A cough and phlegm relieving acupoint sticking traditional Chinese medicine composition, a preparation method and application thereof

Abstract

The application belongs to the technical field of traditional Chinese medicines, and particularly relates to a acupoint pasting traditional Chinese medicine composition for relieving cough and reducing phlegm as well as a preparation method and application thereof. The acupoint pasting traditional Chinese medicine composition for relieving cough and reducing phlegm is composed of perilla seed 0.5-9 parts, yellow radish seed 0.3-6 parts, radix peucedani 1-9 parts, mulberry leaf 0.5-6 parts and zhejiang fritillary bulb 0.5-6 parts in mass parts. The acupoint pasting traditional Chinese medicine composition for relieving cough and reducing phlegm of the application combines cold and warm herbs and promotes lung qi and stops coughing and reduces phlegm, and can effectively relieve paroxysmal cough, coughing white phlegm, throat itching, and other symptoms induced or aggravated by factors such as cold air, dust, irritating gas, exercise, smoke and the like.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for relieving cough and phlegm by applying it to acupoints, its preparation method, and its application. Background Technology

[0002] Post-infectious cough refers to a persistent, intractable cough that persists even after a history of chronic respiratory diseases and other causes of cough, and after chest X-rays show no abnormalities and the acute symptoms of respiratory infection have subsided. Post-infectious cough is a common complication of respiratory infections and can occur at any age. Its main symptoms include cough, sore throat, fever, headache, muscle pain, and fatigue, with varying degrees of severity. Post-infectious cough is somewhat self-limiting, and symptoms may resolve spontaneously in some patients; however, symptoms in a significant number of patients do not resolve on their own. Currently, there is no specific medication for persistent post-infectious cough. Clinically, symptomatic treatment and the use of hormones and antiviral drugs are generally employed. While these can effectively relieve symptoms, long-term use can lead to drug resistance, resulting in poor efficacy of subsequent medications.

[0003] Traditional Chinese medicine external therapies have certain advantages in treating diseases, such as acupoint application, acupoint injection, and cupping. Acupoint application, as a distinctive therapy in traditional Chinese medicine, is increasingly favored by patients and widely used in the treatment of various diseases due to its generally low risk, simple operation, safety, convenience, and significant effects. Currently, research on using acupoint application therapy to treat post-infectious cough is limited, and there are relatively few Chinese herbal patches used clinically for treating post-infectious cough. Therefore, it is necessary to develop a Chinese herbal composition for acupoint application that can effectively treat post-infectious cough to meet clinical needs. Summary of the Invention

[0004] The first objective of this invention is to provide a traditional Chinese medicine composition for relieving cough and phlegm by applying it to acupoints. The second objective of this invention is to provide a method for preparing the traditional Chinese medicine composition. The third objective of this invention is to provide an application of the traditional Chinese medicine composition.

[0005] According to a first aspect of the present invention, a traditional Chinese medicine composition for relieving cough and expectoration by acupoint application is provided, wherein the raw materials comprise, by weight, 0.5-9 parts of perilla seed, 0.3-6 parts of yellow mustard seed, 1-9 parts of angelica root, 0.5-6 parts of mulberry leaf, and 0.5-6 parts of fritillaria bulb.

[0006] This invention posits that cough following an acute upper respiratory tract infection is caused by lingering pathogenic factors, leading to impaired lung function and internal obstruction of phlegm. It often presents as paroxysmal coughing, accompanied by white sputum, itchy throat, and other symptoms, and is frequently triggered or aggravated by factors such as cold air, dust, irritating gases, exercise, and smoke. Therefore, based on its pathogenesis and clinical manifestations, this invention proposes a formula.

[0007] In this formula, Perilla Seed and Peucedanum praeruptorum are the principal herbs. Perilla Seed is pungent and warm, and can lower qi, resolve phlegm, stop cough, and relieve asthma. The *Bielu* records that it can "lower qi and dispel cold in the middle jiao." Peucedanum praeruptorum is bitter, pungent, and slightly cold, and can both lower qi, resolve phlegm, stop cough, and dispel wind. The *Bencao Jingjie* records that it can "treat phlegm fullness, chest and rib fullness, abdominal distension, wind-induced headache, remove phlegm, lower qi, treat typhoid fever with chills and fever, and promote metabolism." The combination of these two herbs, with their warm and cold properties, lowers qi, stops cough, and resolves phlegm, while being mild, neither too hot nor too cold. Mustard Seed and Fritillaria thunbergii are the assistant herbs. Mustard Seed is pungent and warm, and can warm the lungs, resolve phlegm, and promote qi circulation and dissipate stagnation. Fritillaria thunbergii is bitter and cold, and is good at clearing the lungs, resolving phlegm, and stopping cough. The combination of these two herbs, with their warm and cold properties, strengthens the effect of lowering qi, stopping cough, and resolving phlegm. Mulberry leaves, used as an adjuvant, are sweet, bitter, and cold in nature, and enter the lung and liver meridians. They not only dispel wind and moisten the lungs, promoting lung qi, but also soothe and clear the liver. When combined with perilla seeds, angelica root, yellow mustard seeds, and fritillaria bulbs, mulberry leaves work together to restore the lung's function of dispersing and descending qi. Simultaneously, their liver-soothing and liver-clearing effects can improve the liver stagnation caused by prolonged coughing in patients. The entire formula combines cold and warm properties, and promotes both dispersing and descending qi, effectively dispersing lung qi, relieving cough, and resolving phlegm. It can significantly improve the aforementioned symptoms in patients with cough following acute upper respiratory tract infection.

[0008] The raw materials for this formula come from the following sources:

[0009] Perilla seeds: the dried, mature fruits of *Perilla frutescens* (L.) Britt. var. *arguta* (Benth.) Hand.-Mazz. and *P. frutescens* (L.) Britt. var. *purpurascens* (Hayata) HWLi, plants of the genus *Perilla* in the family Lamiaceae.

[0010] Yellow mustard seeds: seeds of Brassica juncea (L.) Czern. et Coss. and Brassia juncea (L.) Czern. et Coss. var. Gracilis Tsenet Lee., both belonging to the Brassicaceae family.

[0011] Peucedanum praeruptorum Dunn or P. decursivum maxin, both belonging to the genus Peucedanum in the family Apiaceae.

[0012] Mulberry leaves: the dried leaves of Morus alba L., a plant belonging to the genus Morus in the family Moraceae.

[0013] Fritillaria thunbergii Miq., a plant belonging to the genus Fritillaria in the family Liliaceae.

[0014] In some embodiments, the dosage form of the traditional Chinese medicine composition is a patch.

[0015] In some implementations, a pharmaceutically acceptable dressing medium may also be added.

[0016] In some embodiments, the dressing medium is at least one of honey, vinegar, sesame oil, petroleum jelly, paraffin oil, and rice wine.

[0017] According to a second aspect of the present invention, a method for preparing the above-mentioned acupoint patch traditional Chinese medicine composition for relieving cough and resolving phlegm is provided. When the dosage form of the traditional Chinese medicine composition is a patch, the preparation method includes the following steps:

[0018] Each raw material is crushed or chopped separately. The crushed or chopped raw materials are then passed through 50-mesh and 100-mesh sieves. Coarse particles that cannot pass through the 50-mesh sieve are further crushed or chopped. Powder that falls between the 50-mesh and 100-mesh sieves is collected. The powders of each raw material are then mixed according to the formula, and the dressing medium is added to make the dressing.

[0019] According to a third aspect of the present invention, the use of the above-described acupoint patch traditional Chinese medicine composition for relieving cough and expectoration in the preparation of a medicament for treating post-infectious cough is provided.

[0020] According to a fourth aspect of the present invention, the use of the above-described acupoint patch traditional Chinese medicine composition for relieving cough and expectoration in the preparation of a medicament for treating cough following acute upper respiratory tract infection is provided.

[0021] The beneficial effects of this invention include:

[0022] (1) The acupoint patch Chinese medicine composition for relieving cough and resolving phlegm of the present invention uses both cold and warm properties, and promotes the flow of qi in the lungs. It can effectively relieve the paroxysmal cough, expectoration of white phlegm, itchy throat, and other symptoms induced or aggravated by cold air, dust, irritating gases, exercise, smoke and other factors in patients with cough after acute upper respiratory tract infection.

[0023] (2) This invention does not use products with strong effects or that are too irritating to the skin. Instead, it uses a combination of cold and warm properties and promotes the downward movement of qi and blood. By restoring the lung's functions of dispersing and descending qi, it can relieve cough and resolve phlegm at the same time. It can also improve the negative emotions caused by the patient's long-term and stubborn cough, thus achieving the effect of effectively treating cough after acute upper respiratory tract infection.

[0024] (3) The acupoint patch traditional Chinese medicine composition for relieving cough and phlegm of the present invention can be prepared into a patch for acupoint application. It can not only promote lung qi, relieve cough and phlegm through the traditional Chinese medicine composition, but also adjust the qi of the meridians and promote cough recovery by stimulating acupoints.

[0025] (4) Clinical trials have shown that the acupoint patch traditional Chinese medicine composition for relieving cough and expectoration of the present invention can significantly relieve cough symptoms and improve the physiological, psychological and social problems caused by cough, thereby improving the quality of life. Detailed Implementation

[0026] The present invention will be further described in detail below with reference to specific embodiments. It is worth noting that the following embodiments are only for better explaining the content of the present invention and do not limit the scope of protection of the present invention. Process steps not disclosed in the embodiments are prior art. Unless otherwise specified, all raw materials are commercially available.

[0027] Example 1

[0028] The acupoint application Chinese herbal patch for relieving cough and phlegm in this embodiment is composed of the following ingredients: 9g of perilla seed, 3g of yellow mustard seed, 9g of angelica root, 6g of mulberry leaf, and 6g of fritillaria bulb.

[0029] Its preparation method includes the following steps:

[0030] (1) Take perilla seeds, crush them, and pass them through 50-mesh and 100-mesh sieves at the same time. Continue to crush the coarse particles that cannot pass through the 50-mesh sieve and take the powder that is between the 50-mesh and 100-mesh sieves.

[0031] (2) Grind the yellow mustard seed, Peucedanum praeruptorum, mulberry leaf and Fritillaria thunbergii into powder according to the method in step (1);

[0032] (3) Mix all the raw material powders evenly, add an appropriate amount of honey as a dressing medium to make a paste, then apply the paste to the adhesive tape, cover it, cut it into small pieces and package it. When using, simply apply the herbal patch to the corresponding acupoints.

[0033] Example 2

[0034] The acupoint application Chinese herbal patch for relieving cough and phlegm in this embodiment is composed of the following ingredients: 6g of perilla seed, 6g of yellow mustard seed, 6g of angelica root, 3g of mulberry leaf, and 3g of fritillaria bulb.

[0035] Its preparation method is the same as that of Example 1.

[0036] Example 3

[0037] The acupoint application Chinese herbal patch for relieving cough and phlegm in this embodiment is composed of the following ingredients: 0.5g of perilla seed, 0.3g of yellow mustard seed, 1g of angelica dahurica, 0.5g of mulberry leaf, and 0.5g of fritillaria thunbergii.

[0038] Its preparation method is the same as that of Example 1.

[0039] To illustrate the efficacy of the acupoint patch traditional Chinese medicine composition for relieving cough and phlegm of the present invention on post-infectious cough, the following clinical trial was conducted.

[0040] 1. Inclusion criteria

[0041] (1) Persistent cough symptoms during the recovery period of acute upper respiratory tract infection, meeting the Western medical diagnostic criteria for post-infectious cough (a. There should be a clear history of respiratory tract infection in the early stage of the disease, with acute catarrhal symptoms of cold such as runny nose, sneezing, fever, headache, sore throat, and cough; b. After the acute catarrhal symptoms of infection disappear, the cough is still persistent or even aggravated, manifested as paroxysmal irritating dry cough or coughing up a small amount of white mucus sputum, which usually lasts for 3-8 weeks; c. No abnormal rales are heard on lung auscultation; d. Other causes of cough are ruled out).

[0042] (2) Age 18-85 years old (inclusive);

[0043] (3) The patient or his or her legal representative shall sign the informed consent form.

[0044] 2. Exclusion criteria

[0045] (1) People with allergies or those allergic to cough patch medications;

[0046] (2) Those with chronic lung diseases such as bronchiectasis, bronchopneumonia, chronic lung abscess, chronic cough for more than 8 weeks, chronic pharyngitis with cough, lung cancer, respiratory bacterial infection, etc., which affect the judgment of cough symptoms;

[0047] (3) Heavy smokers (smoking years × number of cigarettes smoked per day ≥ 400, such as smoking history ≥ 20 years, ≥ 20 cigarettes smoked per day)

[0048] (4) Allergic rhinitis, prodromal symptoms of acute infectious diseases (measles, epidemic hemorrhagic fever, epidemic cerebrospinal meningitis, poliomyelitis, typhus, typhus) and other diseases with flu-like symptoms;

[0049] (5) Acute exacerbations of serious underlying diseases or chronic diseases, such as acute heart failure, and acute cough caused by other serious acute diseases, such as acute myocardial infarction, left ventricular failure, pulmonary embolism, foreign body aspiration, etc.

[0050] (6) Pregnant female subjects;

[0051] (7) Those who participated in or are currently participating in other clinical trials within the month prior to this study;

[0052] (8) Those whose incomplete data affects the judgment of efficacy.

[0053] 3. General Information

[0054] This study included 47 patients, 11 of whom were lost to follow-up, and 36 patients were ultimately included in the analysis.

[0055] All patients were treated with the cough-relieving and phlegm-reducing acupoint patch prepared according to Example 1 of this invention. During use, the patch was applied to the Tian Tu acupoint and bilateral Fei Shu acupoints once daily for 6-8 hours each time, for a course of 5 days (discontinue use once symptoms disappear). No other cough-relieving and phlegm-reducing medications were used during this period.

[0056] 4. Baseline Analysis

[0057] The patient's baseline information is shown in Table 1.

[0058] Table 1 Baseline characteristics of enrolled patients

[0059] variable n＝36 gender male 13(36.1) female 23(63.9) age 42.5(21-82) Time from onset of illness to consultation (d) 28.5(2-1144) BMI 21.5(16.8-29.8) underlying diseases 1(2.7) diabetes 1(2.7) Baseline score Cough Severity Rating Scale (CET) 5.5±2.2 Leicester Cough Score 17.0±2.3 Physiological domain 5.2±0.8 Psychology 6.0±0.8 Social sphere 5.8±1.0

[0060] As shown in Table 1, this study included 36 patients, including 13 males and 23 females, aged 21-82 years, with a mean age of 42.5 years. The time from onset to consultation ranged from 2 to 1144 days, with a median time of 28.5 days.

[0061] The patients’ baseline symptoms are shown in Table 2.

[0062] Table 2 Baseline symptoms of enrolled patients

[0063]

[0064]

[0065] As shown in Table 2, all patients had cough symptoms, and 75% of patients had sputum symptoms. In addition, a small number of patients had symptoms such as fear of cold, fear of wind, sweating, heaviness in the head and body, fatigue, runny nose, sneezing, shortness of breath, and difficulty breathing.

[0066] The severity of the patients' coughs is shown in Table 3.

[0067] Table 3. Severity of cough among enrolled patients

[0068]

[0069]

[0070] As shown in Table 3, the cough symptoms of the patients included in this study were mainly mild to moderate, accounting for 86.1%.

[0071] 5. Therapeutic effect analysis

[0072] This study evaluated and followed up patients on cough resolution time, cough severity scores before and after treatment, and Leicester Cough Scale scores. Kaplan-Meier test showed that the median time to cough resolution was 6 days. Table 4 shows the comparison of cough scores before and after treatment.

[0073] Table 4 Comparison of cough scores before and after treatment

[0074] project Number of examples Before treatment After treatment p-value Cough Severity Rating Scale (CET) Scores 36 5.5±2.2 1.08±1.7 ＜0.001 Leicester Cough Questionnaire Score 36 17.0±2.3 20.0±0.8 ＜0.001 Physiological region integration 36 5.2±0.8 6.4±0.4 ＜0.001 Psychological area integration 36 6.0±0.8 6.7±0.3 ＜0.001 Social area points 36 5.8±1.0 6.9±0.3 ＜0.001

[0075] As shown in Table 4, the cough severity score of patients after treatment decreased significantly compared with that before treatment (P<0.001), and the Leicester Cough Questionnaire score and the scores of physiological, psychological and social areas after treatment increased significantly compared with those before treatment (P<0.001). This suggests that the acupoint patch traditional Chinese medicine composition for relieving cough and expectoration of the present invention can significantly alleviate cough symptoms and improve the physiological, psychological and social problems caused by cough, thereby improving the quality of life.

[0076] In summary, the acupoint patch traditional Chinese medicine composition for relieving cough and phlegm of the present invention can effectively treat patients' cough and improve their quality of life.

[0077] The above descriptions are merely some specific embodiments of the present invention. For those skilled in the art, various modifications and improvements can be made without departing from the inventive concept of the present invention, and all such modifications and improvements fall within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for relieving cough and phlegm, characterized in that, It is made from the following raw materials in parts by weight: 0.5-9 parts of Perilla frutescens seed, 0.3-6 parts of Sinapis alba seed, 1-9 parts of Peucedanum praeruptorum, 0.5-6 parts of Morus alba leaf, and 0.5-6 parts of Fritillaria thunbergii.

2. The acupoint application traditional Chinese medicine composition for relieving cough and resolving phlegm according to claim 1, characterized in that, The dosage form of the traditional Chinese medicine composition is a patch.

3. The acupoint application traditional Chinese medicine composition for relieving cough and resolving phlegm according to claim 1 or 2, characterized in that, Pharmaceutically acceptable dressing media can also be added.

4. The acupoint application traditional Chinese medicine composition for relieving cough and resolving phlegm according to claim 3, characterized in that, The dressing medium is at least one of honey, vinegar, sesame oil, petroleum jelly, paraffin oil, and rice wine.

5. The method for preparing the acupoint application traditional Chinese medicine composition for relieving cough and resolving phlegm according to any one of claims 1-4, characterized in that, When the dosage form of the traditional Chinese medicine composition is a patch, its preparation method includes the following steps: Each raw material is crushed or chopped separately. The crushed or chopped raw materials are then passed through 50-mesh and 100-mesh sieves. Coarse particles that cannot pass through the 50-mesh sieve are further crushed or chopped. Powder that falls between the 50-mesh and 100-mesh sieves is collected. The powders of each raw material are then mixed according to the formula, and the dressing medium is added to make the dressing.

6. The use of the acupoint application traditional Chinese medicine composition for relieving cough and resolving phlegm as described in any one of claims 1-4 in the preparation of a medicament for treating post-infectious cough.

7. The use of the acupoint patch traditional Chinese medicine composition for relieving cough and resolving phlegm as described in any one of claims 1-4 in the preparation of a medicament for treating cough after acute upper respiratory tract infection.

Images