Traditional Chinese medicine composition for treating bronchial asthma cold asthma as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating bronchial asthma cold asthma and a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5 to 10 parts of honey-fried ephedra, 5 to 10 parts of radix peucedani, 10 to 15 parts of fructus perillae, 1 to 5 parts of herba asari, 5 to 10 parts of rhizoma zingiberis, 5 to 10 parts of fructus schizandrae, 5 to 10 parts of cicada slough, 5 to 10 parts of rhizoma pinelliae preparata, 5 to 10 parts of flos farfarae, 5 to 10 parts of pericarpium citri reticulatae, 10 to 20 parts of fried semen lepidii, 10 to 20 parts of radix cynanchi paniculati and 5 to 10 parts of honey-fried liquorice root. The product has a good effect, has the effects of warming lung to dissipate fluid retention, dispelling cold and relieving asthma, and can remarkably improve the asthma control test rate of chronic persistent patients, reduce the acute attack frequency, improve the life quality of the patients and adjust the immune imbalance state of the asthma patients; the traditional Chinese medicine composition is effectively used for sequential treatment of clinical bronchial asthma patients in the acute attack stage and chronic duration (cold asthma), and has application prospects.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly to a traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma, a preparation method thereof, and uses thereof. Background Art

[0002] Bronchial asthma (referred to as asthma for short) is a chronic inflammatory disease of the airway involving multiple cells and cell components, accompanied by airway hyperresponsiveness, reversible airflow limitation, and mucus hypersecretion. Airway remodeling occurs in the late stage. According to clinical manifestations, asthma is divided into acute exacerbation period, chronic persistent period, and clinical control period. The acute exacerbation period and the chronic persistent period are important stages for the prognosis and outcome of asthma. Uncontrolled asthma not only has a direct impact on the physical and mental health of patients, but also can develop into serious social problems, increasing the economic burden on families and society, affecting learning and social activities, restricting career choices, and having an adverse impact on aspects such as the psychological emotions of patients.

[0003] Currently, Western medicine treatment drugs can be divided into two major categories: symptom control drugs and symptom relief drugs. Among them, symptom control drugs mainly include inhaled corticosteroids, systemic corticosteroids, long-acting β2 receptor agonists, etc.; symptom relief drugs mainly include quick-acting inhaled and short-acting oral β2 receptor agonists, inhaled anticholinergic drugs, etc., which have obvious advantages in quickly relieving clinical symptoms. However, after patients are treated with the aforementioned treatment drugs, although the symptoms of asthma are improved, there are still problems such as easy recurrence, more side effects, and poor patient compliance in the long-term treatment of asthma.

[0004] Asthma belongs to the category of "wheezing disorder" in traditional Chinese medicine. Traditional Chinese medicine has obvious advantages in the clinical treatment and long-term disease management of asthma, can improve the clinical symptoms of patients, and enhance the quality of life of patients. However, there is still a lack of traditional Chinese patent medicines that are indicated for the acute exacerbation period and chronic persistent period (cold asthma syndrome) of bronchial asthma and can carry out sequential treatment.

[0005] Chinese invention patent with publication number CN 116763844A discloses a traditional Chinese medicine composition for treating airway inflammation and a preparation method thereof. The traditional Chinese medicine composition contains raw materials in the following weight ratios: honey-fried ephedra 32 - 36 parts, asarum 6 - 10 parts, magnolia flower 32 - 36 parts, perilla seed 6 - 10 parts, bran-fried fructus aurantii 32 - 36 parts, semen lepidii 6 - 10 parts, loquat leaf 6 - 10 parts, wine-processed scutellaria baicalensis 32 - 36 parts, semen zanthoxyli 10 - 14 parts, licorice 6 - 10 parts, and it is used to treat cold asthma syndrome, bronchial asthma, asthmatic bronchitis and other airway inflammations. The dosage of honey-fried ephedra in the above traditional Chinese medicine is too large, and excessive use is likely to cause dissipation of lung qi and trigger complications.

[0006] Therefore, in view of the key syndrome of cold asthma syndrome in the acute exacerbation period and chronic persistent period of bronchial asthma, it is urgent to develop a traditional Chinese medicine composition with simple process, low cost, and convenient use. Summary of the Invention

[0007] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma, its preparation method and use, which can adjust the immune imbalance state of asthma patients and is effectively used for the sequential treatment of patients with acute attack stage and chronic persistent stage (cold asthma syndrome) of clinical bronchial asthma.

[0008] To solve the above problems, the technical solutions adopted by the present invention are as follows: In the first aspect, a traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma is provided, which is composed of the following raw materials in parts by weight: 5-10 parts of honey-fried ephedra, 5-10 parts of peucedanum praeruptorum, 10-15 parts of semen brassicae, 1-5 parts of asarum, 5-10 parts of dried ginger, 5-10 parts of schisandra chinensis, 5-10 parts of cicada slough, 5-10 parts of raw pinellia, 5-10 parts of flos farfarae, 5-10 parts of pericarpium citri reticulatae, 10-20 parts of stir-fried semen lepidii, 10-20 parts of herba cynanchi paniculati, 5-10 parts of roasted licorice root.

[0009] As an embodiment of the present invention, it is composed of the following raw materials in parts by weight: 6 parts of honey-fried ephedra, 9 parts of peucedanum praeruptorum, 12 parts of semen brassicae, 3 parts of asarum, 6 parts of dried ginger, 9 parts of schisandra chinensis, 6 parts of cicada slough, 9 parts of raw pinellia, 9 parts of flos farfarae, 9 parts of pericarpium citri reticulatae, 15 parts of stir-fried semen lepidii, 15 parts of herba cynanchi paniculati, 6 parts of roasted licorice root.

[0010] In the second aspect, a preparation method of the traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma as described in the first aspect is provided, and the method includes: (1) All raw materials are extracted with water to obtain an extract, and then the extract is successively subjected to concentration treatment, drying treatment, and pulverization treatment to obtain a medicinal powder; (2) The medicinal powder is mixed with dextrin and a wetting agent to form granules, and then after drying and packaging, the traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma is obtained.

[0011] As an embodiment of the present invention, in step (1), the extraction includes the following steps: all raw materials are mixed and water is added for the first decoction, and after pouring out the decoction filtrate, water is added again for the second decoction, and the decoction filtrates obtained from the two decoctions are combined to obtain an extract.

[0012] As an embodiment of the present invention, the mass ratio of the water added during the two decoctions (the first decoction and the second decoction) to the total mass of the mixed raw materials is 12:1, and the decoction time is 1 h for both.

[0013] As an embodiment of the present invention, in step (1), the concentration treatment is to concentrate the extract to a thick paste with a relative density of 1.18-1.22 at 60°C.

[0014] As an embodiment of the present invention, in step (2), the mass ratio of the medicinal powder to dextrin is 2:1; the wetting agent is an ethanol aqueous solution with a mass fraction of 80%, and the mass of the wetting agent is 13% of the mass of the medicinal powder.

[0015] As an embodiment of the present invention, in step (2), the prepared granules are dried at 60 °C and then packaged into independent small packages of 10 g / bag, and sealed with a composite film outer bag to obtain the traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma.

[0016] In the third aspect, there is provided the use of a traditional Chinese medicine composition as described in the first aspect in the preparation of a medicament for treating cold asthma syndrome of bronchial asthma.

[0017] The beneficial effects produced by adopting the above technical solutions are as follows: In the prescription of the present invention, honey-fried ephedra is used as the monarch drug, which can disperse cold and relieve exterior syndrome, and ephedra can also promote the dispersing function of the lung qi to relieve asthma and cough; the minister drugs are whiteflower hogfennel root, perilla seed, and tussilago farfara, which can lower the lung qi, and when combined with ephedra, one disperses and the other descends, helping the lung to restore its dispersing and descending functions; dried ginger and asarum are used as the minister drugs, which can warm the lung and resolve fluid retention, and also help ephedra to relieve exterior syndrome and dispel pathogenic factors. However, there is usually fluid retention, and the spleen and lung are inherently weak. If only pungent-warm drugs are used for diaphoresis, it may consume the lung qi. Therefore, schizandra chinensis is used as an assistant drug to astringe the lung and relieve cough; lepidium apetalum can resolve phlegm and relieve asthma, promote diuresis and reduce swelling, and its bitter-cold nature can also restrain the dryness and harshness of warm drugs, and is used as an assistant drug; cicada slough and pyrola calliantha can dispel wind pathogens externally and dredge the lung collaterals internally, helping the pathogenic factors to expel, and are used as assistant drugs; dried tangerine peel and pinellia ternata can dry dampness and resolve phlegm, harmonize the stomach and lower adverse qi, and also protect the spleen and stomach, and are used as assistant drugs; licorice is both an assistant and a guiding drug, which can not only benefit qi and harmonize the middle, but also reconcile the pungent-dispersing and sour-astringing drugs. The whole prescription combines dispersion and descent, regulates both internally and externally, and together exerts the effects of warming the lung and resolving fluid retention, dispersing cold and relieving asthma.

[0018] The components of the present invention are scientifically combined, the raw materials are reliable, the preparation method is easy to operate, the product has good effects, has the effects of warming the lung and resolving fluid retention, dispersing cold and relieving asthma, can significantly improve the asthma control test rate of patients in the chronic persistent stage, reduce the number of acute attacks, improve the quality of life of patients, and at the same time adjust the immune imbalance state of asthma patients, and is effectively used for the sequential treatment of patients with acute attack stage and chronic persistent stage (cold asthma syndrome) of clinical bronchial asthma, and has application prospects.

[0019] In the present invention, the descriptions of each raw material are as follows: Ephedra is the dried herbaceous stem of Ephedra sinica Stapf, Ephedra intermedia Schrenk et C. A. Mey., or Ephedra equisetina Bge. of the Ephedraceae family. It is pungent, slightly bitter, and warm in nature, and belongs to the lung and bladder meridians. It is good at dispersing lung qi, opening the pores, and penetrating the hair follicles, and has the functions of dispersing lung cold, relieving asthma, and promoting diuresis. It is mainly used to treat wind-cold colds, chest tightness and cough, wind-water edema and other diseases. Ephedra stir-fried with honey can enhance its effect of relieving cough and asthma. Modern pharmacological experiments show that this product has various effects such as promoting sweating, relieving asthma, relieving cough and reducing fever, relieving pain and inflammation, antibacterial, regulating the central nervous system, and diuretic.

[0020] Peucedanum root is the dried root of Peucedanum praeruptorum Dunn or Peucedanum decursivum Maxim. of the Umbelliferae family. It is bitter, pungent, and slightly cold in nature, and belongs to the lung meridian. It can disperse wind-heat, lower qi and resolve phlegm, and is used to treat cough, excessive phlegm, sticky sputum, fever, thirst, shortness of breath and other symptoms caused by the failure of the lung to disperse and descend. "Compendium of Materia Medica" says that it can "clear lung heat, resolve phlegm heat, and disperse wind pathogens." Modern pharmacological experiments show that this product has the effects of antipyretic analgesia, anti-inflammatory and swelling reduction, clearing heat and relieving sore throat, and adjusting immune function.

[0021] Perilla fruit is the dried ripe fruit of Perilla frutescens (L.) Britt. of the Lamiaceae family. It is pungent, warm in nature, and belongs to the lung and large intestine meridians. It has the effects of lowering qi and dissipating phlegm, relieving cough and asthma, and moistening the intestines and promoting defecation, and is used to treat phlegm congestion and qi reversal, cough and asthma, and intestinal dryness and constipation. Modern pharmacological experiments show that this product has the effects of anti-inflammatory, antioxidant, and regulating the immune imbalance of the body.

[0022] Asarum is the dried whole herb of Asarum heterotropoides Fr. Schmidt var. mandshuricum (Maxim.) Kitag., Asarum sieboldii Miq. var. seoulense Nakai, or Asarum sieboldii Miq. of the Aristolochiaceae family. It is pungent, warm in nature, and belongs to the heart, lung, and kidney meridians. It can relieve exterior cold, expel wind and relieve pain, open the orifices, warm the lungs and resolve fluid retention, and is used to treat wind-cold colds, headache, toothache, rheumatic arthralgia, nasal sinusitis, lung cold cough, etc. "A Hundred Kinds of Records of Materia Medica" says that it can "disperse wind pathogens in the upper and lower parts, and can penetrate everywhere without omission." Modern pharmacological experiments show that this product has the effects of anti-inflammatory, antioxidant, analgesic, and antipyretic.

[0023] Dry ginger is the dried rhizome of Zingiber officinale Rosc. of the Zingiberaceae family. It is pungent in taste and hot in nature, and enters the spleen, stomach, kidney, heart, and lung meridians. "Shennong Ben Cao Jing" states that it "is mainly used for chest fullness, cough, and reverse qi." It has the effects of warming the lungs to resolve fluid retention and restoring yang to promote blood circulation. Modern pharmacological research shows that dry ginger has anti-inflammatory, antioxidant and other effects.

[0024] Schisandra chinensis is the dried ripe fruit of Schisandra chinensis (Turcz.) Baill. or Schisandra sphenanthera Rehd. et Wils. of the Schisandraceae family. It is sour, sweet in taste and warm in nature, and enters the lung, heart, and kidney meridians. It has the effects of astringing and consolidating, replenishing qi to promote fluid production, and tonifying the kidney to calm the mind. It is used for chronic cough and asthma, spermatorrhea and emission, spontaneous sweating and night sweating, internal heat and thirst, palpitations and insomnia, etc. "Ben Cao Bei Yao" records that it "specifically astringes the lung qi and nourishes the kidney water, replenishing qi and promoting fluid production." Modern pharmacological research shows that Schisandra chinensis has anti-inflammatory, antibacterial, antitussive, expectorant, anti-aging and other effects.

[0025] Cicada slough is the exuviae shed when the larvae of Cryptotympana pustulata Fabricius of the Cicadidae family emerge as adults. Its nature and flavor are sweet and cold, and it enters the liver and lung meridians. Its qi is clear and light, and it has the effects of dispersing wind-heat, ventilating the lungs, and calming convulsions. It is used for wind-heat colds, aphonia, and allergic rhinitis, etc. Modern pharmacological research shows that cicada slough has anti-convulsive, sedative, reducing the tension of striated muscles and blocking ganglia to relieve bronchial smooth muscle spasm, and has anti-allergic and other effects.

[0026] Pinellia ternata is the dried tuber of Pinellia ternata (Thunb.) Breit. of the Araceae family. It is pungent, warm, and poisonous. It enters the spleen and stomach meridians. It has the effects of drying dampness and resolving phlegm, lowering adverse qi and stopping vomiting, and dissipating masses and resolving stagnation. It is used for damp phlegm and cold fluid retention, excessive cough and phlegm, chest and diaphragm fullness, etc. Because of its toxicity, it is mostly used after processing. After processing, Qing Banxia has a milder pungent and warm and dry nature and is good at drying dampness and resolving phlegm. Modern pharmacological experiments show that this product has anti-inflammatory, antitussive, and inhibiting sputum secretion and other effects.

[0027] Flos farfarae is the dried flower bud of Tussilago farfara L. of the Compositae family. It is pungent, slightly bitter in taste and warm in nature, and enters the lung meridian. It has the effects of moistening the lungs to lower qi and relieving cough and resolving phlegm. It is used for new and chronic coughs, asthma, and consumptive cough with hemoptysis. Modern pharmacological experiments show that this product has anti-inflammatory, antitussive, expectorant, and anti-asthmatic and other effects.

[0028] Dried tangerine peel is the dried ripe pericarp of Citrus reticulata Blanco and its cultivated varieties of the Rutaceae family. It is bitter, pungent in taste and warm in nature, and enters the lung and spleen meridians, regulating qi and strengthening the spleen, drying dampness and resolving phlegm.

[0029] Semen Lepidii, the dried ripe seeds of Descurainia sophia (L.) Webb. ex Prantl. or Lepidium apetalum Willd., both belonging to the family Brassicaceae. It is pungent, bitter in taste and cold in nature, and acts on the lung, bladder and large intestine meridians. It has the effects of purging the lung to lower qi, resolving phlegm and relieving asthma, promoting diuresis and alleviating edema. It is mainly used for treating excessive phlegm and cough due to phlegm congestion in the lung, edema, abdominal and thoracic hydrops, dysuria, etc. Because of its bitter and cold nature, the stir-fried Semen Lepidii after frying has a milder property. Descurainia sophia The dried ripe seeds of Descurainia sophia (L.) Webb. ex Prantl. or Lepidium apetalum Willd. of the family Brassicaceae. It tastes pungent and bitter, is cold in nature, and belongs to the lung, bladder, and large intestine meridians. It has the effects of purging the lung and descending qi, resolving phlegm and relieving asthma, promoting diuresis and reducing swelling. It is mainly used to treat excessive phlegm and cough due to phlegm congestion in the lung, edema, abdominal and thoracic fluid accumulation, dysuria, etc. Because of its bitter and cold nature, the stir-fried Semen Lepidii after frying has a milder medicinal property.

[0030] Radix Cynanchi Paniculati, the dried roots and rhizomes of Cynanchum paniculatum (Bge.) Kitag. of the family Asclepiadaceae. It is collected in autumn, impurities are removed, and it is dried in the shade. It tastes pungent and is warm in nature, and belongs to the liver and stomach meridians. It has the functions of dispelling wind, removing dampness, and relieving itching. "Shennong Ben Cao Jing" states that it "is mainly used for treating poisonous insects, pestilence, evil qi, and warm malaria." Radix Glycyrrhizae, the dried roots of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L. of the family Leguminosae. It tastes sweet and is neutral in nature, and has the effects of tonifying qi and invigorating the middle, clearing heat and detoxifying, resolving phlegm and relieving cough, alleviating spasm and pain, and regulating the properties of medicinal herbs. Detailed implementation methods

[0031] To make the purpose, technical solutions and advantages of the present invention clearer, the following describes the invention clearly and completely in combination with specific embodiments.

[0032] Example 1 A traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma, which is composed of the following raw materials in parts by weight: honey-fried Ephedra 5g, Peucedanum praeruptorum Dunn 5g, Perilla Seed 10g, Asarum 1g, Dry Ginger 5g, Schisandra chinensis (Turcz.) Baill. 5g, Cryptotympana pustulata Fabricius 5g, Pinellia ternata (Thunb.) Breit. 5g, Tussilago farfara L. 5g, Pericarpium Citri Reticulatae 5g, stir-fried Semen Lepidii 10g, Radix Cynanchi Paniculati 10g, roasted Radix Glycyrrhizae 5g.

[0033] Its preparation method is as follows: (1) Mix all the raw materials and add 912 g of water for the first decoction, decoct for 1 h; then pour out the decoction filtrate and add 912 g of water again for the second decoction, decoct for 1 h, and combine the decoction filtrates obtained from the two decoctions to obtain an extract; the extract is successively subjected to concentration treatment, drying treatment, and pulverization treatment to obtain a medicinal powder; the concentration treatment is to concentrate the extract to a thick paste with a relative density of 1.22 at 60°C.

[0034] (2) Mix the medicinal powder obtained in step (1) with dextrin and a wetting agent to form granules, then dry them at 60°C and divide them into independent small packages of 10 g / bag, and seal them with a composite film outer bag to obtain the traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma. Among them, the mass ratio of the medicinal powder to dextrin is 2:1; the wetting agent is an ethanol aqueous solution with a mass fraction of 80%, and the mass of the wetting agent is 13% of the mass of the medicinal powder.

[0035] Example 2 A traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma is composed of the following raw materials in parts by weight: 6 g of honey-fried ephedra, 9 g of peucedanum praeruptorum, 12 g of semen brassicae, 3 g of asarum, 6 g of dried ginger, 9 g of schisandra chinensis, 6 g of cicada slough, 9 g of pinellia ternata, 9 g of flos farfarae, 9 g of pericarpium citri reticulatae, 15 g of stir-fried semen lepidii, 15 g of cynanchum paniculatum, and 6 g of roasted licorice root.

[0036] Its preparation method is as follows: (1) Mix all the raw materials and add 1368 g of water for the first decoction for 1 h; then pour out the decoction filtrate and add 1368 g of water again for the second decoction for 1 h, and combine the decoction filtrates obtained from the two decoctions to obtain an extract; sequentially conduct concentration treatment, drying treatment, and pulverization treatment on the extract to obtain a medicinal powder; the concentration treatment is to concentrate the extract to a thick paste with a relative density of 1.20 at 60°C.

[0037] (2) Mix the medicinal powder obtained in step (1) with dextrin and a wetting agent to form granules, then dry them at 60°C and divide them into independent small packages of 10 g / bag, and seal them with a composite film outer bag to obtain the traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma. Among them, the mass ratio of the medicinal powder to dextrin is 2:1; the wetting agent is an ethanol aqueous solution with a mass fraction of 80%, and the mass of the wetting agent is 13% of the mass of the medicinal powder.

[0038] Example 3 A traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma is composed of the following raw materials in parts by weight: 10 g of honey-fried ephedra, 10 g of peucedanum praeruptorum, 15 g of semen brassicae, 5 g of asarum, 10 g of dried ginger, 10 g of schisandra chinensis, 10 g of cicada slough, 10 g of pinellia ternata, 10 g of flos farfarae, 10 g of pericarpium citri reticulatae, 20 g of stir-fried semen lepidii, 20 g of cynanchum paniculatum, and 10 g of roasted licorice root.

[0039] Its preparation method is as follows: (1) Mix all the raw materials and add 1800 g of water for the first decoction for 1 h; then pour out the decoction filtrate and add 1800 g of water again for the second decoction for 1 h, and combine the decoction filtrates obtained from the two decoctions to obtain an extract; sequentially conduct concentration treatment, drying treatment, and pulverization treatment on the extract to obtain a medicinal powder; the concentration treatment is to concentrate the extract to a thick paste with a relative density of 1.18 at 60°C.

[0040] (2) Mix the medicinal powder obtained in step (1) with dextrin and wetting agent, make into granules, then dry at 60°C and divide into independent small packages of 10 g / bag, and seal with a composite film outer bag to obtain the traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma. Among them, the mass ratio of the medicinal powder to dextrin is 2:1; the wetting agent is an ethanol aqueous solution with a mass fraction of 80%, and the mass of the wetting agent is 13% of the mass of the medicinal powder.

[0041] Control Example 1 A traditional Chinese medicine composition (placebo) for treating cold asthma syndrome of bronchial asthma is composed of the following raw materials in parts by weight: 6 g of honey-fried ephedra, 9 g of white hogfennel root, 12 g of semen brassicae, 3 g of asarum, 6 g of dried ginger, 9 g of schizandra chinensis, 6 g of cicada slough, 9 g of raw pinellia tuber, 9 g of flos farfarae, 9 g of tangerine peel, 15 g of stir-fried semen lepidii, 15 g of pyrola, and 6 g of roasted licorice root.

[0042] Its preparation method is as follows: (1) Mix all the raw materials and add 1368 g of water for the first decoction for 1 h; then pour out the decoction filtrate and add 1368 g of water again for the second decoction for 1 h, and combine the decoction filtrates obtained from the two decoctions to obtain an extract; subject the extract to concentration treatment, drying treatment, and pulverization treatment in sequence, and mix the pulverized material with starch in a mass ratio of 5:95 to obtain a powder; the concentration treatment is to concentrate the extract to a thick paste with a relative density of 1.20 at 60°C.

[0043] (2) Mix the medicinal powder obtained in step (1) with dextrin and wetting agent, make into granules, then dry at 60°C and divide into independent small packages of 10 g / bag, and seal with a composite film outer bag to obtain the traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma. Among them, the mass ratio of the medicinal powder to dextrin is 2:1; the wetting agent is an ethanol aqueous solution with a mass fraction of 80%, and the mass of the wetting agent is 13% of the mass of the medicinal powder.

[0044] The appearance, weight, color, and odor of the traditional Chinese medicine composition (placebo) in this control example are consistent with those of the traditional Chinese medicine composition in Example 2.

[0045] Experimental Example 1 This experimental example is used to compare the effects after experimental testers take the traditional Chinese medicine compositions and the traditional Chinese medicine composition (placebo) obtained from Example 2 and Control Example 1 respectively.

[0046] 1. Experimental subjects The experimental cases are patients with chronic persistent bronchial asthma (cold asthma syndrome) admitted to the First Affiliated Hospital of Henan University of Traditional Chinese Medicine from September 2023 to December 2024.

[0047] Selected indicators: (1)Inclusion criteria: ① Patients who meet the diagnostic criteria for the chronic persistent stage of bronchial asthma: Western medicine diagnostic criteria: Refer to the diagnosis of the chronic persistent stage of asthma in the "Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 Edition)".

[0048] ② Patients who meet the syndrome diagnostic criteria for the cold asthma syndrome of traditional Chinese medicine for bronchial asthma: Formulated with reference to the syndrome diagnostic criteria for the cold asthma syndrome in the "Diagnostic Criteria for Syndromes of Traditional Chinese Medicine for Bronchial Asthma" (2016 Edition): ① Shortness of breath or cough or chest tightness and shortness of breath; ② Aversion to cold, no sweating, or soreness or even pain in the limbs; ③ Clear and thin white phlegm or phlegm with foam; ④ Wheezing in the throat; ⑤ White and slippery tongue, or tight pulse or floating and tight pulse or slippery pulse. Have item ① and ②; add 2 items from ③, ④, and ⑤.

[0049] ③ Age ≥ 18 years old and ≤ 80 years old; ④ Have not participated in other clinical studies within 1 month before inclusion; ⑤ Voluntarily participate in the study and sign the informed consent form.

[0050] (2)Exclusion criteria: ① Pregnant and lactating women; ② Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, cardiac function grade 3 and above, stroke, cerebral hemorrhage, etc.); ③ Patients with severe liver and kidney diseases (severe liver diseases refer to cirrhosis, portal hypertension and variceal bleeding, and severe kidney diseases include dialysis and kidney transplantation); ④ Patients with bronchiectasis, pulmonary tuberculosis, pulmonary embolism or other severe respiratory diseases; ⑤ Patients with severe cognitive and mental abnormalities, etc.; ⑥ Those who are participating in other clinical trials within 1 month before inclusion; ⑦ Patients allergic to the known test drugs.

[0051] 2. Experimental design and grouping Grouping is carried out by random allocation method, divided into a control group and an experimental group, with 60 subjects in each group. The experimental group is given standard Western medicine treatment + the traditional Chinese medicine composition obtained in Example 2 for treatment; the control group is given standard Western medicine treatment + the traditional Chinese medicine composition (placebo) obtained in the comparative example for treatment. Take 1 dose per day, orally in 2 divided doses, and each 4 weeks is a treatment course, for a total of 8 weeks of treatment.

[0052] Among them, the standards and methods of standard Western medicine treatment are as follows: The Western medicine treatment measures for the chronic persistent stage of asthma are carried out with reference to the "Guidelines for the Prevention and Treatment of Bronchial Asthma" (2020 Edition). Based on the severity and control level of the patient's condition, the corresponding treatment plan is selected, and regular follow-up and monitoring are carried out. The treatment is adjusted in a timely manner according to the patient's control level to achieve and maintain asthma control. If the patient has not used any Western medicine treatment measures in the past, no Western medicine treatment will be provided to the patient during the treatment period of this study. The treatment medications for the patients during the study period need to be recorded comprehensively and truthfully.

[0053] 3. Observation indicators Observe the changes in the asthma control test rate, the number of acute exacerbations, the asthma quality of life questionnaire, and immunoglobulins: IgE, IgA, IgG, IgM.

[0054] (1) Asthma symptom control: The asthma control test (ACT) score was used for testing. There were a total of 5 questions, and each question was evaluated using a 5-point scale. The scores ranged from 5 to 25 points. The higher the score, the better the symptom control. A score of 25 indicates complete control, 20 - 24 indicates good control, and <20 indicates uncontrolled. While calculating the score, the asthma control test rate was also calculated.

[0055] (2) Number of acute exacerbations: Mainly record the number of acute exacerbations, incentives, treatment locations, treatment medications, prognosis, etc.

[0056] (3) Asthma quality of life assessment: The AQLQ scale contains 35 items, including 12 items of activity limitation, 9 items of asthma symptoms, 5 items of psychological status, 5 items of response to stimuli, and 4 items of concern for one's own health. All are evaluated using a 5-level scoring method of 1 - 5 points, with a full score of 175 points. The higher the total score, the better the quality of life.

[0057] (4) Immunoglobulins: IgE, IgA, IgG, IgM: Blood samples were collected before and after treatment. After centrifugation at 4°C and 3000 rpm for 20 minutes, the supernatant was collected, aliquoted into cryotubes, and stored in a -80°C refrigerator. ELISA method was used for detection.

[0058] 4. Statistical analysis SPSS 26.0 software was used for statistical analysis of the clinically collected data. For the measurement data of the asthma control test score, asthma control test rate, number of acute exacerbations, bronchial asthma quality of life score, serum IgA, IgG, IgA, IgM, according to whether they conform to the normal distribution, independent sample t-test or rank sum test was used between groups, and paired t-test or two-related sample rank sum test was used within groups; chi-square test was used for statistical analysis of categorical variables. P <0.05 indicates that the difference is statistically significant.

[0059] 5. Experimental results After 8 weeks of treatment, 12 cases dropped out during the treatment period, 6 in the experimental group and 6 in the control group. Finally, 108 cases were included in the analysis, including 54 cases in the experimental group, 23 males and 37 females, with an average age of (47.50±15.61) years and an asthma control test score of (16.76±3.29); 54 cases in the control group, 21 males and 39 females, with an average age of (48.28±16.77) years and an asthma control test score of (16.91±3.33). There were no statistically significant differences in gender, age, ethnicity, education level, occupation, marital status, smoking history, drinking history, and allergy history between the two groups of patients before treatment ( P >0.05), and they were comparable.

[0060] The test results are shown in Tables 1 - 8 respectively.

[0061] Table 1 Asthma control test score ( ) Table 2 Asthma control test rate (%) As can be seen from Tables 1 and 2, there were no statistically significant differences in the asthma control level and asthma control test scores between the two groups at the baseline period (before treatment) ( P >0.05). As the intervention time prolonged, the scores and control rates of the experimental group increased significantly. A statistical advantage was shown at 4 weeks ( P <0.05), and the difference further widened at 8 weeks ( P <0.001).

[0062] Table 3 Number of acute exacerbations ( ) As can be seen from Table 3, there was no significant difference in the number of acute exacerbations between the two groups at the baseline period ( P >0.05); at 4 weeks of treatment, the number of exacerbations in the experimental group was less than that in the control group, but the difference was not statistically significant ( P >0.05); at 8 weeks of treatment, the number of exacerbations in the experimental group was significantly lower than that in the control group ( P <0.05).

[0063] Table 4 Asthma quality of life score ( ) As can be seen from Table 4, there was no significant difference in the asthma quality of life scores between the two groups at the baseline period ( P >0.05); at 4 weeks and 8 weeks of treatment, the scores of the experimental group were significantly higher than those of the control group ( P <0.05).

[0064] Table 5 Comparison of IgE between two groups ( ) Table 6 Comparison of IgM between two groups ( ) Table 7 Comparison of IgA between two groups ( ) Table 8 Comparison of IgG between two groups ( ) As can be seen from Tables 5 - 8, after 8 weeks of intervention, the levels of serum IgE and IgM in the experimental group showed a specific downward trend, while there was no obvious decrease in the control group. The difference between the two groups was statistically significant ( P < 0.05). After treatment, IgG and IgA in the experimental group were lower than those before treatment, and the difference was statistically significant (P < 0.001); however, the difference between the two groups was not statistically significant (P > 0.05).

[0065] Experimental Example 2 This experimental example records the information and observation of some patients with bronchial asthma: Case 1, male, 48 years old, previously diagnosed with bronchial asthma (bronchial provocation test: positive). Two days ago, after getting cold, he had persistent wheezing accompanied by chest tightness, cough, and thin and clear sputum. There was no fever, general fatigue, or poor appetite. The admission diagnosis was bronchial asthma (acute attack stage). He was given symptomatic treatment with Western medicine combined with the traditional Chinese medicine composition prepared in Example 2, orally taking 1 bag per day, divided into two doses in the morning and evening. After taking the medicine for 2 days, the wheezing and chest tightness were significantly relieved compared with before, the amount of sputum decreased. On the 4th day, the wheezing and chest tightness basically disappeared, and the fatigue and poor appetite were significantly relieved. On the 7th day, the symptoms basically disappeared. Because the symptoms and signs of the patient tended to be stable and the respiratory symptoms were significantly relieved, he was instructed to continue taking the medicine after discharge and regularly use the inhalation preparation.

[0066] Case 2, female, 23 years old. One week ago, she had an attack of bronchial asthma induced by exposure to pollen and used salbutamol inhaler by herself, and the symptoms were somewhat relieved. The current symptoms are as follows: intermittent shortness of breath, occasional chest tightness, occasional cough, and a large amount of thin and clear sputum, and the spirit is average. The diagnosis was bronchial asthma (chronic persistent stage). When she visited the outpatient clinic, she was given a long-acting inhalation preparation combined with the traditional Chinese medicine composition prepared in Example 2 of the present invention, orally taking 1 bag per day, divided into two doses in the morning and evening. After one week of medication, she came for a follow-up visit and reported that after taking the medicine for 3 days, the symptoms were basically relieved, only occasional cough remained. After taking the medicine for 6 days, the cough symptoms completely disappeared. Because the symptoms and signs of the patient basically disappeared and there were no obvious respiratory symptoms, she was instructed to regularly inhale the medicine after discharge and seek medical attention if there is any discomfort.

[0067] Case 3, female, 38 years old, previously diagnosed with bronchial asthma, not treated regularly, with a poor asthma control level. Two weeks ago, there was an acute exacerbation during weather changes. The symptoms were dyspnea, chest tightness, cough with clear and thin frothy sputum, and poor spirit. The admission diagnosis was bronchial asthma (acute attack stage). Symptomatic treatment was given and the traditional Chinese medicine composition prepared in Example 2 of the present invention was used in combination, orally taking 1 bag, divided into two times, morning and evening. After taking the medicine for 4 days, the dyspnea was significantly relieved compared with before, the amount of expectoration decreased, and it turned into clear and thin sputum. On the 7th day, wheezing and chest tightness basically disappeared and the spirit improved. On the 9th day, the symptoms basically disappeared. Because the symptoms and signs of the patient tended to be stable and the respiratory symptoms were significantly relieved, the patient was instructed to continue taking the medicine after discharge and regularly use the inhalation preparation.

[0068] In summary, the traditional Chinese medicine composition for sequential treatment of acute attack stage and chronic persistent stage (cold asthma syndrome) of bronchial asthma of the present invention has reasonable compatibility and definite curative effect. It can significantly improve the asthma control test rate of patients in the chronic persistent stage, reduce the number of acute attacks, improve the quality of life of patients, and at the same time adjust the immune imbalance state of asthma patients. It is a rare sequential treatment drug for acute attack stage and chronic persistent stage (cold asthma syndrome) of asthma with pertinence and has application prospects.

[0069] Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements for some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma, characterized in that, It is composed of the following raw materials in parts by weight: 5 - 10 parts of honey - fried ephedra, 5 - 10 parts of peucedanum praeruptorum, 10 - 15 parts of semen perillae, 1 - 5 parts of asarum, 5 - 10 parts of dried ginger, 5 - 10 parts of schisandra chinensis, 5 - 10 parts of cicada slough, 5 - 10 parts of pinellia ternata, 5 - 10 parts of flos farfarae, 5 - 10 parts of pericarpium citri reticulatae, 10 - 20 parts of stir - fried semen lepidii, 10 - 20 parts of pyrola decorata, 5 - 10 parts of honey - fried licorice root.

2. The traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma according to claim 1, wherein, It is composed of the following raw materials in parts by weight: 6 parts of honey - fried ephedra, 9 parts of peucedanum praeruptorum, 12 parts of semen perillae, 3 parts of asarum, 6 parts of dried ginger, 9 parts of schisandra chinensis, 6 parts of cicada slough, 9 parts of pinellia ternata, 9 parts of flos farfarae, 9 parts of pericarpium citri reticulatae, 15 parts of stir - fried semen lepidii, 15 parts of pyrola decorata, 6 parts of honey - fried licorice root.

3. A preparation method of a traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma as described in claim 1 or 2, characterized in that, The method includes: (1) All raw materials are extracted with water to obtain an extraction solution, and then the extraction solution is successively subjected to concentration treatment, drying treatment, and pulverization treatment to obtain medicinal powder. (2) The medicinal powder is mixed with dextrin and a wetting agent to form granules, and then after drying and packaging, the traditional Chinese medicine composition for treating cold - type asthma syndrome of bronchial asthma is obtained.

4. The preparation method of a traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma according to claim 3, characterized in that, In step (1), the extraction includes the following steps: all raw materials are mixed and water is added for the first decoction. After pouring out the decoction filtrate, water is added again for the second decoction. The decoction filtrates obtained from the two decoctions are combined to obtain the extraction solution.

5. The preparation method of a traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma according to claim 4, characterized in that, The mass ratio of the water added during the two decoctions to the total mass of the mixed raw materials is 12:1, and the decoction time is 1 h for both.

6. The preparation method of a traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma according to claim 3, wherein, In step (1), the concentration treatment is to concentrate the extraction solution to a thick paste with a relative density of 1.18 - 1.22 at 60 °C.

7. The preparation method of a traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma according to claim 3, characterized in that, In step (2), the mass ratio of the medicinal powder to dextrin is 2:1; the wetting agent is an ethanol aqueous solution with a mass fraction of 80%, and the mass of the wetting agent is 13% of the mass of the medicinal powder.

8. The preparation method of a traditional Chinese medicine composition for treating cold asthma syndrome of bronchial asthma according to claim 3, characterized in that, In step (2), the prepared granules are dried at 60 °C and then packaged into independent small packages of 10 g / bag and sealed with a composite film outer bag to obtain the traditional Chinese medicine composition for treating cold - type asthma syndrome of bronchial asthma.

9. Use of a traditional Chinese medicine composition as described in claim 1 or 2 in the preparation of a drug for treating cold - type asthma syndrome of bronchial asthma.

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