, 9 parts of sophora flavescens, 12 parts of geranium, 8 parts of earthworms, 9 parts of uncaria rhynchophylla, 9 parts of thunbergia bulbs, and 6 parts of liquorice.

4. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition for treating acute exacerbation of COPD is composed of the following raw materials in parts by weight: 12 parts of roasted ephedra, 12 parts of scutellaria baicalensis seeds, 12 parts of perilla seeds, 12 parts of peucedanum, 30 parts of pyrrosia, 30 parts of plankton, 15 parts of pumice, 12 parts of sophora flavescens, 15 parts of geranium, 10 parts of earthworms, 12 parts of uncaria rhynchophylla, 12 parts of thunbergia bulbs, and 9 parts of liquorice.

5. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a drug for treating acute exacerbation of chronic obstructive pulmonary disease.

6. A product for treating acute exacerbation of chronic obstructive pulmonary disease, characterized in that: The invention relates to a Chinese medicine composition according to any one of claims 1 to 4; the dosage form of the product is a decoction.

7. A method for preparing a decoction for treating acute exacerbation of chronic obstructive pulmonary disease, characterized in that: The steps include: Mix roasted ephedra, scutellaria baicalensis, perilla seed, peucedanum peucedanum, pyrrosia lanceolata, plantain wood, pumice stone, sophora flavescens, geranium herb, earthworm, thunbergia thunbergii, and liquorice, soak in water, heat and boil for the first time, add Uncaria rhynchophylla after boiling to obtain the first medicinal solution, boil again, and combine the medicinal solutions to obtain the product; The mass ratio of the roasted ephedra, scutellaria baicalensis seeds, perilla seeds, peucedanum peucedanum, pyrrosia azedarach, cyperus rotundus, pumice stone, sophora flavescens, geranium herb, earthworm, Uncaria rhynchophylla, fritillaria thunbergii, and liquorice is (6-12): (6-12): (6-12): (6-12): (20-30): (20-30): (9-15): (6-12): (9-15): (6-10): (6-12): (6-12): (3-9); The mass ratio of the total amount of the roasted ephedra, scutellaria baicalensis, perilla seed, peucedanum peucedanum, pyrrosia lappa, pumice stone, sophora flavescens, geranium herb, earthworm, Uncaria rhynchophylla, fritillaria thunbergii and liquorice to water is 1:

5.

8. The preparation method according to claim 7, characterized in that The soaking time is 15 to 20 minutes; the first decoction is specifically to add Uncaria rhynchophylla after boiling over high heat and to heat over low heat for 20 to 25 minutes; the second decoction is to boil over high heat and then to heat over low heat for 10 to 15 minutes.