Traditional Chinese medicine composition for treating chronic obstructive pulmonary disease in stable phase as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease in a stable phase, which is prepared from the following raw materials in parts by weight: 6-9 parts of cordyceps sinensis, 15-30 parts of astragalus membranaceus, 12-15 parts of wine-processed rhizoma polygonati, 6-12 parts of rhodiola rosea, 3-6 parts of honey-fried ephedra, 6-9 parts of fried semen armeniacae amarae, 9-15 parts of semen lepidii, 9-12 parts of honey-fried radix asteris, 9-12 parts of fried fructus perillae, 6-9 parts of ginkgo kernel, 9-12 parts of earthworm and 6-9 parts of liquorice. Through scientific compatibility of the traditional Chinese medicine raw materials, clinical symptoms of chronic obstructive pulmonary disease patients in the stable phase can be effectively relieved, the acute exacerbation frequency of the chronic obstructive pulmonary disease patients is 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 disease.

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 stable 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. The stable stage of COPD refers to the stage when the patient's symptoms such as cough, sputum, and shortness of breath are stable or mild, and there is no acute exacerbation within 6 weeks. Patients in the stable stage of COPD will experience a symptom burden composed of multiple symptoms, including but not limited to respiratory symptoms such as dyspnea, cough, sputum, and wheezing, as well as changes in systemic conditions such as fatigue, anxiety, depression, and insomnia, accompanied by a rapid decline in lung function. With the aging of the population and the long-term exposure to COPD risk factors, the incidence and mortality of COPD have increased year by year. It has become one of the most common chronic diseases with the most serious disease burden in my country. It is expected that the burden of COPD-related diseases will gradually increase in the next few decades.

[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, with phlegm, blood stasis, and water retention as symptoms. It is often aggravated by wind and cold evil qi invading the skin and fur and combining with the lungs. The lung is the sign of qi, and the kidney is the root of qi. Qi has a master and breathing has a root. The most common syndrome type in the stable stage of COPD is qi and yin deficiency, and phlegm and blood stasis obstruction. Lung qi deficiency is more common at the beginning. If the disease is prolonged and not cured, it will develop into lung and spleen qi deficiency, and finally it can affect the kidneys and turn into lung and kidney qi deficiency.

[0004] Prevention and treatment of COPD in the stable stage is the key to delaying the progression of COPD. At present, Western medicine often uses bronchodilators, glucocorticoids and other drugs to treat COPD in the stable stage, mainly in the form of inhaled preparations. However, some patients still have poor symptom control, rapid decline in lung function, and a high risk of acute exacerbation after treatment. Modern medical anti-inflammatory drugs cannot effectively relieve COPD symptoms, delay the progression of acute exacerbations, and reduce the decline in lung function. Therefore, it is particularly important to propose a Chinese medicine composition that is effective in treating COPD in the stable stage. Summary of the invention

[0005] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating COPD in the stable stage, and a preparation method and application thereof, so as to achieve effective treatment of COPD in the stable stage.

[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 the stable stage of chronic obstructive pulmonary disease. The raw materials for preparing the traditional Chinese medicine composition include, by weight: 6-9 parts of Cordyceps sinensis, 15-30 parts of Astragalus, 12-15 parts of Polygonatum odoratum, 6-12 parts of Rhodiola rosea, 3-6 parts of honey ephedra, 6-9 parts of stir-fried bitter almonds, 9-15 parts of Lemongrass seeds, 9-12 parts of honey Aster, 9-12 parts of stir-fried Perilla seeds, 6-9 parts of Ginkgo nuts, 9-12 parts of Pheretima and 6-9 parts of Licorice.

[0008] As a preferred embodiment of the present invention, the raw materials for preparing the Chinese medicine composition include, by weight: 9 parts of Cordyceps sinensis, 30 parts of Astragalus, 12 parts of Polygonatum odoratum, 12 parts of Rhodiola rosea, 6 parts of honey ephedra, 9 parts of stir-fried bitter almonds, 15 parts of Lemongrass seeds, 12 parts of honey Aster, 12 parts of stir-fried Perilla seeds, 9 parts of Ginkgo nuts, 12 parts of Pheretima and 6 parts of licorice tablets.

[0009] The second aspect of the present invention provides a medicine for treating stable 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 each raw material according to weight, soaking it in water, and obtaining a mixture;

[0014] S2: boiling the obtained mixture for the first time, and then filtering it to obtain a first medicinal solution and a first filter residue;

[0015] S3: adding water to the obtained first filter residue for a second 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 each raw material;

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

[0020] As a preferred embodiment of the present invention, in step S2, the first decoction method is: first use high heat 220-230°C to boil, and then use low heat 160-170°C to continue boiling for 20-25 minutes.

[0021] As a preferred embodiment of the present invention, in step S3,

[0022] The amount of water added should be 2 to 3 cm above the medicine surface;

[0023] The second 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.

[0024] 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 stable COPD.

[0025] Usage and dosage: Taking the decoction prepared by the above method as an example, take twice a day, 200 ml each time.

[0026] Explanation of the prescription: Cordyceps sinensis and Astragalus membranaceus are the main drugs; Polygonatum sibiricum, Rhodiola rosea, honey ephedra, stir-fried bitter almonds, Lemongrass seeds, honey aster, and stir-fried Perilla seeds are the assistant drugs; Ginkgo nuts and earthworms are the adjuvant drugs; and Licorice is the guiding drug.

[0027] Junyao

[0028] Cordyceps sinensis: sweet in taste, neutral in nature, enters the lung and kidney meridians; has the effects of nourishing the lungs and kidneys, stopping bleeding and resolving phlegm. It can be used to treat chronic cough and asthma, cough due to fatigue and hemoptysis, impotence and spermatorrhea, and soreness of waist and knees. In addition, Cordyceps sinensis contains rich protein, amino acids and cordyceps polysaccharides, which can enhance the body's immunity, improve myocardial function, and prevent arrhythmia.

[0029] Astragalus: sweet, slightly warm, enters the lung and spleen meridians; has the effects of replenishing qi and strengthening the exterior, promoting diuresis and expelling toxins, draining pus, healing sores and promoting tissue regeneration. It can be used to treat qi deficiency and fatigue, poor appetite and loose stools, sinking of qi in the middle, chronic diarrhea and prolapse of the anus, bloody stool and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, carbuncle that is difficult to ulcerate, long-term ulceration that does not heal, blood deficiency and jaundice, internal heat and thirst, etc. In addition, it also has a certain therapeutic effect on chronic nephritis proteinuria, diabetes, etc.

[0030] Minister medicine

[0031] Polygonatum sibiricum: sweet in taste, neutral in nature, enters the spleen, lung and kidney meridians, and has the effects of tonifying the middle and replenishing qi, nourishing yin and moistening the lungs. It can be used to treat yin deficiency and lung dryness, dry cough without sputum, soreness of waist and knees, dizziness, spleen deficiency and poor appetite, and post-illness deficiency. Wine-cured Polygonatum sibiricum is obtained after Polygonatum sibiricum is processed with wine. After processing with wine, the medicinal effect of Polygonatum sibiricum is enhanced, and the irritation and side effects of Polygonatum sibiricum are eliminated. Compared with Polygonatum sibiricum, wine-cured Polygonatum sibiricum has a strong sugar and a good taste, which is more conducive to taking.

[0032] 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.

[0033] 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.

[0034] Almonds: bitter, slightly warm, 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, asthma, dry intestines and constipation. In addition, almonds can also enhance human immunity and regulate blood lipids.

[0035] 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.

[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] 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.

[0038] Adjuvant

[0039] Earthworm: salty in taste, cold in nature, enters the liver, spleen, and bladder meridians; has the effects of clearing away heat and calming the nerves, unblocking meridians, calming asthma, and diuresis. It can be used to treat high fever coma, epilepsy convulsions, joint pain, limb numbness, hemiplegia, lung heat cough, oliguria, edema, and hypertension.

[0040] Ginkgo nuts: sweet, bitter, astringent, neutral in nature, enter the lung meridian; has the effects of astringing the lungs and calming asthma, stopping leukorrhea, and reducing bowel movements. It can be used to treat cough with excessive phlegm, leukorrhea, leukorrhea, enuresis, and frequent urination.

[0041] Drug

[0042] 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.

[0043] Beneficial Effects

[0044] The effects of the combination of the components of the present invention far exceed the effects of a single dose of medicine. The present invention uses Cordyceps sinensis and Astragalus as the main drugs, uses Polygonatum odoratum, Rhodiola rosea, Ephedra honey, stir-fried Apricot kernel, Lemongrass seeds, Aster honey, stir-fried Perilla seeds as the assistant drugs, uses Ginkgo nuts and Pheretima as the adjuvant drugs, and uses Licorice as the guiding drug to coordinate the drugs, so that the obtained Chinese medicine preparation has the effects of fast onset, high treatment rate, and low recurrence, and at the same time plays the role of invigorating Qi and nourishing Yin, promoting blood circulation and resolving phlegm.

[0045] The present invention can effectively alleviate the clinical symptoms of patients in the stable stage of COPD by scientifically combining Chinese medicine raw materials, including but not limited to reducing the number of acute exacerbations of COPD patients, delaying the decline of lung function, and other symptoms. The Chinese medicine composition of the present invention has no toxic side effects and has many advantages in the treatment of COPD, such as good efficacy, rapid onset of action, strong efficacy, and low recurrence.

[0046] 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

[0047] 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.

[0048] Unless otherwise specified, the experimental methods used in the following examples are all conventional methods.

[0049] Unless otherwise specified, the materials and reagents used in the following examples can be obtained from commercial sources.

[0050] 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.

[0051] The Chinese medicine composition for treating stable COPD provided by the present invention is mainly aimed at patients with frequent acute exacerbations of COPD with qi and yin deficiency and phlegm and blood stasis syndrome in stable period. The Chinese medicine composition is prepared by combining Cordyceps sinensis, Astragalus, Polygonatum odoratum, Rhodiola rosea, Pheretima honey, Apricot kernel, Lemongrass seed, Perilla seed, Aster, Ginkgo seed, Licorice and other medicines. The prescription is based on the perspective of state differentiation and treatment, that is, diagnosis and treatment from multiple dimensions such as viscera, exterior and interior, cold and heat, deficiency and excess, combined with the idea of ​​horn medicine, and multiple combinations of three medicines are used, focusing on treating the lungs and kidneys at the same time, treating the exterior and interior at the same time, and regulating the qi. The combination of Cordyceps sinensis, Perilla seed, and Rhodiola rosea in the formula targets the pathogenesis of lung and kidney qi and yin deficiency and phlegm and blood stasis in COPD patients. It works from three aspects: tonifying deficiency, resolving phlegm, and promoting blood circulation. It can tonify the lung and kidney, promote blood circulation and resolve phlegm. It is used for wheezing, chest tightness, shortness of breath, aggravated by movement, cough, and sputum caused by lung and kidney qi and yin deficiency and phlegm and blood stasis. The combination of Astragalus, Aster, and Pheretima can tonify spleen qi, promote blood circulation and resolve blood stasis, relieve cough and resolve phlegm. It is used for wheezing, cough, and sputum caused by spleen qi deficiency and phlegm and blood stasis. The combination of Jing, Trichosanthes kirilowii and Rhodiola rosea targets the pathogenesis of lung, spleen and kidney deficiency and phlegm and blood stasis blocking the lung meridians in patients with COPD. It works from the three aspects of tonifying deficiency, resolving phlegm and promoting blood circulation. It can tonify the lung, spleen and kidney, promote blood circulation and resolve phlegm. It is used for wheezing, chest tightness, shortness of breath (aggravated by movement), cough and sputum caused by lung, spleen and kidney qi deficiency and phlegm and blood stasis. The combination of Ephedra, Apricot kernel and Ginkgo seed can restore the lung's nature of promoting and descending from the perspectives of astringing the lungs, promoting qi, descending qi and relieving wheezing. It is used for wheezing, cough and sputum caused by lung qi ascending.

[0052] The most commonly used TCM treatment method for stable COPD is to invigorate qi, nourish yin, activate blood circulation and remove blood stasis. In the Chinese medicine composition of the present invention, Cordyceps sinensis and Astragalus membranaceus are used as the main medicines, which enter the lung, spleen and kidney meridians, invigorate the lung and kidney, and strengthen the body and consolidate the metal; Polygonatum sibiricum and Rhodiola rosea are used as the assistant medicines, which further increase the power of invigorating qi, nourishing yin and strengthening the body. The assistant medicines are further added with Trichosanthes kirilowii and Aster tataricus to enter the lung meridian to lower qi, relieve asthma, stop cough and eliminate phlegm; Pheretima and Ginkgo biloba are used as the auxiliary medicines to invigorate the lung and eliminate phlegm, clear away heat and dredge the meridians, and take into account the expectoration while strengthening the body. The whole prescription combination has the functions of invigorating qi, nourishing yin, activating blood circulation and removing phlegm, so as to strengthen the body and protect the lung metal.

[0053] Example 1: Preparation of Chinese herbal decoction

[0054] The raw materials of the Chinese medicine composition are as follows: 9g of Cordyceps sinensis, 30g of Astragalus, 12g of Polygonatum odoratum, 12g of Rhodiola rosea, 6g of honeyed ephedra, 9g of stir-fried bitter almonds, 15g of Lemongrass seeds, 12g of honeyed Aster, 12g of stir-fried Perilla seeds, 9g of Ginkgo nuts, 12g of Pheretima, and 6g of Licorice tablets. The Chinese medicine composition is prepared into a decoction by the following specific method:

[0055] Accurately weigh the above raw material components and put them into a casserole. Add 1000ml of water to the casserole and soak for 20 minutes to obtain a mixture. The obtained mixture is decocted for the first time, that is, first boiled with high heat, then heated with slow fire for 25 minutes, and filtered after the temperature drops slightly to obtain the first medicinal liquid and the first filter residue. Add water to the obtained first filter residue to 2 to 3cm above the medicine surface for the second decoction, that is, first boiled with high heat, then heated with slow fire for 15 minutes, and filtered after the temperature drops slightly to obtain the second medicinal liquid. 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 obtained Chinese medicine decoction is sterilized, filled, sealed, and refrigerated. It should be noted that the above-mentioned Chinese medicine decoction is the daily dosage of one patient, and more Chinese medicine decoctions can be prepared in multiple pots and / or multiple times according to the number of patients and the number of days of taking.

[0056] Example 2: Clinical trial evaluation of Chinese herbal decoction

[0057] 1. Case source

[0058] 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 COPD in the stable stage 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.

[0059] 2. Diagnostic criteria

[0060] The diagnostic criteria for chronic obstructive pulmonary disease are formulated with reference to GOLD (global initiative for chronic obstructive lung disease) 2024 and the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2021 Revised Edition)".

[0061] (1) Clinical manifestations: dyspnea, chronic cough, sputum, wheezing, and chest tightness. Advanced or severe patients may also have other systemic symptoms, such as weight loss, loss of appetite, and peripheral muscle atrophy.

[0062] (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.

[0063] (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.

[0064] (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.

[0065] (5) Stable COPD stage: The patient's symptoms such as cough, sputum, and shortness of breath are stable or mild, and there is no acute exacerbation within 6 weeks.

[0066] 3. Case grouping and treatment plan

[0067] The 90 patients were divided into two groups: treatment group and control group, with 45 cases in each group. Then the patients in each group were given corresponding treatment. The specific treatment plan was as follows:

[0068] 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 and antiasthmatic, anti-inflammatory, expectorant, cough 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 it. One month is a course of treatment, and 3 courses are taken continuously.

[0069] 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.

[0070] 4. Efficacy evaluation

[0071] (1) Safety evaluation

[0072] 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.

[0073] (2) Comprehensive efficacy evaluation

[0074] Main efficacy indicators:

[0075] The comprehensive efficacy of the two treatment plans was evaluated according to the changes in the total score of TCM syndromes before and after treatment. The efficacy index was calculated using the nimodipine method: efficacy index = (score before treatment - score after treatment) / score before treatment × 100%. Cured: efficacy index ≥ 90%; markedly effective: 60% ≤ efficacy index < 90%; effective: 30% ≤ efficacy index < 60%; ineffective: efficacy index < 30%. Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%.

[0076] Secondary efficacy indicators:

[0077] a. Number of acute exacerbations

[0078] The number of acute exacerbations of the two groups of patients before treatment and within 6 months after the end of treatment was recorded.

[0079] b. Pulmonary function test

[0080] 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) were recorded before treatment and 3 months after treatment in both groups of patients.

[0081] c. TCM Syndrome Scale Score

[0082] A TCM syndrome scale for COPD was developed, 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 as the total score of TCM syndrome. The score levels before treatment and 3 months after treatment were recorded.

[0083] Table 1 TCM syndrome scale

[0084]

[0085]

[0086]

[0087] d. COPD Questionnaire score

[0088] The changes in the scores of the modified Medical Research Council Dyspnea Scale (mMRC) and the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) were recorded before treatment and 3 months after treatment.

[0089] 5. Statistical methods

[0090] SPSS Statistics 26.0.0 statistical analysis software was used for data analysis. The count data were expressed as rate or constituent ratio, and the chi-square test or Fisher's exact test was used for inter-group comparison. The measurement data were expressed as mean ± standard deviation () or median (quartile) [M(P25, P75)]. If the data conformed to the normal distribution, the paired t-test was used for intra-group comparison, and the independent sample t-test was used for inter-group comparison. If the data did not conform to the normal distribution, the Wilcoxon rank sum test was used for intra-group comparison, and the Mann-Whitney rank sum test was used for inter-group comparison. The Mann-Whitney rank sum test was used for rank data. All tests were bilateral, and P < 0.05 was considered statistically significant.

[0091] 6. Clinical trial results

[0092] (1) Safety evaluation

[0093] According to the monitoring and examination results: during the period of patients taking the medicine, there were no obvious abnormalities in the vital signs, routine urine and stool examinations, blood routine tests, electrocardiograms, liver and kidney functions of all patients before, during and after treatment.

[0094] (2) Comprehensive efficacy evaluation

[0095] Main efficacy: The results are shown in Table 2.

[0096] Table 2 Comparison of comprehensive treatment efficacy between the two groups of patients

[0097]

[0098] As shown in Table 2, by statistically analyzing the comprehensive therapeutic efficacy of the two groups of patients in the treatment group and the control group, the results showed that the total effective rate of the treatment group was 93.33% (42 / 45), and the total effective rate of the control group was 75.56% (34 / 45), and the total effective rate of the treatment group was significantly higher than that of the control group. It can be seen that compared with the control group treated with Western medicine alone, the treatment group can significantly improve the therapeutic effect on COPD patients through the combined treatment of Western medicine and the decoction of Example 1 of the present invention.

[0099] Secondary efficacy:

[0100] a. Number of acute exacerbations

[0101] The results are shown in Table 3.

[0102] Table 3 Comparison of the number of acute exacerbations between the two groups of patients [M(P25,P75)]

[0103]

[0104] Note: Compared with the group before treatment #P<0.05, compared with the control group after treatment * P<0.05.

[0105] As shown in Table 3, the number of acute exacerbations of the two groups of patients before treatment and within 6 months of follow-up after treatment was statistically analyzed. The results showed that the number of acute exacerbations of the two groups of patients before treatment was the same, with no significant difference. However, after treatment with each group of regimens, the number of acute exacerbations of the treatment group was significantly reduced, while there was no significant change in the control group.

[0106] b. Pulmonary function test

[0107] The results are shown in Tables 4 and 5.

[0108] Table 4 Comparison of lung function indicators between the two groups of patients [M (P25, P75)]

[0109]

[0110] Note: Compared with the group before treatment # P<0.05, compared with the control group after treatment * P<0.05.

[0111] Table 5 Comparison of lung function index differences between the two groups of patients before and after treatment [M (P25, P75)]

[0112]

[0113] As shown in Table 4, by comparing the lung function indicators of the patients who completed the lung function test before and after treatment in the treatment group and the control group, the results showed that the indicators of FEV1, FEV1%pred, FEV1 / FVC in the treatment group were significantly improved compared with those before treatment (P<0.05), and the indicators of FEV1 and FVC in the control group were significantly decreased compared with those before treatment (P<0.05), and FEV1 / FVC was significantly increased compared with those before treatment (P<0.05). It can be seen from the comparison between the two groups that there was no statistically significant difference in the lung function indicators of the two groups after treatment (P>0.05).

[0114] As shown in Table 5, the differences of various lung function indicators before and after treatment between the treatment group and the control group were compared. X (d X =F 后 -F 前 ) were compared, and the results showed that the differences in lung function indicators such as FEV1, FEV1%pred, and FVC before and after treatment between the two groups were statistically significant (P<0.05).

[0115] c. TCM Syndrome Scale Score

[0116] The results are shown in Tables 6 to 8.

[0117] Table 6 Comparison of total TCM syndrome scores between the two groups of patients

[0118]

[0119] Note: Compared with the group before treatment # P<0.05, compared with the control group after treatment * P<0.05.

[0120] Table 7 Comparison of the main TCM symptom scores between the two groups of patients

[0121]

[0122] Note: Compared with the group before treatment # P<0.05, compared with the control group after treatment * P<0.05.

[0123] Table 8 Comparison of minor TCM symptom scores between the two groups of patients

[0124]

[0125] Note: Compared with the group before treatment # P<0.05, compared with the control group after treatment * P<0.05.

[0126] As shown in Table 6, the total TCM syndrome scores of the treatment group and the control group were statistically analyzed. The results showed that before treatment, the total TCM syndrome scores of the treatment group and the control group were similar, which were 21.47±4.53 and 21.56±2.82, respectively. However, after the corresponding treatment of each group, the total TCM syndrome scores of the two groups of patients decreased, which were 9.93±1.44 and 9.93±1.44, respectively. #* , 13.44±2.55 # Compared with the control group, the total score of TCM syndrome in the treatment group was more significantly improved (P<0.05).

[0127] As shown in Table 7, the statistical results of the main TCM symptom scores of the two groups of patients showed that before treatment, the scores of the main TCM symptoms (including cough, sputum, wheezing, chest tightness, and shortness of breath) of the two groups of patients were similar, but after the corresponding treatment of each group, the main TCM symptoms of the two groups of patients were significantly improved compared with before treatment (P < 0.05), and compared with the control group, the scores of the treatment group patients improved more significantly (P < 0.05).

[0128] As shown in Table 8, the scores of minor TCM symptoms in the treatment group and the control group were statistically analyzed. The results showed that before treatment, the scores of minor TCM symptoms (including fatigue, palpitations, and sweating) in the treatment group and the control group were similar. However, after the corresponding treatment of each group, the minor TCM symptoms of the two groups of patients were significantly improved compared with those before treatment (P < 0.05), and compared with the control group, the scores of the treatment group patients improved more significantly (P < 0.05).

[0129] d. COPD Questionnaire score

[0130] The results are shown in Tables 9 and 10.

[0131] Table 9 Comparison of mMRC scores between the two groups of patients [M(P25,P75)]

[0132]

[0133] Table 10 Comparison of CAT scores between the two groups of patients

[0134]

[0135] As shown in Table 9, by comparing the mMRC scores of the treatment group and the control group, the results showed that before treatment, the mMRC scores of the two groups of patients were the same, but after the corresponding treatment of each group, the mMRC scores of the two groups of patients were significantly improved compared with before treatment, and compared with the control group, the improvement effect of the treatment group was significantly better, and the differences were statistically significant (P < 0.01).

[0136] As shown in Table 10, by comparing the CAT scores of the treatment group and the control group, the results showed that before treatment, the CAT scores of the two groups were similar, but after the corresponding treatment of each group, the CAT scores of the two groups were significantly improved compared with those before treatment, and compared with the control group, the improvement effect of the treatment group was significantly better, and the differences were statistically significant (P < 0.01).

[0137] 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 stable 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 Cordyceps sinensis, 15-30 parts of Astragalus, 12-15 parts of Polygonatum odoratum, 6-12 parts of Rhodiola rosea, 3-6 parts of honey ephedra, 6-9 parts of stir-fried bitter almonds, 9-15 parts of Lemongrass seeds, 9-12 parts of honey Aster, 9-12 parts of stir-fried Perilla seeds, 6-9 parts of Ginkgo nuts, 9-12 parts of earthworms and 6-9 parts of licorice.

2. The Chinese medicine composition according to claim 1, characterized in that: In terms of weight, the raw materials for preparing the Chinese medicine composition include: 9 parts of Cordyceps sinensis, 30 parts of Astragalus, 12 parts of Polygonatum odoratum, 12 parts of Rhodiola rosea, 6 parts of honey ephedra, 9 parts of stir-fried bitter almonds, 15 parts of Lemongrass seeds, 12 parts of honey Aster, 12 parts of stir-fried Perilla seeds, 9 parts of Ginkgo nuts, 12 parts of Pheretima and 6 parts of licorice tablets.

3. A drug for treating stable 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 each raw material according to weight, soaking it in water, and obtaining a mixture; S2: boiling the obtained mixture for the first time, and then filtering it to obtain a first medicinal solution and a first filter residue; S3: adding water to the obtained first filter residue for a second 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 each raw material; The soaking time is 15 to 20 minutes.

8. The drug according to claim 6, characterized in that In step S2, the first decoction method is: first use high heat 220-230° C. to boil, and then use low heat 160-170° C. to continue boiling 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 second 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 stable chronic obstructive pulmonary disease.

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