A traditional Chinese medicine composition for treating chronic bronchitis combined with emphysema and its preparation method

Abstract

The present invention discloses a traditional Chinese medicine composition for treating chronic bronchitis combined with emphysema. The composition is prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: 20-30 parts of ginseng, 15-25 parts of astragalus, 20-30 parts of prepared rehmannia, 18-22 parts of schisandra, 15-25 parts of pinellia, and 20-30 parts of poria. The composition nourishes the liver, spleen, and kidneys, reduces stomach qi, purges the lungs, and relieves asthma, promotes diuresis and reduces swelling, promotes blood circulation and removes blood stasis, regulates qi and resolves phlegm, and is suitable for treating chronic bronchitis combined with emphysema. The present invention also discloses a preparation method and use thereof.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating chronic bronchitis combined with emphysema and a preparation method thereof. Background Art

[0002] Chronic bronchitis is a chronic, nonspecific inflammation of the trachea, bronchial mucosa, and surrounding tissues. Clinically, it is characterized by symptoms such as cough, sputum production, and shortness of breath, along with a recurring, chronic course. Severe cases may develop chronic obstructive pulmonary emphysema and cor pulmonale. The disease is caused by multiple factors, typically including chronic, specific inflammation of the trachea, bronchial mucosa, and surrounding tissues. Common pathological manifestations of chronic bronchitis include a sudden increase in mucus secretion and hyperplasia of bronchial glands. Patients with chronic bronchitis typically experience persistent coughing and sputum production for more than three months, and may even experience wheezing. Most patients experience relatively mild clinical symptoms in the early stages of the disease. Chronic bronchitis is milder in the spring and more severe in the winter. In the late stages, severe cases can present with prolonged clinical symptoms. Recurrent attacks of chronic bronchitis cause many patients to lose their ability to work and experience severe mental distress. Chronic bronchitis and emphysema often coexist.

[0003] The cause of emphysema is long-term lung deficiency, which makes it susceptible to external pathogens. The accumulation of phlegm and turbidity causes the condition to gradually worsen and develop. Therefore, its development and progression are driven by both internal and external factors. The lesions first affect the lungs, subsequently affecting the spleen and kidneys, and later on, the heart. The lungs govern qi and respiration, opening up through the nose and defending the exterior. Therefore, external pathogens often easily invade through the mouth, nose, and skin, first attacking the lungs. Pathogenic pathogens stagnate in the lungs, hindering the airway and causing abnormal qi movement, resulting in shortness of breath, coughing, and expectoration. Furthermore, the lungs serve as a canopy for the five internal organs, connecting all the meridians to other organs. The lungs are delicate organs and are vulnerable to pathogenic invasion. The upward invasion of pathogenic qi from other organs can also cause the lungs to fail to descend, resulting in bloating of lung qi, obstruction of the airway, and respiratory difficulties, leading to shortness of breath. This combination of internal and external pathogens can lead to prolonged, recurring episodes, ultimately leading to lung depletion. Consequently, lung deficiency can lead to qi loss of control, resulting in shortness of breath and increasing shortness of breath. Chronic lung deficiency and kidney deficiency can lead to the lungs failing to control qi, and the kidneys failing to absorb qi. This leads to severe wheezing with movement, difficulty inhaling, and shortness of breath that is difficult to maintain. Due to lung qi deficiency, the lungs fail to regulate their function and cannot assist the heart in circulating blood. Furthermore, heart yang, rooted in the fire of the gate of life, is also deficient in kidney deficiency, leading to a deficiency in both heart qi and heart yang, which cannot stimulate blood circulation. This leads to blood stasis, resulting in cyanosis of the face, lips, tongue, and nail beds, worsening shortness of breath, and chest fullness that prevents sleeping. These recurring symptoms worsen lung and kidney deficiency, creating a vicious cycle that deepens the disease.

[0004] Traditional Chinese Medicine (TCM) has a positive effect on the treatment of respiratory diseases, particularly demonstrating the unique advantages of TCM respiratory medicine in the prevention and treatment of respiratory diseases. Traditional Chinese medicine has played an irreplaceable, and even increasingly important, role in respiratory medicine, past, present, and future, that Western medicine cannot replace. It possesses unique advantages in the prevention and treatment of respiratory diseases and respiratory disorders. Summary of the Invention

[0005] In response to the shortcomings of existing problems, the present invention aims to provide a traditional Chinese medicine composition for treating chronic bronchitis combined with emphysema and a preparation method thereof. The present invention has the effects of nourishing the liver, spleen, and kidneys, reducing stomach qi, purging the lungs and relieving asthma, promoting diuresis and reducing swelling, promoting blood circulation and removing blood stasis, and regulating qi and resolving phlegm. It achieves the purpose of treating the disease while regulating the patient's physical condition. It is clinically used to treat chronic bronchitis combined with emphysema, with rapid efficacy and no toxic side effects.

[0006] The technical solution adopted by the present invention to solve the technical problem is:

[0007] A traditional Chinese medicine composition for treating chronic bronchitis combined with emphysema is prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: 20-30 parts of ginseng, 15-25 parts of astragalus, 20-30 parts of prepared rehmannia, 18-22 parts of schisandra chinensis, 15-25 parts of pinellia, 20-30 parts of poria, 15-25 parts of inula flower, 15-25 parts of calcined citrus fruit, 20-30 parts of trichosanthes, 15-25 parts of fritillaria, 18-22 parts of scutellaria baicalensis fruit, 15-25 parts of morus alba bark, 10-20 parts of panax notoginseng, 20-30 parts of madder, 18-22 parts of fructus aurantii, and 20-30 parts of dried tangerine peel.

[0008] The traditional Chinese medicine composition for treating chronic bronchitis combined with emphysema is prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: 25 parts of ginseng, 20 parts of astragalus, 25 parts of cooked rehmannia, 20 parts of schisandra chinensis, 20 parts of pinellia, 25 parts of poria, 20 parts of inula flower, 20 parts of calcined corrugated fruit, 25 parts of trichosanthes, 20 parts of fritillaria, 20 parts of scutellaria baicalensis, 20 parts of mulberry bark, 15 parts of panax notoginseng, 25 parts of madder, 20 parts of aurantium, and 25 parts of tangerine peel.

[0009] The traditional Chinese medicine composition for treating chronic bronchitis combined with emphysema is prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: 20 parts of ginseng, 25 parts of astragalus, 20 parts of prepared rehmannia, 22 parts of schisandra, 15 parts of pinellia, 30 parts of poria, 15 parts of inula flower, 25 parts of calcined citrus fruit, 20 parts of trichosanthes, 25 parts of fritillaria, 18 parts of scutellaria baicalensis, 25 parts of mulberry bark, 10 parts of panax notoginseng, 30 parts of madder, 18 parts of fructus aurantii, and 30 parts of dried tangerine peel.

[0010] The traditional Chinese medicine composition for treating chronic bronchitis combined with emphysema is prepared by extracting the following traditional Chinese medicine raw materials in parts by weight: 30 parts of ginseng, 15 parts of astragalus, 30 parts of cooked rehmannia, 18 parts of schisandra chinensis, 25 parts of pinellia, 20 parts of poria, 25 parts of inula flower, 15 parts of calcined corrugated fruit, 30 parts of trichosanthes, 15 parts of fritillaria, 22 parts of scutellaria baicalensis seeds, 15 parts of mulberry bark, 20 parts of panax notoginseng, 20 parts of madder, 22 parts of fructus aurantii, and 20 parts of dried tangerine peel.

[0011] The preparation method of the traditional Chinese medicine composition for treating chronic bronchitis combined with emphysema comprises the following specific steps:

[0012] (1) crushing, sieving and uniformly mixing the Chinese medicinal raw materials in parts by weight;

[0013] (2) Decoction with water twice, adding 9 to 11 times the weight of the Chinese medicine each time, extracting for 80 to 120 minutes each time, filtering to remove the residue, collecting the liquid, concentrating under reduced pressure to obtain a clear paste, and drying to obtain a dry extract;

[0014] (3) Add auxiliary materials to the dry extract obtained in step (2), mix them evenly, and prepare a preparation.

[0015] The traditional Chinese medicine composition for treating chronic bronchitis combined with emphysema has a preparation method in which the temperature for the reduced pressure concentration is 60-80°C, and the temperature for the drying is 60-80°C.

[0016] The traditional Chinese medicine composition for treating chronic bronchitis combined with emphysema is in the form of granules, tablets and capsules.

[0017] The invention relates to an application of the traditional Chinese medicine composition for treating chronic bronchitis combined with emphysema in preparing medicine for treating chronic bronchitis combined with emphysema.

[0018] The use of the traditional Chinese medicine composition for treating chronic bronchitis combined with emphysema in preparing a medicine for treating chronic bronchitis combined with emphysema is characterized in that chronic bronchitis combined with emphysema belongs to the lung and kidney deficiency type.

[0019] Chronic bronchitis combined with emphysema, known in Traditional Chinese Medicine as "lung distension," is characterized by persistent coughing, asthma, and other symptoms that persist over time, leading to lung, spleen, and kidney deficiency and airway obstruction. Symptoms include chest fullness, shortness of breath, coughing, and wheezing, particularly with movement, or accompanied by excessive phlegm. In severe cases, symptoms include a dull complexion, cyanosis of the lips and tongue, and edema of the face and limbs. The condition can be protracted and difficult to resolve. Deficiency syndromes are more common and are categorized as either lung or kidney deficiency or spleen and kidney deficiency, with lung and kidney deficiency being the most common. Symptoms include shortness of breath, a low, timid voice, wheezing with movement, a dull complexion, or facial edema. A pale tongue with a white coating and a deep, weak pulse are common. Lung and kidney yin deficiency manifests as cough with scant sputum, chest fullness and irritability, hot hands and soles, shortness of breath with movement, dry mouth and thirst, a red tongue with a clear coating, and a deep, thready pulse. The lungs govern qi, while the kidneys receive qi. The lungs are the master of qi, while the kidneys are its root. Lung deficiency impairs the function of clearing and purging, while kidney deficiency incapacitates qi. Clear qi struggles to enter, while oily qi struggles to escape, leading to chest fullness, shortness of breath, and shortness of breath with movement. Insufficient lung qi results in a low, timid voice. A dull complexion indicates qi deficiency and blood stasis. Facial edema indicates qi deficiency and water retention. A pale tongue coating and a deep, weak pulse are also signs of lung and kidney qi deficiency. Lung and kidney yin deficiency generates internal heat, resulting in hot palms and soles, dry mouth, and irritability. Internal lung yin deficiency, with its inability to purify and descend, leads to chest fullness, persistent cough, and scanty, labored sputum. A vibrant, red, and thin pulse with no coating is a sign of lung and kidney yin deficiency. The present invention treats by the following therapeutic principles: one, invigorating qi and tonifying the lungs and nourishing the kidneys and restraining the lungs; two, since phlegm is generated by dampness, the dampness will be transformed naturally when the spleen is healthy, and the phlegm will be eliminated when the dampness is removed, and the qi mechanism will be unobstructed, so the spleen can be healthy, so the method of invigorating the spleen is adopted; three, since the main disease site is in the lungs, in the early stage, it is mostly caused by lung qi disharmony, failure to promote descent, and endogenous phlegm dampness, resulting in cough and spitting, which lasts for a long time and does not heal, and often involves other organs, and is mostly a syndrome of wood deficiency and superficial excess, in which superficial excess is phlegm turbidity (heat) blocking the lungs, and the underlying deficiency is that the lungs, spleen, and kidneys are all deficient. The therapeutic principles of dispelling pathogenic factors, detoxifying and resolving phlegm, purging the lungs and relieving asthma, and promoting diuresis and reducing swelling are adopted; four, since lung qi is smooth by descending, and stomach qi is harmonious by descending, "descending" is a common characteristic of lung qi and stomach qi. The stomach and lungs are adjacent, but share the same respiratory system. Any pathogenic qi that disrupts the stomach's descending function can affect the lung's descending function, leading to upward lung qi reversal and cough. Therefore, the Suwen (Suwen) Cough Theory summarizes the pathogenesis of cough by stating that it "gathers in the stomach and connects to the lungs." Methods are used to reduce stomach qi and resist gastric acid, focusing on protecting the lung's defensive qi and the spleen and stomach's qi to strengthen the defensive functions of the respiratory and gastrointestinal mucosa. Zhu Danxi of the Yuan Dynasty, in his book Danxi's Heart Method Cough, notes that lung distension is linked to the intertwining of phlegm and blood stasis: "Lung distension and cough, either on the left or right side, with insomnia, are caused by phlegm and blood stasis obstructing qi. It is advisable to nourish the blood to circulate qi, and to reduce fire and soothe the liver to clear phlegm." Fifthly, blood-activating and blood-stasis-removing drugs are used to clear accumulated phlegm and blood stasis in the lungs, clearing the lung meridians and promoting smooth flow of qi and blood. Sixthly, because qi originates in the kidneys and is governed by the lungs, persistent cough and asthma, year after year, inevitably damage lung qi. This, in turn, affects the lungs and kidneys, leading to deficiency in both the lungs and kidneys. When the lungs fail to control qi, qi stagnation occurs, while when the kidneys fail to receive qi, qi reverses. The qi of the lungs and kidneys cannot flow freely, preventing clear qi from entering and turbid qi from leaving. This stagnation causes the lungs to swell and distend, leading to distension. As Chao Yuanfang of the Sui Dynasty wrote in his Treatise on the Origin and Symptoms of Various Diseases: Symptoms of Qi Diseases, "The lungs control qi. When pathogenic factors invade the lungs, they distend. Disturbance leads to obstruction of the lung tubes, which in turn leads to obstruction of the airways, resulting in asthma and wheezing." Therefore, the principle of regulating qi and resolving phlegm is adopted.

[0020] The present invention adopts ginseng and astragalus to invigorate qi and tonify the lungs, rehmannia glutinosa and schisandra chinensis to nourish the kidneys and restrain the lungs, pinellia tuber and poria to strengthen the spleen and eliminate dampness, inula flower and calcined corrugated fruit to reduce stomach qi, which are all monarch drugs; trichosanthes root and fritillaria thunbergii to detoxify and resolve phlegm, purge the lungs, scutellaria baicalensis fruit and mulberry bark to purge the lungs and relieve asthma, promote diuresis and reduce swelling, which are all ministerial drugs; panax notoginseng and madder root to promote blood circulation and remove blood stasis, which are adjuvant drugs; and fructus aurantii and tangerine peel to regulate qi and resolve phlegm, and the whole formula comprises ginseng, astragalus root, rehmannia glutinosa, schisandra chinensis, pinellia tuber, poria, inula flower, calcined corrugated fruit, trichosanthes root, fritillaria thunbergii, scutellaria baicalensis fruit, mulberry bark, panax notoginseng, madder root, fructus aurantii and tangerine peel, which have the effects of nourishing the liver, spleen and kidneys, reducing stomach qi, purging the lungs and relieving asthma, promoting diuresis and reducing swelling, promoting blood circulation and removing blood stasis, regulating qi and resolving phlegm, and is suitable for treating chronic bronchitis combined with emphysema. DETAILED DESCRIPTION

[0021] Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiments are only used to illustrate the present invention and are not used in limiting the scope of the present invention.In addition, should be understood that after reading the content of the present invention record, those skilled in the art can make various changes or modifications to the present invention, but these equivalent forms fall within the scope limited by the application's appended claims equally.

[0022] Example 1: Take 250g of ginseng, 200g of astragalus, 250g of cooked rehmannia, 200g of schisandra, 200g of pinellia, 250g of poria, 200g of inula flower, 200g of calcined corrugated fruit, 250g of trichosanthes, 200g of fritillaria, 200g of scutellaria baicalensis, 200g of mulberry bark, 150g of panax notoginseng, 250g of madder, 200g of fructus aurantii, and 250g of tangerine peel. The preparation method comprises the following specific steps:

[0023] (1) crushing, sieving and uniformly mixing the Chinese medicinal raw materials in parts by weight;

[0024] (2) Decoction with water twice, adding 10 times the weight of the Chinese medicine each time, extracting for 100 min each time, filtering to remove the residue, collecting the liquid, concentrating under reduced pressure at 70°C to obtain a clear paste, and drying at 70°C to obtain a dry extract;

[0025] (3) Add starch to the dry extract obtained in step (2), mix well, and prepare granules.

[0026] Example 2: Take 200g of ginseng, 250g of astragalus, 200g of cooked rehmannia, 220g of schisandra, 150g of pinellia, 300g of poria, 150g of inula flower, 250g of calcined corrugated fruit, 200g of trichosanthes, 250g of fritillaria, 180g of scutellaria baicalensis, 250g of mulberry bark, 100g of panax notoginseng, 300g of madder, 180g of fructus aurantii, and 300g of tangerine peel. The preparation method comprises the following specific steps:

[0027] (1) crushing, sieving and uniformly mixing the Chinese medicinal raw materials in parts by weight;

[0028] (2) Decoction with water twice, adding 9 times the weight of the Chinese medicine each time, extracting for 120 min each time, filtering to remove the residue, collecting the liquid, concentrating under reduced pressure at 60°C to obtain a clear paste, and drying at 80°C to obtain a dry extract;

[0029] (3) Add dextrin to the dry extract obtained in step (2), mix well, and prepare tablets.

[0030] Example 3: Take 300g of ginseng, 150g of astragalus, 300g of cooked rehmannia, 180g of schisandra, 250g of pinellia, 200g of poria, 250g of inula flower, 150g of calcined corrugated fruit, 300g of trichosanthes, 150g of fritillaria, 220g of scutellaria baicalensis, 150g of mulberry bark, 200g of panax notoginseng, 200g of madder, 220g of fructus aurantii, and 200g of tangerine peel. The preparation method comprises the following specific steps:

[0031] (1) crushing, sieving and uniformly mixing the Chinese medicinal raw materials in parts by weight;

[0032] (2) Decoction with water twice, adding 11 times the weight of the Chinese medicine each time, extracting for 80 minutes each time, filtering to remove the residue, collecting the liquid, concentrating under reduced pressure at 80°C to obtain a clear paste, and drying at 60°C to obtain a dry extract;

[0033] (3) adding microcrystalline cellulose to the dry extract obtained in step (2), mixing them evenly, and preparing capsules.

[0034] Example 4: Pharmacodynamic study of the present invention on emphysema

[0035] Experimental Principle: Previous studies suggest that an imbalance in the protease / antiprotease system in emphysematous lung tissue is a major contributing factor, with elastase playing a crucial role in the development and progression of emphysema. The pharmacodynamics of the present invention against emphysema were studied using an elastase-induced rat experimental emphysema model.

[0036] Experimental Animals and Reagents: Male SD rats, weighing 250-280 g, were provided by the Experimental Animal Center of Yangzhou University. Reagents: Elastase (Porcine pancreatic elastase PPE) was produced by Changzhou Qianhong Biopharmaceutical Co., Ltd., batch number 73100303; 1 mg = 17.5 μg activity units (μg), dissolved in sterile saline and prepared to the desired concentration. Instrument: RM-6000 polygraph, manufactured by Nihon Kohden.

[0037] Modeling experiment: After the experimental rats were anesthetized with ether, they were fixed in the supine position, with a midline incision of about 1.5 cm in the neck. After separating the trachea, a sterile physiological saline solution of elastase was injected from the trachea with a 5# needle, at a dosage of 100u / 100g, in a volume of 0.2ml / . The rats were then upright and gently rotated so that the solution evenly contacted the lung tissue to keep the airway open. The skin was then sutured and penicillin was topically instilled to prevent infection. Rats that survived 24 hours after the operation were taken and randomly divided into a model group, a normal control group, and the Example 1 group. The model group and the normal control group were given normal saline orally at a dosage of 20ml / kg, and the Example 1 group was given the granules prepared by Example 1, with a dosage of 20g crude drug amount / kg. The administration was given orally by gavage once a day for 30 consecutive days.

[0038] Observation index 1: Determination of pulmonary artery pressure (PPA): 24 hours after the last administration, rats were anesthetized with 40 mg / kg ip of sodium pentobarbital, the thoracotomy was performed at the left edge of the sternum, and artificial positive pressure respiration was performed with a small animal ventilator. Then, a cannula was inserted into the pulmonary artery, and the pulmonary artery pressure was recorded with an RM-6000 polychannel physiological recorder.

[0039] Observation index 2: Ratio of right ventricle to left ventricle plus ventricular septum (RV / LV+S): After measuring pulmonary artery pressure, rats were bled to death, the hearts were dissected, residual blood was flushed out, large blood vessels and atrial appendages were cut off, the right ventricle was cut from the edge of the junction of the right ventricle and the ventricular septum, and the remaining left ventricle and ventricular septum were weighed separately. The percentage of left ventricle (RV) divided by left ventricle (LV) + ventricular septum (S) was used as an indicator to observe right ventricular hypertrophy.

[0040] The experimental results are shown in Table 1.

[0041] Table 1 Effects of the present invention on PPA and RV / LV+S in experimental emphysema in rats

[0042] Grouping PPA (mmHg.x±s) RV / LV+S(%.x±s) Normal control group 21.45±2.76 29.13±4.97 Model Group 28.37±2.14## 37.75±3.24## Example 1 group 22.74±2.47* 30.76±4.04*

[0043] Note: ##P<0.01; *P<0.05; #Compared with the normal group; *Compared with the model group;

[0044] As shown in Table 1, the pulmonary artery pressure in the experimental emphysema rats after modeling was significantly elevated, and the RV / LV+S ratio increased. Compared with the normal control group, the difference was significant (P<0.05), indicating successful modeling. Continuous administration of the granules in the Example 1 group for 30 days reduced the PPA in the rats and the RV / LV+S ratio. This indicates that the present invention can significantly reduce the elevated pulmonary artery pressure and the RV / LV+S ratio in the experimental emphysema rat model, and also demonstrates a significant improvement in the experimental emphysema rat model.

[0045] Example 5: Clinical Trial

[0046] Case selection: 100 patients with chronic bronchitis combined with emphysema of the lung and kidney deficiency type admitted to Taizhou Hospital of Traditional Chinese Medicine from January 2022 to October 2023 were divided into two groups, with 50 cases in each group.

[0047] Inclusion criteria: Recurrent cough, sputum production, and wheezing, with episodes lasting for more than three months annually for more than three years. Pulmonary function tests revealed increased residual volume (RVV / FVC) >35% and expiratory volume in one second / forced vital capacity <60%. A Traditional Chinese Medicine diagnosis of lung and kidney deficiency included shortness of breath, a low, timid voice, wheezing with exertion, a dull complexion, or facial edema. A pale tongue with a white coating and a deep, weak pulse. Lung and kidney yin deficiency manifests as cough with scant sputum, chest fullness and irritability, hot hands and soles, shortness of breath with exertion, dry mouth and thirst, a red tongue with a clear coating, and a deep, thready pulse.

[0048] Exclusion criteria: (1) patients in the acute stage of chronic obstructive pulmonary emphysema; (2) patients with concurrent bronchial asthma, bronchitis, or respiratory malignant tumors; (3) patients with peptic ulcer; (4) pregnant women; (5) patients with mental disorders; and (6) patients with poor treatment compliance.

[0049] Treatment method: The control group received conventional treatment, i.e., 18 μg of tiotropium bromide powder for inhalation (Boehringer Ingelheim, Germany, batch number 20210308), once daily. Group 1 received the granules prepared in Example 1 above, with a daily dosage of 25 g of ginseng, 20 g of astragalus, 25 g of prepared rehmannia, 20 g of schisandra chinensis, 20 g of pinellia, 25 g of poria, 20 g of inula flower, 20 g of calcined corrugated fruit, 25 g of trichosanthes root, 20 g of fritillaria, 20 g of scutellaria baicalensis, 20 g of morus alba bark, 15 g of panax notoginseng, 25 g of madder root, 20 g of fructus aurantii, and 25 g of dried tangerine peel, taken three times daily.

[0050] Observation indicators: (1) Pulmonary function index, including FEV1 / FVC, FVC, PEF, detected by spirometry (Japan Minon Company, model AS-507); (2) CAT score, TCM syndrome score, 6-min walking distance, where CAT score includes 7 items: sleep, going out, expectoration, activity, climbing stairs, chest tightness, and cough, and is divided into 3 levels according to severity. The higher the grade, the more severe the condition, with a maximum score of 5 points; TCM syndrome score includes cough and expectoration (2 points, occasional attacks) ; 4 points, recurrent attacks; 6 points, persistent cough and sputum, difficult to relieve), chest tightness and shortness of breath (2 points, occasional chest tightness and shortness of breath, which can be relieved by itself; 4 points, frequent chest tightness and shortness of breath; 6 points, persistent), shortness of breath (1 point, slight shortness of breath; 2 points, recurrent shortness of breath, which can be temporarily relieved; 3 points, persistent shortness of breath, which occurs with movement), soreness of waist and knees and spontaneous sweating (1 point, mild, less than 3 days a week; 2 points, 3-6 days a week; 3 points, daily attacks).

[0051] Experimental results: see Table 2 and Table 3.

[0052] Table 2 Comparison of pulmonary function indicators (x±s, n=50)

[0053]

[0054] Note: Compared with the same group before treatment, # P<0.05; compared with the control group after treatment, △ P<0.05.

[0055] Table 3 Comparison of CAT score, TCM syndrome score and 6-min walking distance

[0056]

[0057] Note: Compared with the same group before treatment, # P<0.05; compared with the control group after treatment, △ P<0.05.

[0058] Experimental conclusion: As can be seen from the results in Table 2 and Table 3, after drug treatment in the control group and Example 1 group, FEV1 / FVC, FVC, and PEF in the two groups increased (P < 0.05), and the Example 1 group was more obvious (P < 0.05). After treatment, the CAT scores and TCM syndrome scores of the two groups decreased (P < 0.05), and the 6-min walking distance was extended (P < 0.05), and the Example 1 group was more obvious (P < 0.05), indicating that the present invention has a good therapeutic effect on patients with chronic bronchitis combined with emphysema of the lung and kidney deficiency type.

[0059] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for treating chronic bronchitis combined with emphysema, characterized in that: The invention is prepared by extracting the following Chinese medicinal raw materials in parts by weight: 20-30 parts of ginseng, 15-25 parts of astragalus, 20-30 parts of prepared rehmannia, 18-22 parts of schisandra chinensis, 15-25 parts of pinellia, 20-30 parts of poria, 15-25 parts of inula flower, 15-25 parts of calcined citrus fruit, 20-30 parts of trichosanthes, 15-25 parts of fritillaria, 18-22 parts of scutellaria baicalensis, 15-25 parts of mulberry bark, 10-20 parts of panax notoginseng, 20-30 parts of madder, 18-22 parts of fructus aurantii, and 20-30 parts of dried tangerine peel. Chronic bronchitis combined with emphysema belongs to the type of deficiency of both lung and kidney. The preparation method comprises the following specific steps: (1) crushing, sieving and mixing the Chinese medicinal raw materials in parts by weight; (2) Decoction twice with water, adding 9 to 11 times the weight of the Chinese medicine each time, extracting for 80 to 120 minutes each time, filtering to remove the residue, collecting the liquid, concentrating under reduced pressure to obtain a clear paste, and drying to obtain a dry extract; (3) Add auxiliary materials to the dry extract obtained in step (2), mix them evenly, and prepare a preparation.

2. A Chinese medicine composition for treating chronic bronchitis combined with emphysema according to claim 1, characterized in that: The product is extracted and prepared from the following Chinese medicinal raw materials in parts by weight: 25 parts of ginseng, 20 parts of astragalus, 25 parts of cooked rehmannia, 20 parts of schisandra chinensis, 20 parts of pinellia, 25 parts of poria, 20 parts of inula flower, 20 parts of calcined corrugated fruit, 25 parts of trichosanthes, 20 parts of fritillaria, 20 parts of scutellaria baicalensis, 20 parts of mulberry bark, 15 parts of panax notoginseng, 25 parts of madder, 20 parts of aurantium and 25 parts of tangerine peel.

3. A Chinese medicine composition for treating chronic bronchitis combined with emphysema according to claim 1, characterized in that: The medicine is extracted and prepared from the following Chinese medicinal raw materials in parts by weight: 20 parts of ginseng, 25 parts of astragalus, 20 parts of cooked rehmannia, 22 parts of schisandra, 15 parts of pinellia, 30 parts of poria, 15 parts of inula flower, 25 parts of calcined citrus fruit, 20 parts of trichosanthes, 25 parts of fritillaria, 18 parts of scutellaria baicalensis, 25 parts of mulberry bark, 10 parts of panax notoginseng, 30 parts of madder, 18 parts of aurantium and 30 parts of tangerine peel.

4. A Chinese medicine composition for treating chronic bronchitis combined with emphysema according to claim 1, characterized in that: The medicine is extracted and prepared from the following Chinese medicinal raw materials in parts by weight: 30 parts of ginseng, 15 parts of astragalus, 30 parts of cooked rehmannia, 18 parts of schisandra, 25 parts of pinellia, 20 parts of poria, 25 parts of inula flower, 15 parts of calcined citrus fruit, 30 parts of trichosanthes, 15 parts of fritillaria, 22 parts of scutellaria baicalensis seeds, 15 parts of mulberry bark, 20 parts of panax notoginseng, 20 parts of madder, 22 parts of aurantium and 20 parts of tangerine peel.

5. A Chinese medicine composition for treating chronic bronchitis combined with emphysema according to claim 1, characterized in that: In the preparation method, the temperature for the reduced pressure concentration is 60-80°C, and the temperature for the drying is 60-80°C.

6. A Chinese medicine composition for treating chronic bronchitis combined with emphysema according to claim 1, characterized in that: The dosage form of the preparation is one of granules, tablets and capsules.

7. Use of a traditional Chinese medicine composition for treating chronic bronchitis combined with emphysema according to claim 1 in preparing a medicine for treating chronic bronchitis combined with emphysema.

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