Traditional Chinese medicine composition for treating chronic bronchitis, chronic obstructive pulmonary disease and emphysema and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating chronic bronchitis, chronic obstructive pulmonary disease and emphysema and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 4-14 parts of astragalus membranaceus, 2-6 parts of wine-processed desert cistanche, 2-6 parts of schizonepeta spike, 2-6 parts of divaricate saposhnikovia root, 1-5 parts of fried perilla fruit, 2-6 parts of wine-processed rhizoma polygonati, 2-6 parts of salted fructus alpiniae oxyphyllae, 2-6 parts of teasel root tablet, 1-3 parts of calcined clam shell, 1-5 parts of thunberg fritillary bulb, 2-6 parts of motherwort fruit, 1-3 parts of scutellaria baicalensis, 2-6 parts of fructus forsythiae, 2-4 parts of cicada slough, 2-6 parts of radix cyathulae, 1-5 parts of rhizoma pinelliae preparata, 1-5 parts of scorpion and 1 The traditional Chinese medicine composition can effectively improve the chronic obstructive pulmonary disease stable phase lung and kidney qi deficiency symptom of a patient, has the treatment effect superior to that of salmeterol and ticasone, has good clinical application value and is worthy of clinical popularization.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine compositions, and in particular to a Chinese medicine composition for treating chronic bronchitis, chronic obstructive pulmonary disease and emphysema and a preparation method thereof. Background Art

[0002] Chronic obstructive pulmonary disease (COPD) belongs to the category of lung distension, wheezing and cough in traditional Chinese medicine. The basic disease nature belongs to the deficiency of the root and the excess of the superficial. The pathological factors are mainly turbid phlegm, water retention and blood stasis. The basic principle of clinical diagnosis and treatment is to eliminate evil and strengthen the body. The common symptoms of COPD are chronic cough, sputum, shortness of breath, dyspnea, wheezing and chest tightness, and acute exacerbation often occurs. From the clinical manifestations of patients, it is mainly manifested as persistent airflow limitation, and this symptom has a progressive development trend. After the disease, the mortality rate and disability rate of patients are high, which brings serious disease and economic burden to patients. At present, it has gradually developed into a major chronic disease that has attracted widespread attention from the world. In summary, the mortality rate, disability rate and morbidity of chronic obstructive pulmonary disease have increased year by year because this disease is easy to recur in the process of development, and long-term medication is required, which not only seriously affects the quality of life of patients, but also causes a serious economic burden.

[0003] From the perspective of clinical research, COPD can be prevented and treated, which is undoubtedly hope and good news for COPD patients. However, the danger of COPD during the attack period cannot be ignored, so it is very important to carry out symptomatic treatment for COPD during the stable period. In modern medicine, the commonly used treatment method is to use bronchodilators combined with inhaled glucocorticoids for treatment, which is also a very widely used anti-inflammatory therapy. However, this treatment method has two sides. On the one hand, it is indeed effective in the overall treatment process, which can relieve the patient's symptoms and pain, but its side effects and adverse reactions are also very obvious, such as hoarseness and easy to develop drug resistance. In traditional medicine, the treatment method generally adopted is multi-link and multi-pathway, so it has significant advantages in the prevention and treatment of COPD during the stable period. Chinese medicine can not only inhibit inflammatory cells and inflammatory mediators, reduce the response of airway inflammation, but also regulate the body's immune mechanism, enhance the patient's respiratory muscles and lung function, and reduce the drug resistance and side effects caused by long-term medication. Therefore, it is crucial to provide a Chinese medicine treatment plan that is not easy to develop drug resistance and has low side effects. Summary of the invention

[0004] The purpose of the present invention is to provide a Chinese medicine composition for treating chronic bronchitis, chronic obstructive pulmonary disease and emphysema and a preparation method thereof, so as to solve the problems existing in the above-mentioned prior art.

[0005] To achieve the above object, the present invention provides the following solutions:

[0006] One of the technical solutions of the present invention is a traditional Chinese medicine composition for treating chronic bronchitis, chronic obstructive pulmonary disease and emphysema, which is prepared from the following components in parts by weight: 4-14 parts of astragalus, 2-6 parts of wine Cistanche, 2-6 parts of Schizonepeta spicate, 2-6 parts of Saposhnikovia divaricata, 1-5 parts of stir-fried Perilla seeds, 2-6 parts of wine Polygonatum, 2-6 parts of salt Alpinia oxyphylla, 2-6 parts of Dipsacus asper, 1-3 parts of calcined clam shell, 1-5 parts of Fritillaria thunbergii, 2-6 parts of Cnidium monnieri, 1-3 parts of Scutellaria baicalensis, 2-6 parts of Forsythia suspensa, 2-4 parts of Periostracum cicadae, 2-6 parts of Cyathula capitata, 1-5 parts of Pinellia ternata, 1-5 parts of Scorpio, and 1-9 parts of stir-fried White Peony Root.

[0007] The second technical solution of the present invention is the use of the Chinese medicine composition in the preparation of medicines for treating chronic bronchitis, chronic obstructive pulmonary disease and emphysema.

[0008] The third technical solution of the present invention is a medicine for treating chronic bronchitis, chronic obstructive pulmonary disease and emphysema, comprising the Chinese medicine composition and pharmaceutically acceptable excipients.

[0009] A fourth technical solution of the present invention is the use of the Chinese medicine composition in the preparation of a drug for alleviating respiratory inflammation.

[0010] Based on the above technical solution, the present invention has the following technical effects:

[0011] The present invention provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease. The traditional Chinese medicine composition can effectively improve the symptoms of lung and kidney qi deficiency in patients with stable COPD, mainly including symptoms such as wheezing and shortness of breath, and has a better therapeutic effect than salmeterol and fluticasone. The traditional Chinese medicine composition can effectively improve the quality of life of patients, improve the FEV1 / FVC% level of lung function of patients with COPD, improve the degree of airflow limitation of patients, effectively reduce serum IL-6 and FeNO levels, and reduce the probability and degree of airway inflammation. The traditional Chinese medicine composition has good clinical application value and is worthy of clinical promotion. DETAILED DESCRIPTION

[0012] Now, various exemplary embodiments of the present invention are described in detail. The methods in the examples are conventional methods unless otherwise specified, and the reagents used are conventional commercially available reagents or reagents prepared by conventional methods unless otherwise specified. This detailed description should not be considered as a limitation of the present invention, but should be understood as a more detailed description of certain aspects, features and embodiments of the present invention.

[0013] It should be understood that the terms described in the present invention are only for describing a particular embodiment and are not intended to limit the present invention. In addition, for the numerical range in the present invention, it should be understood that each intermediate value between the upper and lower limits of the scope is also specifically disclosed. The intermediate value in any stated value or stated range, and each smaller range between any other stated value or intermediate value in the described range is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded in the scope.

[0014] Unless otherwise indicated, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Although the present invention describes only preferred methods and materials, any methods and materials similar or equivalent to those described herein may also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials associated with the documents. In the event of a conflict with any incorporated document, the content of this specification shall prevail.

[0015] It will be apparent to those skilled in the art that various modifications and variations may be made to the specific embodiments of the present invention description without departing from the scope or spirit of the present invention. Other embodiments derived from the present invention description will be apparent to the skilled artisan. The present invention description and examples are exemplary only.

[0016] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0017] The technical solutions described in the present invention, unless otherwise specified, are all conventional solutions in the art, and the reagents or raw materials used, unless otherwise specified, are purchased from commercial channels or are publicly available.

[0018] The embodiment of the present invention provides a traditional Chinese medicine composition for treating chronic bronchitis, chronic obstructive pulmonary disease and emphysema, which is prepared from the following components in parts by weight: 4-14 parts of astragalus, 2-6 parts of wine cistanche, 2-6 parts of schizonepeta spicate, 2-6 parts of siler, 1-5 parts of stir-fried perilla seeds, 2-6 parts of wine polygonatum, 2-6 parts of salt-soaked alkyl oxyphylla seeds, 2-6 parts of dipsacus root, 1-3 parts of calcined clam shells, 1-5 parts of thunbergii bulbs, 2-6 parts of cnidaria seeds, 1-3 parts of scutellaria, 2-6 parts of forsythia, 2-4 parts of cicada shells, 2-6 parts of cyathula, 1-5 parts of qingbanxia, ​​1-5 parts of scorpion, and 1-9 parts of stir-fried white peony root.

[0019] In some specific embodiments, the composition is made of the following components in parts by weight: 9 parts of Astragalus, 4 parts of Cistanche deserticola, 4 parts of Schizonepeta spicate, 4 parts of Saposhnikovia divaricata, 3 parts of stir-fried Perilla seeds, 4 parts of Polygonatum sibiricum, 4 parts of Alpinia oxyphylla with salt, 4 parts of Dipsacus asper, 2 parts of calcined clam shell, 3 parts of Fritillaria thunbergii, 4 parts of Cnidium monnieri, 2 parts of Scutellaria baicalensis, 4 parts of Forsythia suspensa, 3 parts of Periostracum cicadae, 4 parts of Cyathula capitata, 3 parts of Pinellia ternata, 3 parts of Scorpio, and 5 parts of stir-fried White Peony Root.

[0020] The water pill processing technology and related instruments and equipment of the preparation room of Ningxia Hospital of Traditional Chinese Medicine and Institute of Traditional Chinese Medicine were applied to prepare water pills, that is, the Chinese medicine components in this embodiment were prepared through selecting medicinal materials → cleaning medicinal materials → air drying → crushing and sieving → drug fine powder → pill making (wetting agent, adhesive) → demolding → wet pills → selecting cover surface → drying and sorting → dry pills → polishing → coating → packaging → inspection, and then made into pills, namely, Feizhang Ping Pills.

[0021] Astragalus and Cistanche are the main medicines.

[0022] Astragalus: It is the best tonic, especially good at replenishing the qi of the spleen and lungs. It is sweet and warm in nature, and belongs to the spleen and lung meridians. When the lungs are adequate, the body's defense function is adequate, so this prescription takes its function of replenishing qi and strengthening the surface. When the qi of the middle jiao spleen and stomach is moderate, the earth can produce gold, and the lung qi is strong; Astragalus replenishes the middle and raises qi, the kidneys collect shade, replenish the acquired to nourish the innate, and match it with fangfeng and perilla seeds, so that its function of replenishing qi can quickly reach the surface. Dong Heng said, "When Astragalus is combined with fangfeng, its function is even greater, and they fear each other but use each other." At the same time, it can also dispel wind.

[0023] Cistanche deserticola: sweet, sour, salty and warm, sweet and warm in nature, salty and moist in quality, replenishes yang without being dry, replenishes yin without being greasy, warm in nature and replenishes without being harsh, enters the blood of the kidney meridian, replenishes the life gate fire, and can also moisturize the five internal organs. Astragalus and Cistanche deserticola are used together as the main medicine of this prescription to replenish the lungs and kidneys.

[0024] Schizonepeta spicate, Saposhnikovia divaricata and Perilla seed can dispel wind and resolve phlegm.

[0025] Schizonepeta Spike: Pungent, slightly warm, enters the liver and lung meridians, lightly dispels wind and regulates blood. Pungent and warm, aromatic and dispersing, the aroma enters the spleen, helps the spleen digest food. Enters the liver meridian qi division, and also moves the blood division. Its nature is ascending and floating, can induce sweating, dispel rheumatism, clear the head and eyes, and benefit the throat; it can clear the blood vessels, clear heat and dissipate blood stasis, break up knots and detoxify, and is a wind medicine, blood medicine, and a holy medicine for sores. The spike is at the top, so it is especially good at ascending hair. This recipe uses Schizonepeta Spike for its ascending function.

[0026] Saposhnikovia divaricata: pungent, sweet and slightly warm, rising and floating is yang, dispersing qi and draining the lungs, and dispersing stagnant qi in the head and eyes. It runs through the spleen and stomach meridians, and is an important medicine for dispelling wind and dampness. After use, it helps to dispel external wind and stop internal wind. Dongyuan called it "the emollient of wind medicine". Together with Astragalus and Paeonia lactiflora, it can stop sweating. Modern medicine has found that the main functions of Saposhnikovia divaricata are anti-microbial and anti-inflammatory.

[0027] Perilla seed: pungent, warm, enters the lung and large intestine meridians, releases cold, descends qi and resolves phlegm, relieves cough and asthma. Pungent taste enters the qi, purple color enters the blood, fragrant and warm to dispel cold, clears the heart and lungs, stimulates appetite and benefits the spleen, induces sweating and relieves muscles, harmonizes blood and descends qi, relieves the middle and eliminates phlegm, dispels wind and relieves asthma. It is especially good at descending qi and relieving asthma, relieving cough and eliminating phlegm, relieving diaphragm and widening intestines, warming the middle and relieving depression.

[0028] Wine-soaked Polygonatum, salt-soaked Alpinia oxyphylla, Dipsacus asper, astragalus and Cistanche deserticola can strengthen the lung and kidney functions.

[0029] Huangjing with wine: mild and nourishing, sweet and mild in nature, it enters the lung, spleen and kidney meridians. Among many Chinese medicine prescriptions, it has the effects of tonifying the middle and replenishing qi, calming the five internal organs, benefiting the spleen and stomach, moistening the heart and lungs, filling the essence, and not feeling hungry after long-term use. COPD patients in the stable stage are characterized by deficiency of the lung, spleen and kidney. This medicine can not only be used together with Astragalus to play the role of tonifying the middle and replenishing qi, but also calm the lungs, spleen and kidneys, achieving the effect of tonifying the middle and replenishing qi, tonifying the lungs and moistening dryness, and tonifying the kidneys and replenishing essence.

[0030] Salted Alpinia oxyphylla: pungent and hot. This medicine enters the spleen and earth, and enters the heart and kidney meridians. It controls the two fires of the monarch and the minister, and replenishes the deficiency of the heart qi, the gate of life, and the three burners. It is pungent and warm to strengthen the kidney, astringent to strengthen the essence and qi; it dries the spleen and earth, warms the middle and controls saliva; Dipsacus: bitter, slightly warm, pungent in taste, bitter and warm to nourish the kidney, pungent and warm to nourish the liver, and sweet in taste to hurt the middle. It promotes blood circulation and breaks up blood stasis. Modern medical research has found that Dipsacus has anti-inflammatory and bactericidal effects.

[0031] Dipsacus asper Wall. ex Henry: Dipsacus asper Wall. ex Henry is the first recorded in Shennong's Herbal Classic. It is a top-grade medicine. It is the dried root of Dipsacus asper Wall. ex Henry, a plant of the Dipsacus family. It is bitter and warm to nourish the kidney, pungent and warm to nourish the liver, and can circulate blood and regulate tendons and bones. It is used to treat injuries and to replenish deficiencies. According to the Classic of Medicine, it is sweet in taste. It has the effects of nourishing the liver and kidney, strengthening tendons and bones, healing fractures, stopping metrorrhagia, and calming the fetus. Shennong's Herbal Classic says: "It is used to treat colds, to replenish deficiencies, wounds, carbuncles, fractures, healing tendons and bones, and women's lactation difficulties. Long-term use can improve energy and strength."

[0032] Clam shells, Fritillaria thunbergii and Cnidium monnieri enhance the effect of resolving phlegm and lowering qi.

[0033] Clam shell: bitter, salty, cold in nature, enters the lung, kidney, and stomach meridians. Clam shell is salty and cold in nature. It enters the blood of the kidney meridian. It softens hard phlegm. It eliminates old blood. It clears heat and promotes diuresis. It is salty and cold and moistens the lower part. As for the function of nourishing the body and stimulating the appetite, it also clears heat and phlegm. It benefits the lungs and stomach. It has the same function as corrugated seeds. It can be used as powder. It can also dry out dampness. It is also similar to the function of oysters.

[0034] Fritillaria thunbergii: slightly bitter and cold. Bitterness can relieve heart fire, pungent flavor can disperse lung depression. It enters the qi of the lung meridian, and the lung qi is calmed when heart fire is reduced. It moisturizes the heart and lungs, clears phlegm, and can treat cough, pulmonary tuberculosis and lung abscess. The medicinal effect of Fritillaria thunbergii is more tonic, mainly to strengthen the body, and is suitable for chronic cough. Modern medicine has found that Fritillaria thunbergii extract has shown strong antiviral effects in both in vivo and in vitro experiments.

[0035] Cnidium monnieri: Also known as Yi Mu Cao Zi, it is bitter and slightly cold, and it enters the pericardium and liver meridians. It mainly enters the blood, is good at promoting blood circulation, removing blood stasis and dredges the menstruation, and is a medicine for various gynecological symptoms of menstruation and childbirth. "Ben Cao Jing Shu" says: Cnidium monnieri is an essential medicine for regulating menstruation for women. This medicine is both tonifying and able to move, and is both pungent and moist. It regulates menstruation and improves essence, improves eyesight, promotes blood circulation, and smoothes qi and expels wind. Zhu Zhenheng said: Cnidium monnieri can promote blood circulation and qi, and has the function of tonifying yin.

[0036] Scutellaria baicalensis, Forsythia suspensa, and Periostracum cicadae are used as adjuvant drugs to clear the lungs and eliminate heat, so as to prevent stagnant heat from damaging the lungs.

[0037] Scutellaria baicalensis: Cold overcomes heat, bitter enters the heart, and enters the lung, gallbladder, spleen, stomach, large intestine, and small intestine meridians. It treats wind-heat and damp-heat in the upper burner, drains the actual fire in the middle burner, and eliminates damp-heat in the spleen.

[0038] Forsythia suspensa: slightly cold and floating, light and clear, bitter and enters the heart, "all sores, pains and itches belong to the heart", can disperse knots and reduce swelling, and is known as the "holy medicine for sores". It disperses blood stasis and Qi accumulation in the meridians, and clears the disharmony of the Ying and Wei. Modern medical research has also shown that Forsythia suspensa has antibacterial and anti-inflammatory effects.

[0039] Cicada slough: sweet and salty, non-toxic, enters the lung and liver meridians and floats upward, dissipates wind and heat, promotes lung function, and calms spasms. This prescription takes its "promoting lung function" and is mainly used to treat cough and asthma. Scorpion combined with cicada slough can relieve wind and stop spasms, regulate qi and resolve phlegm to treat internal obstruction of wind and phlegm.

[0040] Achyranthes bidentata: bitter, sour and neutral, it enters the liver and kidney meridians, can nourish the liver and kidney, drain bad blood, and can lead all medicines downward. Due to their different origins, there are Sichuan Achyranthes bidentata and Huai Achyranthes bidentata. The difference between the two is that the emphasis of their functions and indications is slightly different. Huai Achyranthes bidentata focuses on nourishing, while Sichuan Achyranthes bidentata focuses on clearing. Huai Achyranthes bidentata is good at nourishing the liver and kidney. Sichuan Achyranthes bidentata is often used to promote blood circulation and remove blood stasis. This recipe selects Sichuan Achyranthes bidentata for its function of promoting blood circulation and removing blood stasis, with a focus on clearing.

[0041] Qing Banxia: warm and toxic, it enters the spleen and stomach meridians, dries dampness and phlegm, moistens the kidney, and promotes the flow of yin and yang. It is slippery and dry, can move and disperse, can moisten and dry. Cheng Wuji said: Banxia is pungent and dispersing, can move water and qi and moisten the kidney; it harmonizes the stomach and strengthens the spleen, nourishes the liver and moistens the kidney, removes dampness and resolves phlegm, releases depression, lowers adverse qi, and stops nausea and vomiting. "Suwen" said: If the stomach is not harmonious, you will not be able to sleep well. Banxia can harmonize the stomach qi and promote yin and yang. It can disperse the spleen and remove goiter, reduce swelling and stop sweating. Raw Banxia is toxic and is mostly used externally to reduce swelling and disperse knots. After being processed by different methods, the effects of the obtained Chinese medicine slices have different focuses. The dryness of the French Banxia is milder. In addition to drying dampness and resolving phlegm, it also has the function of regulating the spleen and stomach. The toxicity of Jiang Banxia has been reduced, and it is warm and dry in nature. It has the functions of drying dampness and resolving phlegm, lowering adverse qi and stopping vomiting. The toxicity and pungent and dry nature of Banxia are reduced, and the expectorant effect is enhanced. Modern medical findings indicate that Banxia is more effective in inhibiting inflammatory factors than other processed products. Wang Haogu said: Banxia is only a symptom of expectorant, but it cannot cure the root of the phlegm. To cure the root is to cure the kidney. Cough is invisible, but phlegm is visible. Invisible things moisten the spleen, while visible things dry it. Therefore, it is a medicine that removes dampness from the spleen and moistens the dryness of the kidney. When the qi is smooth and the fire is reduced, the phlegm disappears.

[0042] Scorpion: pungent and sweet, poisonous, belongs to the liver meridian, calms wind and stagnation, attacks toxins and disperses knots, dredges and relieves pain. Green in color, belongs to wood, so it can treat all kinds of wind, dizziness, convulsions, and crooked mouth and eyes. Dongyuan said: All hernias and leukorrhea belong to wind. Scorpion is an important medicine for treating wind, so it is suitable to be added and used; Scale: salty and neutral, belongs to the lung and kidney meridians, nourishes the lungs and moistens the kidneys, benefits essence and helps yang, treats thirst and relieves stranguria; calms asthma and cough, pulmonary tuberculosis and hemoptysis, and is suitable for those with qi deficiency and blood deficiency; it can nourish the lungs and benefit the water source. Li Shizhen said: nourishing the lungs and relieving cough, the function is the same as ginseng; replenishing qi and supporting the body, the function is the same as mutton. "Jingshu" said: cough caused by external wind, cold and external evil should not be used.

[0043] White peony root: bitter, sour and slightly cold, enters the liver and spleen blood, enters the lung and spleen meridians, nourishes blood, purges the liver, is astringent, and astringes yin. Sourness astringes the liver, the liver is astringent and dispersing; calms the spleen and lungs, consolidates the pores, the lung governs the spleen and skin, the spleen governs the muscles, the spleen is astringent if the liver wood does not overcome the earth, the lung is astringent if the earth is strong and can produce gold, the spleen is astringent if the lungs are astringent, and the pores are astringent if the spleen and lungs are astringent; harmonizes the blood vessels, collects yin qi, and collects adverse qi; disperses bad blood, promotes urination; relieves pain. Stir-fried white peony root becomes milder in coldness after being stir-fried, and its effects focus on nourishing blood and nourishing, strengthening the spleen and stomach, and astringing yin and stopping sweating.

[0044] The embodiment of the present invention also provides the use of the traditional Chinese medicine composition in preparing medicines for treating chronic bronchitis, chronic obstructive pulmonary disease and emphysema.

[0045] The embodiment of the present invention also provides a medicine for treating chronic bronchitis, chronic obstructive pulmonary disease and emphysema, comprising the Chinese medicine composition and pharmaceutically acceptable excipients.

[0046] In some specific embodiments, the medicament is a pill.

[0047] The embodiment of the present invention also provides the use of the traditional Chinese medicine composition in preparing a medicine for alleviating respiratory inflammation.

[0048] Example 1

[0049] The traditional Chinese medicine composition for treating chronic obstructive pulmonary disease of this embodiment is prepared from the following components in parts by weight: 9 parts of astragalus, 4 parts of wine cistanche, 4 parts of schizonepeta spicate, 4 parts of siler, 3 parts of stir-fried perilla seeds, 4 parts of wine polygonatum, 4 parts of salt-soaked alkyl oxyphylla seeds, 4 parts of dipsacus root, 2 parts of calcined clam shell, 3 parts of thunbergii bulb, 4 parts of cuneiform seed, 2 parts of scutellaria, 4 parts of forsythia, 3 parts of cicada shell, 4 parts of cyathula, 3 parts of qingbanxia, ​​3 parts of scorpion, and 5 parts of stir-fried white peony root.

[0050] The water pill processing technology and related instruments and equipment of the preparation room of Ningxia Hospital of Traditional Chinese Medicine and Institute of Traditional Chinese Medicine were applied to prepare water pills, that is, the Chinese medicine components in this embodiment were prepared through selecting medicinal materials → cleaning medicinal materials → air drying → crushing and sieving → drug fine powder → pill making (wetting agent, adhesive) → demolding → wet pills → selecting cover surface → drying and sorting → dry pills → polishing → coating → packaging → inspection, and then made into pills, namely, Feizhang Ping Pills.

[0051] Example 2

[0052] The traditional Chinese medicine composition for treating chronic obstructive pulmonary disease of this embodiment is prepared from the following components in parts by weight: 8 parts of astragalus, 3 parts of wine cistanche, 3 parts of schizonepeta spicate, 3 parts of siler, 2 parts of stir-fried perilla seeds, 3 parts of wine polygonatum, 3 parts of salt-soaked alkyl oxyphylla, 5 parts of dipsacus root, 3 parts of calcined clam shell, 4 parts of thunbergia thunbergii, 3 parts of cuneiformis, 3 parts of scutellaria baicalensis, 5 parts of forsythia, 2 parts of cicada shell, 3 parts of cyathula capitata, 2 parts of pinellia ternata, 2 parts of scorpion, and 4 parts of stir-fried white peony root.

[0053] The water pill processing technology and related instruments and equipment of the preparation room of Ningxia Hospital of Traditional Chinese Medicine and Institute of Traditional Chinese Medicine were applied to prepare water pills, that is, the Chinese medicine components in this embodiment were prepared through selecting medicinal materials → cleaning medicinal materials → air drying → crushing and sieving → drug fine powder → pill making (wetting agent, adhesive) → demolding → wet pills → selecting cover surface → drying and sorting → dry pills → polishing → coating → packaging → inspection, and then made into pills, namely, Feizhang Ping Pills.

[0054] Effect Example 1

[0055] 1.1 A total of 80 patients with stable COPD who met the criteria for lung and kidney qi deficiency according to TCM differentiation and visited the outpatient department of pulmonary disease at the Chinese Academy of Traditional Chinese Medicine from January to September 2021 were selected.

[0056] 1.2 Diagnostic criteria

[0057] 1.2.1 Western medicine diagnostic criteria

[0058] The Western medicine diagnostic standards refer to the diagnosis, staging, and grading standards of the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2021 Revised Edition)" and the "2023 GOLD Global Strategy for the Diagnosis, Treatment, and Prevention of Chronic Obstructive Pulmonary Disease". The staging is stable and the grade is moderate.

[0059] 1.2.2 TCM diagnostic criteria

[0060] The cases selected for inclusion in the present invention are patients with lung and kidney qi deficiency syndrome in the stable stage of COPD, with reference to the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease in Traditional Chinese Medicine (2011 Edition)" jointly formulated by the Pulmonary Disease Professional Committee of the Internal Medicine Branch of the Chinese Association of Traditional Chinese Medicine in 201117, and the diagnosis of lung and kidney qi deficiency syndrome listed therein:

[0061] ① Shortness of breath, more severe panting when moving; ② Fatigue, sweating when moving; ③ Easy to catch cold, aversion to wind; ④ Weakness in waist and knees; ⑤ Tinnitus; ⑥ Frequent urination at night; ⑦ Pale tongue with white coating, deep and thin pulse or weak pulse.

[0062] According to the above standards, if two of ①, 2, and ③ are met, as well as two of ④, ⑤, ⑥ and ⑦, then it can be determined that the patient suffers from lung and kidney qi deficiency.

[0063] 1.3 Inclusion criteria

[0064] (1) Patients with stable COPD who meet the criteria;

[0065] (2) Patients with lung and kidney qi deficiency syndrome who meet the TCM diagnostic criteria;

[0066] (3) lung function distribution is in grades I-II;

[0067] (4) No other types of drug clinical research were conducted within one month;

[0068] (5) Age distribution ranges from 40 to 75 years old;

[0069] (6) Those who were informed and agreed to participate in this study.

[0070] Patients who meet the above 6 items can be included in the experimental cases.

[0071] 1.4 Exclusion criteria

[0072] (1) Other lung diseases (such as lung cancer, tuberculosis, etc.);

[0073] (2) Women who are pregnant, trying to get pregnant, or breastfeeding;

[0074] (3) Suffering from mental illness;

[0075] (4) Suffering from other diseases that cause changes in ventilation function;

[0076] (5) Suffering from severe liver and kidney diseases;

[0077] (6) Other drugs are currently undergoing clinical trials.

[0078] If any of the above items are met, it should be excluded.

[0079] 2. Treatment methods

[0080] Control group: salmeterol / fluticasone acetate powder for inhalation (specification 50 μg / 250 μg × 60 bubbles / box, trade name Seretide, produced by GlaxoSmithKline, its drug registration certificate number is H20150324), 2 times a day, each inhaled drug amount is 50 μg / 250 μg.

[0081] Treatment group: Orally take the Feizhangping Pills prepared in Example 1 of the present invention, 5 g / time, 3 times / day, half an hour after meals.

[0082] During the treatment of both groups of patients, all received COPD health education, and were required to quit smoking, inhale oxygen, and perform breathing exercises. The course of treatment was set at 3 months.

[0083] Note that if an acute exacerbation suddenly occurs during the patient's participation in the trial, the patient should be provided with corresponding treatment immediately in accordance with clinical guidelines.

[0084] 3. Observation of therapeutic effect

[0085] 3.1 Observation indicators

[0086] According to the relevant content of the 2002 edition of the "Guidelines for Clinical Research of New Chinese Medicines (Trial)", the key symptoms corresponding to COPD were graded and compared. And the scores before and after treatment were recorded. ① TCM symptom score: According to the symptoms, the score is completed according to 4 levels. The normal score of the main symptom is 0, the mild score is 2, the moderate score is 4, and the severe score is 6. The normal score of the secondary symptom is 0, the mild score is 1, the moderate score is 2, and the severe score is 3. The tongue and pulse refer to the actual situation and are not included in the score. ② Total score of quality of life, Note: When the patient's CAT score is counted, the score range is 0-40 points. A score of 0-10 points indicates that the patient's COPD is "slightly affected", a score of 11-20 points indicates that the patient's COPD is "moderately affected", a score of 21-30 points indicates that the patient's COPD is "severely affected", and a score of 31-40 points indicates that the patient's COPD is "particularly severely affected".

[0087] 3.2 Efficacy criteria

[0088] In the process of judging the clinical efficacy, the clinical efficacy is mainly assessed by the efficacy index after treatment, and is divided into clinical control, significant effect, effectiveness and ineffectiveness with reference to the clinical efficacy classification.

[0089] From the perspective of clinical control effect, clinical symptoms have basically disappeared, and the treatment effectiveness index is >95%;

[0090] From the perspective of marked efficacy, the clinical symptoms of patients were significantly improved, with 70%s effective index <95%;

[0091] In terms of effective effects, clinical symptoms improved to varying degrees, with 30%s effective index <70%;

[0092] From the perspective of ineffective effects, the patient's clinical symptoms did not improve significantly, and the effective index was <30%.

[0093] Efficacy index = (TCM symptom score before treatment - TCM symptom score after treatment) / TCM symptom score before treatment × 100% (Nimodipine method).

[0094] 3.3 Statistical methods

[0095] After 3 months of clinical observation of the patients, information and data were collected and analyzed using SPSS26.0. P<0.05 was selected as the criterion for determining the significance of the effect, and a two-sided test was used. The measurement data were described using mean ± standard deviation, such as TCM symptom score, serum interleukin-6, and exhaled nitric oxide detection. If the overall sample distribution satisfies the normal distribution, the independent sample t test is used in the process of inter-group comparison, otherwise the rank sum test is used. In the process of comparing before and after treatment within the group, if the difference is normal, the paired sample t test is used, otherwise the rank sum test is used. In the process of testing the counting data, the chi-square (X 2 )test.

[0096] 3.3.1 Gender comparison

[0097] From the composition of the treatment group, there were 29 male patients and 11 female patients, and from the composition of the control group, there were 27 male patients and 13 female patients. When comparing gender data, the chi-square test was used, and the data of the two groups were comparable (P>0.05). (See Table 1)

[0098] Table 1 Gender comparison data

[0099]

[0100] 3.3.2 Age comparison

[0101] For the treatment group, the age distribution of patients was 57.05+10.34 years old, and for the control group, the age distribution of patients was 59.03+8.85 years old. From the age data, the two groups of data are comparable (P>0.0s). See Table 2)

[0102] Table 2 Comparison of age data

[0103]

[0104]

[0105] 3.3.3 Comparison of TCM symptom scores between the two groups

[0106] The conditions of the two groups of patients before and after treatment were analyzed. From the perspective of the TCM syndrome scores of the patients, the overall distribution was normal. Using the t-test, P>0.05 before treatment, which was comparable. After 3 months of treatment, the scores were compared within the group before and after, and all of them decreased significantly, and both groups had significant statistical significance (P<0.05), indicating that the symptoms of both groups of patients improved and the treatment plans were effective. From the perspective of the difference between the two groups, the difference was statistically significant (P<0.05), which means that the treatment group had a better improvement effect. (See Table 3)

[0107] Table 3 Comparison of total TCM symptom scores between the two groups of patients before and after treatment

[0108]

[0109] 3.3.4 Comparison of lung function FEV1 / FVC%

[0110] The lung function FEV1 / FVC% index of the two groups of patients was analyzed and met the corresponding normal distribution. Therefore, after the t-test was performed between the two groups before treatment, P>0.05, and the two groups were comparable. After 3 months of treatment, the patients were compared again before and after. From the perspective of the treatment group, t=-5.208, from the perspective of the control group, t=-2.079, and P<0.05 for both groups. The difference was statistically significant, indicating that after 3 months of treatment, the patient's indicators showed significant improvement. After 3 months of treatment, statistical analysis was performed on the two groups, and t=-2.093, P=0.040<0.05, and the difference was statistically significant. (See Table 4 for details)

[0111] Table 4 Comparison of pulmonary function FEVI1FVC% between the two groups of patients

[0112]

[0113] 3.3.5 Comparison of exhaled nitric oxide detection (FeNO)

[0114] The FeNO indexes of the two groups before treatment were compared, and the data of the two groups were comparable using the (test P>0.05. After 3 months of intervention: FeNO of both groups decreased before and after treatment, and the difference was statistically significant (P<0.05), indicating that both treatments played a role: FeNO indexes of the two groups after treatment were compared, and the difference was not statistically significant (P>0.05). (See Table 5)

[0115] Table 5 Exhaled nitric oxide detection (ppb)

[0116]

[0117] 3.3.6 Comparison of serum IL-6 levels

[0118] Serum IL-6 concentration is a quantitative data. The data of the two groups of patients before treatment showed a normal distribution. The t-test showed that the difference was not statistically significant (P>0.05), so the data were comparable. After treatment, the differences before and after treatment in the two groups were statistically significant (P<0.05), indicating that both interventions played a certain role. After treatment, the IL-6 levels of the two groups were compared, t=-2.294, P=0.024, indicating that the difference was statistically significant (P<0.05). Compared with the control group, the serum IL-6 concentration in the treatment group decreased more significantly, indicating that the actual effect of the treatment group was better (see Table 6).

[0119] Table 6 Comparison of IL-6 between the two groups of patients before and after treatment (pg / mL)

[0120]

[0121] 3.3.7 Comparison of CAT scores in quality of life in patients with COPD

[0122] CAT score belongs to quantitative data. The CAT scores of the two groups of patients were recorded and compared, and the overall normal distribution was shown. Then, the test was used. From the CAT score data before treatment, the difference between the two groups was not statistically significant (P>0.05), and it was comparable. After 3 months of treatment, the CAT scores of both groups were reduced compared with before treatment, indicating that the treatment of both groups of patients can improve the quality of life of patients. After 3 months of treatment, the CAT scores of the two groups of patients after treatment were tested by independent samples, t=-3.993, P<0.05, and the difference was statistically significant, indicating that after treatment, the CAT scores of both groups showed a downward trend, and the downward trend of the treatment group was more obvious, and the effect was better (see Table 7).

[0123] Table 7 Comparison of CAT scores between the two groups before and after treatment

[0124]

[0125] 3.3.8 Comparison of treatment effectiveness

[0126] After 3 months of treatment, the Feizhangping Pills group was analyzed and its overall effective rate was higher than that of the control group. The rank sum test was conducted on the two groups of data, and the result was Z = -3.760, P = 0.000. This shows that the difference is statistically significant (P < 0.05), and the effective rate of the treatment group is significantly higher. (See Table 8)

[0127] Table 8 Comparison of the effective rate of treatment between the two groups (%)

[0128]

[0129] 3.4 Analysis of safety indicators of the two groups

[0130] After 3 months of treatment for the patients in the treatment group and the control group, the patients' urine routine, blood routine, liver and kidney function, electrocardiogram and other indicators were tested, and no abnormal changes were found. No adverse reactions occurred during the treatment of both groups of patients, indicating that the safety of Feizhangping Pills during treatment is relatively good.

[0131] Effect Example 2

[0132] 1 Patient Zheng Yiwu, male, 66 years old, had symptoms before taking the medicine: cough, expectoration, white sputum, sticky, large amount, easy to cough up, accompanied by chest tightness, shortness of breath, dyspnea, significantly aggravated after activity, sweating, good appetite, good sleep, normal bowel movements. He took Feizhangping Pills for 4 weeks (5g each time, 3 times / day, 30 minutes after breakfast and dinner). After taking it for 4 weeks, the symptoms were: cough basically disappeared, the amount of sputum was significantly reduced compared with before, the symptoms of chest tightness and shortness of breath were significantly relieved, there was no dyspnea, the symptoms of sweating were alleviated, the appetite was good, the sleep was good, and the bowel movements were normal.

[0133] 2 Patient Sun Guoqiang, male, 83 years old, had symptoms before taking the medicine: cough, expectoration, sputum with white and sticky color, not easy to cough up, chest tightness, shortness of breath when moving, unable to tolerate physical labor, obvious wheezing and shortness of breath after walking 100 meters on a flat road, precordial tightness and discomfort, occasional precordial dull pain, fatigue, poor appetite, frequent urination, urgent urination, and normal stool. He took Feizhangping Pills for 4 weeks (5g each time, 3 times / day, taken 30 minutes after breakfast and dinner). After taking it for 4 weeks, the symptoms were: cough symptoms were significantly relieved compared with before, the amount of sputum was reduced and easy to cough up, chest tightness symptoms were significantly improved, daily activities could be tolerated, there was no wheezing and shortness of breath when walking on a flat road, the symptoms of precordial tightness and discomfort were alleviated, the frequency of precordial dull pain was reduced compared with before, fatigue was significantly improved, appetite was normal, frequent urination symptoms were relieved, occasional urinary pain, and normal stool.

[0134] 3 Patient Li Wenhuan, male, 78 years old, symptoms before taking the medicine: cough, occasional large amount of yellow sputum, sore throat and itchy throat, chest tightness and shortness of breath, dry mouth and bitter taste, obvious fatigue, good appetite, good sleep at night, and normal bowel movements. He took Feizhangping Pills for 4 weeks (5g each time, 3 times / day, taken 30 minutes after breakfast and dinner). After taking it for 4 weeks, symptoms: cough basically disappeared, coughed up a small amount of white sputum, which was easy to cough up, chest tightness and shortness of breath were lighter and significantly relieved, no dry mouth and bitter taste, fatigue symptoms basically disappeared, good appetite, good sleep at night, and normal bowel movements.

[0135] Obviously, the above embodiments of the present invention are merely examples for clearly explaining the present invention, and are not intended to limit the implementation methods of the present invention. For ordinary technical users in the relevant field, other different forms of changes or modifications can be made on the basis of the above description. It is not necessary and impossible to list all the implementation methods here. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. A Chinese medicine composition for treating chronic bronchitis, chronic obstructive pulmonary disease and emphysema, characterized in that: The invention is prepared from the following components in parts by weight: 4-14 parts of astragalus, 2-6 parts of wine cistanche, 2-6 parts of schizonepeta spicate, 2-6 parts of siler, 1-5 parts of stir-fried perilla seeds, 2-6 parts of wine polygonatum, 2-6 parts of salt-soaked alkyl oxyphylla seeds, 2-6 parts of dipsacus root, 1-3 parts of calcined clam shell, 1-5 parts of thunbergii bulbs, 2-6 parts of cnidaria seed, 1-3 parts of scutellaria, 2-6 parts of forsythia, 2-4 parts of cicada shell, 2-6 parts of cyathula, 1-5 parts of radix pinelliae, 1-5 parts of scorpio, and 1-9 parts of stir-fried white peony root.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention is prepared from the following components in parts by weight: 4-14 parts of astragalus, 2-6 parts of wine cistanche, 2-6 parts of schizonepeta spicate, 2-6 parts of siler, 1-5 parts of stir-fried perilla seeds, 2-6 parts of wine polygonatum, 2-6 parts of salt-soaked alkyl oxyphylla seeds, 2-6 parts of dipsacus root, 1-3 parts of calcined clam shell, 1-5 parts of thunbergii bulbs, 2-6 parts of cnidaria seed, 1-3 parts of scutellaria, 2-6 parts of forsythia, 2-4 parts of cicada shell, 2-6 parts of cyathula, 1-5 parts of radix pinelliae, 1-5 parts of scorpio, and 1-9 parts of stir-fried white peony root.

3. Use of the Chinese medicine composition as claimed in claim 1 or 2 in the preparation of medicines for treating chronic bronchitis, chronic obstructive pulmonary disease and emphysema.

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

5. Use of the Chinese medicine composition as claimed in claim 1 or 2 in the preparation of a medicament for alleviating respiratory inflammation.

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