Traditional Chinese medicine composition for treating acute tracheobronchitis and preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating acute tracheobronchitis, which is prepared from the following raw materials in parts by weight: 9-15 parts of semen lepidii, 9-15 parts of honey-fried radix asteris, 9-15 parts of fried fructus perillae, 9-12 parts of radix peucedani, 9-12 parts of cynanchum glaucescens, 9-15 parts of bulbus fritillariae thunbergii, 9-15 parts of folium eriobotryae and 15-30 parts of rhizoma phragmitis. By scientific compatibility of the traditional Chinese medicine raw materials, clinical symptoms of patients with acute tracheobronchitis can be effectively relieved, the cough and expectoration times of the patients are reduced, and the duration time of the cough and expectoration symptoms is shortened. The traditional Chinese medicine composition is free of toxic and side effects, and has the advantages of being good in curative effect, fast in effect taking, strong in medicine effect, not prone to relapse and the like in the aspect of treating acute tracheobronchitis.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition for treating acute tracheobronchitis, and a preparation method and application thereof. Background Art

[0002] Acute tracheobronchitis is an acute inflammation of the tracheobronchial mucosa caused by biological or non-biological factors and is a type of acute respiratory infection. The disease often occurs in cold seasons or during climate change, is often caused by direct viral infection, and is a common reason for patients to visit respiratory outpatient clinics. The main symptom of acute tracheobronchitis is cough, which may be accompanied by sputum. In the early stages, symptoms of upper respiratory tract infection such as nasal congestion, runny nose, sore throat, and hoarseness are common. Systemic symptoms such as fever, chills, headache, muscle aches, and fatigue are generally mild. The lesions of acute tracheobronchitis are generally limited to the trachea and bronchi. In severe cases, they can spread to the bronchioles and alveoli, causing vascular necrosis and hemorrhage. Acute tracheobronchitis has a high incidence rate and affects the patient's quality of life. If not treated promptly, it may further develop into pneumonia or chronic bronchitis.

[0003] Acute tracheobronchitis falls under the category of "cough" in Traditional Chinese Medicine (TCM). According to TCM, cough is a lung disease characterized by the lungs failing to clear and control their qi, leading to an upward flow of lung qi, forcing the glottis to produce a cough or expectoration. The lungs are a delicate organ, externally connected to the skin and fur, and internally serving as the umbrella for the five internal organs. They control qi and respiration, making them susceptible to invasion by internal and external pathogenic qi, making them the key to the development of cough. The causes of cough are always linked to the lungs, but are also related to external pathogenic factors and visceral dysfunction. The causes of acute tracheobronchitis can be divided into external and internal factors. External factors are often caused by the six exogenous pathogens, while internal factors are often related to phlegm and fluid retention. Among the syndromes of acute tracheobronchitis, a combination of wind-heat, phlegm-heat, and wind-cold is the most common, with the disease often located on the surface of the lungs. Clinical treatment often focuses on promoting lung function, dispelling pathogenic factors, clearing heat, resolving phlegm, and relieving cough.

[0004] Clinical treatment for acute tracheobronchitis often focuses on symptomatic treatment. Currently, Western medicine primarily uses antitussive, expectorant, anti-infective, and bronchodilator medications. While these antitussive and expectorant medications can achieve some clinical efficacy, they carry the risk of various adverse reactions. Furthermore, these medications often have only short-term efficacy, but are ineffective with long-term use and may even increase the risk of disease exacerbation. Therefore, developing an effective treatment for acute tracheobronchitis is crucial. Summary of the Invention

[0005] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating acute tracheobronchitis, a preparation method and application thereof, so as to achieve effective treatment of acute tracheobronchitis.

[0006] To this end, the present invention provides the following technical solutions.

[0007] The first aspect of the present invention provides a traditional Chinese medicine composition for treating acute tracheobronchitis. The raw materials for preparing the traditional Chinese medicine composition include, by weight, 9-15 parts of scutellaria baicalensis seeds, 9-15 parts of honey aster, 9-15 parts of stir-fried perilla seeds, 9-12 parts of peucedanum peucedanum, 9-12 parts of white scutellaria baicalensis, 9-15 parts of thunbergia thunbergii, 9-15 parts of loquat leaves, and 15-30 parts of reed rhizome.

[0008] As a preferred embodiment of the present invention, the raw materials for preparing the traditional Chinese medicine composition include, by weight: 15 parts of scutellaria baicalensis seeds, 15 parts of honey aster, 15 parts of stir-fried perilla seeds, 12 parts of peucedanum chinense, 12 parts of white scutellaria baicalensis, 15 parts of thunbergia thunbergii, 15 parts of loquat leaves, and 30 parts of reed rhizome.

[0009] The second aspect of the present invention provides a medicine for treating acute tracheobronchitis, comprising the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0010] As a preferred embodiment of the present invention, the auxiliary material is selected from one or more of fillers, emulsifiers, disintegrants, lubricants, suspending agents, adhesives, sweeteners, flavoring agents, preservatives, and bases.

[0011] As a preferred embodiment of the present invention, the dosage form of the drug is a decoction, suspension, syrup, mixture, tincture, ointment, granule, pill, powder, tablet, capsule, drop, inhalant or injection.

[0012] As a preferred embodiment of the present invention, the preparation method of the decoction is:

[0013] S1: taking each raw material according to weight, soaking it in water to obtain a mixture;

[0014] S2: boiling the obtained mixture for the first time, and then filtering it to obtain a first medicinal liquid and a first filter residue;

[0015] S3: adding water to the obtained first filter residue for a second decoction, and then filtering to obtain a second medicinal solution and a second filter residue;

[0016] S4: combining the first medicinal liquid and the second medicinal liquid to obtain the decoction.

[0017] As a preferred embodiment of the present invention, in step S1,

[0018] The amount of water added is 4 to 6 times the total mass of the raw materials;

[0019] The soaking time is 15 to 20 minutes.

[0020] As a preferred embodiment of the present invention, in step S2, the first decoction method is: first use high heat 220-230° C. to boil, and then use low heat 160-170° C. to continue boiling for 20-25 minutes.

[0021] As a preferred embodiment of the present invention, in step S3,

[0022] The amount of water added should be 2 to 3 cm above the medicine surface;

[0023] The second decoction method is: first use high heat 220-230° C. to boil, and then use low heat 160-170° C. to continue boiling for 10-15 minutes.

[0024] The third aspect of the present invention provides a use of the aforementioned traditional Chinese medicine composition or medicine in the preparation of a medicine for treating acute tracheobronchitis.

[0025] Usage and dosage: Taking the decoction prepared by the above method as an example, take twice a day, 200 ml each time.

[0026] Explanation of the prescription: The present invention uses scutellaria baicalensis seeds, honey aster, and stir-fried perilla seeds as the main medicines; uses peucedanum chinense and white scutellaria baicalensis as the auxiliary medicines; uses fritillaria thunbergii and loquat leaves as the adjuvant medicines; and uses reed root as the guiding medicine.

[0027] monarch drug

[0028] Tenglizi: Pungent, bitter, and extremely cold, it enters the lung and bladder meridians and can purge the lungs and relieve asthma. The "Compendium of Materia Medica" states, "Tenglizi is a main herb for the hand Taiyin meridian, hence the use of it in Zhang Zhongjing's Xiefei Decoction... its pungent properties can disperse, its bitter properties can purge, and its extremely cold properties can sink yin and expel water... It is an essential herb for treating swelling and fullness." Xu Dachun's "Shennong Bencao Jing Baizhonglu" states, "Tenglizi is smooth and fragrant, specifically designed to purge lung qi. The lungs are like a source of water, so to purge the lungs is to purge water. This herb is the primary treatment for any accumulation of cold or heat arising from water vapor." This herb can be used for a variety of lung diseases, relieving lung qi congestion and relieving asthma and fullness.

[0029] Honey Aster: Pungent, bitter, and warm, it enters the Lung Meridian, moistening the lungs and descending Qi, dissipating phlegm and relieving coughs. Changsha Yaojie states: "It tastes bitter and pungent, and enters the hand Taiyin Lung Meridian. It descends Qi and relieves coughs, calms dysentery, and stops wheezing." Li Zhongzi's Bencao Tongxuan states: "Aster is pungent without being dry, moistening without being cold, and nourishing without being stagnant." Its pungent properties can enter the lungs, while its bitter properties can descend Qi, dredging lung Qi, clearing congestion, and resolving phlegm. Zhang Lu's Bencao Fengyuan also describes it as a "medicine for the lung metal and blood," able to "relieve cough, reverse qi, chest cold and heat, and qi accumulation, and its properties are to dredge the blood and Qi of the lung meridian." Honey-roasted Aster enhances its lung-moistening and cough-relieving properties, and when combined with scutellaria baicalensis, it can relieve stagnant lung Qi.

[0030] Stir-fried Perilla Seed: Pungent and warm, it enters the Lung Meridian and can lower Qi and resolve phlegm, relieving cough and asthma. This herb is warm and moist in nature, promoting dispersing and dispersing effects, and is effective in relieving lung congestion. The Compendium of Materia Medica states: "Perilla seed is very effective in dispersing Qi, and is particularly effective in clearing the upper and lower Qi, and effectively relieving asthma and phlegm." The pungent and warm nature of perilla seed can promote lung Qi, and stir-frying it can mitigate its pungent and dispersing properties, enhancing its lung-warming and Qi-lowering effects. Perilla seed, with its pungent and warm properties, is effective in lowering lung Qi and resolving phlegm. Tripterygium wilfordii seed, with its bitter, pungent, and extremely cold properties, specifically clears water retention, phlegm, and fire in the lungs, relieving asthma and cough. The combination of these two herbs enhances their Qi-lowering, phlegm-resolving, and asthma-relieving effects, making them suitable for coughs caused by lung heat. Combining Perilla seed with Aster tataricus can enhance its Qi-lowering, cough-relieving, and expectorant effects.

[0031] Minister medicine

[0032] Peucedanum chinense: Bitter, pungent, and slightly cold, it enters the lung meridian and can descend qi and resolve phlegm, dissipate wind and clear heat. Compendium of Materia Medica states that it "is particularly effective in descending qi, and therefore can treat phlegm-heat-induced wheezing, coughing, abdominal distension, vomiting, and other ailments. When qi descends, fire and phlegm also descend, making it a key remedy for phlegm and qi." This herb is often combined with Radix Phellodendri to enhance its qi-descent and phlegm-resolving properties.

[0033] Baiqian: Pungent, bitter, and slightly warm, it enters the lung meridian. It can both descend qi and relieve phlegm and cough, making it a key medicine for treating wheezing and coughing. "Compendium of Materia Medica" states, "Baiqian is a medicine that relieves lung qi and calms wheezing and coughing. It treats wheezing in the throat and is the first-line remedy for coughs. It also relieves fullness and stuffiness in the diaphragm and is a top-grade medicine for descending qi." "Compendium of Materia Medica" also states, "Baiqian is sweet, pungent, and slightly warm, and is a key medicine for descending qi, dispelling wind, and removing phlegm. When qi is full, phlegm accumulates, and phlegm accumulates, causing wind. When wind and phlegm become stuck together, the lungs become restless, leading to wheezing, coughing, shortness of breath, and swelling. If this herb is used to relieve the phlegm and wind evil in the lungs, qi can be easily descended, and cough and cough can be stopped." Baiqian is pungent, pungent, and slightly warm, and is good at descending qi and resolving phlegm. Ziyuan is sweet, moist, and bitter, and is good at moistening the lungs and resolving phlegm. Together, they warm and dispel cold, dampness, and turbid phlegm without damaging the lung's qi and yin. When phlegm is eliminated, the cough subsides.

[0034] adjuvant

[0035] Fritillaria thunbergii: Bitter and cold, it enters the lung and heart meridians, clearing heat, resolving phlegm, and relieving cough. The "Supplement to Compendium of Materia Medica" states that it can "detoxify, eliminate phlegm, and invigorate the lungs. It is suitable for those with lung problems with phlegm and fire." Fritillaria thunbergii has a bitter and cold nature, dissipating heat to resolve phlegm and fire in the lungs, and can also invigorate and promote lung qi, dispersing stagnant lung qi. When combined with loquat leaves, it can enhance the effectiveness of clearing phlegm and fire in the lungs.

[0036] Loquat leaves: bitter, slightly cold, enter the lung and stomach meridians, can clear the lungs and relieve cough, reduce adverse reactions and stop vomiting. The loquat leaves used in this prescription are honey loquat leaves. "Compendium of Materia Medica" records that it is "bitter, pungent and neutral, and is a medicine for the lungs and stomach. It can clear the lungs, reduce fire and eliminate phlegm and cough, and harmonize the stomach, relieve fullness and stop vomiting. For stomach problems, apply ginger juice to it, and for lung diseases, apply honey water to it." "Compendium of Materia Medica" records that "loquat leaves specifically enter the lungs, are bitter and neutral in nature. All books say that they can purge the lungs and cure coughs. The reason for this is that the taste is mostly caused by stomach disharmony and lung disharmony, which leads to fire and phlegm congestion, and thus constant coughing. Danxi said that excess qi is fire, and when fire arises, phlegm is produced. Taking this bitter and neutral taste will clear the lung metal, and the qi will not be able to go up and will go smoothly. When the qi is smooth, phlegm and fire will also go smoothly. Phlegm, qi, and fire are of the same kind, but those who are going up will not go up, those who are vomiting will not vomit, those who are coughing will not cough, and those who are thirsty will not be thirsty. You know that this is an essential medicine for clearing the lungs, treating fire and stopping coughs."

[0037] Enforcer

[0038] Reed root: Sweet and cold, it enters the lung and stomach meridians, clearing heat and purging fire, promoting fluid production and quenching thirst. "Bencao Beiyao" states, "Because reed root is hollow, it enters the heart and lungs, clearing heat from the upper burner, and once heat is relieved, the lung qi is transformed and circulated." This herb can clear excess heat in the lungs and stomach, purging fire to clear lung heat and promoting fluid production to moisten dry lungs. When used in combination with the aforementioned herbs, it can clear lung heat and prevent the damaging effects of bitter and cold herbs on lung fluid.

[0039] Beneficial effects

[0040] The effects of the combination of the components of the present invention far exceed those of a single dose. The traditional Chinese medicine composition of the present invention uses scutellaria baicalensis seeds, honey aster, and stir-fried perilla seeds as the main ingredients; radix pekinensis and radix scutellariae as the auxiliary ingredients; fritillaria thunbergii and loquat leaves as the adjuvant ingredients; and reed rhizome as the guiding ingredient. This results in a traditional Chinese medicine preparation with rapid onset, high cure rate, and low recurrence rates, while also promoting the descending and antitussive effects, clearing the lungs, and removing phlegm.

[0041] By scientifically combining traditional Chinese medicine ingredients, the present invention effectively improves symptoms such as cough and expectoration associated with acute tracheobronchitis, shortens the course of the disease, and improves patient CET scores, cough symptom VAS scores, and other indicators. The traditional Chinese medicine composition of the present invention is non-toxic and has numerous advantages in treating acute tracheobronchitis, including good efficacy, rapid onset of action, strong efficacy, and low recurrence rate.

[0042] The above description is only an overview of the technical solution of the present invention. In order to more clearly understand the technical means of the present invention and implement it according to the contents of the specification, the following is a detailed description of the preferred embodiments of the present invention. DETAILED DESCRIPTION

[0043] In order to make the technical means, creative features, objectives and effects achieved by the present invention easy to understand, the technical solutions of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0044] Unless otherwise specified, the experimental methods used in the following examples are conventional methods.

[0045] Unless otherwise specified, the materials and reagents used in the following examples can be obtained from commercial sources.

[0046] Unless otherwise specified, the high heat described in the following embodiments refers to a temperature between 220 and 230°C, and the low heat refers to a temperature between 160 and 170°C.

[0047] Acute tracheobronchitis can be classified as a "cough". Its main disease site is the lungs, and the syndrome type is mostly a combination of wind-heat, phlegm-heat, and wind-cold. Clinical treatment is often based on promoting lung function and eliminating pathogens, clearing away heat, resolving phlegm, and relieving cough. The Chinese medicine composition for treating acute tracheobronchitis provided by the present invention is mainly aimed at patients with acute tracheobronchitis with phlegm-heat blocking the lungs. The Chinese medicine composition is composed of scutellaria baicalensis seeds, honey aster, stir-fried perilla seeds, peucedanum chinense, white qianqian, thunbergia thunbergii, loquat leaves, and reed rhizome. In the formula, scutellaria baicalensis seeds can purge the lungs and relieve asthma; honey aster moistens the lungs and lowers qi, eliminates phlegm and relieves cough; stir-fried perilla seeds can descend qi and resolve phlegm, relieve cough and relieve asthma. The three are collectively the main medicines. Peucedanum chinense descends qi and resolves phlegm, dispersing wind and clearing heat. Compendium of Materia Medica states that it "excels at descending qi, thus treating phlegm-heat wheezing, coughing, abdominal distension, vomiting, and other ailments. When qi descends, fire and phlegm also descend, thus achieving the effect of promoting renewal and promoting the old, making it a key herb for treating phlegm and qi." Baiqian (Scutellaria baicalensis) descends qi and relieves phlegm and cough, making it a key herb for treating wheezing and cough. These two herbs serve as assistant herbs. Fritillaria thunbergii (Thunbergia thunbergii) is bitter and cold, dissipating heat to resolve phlegm and fire in the lungs, while also promoting lung qi and dispersing stagnant lung qi. Loquat leaves clear the lungs, relieve coughs, and descend adverse reactions to stop vomiting. These two herbs serve as adjuvant herbs. Phragmites australis (Reed root) clears heat and purges fire, promoting fluid production and quenching thirst, clearing excess heat in the lung and stomach qi. It purges fire to clear lung heat and promotes fluid production to moisten dry lungs. Combining these herbs with these herbs can clear lung heat and prevent the bitter and cold herbs from damaging lung fluid, thus serving as a guiding herb. The entire formula works together to achieve the effects of descending heat, relieving cough, and clearing the lungs and removing phlegm.

[0048] Example 1: Preparation of Chinese herbal decoction

[0049] The raw materials of the Chinese medicine composition are as follows: 15g of scutellaria baicalensis seeds, 15g of honey aster, 15g of stir-fried perilla seeds, 12g of peucedanum, 12g of white scutellaria, 15g of thunbergii bulb, 15g of loquat leaves, and 30g of reed rhizome. The Chinese medicine composition is prepared into a decoction by the following method:

[0050] Accurately weigh the above raw materials and put them into a casserole. Add 1000 ml of water to the casserole and soak for 20 minutes to obtain a mixture. The obtained mixture is decocted for the first time, that is: first boil it with high heat, then heat it with low heat for 25 minutes, wait for the temperature to drop slightly, and filter it to obtain a first medicinal liquid and a first filter residue. Add water to the obtained first filter residue until it is 2 to 3 cm above the medicinal surface and decoct it for the second time, that is: first boil it with high heat, then heat it with low heat for 15 minutes, wait for the temperature to drop slightly, and filter it to obtain a second medicinal liquid and a second filter residue. The first medicinal liquid and the second medicinal liquid obtained by the above two decoctions are placed in the same container to obtain a total of about 400 ml of Chinese herbal decoction. Finally, the obtained Chinese herbal decoction is sterilized, filled, sealed, and refrigerated. It should be noted that the above-mentioned Chinese herbal decoction is the daily dosage for one patient. More Chinese herbal decoctions can be prepared in multiple pots and / or multiple times according to the number of patients and the number of days of administration.

[0051] Example 2: Clinical trial evaluation of Chinese herbal decoction

[0052] 1. Source of cases

[0053] The cases selected for this article were all from patients attending the Department of Respiratory Medicine of the Third Affiliated Hospital of Beijing University of Chinese Medicine. They were diagnosed with acute tracheobronchitis according to the following diagnostic criteria and received subsequent clinical treatment. Detailed clinical data related to the clinical treatment were obtained with the patients' written informed consent.

[0054] 2. Diagnostic criteria

[0055] Developed with reference to the "Guidelines for Diagnosis, Treatment and Management of Cough in China" (2024 edition):

[0056] (1) Acute onset, with cough as the main symptom;

[0057] (2) Auscultation can detect coarse breath sounds in both lungs, or rales and wheezing; routine blood tests show no obvious abnormalities, or may reveal an increase in white blood cell count, neutrophil ratio, and CRP level;

[0058] (3) chest imaging examination showed no obvious abnormalities or only thickening of lung markings;

[0059] (4) The diagnosis can be made after excluding cough caused by other diseases such as upper respiratory tract infection, pneumonia, lung abscess, tuberculosis, bronchial asthma, etc.

[0060] 3. Case grouping and treatment plan

[0061] This study adopted a non-randomized controlled study method. According to the patients' treatment wishes, patients who voluntarily chose to take the Chinese herbal decoction of Example 1 were the treatment group, and those who used the Chinese patent medicine Feili Ke mixture were the control group. A total of 61 patients were included, including 31 patients in the treatment group and 30 patients in the control group. The specific treatment plan was:

[0062] Control group: The patients were given the treatment regimen of Feilike Hexie, which was produced by Guizhou Jianxing Pharmaceutical Co., Ltd. with production batch number Z20025136. The patients were asked to take 20 ml orally each time, 3 times a day.

[0063] Treatment group: The patients were given the Chinese herbal decoction of Example 1 of the present invention, i.e. the decoction was taken twice a day, 200 ml each time, and was slightly heated before taking.

[0064] The medication time for both groups was 14 days.

[0065] 4. Efficacy evaluation

[0066] (1) Safety evaluation

[0067] All subjects were monitored before and after treatment for the following indicators: vital signs (blood pressure, respiration, heart rate, pulse); routine urine and stool examinations; blood tests; electrocardiograms; liver and kidney function; adverse events, including dizziness, chest tightness, and abdominal distension. The time of occurrence, severity, frequency, duration, measures taken, and outcomes of adverse events were recorded. Adverse reactions during medication were also monitored. If a severe adverse reaction of grade 3 or above occurred, the medication was immediately discontinued.

[0068] (2) Comprehensive efficacy evaluation

[0069] Main efficacy indicators:

[0070] The comprehensive efficacy of the two treatment regimens was evaluated based on changes in the total score of TCM symptoms before and after treatment. A TCM syndrome score table was developed with reference to the "Guiding Principles for Clinical Research of New Chinese Medicines (Trial Implementation)" (Table 1). Primary symptoms included cough and sputum, with scores ranging from mild to severe: 0, 2, 4, and 6, respectively. Secondary symptoms included fever, dry throat, dry mouth, chest tightness, shortness of breath, and constipation, with scores ranging from mild to severe: 0, 1, 2, and 3, respectively. The sum of the primary and secondary symptom scores was the TCM syndrome score. Patients were assessed before treatment and on the 7th and 14th days of treatment. The efficacy index was calculated using the nimodipine method: efficacy index = (pre-treatment score - post-treatment score) / pre-treatment score × 100%. Cured: Clinical symptoms in TCM have essentially disappeared or completely disappeared, with an efficacy index ≥ 95%; Markedly effective: Clinical symptoms in TCM have been significantly alleviated, with an efficacy index of 70% or less and less than 95%; Effective: Clinical symptoms have improved somewhat, with an efficacy index of 30% or less and less than 70%; Ineffective: Clinical symptoms in TCM have not significantly improved or may even have worsened, with an efficacy index of less than 30%. Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%.

[0071] Table 1 Traditional Chinese Medicine Syndrome Scale

[0072]

[0073] Secondary efficacy indicators:

[0074] a. Simple cough severity score (CET):

[0075] Patients were scored using the Simple Cough Extent Scale (CET) before and after treatment, as described in the "Guidelines for Primary Diagnosis, Treatment, and Management of Cough in China" (2024 edition). As shown in Table 2, this scale assesses cough severity during the day, the impact of nighttime cough on sleep, cough severity, and the impact of cough on daily life and psychology. Scores are assigned from mild to severe, with higher scores indicating more severe cough. Assessments were performed before treatment and on the 7th and 14th days of treatment.

[0076] Table 2 Cough Efficiency Scale (CET) Please read the following questions and tick the corresponding boxes according to your current coughing condition.

[0077]

[0078] Note: a Daytime refers to the period from waking up in the morning to going to bed

[0079] b. Visual Analogue Scale (VAS) for cough severity:

[0080] Patients were asked to rate their cough severity on a linear scale of 0-10 (see Table 3). Higher numbers indicate more severe coughs. Assessments were performed before treatment and on the 7th and 14th days of treatment.

[0081] Table 3 Visual Assessor of Cough (VAS) Please rate the severity of your cough based on the color depth:

[0082]

[0083] c. Time for cough and sputum symptoms to be relieved:

[0084] Relief of cough symptoms was defined as a decrease in the VAS score after medication compared with the previous day, and relief of sputum symptoms was defined as a decrease in the sputum symptom score by at least 1 level (e.g., a decrease in the sputum symptom score from 4 to 2 points).

[0085] d. Time for cough and sputum symptoms to disappear:

[0086] The disappearance of cough symptoms was defined as a VAS score ≤ 1; the disappearance of sputum symptoms was defined as a sputum symptom score of 0.

[0087] e. Cough and sputum symptom disappearance rate:

[0088] The complete relief rates of cough and sputum in the two groups were calculated on the 7th and 14th days of treatment respectively.

[0089] 5. Statistical methods

[0090] The collected data were organized and a database was established using Excel tables. SPSS 25.0 statistical software was used for data analysis. The measurement data were in accordance with the normal distribution and were expressed as mean ± standard deviation. Description, if it does not conform to the normal distribution, use the median and quartiles [M(P 25 ,P 75 )]; enumeration data are expressed as frequency and / or percentage. Continuous data were analyzed using the t-test or rank-sum test, and enumeration data were analyzed using the chi-square test or Fisher's exact test. All statistical tests were two-sided, with a P value of < 0.05.

[0091] 6. Clinical trial results

[0092] (1) Safety evaluation

[0093] According to the monitoring and examination results, during the period of patients taking the medicine, there were no obvious abnormalities in the vital signs, routine urine and stool examinations, blood routine, electrocardiogram, liver and kidney function of all patients before, during and after treatment.

[0094] (2) Comprehensive efficacy evaluation

[0095] Main efficacy:

[0096] a. TCM syndrome score

[0097] The statistical results of TCM syndrome scores are shown in Table 4.

[0098] Table 4 Comparison of TCM syndrome scores between the two groups of patients (points)

[0099]

[0100] Note: a) indicates comparison between groups at the same stage, P < 0.05; b) indicates comparison with the previous stage of the same group, P < 0.05.

[0101] As shown in Table 4, before treatment, the TCM syndrome score of the treatment group was 10 (8, 11) points, and the TCM syndrome score of the control group was 9 (8, 10). The Mann-Whitney rank sum test showed that there was no statistically significant difference in the TCM syndrome score between the two groups before treatment (Z = -1.408, P = 0.159). The TCM syndrome score of the treatment group was 0 (0, 3) points after 7 days of medication, and the TCM syndrome score of the control group was 4 (1.75, 5) points after 7 days of medication. The Mann-Whitney rank sum test showed that there was a statistically significant difference in the TCM syndrome score between the two groups after 7 days of medication (Z = -3.404, P < 0.01). The Wilcoxon rank sum test showed that the TCM syndrome scores of both groups were lower after 7 days of medication than before treatment (Z = -4.884, P < 0.01 for the treatment group; Z = -4.802, P < 0.01 for the control group). The TCM syndrome scores of the treatment group and the control group were 0 (0, 0) points at 14 days of medication. The Mann-Whitney rank sum test was used for inter-group comparison, and no statistically significant difference was found in the TCM syndrome scores between the two groups at 14 days of medication (Z = -1.059, P = 0.29). The Wilcoxon rank sum test was used for intra-group comparison, and the TCM syndrome scores of the two groups at 14 days of medication were lower than those at 7 days of medication (Z = -3.205, P < 0.01 for the treatment group; Z = -4.309, P < 0.01 for the control group).

[0102] b. TCM syndrome efficacy

[0103] The statistical results of TCM syndrome efficacy are shown in Table 5.

[0104] Table 5 Comparison of TCM syndrome efficacy between the two groups of patients (cases)

[0105]

[0106] As shown in Table 5, after 7 days of medication, 18 cases in the treatment group were cured, 10 cases were significantly effective, 3 cases were effective, and 0 cases were ineffective; while 5 cases in the control group were cured, 8 cases were significantly effective, 15 cases were effective, and 2 cases were ineffective. The difference in the efficacy of TCM syndromes between the two groups was statistically significant (Z = -4.094, P < 0.01). After 14 days of medication, 30 cases in the treatment group were cured, 1 case was significantly effective, 0 cases were effective, and 0 cases were ineffective. After 27 cases in the control group were cured, 2 cases were significantly effective, 0 cases were effective, and 1 case was ineffective. There was no statistically significant difference in the efficacy of TCM syndromes between the two groups (Z = -1.076, P = 0.294).

[0107] Secondary efficacy:

[0108] a. Comparison of simple cough severity scores between the two groups

[0109] The simple cough severity scores of the two groups of patients are shown in Table 6.

[0110] Table 6 Comparison of simple cough severity scores between the two groups of patients (points)

[0111]

[0112] Note: a) indicates comparison between groups at the same stage, P < 0.05; b) indicates comparison with the previous stage of the same group, P < 0.05.

[0113] As shown in Table 6, the CET score before treatment was 15.42±2.63 in the treatment group and 15.57±2.36 in the control group. Using an independent sample t-test, no statistically significant difference in the CET scores between the two groups was observed (t=-0.23, P=0.819). The CET score after 7 days of treatment was 5 (5, 8) in the treatment group and 11 (5, 12.25) in the control group. The Mann-Whitney rank sum test showed a statistically significant difference in the CET scores between the two groups after 7 days of treatment (Z=-3.213, P<0.01). Using the Wilcoxon rank sum test, the CET scores in both groups decreased after 7 days of treatment compared with those before treatment (Z=-4.868, P<0.01 in the treatment group and Z=-4.789, P<0.01 in the control group). The CET score was 5 (5, 5) in the treatment group and 5 (5, 5) in the control group on day 14. The Mann-Whitney rank sum test was used for intergroup comparison, and no statistically significant difference was found between the two groups on day 14 (Z = -0.655, P = 0.513). The Wilcoxon rank sum test was used for intragroup comparison, and the CET score was significantly lower in both groups on day 14 than on day 7 (Z = -3.195, P < 0.01 for the treatment group and Z = -4.117, P < 0.01 for the control group).

[0114] b. Comparison of visual analogue scale scores of cough severity between the two groups

[0115] The visual analogue scale scores of cough severity in the two groups of patients are shown in Table 7.

[0116] Table 7 Comparison of visual analogue scale scores of cough severity between the two groups of patients (points)

[0117]

[0118]

[0119] Note: a) indicates comparison between groups at the same stage, P < 0.05; b) indicates comparison with the previous stage of the same group, P < 0.05.

[0120] As shown in Table 7, the VAS score before treatment was 7 (6, 8) in the treatment group and 6.5 (6, 7) in the control group. The Mann-Whitney rank sum test showed no statistically significant difference in the VAS scores between the two groups (Z = -1.677, P = 0.094). The VAS score after 7 days of treatment was 0 (0, 3) in the treatment group and 4 (0, 5) in the control group. The Mann-Whitney rank sum test showed a statistically significant difference in the VAS scores after 7 days of treatment between the two groups (Z = -2.802, P < 0.01). The Wilcoxon rank sum test showed that the VAS scores after 7 days of treatment were significantly lower in both groups compared with those before treatment (Z = -4.885, P < 0.01 for the treatment group and Z = -4.811, P < 0.01 for the control group). The VAS score was 0 (0, 0) in the treatment group and 0 (0, 0) in the control group on day 14. The Mann-Whitney rank sum test was used for inter-group comparison, and no statistically significant difference was found between the two groups on day 14 (Z = -0.635, P = 0.525). The Wilcoxon rank sum test was used for intra-group comparison, and the VAS score was significantly lower in both groups on day 14 than on day 7 (Z = -3.220, P < 0.01 in the treatment group and Z = -4.047, P < 0.01 in the control group).

[0121] c. Comparison of cough and sputum symptom relief time between the two groups of patients

[0122] The time of relief of cough and sputum symptoms in the two groups of patients are shown in Tables 8 and 9.

[0123] Table 8 Cough relief time of patients in the two groups (days)

[0124]

[0125] Table 9 Time for expectoration relief in two groups of patients (days)

[0126]

[0127] As shown in the results of Tables 8 and 9, the duration of cough relief in the treatment group was 2 (1, 2) days, while the duration of cough relief in the control group was 2.5 (2, 3) days. Using the Mann-Whitney rank sum test, the difference in cough relief time between the two groups was statistically significant (Z = -3.176, P < 0.01). The duration of expectoration relief in the treatment group was 3 (3, 5) days, while the duration of expectoration relief in the control group was 5 (3, 6) days. Using the Mann-Whitney rank sum test, the difference in expectoration relief time between the two groups was statistically significant (Z = -2.738, P < 0.01).

[0128] d. Comparison of the time of disappearance of cough and sputum symptoms between the two groups of patients

[0129] The statistics of the time for disappearance of cough and sputum symptoms in the two groups of patients are shown in Tables 10 and 11.

[0130] Table 10 Time for cough to disappear in two groups of patients (days)

[0131]

[0132] Table 11 Time for sputum to disappear in two groups of patients (days)

[0133]

[0134] As shown in Tables 10 and 11, the cough disappeared in 7.06±2.50 days in the treatment group and 8.60±3.18 days in the control group. Using the independent sample t-test, the difference in cough disappearance time between the two groups was statistically significant (t=-2.1, P=0.04). The sputum disappearance time in the treatment group was 5 (3, 6) days, while the sputum disappearance time in the control group was 5 (3.75, 7) days. Using the Mann-Whitney rank sum test, there was no statistically significant difference in sputum disappearance time between the two groups (Z=-1.113, P=0.266).

[0135] e. Comparison of the disappearance rate of cough and sputum symptoms between the two groups of patients

[0136] The statistics of the disappearance rates of cough and sputum symptoms in the two groups of patients are shown in Tables 12 and 13.

[0137] Table 12 Comparison of the disappearance rate of cough and sputum in the two groups of patients after 7 days of medication (cases)

[0138]

[0139] Table 13 Comparison of the disappearance rate of cough and sputum in the two groups of patients after 14 days of medication (cases)

[0140]

[0141] As shown in Table 12, 18 patients in the treatment group had their cough symptoms resolved after 7 days of medication, while 13 had their cough symptoms persist. In the control group, 8 patients had their cough symptoms resolved after 7 days of medication, while 22 had their cough symptoms persist. Using a chi-square test, the difference in cough resolution between the two groups was statistically significant (chi-square value = 6.146, P = 0.02). In the treatment group, 27 patients had their sputum symptoms resolved after 7 days of medication, while 4 had their sputum symptoms persist. In the control group, 24 patients had their sputum symptoms resolved after 7 days of medication, while 6 had their sputum symptoms persist. Using a chi-square correction test, the difference in sputum resolution between the two groups was not statistically significant (chi-square value = 0.162, P = 0.687).

[0142] As shown in Table 13, 30 patients in the treatment group had their cough symptoms resolved after 14 days of treatment, while 1 patient had their cough symptoms persist. In the control group, 28 patients had their cough symptoms resolved after 14 days of treatment, while 2 patients had their cough symptoms persist. Using Fisher's exact test, there was no statistically significant difference in the cough resolution rate between the two groups (P = 0.612). In the treatment group, 31 patients had their sputum symptoms resolved after 14 days of treatment, while 0 patients had their sputum symptoms persist. In the control group, 29 patients had their sputum symptoms resolved after 14 days of treatment, while 1 patient had their sputum symptoms persist. Using Fisher's exact test, there was no statistically significant difference in the sputum resolution rate between the two groups (P = 0.492).

[0143] The above description is merely a preferred embodiment of the present invention and does not constitute any form of limitation to the present invention. Although the present invention has been disclosed as a preferred embodiment as above, it is not intended to limit the present invention. Any technician familiar with this profession can make slight changes or modifications to equivalent embodiments of the methods and technical contents disclosed above without departing from the scope of the technical solution of the present invention. However, any simple modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for treating acute tracheobronchitis, characterized in that: In terms of weight, the raw materials for preparing the traditional Chinese medicine composition include: 9-15 parts of scutellaria baicalensis seeds, 9-15 parts of honey aster, 9-15 parts of stir-fried perilla seeds, 9-12 parts of peucedanum chinense, 9-12 parts of white scutellaria baicalensis, 9-15 parts of thunbergia thunbergii, 9-15 parts of loquat leaves, and 15-30 parts of reed rhizome.

2. The Chinese medicine composition according to claim 1, characterized in that According to the weight parts, the raw materials for preparing the traditional Chinese medicine composition include: 15 parts of scutellaria baicalensis seeds, 15 parts of honey aster, 15 parts of stir-fried perilla seeds, 12 parts of peucedanum chinense, 12 parts of white scutellaria baicalensis, 15 parts of thunbergia thunbergii, 15 parts of loquat leaves, and 30 parts of reed rhizome.

3. A drug for treating acute tracheobronchitis, characterized in that: The invention comprises the Chinese medicine composition according to claim 1 or 2, and pharmaceutically acceptable excipients.

4. The drug according to claim 3, characterized in that The auxiliary materials are selected from one or more of fillers, emulsifiers, disintegrants, lubricants, suspending agents, adhesives, sweeteners, flavoring agents, preservatives, and bases.

5. The drug according to claim 3, characterized in that The dosage form of the medicine is decoction, suspension, syrup, mixture, tincture, ointment, granule, pill, powder, tablet, capsule, drop, inhalant or injection.

6. The drug according to claim 5, characterized in that The preparation method of the decoction is: S1: taking each raw material according to weight, soaking it in water to obtain a mixture; S2: boiling the obtained mixture for the first time, and then filtering it to obtain a first medicinal liquid and a first filter residue; S3: adding water to the obtained first filter residue for a second decoction, and then filtering to obtain a second medicinal solution and a second filter residue; S4: combining the first medicinal liquid and the second medicinal liquid to obtain the decoction.

7. The drug according to claim 6, characterized in that In step S1, The amount of water added is 4 to 6 times the total mass of the raw materials; The soaking time is 15 to 20 minutes.

8. The drug according to claim 6, characterized in that In step S2, the first decoction is as follows: first, boil the mixture at high heat of 220-230° C. until boiling, and then continue to boil the mixture at low heat of 160-170° C. for 20-25 minutes.

9. The drug according to claim 6, characterized in that In step S3, The amount of water added should be 2 to 3 cm above the medicine surface; The second decoction method is: first use high heat 220-230° C. to boil, and then use low heat 160-170° C. to continue boiling for 10-15 minutes.

10. Use of the traditional Chinese medicine composition according to claim 1 or 2 or the medicine according to any one of claims 3 to 9 in the preparation of a medicine for treating acute tracheobronchitis.

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