A traditional Chinese medicine composition for treating airway inflammation and its preparation method

Abstract

The present invention discloses a traditional Chinese medicine composition for treating airway inflammation and a preparation method thereof. The traditional Chinese medicine composition comprises raw materials in the following weight ratios: 32-36 parts of honey-fried ephedra, 6-10 parts of asarum, 32-36 parts of magnolia flower, 6-10 parts of perilla seed, 32-36 parts of stir-fried immature bitter orange with bran, 6-10 parts of semen lepidii, 6-10 parts of loquat leaf, 32-36 parts of wine-processed scutellaria baicalensis, 10-14 parts of semen zanthoxyli, and 6-10 parts of liquorice. The selected raw materials of the traditional Chinese medicine composition conform to the compatibility principle of "sovereign, minister, assistant, and guide". Each component synergistically or jointly functions, so that the traditional Chinese medicine composition has the effects of relieving exterior syndrome and dispersing lung qi, regulating qi and resolving phlegm, relieving cough and asthma. Looking at the whole prescription, the compatibility of various herbs is rigorous and reasonable, closely following the etiology and pathogenesis of asthma, embodying the principle of treating the symptoms first in traditional Chinese medicine, and mainly treating airway inflammations such as cold asthma syndrome, bronchial asthma, and asthmatic bronchitis, and the effect is ideal.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating airway inflammation and a preparation method thereof. Background Art

[0002] Bronchial asthma is an airway inflammation involving multiple inflammatory cells, especially mast cells, eosinophils, and T lymphocytes. Due to the high reactivity of the bronchial mucosa, under the stimulation of allergens or other factors, the bronchial mucosa becomes congested and edematous, the mucosal glands secrete hyperfunctionally, resulting in the contraction of bronchial smooth muscle and symptoms such as wheezing, shortness of breath, shortness of breath, chest tightness, and coughing. Traditional Chinese medicine classifies bronchial asthma into the category of wheezing syndrome. Wheezing syndrome is a disease characterized by sudden onset, with symptoms of dyspnea and wheezing sounds in the throat. Since wheezing is always accompanied by dyspnea, wheezing syndrome is also called asthma. It is a complex disease with intermingled deficiency and excess, cold and heat syndromes. It is a common and frequently-occurring disease that seriously affects the study, work, and life of patients.

[0003] Data shows that: the prevalence rate of adult asthma in China is close to 3%, and it is particularly common among the elderly. Among adult asthma patients, those over 40 years old account for about 76%. It may be due to the long-term accumulation of various environmental factors and the influence of potential diseases in elderly patients, making them prone to chronic severe asthma. How to prevent and treat asthma in middle-aged and elderly people is a difficult problem faced by the medical community. In addition, due to seasonal changes, especially in spring and winter, people are prone to being invaded by wind-cold and suffering from cold phlegm cough and dyspnea. At the same time, due to the influence of factors such as air pollution, occupational factors, genetic factors, and smoking, recent statistical data shows that the number of asthma patients is on the rise. Currently, the commonly used drugs for treating asthma in Western medicine are anti-infective drugs, bronchodilators, expectorants, and sometimes combined with hormones, but the curative effect is not ideal, and drug side effects and hormone dependence are likely to occur. Through thousands of years of medical practice, traditional Chinese medicine has a unique and complete theory system of overall syndrome differentiation and treatment, treating both the symptoms and the root causes, and has characteristics in the treatment of asthma, accumulating rich experience. This composition has been used clinically for many years, with remarkable curative effect, safety, and reliability. Summary of the Invention

[0004] In view of this, the present invention is necessary to provide a traditional Chinese medicine composition. This traditional Chinese medicine composition uses honey-fried ephedra as the monarch drug, asarum and magnolia flower as the ministerial drugs, semen brassicae, stir-fried fructus aurantii, semen lepidii, folium eriobotryae, wine-processed scutellaria baicalensis, and semen zanthoxyli as the adjuvant drugs, and licorice as the guiding drug. Each component synergistically or jointly exerts the effects of relieving the exterior and dispersing the lung qi, regulating qi and resolving phlegm, relieving cough and asthma, so as to provide an ideal traditional Chinese medicine composition that can be used to treat airway inflammations such as cold wheezing syndrome, bronchial asthma, and asthmatic bronchitis.

[0005] In order to achieve the above object, the present invention adopts the following technical solutions:

[0006] The present invention first provides a traditional Chinese medicine composition for treating airway inflammation, which comprises raw materials in the following weight ratios: 32-36 parts of honey-fried ephedra, 6-10 parts of asarum, 32-36 parts of magnolia flower, 6-10 parts of perilla seed, 32-36 parts of stir-fried fructus aurantii with bran, 6-10 parts of semen lepidii, 6-10 parts of loquat leaf, 32-36 parts of wine-processed scutellaria baicalensis, 10-14 parts of semen zanthoxyli bungeani, 6-10 parts of liquorice;

[0007] A further embodiment comprises raw materials in the following weight ratios: 32-34 parts of honey-fried ephedra, 6-8 parts of asarum, 32-34 parts of magnolia flower, 6-8 parts of perilla seed, 32-34 parts of stir-fried fructus aurantii with bran, 6-8 parts of semen lepidii, 6-8 parts of loquat leaf, 32-34 parts of wine-processed scutellaria baicalensis, 10-12 parts of semen zanthoxyli bungeani, 6-8 parts of liquorice.

[0008] A further embodiment comprises raw materials in the following weight ratios: 32 parts of honey-fried ephedra, 6 parts of asarum, 32 parts of magnolia flower, 6 parts of perilla seed, 32 parts of stir-fried fructus aurantii with bran, 6 parts of semen lepidii, 6 parts of loquat leaf, 32 parts of wine-processed scutellaria baicalensis, 10 parts of semen zanthoxyli bungeani, 6 parts of liquorice;

[0009] or 34 parts of honey-fried ephedra, 8 parts of asarum, 34 parts of magnolia flower, 8 parts of perilla seed, 34 parts of stir-fried fructus aurantii with bran, 8 parts of semen lepidii, 8 parts of loquat leaf, 34 parts of wine-processed scutellaria baicalensis, 12 parts of semen zanthoxyli bungeani, 7 parts of liquorice;

[0010] or 36 parts of honey-fried ephedra, 10 parts of asarum, 36 parts of magnolia flower, 10 parts of perilla seed, 36 parts of stir-fried fructus aurantii with bran, 10 parts of semen lepidii, 10 parts of loquat leaf, 36 parts of wine-processed scutellaria baicalensis, 14 parts of semen zanthoxyli bungeani, 8 parts of liquorice.

[0011] A further embodiment is that the traditional Chinese medicine composition is any pharmaceutically acceptable dosage form.

[0012] A further embodiment is that the pharmaceutically acceptable dosage form is granules, oral solution, tablets, capsules or pills.

[0013] A further embodiment is that the airway inflammation is cold asthma syndrome, bronchial asthma or asthmatic bronchitis.

[0014] The present invention further provides a preparation method of the traditional Chinese medicine composition for treating airway inflammation as described above, comprising the following steps:

[0015] A) Mix asarum and magnolia flower, soak in water for 1-3 hours, extract volatile oil by steam distillation for 2-6 hours, re-distill the volatile oil, collect the re-distilled liquid, perform inclusion on the re-distilled liquid to obtain a volatile oil inclusion complex for standby; filter the aqueous solution after distillation, collect it separately, and reserve the medicinal residues for standby;

[0016] B) boiling the residue obtained in step A) with ephedra, perilla seed, bran-fried fructus aurantii, scutellaria baicalensis, loquat leaf, scutellaria baicalensis, zanthoxylum, and liquorice 2 to 3 times for 1 to 2 hours each time, combining the decoctions, filtering, and combining the filtrate with the aqueous solution in step A) to obtain an extract;

[0017] C) concentrating the extract obtained in step B) under reduced pressure to obtain a concentrated solution, wherein the relative density of the concentrated solution at a temperature of 70 to 75° C. is 1.10 to 1.12;

[0018] D) mixing the concentrated solution in step C) with ethanol until the alcohol content is 60% to 70%, stirring evenly, and standing for 24 hours to obtain an alcohol precipitation supernatant;

[0019] E) concentrating the alcohol precipitation supernatant to obtain a thick paste, wherein the relative density of the thick paste at a temperature of 70 to 75° C. is 1.30 to 1.35;

[0020] F) uniformly mixing the thick paste with auxiliary materials and the volatile oil inclusion compound obtained in step A) to obtain the traditional Chinese medicine composition.

[0021] In a further embodiment, the time for extracting the volatile oil in step A) is 3 hours.

[0022] In a further embodiment, the reduced pressure concentration in step C) is carried out at a pressure of 0.1 to 1.0 MPa; the temperature of the reduced pressure concentration is 65 to 75°C.

[0023] In a further embodiment, the auxiliary materials in step F) include dextrin and steviol glycoside.

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] The Chinese medicine composition provided by the present invention has the effects of dispelling exterior pathogens, promoting lung function, regulating qi and resolving phlegm, relieving cough and relieving asthma. Looking at the whole prescription, the compatibility of various medicines is rigorous and reasonable, closely following the etiology and pathogenesis of asthma, embodying the principle of treating the symptoms in an emergency in traditional Chinese medicine, and is mainly used to treat airway inflammations such as cold asthma, bronchial asthma and asthmatic bronchitis, and the effect is ideal. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 The pathological picture of the effect of the normal group on the alveolar membrane tissue of asthmatic guinea pigs;

[0027] Figure 2 The pathological picture of the model group's effect on the alveolar membrane tissue of asthmatic guinea pigs;

[0028] Figure 3 The pathological picture of the positive group's effect on the alveolar membrane tissue of asthmatic guinea pigs;

[0029] Figure 4Pathological diagrams of the effect of a small dose of the traditional Chinese medicine composition granules in Example 1 on the alveolar membrane tissue of asthmatic guinea pigs;

[0030] Figure 5 Pathological diagrams of the effect of a medium dose of the traditional Chinese medicine composition granules in Example 1 on the alveolar membrane tissue of asthmatic guinea pigs;

[0031] Figure 6 Pathological diagrams of the effect of a high dose of the traditional Chinese medicine composition granules in Example 1 on the alveolar membrane tissue of asthmatic guinea pigs;

[0032] Figure 7 Pathological diagrams of the effect of the traditional Chinese medicine composition granule doses in Comparative Examples 1-5 on the alveolar membrane tissue of asthmatic guinea pigs. Detailed implementation manners

[0033] For the convenience of understanding the present invention, the present invention will be described more comprehensively below in conjunction with specific embodiments. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, these embodiments are provided to make the disclosure of the present invention more thorough and comprehensive.

[0034] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which the present invention belongs. The terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0035] The first aspect of the present invention discloses a traditional Chinese medicine composition for treating airway inflammation, which comprises the following raw materials in the following weight ratios: 32-36 parts of honey-fried ephedra, 6-10 parts of asarum, 32-36 parts of magnolia flower, 6-10 parts of perilla seed, 32-36 parts of stir-fried immature bitter orange with bran, 6-10 parts of semen lepidii, 6-10 parts of eriobotrya leaf, 32-36 parts of scutellaria baicalensis Georgi with wine, 10-14 parts of semen zanthoxyli, and 6-10 parts of liquorice.

[0036] In the Chinese medicine composition, the main drug honey ephedra tastes sweet and slightly bitter, is warm and moist in nature, has a mild pungent and dispersing sweating effect, and has a strong effect of clearing the lungs, relieving asthma and relieving cough. Asarum is pungent and warm, warms the lungs and resolves phlegm, dispels cold and dispels wind, and clears the nasal passages. The lung opens the nose and has the effect of promoting qi and removing phlegm, and phlegm disappears when qi is smooth. Magnolia is pungent and warm, and enters the lung and stomach meridians. "Compendium of Materia Medica" says: "The pungent and warm nature of magnolia moves qi into the lungs." "Wuqiu Yaojie" says: "It can relieve the lungs and reduce adverse reactions, promote qi and break congestion." This prescription uses it together with ephedra to play the role of dispersing cold and eliminating evil, clearing the lungs and promoting qi, resolving phlegm and relieving asthma, and they are all minister drugs. Citrus aurantium is bitter, pungent and warm, has the effect of regulating qi and resolving phlegm, and widening the chest, which can be said to be "qi is smooth and phlegm disappears", and the strong nature of bran-fried Citrus aurantium is moderate, and it is good at regulating qi. Scutellaria baicalensis is bitter and cold, and its function is to clear the lungs and resolve phlegm. Scutellaria baicalensis with wine uses the nature of wine to ascend and disperse, leading the medicine into the blood, and can rise and flow outward to treat cough in the upper part of the body. At the same time, because the nature of wine is very hot, it can alleviate the bitter and cold nature of Scutellaria baicalensis to avoid damaging the spleen yang and causing abdominal pain. Zanthoxylum is bitter and cold, and can relieve asthma. The "Compendium of Materia Medica" calls it "fixing phlegm and asthma". In this prescription, a small amount of Scutellaria baicalensis is added. The bitter and cold nature of Zanthoxylum can restrain the dryness of warm medicines to avoid damaging body fluids. At the same time, it can also clear the heat of long-term depression to prevent the cold evil from turning into heat and entering the interior. They are all adjuvants. Licorice is sweet and flat in taste, harmonizes the middle and relieves urgency, moistens the lungs, and harmonizes all medicines. The above-mentioned medicines are used together. Looking at the whole prescription, the compatibility of the medicines is rigorous and reasonable, closely following the etiology and pathogenesis of asthma, reflecting the principle of TCM to treat the symptoms in an emergency, and playing the effect of relieving the exterior and promoting lung function, regulating qi and resolving phlegm, and relieving cough and asthma.

[0037] In a further embodiment, the Chinese medicine composition comprises the following raw materials in a weight ratio: 32-34 parts of honey ephedra, 6-8 parts of asarum, 32-34 parts of magnolia, 6-8 parts of perilla seeds, 32-34 parts of fried aurantium with bran, 6-8 parts of scutellaria seeds, 6-8 parts of loquat leaves, 32-34 parts of wine scutellaria, 10-12 parts of zanthoxylum, and 6-8 parts of licorice.

[0038] Preferably, in one or more embodiments of the present invention, the Chinese medicine composition comprises the following raw materials in weight ratio: 32 parts of honey ephedra, 6 parts of asarum, 32 parts of magnolia, 6 parts of perilla seeds, 32 parts of bran-fried aurantium, 6 parts of scutellaria, 6 parts of loquat leaves, 32 parts of wine scutellaria, 10 parts of zanthoxylum, and 6 parts of licorice;

[0039] Or 34 parts of honey ephedra, 8 parts of asarum, 34 parts of magnolia, 8 parts of perilla seeds, 34 parts of bran-fried aurantium, 8 parts of scutellaria, 8 parts of loquat leaves, 34 parts of wine scutellaria, 12 parts of zanthoxylum, and 7 parts of liquorice;

[0040] Or 36 parts of honey ephedra, 10 parts of asarum, 36 parts of magnolia, 10 parts of perilla seeds, 36 parts of stir-fried bitter orange fructus with bran, 10 parts of scutellaria baicalensis, 10 parts of loquat leaves, 36 parts of wine scutellaria, 14 parts of zanthoxylum, and 8 parts of liquorice.

[0041] In a further embodiment, the Chinese medicine composition further comprises a pharmaceutically acceptable excipient, so that the Chinese medicine composition can be in any pharmaceutically acceptable dosage form, such as granules, oral solution, tablets, capsules or pills.

[0042] In a further aspect, the traditional Chinese medicine composition of the present invention is used for treating airway inflammations such as cold asthma syndrome, bronchial asthma or asthmatic bronchitis.

[0043] In the second aspect of the present invention, a preparation method of the traditional Chinese medicine composition according to any one of the first aspect of the present invention is provided. The raw materials are successively subjected to distillation extraction, volatile oil extraction, water extraction, alcohol precipitation, and granulation, so as to extract the effective components from the pharmaceutical composition to the greatest extent, and the same effects are still achieved after being made into oral solution, tablets, capsules or pills. Specifically, the preparation of the traditional Chinese medicine composition includes the following steps:

[0044] A) Mix asarum and magnolia flower, soak in water for 1 - 3 hours, extract volatile oil for 2 - 6 hours by steam distillation method, re - distill the volatile oil, collect the re - distilled liquid, perform inclusion on the re - distilled liquid to obtain volatile oil inclusion compound for standby; filter the aqueous solution after distillation, collect it separately, and reserve the medicinal residues for standby; preferably, the time for extracting volatile oil is 3h.

[0045] B) Decoct the medicinal residues obtained in step A) together with ephedra, semen brassicae, stir - fried fructus aurantii, semen lepidii, folium eriobotryae, scutellaria baicalensis, semen zanthoxyli, and licorice twice with water, each time for 1 hour, combine the decoction liquids, filter, and combine the filtrate with the aqueous solution in step A) above to obtain an extraction solution;

[0046] C) Concentrate the extraction solution in step B) under reduced pressure to a clear paste with a relative density of 1.10 - 1.12 (measured at 70 - 75 °C) to obtain a concentrated solution;

[0047] D) Mix the concentrated solution in step C) with ethanol until the alcohol content is 60% - 70%, stir evenly, stand for 24 hours, and obtain the supernatant of alcohol precipitation;

[0048] E) Concentrate the supernatant of alcohol precipitation to a thick paste with a relative density of 1.30 - 1.35 (measured at 70 - 75 °C);

[0049] F) Mix the thick paste evenly with excipients and the volatile oil inclusion compound obtained in step A) to obtain the traditional Chinese medicine composition. Further, the excipients include dextrin and stevioside.

[0050] In one or more embodiments of the present invention, the extraction solution is concentrated under reduced pressure at a pressure of 0.1 - 1.0 Mpa, the temperature of reduced - pressure concentration is 65 - 75 °C, specifically, it can be set to 60 °C, 65 °C or 75 °C, and concentrated to a clear paste with a relative density of 1.10 - 1.12 (measured at 70 - 75 °C) to obtain a concentrated solution.

[0051] In the volatile oil inclusion complex described in the present invention, conventional inclusion methods in the art can be used without special limitations. In one or more embodiments of the present invention, the specific steps are as follows: The β-cyclodextrin direct addition method is used for inclusion. The inclusion process is optimized orthogonally with the volatile oil inclusion rate and the inclusion complex yield as indicators: the ratio of oil: water: β-cyclodextrin is 1 ml: 100 ml: 8 g, the inclusion temperature is 60 °C, and the inclusion time is 1 hour;

[0052] Wet granulation can reduce the process steps, shorten the preparation cycle, and is easy for industrial production. In this process, dextrin is selected as the excipient for tablet forming. Dextrin is a commonly used excipient for granules, with good anti-hygroscopicity and low price. The finished product granules have good water solubility. Since the relative density of the thick paste is 1.30 - 1.35 (measured at 70 - 75 °C) and is relatively thick, an appropriate amount of 95% ethanol is added as a diluent to reduce the viscosity, making it easy to mix and granulate. Therefore, the thick paste, dextrin, stevioside, and volatile oil inclusion complex are mixed evenly, and then 95% ethanol is added for granulation.

[0053] Specifically:

[0054] When the traditional Chinese medicine composition is a granule, wet granulation can reduce the process steps, shorten the preparation cycle, and is easy for industrial production.

[0055] When the traditional Chinese medicine composition is a tablet, the dried solid is crushed, sieved, and then mixed with excipients for granulation and tabletting to obtain the tablet; the granulation in the above steps is fluidized bed granulation, and the tabletting parameters are a pressure range of 10 - 30 KN and a tabletting speed of 27000 tablets per hour.

[0056] When the traditional Chinese medicine composition is a capsule, the dried solid is crushed, sieved, and then mixed with excipients for granulation and filling into capsules; the granulation in the above steps is granulation with 80% ethanol and a 24-mesh sieve, the ethanol dosage is 12 mL / 50 g, the stirring time is 1 min, and the drying time is 0.5 h;

[0057] When the traditional Chinese medicine composition is an oral solution, the traditional Chinese medicine raw materials are made into oral liquid through processes such as alcohol extraction, volatile oil extraction, water extraction, alcohol precipitation, concentration, dilution, and refrigeration; the dilution in the above steps is to dilute the concentrated solution with purified water and refrigerate at 4 - 8 °C for 48 hours.

[0058] The technical solution of the present invention will be described more completely in combination with specific embodiments below.

[0059] Preparation of Traditional Chinese Medicine Composition in Example 1

[0060] The traditional Chinese medicine composition contains the following raw materials: 32 parts of honey-fried ephedra, 6 parts of asarum, 32 parts of magnolia flower, 6 parts of perilla seed, 32 parts of stir-fried immature bitter orange, 6 parts of semen lepidii, 6 parts of loquat leaf, 32 parts of wine-processed scutellaria baicalensis, 10 parts of semen zanthoxyli, and 6 parts of liquorice;

[0061] The specific preparation steps are as follows:

[0062] 1) Asarum and Magnolia Flower are mixed, added with 20 times the amount of water, and the volatile oil is extracted by steam distillation for 3 hours. The volatile oil is redistilled, and the redistilled liquid is collected according to oil: water (1 ml: 100 ml). The β-CD direct addition method is used for inclusion. The ratio of volatile oil: water: β-CD is 1 ml: 100 ml: 8 g. The inclusion temperature is 60 °C, the inclusion time is 1 hour, refrigerated (4 - 10 °C) for 24 hours, filtered by suction, the filter residue is collected, dried under low temperature and vacuum, pulverized to obtain the β-CD inclusion complex for standby. The aqueous solution after distillation is filtered and collected separately;

[0063] 2) The medicinal residues are combined with the other eight flavors such as honey-fried Ephedra, added with water and decocted twice. Each time, 12 times the amount of water is added and decocted for 1 hour. The decoction liquids are combined, filtered, and the filtrate is combined with the above aqueous solution, and concentrated under reduced pressure to a clear paste with a relative density of 1.10 - 1.12 (measured at 70 - 75 °C);

[0064] 3) Ethanol is added to the obtained clear paste to make the alcohol content reach 60%, stirred evenly, allowed to stand for 24 hours, the supernatant is sucked out, ethanol is recovered under reduced pressure, and further concentrated to a thick paste with a relative density of 1.33 - 1.35 (measured at 70 - 75 °C),

[0065] 4) An appropriate amount of dextrin, steviol glycoside and the β-CD inclusion complex of the above volatile oil are added to the obtained thick paste, mixed evenly, made into granules, and dried to obtain the said traditional Chinese medicine composition.

[0066] Preparation of Traditional Chinese Medicine Composition in Example 2

[0067] This traditional Chinese medicine composition contains the following raw materials: 34 parts of honey-fried Ephedra, 8 parts of Asarum, 34 parts of Magnolia Flower, 8 parts of Perilla Seed, 34 parts of stir-fried Fructus Aurantii, 8 parts of Lepidium apetalum, 8 parts of Loquat Leaf, 34 parts of wine-processed Scutellaria baicalensis, 12 parts of Zanthoxylum nitidum, 7 parts of Licorice;

[0068] The preparation method is the same as that in Example 1.

[0069] Preparation of Traditional Chinese Medicine Composition in Example 3

[0070] This traditional Chinese medicine composition contains the following raw materials: 36 parts of honey-fried Ephedra, 10 parts of Asarum, 36 parts of Magnolia Flower, 10 parts of Perilla Seed, 36 parts of stir-fried Fructus Aurantii, 10 parts of Lepidium apetalum, 10 parts of Loquat Leaf, 36 parts of wine-processed Scutellaria baicalensis, 14 parts of Zanthoxylum nitidum, 8 parts of Licorice.

[0071] The preparation method is the same as that in Example 1.

[0072] Preparation of the related disassembled traditional Chinese medicine composition

[0073] Drug Prescription without Asarum in Comparative Example 1

[0074] The traditional Chinese medicine composition comprises the following raw materials: 32 parts of honey-fried ephedra, 32 parts of magnolia flower, 6 parts of perilla seed, 32 parts of stir-fried fructus aurantii with bran, 6 parts of semen lepidii, 6 parts of folium eriobotryae, 32 parts of wine-processed scutellaria baicalensis, 10 parts of semen zanthoxyli, 6 parts of liquorice;

[0075] The preparation method is the same as that in Example 1.

[0076] Drug Prescription without Magnolia Flower Bud in Comparative Example 2

[0077] 32 parts of honey-fried ephedra, 6 parts of asarum, 6 parts of perilla seed, 32 parts of stir-fried fructus aurantii with bran, 6 parts of semen lepidii, 6 parts of folium eriobotryae, 32 parts of wine-processed scutellaria baicalensis, 10 parts of semen zanthoxyli, 6 parts of liquorice;

[0078] The preparation method is the same as that in Example 1.

[0079] Drug Prescription without Stir-fried Immature Bitter Orange and Perilla Seed in Comparative Example 3

[0080] 32 parts of honey-fried ephedra, 6 parts of asarum, 32 parts of magnolia flower, 6 parts of semen lepidii, 6 parts of folium eriobotryae, 32 parts of wine-processed scutellaria baicalensis, 10 parts of semen zanthoxyli, 6 parts of liquorice;

[0081] The preparation method is the same as that in Example 1.

[0082] Drug Prescription without Wine-processed Scutellaria baicalensis Georgi and Seed of Zanthoxylum bungeanum Maxim. in Comparative Example 4

[0083] 32 parts of honey-fried ephedra, 6 parts of asarum, 32 parts of magnolia flower, 6 parts of perilla seed, 32 parts of stir-fried fructus aurantii with bran, 6 parts of semen lepidii, 6 parts of folium eriobotryae, 6 parts of liquorice;

[0084] Drug Prescription without Lepidium apetalum Willd. in Comparative Example 5

[0085] 32 parts of honey-fried ephedra, 6 parts of asarum, 32 parts of magnolia flower, 6 parts of perilla seed, 32 parts of stir-fried fructus aurantii with bran, 6 parts of folium eriobotryae, 32 parts of wine-processed scutellaria baicalensis, 10 parts of semen zanthoxyli, 6 parts of liquorice;

[0086] The preparation method is the same as that in Example 1.

[0087] Test Example

[0088] I. Pharmacological experiment to investigate the effect of the traditional Chinese medicine composition in the present invention on the guinea pig asthma model.

[0089] 1. Experimental materials

[0090] Drugs:

[0091] 1) The drug granule of the present invention: the granule prepared from the traditional Chinese medicine composition in Example 1.

[0092] 2) Qingshi Chongji: a positive control drug, produced by Hainan Lingrui Pharmaceutical Co., Ltd., batch number 000906.

[0093] Animals:

[0094] Kunming mice, Wistar rats and guinea pigs were provided by the Animal Center of Anhui Institute of Medical Sciences. The certificate numbers for the mice and rats were: Anhui Medical Experimental Animal Approval No. 01 and No. 03.

[0095] 2. Influence on the treatment of asthmatic guinea pigs

[0096] A total of 110 male guinea pigs weighing 250 - 300 g were randomly divided into a normal group, a model group, a positive drug group (Qingshi Chongji at 15.6 g / kg, calculated according to body surface area, equivalent to 4 times the daily adult clinical dosage of 30 g), the small, medium, and large dose groups of the granules in Example 1 of the present invention (6.0, 12.0, 24.0 g of crude drug / kg, calculated according to body surface area, equivalent to 1, 2, and 4 times the adult clinical dosage of 46 g), and the granule groups prepared from the related disassembled traditional Chinese medicine compositions in Comparative Examples 1 - 5 (12.0 g of crude drug / kg, calculated according to body surface area, equivalent to 2 times the adult clinical dosage of 46 g). Except for the normal group, the other groups of guinea pigs were injected with 1 ml / animal of 4% ovalbumin saline solution into the thigh muscle, while the normal group was injected with an equal volume of normal saline. On the 14th day, except for the normal group, each group was atomized with 5% ovalbumin for 15 s, and the asthma latency (if it exceeded 180 s, it was counted as 180 s) of the guinea pigs showing symptoms such as shortness of breath and dyspnea was recorded. Then, the guinea pigs in each group were administered drugs according to the doses in Table 1 for 2 consecutive weeks. On the 21st and 28th days, 1 hour after drug administration, they were atomized and sensitized with 5% ovalbumin to induce asthma. When measuring the asthma latency, the guinea pigs were anesthetized intraperitoneally with 20% urethane, and blood was taken from the abdominal aorta. IL-4 was measured by radioimmunoassay, and NO was measured using a 721 ultraviolet spectrophotometer at (550 nm) according to the instructions. Then, tracheal intubation was performed, and 5 ml of 37°C normal saline with a pH of 7.4 was slowly injected into the lungs of the guinea pigs and retained for 3 minutes, and the lavage fluid was aspirated back. This process was repeated 2 times, and the two aspirated lavage fluids were mixed. After centrifugation at 1500 r / min for 10 min, the supernatant was collected and TP was measured using an Italian BT-224 type automatic biochemical analyzer, WBC was measured using a Japanese-made F-820 blood cell analyzer, and the percentage of eosinophils (EOS) was measured manually. The results are shown in Tables 1 and 2. The changes in the lung tissues of the guinea pigs were observed using an optical microscope.

[0097] Table 1 Influence of the traditional Chinese medicine composition on the latency of asthmatic guinea pigs

[0098]

[0099] Note: Compared with the normal group, ** P < 0.01.

[0100] Table 2 Influence of the traditional Chinese medicine composition on WBC, EOS, TP, and NO in asthmatic guinea pigs (n = 10 )

[0101]

[0102]

[0103] Note: Compared with the normal group, ** P < 0.01; compared with the model group # P < 0.05, compared with the model group ## P < 0.01.

[0104] As can be seen from Tables 1 and 2, each dose group of the traditional Chinese medicine composition can significantly prolong the cough induction latency of guinea pigs with asthma models, reduce the number of WBCs, TP content, EOS%, and NO content in the bronchoalveolar lavage fluid, and there are significant differences compared with the model group. The relevant decoction-separated traditional Chinese medicine compositions of Comparative Examples 1-5 can also significantly prolong the cough induction latency of guinea pigs with asthma models, but there are no statistical differences, indicating that the effect of the decoction-separated group is significantly inferior to that of the whole formula group.

[0105] 2. Influence on the cough suppression test

[0106] Take 100 mice weighing 18 - 22 g, with 50 males and 50 females. Randomly divide them into a normal group (equal volume of distilled water), a positive drug group (Qingshi Granules at 15.6 g / kg, calculated according to body surface area, equivalent to 4 times the daily clinical dosage of 30 g for adults), the small, medium, and large dose groups of the granules in Example 1 of the present invention (6.0, 12.0, 24.0 g of crude drug / kg, calculated according to body surface area, equivalent to 1, 2, and 4 times the clinical dosage of 46 g for adults), and the granule groups of the relevant decoction-separated traditional Chinese medicine compositions of Comparative Examples 1-5 (12.0 g of crude drug / kg, calculated according to body surface area, equivalent to 2 times the clinical dosage of 46 g for adults). Administer the drugs by ig according to the dosage, continuously ig for 7 days. 40 minutes after the last dose, place the mice in a sealed glass box (40×40 cm 2 ), and use an ultrasonic nebulizer (PARI BOY 037G6000 type, made in Germany) to spray concentrated ammonia water into the box for about 10 s, with a spray volume of about 3 ml, to cause the cough reflex of the mice. Record the number of coughs of the mice within 2 minutes, and the results are shown in Table 3.

[0107] Table 3 Inhibitory effect of the traditional Chinese medicine composition on cough induced by concentrated ammonia water

[0108]

[0109]

[0110] Note: Compared with the normal group, ** P < 0.01.

[0111] As can be seen from Table 3, in Example 1 of the present invention, each dose group of the prepared granules significantly inhibited the cough reflex in mice caused by concentrated ammonia water, showing a significant difference compared with the normal group. The related decocted traditional Chinese medicine compositions in Comparative Examples 1-5 could also significantly inhibit the cough reflex in mice caused by concentrated ammonia water, but there was no statistical difference, indicating that the effect of the decocted group was significantly inferior to that of the whole formula group.

[0112] 3. Influence on anti-asthma test

[0113] Take 100 guinea pigs weighing 200-250 g, both male and female, and randomly divide them into a normal group, a positive drug group (Qingshi Granules 15.6 g / kg, calculated according to body surface area, equivalent to 4 times the daily adult clinical dosage of 30 g), the small, medium, and large dose groups of the granules in Example 1 of the present invention (6.0, 12.0, 24.0 g of crude drug / kg, calculated according to body surface area, equivalent to 1, 2, and 4 times the adult clinical dosage of 46 g), and the granule group prepared from the related decocted traditional Chinese medicine compositions in Comparative Examples 1-5 (12.0 g of crude drug / kg, calculated according to body surface area, equivalent to 2 times the adult clinical dosage of 46 g). Place the guinea pigs in sealed glass containers respectively, and use an ultrasonic nebulizer to spray a 2% acetylcholine and 0.1% histamine equal-volume mixture into the container for 15 s at a constant pressure. Observe and record the time of asthma attack and convulsion and fall in the guinea pigs (i.e., the induction latency), and then administer the drugs orally according to the doses in Table 4. For 7 consecutive days, 30 min after the last administration, conduct the induction of asthma by the same method as above, and the results are shown in Table 4.

[0114] Table 4 Influence of the traditional Chinese medicine composition on the induction latency of asthma in normal guinea pigs

[0115]

[0116]

[0117] Note: Compared with the normal group, * P<0.05, ** P<0.01.

[0118] As can be seen from Table 4, each dose group of the traditional Chinese medicine composition could significantly counteract the asthma induced by acetylcholine and histamine, significantly prolonging the induction latency. Compared with the normal group, there was a significant difference. The related decocted traditional Chinese medicine compositions in Comparative Examples 1-5 could also significantly counteract the asthma induced by acetylcholine and histamine, significantly prolonging the induction latency, but there was no statistical difference, indicating that the effect of the decocted group was significantly inferior to that of the whole formula group.

[0119] 4. Experimental results

[0120] The traditional Chinese medicine composition can significantly reduce the number of WBC, the percentage of EOS, the decrease of TP in the tracheal lavage fluid of the guinea pig model with asthma, and the content of NO in the serum of the guinea pig model with asthma; significantly counteract the cough response of mice induced by ammonia water; have a significant anti-asthmatic effect, and can inhibit the latent period of asthma in guinea pigs induced by the mixture of acetylcholine and histamine and the latent period of asthma in the guinea pig model replicated by ovalbumin. The above results show that the traditional Chinese medicine composition has good effects of relieving exterior syndrome and dispersing lung qi, regulating qi and resolving phlegm, relieving cough and asthma, and is a good medicine for treating cold asthma syndrome, bronchial asthma, and asthmatic bronchitis.

[0121] Figure 1 - Figure 6 Pathological diagrams showing the effects of the normal group, model group, positive group, and low-dose, medium-dose, and high-dose groups of the granules of Example 1 on the alveolar membrane tissue of guinea pigs with asthma are respectively shown. Figure 7 Pathological diagrams showing the effects of the traditional Chinese medicine compositions in Comparative Examples 1-5 on the lung tissue of guinea pigs with asthma are respectively shown. It can be seen from the figures that the bronchial epithelium of guinea pigs in the normal group is intact, the lumen has no secretions, and the alveolar wall has no thickening. In the model control group, the normal tissue structures such as alveoli and bronchioles disappear, connective tissue proliferates, and a large number of lymphocytes infiltrate. The pathological changes in the low-dose, medium-dose, and high-dose groups are improved, the lung tissue structure is relatively complete, and a small amount of lymphocyte infiltration can be occasionally seen, and the alveoli, bronchioles, etc. are in complete shape. In the groups of Example 1 and Comparative Examples 1-5, the lung tissue structure of guinea pigs is relatively complete, and the pathological improvement is significant.

[0122] The above-described embodiments merely represent several implementation manners of the present invention, and the description thereof is relatively specific and detailed, but it should not be construed as a limitation to the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several deformations and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the present invention patent shall be subject to the appended claims.

Claims

1. A traditional Chinese medicine composition for treating airway inflammation, characterized in that, It is made from the following raw materials in the following weight ratios: 32 parts of honey-fried Ephedra, 6 parts of Asarum, 32 parts of Magnolia Flower, 6 parts of Perilla Seed, 32 parts of stir-fried Fructus Aurantii with bran, 6 parts of Lepidium Seed, 6 parts of Loquat Leaf, 32 parts of wine-fried Scutellaria baicalensis, 10 parts of Semen Zanthoxyli, 6 parts of Licorice Root.

2. A traditional Chinese medicine composition for treating airway inflammation, characterized in that, It is made from the following raw materials in the following weight ratios: 34 parts of honey-fried Ephedra, 8 parts of Asarum, 34 parts of Magnolia Flower, 8 parts of Perilla Seed, 34 parts of stir-fried Fructus Aurantii with bran, 8 parts of Lepidium Seed, 8 parts of Loquat Leaf, 34 parts of wine-fried Scutellaria baicalensis, 12 parts of Semen Zanthoxyli, 7 parts of Licorice Root.

3. A traditional Chinese medicine composition for treating airway inflammation, characterized in that, It is made from the following raw materials in the following weight ratios: 36 parts of honey-fried Ephedra, 10 parts of Asarum, 36 parts of Magnolia Flower, 10 parts of Perilla Seed, 36 parts of stir-fried Fructus Aurantii with bran, 10 parts of Lepidium Seed, 10 parts of Loquat Leaf, 36 parts of wine-fried Scutellaria baicalensis, 14 parts of Semen Zanthoxyli, 8 parts of Licorice Root.

4. The traditional Chinese medicine composition for treating airway inflammation according to any one of claims 1 to 3, characterized in that, The airway inflammation is cold asthma syndrome, bronchial asthma or asthmatic bronchitis.

5. The traditional Chinese medicine composition for treating airway inflammation according to any one of claims 1 to 3, characterized in that, The traditional Chinese medicine composition is any pharmaceutically acceptable dosage form.

6. The traditional Chinese medicine composition for treating airway inflammation according to claim 5, wherein, The pharmaceutically acceptable dosage forms are granules, oral solutions, tablets, capsules or pills.

7. The preparation method of the traditional Chinese medicine composition for treating airway inflammation according to any one of claims 1 to 6, characterized in that It includes the following steps: A) Mix Asarum and Magnolia Flower, soak in water for 1 - 3 hours, extract volatile oil by steam distillation for 2 - 6 hours, re-distill the volatile oil, collect the re-distilled liquid, perform inclusion on the re-distilled liquid to obtain the volatile oil inclusion complex, and set aside; filter the aqueous solution after distillation, collect separately, and set aside the medicinal residues; B) Mix the medicinal residues obtained in step A) with Ephedra, Perilla Seed, stir-fried Fructus Aurantii with bran, Lepidium Seed, Loquat Leaf, Scutellaria baicalensis, Semen Zanthoxyli, and Licorice Root, decoct with water 2 - 3 times, each time for 1 - 2 hours, combine the decoction liquids, filter, and combine the obtained filtrate with the aqueous solution after distillation in step A) above to obtain the extract; C) Concentrate the extract obtained in step B) under reduced pressure to obtain a concentrated liquid, and the relative density of the concentrated liquid at a temperature of 70 - 75 °C is 1.10 - 1.12; D) Mix the concentrated liquid in step C) with ethanol until the alcohol content is 60% - 70%, stir evenly, let stand, and obtain the supernatant of alcohol precipitation; E) Concentrate the supernatant of alcohol precipitation to obtain a thick paste, and the relative density of the thick paste at a temperature of 70 - 75 °C is 1.30 - 1.35; F) Mix the thick paste, auxiliary materials and the volatile oil inclusion complex obtained in step A) evenly to obtain the traditional Chinese medicine composition.

8. The preparation method of the traditional Chinese medicine composition for treating airway inflammation according to claim 7, characterized in that, In step A), the time for extracting volatile oil by steam distillation is 3 hours.

9. The preparation method of the traditional Chinese medicine composition for treating airway inflammation according to claim 7, characterized in that, In step C), the pressure for concentration under reduced pressure is 0.1 - 1.0 Mpa; the temperature for concentration under reduced pressure is 65 - 75 °C.

10. The preparation method of the traditional Chinese medicine composition for treating airway inflammation according to claim 7, characterized in that, In step F), the auxiliary materials include dextrin and stevioside.

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