Traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, which is prepared from the following raw materials in parts by weight: 6-9 parts of honey-fried ephedra, 30-40 parts of gypsum, 6-9 parts of fried semen armeniacae amarae, 9-15 parts of fructus perillae, 9-15 parts of semen lepidii, 9-15 parts of radix asteris, 9-12 parts of radix peucedani, 9-12 parts of cynanchum glaucescens, 9-15 parts of thunberg fritillary bulb, 9-15 parts of honey-fried folium eriobotryae, 6-12 parts of rhodiola rosea and 6-9 parts of liquorice. Through scientific compatibility of the traditional Chinese medicine raw materials, clinical symptoms of patients in the acute exacerbation period of the chronic obstructive pulmonary disease can be effectively relieved, the acute exacerbation frequency and degree of the patients with the chronic obstructive pulmonary disease are reduced, and lung function decline is delayed. The traditional Chinese medicine composition is free of toxic and side effects and has the advantages of being good in curative effect, fast in effect taking, high in medicine effect, not prone to relapse and the like in the aspect of treating chronic obstructive pulmonary acute exacerbation.

Description

Technical Field

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

[0002] Chronic obstructive pulmonary disease (COPD) is a respiratory disease characterized by continuous and progressive airflow limitation, with high morbidity and mortality. The long-term clinical symptoms of COPD, such as dyspnea, cough, fatigue, and related medical expenses, bring serious physical, psychological and economic burdens to patients. Acute exacerbation of COPD is an important event in the management of COPD. It refers to an event characterized by worsening dyspnea and / or cough and sputum within 14 days, which may be accompanied by shortness of breath and / or tachycardia, and is usually related to the aggravation of local and / or systemic inflammatory response caused by respiratory tract infection, air pollution or other reasons. The typical clinical manifestations of acute exacerbation of COPD are: worsening dyspnea, worsening cough, increased sputum volume, changes in sputum color and (or) viscosity, and fever, etc. Non-specific symptoms such as general discomfort, insomnia, drowsiness, fatigue, depression and mental disorders may also occur.

[0003] Chronic obstructive pulmonary disease is called "lung distension" in traditional Chinese medicine. The main symptoms in traditional Chinese medicine are cough, expectoration, wheezing, shortness of breath, chest tightness, and dyspnea. The etiology and pathogenesis of lung distension are often based on lung and kidney qi deficiency, and phlegm, blood stasis, and water retention are symptoms. It is often aggravated by wind and cold evil qi invading the skin and fur and combining with the lungs. The basic characteristics of the acute exacerbation of COPD are a mixture of deficiency, phlegm, stasis, and toxicity. The pathogenesis is characterized by a mixture of deficiency and excess, and deficiency in the root and excess in the symptom. The most common syndromes are phlegm-heat obstructing the lungs, phlegm and stasis blocking the lungs, and lung and kidney qi deficiency. The lung is the sign of Qi, and the kidney is the root of Qi. Qi has a master and breathing has a root. Pathogenic pathogens invade the human body for a long time, leading to the deficiency of lung Qi, abnormal descending and ascending, and disorder of Qi and blood circulation. The mother's disease affects the child, and the lung disease affects the kidney. In addition, the disease lasts for a long time and consumes the kidney Qi, and the kidney fails to absorb; the child steals the mother's Qi, and the lung disease affects the spleen, and the spleen fails to transport and transform, and produces phlegm and turbidity; the lungs, kidneys, and spleen are all weak, and the disease recurs and lasts for a long time. If the body is weak, it is weak to resist the evil, and the evil moves the Qi, which then touches the internal phlegm and blood stasis, resulting in aggravation of coughing and wheezing symptoms.

[0004] The goal of treatment for acute exacerbation of COPD is to reduce the adverse effects caused by the current acute exacerbation and prevent the occurrence of another acute exacerbation. At present, the main drugs used in Western medicine to treat acute exacerbation of COPD are bronchodilators, glucocorticoids, antibacterial drugs and expectorants. Although Western medicine treatment of this disease is effective, it is expensive and has certain adverse reactions. Traditional Chinese medicine treatment has the advantages of being simple, convenient, cheap and effective. The combination of traditional Chinese and Western medicine can not only improve the efficacy, but also reduce the cost of patient treatment, reduce the dosage of Western medicine, and thus reduce adverse reactions. Based on the fact that modern medical anti-inflammatory drugs cannot effectively relieve the symptoms of COPD, delay the process of acute exacerbation, and reduce the decline in lung function, it is particularly important to propose a drug that effectively treats acute exacerbation of COPD. Summary of the invention

[0005] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, and a preparation method and application thereof, so as to achieve effective treatment of acute exacerbation of chronic obstructive pulmonary disease.

[0006] To this end, the present invention provides the following technical solutions.

[0007] The first aspect of the present invention provides a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease. The raw materials for preparing the traditional Chinese medicine composition include, by weight: 6-9 parts of honey ephedra, 30-40 parts of gypsum, 6-9 parts of stir-fried bitter almonds, 9-15 parts of perilla seeds, 9-15 parts of scutellaria seeds, 9-15 parts of aster, 9-12 parts of peucedanum peucedanum, 9-12 parts of white scutellaria, 9-15 parts of thunbergii bulbs, 9-15 parts of honey loquat leaves, 6-12 parts of rhodiola rosea, and 6-9 parts of licorice.

[0008] As a preferred embodiment of the present invention, the raw materials for preparing the traditional Chinese medicine composition include, by weight: 6 parts of honey ephedra, 30 parts of gypsum, 9 parts of stir-fried bitter almonds, 15 parts of perilla seeds, 15 parts of scutellaria seeds, 15 parts of aster, 12 parts of peucedanum, 12 parts of scutellaria baicalensis, 15 parts of fritillaria thunbergii, 15 parts of honey loquat leaves, 12 parts of rhodiola rosea, and 6 parts of licorice.

[0009] The second aspect of the present invention provides a medicine for treating acute exacerbation of COPD, comprising the Chinese medicine composition as described above, and pharmaceutically acceptable excipients.

[0010] As a preferred embodiment of the present invention, the auxiliary material is selected from one or more of fillers, emulsifiers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and bases.

[0011] As a preferred embodiment of the present invention, the dosage form of the drug is a decoction, suspension, syrup, mixture, tincture, ointment, granules, pills, powder, tablets, capsules, drops, inhalants or injections.

[0012] As a preferred embodiment of the present invention, the preparation method of the decoction is:

[0013] S1: taking raw materials according to weight, mixing the raw materials except gypsum and soaking them in water to obtain a mixture;

[0014] S2: adding water to gypsum and boiling it for the first time, then adding the mixture and boiling it for the second time, filtering, and obtaining a first liquid medicine and a first filter residue;

[0015] S3: adding water to the obtained first filter residue to perform a third decoction, and then filtering to obtain a second medicinal solution and a second filter residue;

[0016] S4: combining the first medicinal liquid and the second medicinal liquid to obtain the decoction.

[0017] As a preferred embodiment of the present invention, in step S1,

[0018] The amount of water added is 4 to 6 times the total mass of all raw materials except gypsum;

[0019] The soaking time is 15 to 20 minutes.

[0020] As a preferred embodiment of the present invention, in step S2,

[0021] The amount of water added should be 2 to 3 cm above the medicine surface;

[0022] The first decoction method is: first use high heat 220-230°C to boil, then use low heat 160-170°C to continue boiling for 20-25 minutes;

[0023] The second decoction method is: simmer at 160-170° C. for 20-25 minutes.

[0024] As a preferred embodiment of the present invention, in step S3,

[0025] The amount of water added should be 2 to 3 cm above the medicine surface;

[0026] The third decoction method is: first use high heat 220-230° C. to boil, and then use low heat 160-170° C. to continue boiling for 10-15 minutes.

[0027] The third aspect of the present invention provides a use of the Chinese medicine composition or medicine as described above in the preparation of a medicine for treating acute exacerbation of COPD.

[0028] Usage and dosage: Taking the decoction prepared by the above method as an example, take twice a day, 200 ml each time.

[0029] Explanation of the prescription: The present invention uses honey ephedra and gypsum as the main medicines; uses fried bitter almonds as the assistant medicine; uses perilla seed, scutellaria baicalensis seed, aster, peucedanum peucedanum, radix scutellariae, fritillariae thunbergii, and honey loquat leaves as the adjuvant medicines; uses rhodiola rosea and liquorice as the guiding medicines.

[0030] Junyao

[0031] Honey ephedra: spicy, slightly bitter, warm in nature, enters the lung and bladder meridians; has the effects of sweating and dispelling cold, clearing the lungs and relieving asthma, promoting diuresis and reducing swelling. It can be used to treat colds, chest tightness, coughing, edema due to wind and water, etc.; it can also be used to treat bronchial asthma. Honey ephedra is obtained by processing ephedra with honey. Compared with ordinary ephedra, honey ephedra is warmer and moister in nature, and has a stronger effect of moistening the lungs and relieving cough. It is mostly used for the treatment of asthma and cough when the external symptoms have been relieved.

[0032] Gypsum: Spicy, sweet, and extremely cold, it enters the spleen and stomach meridians; raw use has the effects of clearing away heat and purging fire, relieving restlessness and quenching thirst. It can be used to treat exogenous febrile diseases, high fever and thirst, lung heat and cough, hyperactivity of stomach fire, headache, toothache, etc.

[0033] Minister medicine

[0034] Fried bitter almonds: bitter, slightly warm, slightly toxic; enter the lung and large intestine meridians; have the effects of relieving cough and reducing phlegm, moistening the intestines and relieving constipation, etc., and can be used to treat cough and asthma, chest fullness and phlegm, dry intestines and constipation. Fried bitter almonds reduce the toxicity of amygdalin through processing, making it more suitable for medicinal use. In addition, almonds can also enhance human immunity and regulate blood lipids.

[0035] Adjuvant

[0036] Perilla seeds: spicy, warm in nature, enter the lung meridian; has the effects of lowering qi, eliminating phlegm, calming asthma, and lubricating the intestines. It can be used to treat phlegm-blocked qi, cough, asthma, and dry intestines and constipation.

[0037] Tinglizi: pungent and bitter in taste, enters the lung and bladder meridians; has the effects of purging the lungs and relieving asthma, promoting water circulation and reducing swelling. It can be used to treat phlegm blocking the lungs, asthma, coughing and sputum, chest and flank distension, inability to lie flat, chest and abdominal edema, and difficulty urinating; it also has a certain effect on edema caused by cor pulmonale.

[0038] Aster: Spicy and bitter in taste, warm in nature, belongs to the lung meridian; has the effects of moistening the lungs and lowering qi, eliminating phlegm and relieving cough. It can be used to treat wheezing and coughing with excessive phlegm, new and long-term cough, and coughing up blood due to fatigue.

[0039] Radix Peucedanum: bitter, pungent, slightly cold, enters the lung meridian. It has the effects of descending qi and resolving phlegm, dispersing wind and clearing heat. It can be used to treat phlegm-heat wheezing, yellow and thick sputum, and wind-heat cough with excessive sputum.

[0040] Baiqian: bitter, pungent, slightly warm, enters the lung meridian. It has the effects of lowering qi, eliminating phlegm, and relieving cough. It can be used to treat lung qi stagnation, cough with phlegm, chest fullness and shortness of breath.

[0041] Fritillaria thunbergii: bitter, cold, enters the lung and heart meridians. It has the effects of clearing away heat, resolving phlegm and relieving cough, detoxifying, dispersing knots and eliminating carbuncle. It can be used to treat wind-heat cough, phlegm-fire cough, lung carbuncle, breast carbuncle, scrofula, and sores.

[0042] Honey loquat leaf: bitter, slightly cold, enters the lung and stomach meridians. It has the effects of clearing the lungs and relieving cough, lowering adverse qi and stopping vomiting. It can be used to treat lung heat cough, qi reverse and shortness of breath, stomach heat vomiting, and irritability and thirst.

[0043] Drug

[0044] Rhodiola rosea: sweet in taste, cold in nature, enters the lung meridian; has the effects of replenishing qi and clearing the lungs, improving intelligence and nourishing the heart, astringing and stopping bleeding, dispersing blood stasis and reducing swelling, etc. At the same time, it also has certain effects on qi deficiency and physical weakness, fear of cold after illness, shortness of breath and fatigue, lung heat cough, hemoptysis, leucorrhea and diarrhea, traumatic injuries, burns, neurosis, altitude sickness, etc.

[0045] Licorice: sweet in taste, neutral in nature, enters the heart, lung, spleen, and stomach meridians; it has the effects of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving pain, and harmonizing various medicines. It can be used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with sputum, abdominal and limb cramps and pain, carbuncle, sore, and relieve drug toxicity and potency.

[0046] Beneficial Effects

[0047] The effects of the combination of the components of the present invention far exceed the effects of a single dose of the drug. The present invention uses honey ephedra and gypsum as the main drugs; stir-fried bitter almonds as the assistant drugs; perilla seeds, scutellaria seeds, aster, peucedanum, radix scutellariae, thunbergii bulbs, honey loquat leaves as adjuvant drugs; and rhodiola rosea and liquorice as the guiding drugs to harmonize the drugs, so that the obtained traditional Chinese medicine preparation has the effects of fast onset, high treatment rate, and low recurrence, and at the same time plays the role of clearing the lungs and relieving cough, promoting blood circulation and resolving phlegm.

[0048] The present invention can effectively improve the symptoms of acute exacerbation-related wheezing, shortness of breath, chest tightness, cough and sputum in COPD patients after activities by scientifically combining Chinese medicinal raw materials, reduce the number of acute exacerbations, reduce the mortality rate of patients, delay the decline of FEV1 of lung function of patients, and improve the symptoms of patients such as CAT score, mMRC score, 6MWT distance, etc. The Chinese medicine composition of the present invention has no toxic side effects, and has many advantages in treating acute exacerbation of COPD, such as good efficacy, rapid onset, strong efficacy, and low recurrence.

[0049] The above description is only an overview of the technical solution of the present invention. In order to more clearly understand the technical means of the present invention and implement it according to the contents of the specification, the preferred embodiments of the present invention are described in detail as follows. DETAILED DESCRIPTION

[0050] In order to make the technical means, creative features, objectives and effects of the present invention easy to understand, the technical solution of the present invention will be clearly and completely described below in combination with the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0051] Unless otherwise specified, the experimental methods used in the following examples are all conventional methods.

[0052] Unless otherwise specified, the materials and reagents used in the following examples can be obtained from commercial sources.

[0053] If not otherwise specified, the high heat described in the following embodiments refers to a temperature between 220 and 230°C, and the low heat refers to a temperature between 160 and 170°C.

[0054] The basic characteristics of acute exacerbation of COPD are mixed deficiency, phlegm, blood stasis, and toxins, and the pathogenesis is mixed deficiency and excess, and deficiency in the root and excess in the superficial. The common syndromes of acute exacerbation of COPD are phlegm-heat obstructing the lungs, phlegm and blood stasis, obstructing the lungs, and lung-kidney qi deficiency. The basic treatment of this disease is to clear away heat and resolve phlegm, and to activate blood circulation and remove blood stasis. The present invention is a prescription established based on the core pathogenesis of phlegm-heat and blood stasis in the lungs during acute exacerbation of COPD. The prescription of the present invention is composed of honey ephedra, stir-fried bitter almonds, gypsum, perilla seeds, scutellaria seeds, aster, peucedanum, scutellaria, thunbergii, fritillaria thunbergii, honey loquat leaves, rhodiola rosea, and licorice, and contains Ma Xing Shi Gan Tang. Modern pharmacological studies have shown that Ma Xing Shi Gan Tang has antitussive, antiasthmatic, anti-inflammatory, anti-allergic, immune-regulating, antibacterial, and antiviral effects. Clinical studies have also found that Ma Xing Shi Gan Tang plus or minus has significant effects in treating acute exacerbation of COPD, can effectively improve clinical symptoms and lung function of patients, reduce inflammatory response of the body, and has high safety. In the prescription of the present invention, honey ephedra can diaphoretically relieve the symptoms, promote lung function and relieve asthma, while gypsum is pungent in clearing away heat and purging fire, and relieves restlessness and cough. The two are both the main medicines; fried bitter almonds are bitter in descending lung qi, relieving cough and relieving asthma. "Changsha Yaojie" records that it "clears and clears, breaks obstruction and descends adverse, is good at relieving numbness and stopping asthma... regulating the depression of qi without any difference." It is the minister medicine. Perilla seed can lower Qi and resolve phlegm, relieve cough and asthma. In addition, "Lingshu Benshu Pian" states: "The lung is connected to the large intestine, and the large intestine is the organ of conduction", which can clear the large intestine and regulate Qi. When used together with fried bitter almonds and other drugs that can resolve phlegm and relieve asthma, promote blood circulation and remove blood stasis, it can resolve phlegm, promote blood circulation, and clear the intestines and reduce the number of acute exacerbations of COPD and the number of days of acute exacerbations. Lepidium seed can clear the lungs and relieve asthma, promote diuresis and reduce swelling, and can balance the helper T cells 17( The ratio of Th17 and regulatory T cells (Treg), inhibits apoptosis of lung tissue cells, and can upregulate AQ5 protein expression to improve acute lung injury and exert its efficacy on this basis; Aster, Peucedanum, and Radix Phellodendri can reduce qi, resolve phlegm and relieve cough; Fritillaria thunbergii and loquat leaves can clear heat, resolve phlegm and relieve cough. "Ben Cao Hui Yan" states: "Fritillaria is a drug that can relieve depression, reduce qi and resolve phlegm. It moistens the lungs and eliminates phlegm, relieves cough and relieves asthma." The above drugs are adjuvants; Rhodiola rosea can invigorate qi and activate blood circulation, dredge meridians and relieve asthma. Raw licorice protects stomach qi and harmonizes all drugs, and is a guiding drug.

[0055] Example 1: Preparation of Chinese herbal decoction

[0056] The raw materials of the Chinese medicine composition are as follows: 6g honey ephedra, 30g gypsum, 9g fried bitter almond, 15g perilla seed, 15g scutellaria seed, 15g aster, 12g peucedanum, 12g radix scutellariae, 15g thunbergii, 15g honey loquat leaf, 12g rhodiola rosea, and 6g liquorice. The Chinese medicine composition is prepared into a decoction, and the specific method is as follows:

[0057] Accurately weigh the above raw material components, mix honey ephedra, stir-fried bitter almond, perilla seed, scutellaria baicalensis, aster, peucedanum, scutellaria baicalensis, fritillaria thunbergii, honey loquat leaf, rhodiola rosea, and licorice, and add 5 times of their total mass of water to soak for 20 minutes to obtain a mixture. Add 1000ml of water to a casserole, add gypsum, and perform the first decoction, that is, first boil with high heat, and then heat with slow fire for 25 minutes. Then add the mixture and perform the second decoction, that is, continue to heat with slow fire for 25 minutes, and filter after the temperature drops slightly to obtain the first medicinal liquid and the first filter residue. Add water to the obtained first filter residue until it is 2 to 3cm above the medicine surface for the third decoction, that is, first boil with high heat, and then heat with slow fire for 15 minutes, and filter after the temperature drops slightly to obtain the second medicinal liquid and the second filter residue. The first medicinal liquid and the second medicinal liquid obtained by the above two decoctions are placed in the same container to obtain a total of about 400 ml of Chinese medicine decoction. Finally, the prepared Chinese herbal decoction is sterilized, filled, sealed, and refrigerated. It should be noted that the prepared Chinese herbal decoction is the daily dosage for one patient, and more Chinese herbal decoctions can be prepared in multiple pots and / or multiple times according to the number of patients and the number of days of taking the decoction.

[0058] Example 2: Clinical trial evaluation of Chinese herbal decoction

[0059] 1. Case source

[0060] The cases selected in this invention are all from patients who visited the Department of Respiratory Medicine of the Third Affiliated Hospital of Beijing University of Chinese Medicine. They were diagnosed as having acute exacerbation of COPD according to the following diagnostic criteria and then received subsequent clinical treatment. The detailed clinical data involved in the clinical treatment were obtained with the written informed consent of the patients.

[0061] 2. Diagnostic criteria

[0062] The diagnostic criteria for chronic obstructive pulmonary disease are formulated in reference to the "2024 GOLD Guidelines for Chronic Obstructive Pulmonary Disease" and the "Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (ACECPD) (2017 Updated Version)".

[0063] (1) Clinical manifestations: worsening dyspnea, aggravated cough, increased sputum volume, changes in sputum color and / or viscosity, and fever. Non-specific symptoms such as general malaise, insomnia, drowsiness, fatigue, depression, and mental disorders may also occur.

[0064] (2) Medical history: a. History of exposure to risk factors: history of smoking, occupational or environmental exposure to hazardous substances; b. Past medical history: history of asthma, allergies, childhood respiratory infections, and other respiratory diseases; c. Family history of COPD.

[0065] (3) Physical signs: Early signs may not be obvious. As the disease progresses, the following symptoms may appear: barrel chest, shallow breathing, increased breathing rate, participation of accessory respiratory muscles in respiratory movements, and even chest-abdominal paradoxical breathing. The lungs may sound too clear when percussed, heart sounds may be distant when auscultated, breath sounds in both lungs may weaken, exhalation may be prolonged, and dry and wet rales may be heard during calm breathing.

[0066] (4) Laboratory examination: Pulmonary function test indicators are the gold standard for diagnosing COPD. After inhalation of 100 mg of the bronchodilator methacholine chloride by nebulization, if the ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) is less than 70%, it can be determined as incompletely reversible airflow limitation, which is a necessary condition for diagnosis.

[0067] (5) Acute exacerbation of COPD: refers to an event within 14 days characterized by worsening dyspnea and / or cough and sputum production, which may be accompanied by shortness of breath and / or tachycardia, and is usually related to worsening local and / or systemic inflammatory response caused by respiratory tract infection, air pollution or other reasons.

[0068] 3. Case grouping and treatment plan

[0069] The 60 patients were divided into two groups: treatment group and control group, with 30 cases in each group. Then the patients in each group were given corresponding treatment. The specific treatment plan was as follows:

[0070] Treatment group: adopt the treatment method of combining traditional Chinese and Western medicine, that is, conventional Western medicine treatment combined with the treatment scheme of the Chinese medicine decoction of Example 1 of the present invention; wherein, the Western medicine treatment scheme is: conventional Western medicine treatment such as bronchodilators, inhaled glucocorticoids, etc.; refer to GOLD 2024 and the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2021 Revised Edition)", and give Western medicine antispasmodic, anti-asthmatic, anti-inflammatory, expectorant, cough-relieving and other comprehensive treatments; the Chinese medicine treatment scheme is: take the decoction twice a day, 200 ml each time, and slightly heat it before taking. The course of treatment is 7 days.

[0071] Control group: The patients received the same conventional western medicine treatment as the treatment group, but they did not take the Chinese medicine decoction of Example 1.

[0072] 4. Efficacy evaluation

[0073] (1) Safety evaluation

[0074] All subjects were monitored for the following indicators before and after treatment: vital signs (blood pressure, respiration, heart rate, pulse); routine examination of urine and stool; blood routine; electrocardiogram; liver and kidney function; adverse events, including dizziness, chest tightness, abdominal distension, etc., and the time, severity, frequency, duration, measures taken and outcome of adverse events were recorded. At the same time, the adverse reactions of patients during medication were monitored. If a serious adverse reaction of grade 3 or above occurred, the medication process was terminated immediately.

[0075] (2) Comprehensive efficacy evaluation

[0076] Main efficacy indicators:

[0077] The main efficacy was evaluated based on the changes in the number of acute exacerbations before and after treatment. The number of acute exacerbations of the patients in the first three months of treatment was recorded, and the two groups of patients were followed up for three months after treatment and the number of acute exacerbations of the patients was recorded.

[0078] Secondary efficacy indicators:

[0079] a. Acute exacerbation

[0080] The severity of acute exacerbation before treatment and 7 days after treatment was recorded in the two groups of patients, and the changes in the severity of acute exacerbation before and after treatment were observed in the two groups of patients.

[0081] b. Pulmonary function test

[0082] The forced expiratory volume in 1 second (FEV1) and its percentage of predicted value (FEV1%pred), forced vital capacity (FVC) and forced expiratory volume in 1 second / forced vital capacity (FEV1 / FVC) levels were recorded before treatment and 3 months after treatment in both groups of patients in order to evaluate the changes in lung function before and after treatment in both groups of patients.

[0083] c. TCM Syndrome Scale Score

[0084] The TCM syndrome scale for COPD was developed with reference to the 2019 edition of the Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease in Traditional Chinese Medicine

[13] . As shown in Table 1, the severity scores of the main symptoms of cough, sputum, wheezing, chest tightness, and shortness of breath were recorded as 0 (none), 2 (mild), 4 (moderate), and 6 (severe), respectively; the severity scores of the secondary symptoms of fatigue, palpitations, and sweating were recorded as 0 (none), 1 (mild), 2 (moderate), and 3 (severe), respectively; the scores of all symptoms were added together to form the total TCM syndrome score. The changes in the score levels before and after 7 days of treatment were recorded.

[0085] Table 1 TCM syndrome scale

[0086]

[0087]

[0088] d. COPD Assessment Test (CAT)

[0089] The CAT score was used to score the clinical symptoms of patients with acute exacerbation of COPD, including cough, expectoration, chest tightness, worsening shortness of breath when climbing stairs, home activities, going out, sleep, and energy. The sum of the scores of each item was the CAT score. The score changes were observed before treatment and 7 days after treatment.

[0090] e. Modified Medical Research Council Dyspnea Scale (mMRC)

[0091] The mMRC questionnaire was used to score the degree of dyspnea in patients, and the score was scored from 0 to 4 points from mild to severe. The score was the mMRC questionnaire score. The score changes before treatment and 7 days after treatment were observed.

[0092] f. C-reactive protein (CRP) level, white blood cell (WBC) count

[0093] Observe the changes in CRP level and white blood cell count before treatment and 7 days after treatment, namely:

[0094] CRP detection reagent: high-sensitivity C-reactive protein (hs-CRP) detection kit (latex-enhanced immunoscattering turbidimetry), manufactured by Mindray Nanjing Biotechnology Co., Ltd.;

[0095] White blood cell detection reagent: M-60FN blood cell analysis staining solution, manufactured by Mindray Nanjing Biotechnology Co., Ltd.; detection instrument model: LABOSPECT 008AS, manufactured by Hitachi.

[0096] 5. Statistical methods

[0097] The data were analyzed using Excel spreadsheets and SPSS Statistics 26.0.0 statistical analysis software. The measurement data were expressed as (mean ± standard deviation). If the data conformed to the normal distribution and the variance was equal, the independent sample t-test was used for comparison between the two groups, and the paired t-test was used for comparison before and after treatment within the group. If the data did not conform to the normal distribution, nonparametric tests were used. The Mann-Whitney U method was used for measurement data, and the Fisher exact test was used for count data. All tests were performed using two-sided tests, and P < 0.05 was considered statistically significant.

[0098] 6. Clinical trial results

[0099] (1) Safety evaluation

[0100] The monitoring and examination results showed that the safety indicators such as blood routine, liver and kidney function in both groups of patients were not abnormal or aggravated due to treatment. No adverse reactions occurred in the 60 patients during the observation period.

[0101] (2) Comprehensive efficacy evaluation

[0102] Main efficacy: The results of the acute exacerbation times of the two groups of patients before and after treatment are shown in Table 2.

[0103] Table 2 Comparison of the number of acute exacerbations before and after treatment between the two groups of patients (mean ± standard deviation)

[0104]

[0105] Note: Compared with the group before treatment 1) P<0.05, 2) P<0.01; compared with the control group after treatment 3) P

[0106] <0.05, 4) P<0.01.

[0107] As shown in Table 2, the number of acute exacerbations in the three months before treatment and the three months after treatment of the two groups of patients were statistically analyzed. The results showed that within the three months before treatment, there was no statistical difference in the number of acute exacerbations between the treatment group and the control group (P>0.05); within three months after treatment, there was no statistical difference in the number of acute exacerbations in the control group compared with before treatment (P>0.05), but the number of acute exacerbations in the treatment group (1.33±0.84) was reduced compared with the number of acute exacerbations before treatment (2.73±0.98), and the difference was statistically significant (P<0.05); within three months after treatment, the comparison between the two groups showed that the number of acute exacerbations in the treatment group (1.33±0.84) was reduced compared with the number of acute exacerbations in the control group (2.47±1.04), and the difference was statistically significant (P<0.05).

[0108] Secondary efficacy:

[0109] a. Acute exacerbation

[0110] The results are shown in Table 3.

[0111] Table 3 Comparison of acute exacerbation between the two groups of patients

[0112]

[0113] Note: Compared with the group before treatment 1) P<0.05, 2) P<0.01; compared with the control group after treatment 3) P<0.05, 4) P<0.01.

[0114] As shown in Table 3, the acute exacerbation degree of the two groups of patients before treatment and 7 days after treatment was statistically analyzed. The results showed that before treatment, there was no statistical difference in the acute exacerbation degree between the treatment group and the control group (P>0.05); 7 days after treatment, the intra-group comparison showed that there was no statistical difference in the acute exacerbation degree of the control group compared with that before treatment (P>0.05), but the acute exacerbation degree of the treatment group was significantly improved compared with that before treatment, and the difference was statistically significant (P<0.05); 7 days after treatment, the inter-group comparison showed that the acute exacerbation degree of the treatment group was significantly improved compared with that of the control group, and the difference was statistically significant (P<0.05).

[0115] b. Pulmonary function test

[0116] The results are shown in Table 4.

[0117] Table 4 Comparison of lung function indicators between the two groups of patients before and after treatment (mean ± standard deviation)

[0118]

[0119] Note: Compared with the group before treatment 1) P<0.05, 2) P<0.01; compared with the control group after treatment 3) P<0.05, 4) P<0.01.

[0120] As shown in Table 4, by comparing the pulmonary function indicators of the patients in the treatment group and the control group who completed the pulmonary function test before and after treatment, the results showed that: before treatment, there was no statistical difference in the pulmonary function indicators between the treatment group and the control group (P>0.05); three months after treatment, the intra-group comparison showed that the FEV1, FEV1%pred, FVC and FEV1 / FVC in the treatment group and the control group were significantly increased compared with those before treatment, and the difference was statistically significant (P<0.05); three months after treatment, the FEV1 and FVC in the treatment group were significantly increased compared with those in the control group, and the difference was statistically significant (P<0.05), and there was no statistical difference in FEV1%pred and FEV1 / FVC (P>0.05).

[0121] c. TCM Syndrome Scale Score

[0122] The results are shown in Table 5.

[0123] Table 5 Comparison of main symptoms and TCM syndrome scores between the two groups of patients before and after treatment (mean ± SD)

[0124]

[0125] Note: Compared with the group before treatment 1) P<0.05, 2) P<0.01; compared with the control group after treatment 3) P<0.05, 4) P<0.01.

[0126] As shown in Table 5, the total score of TCM syndromes in the treatment group and the control group was statistically analyzed. The results showed that before treatment, there was no statistical difference in the TCM syndrome scores between the treatment group and the control group (P>0.05); after 7 days of treatment, the intra-group comparison showed that the scores of wheezing, cough, sputum, chest tightness, shortness of breath, fatigue and total score in the treatment group and the scores of cough, sputum, chest tightness, fatigue, palpitations and total score in the control group were significantly decreased compared with those before treatment, and the difference was statistically significant (P<0.05); after 7 days of treatment, the scores of wheezing, cough, chest tightness and shortness of breath in the treatment group and the total score were significantly decreased compared with those in the control group, and the difference was statistically significant (P<0.05), and there was no statistical difference in the scores of other individual symptoms compared with those in the control group (P>0.05).

[0127] d. Comparison of CAT scores

[0128] The results are shown in Table 6.

[0129] Table 6 Comparison of CAT scores between the two groups of patients before and after treatment (mean ± standard deviation)

[0130]

[0131] Note: Compared with the group before treatment 1)P<0.05, 2) P<0.01; compared with the control group after treatment 3) P<0.05, 4) P<0.01.

[0132] As shown in Table 6, by comparing the CAT scores of the treatment group and the control group, the results showed that before treatment, there was no statistical difference in CAT scores between the treatment group and the control group (P>0.05); 7 days after treatment, the cough, sputum, chest tightness, climbing stairs, activity, going out, energy, and total score of the treatment group and the cough, sputum, chest tightness, sleep, energy, and total score of the control group were significantly reduced compared with those before treatment, and the difference was statistically significant (P<0.05); 7 days after treatment, the cough, sputum, chest tightness, going out, activity and total score of the treatment group were significantly reduced compared with those of the control group, and the difference was statistically significant (P<0.05), and there was no statistical difference in the other single symptom scores compared with the control group (P>0.05).

[0133] e. Comparison of mMRC scores

[0134] The results are shown in Table 7.

[0135] Table 7 Comparison of mMRC scores between the two groups of patients before and after treatment (mean ± standard deviation)

[0136]

[0137] Note: Compared with the group before treatment 1) P<0.05, 2) P<0.01; compared with the control group after treatment 3) P<0.05, 4) P<0.01.

[0138] As shown in Table 7, by comparing the mMRC scores of the treatment group and the control group, the results showed that: before treatment, there was no statistical difference in the mMRC scores between the treatment group and the control group (P>0.05); after 7 days of treatment, the mMRC scores of the treatment group and the control group were significantly decreased compared with those before treatment, and the difference was statistically significant (P<0.05); after 7 days of treatment, there was no statistical difference in the mMRC score between the treatment group and the control group (P>0.05).

[0139] f. Changes in CRP levels and white blood cell counts

[0140] The results are shown in Table 8.

[0141] Table 8 Comparison of CRP and white blood cell counts between the two groups of patients before and after treatment (mean ± standard deviation)

[0142]

[0143]

[0144] Note: Compared with the group before treatment 1) P<0.05, 2) P<0.01; compared with the control group after treatment 3) P<0.05, 4) P<0.01.

[0145] As shown in Table 8, by comparing the CRP and white blood cell counts of the treatment group and the control group before and after treatment, the results showed that: before treatment, there was no statistical difference in CRP level and white blood cell count between the treatment group and the control group (P>0.05); after 7 days of treatment, the CRP level and white blood cell count of the treatment group and the control group were significantly decreased compared with those before treatment, and the difference was statistically significant (P<0.05); after 7 days of treatment, there was no statistical difference in CRP level and white blood cell count between the treatment group and the control group (P>0.05).

[0146] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form. Although the present invention has been disclosed as a preferred embodiment as above, it is not used to limit the present invention. Any technician familiar with this profession can make some changes or modifications to equivalent embodiments of equivalent changes by using the methods and technical contents disclosed above without departing from the scope of the technical solution of the present invention. However, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, characterized in that: In terms of weight, the raw materials for preparing the traditional Chinese medicine composition include: 6-9 parts of honey ephedra, 30-40 parts of gypsum, 6-9 parts of fried bitter almonds, 9-15 parts of perilla seeds, 9-15 parts of scutellaria seeds, 9-15 parts of aster, 9-12 parts of peucedanum, 9-12 parts of white scutellaria, 9-15 parts of thunbergii, 9-15 parts of honey loquat leaves, 6-12 parts of rhodiola rosea, and 6-9 parts of licorice.

2. The Chinese medicine composition according to claim 1, characterized in that: According to the weight parts, the raw materials for preparing the traditional Chinese medicine composition include: 6 parts of honey ephedra, 30 parts of gypsum, 9 parts of fried bitter almonds, 15 parts of perilla seeds, 15 parts of scutellaria seeds, 15 parts of aster, 12 parts of peucedanum, 12 parts of scutellaria baicalensis, 15 parts of fritillaria thunbergii, 15 parts of honey loquat leaves, 12 parts of rhodiola rosea, and 6 parts of licorice.

3. A drug for treating acute exacerbation of chronic obstructive pulmonary disease, characterized in that: The invention comprises the Chinese medicine composition according to claim 1 or 2, and pharmaceutically acceptable excipients.

4. The drug according to claim 3, characterized in that The auxiliary material is selected from one or more of fillers, emulsifiers, disintegrants, lubricants, suspending agents, adhesives, sweeteners, flavoring agents, preservatives, and bases.

5. The drug according to claim 3, characterized in that The dosage form of the medicine is decoction, suspension, syrup, mixture, tincture, ointment, granule, pill, powder, tablet, capsule, drop, inhalant or injection.

6. The drug according to claim 5, characterized in that The preparation method of the decoction is: S1: taking raw materials according to weight, mixing the raw materials except gypsum and soaking them in water to obtain a mixture; S2: adding water to gypsum and boiling it for the first time, then adding the mixture and boiling it for the second time, filtering, and obtaining a first liquid medicine and a first filter residue; S3: adding water to the obtained first filter residue to perform a third decoction, and then filtering to obtain a second medicinal solution and a second filter residue; S4: combining the first medicinal liquid and the second medicinal liquid to obtain the decoction.

7. The drug according to claim 6, characterized in that In step S1, The amount of water added is 4 to 6 times the total mass of all raw materials except gypsum; The soaking time is 15 to 20 minutes.

8. The drug according to claim 6, characterized in that In step S2, The amount of water added should be 2 to 3 cm above the medicine surface; The first decoction method is: first use high heat 220-230°C to boil, then use low heat 160-170°C to continue boiling for 20-25 minutes; The second decoction method is: simmer at 160-170° C. for 20-25 minutes.

9. The drug according to claim 6, characterized in that In step S3, The amount of water added should be 2 to 3 cm above the medicine surface; The third decoction method is: first use high heat 220-230° C. to boil, and then use low heat 160-170° C. to continue boiling for 10-15 minutes.

10. Use of the Chinese medicine composition according to claim 1 or 2 or the medicine according to any one of claims 3 to 9 in the preparation of a medicine for treating acute exacerbation of chronic obstructive pulmonary disease.

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