Traditional Chinese medicine composition for treating acute upper respiratory infection as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating acute upper respiratory infection with cough as a main symptom. The traditional Chinese medicine composition is prepared from the following raw materials: 9-12 parts of adenophora tetraphylla, 12-15 parts of radix scrophulariae, 12-15 parts of poria cocos, 6-9 parts of exocarpium citri rubrum, 12-15 parts of honey-fried folium eriobotryae, 12-15 parts of thunberg fritillary bulb, 12-15 parts of lalang grass rhizome, 6-9 parts of liquorice, 9-12 parts of fried burdock, 6-9 parts of ginkgo kernel, 6-9 parts of mint, 9-12 parts of radix stemonae, 9-12 parts of radix peucedani and 9-12 parts of cynanchum glaucescens. Through scientific compatibility of the traditional Chinese medicine raw materials, the total curative effect of acute upper respiratory infection with cough as a main symptom can be effectively improved. The traditional Chinese medicine composition has small toxic and side effects, and has the advantages of good curative effect, quick response, high safety and the like in the aspect of treating acute upper respiratory tract infection with cough as a main symptom.

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 upper respiratory tract infection with cough as a main symptom, and a preparation method and application thereof. Background Art

[0002] Cough is one of the most common symptoms leading patients to seek outpatient help. It is a protective physiological reflex that helps clear airway secretions or inhaled material. Although coughing is beneficial for airway clearing, frequent and severe coughing can significantly impact quality of life and increase socioeconomic burdens. In a cross-sectional study in France, cough affected 92.7% of patients' family life, 81.7% of their work life, and 90.8% of their social life. Furthermore, cough also causes related symptoms, such as fatigue in 47.3% of patients, nausea in 38.8%, vomiting in 15.8%, and stress urinary incontinence in 14.0%, with the incidence of this symptom reaching 28.0% in women. Coughing caused difficulty falling asleep in 76.7% of patients, and 24.4% of patients had an Epworth score greater than 18, indicating a high risk of daytime sleepiness. Furthermore, the average CQLQ quality of life score of patients was only 56, reflecting the significant reduction in their quality of life due to cough. Therefore, the search for effective cough treatments goes far beyond treating the symptom itself. Adult coughs are divided into three categories based on the duration of the cough: acute cough (duration of 3 weeks). Acute viral upper respiratory tract infection (i.e., the common cold) is the primary cause of acute cough. However, because this type of cough is self-limiting and resolves on its own without treatment, and its symptoms are simple, it is easily overlooked by patients and even clinicians, leading to chronic cough. Long-term cough affects patients' quality of life and work, and seriously threatens their physical and mental health. Therefore, timely and early diagnosis and treatment are the key to treating cough associated with acute upper respiratory tract infection.

[0003] Cough caused by an acute upper respiratory tract infection falls under the category of "cough" in Traditional Chinese Medicine (TCM). From a TCM perspective, cough refers to a condition characterized by unclear lung qi, a failure of the lungs to clear and clear qi, and an upward flow of qi, manifested primarily by coughing or spitting. 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 govern qi and respiration, making them susceptible to invasion by both internal and external pathogenic qi, making them the key to the development of cough. The etiology of cough is always linked to the lungs, but it is also related to external pathogenic invasion and internal organ dysfunction. As the "Three-Character Classic of Medicine" states: "Cough is not confined to the lungs, but it is also inseparable from the lungs."

[0004] Acute upper respiratory tract infections (ARTIs) have an acute onset and typically a short course. Currently, symptomatic treatment is the primary approach for these conditions. Treatment for the cough they cause is also aimed at suppressing symptoms (antitussive therapy). Commonly used medications include nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen and acetaminophen, antihistamines (such as diphenhydramine), expectorants (such as acetylcysteine ​​and carbocysteine), and antitussives (dextromethorphan and codeine). Currently, Western medicine still primarily treats coughs with symptomatic treatment, and there is no specific and effective treatment. Therefore, a safe and effective cough suppressant is urgently needed. Summary of the Invention

[0005] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating acute upper respiratory tract infection with cough as the main symptom, as well as a preparation method and application thereof, so as to achieve effective treatment of acute upper respiratory tract infection with cough as the main symptom.

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

[0007] A traditional Chinese medicine composition for treating acute upper respiratory tract infection with cough as a main symptom. The raw materials for preparing the traditional Chinese medicine composition comprise, by weight, 9-12 parts of Adenophora australis, 12-15 parts of Scrophularia ningpoensis, 12-15 parts of Poria cocos, 6-9 parts of dried tangerine peel, 12-15 parts of honey loquat leaves, 12-15 parts of Fritillaria thunbergii, 12-15 parts of Imperata cylindrica roots, 6-9 parts of liquorice, 9-12 parts of stir-fried burdock fruits, 6-9 parts of ginkgo nuts, 6-9 parts of peppermint, 9-12 parts of Stemona tuberosa, 9-12 parts of Peucedanum chinense, and 9-12 parts of Radix Paeoniae Alba.

[0008] As a preferred embodiment of the present invention, the raw materials for preparing the traditional Chinese medicine composition include, by weight: 12 parts of Adenophora australis, 15 parts of Scrophularia ningpoensis, 15 parts of Poria cocos, 9 parts of dried tangerine peel, 15 parts of honey loquat leaves, 15 parts of Fritillaria thunbergii, 15 parts of Imperata cylindrica roots, 6 parts of licorice, 12 parts of stir-fried burdock fruits, 9 parts of ginkgo nuts, 6 parts of mint, 12 parts of Stemona tuberosa, 12 parts of Peucedanum chinense, and 12 parts of Radix Paeoniae Alba.

[0009] The second aspect of the present invention provides a medicine for treating acute upper respiratory tract infection with cough as the main symptom, comprising the above-mentioned 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 the raw materials according to weight, mixing the raw materials except mint and soaking them in water to obtain a mixture;

[0014] S2: boiling the mixture for the first time, adding mint, boiling and filtering for the second time to obtain a first medicinal liquid and a first filter residue;

[0015] S3: adding water to the obtained first filter residue and boiling it for a third time, 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 all raw materials except mint;

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

[0020] As a preferred embodiment of the present invention, in step S2,

[0021] The first decoction method is: first use high heat 220-230 ° C to boil, then use low heat 160-170 ° C to continue boiling for 15-20 minutes;

[0022] The second decoction method is: simmering at 160-170° C. for 5-10 minutes.

[0023] As a preferred embodiment of the present invention, in step S3,

[0024] The amount of water added should be 2 to 3 cm above the medicine surface;

[0025] The third 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.

[0026] 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 upper respiratory tract infection with cough as the main symptom.

[0027] Usage and dosage: Taking the decoction prepared by the above method as an example, take twice a day, 200 ml each time.

[0028] Explanation of the prescription: The present invention uses Adenophora australis as the main medicine; Poria cocos and Citrus aurantium as the assistant medicines; Scrophularia ningpoensis, Imperata cylindrica root, loquat leaf, Fritillaria thunbergii, Peucedanum peucedanum, Radix Scutellariae, Ginkgo biloba, Arctium lappa, Mentha, and Stemona tuber as the adjuvant medicines; and Licorice as the guiding medicine.

[0029] monarch drug

[0030] Adenophora australis: Sweet in flavor, slightly cold in nature. It enters the lung and stomach meridians; it nourishes yin and clears the lungs, benefits the stomach and promotes fluid production, resolves phlegm, and invigorates qi. It can be used to treat lung heat and dry cough, yin deficiency and fatigue cough, dry cough with sticky phlegm, stomach yin deficiency, loss of appetite and vomiting, qi and yin deficiency, and restlessness, fever, and dry mouth.

[0031] Minister medicine

[0032] Poria cocos: Sweet, light, and neutral in nature; it enters the Heart, Lung, Spleen, and Kidney meridians; it promotes diuresis, invigorates the spleen, and calms the mind. It can be used to treat edema, oliguria, phlegm and fluid retention, dizziness and palpitations, spleen deficiency, poor appetite, loose stools, restlessness, palpitations, and insomnia.

[0033] Tangerine peel: Pungent, bitter, and warm in nature; enters the lung and spleen meridians; has the effects of regulating qi, relieving fullness, and removing dampness and resolving phlegm. It can be used to treat cough with excessive phlegm, food stagnation, alcoholism, vomiting, nausea, and fullness in the stomach.

[0034] adjuvant

[0035] Scrophularia: Sweet, bitter, and salty in flavor, slightly cold in nature; enters the lung, stomach, and kidney meridians; clears heat and cools blood, nourishes yin and reduces internal heat, and detoxifies and resolves stagnation. It can be used to treat heat invading the blood, fever-induced rashes, yin damage caused by febrile illnesses, red tongue and thirst, constipation caused by loss of fluid, bone steaming and cough, red eyes, sore throat, diphtheria, scrofula, and carbuncles and ulcers.

[0036] Imperata root: sweet in flavor, cold in nature; enters the lung, stomach, and bladder meridians; has the effects of cooling blood, stopping bleeding, clearing heat, and promoting urination. It is used to treat hematemesis due to blood heat, epistaxis, hematuria, fever-induced thirst, damp-heat jaundice, edema, oliguria, and painful stranguria due to heat.

[0037] Loquat leaf: bitter, slightly cold in nature; enters the lung and stomach meridians; has the effects of clearing the lungs and relieving coughs, lowering adverse qi and stopping vomiting. It can be used to treat lung heat cough, qi reflux and shortness of breath, stomach heat and vomiting, and irritability and thirst.

[0038] Fritillaria thunbergii: bitter in taste, cold in nature; enters the lung and heart meridians; has the effects of clearing heat, resolving phlegm, relieving cough, detoxifying, dispersing stagnation and eliminating carbuncle. It can be used to treat wind-heat cough, phlegm-fire cough, lung abscess, breast abscess, scrofula, and sores.

[0039] Peucedanum chinense: bitter, pungent, slightly cold in nature; enters the lung meridian; has the effects of descending qi, resolving phlegm, dispersing wind and clearing heat. It can be used to treat wheezing due to phlegm-heat, coughing up yellow and thick phlegm, and wind-heat cough with excessive phlegm.

[0040] Baiqian: Spicy, bitter, and slightly warm in nature; enters the lung meridian; has the effects of lowering qi, eliminating phlegm, and relieving cough. It can be used to treat lung qi stagnation, cough with excessive phlegm, and chest fullness and shortness of breath.

[0041] Ginkgo: Sweet, bitter, astringent, neutral in nature; toxic; enters the lung and kidney meridians; has the effects of astringing the lungs and relieving asthma, stopping leukorrhea and reducing urination. It can be used to treat cough and wheezing with excessive phlegm, leukorrhea with white turbidity, and enuresis and frequent urination.

[0042] Burdock seeds: Pungent, bitter, and cold in nature; enter the lung and stomach meridians; have the effects of dispersing wind-heat, clearing the lungs and relieving rashes, and detoxifying and relieving sore throats. They can be used to treat wind-heat colds, coughs with sputum, measles, rubella, sore throats, mumps, erysipelas, and carbuncles.

[0043] Peppermint: Pungent, cool in nature; enters the lung and liver meridians; dispels wind-heat, clears the head and eyes, relieves sore throat, clears rashes, and soothes the liver and promotes qi. It can be used to treat wind-heat colds, the initial onset of wind-heat, headaches, red eyes, throat congestion, mouth sores, rubella, measles, and chest and flank distension.

[0044] Stemona radix: Sweet, bitter, and slightly warm in nature, it enters the Lung meridian and has the effects of moistening the lungs, relieving coughs, and killing insects and lice. It can be used for new and chronic coughs, coughs caused by tuberculosis, and sudden coughs. It can also be used externally to treat head and body lice, pinworms, and vaginal itching. Honeyed Stemona radix also moistens the lungs and relieves coughs, and is also effective for yin deficiency and overworked coughs.

[0045] Enhancing drug

[0046] Licorice: Sweet and neutral in nature, it enters the Heart, Lung, Spleen, and Stomach meridians. It tonifies the spleen and replenishes Qi, clears away heat and detoxifies, eliminates phlegm and relieves cough, relieves pain, and harmonizes various medicinal properties. It can be used to treat spleen and stomach deficiency, fatigue, palpitations and shortness of breath, cough with sputum, abdominal and limb cramps and pain, carbuncles, sores, and to alleviate drug toxicity and potency.

[0047] Beneficial effects

[0048] The effects of the combination of the components of the present invention far exceed those of a single-dose drug. The present invention uses Adenophora australis as the main herb; Poria cocos and Citrus aurantium as the auxiliary herb; Scrophularia ningpoensis, honey loquat leaves, Fritillaria thunbergii, Imperata cylindrica root, stir-fried burdock fruit, ginkgo seed, mint, Stemona tuber, Peucedanum chinense, and Radix Scutellariae as the adjuvant; and Licorice root as the guiding herb to harmonize the various herbs. The resulting traditional Chinese medicine preparation has the effects of rapid onset, high cure rate, and low recurrence rate, while also clearing the lungs, relieving cough, and promoting blood circulation and resolving phlegm.

[0049] By scientifically combining traditional Chinese medicine ingredients, the present invention can effectively improve symptoms such as cough, itchy throat, sore throat, foreign body sensation in the throat, runny nose, thirst, and sweating in patients with acute upper respiratory tract infections primarily characterized by cough, and reduce the VAS visual analogue scale, CET simplified cough severity scale, and LCQ Leicester cough score. The traditional Chinese medicine composition of the present invention has minimal toxic and side effects and offers numerous advantages in treating acute upper respiratory tract infections primarily characterized by cough, including good efficacy, rapid onset of action, and high safety.

[0050] 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

[0051] 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.

[0052] Unless otherwise specified, the experimental methods used in the following examples are conventional methods.

[0053] Unless otherwise specified, the materials and reagents used in the following examples can be obtained from commercial sources.

[0054] 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.

[0055] Cough caused by acute upper respiratory tract infection can be classified as "cough". Its main disease site is the lung, and the common syndrome is lung heat and yin deficiency syndrome. The basic treatment method of this disease is to clear heat and nourish yin, relieve cough and relieve asthma. The Chinese medicine composition for treating acute upper respiratory tract infection provided by the present invention is mainly for patients with acute upper respiratory tract infection with lung heat and yin deficiency syndrome. The Chinese medicine composition is composed of Adenophora australis, Scrophularia ningpoensis, Poria cocos, Tangerine peel, honey loquat leaves, Fritillaria thunbergii, Imperata cylindrica root, Licorice root, stir-fried Burdock fruit, Ginkgo biloba seed, Mentha arvense, Stemona tuber, Peucedanum chinense, and Radix Scutellariae. In the formula, Adenophora australis is the main drug, which tastes sweet and has a slightly cold nature. It can clear the lungs and nourish yin, benefit the stomach and promote fluid production. It is characterized by a light and clear body and a light smell. It is good at entering the upper part of the body to nourish lung yin, clear lung heat, moisten the dry lungs, and has the function of resolving phlegm. It is an important medicine for clearing the lungs and nourishing yin, clearing the lungs and resolving phlegm, and can target the pathogenesis of lung heat and yin deficiency to achieve better therapeutic effects. The combination of Poria cocos and Tangerine Peel strengthens the spleen and promotes diuresis, dispelling qi and eliminating phlegm, and is often used to treat coughs with excessive phlegm. Scrophularia also plays a key role in the formula. The throat, part of the lung system, is connected to the lungs and serves as a vital channel for the flow of qi. Febrile illness, resulting in insufficient body fluids and prolonged coughing, can lead to laryngeal paralysis. Scrophularia not only clears heat but also dissipates phlegm, making it highly effective for these conditions. Pharyngitis falls under this category, and modern clinical research confirms its efficacy. Peppermint and Arctium lappa are also added to further enhance the throat-clearing effect. In addition to the aforementioned herbs, Imperata cylindrica root clears heat and reduces internal heat; Ginkgo biloba seed, Stemona tuber, Peucedanum chinense, and Radix Paeoniae Alba clear qi, resolve phlegm, and relieve cough; Fritillaria thunbergii and loquat leaves clear heat, resolve phlegm, and relieve cough. The "Compendium of Materia Medica" states: "Fritillaria thunbergii relieves depression, dispels qi, and resolves phlegm. It moistens the lungs, eliminates phlegm, and relieves cough and asthma." These herbs serve as adjuvants. Licorice protects the stomach qi, harmonizes various medicines, and serves as a guiding medicine.

[0056] Example 1: Preparation of Chinese herbal decoction

[0057] The raw materials of the Chinese medicine composition are as follows: 12g of Adenophora australis, 15g of Scrophularia ningpoensis, 15g of Poria cocos, 9g of Dried Tangerine Peel, 15g of Honey Loquat Leaf, 15g of Fritillaria thunbergii, 15g of Imperata cylindrica Rhizome, 6g of Licorice Root, 12g of Sautéed Burdock Fruit, 9g of Ginkgo Biloba Seed, 6g of Menthol, 12g of Stemona Radix, 12g of Peucedanum chinense, and 12g of Radix Paeoniae Alba. The Chinese medicine composition is prepared into a decoction by the following method:

[0058] Accurately weigh each of the above-mentioned raw material components, mix Adenophora australis, Scrophularia ningpoensis, Poria cocos, Dried Tangerine Peel, Honey Loquat Leaf, Fritillaria thunbergii, Imperata cylindrica, Licorice root, stir-fried Burdock Fructus, Ginkgo biloba seed, Stemona root, Peucedanum chinense, and Radix Paeoniae Alba and place in a casserole. Add 1000ml 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 boiled with high heat, then heated with slow heat for 20 minutes, then mint is added and decocted for the second time, that is, continued to heat with slow heat for 5 minutes, after the temperature drops slightly, filtered to obtain a first medicinal liquid and a first filter residue. Water is added to the obtained first filter residue to a height of 2-3cm above the medicinal surface and decocted for the third time, that is, first boiled with high heat, then heated with slow heat for 15 minutes, after the temperature drops slightly, filtered to obtain a second medicinal liquid and a second filter residue. The first medicinal liquid and the second medicinal liquid obtained by the above-mentioned two decoctions are placed in the same container to obtain a total of approximately 400 ml of Chinese herbal decoction. Finally, the prepared Chinese herbal decoction is sterilized, filled, sealed, and refrigerated. It should be noted that the prepared Chinese herbal decoction is a daily dosage for one patient, and 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.

[0059] Example 2: Clinical trial evaluation of Chinese herbal decoction

[0060] 1. Source of cases

[0061] The cases selected for this article were all from patients attending the Respiratory Department of the Third Affiliated Hospital of Beijing University of Chinese Medicine. They were diagnosed with acute upper respiratory tract infection with cough as the primary symptom according to the following diagnostic criteria and subsequently underwent clinical treatment. Detailed clinical data related to the clinical treatment were obtained with the patients' written informed consent.

[0062] 2. Diagnostic criteria

[0063] The Western medicine diagnostic standards refer to the 2018 "Guidelines for the Diagnosis and Treatment of Acute Upper Respiratory Tract Infections at the Primary Level", which are as follows:

[0064] (1) Medical history: acute onset and short course;

[0065] (2) Clinical symptoms: Cough is the main clinical manifestation, which may be accompanied by nasal congestion, runny nose, sneezing and other upper respiratory tract catarrhal symptoms, dry throat, sore throat, sputum, fever, headache, muscle aches, etc.

[0066] (3) Physical examination: Nasal mucosa and pharynx are congested, edematous, and have secretions; tonsils are enlarged and congested; there are usually no abnormal signs in the lungs;

[0067] (4) Auxiliary examinations: In viral infections, the peripheral blood leukocyte count is normal or low, and the lymphocyte ratio is increased; in bacterial infections, the total peripheral leukocyte count and the neutrophil ratio increase, and there is a nuclear left shift. Generally, X-ray examination is not required, but it can be considered when distinguishing pneumonia;

[0068] (5) Exclude the prodromal symptoms of allergic rhinitis, influenza, acute tracheobronchitis and certain acute infectious diseases.

[0069] 3. Case grouping and treatment plan

[0070] 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 of the present invention were treated as the treatment group, and those who used the Chinese patent medicine Yangyin Qingfei oral liquid were treated as the control group. A total of 120 patients were included, including 59 patients in the treatment group and 61 patients in the control group. The specific treatment plan is:

[0071] 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.

[0072] The control group was given the Chinese patent medicine Yangyin Qingfei Oral Liquid (manufacturer: Hulunbuir Songlu Pharmaceutical Co., Ltd., national medicine standard number: Z10890016, specification: 10ml and usage and dosage: 1 bottle / time, 2 times / day).

[0073] The medication time for both groups was 7 days.

[0074] 4. Efficacy evaluation

[0075] (1) Safety evaluation

[0076] 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.

[0077] (2) Comprehensive efficacy evaluation

[0078] Main efficacy indicators:

[0079] 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 based on the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial Implementation)" (see Table 1). The primary symptom was cough, scored 0, 2, 4, and 6 points from mild to severe. Secondary symptoms included expectoration, itchy throat, sore throat, foreign body sensation in the throat, fever, nasal congestion, runny nose, limb aches, thirst, and sweating, scored 0, 1, 2, and 3 points from mild to severe. The sum of the primary and secondary symptom scores was the TCM syndrome score. The efficacy index was calculated using the nimodipine method: efficacy index = (pre-treatment score - post-treatment score) / pre-treatment score × 100%. Cured: TCM clinical symptoms essentially disappeared or completely disappeared (efficacy index ≥ 95%); markedly effective: TCM clinical symptoms significantly alleviated (efficacy index ≤ 70% < 95%); effective: TCM clinical symptoms improved (efficacy index ≤ 30% < 70%); ineffective: TCM clinical symptoms showed no significant improvement or even worsened (efficacy index < 30%). Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%.

[0080] Table 1 Traditional Chinese Medicine Syndrome Scale

[0081]

[0082]

[0083]

[0084] Secondary efficacy indicators:

[0085] a. Simple cough severity score (CET)

[0086] According to the "Guidelines for the Diagnosis and Treatment of Cough (2021 Edition)" of the Asthma Group of the Respiratory Diseases Branch of the Chinese Medical Association, a simple cough severity score (CET) table was developed, as shown in Table 2, which includes 5 items: the patient's daytime cough severity, the impact of nighttime cough on sleep, the severity of cough, and the impact of cough on daily life and psychology, with scores of 1, 2, 3, 4, and 5 from mild to severe.

[0087] Table 2 Cough Efficiency Scale (CET) Please read the following questions and tick the corresponding boxes according to your current coughing condition.

[0088]

[0089] Note: a Daytime refers to the time from waking up in the morning to going to bed

[0090] b. Visual Analog Scale (VAS)

[0091] A cough visualization scale was developed based on the "Guidelines for the Diagnosis and Treatment of Cough (2021 Edition)" of the Asthma Group of the Respiratory Diseases Branch of the Chinese Medical Association, as shown in Table 3. A linear scoring method was used, with patients being asked to rate the severity of their cough on a scale of 0-10.

[0092] Table 3 Visual Assessor of Cough (VAS) Please rate the severity of your cough based on the color depth:

[0093]

[0094]

[0095] c. Leicester Cough Questionnaire (LCQ)

[0096] The Leicester Cough Score was developed based on the "Guidelines for the Diagnosis and Treatment of Cough (2021 Edition)" of the Asthma Group of the Respiratory Diseases Branch of the Chinese Medical Association. As shown in Table 4, it contains a total of 19 items to assess the patient's cough-related quality of life from three aspects: physiological, psychological, and social.

[0097] Table 4 Leicester Cough Scale (LCQ) Please select the corresponding number based on your experience in the past two weeks

[0098]

[0099] 5. Statistical methods

[0100] Excel spreadsheets were used to analyze the data, and SPSS Statistics 26.0.0 statistical analysis software was used for processing. The measurement data were expressed as (mean ± standard deviation). If the data conformed to the normal distribution and the variance was equal, the independent sample t-test was used for comparison between the two groups, and the paired t-test was used for comparison before and after treatment within the group. If the data did not conform to the normal distribution, nonparametric tests were used. The Mann-Whitney U method was used for measurement data, and the Fisher exact test was used for count data. All tests were two-sided, and P < 0.05 was considered statistically significant.

[0101] 6. Clinical trial results

[0102] (1) Safety evaluation

[0103] 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.

[0104] (2) Comprehensive efficacy evaluation

[0105] Main efficacy:

[0106] a. The results of TCM syndrome scores are shown in Tables 5 and 6.

[0107] Table 5 Comparison of TCM syndrome scores between the two groups of patients (first half)

[0108]

[0109] Note: Compared with the group before treatment 1 )P<0.05, 2) P<0.01; compared with the control group after treatment 3 )P<0.05, 4) P<0.01

[0110] Table 6 Comparison of TCM syndrome scores between the two groups of patients (second half)

[0111]

[0112]

[0113] Note: Compared with the group before treatment 1) P<0.05, 2) P<0.01; compared with the control group after treatment 3) P<0.05, 4) P<0.01

[0114] As shown in Tables 5 and 6, before treatment, there was no statistically significant difference in the TCM syndrome scores between the treatment and control groups (P>0.05). Three days after treatment, the scores and total scores for cough, sputum, pharyngeal itching, pharyngeal pain, pharyngeal foreign body sensation, nasal congestion, runny nose, thirst, and sweating decreased in the treatment group compared with those before treatment (P<0.05), with no statistically significant difference in the fever score (P>0.05). Three days after treatment, the scores and total scores for cough, sputum, pharyngeal itching, pharyngeal pain, pharyngeal foreign body sensation, nasal congestion, runny nose, thirst, and sweating decreased in the control group (P<0.05), with no statistically significant difference in the fever score (P>0.05). Three days after treatment, the scores and total scores for cough, sputum, pharyngeal foreign body sensation decreased in the treatment group compared with those in the control group (P<0.05), with no statistically significant difference in the scores for the other individual symptoms (P>0.05). Compared with those before treatment, the scores and total scores of cough, expectoration, pharyngeal itching, pharyngeal pain, pharyngeal foreign body sensation, nasal congestion, runny nose, thirst, sweating, and fever in the treatment group decreased after 7 days of treatment, with statistically significant differences (P < 0.05). The scores and total scores of cough, expectoration, pharyngeal itching, pharyngeal pain, pharyngeal foreign body sensation, nasal congestion, runny nose, thirst, sweating, and fever in the control group decreased after 7 days of treatment, with statistically significant differences (P < 0.05). After 7 days of treatment, the scores and total scores of cough, expectoration, and pharyngeal foreign body sensation in the treatment group decreased after 7 days of treatment, with statistically significant differences (P < 0.05). There were no statistically significant differences in the scores of other individual symptoms (P > 0.05).

[0115] b. The efficacy of TCM syndromes is shown in Table 7.

[0116] Table 7 Comparison of TCM syndrome efficacy between the two groups of patients

[0117]

[0118] As shown in Table 7, the total TCM syndrome scores of each group on days 3 and 7 after treatment were calculated, and the efficacy index before and after treatment was calculated using the nimodipine method to compare the efficacy distribution between the two groups. On day 3, 0 patients in the treatment group were cured, 10 patients were significantly effective, and 46 patients were effective, with a total effective rate of 94.9%. A total of 3 patients were ineffective. In the control group, 0 patients were cured, 1 patient was significantly effective, and 49 patients were effective, with a total effective rate of 85.2%. There were 11 patients who were ineffective. On day 7, 2 patients in the treatment group were cured, 41 patients were significantly effective, and 14 patients were effective, with a total effective rate of 96.6%. There were 2 patients who were ineffective. In the control group, 2 patients were cured, 25 patients were significantly effective, and 24 patients were effective, with a total effective rate of 83.6%. There were 10 patients who were ineffective. Fisher's exact test showed that the total effective rates on days 3 and 7 of treatment were statistically significant in both groups (P < 0.05).

[0119] Secondary efficacy:

[0120] a.VAS visual analogue scale

[0121] The results are shown in Table 8.

[0122] Table 8 Comparison of VAS visual analogue score between the two groups of patients

[0123]

[0124] Note: Compared with the group before treatment 1) P<0.05, 2) P<0.01; compared with the control group after treatment 3) P<0.05, 4) P<0.01

[0125] As shown in Table 8, before treatment, there was no statistically significant difference in the VAS scores between the treatment group and the control group (P>0.05). Compared with the group before treatment, the VAS score of the treatment group decreased after 3 days, and the difference was statistically significant (P<0.01); the VAS score of the control group decreased after 3 days (P<0.01). Compared with the control group after 3 days of treatment, the VAS score of the treatment group decreased after 3 days of treatment, and the difference was statistically significant (P<0.05). The VAS score of the treatment group decreased after 7 days of treatment, and the difference was statistically significant (P<0.01); the VAS score of the control group decreased after 7 days of treatment (P<0.01). Compared with the control group after 7 days of treatment, the VAS score of the treatment group decreased after 7 days of treatment, and the difference was statistically significant (P<0.01).

[0126] b. CET Simple Cough Score

[0127] The results are shown in Table 9.

[0128] Table 9 Comparison of CET simple cough severity scores between the two groups of patients

[0129]

[0130] Note: Compared with the group before treatment 1) P<0.05, 2) P<0.01; compared with the control group after treatment 3) P<0.05, 4) P<0.01

[0131] As shown in Table 9, before treatment, there was no statistically significant difference in CET scores between the treatment and control groups (P>0.05). Three days after treatment, the CET scores in the treatment group decreased compared with those before treatment (P<0.05); the CET scores in the control group decreased after three days (P<0.05). Three days after treatment, the CET scores in the treatment group decreased compared with those in the control group (P<0.05). Seven days after treatment, the CET scores in the treatment group decreased compared with those in the control group (P<0.05); the CET scores in the control group decreased after seven days (P<0.05). Seven days after treatment, the CET scores in the treatment group decreased compared with those in the control group (P<0.05).

[0132] c. LCQ Leicester Cough Score

[0133] The results are shown in Table 10.

[0134] Table 10 Comparison of LCQ Leicester cough scores between the two groups of patients

[0135]

[0136]

[0137] Note: Compared with the group before treatment 1) P<0.05, 2) P<0.01; compared with the control group after treatment 3) P<0.05, 4) P<0.01

[0138] As shown in Table 10, there was no statistically significant difference in LCQ scores between the treatment and control groups before treatment (P>0.05). Three days after treatment, the treatment group showed a significant decrease in LCQ scores for physical, psychological, social, and total scores (P<0.05). Three days after treatment, the control group showed a significant decrease in LCQ scores for physical, psychological, social, and total scores (P<0.05). Three days after treatment, the treatment group showed no significant difference in LCQ scores compared with the control group (P>0.05). Seven days after treatment, the treatment group showed a significant decrease in LCQ scores for physical, psychological, social, and total scores (P<0.05). Seven days after treatment, the control group showed a significant decrease in LCQ scores for physical, psychological, social, and total scores (P<0.05). There was no statistically significant difference in LCQ scores between the treatment and control groups (P>0.05).

[0139] 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 upper respiratory tract infection with cough as the main symptom, characterized in that: In terms of weight, the raw materials for preparing the traditional Chinese medicine composition include: 9-12 parts of Adenophora australis, 12-15 parts of Scrophularia ningpoensis, 12-15 parts of Poria cocos, 6-9 parts of dried tangerine peel, 12-15 parts of honey loquat leaves, 12-15 parts of Fritillaria thunbergii, 12-15 parts of Imperata cylindrica roots, 6-9 parts of licorice, 9-12 parts of stir-fried burdock fruits, 6-9 parts of ginkgo nuts, 6-9 parts of mint, 9-12 parts of Stemona tuberosa, 9-12 parts of Peucedanum chinense, and 9-12 parts of Radix Paeoniae Alba.

2. The Chinese medicine composition according to claim 1, characterized in that In terms of weight, the raw materials for preparing the traditional Chinese medicine composition include: 12 parts of Adenophora australis, 15 parts of Scrophularia ningpoensis, 15 parts of Poria cocos, 9 parts of Citrus aurantium, 15 parts of honey loquat leaves, 15 parts of Fritillaria thunbergii, 15 parts of Imperata cylindrica roots, 6 parts of Licorice root, 12 parts of stir-fried Burdock fruits, 9 parts of Ginkgo nuts, 6 parts of Menthol, 12 parts of Stemona tuberosa, 12 parts of Peucedanum chinense, and 12 parts of Radix Paeoniae Alba.

3. A medicine for treating acute upper respiratory tract infection with cough as the main symptom, 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 raw materials in parts by weight, mixing the raw materials except mint and soaking them in water to obtain a mixture; S2: boiling the mixture for the first time, adding mint, boiling and filtering for the second time to obtain a first medicinal liquid and a first filter residue; S3: adding water to the obtained first filter residue and boiling it for a third time, 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 all raw materials except mint; The soaking time is 15 to 20 minutes.

8. The drug according to claim 6, characterized in that In step S2, The first decoction method is: first use high heat 220-230 ° C to boil, then use low heat 160-170 ° C to continue boiling for 15-20 minutes; The second decoction method is: simmering at 160-170° C. for 5-10 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 third 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 upper respiratory tract infection with cough as the main symptom.

Images