CN108355124B

CN108355124B - Traditional Chinese medicine composition for treating airway mucus hypersecretion and application thereof

Info

Publication number: CN108355124B
Application number: CN201810507947.XA
Authority: CN
Inventors: 汤杰; 钟秀君; 王庆其; 张谊; 李海燕; 杨佩兰; 顾文燕; 李丽娜; 张静灏
Original assignee: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of TCM
Current assignee: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of TCM
Priority date: 2018-05-24
Filing date: 2018-05-24
Publication date: 2021-02-19
Anticipated expiration: 2038-05-24
Also published as: CN108355124A

Abstract

The invention discloses a traditional Chinese medicine composition for treating airway mucus hypersecretion and application thereof, wherein the traditional Chinese medicine composition comprises the following components: raw ephedra, cassia twig, gentian, asarum, dried ginger, raw astragalus, root of rehmannia, fried scutellaria, dandelion, Chinese violet, chezicar meat, ginger processed pinellia and raw liquorice. The invention also relates to application of the traditional Chinese medicine composition in preparing a medicine for treating or inhibiting airway mucus hypersecretion. The traditional Chinese medicine and western medicine combined treatment effect on the chronic obstructive pulmonary disease is remarkable, the traditional Chinese medicine symptoms of the patient asthma can be better relieved, the MMRC score can be improved, and the number of hospitalization days of the patient can be shortened. The traditional Chinese medicine and western medicine conventional treatment AECOPD can reduce the blood CRP and PCT levels of patients, is helpful for AECOPD bacterial infection control, can improve the auxiliary respiratory muscle movement score of the patients, and can reduce the work of respiratory muscles.

Description

Traditional Chinese medicine composition for treating airway mucus hypersecretion and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating airway mucus hypersecretion and application thereof.

Background

High secretion of airway mucus is an important pathophysiology and clinical manifestation of chronic airway inflammatory diseases such as chronic obstructive pulmonary diseases (chronic obstructive lung), bronchial asthma (asthma), bronchiectasis, pulmonary cystic fibrosis and the like. In recent years, the research finds that under the stimulation of various factors such as inflammation, oxidative stress and the like, excessive mucus is produced and secreted by glands and goblet cells, is involved in the onset of chronic airway inflammatory diseases, and is closely related to the clinical outcome of the chronic airway inflammatory diseases. There are reports in the literature of the important role of high secretion of airway mucus in common respiratory diseases, and many patients are found in clinical practice to die of airway obstruction or asphyxia caused by high secretion of airway mucus.

Mucus is a mixture of mucin secreted by goblet cells in the trachea and bronchi and water, carbohydrates, proteins, lipids and minerals secreted by submucosal glands. Normally secreted airway mucus has the functions of protecting airways, moistening air and the like, but under the action of a plurality of pathogenic factors such as smoking, infection, oxidative stress and the like, a large amount of secretion promoting factors can be generated to act on secretory cells, so that airway goblet cells are hypertrophic and hyperplastic, and excessive mucus is generated. Airway mucus hypersecretion and ciliary dysfunction are characteristic pathophysiological changes in chronic obstructive pulmonary, asthma, bronchiectasis. In the process of chronic obstructive pulmonary disease, synthesis and release of neutrophil protease and matrix metalloproteinase-9 (MMP-9) are increased, and mucus secretion is accelerated. The content of mucus in the airway of asthma patients is increased, such as MUC5AC and MUC5B, the epithelium is damaged, ciliated cells are exfoliated, goblet cells are obviously proliferated, and submucosal glands are thickened, so that airway mucus is highly secreted. The mucus removing function is damaged due to irreversible expansion of the patient with bronchiectasis, bacteria are easy to fix and plant, toxic media secreted by the bacteria and decomposed products after the bacteria die stimulate the goblet formation of airway epithelial cells to generate excessive mucus, and the airway mucus is highly secreted. In a word, the generation of high mucus secretion of the airway relates to various pathophysiological mechanisms such as inflammatory reaction, oxidative stress, protease imbalance, cholinergic nerve dysfunction and the like, and is important pathophysiological changes and clinical manifestations of common respiratory diseases such as chronic obstructive pulmonary disease, asthma, bronchiectasis and the like.

Mucus in the air passage is highly secreted, so that excessive mucus is accumulated in the cavity of the air passage to block the air passage, so that the air flow is limited, and the decline process of the lung function is accelerated; at the same time, the inflammatory response causes a decrease in cilia clearance, loss of alveolar surfactant and changes in the biophysical properties of mucus, leading to repeated infection, obstruction and remodeling of airways, forming a vicious circle. Research proves that high secretion of airway mucus is an important risk factor influencing the onset, clinical development and prognosis of chronic airway inflammatory diseases.

Chinese journal "journal of traditional Chinese medicine" 2015 3 month publication thesis "random control double blind study of treating chronic obstructive pulmonary disease by combining Juanyin lung-purging prescription with western medicine", compares the clinical curative effects of treating chronic obstructive pulmonary disease acute exacerbation phlegm-heat lung obstruction syndrome by combining the Juanyin lung-purging prescription and the heat-clearing phlegm-resolving prescription with western medicine respectively, and discloses a prescription: 9g of ephedra, 15g of cassia twig, 9g of gentian, 6g of asarum, 9g of dried ginger, 15g of astragalus, 15g of radix rehmanniae recen, 15g of scutellaria baicalensis, 9g of bitter apricot seed, 9g of schisandra chinensis, 15g of white paeony root, 15g of ginger processed pinellia tuber, 15g of fructus aurantii and 6g of liquorice. Chinese patent 2014105043446 discloses a traditional Chinese medicine for treating bronchial asthma: 5-15 g of ephedra, 5-15 g of platycodon grandiflorum, 5-15 g of radix stemonae, 5-15 g of coptis chinensis, 5-15 g of honeysuckle, 5-15 g of codonopsis pilosula, 5-15 g of scutellaria baicalensis, 5-15 g of lumbricus, 5-15 g of schisandra chinensis, 5-15 g of gypsum, 10-20 g of bulbus fritillariae cirrhosae, 10-20 g of cassia twig, 10-20 g of pinellia ternata, 10-20 g of radix paeoniae alba, 10-20 g of almond, 15-25 g of radix sileris, 15-25 g of astragalus membranaceus, 3-8 g of dried ginger, 2-5 g of asarum and 2-5. Chinese patent 2013107048721 discloses a Chinese medicinal composition for treating bronchial asthma: 30g of astragalus, 30g of bighead atractylodes rhizome, 25 g of divaricate saposhnikovia root, 10 g of white mustard seed, 10 g of honeysuckle, 10 g of baical skullcap root, 10 g of Chinese magnoliavine fruit, 10 g of gypsum, 10 g of perilla fruit, 10 g of pinellia tuber, 10 g of prepared rehmannia root, 10 g of almond, 10 g of cicada slough, 10 g of earthworm, 10 g of dried orange peel, 6g of unibract fritillary bulb, 6g of ephedra herb, 6g of platycodon root, 2g of asarum, 8g of ginger, 5g of Chinese date. However, in the prior art, no report is found about the traditional Chinese medicine composition for treating airway mucus hypersecretion.

Disclosure of Invention

The first purpose of the present invention is to provide a traditional Chinese medicine composition for treating airway mucus hypersecretion, which aims at the defects in the prior art.

The second purpose of the invention is to provide the pharmaceutical application of the traditional Chinese medicine composition.

In order to achieve the first purpose, the invention adopts the technical scheme that:

a traditional Chinese medicine composition for treating airway mucus hypersecretion is prepared from the following raw material medicines in parts by weight: 4-14 parts of raw ephedra herb, 7-17 parts of cassia twig, 4-14 parts of gentian, 1-11 parts of asarum, 4-14 parts of dried ginger, 25-35 parts of raw astragalus root, 7-17 parts of dried rehmannia root, 7-17 parts of fried scutellaria root, 25-35 parts of dandelion, 25-35 parts of Chinese violet, 7-17 parts of chebula meat, 7-17 parts of ginger processed pinellia tuber and 1-11 parts of raw liquorice.

As a preferred embodiment of the invention, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 6-12 parts of raw ephedra herb, 9-15 parts of cassia twig, 6-12 parts of gentian, 3-9 parts of asarum, 6-12 parts of dried ginger, 27-33 parts of raw astragalus root, 9-15 parts of radix rehmanniae, 9-15 parts of fried scutellaria root, 27-33 parts of dandelion, 27-33 parts of Chinese violet, 9-15 parts of chebula meat, 9-15 parts of ginger processed pinellia tuber and 3-9 parts of raw liquorice.

As a preferred embodiment of the invention, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 9 parts of raw ephedra, 12 parts of cassia twig, 9 parts of gentian, 6 parts of asarum, 9 parts of dried ginger, 30 parts of raw astragalus, 12 parts of radix rehmanniae, 12 parts of fried scutellaria baicalensis, 30 parts of dandelion, 30 parts of Chinese violet, 12 parts of chebula meat, 12 parts of ginger processed pinellia and 6 parts of raw liquorice.

Square solution: the whole formula uses cold and heat simultaneously, pungent flavor and bitter taste are reduced, and the opposite phases are formed, and the reverse excitation is realized.

Monarch: raw ephedra, cassia twig and gentian root.

The mutual reinforcement of Ma Huang and Gui Zhi is the monarch herb, which can induce sweat and dispel cold to relieve exterior syndrome, and Ma Huang can also disperse lung qi to relieve dyspnea and cough, Gui Zhi can resolve qi and promote diuresis to promote diuresis. Gentiana scabra Bunge is bitter and cold in property, can reduce qi of lung and stomach, and clear damp-heat of liver and gallbladder, while Chuan Lao believes that Gentiana scabra Bunge can clear fire of triple energizer, and is commonly used for clearing lung heat, relieving heat, and relieving cough and asthma due to qi descending.

Minister: asarum herb, dried ginger, astragalus root, rehmannia root, fried scutellaria root.

Asarum herb, dried ginger and cinnamon bark, cortex cinnamomi, both assist in expelling superficial evils and eliminating pathogens. The astragalus root has the functions of tonifying lung and qi, the rehmannia root has the functions of nourishing yin and promoting the production of body fluid, and the qi is consumed to damage yin due to chronic cough. Stir-baked Huang Qin with bitter taste and cold property can purge lung, clear heat and remove toxicity.

And (2) adjuvant: fructus Chebulae, rhizoma Pinelliae preparata, herba Taraxaci, and herba Violae.

The combination of Kezi meat with pungent powder can strengthen the action of relieving cough and dyspnea, and restrict the excessive warming and dryness of various herbs with pungent flavor. Treatment of symptoms and symptoms rope: for the syndrome of good treatment of phlegm, qi is treated but not treated, qi is smooth and body fluids are smooth and smooth with qi , Jiang ban Xia eliminates dampness and phlegm, regulates stomach and lowers adverse flow of qi. The dandelion and the herba violae are used together to clear away the lung-heat and resolve phlegm, clear away heat and toxic material.

The following steps are performed: radix Glycyrrhizae

Herbs that can relieve cough and resolve phlegm also can harmonize the other herbs.

(3) The formula is characterized in that:

gentian, fried scutellaria root-asarum herb, dried ginger: when cold and heat are combined, pungent flavor and bitter flavor decrease, the opposite phases become, and the reverse excitation is reversed. Pungent flavor can disperse pathogen accumulation, warm property can resolve phlegm-fluid retention, bitter flavor can descend adverse rising lung qi, and clear phlegm-heat accumulated in the interior.

Raw ephedra, cassia twig-terminalia fruit flesh: one is Xuan-Su. The lung failing to disperse and descend is the main pathogenesis of cough, especially the symptoms caused by exogenous pathogens, such as unsmooth cough, uncomfortable expectoration, the manifestation of lung qi failing to disperse, the rapid dyspnea with rapid respiration, the manifestation of lung qi failing to descend and the manifestation of adverse rising of lung qi failing to descend, and both of them coexist, so the lung-dispersing and lung-descending herbs are applied together in the theory of free movement.

Asarum, dried ginger-chezi meat: and (5) recovering the pungent and dispersing acids. For chronic cough and severe cough, pungent herbs can disperse lung qi and dispel cold pathogen, and sour herbs can astringe lung qi to relieve cough, so that the pathogenic qi can be removed and the lung qi can be harmonized.

Raw astragalus root, dried rehmannia root-gentian, fried scutellaria root, dandelion, Chinese violet: one for supplementing and one for discharging, the other for the opposite phase. Dispelling pathogenic factors and tonifying lung, and being bitter and cold without damaging body resistance and purging lung without damaging yin.

Radix rehmanniae-ginger processed pinellia: moistening and drying, and stimulating the phases. Pungent dryness can promote fluid consumption and promote wound healing alone, and yin-nourishing can help moisten body fluid, nourish yin and clear heat, dry dampness and resolve phlegm, all of which are responsible for mutual assistance.

As a preferred embodiment of the invention, the Chinese medicinal preparation is prepared into a clinically acceptable medicinal preparation according to a conventional Chinese medicinal preparation method.

As a preferred embodiment of the present invention, the pharmaceutical preparation is granules, powders, capsules, tablets, mixtures or oral liquids.

In order to achieve the second object, the invention adopts the technical scheme that:

the application of the traditional Chinese medicine composition in preparing a medicine for treating or inhibiting airway mucus hypersecretion.

The application of the traditional Chinese medicine composition in preparing a medicine for treating chronic airway inflammatory diseases. The chronic airway inflammatory diseases comprise chronic obstructive pulmonary diseases, bronchial asthma, bronchiectasis and lung cystic fibrosis.

The medicament may further comprise conventional carriers such as: diluents, excipients, and water, and the like, fillers such as starch, sucrose, lactose, microcrystalline cellulose, and the like; binders such as cellulose derivatives, alginates, gelatin, and polyvinylpyrrolidone; humectants such as glycerol; disintegrating agents such as sodium carboxymethyl starch, hydroxypropyl cellulose, cross-linked carboxymethyl cellulose, agar, calcium carbonate and sodium bicarbonate; absorption enhancers such as quaternary ammonium compounds; surfactants such as cetyl alcohol, sodium lauryl sulfate; adsorption carriers such as kaolin and bentonite; lubricants such as talc, calcium and magnesium stearate, micronized silica gel, polyethylene glycol, and the like. Other adjuvants such as flavoring agent, sweetener, etc. can also be added into the composition.

The invention has the advantages that:

1. the traditional Chinese medicine composition has an obvious curative effect on treating the chronic obstructive pulmonary disease by combining with western medicines, and compared with a control group heat-clearing and phlegm-eliminating formula, the traditional Chinese medicine composition can better relieve the asthma and the traditional Chinese medicine symptoms of a patient, improve the MMRC score and shorten the hospitalization days of the patient.

2. The traditional Chinese medicine composition disclosed by the invention can be combined with conventional western medicine treatment AECOPD to reduce the blood CRP and PCT levels of patients, is beneficial to the control of AECOPD bacterial infection, can improve the auxiliary respiratory muscle movement score of the patients and reduce the work of respiratory muscles.

3. The components of the traditional Chinese medicine composition and the proportion thereof are screened by tests, and the traditional Chinese medicine composition has the advantage of remarkable effect.

Detailed Description

The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Furthermore, it should be understood that various changes and modifications can be made by those skilled in the art after reading the disclosure of the present invention, and equivalents fall within the scope of the appended claims.

Example 1A Chinese medicinal composition for treating airway mucus hypersecretion

Taking the traditional Chinese medicine raw materials in proportion: 9 parts of raw ephedra, 12 parts of cassia twig, 9 parts of gentian, 6 parts of asarum, 9 parts of dried ginger, 30 parts of raw astragalus, 12 parts of radix rehmanniae, 12 parts of fried scutellaria baicalensis, 30 parts of dandelion, 30 parts of Chinese violet, 12 parts of chebula meat, 12 parts of ginger processed pinellia and 6 parts of raw liquorice.

Example 2 Chinese medicinal composition for treating airway mucus hypersecretion

Taking the traditional Chinese medicine raw materials in proportion: 4 parts of raw ephedra, 7 parts of cassia twig, 4 parts of gentian, 1 part of asarum, 14 parts of dried ginger, 35 parts of raw astragalus, 17 parts of radix rehmanniae, 17 parts of fried scutellaria baicalensis, 35 parts of dandelion, 35 parts of Chinese violet, 17 parts of chezid meat, 17 parts of ginger processed pinellia and 11 parts of raw liquorice.

Example 3 Chinese medicinal composition for treating airway mucus hypersecretion

Taking the traditional Chinese medicine raw materials in proportion: 14 parts of raw ephedra herb, 17 parts of cassia twig, 14 parts of gentian, 11 parts of asarum, 4 parts of dried ginger, 25 parts of raw astragalus, 7 parts of radix rehmanniae, 7 parts of fried scutellaria baicalensis, 25 parts of dandelion, 25 parts of Chinese violet, 7 parts of chezid meat, 7 parts of ginger processed pinellia and 1 part of raw liquorice.

Example 4 Chinese medicinal composition for treating airway mucus hypersecretion (IV)

Taking the traditional Chinese medicine raw materials in proportion: 4 parts of raw ephedra, 17 parts of cassia twig, 4 parts of gentian, 11 parts of asarum, 4 parts of dried ginger, 35 parts of raw astragalus, 7 parts of radix rehmanniae, 17 parts of fried scutellaria baicalensis, 25 parts of dandelion, 35 parts of Chinese violet, 7 parts of chezid meat, 17 parts of ginger processed pinellia and 1 part of raw liquorice.

Example 5 Chinese medicinal composition for treating airway mucus hypersecretion (V)

Taking the traditional Chinese medicine raw materials in proportion: 14 parts of raw ephedra herb, 7 parts of cassia twig, 14 parts of gentian, 1 part of asarum, 14 parts of dried ginger, 25 parts of raw astragalus, 17 parts of raw rehmannia root, 7 parts of fried scutellaria baicalensis, 35 parts of dandelion, 25 parts of Chinese violet, 17 parts of chezid meat, 7 parts of ginger processed pinellia tuber and 11 parts of raw liquorice.

Example 6 Chinese medicinal composition for treating airway mucus hypersecretion (VI)

Taking the traditional Chinese medicine raw materials in proportion: 6 parts of raw ephedra, 9 parts of cassia twig, 6 parts of gentian, 3 parts of asarum, 12 parts of dried ginger, 33 parts of raw astragalus, 15 parts of radix rehmanniae, 15 parts of fried scutellaria, 33 parts of dandelion, 33 parts of Chinese violet, 15 parts of chezid meat, 15 parts of ginger processed pinellia and 9 parts of raw liquorice.

Example 7 Chinese medicinal composition (seven) for treating airway mucus hypersecretion

Taking the traditional Chinese medicine raw materials in proportion: 12 parts of raw ephedra, 15 parts of cassia twig, 12 parts of gentian, 9 parts of asarum, 6 parts of dried ginger, 27 parts of raw astragalus, 9 parts of radix rehmanniae, 9 parts of fried scutellaria, 27 parts of dandelion, 27 parts of Chinese violet, 9 parts of chezid meat, 9 parts of ginger processed pinellia and 3 parts of raw liquorice.

Example 8 Chinese medicinal composition (eight) for treating airway mucus hypersecretion

Taking the traditional Chinese medicine raw materials in proportion: 6 parts of raw ephedra, 15 parts of cassia twig, 6 parts of gentian, 9 parts of asarum, 6 parts of dried ginger, 33 parts of raw astragalus, 9 parts of radix rehmanniae, 15 parts of fried scutellaria baicalensis, 27 parts of dandelion, 33 parts of Chinese violet, 9 parts of chezid meat, 15 parts of ginger processed pinellia and 3 parts of raw liquorice.

Example 9 Chinese medicinal composition for treating airway mucus hypersecretion (nine)

Taking the traditional Chinese medicine raw materials in proportion: 12 parts of raw ephedra, 9 parts of cassia twig, 12 parts of gentian, 3 parts of asarum, 12 parts of dried ginger, 27 parts of raw astragalus, 15 parts of radix rehmanniae, 9 parts of fried scutellaria baicalensis, 33 parts of dandelion, 27 parts of Chinese violet, 15 parts of chezid meat, 9 parts of ginger processed pinellia and 9 parts of raw liquorice.

EXAMPLE 10 preparation of decoction

The Chinese medicinal composition of any one of embodiments 1 to 9 is taken and added with water to be decocted according to a conventional method. The Chinese medicinal materials are taken according to the weight part ratio, and are decocted into decoction by adding water.

EXAMPLE 11 preparation of mixture/granules

(1) Taking 9 parts of raw ephedra, 12 parts of cassia twig, 9 parts of gentian, 6 parts of asarum, 9 parts of dried ginger, 30 parts of raw astragalus, 12 parts of radix rehmanniae and 12 parts of fried scutellaria baicalensis, cleaning, sterilizing, and adding hot water for soaking for 30-60 minutes;

(2) adding 30 parts of dandelion, 30 parts of Chinese violet, 12 parts of fructus chebulae, 12 parts of ginger processed pinellia tuber and 6 parts of raw liquorice, decocting for 60-120 minutes, and decocting for 2-3 times;

(3) mixing decoctions, filtering the residue, and concentrating to obtain fluid extract;

(4) taking the clear paste obtained in the step (3), adding a proper amount of preservative, adding purified water to a specified amount, and filtering to obtain a traditional Chinese medicine mixture; or taking the clear paste obtained in the step (3), drying and crushing the clear paste into dry extract powder, adding a filling agent applicable to granules, granulating and drying to obtain the traditional Chinese medicine granules.

EXAMPLE 12 preparation of Chinese medicinal tablet/Capsule

(3) mixing decoctions, filtering the residue, drying, and pulverizing to obtain extract powder;

(4) taking the dry extract powder in the step (3), adding auxiliary materials suitable for tablets, granulating, drying, adding a lubricant suitable for tablets, and tabletting or coating to obtain the traditional Chinese medicine tablets; or taking the dry extract powder in the step (3), adding auxiliary materials suitable for capsules, or granulating, drying and filling into hollow capsules to obtain the traditional Chinese medicine capsules.

EXAMPLE 13 preparation of concentrated pellets

(1) Pulverizing 9 parts of raw ephedra herb, 12 parts of cassia twig and 9 parts of gentian into medicinal fine powder, and uniformly mixing for later use;

(2) decocting 6 parts of asarum, 9 parts of dried ginger, 30 parts of raw astragalus, 12 parts of radix rehmanniae, 12 parts of fried scutellaria baicalensis, 30 parts of dandelion, 30 parts of Chinese violet, 12 parts of chebula meat, 12 parts of ginger processed pinellia and 6 parts of raw liquorice in water for 1-2 hours and 2-3 times;

(4) and (3) taking the fine powder of the medicinal materials in the step (1) and the clear paste in the step (2) as an adhesive, preparing the fine powder into concentrated pills, drying and polishing the concentrated pills to obtain the concentrated pills.

Effect example 1

1 clinical data

1.1 general data

69 hospitalized patients in respiratory medical ward from 9 months 2014 to 12 months 2017 were collected and divided into 36 patients in the treatment group and 33 patients in the control group according to a random digital table method. 31 men and 5 women in the treatment group; the age is 52-81 years, and the average (68.72 +/-11.36) years; the disease course is 1-17 years, and the average (6.51 +/-8.72) years. 27 men and 6 women in the control group; the age is 52-82 years, the average (73.18 +/-9.66) year, the course of disease is 2-22 years, and the average (7.37 +/-8.22) year. The general data comparison of two groups of patients has no statistical significance (P is more than 0.05) and is comparable.

1.2 diagnostic criteria

According to the diagnosis standards of AECOPD in the guidelines for diagnosing and treating chronic obstructive pulmonary disease (revised 2013) of the respiratory disease academic group of the Chinese medical society in Western medicine, the traditional Chinese medicine diagnosis refers to the diagnosis standards of lung distension disease phlegm-heat accumulation lung disease in the traditional Chinese medicine part of the diagnosis and treatment guidelines of common diseases in Chinese medicine of the Chinese medical society.

1.3 inclusion criteria

(1) Meets the above diagnosis and syndrome differentiation standard.

(2) The age is 50-85 years.

(3) Signing the informed consent.

1.4 exclusion criteria

(1) Respiratory failure has occurred and survival times are estimated to be less than 1 year.

(2) Those with hemoptysis or active pulmonary tuberculosis, and those with severe insufficiency of heart, liver and kidney functions.

(3) Women in gestation period.

(4) Other drug clinical tests are added within nearly 3 months, and effect index observers of the research are affected.

(5) Mental disorder, etc.

(6) Suspected alcohol, drug abuse history, or other history that, according to investigator judgment, has reduced or complicated enrollment, such as frequent changes in working environment, is prone to missed visits.

2 method

2.1 methods of treatment

Both groups are treated by western medicine, including antibiotics (levofloxacin injection 0.5g each time, 1 time per day, intravenous drip), glucocorticoid (methylprednisolone 40mg, 1 time per day, intravenous drip), bronchodilator (doxofylline 0.2g, 1 time per day, intravenous drip), etc. The treatment group takes the decoction of the traditional Chinese medicine composition in the embodiment 1 on the basis of the comprehensive treatment of western medicine, and the prescription is as follows: 9g of raw ephedra herb, 12g of cassia twig, 9g of gentian, 6g of asarum, 9g of dried ginger, 30g of raw astragalus, 12g of radix rehmanniae, 12g of fried scutellaria baicalensis, 30g of dandelion, 30g of Chinese violet, 12g of chebula meat, 12g of ginger processed pinellia tuber and 6g of raw liquorice. The preparation is administered orally in 2 times per dose. The control group takes the heat-clearing and phlegm-eliminating prescription recommended in Chinese medical diagnosis and treatment guidelines for chronic obstructive pulmonary disease (2011 edition) on the basis of western medicine treatment, namely: 12g of cortex mori radicis, 9g of scutellaria baicalensis, 9g of bitter almond, 15g of fructus trichosanthis, 9g of ginger processed pinellia tuber, 9g of thunberg fritillary bulb, 9g of cape jasmine fruit, 12g of Chinese pulsatilla root, 18g of houttuynia cordata, 12g of radix ophiopogonis and 9g of dried orange peel. The preparation is administered orally in 2 times per dose. The above two groups are treated for 7 days.

2.2 Observation indicators and methods

The following indices were observed before and after 7 days of treatment, respectively.

2.2.1 Chinese medicine syndrome integration: the major symptoms and minor symptoms are classified into 4 grades, normal, mild, moderate and severe. The main symptoms comprise cough, wheeze, chest distress and expectoration which are respectively counted as 0 point, 2 points, 4 points and 6 points according to none, light, medium and heavy points; the secondary symptoms comprise fever, chest pain, thirst and constipation, and are respectively counted as 0 point, 1 point, 2 points and 3 points in terms of none, light, medium and heavy points.

2.2.2 clinical efficacy evaluation criteria

And (3) clinical control: the traditional Chinese medicine syndrome integral is reduced by more than or equal to 95 percent after treatment; the effect is shown: the traditional Chinese medicine syndrome integral is reduced by more than or equal to 70 percent and less than 95 percent; the method has the following advantages: the traditional Chinese medicine syndrome integral is reduced by less than 70 percent within 30 percent; and (4) invalidation: the traditional Chinese medicine syndrome integral is reduced by less than 30 percent.

2.2.3 dyspnea score (MMRC score) criteria

0 minute: breathing difficulties are generally not felt unless strenuous exercise; 1 minute: the air is short when the land is in a sharp walk or goes up a slope; and 2, dividing: walking on the flat ground is slower than that of the same-age people due to shortness of breath, or the walking on the flat ground is stopped to gasp when walking at the self pace; and 3, dividing: when the user walks on the flat ground for 100 meters or several minutes, the user can feel breathed; and 4, dividing: obvious shortness of breath, inability to leave the house, and shortness of breath when dressing and undressing.

2.2.4 Scoring Standard for Assistant respiratory muscular movement

0 minute: no significant neck muscle tension or periodic contractions; 1 minute: neck muscles are tense but there is no significant muscle activity; and 2, dividing: slight contraction activity of the neck muscles is visible; and 3, dividing: moderate and periodic contraction of neck muscles without supraclavicular fossa and intercostal invagination; and 4, dividing: the muscle of the neck is strongly and periodically contracted with the invagination of the supraclavicular fossa and the intercostals; and 5, dividing: the neck muscles contract strongly and periodically with paradoxical movements of the abdomen.

2.2.5 blood C-reactive protein (CRP), PCT levels

All patients had peripheral venous blood drawn. Blood CRP is measured by a rate scattering turbidimetry method; blood PCT was measured by ELISA (FACSVerse flow cytometer from BD corporation, usa) and was performed by the clinical laboratory of yueyang chinese and western medicine integrated hospital affiliated to the university of medicine in shanghai and chinese.

2.2.6 days of hospitalization two groups of patients were recorded and compared.

2.3 statistical methods

Processing with SPSS16.0 software. The measured data conforms to normal distribution, two independent samples are adopted for t test when the variances are uniform, and non-parametric test is adopted when the variances do not conform to the normal distribution; the counting data were examined by X2.

3 results

3.1 clinical efficacy comparison of two groups of patients

Treatment group 36, completed visit 33; the control group had 33 cases, and the follow-up was completed 31 cases. The results are shown in table 1, the total effective rate of the treatment group is 96.97%, the total effective rate of the control group is 96.77%, and the comparison difference of the total effective rates of the two groups has no statistical significance (P is more than 0.05).

TABLE 1 comparison of clinical efficacy of two groups of patients [ case (%) ]

Group of	Number of examples	Clinical control	Show effect	Is effective	Invalidation	Total effective
							Treatment group	33	0	6(18.18)	26(78.79)	1(3.03)	32(96.97)
Control group	31	0	3(9.68)	27(87.10)	1(3.22)	30(96.77)

3.2 integral comparison of Chinese medicine syndrome of two groups of patients

As shown in Table 2, the difference between the total integrals of the syndrome in TCM before the treatment of the two groups has no statistical significance (P > 0.05). The total integral of the traditional Chinese medicine symptoms is obviously reduced (P is less than 0.01) compared with the total integral of the traditional Chinese medicine symptoms before the treatment of the two groups; the difference of the total integrals of the traditional Chinese medicine symptoms in the two groups after treatment has no statistical significance (P is more than 0.05).

TABLE 2 integral comparison of Chinese medicine symptoms (score, x + -s) of two groups of AECOPD patients with phlegm-heat obstructing lung syndrome

Group of	Number of examples	Before treatment	After treatment
				Treatment group	28	12.26±3.77	5.62±2.41*
Control group	27	12.85±3.51	6.58±2.72*

Note: p < 0.01 compared to the group before treatment

The single Chinese medicine syndrome integrals before and after the two groups of treatments are counted, and the differences are compared with the single Chinese medicine syndrome integrals before and after the two groups of treatments, and have no statistical significance (P is more than 0.05). After the traditional Chinese medicine syndrome integration treatment, the syndrome integration of the treatment group is obviously reduced (P is less than 0.05) compared with that before the treatment, the syndrome integration of the wheezing of the treatment group is obviously reduced (P is less than 0.05) compared with that of the control group, and the difference is not statistically significant (P is more than 0.05) when the other traditional Chinese medicine syndrome integration groups are compared.

3.3 comparison of MMRC and auxiliary respiratory muscle movement scores of two groups of patients

As shown in Table 3, the comparison of the MMRC and auxiliary respiratory muscle movement score before treatment in the two groups has no statistical significance (P is more than 0.05); after treatment, the MMRC score of the two groups and the auxiliary respiratory muscle movement score are obviously improved compared with the MMRC score of the group before treatment (P is less than 0.01), and the MMRC score of the treatment group is better than that of the control group (P is less than 0.01).

TABLE 3 comparison of MMRC, respiratory muscle tone score (points, x + -s) for two groups of patients

Note: p < 0.01 compared to the group before treatment; compared with the control group after treatment, the delta P is less than 0.01

3.4 comparison of blood CRP and PCT levels in two groups of patients

As shown in Table 4, the comparison of the blood CRP and PCT levels in the two groups of patients before treatment was not statistically significant (P > 0.05). The blood CRP and PCT levels were significantly reduced after treatment in the treatment group (P < 0.05), and only PCT was reduced after treatment in the control group (P < 0.05). Comparison of differences between the blood CRP and PCT levels in the two groups after treatment was not statistically significant (P > 0.05).

TABLE 4 comparison of CRP and PCT levels (x. + -. s) for two groups of patients

Note: p < 0.01 compared to the group before treatment

3.5 comparison of days of hospitalization in two groups of patients

The average hospitalization (11.27 + -2.56 days) in the treatment group was significantly lower than that in the control group (13.85 + -5.42 days) (P < 0.05).

4 conclusion

The traditional Chinese medicine composition has an obvious curative effect on treating the chronic obstructive pulmonary disease by combining with western medicines, and compared with a control group heat-clearing and phlegm-eliminating formula, the traditional Chinese medicine composition can better relieve the asthma and the traditional Chinese medicine symptoms of a patient, improve the MMRC score and shorten the hospitalization days of the patient. The blood CRP and PCT levels of AECOPD patients are important indicators reflecting the therapeutic efficacy of AECOPD bacterial infection judgment and the rational use of antibiotics. The traditional Chinese medicine composition disclosed by the invention can be combined with conventional western medicine treatment AECOPD to reduce the blood CRP and PCT levels of patients, and is helpful for AECOPD bacterial infection control; and can improve the score for assisting the respiration muscle of the patient and reduce the work of the respiration muscle.

Effect example 2

1. Materials and methods

1.1 materials

Human bronchial epithelial cells 16HBE were purchased from Kilton Biotechnology (Shanghai) Co., Ltd., DMEM culture solution was purchased from Hyclone Co., fetal bovine serum was purchased from Gibco Co., USA, LPS was purchased from Sigma Co., USA, CCK-8(cell counting kit-8) reagent was purchased from SAB Co., BCA protein quantification kit was purchased from thermo Co., USA, primary antibody was purchased from abcam, and secondary antibody was purchased from Byunnan Co., Ltd.

1.2 cell culture

The 16HBE cells are cultured in 1640 culture medium containing 10% fetal calf serum and 1% double antibody (streptomycin qing mixed solution) at 37 deg.C and 5% CO₂The culture box is used for culturing, and cells are observed to be adherent cells under a microscope.

1.3LPS Induction

Groups were divided into 0, 0.5, 1, 6, 12 and 24h based on the length of stimulation of 16HBE cells by LPS, wherein 0h group had no LPS stimulation and was treated with the same volume of phosphate buffer only, and the concentration of LPS stimulation was 1mg/L for the remaining groups. After the stimulation is finished, cell lysis supernatant is collected respectively, the relative expression quantity of MUC5AC protein and SOCSl protein is measured, the expression level of MUC5AC and SOCSl in each group is observed, and the stimulation duration of the subsequent experiment is determined.

1.4 pharmaceutical preparation

The traditional Chinese medicine composition in the embodiment 1 is prepared into the concentration which is equivalent to the total medicine concentration of 8.1g/ml and the medicine concentration which acts on cells of 0.081g/L (namely 0.001%), 0.405g/L (namely 0.005%) and 0.81g/L (namely 0.01%).

1.5 optimal drug concentration

Cells in logarithmic growth phase were trypsinized and counted under microscope to 5X 10⁴Cells per mlAnd (3) suspending. 100. mu.l to 96-well culture plates were individually prepared, and each plate of each group of cells was inoculated with 3 identical wells as multiple wells, 5X 10³Cells/well were blanked with 100. mu.l of culture medium and incubated overnight at 37 ℃. Eight groups are provided per board. Blank group: adding 1640 complete culture medium without medicine; the traditional Chinese medicine comprises: adding 1640 complete culture medium containing 0.001%, 0.005%, and 0.01% of Chinese medicinal materials respectively; LPS group: adding 1640 complete medium containing 1mg/L LPS; LPS + traditional Chinese medicine group: adding 1640 complete culture medium containing 1mg/L LPS + 0.001% of traditional Chinese medicine, 1mg/L LPS + 0.005% of traditional Chinese medicine, and 1mg/L LPS + 0.01% of traditional Chinese medicine respectively. Cell Counting Kit-8(CCK-8) and serum-free essential minimal medium were mixed at a volume ratio of 1:10 for 0h, 24h, 48h, and 72h after administration, respectively, 100. mu.L per well was added to the well to be tested, and 5% CO was added at 37 ℃ to₂Incubate in incubator for 1 h. The absorbance at the wavelength of 450nm was measured by a microplate reader. The values for each plate were recorded.

1.6 Experimental groups

The cells were removed from the incubator and the set up according to the experimental purpose were as follows: control group: without LPS stimulation, only the same volume of phosphate buffer treatment was given; high mucus expression panel (LPS): the stimulation concentration of only LPS is 1mg/L, and the action time is 6 h; chinese medicine preparation: adding 1mg/L LPS to stimulate for 6 hr, and treating 16HBE cells with 0.005% Chinese medicinal material for 48 hr. The relative expression quantity of MUC5AC protein and SOCS1 protein after the traditional Chinese medicine and the LPS act is measured, and the expression level of MUC5AC and SOCS1 in each group is observed.

1.7Western blotting method for detecting relative expression quantity of SOCSl and MUC5AC proteins in cell lysate

Conventionally extracting cell lysate, detecting by a bis-quinoline methyl method, adjusting the concentration of each histone, performing electrophoresis by sodium dodecyl sulfate polyacrylamide gel, transferring a polyvinylidene fluoride membrane to the membrane, sealing 5% skim milk at room temperature for 1h, incubating the corresponding primary antibody at 4 ℃ overnight, incubating a horseradish peroxidase-labeled secondary antibody at 37 ℃ for 1h, developing by a sensitization chemiluminescence method for 5min, performing luminescence development, and comparing with internal reference GAPDH. And (4) placing the target protein into an imaging system for scanning, and expressing the relative expression quantity of the target protein by using the gray scale ratio of the target band to the internal reference band.

1.8 statistical treatment

Statistical analysis was performed using SPSS 19.0 software. All experiments were repeated 3 times with normally distributed data to

Showing that the difference between groups is compared by t test and the difference between groups is compared by one-way anova with P<A difference of 0.05 is statistically significant.

2 results

The results show that: the traditional Chinese medicine solution in the culture medium has the effect of inhibiting the growth of 16HBE when the concentration is high, the traditional Chinese medicine solution has the best effect on the cell treatment after stimulation of LPS when the concentration is 0.005%, the action concentration of the subsequent experimental medicine is selected to be 0.005%, and the action time is 48 hours. LPS can stimulate 16HBE cells to express MUC5AC, and inhibit the expression of SOCS 1; the traditional Chinese medicine treatment can inhibit MUC5AC expression induced by LPS (P is less than 0.01), reduce relative expression quantity by 0.1522 +/-0.0049, promote expression of SOCS1 (P is less than 0.01) after the action of LPS, and increase relative expression quantity by 0.1186 +/-0.0041. The traditional Chinese medicine composition can inhibit lipopolysaccharide-induced airway mucin MUC5AC expression, and the action mechanism of the traditional Chinese medicine composition is probably related to SOCS 1.

Effect example 3

1. Rat airway mucus hypersecretion model

Healthy male Wistar rats, neutrophil elastase, were made up to 100U/ml in 0.9% physiological saline, administered first by ultrasound nebulization at a dose of 10U/g and at a rate of 0.2ml/min, and later administered at the same rate at a dose of 1U/g daily for 3 consecutive weeks 1 time a day.

2. Grouping and processing

After the molding is successful, the random number table method is adopted to randomly divide the materials into the following groups: (1) normal control group, normal rats not stimulated with NE; (2) model group, NE-stimulated rats, without any treatment, given saline only; (3) the traditional Chinese medicine group comprises: after NE stimulation, the traditional Chinese medicine decoction (9 parts of raw ephedra herb, 12 parts of cassia twig, 9 parts of gentian, 6 parts of asarum, 9 parts of dried ginger, 30 parts of raw astragalus root, 12 parts of dried rehmannia root, 12 parts of fried scutellaria root, 30 parts of dandelion, 30 parts of Chinese violet, 12 parts of lithospermum, 12 parts of ginger processed pinellia tuber and 6 parts of raw liquorice) is given, the dose is 20 mg/kg.d, and the medicine is administrated by gastric perfusion for 3 times a day. (4) Two groups of traditional Chinese medicines are adopted: after NE stimulation, the traditional Chinese medicine decoction (9 parts of raw ephedra herb, 12 parts of cassia twig, 9 parts of gentian, 6 parts of asarum, 9 parts of dried ginger, 30 parts of raw astragalus, 12 parts of dried rehmannia root, 12 parts of fried scutellaria baicalensis, 12 parts of ginger processed pinellia tuber and 6 parts of raw liquorice) is given, the dosage is 20 mg/kg.d, and the stomach is filled for administration, 3 times a day. (3) Three groups of traditional Chinese medicines: after NE stimulation, the traditional Chinese medicine decoction (15 parts of raw ephedra herb, 15 parts of cassia twig, 15 parts of gentian, 12 parts of asarum, 15 parts of dried ginger, 15 parts of raw astragalus root, 15 parts of dried rehmannia root, 12 parts of fried scutellaria root, 12 parts of dandelion, 12 parts of Chinese violet, 20 parts of myrobalan, 20 parts of pinellia tuber and 6 parts of raw liquorice) is given, the dose is 20 mg/kg.d, and the stomach filling administration is carried out for 3 times a day.

ELISA detection of MUC5AC content in bronchoalveolar lavage fluid

After abdominal anesthesia, the neck of each group of rats is cut open and inserted into a tracheal catheter, 10ml of calcium-magnesium-free Hanks liquid is used for lavage twice at 4 ℃, BALF is recovered to be not less than 5ml, and the rat is centrifuged at 1000r/min for 10 min. Taking 0.1ml of BALF supernatant to coat an enzyme label plate, standing overnight at 4 ℃, sealing with PBS containing 1% bovine serum albumin and 0.05% Tween20 at room temperature for 1h, incubating for 1h at 37 ℃ with 1:500 diluted anti-rat airway MUC monoclonal antibody RTE 11100. mu.l, incubating for 1h at 37 ℃ with 1:1000 diluted horseradish peroxidase to mark 100. mu.l of goat anti-mouse IgG, incubating for 1h at 37 ℃, incubating for 100. mu.l of substrate solution, developing for 15min at 37 ℃, and stopping reaction. The optical density value was measured at 492nm as the relative value of MUC content.

4. Results

NE treatment induces the increase of the synthesis of airway mucin of rats, and the content of MUC5AC in the tracheal alveolar lavage fluid is reduced after Chinese medicament treatment. The data in the table show: the traditional Chinese medicine composition can inhibit NE-induced airway mucin MUC5AC expression, and a group of traditional Chinese medicines have optimal effects.

TABLE 5 influence of different Chinese medicinal groups on the MUC5AC content in bronchoalveolar lavage fluid

Group of	MUC5AC
		Control group	0.28±0.09
Model set	0.96±0.21*
		Chinese medicine group	0.37±0.10△
Two groups of traditional Chinese medicines	0.86±0.26
		Three groups of traditional Chinese medicines	0.81±0.35

Note: p <0.05 compared to control and P <0.05 compared to model.

The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.

Claims

1. The traditional Chinese medicine composition for treating airway mucus hypersecretion is characterized by being prepared from the following raw material medicines in parts by weight: 9 parts of raw ephedra, 12 parts of cassia twig, 9 parts of gentian, 6 parts of asarum, 9 parts of dried ginger, 30 parts of raw astragalus, 12 parts of radix rehmanniae, 12 parts of fried scutellaria baicalensis, 30 parts of dandelion, 30 parts of Chinese violet, 12 parts of chebula meat, 12 parts of ginger processed pinellia and 6 parts of raw liquorice.

2. The traditional Chinese medicine composition of claim 1, which is prepared into a clinically acceptable pharmaceutical preparation according to a conventional traditional Chinese medicine preparation method.

3. The traditional Chinese medicine composition of claim 2, wherein the pharmaceutical preparation is a granule, powder, capsule, tablet or oral liquid.

4. Use of the Chinese medicinal composition of claim 1 in the preparation of a medicament for treating airway mucus hypersecretion.

5. The use of the Chinese medicinal composition of claim 1 in the preparation of a medicament for treating phlegm-heat obstructing lung syndrome in acute exacerbation of chronic obstructive pulmonary disease.