A cough-relieving and asthma-relieving traditional Chinese medicine composition, a preparation method thereof and application thereof

Abstract

The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for relieving cough and asthma, and a preparation method and application thereof. The traditional Chinese medicine composition comprises, in mass parts, perilla seed 5-15 parts, radish seed 5-15 parts, white mulberry bark 5-15 parts, orange red or processed orange red 5-15 parts, and cassia 5-15 parts. The traditional Chinese medicine composition has the effect of relieving cough and asthma, can effectively improve the clinical symptoms such as cough, expectoration and wheezing of patients with chronic obstructive pulmonary disease, promote lung rehabilitation, improve the dyspnea condition of the patients, and improve the life quality of the patients.

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 asthma, its preparation method, and its application. Background Technology

[0002] Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable chronic airway disease characterized by persistent airflow limitation and corresponding respiratory symptoms. COPD is caused by a combination of pathogenic factors, leading to elevated levels of various inflammatory factors, primarily manifested as small airway remodeling, increased goblet cells in the airways, and hypersecretion of mucus. Ultimately, this results in irreversible pathological changes in the bronchi, pulmonary vessels, and lung parenchyma. Clinical symptoms mainly include cough, sputum production, and wheezing. COPD is a chronic respiratory disease with a protracted course. Current clinical medications mainly consist of topical corticosteroids, which have certain adverse reactions and may increase the risk of infection.

[0003] In recent years, with the accumulation of clinical evidence, the treatment of COPD using traditional Chinese medicine (TCM) based on syndrome differentiation has gradually gained attention. Studies have found that combining Western medicine with TCM in the treatment of COPD has advantages such as improving clinical efficacy, promoting pulmonary rehabilitation, and reducing adverse reactions. Patients with stable COPD often experience recurring cough, sputum, and wheezing symptoms that affect their daily lives and increase medical expenses. Western medicine treatment for COPD in the stable phase mainly focuses on long-term oxygen therapy and reducing airway oxidative stress, but the treatment effect is not entirely ideal. Therefore, it is necessary to develop a TCM composition that can effectively treat COPD, especially stable COPD, to meet clinical medication needs. Summary of the Invention

[0004] The first objective of this invention is to provide a traditional Chinese medicine composition for relieving cough and asthma; the second objective of this invention is to provide a method for preparing the traditional Chinese medicine composition; and the third objective of this invention is to provide the 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 asthma is provided, wherein the raw materials comprising, by weight, are: 5-15 parts of perilla seed, 5-15 parts of radish seed, 5-15 parts of mulberry bark, 5-15 parts of tangerine peel or dried tangerine peel, and 5-15 parts of cinnamon.

[0006] This invention believes that the main manifestations of chronic obstructive pulmonary disease are recurrent cough, sputum production, and shortness of breath. Based on its pathogenesis and clinical manifestations, this invention proposes a formula using the methods of syndrome differentiation and treatment in traditional Chinese medicine.

[0007] In this formula, perilla seeds have the effect of dispelling wind, relieving exterior symptoms, and lowering qi; radish seeds have the effect of lowering adverse qi, stopping cough, and relieving asthma. The combination of these two herbs can relieve chest tightness, lower qi, stop cough, and relieve asthma, making them the principal herbs in the formula. Mulberry bark can purge lung heat and relieve asthma; combined with perilla seeds and radish seeds, it enhances the effect of stopping cough and relieving asthma, making it the assistant herb. Tangerine peel (or processed tangerine peel) can regulate qi, relieve chest tightness, dry dampness, resolve phlegm, and stop cough; cinnamon can warm and tonify the spleen and kidneys, and warm and unblock the lung channels. The combination of these two herbs warms the lungs, strengthens the spleen and kidneys, resolves phlegm, unblocks the channels, stops cough, and relieves asthma, making them the adjuvant herbs. At the same time, mulberry bark, tangerine peel (or processed tangerine peel), and cinnamon, with their combined warming and cooling properties, harmonize lung qi. The entire formula, when used together, achieves the effect of stopping cough and relieving asthma, effectively improving the clinical symptoms of patients with chronic obstructive pulmonary disease.

[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] Radish seeds: the dried, mature seeds of Raphanus sativus L., a plant belonging to the genus Raphanus in the family Brassicaceae.

[0011] Mulberry bark: The root bark of Morus alba L., a plant belonging to the genus Morus in the family Moraceae.

[0012] Orange peel: The dried outer pericarp of Citrus reticulata Blanco and its cultivated varieties, belonging to the Rutaceae family.

[0013] Huazhou tangerine peel: the immature or nearly mature outer peel of Citrus grandis (L.) Osbeck var. tomentosa Hort. (C. grandis Tomentosa) or C. grandis (L.) Osbeck, belonging to the Rutaceae family.

[0014] Cinnamon: The dried bark of Cinnamomum cassia Presl, a plant belonging to the genus Cinnamomum in the family Lauraceae.

[0015] In some embodiments, the dosage form of the traditional Chinese medicine composition is an oral solution, powder, granule, or patch.

[0016] In some implementations, pharmaceutically acceptable excipients may also be added.

[0017] According to a second aspect of the present invention, a method for preparing the above-mentioned antitussive and antiasthmatic traditional Chinese medicine composition is provided, wherein when the dosage form of the traditional Chinese medicine composition is an oral solution, the preparation method includes the following steps:

[0018] Soak the raw materials in 8-12 times their weight of water for 20-40 minutes, then heat to boiling and maintain a gentle boil for 1-2 hours. Filter the mixture and boil the residue 1-2 times. Combine the filtrates to obtain the final product.

[0019] According to a third aspect of the present invention, a method for preparing the above-mentioned antitussive and antiasthmatic traditional Chinese medicine composition is provided, wherein when the dosage form of the traditional Chinese medicine composition is a powder, the preparation method includes the following steps:

[0020] Crush or chop each raw material separately, then pass the crushed or chopped raw materials through 10-mesh and 50-mesh sieves respectively. Continue to crush or chop the coarse particles that cannot pass through the 10-mesh sieve, and take the powder that is between the 10-mesh and 50-mesh sieves. Then mix the powders of each raw material according to the formula, put them into a packaging bag, and seal it.

[0021] According to a fourth aspect of the present invention, a method for preparing the above-mentioned antitussive and antiasthmatic traditional Chinese medicine composition is provided, wherein when the dosage form of the traditional Chinese medicine composition is a patch, the preparation method includes the following steps:

[0022] 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.

[0023] In some embodiments, the dressing medium is at least one of honey, vinegar, sesame oil, petroleum jelly, paraffin oil, and rice wine.

[0024] According to a fifth aspect of the present invention, the use of the above-described antitussive and antiasthmatic traditional Chinese medicine composition in the preparation of a medicament for treating chronic obstructive pulmonary disease is provided.

[0025] According to a sixth aspect of the present invention, the use of the above-described antitussive and antiasthmatic traditional Chinese medicine composition in the preparation of an antitussive and antiasthmatic medicament is provided.

[0026] The beneficial effects of this invention include:

[0027] (1) The traditional Chinese medicine composition of the present invention has the effects of relieving cough and asthma, and can effectively improve the clinical symptoms of cough, sputum, wheezing and other symptoms of patients with chronic obstructive pulmonary disease, promote lung recovery, improve the patient's breathing difficulties and improve the patient's quality of life.

[0028] (2) This invention uses a clever combination of herbs, with the chief herbs, perilla seed and radish seed, and the assistant herb, mulberry bark, to relieve chest tightness, lower qi, purge lungs, stop cough and relieve asthma. At the same time, it is combined with tangerine peel (or tangerine peel) and cinnamon to warm the lungs, strengthen the spleen and kidneys, resolve phlegm and unblock the meridians, stop cough and relieve asthma. The whole formula uses both cold and warm herbs, purging the lungs while warming the lungs. It is warm without being dry and cold without harming yang, so as not to deplete lung qi and lung yin, thus achieving the effect of stopping cough and relieving asthma. Detailed Implementation

[0029] 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.

[0030] Example 1

[0031] The oral solution for relieving cough and asthma in this embodiment consists of the following ingredients: 10g of perilla seed, 10g of radish seed, 10g of mulberry bark, 10g of tangerine peel, and 10g of cinnamon.

[0032] Its preparation method includes the following steps:

[0033] (1) Soak the raw materials in 10 times their weight of water for 30 minutes, then heat to boiling and keep simmering for 1 hour. After separation, the first decoction and the dregs are obtained. Take the dregs obtained after the first decoction, add water equivalent to 8 times the total weight of the raw materials, heat to boiling and keep simmering for 1 hour. After separation, the second decoction and the dregs are obtained. Combine the first decoction and the second decoction to obtain an oral solution.

[0034] (2) Cool the obtained oral solution and dispense it into individual containers. This ratio is for one dose, which is approximately 150 mL.

[0035] Example 2

[0036] The cough-relieving and asthma-relieving powder of this embodiment is composed of the following ingredients: 10g of perilla seed, 10g of radish seed, 10g of mulberry bark, 10g of tangerine peel, and 10g of cinnamon.

[0037] Its preparation method includes the following steps:

[0038] (1) Take perilla seeds, crush them, and pass them through 10-mesh and 50-mesh sieves at the same time. Continue to crush the coarse particles that cannot pass through the 10-mesh sieve, and take the powder that is between the 10-mesh and 50-mesh sieves.

[0039] (2) Grind radish seeds, mulberry bark, tangerine peel, and cinnamon into powder according to the method in step (1);

[0040] (3) Mix all the raw material powders evenly, put them into a packaging bag, and seal it.

[0041] (4) When needed, take it with 150mL of warm water.

[0042] Example 3

[0043] The cough-relieving and asthma-relieving patch of this embodiment is composed of the following ingredients: 10g of perilla seeds, 10g of radish seeds, 10g of mulberry bark, 10g of tangerine peel, and 10g of cinnamon.

[0044] (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.

[0045] (2) Grind radish seeds, mulberry bark, tangerine peel, and cinnamon into powder according to the method in step (1);

[0046] (3) Mix all the raw material powders evenly, add an appropriate amount of honey as a dressing medium to make an ointment, then apply the ointment to the adhesive tape, cover it, cut it into small pieces and package it. When using, simply apply the patch to the corresponding acupoint.

[0047] Example 4

[0048] The oral solution for relieving cough and asthma in this embodiment consists of the following ingredients: 15g of perilla seed, 5g of radish seed, 5g of mulberry bark, 15g of tangerine peel, and 15g of cinnamon.

[0049] Its preparation method is similar to that of Example 1.

[0050] Example 5

[0051] The cough-relieving and asthma-relieving patch of this embodiment is composed of the following ingredients: 5g of perilla seeds, 15g of radish seeds, 15g of mulberry bark, 5g of tangerine peel, and 5g of cinnamon.

[0052] Its preparation method is similar to that of Example 3.

[0053] Example of effect

[0054] 1. Inclusion criteria

[0055] (1) Meets the diagnostic criteria for chronic obstructive pulmonary disease;

[0056] (2) Symptoms include cough, sputum production, and shortness of breath:

[0057] (3) Patients who voluntarily participated in the above study and were eligible for follow-up had all signed informed consent forms and were able to cooperate with all examinations related to this study.

[0058] 2. Exclusion criteria

[0059] (1) Patients who require hospitalization;

[0060] (2) Pregnant or lactating women;

[0061] (3) Subjects who are deemed unsuitable to participate in the study by the researcher, such as those with poor compliance or lack of willingness to receive treatment, are likely to be lost to follow-up.

[0062] 3. General Information

[0063] The study included 37 hospitalized patients with chronic obstructive pulmonary disease (COPD) who met the inclusion criteria but did not meet the exclusion criteria, collected from a hospital in Guangzhou between January 9, 2025 and March 8, 2025.

[0064] We collected data on the patient's gender, age, and follow-up, and scored their primary and secondary symptoms. Before treatment, the patient's primary symptoms included cough, sputum production, and wheezing; secondary symptoms included fatigue, chest tightness, rib pain, aversion to wind, loss of appetite, abdominal distension, and spontaneous sweating.

[0065] In addition to standard Western medicine treatments such as anti-inflammatory, antispasmodic, and bronchodilator the patients were given the patch prepared in Example 3. The method of use was as follows: apply the patch to the Tian Tu acupoint, the Tan Zhong acupoint, and the bilateral Ding Chuan acupoints. One patch was applied daily for 6-8 hours each time, and one course of treatment lasted for 7 days.

[0066] Before and after treatment, the patient's primary and secondary symptoms were scored to assess the patient's chronic obstructive pulmonary disease (COPD) symptoms; the patient's cough symptoms were assessed using the VAS score before and after treatment; the patient's dyspnea was assessed using the mMRC score before and after treatment; and the patient's COPD symptoms were assessed using the CAT score before and after treatment to assess the impact of COPD symptoms on the patient's life.

[0067] 4. Therapeutic effect analysis

[0068] The scores of the patient's primary and secondary symptoms before and after treatment are shown in Table 1.

[0069] Table 1. Scores of primary and secondary symptoms of patients before and after treatment ( ±s)

[0070]

[0071] Note: In the table, P indicates that the difference between day 7 and day 1 is statistically significant.

[0072] As shown in Table 1, the scores of the main symptoms and secondary symptoms of patients after 7 days of treatment were significantly lower than those on day 1 (P<0.001), indicating that the antitussive and antiasthmatic Chinese medicine composition of the present invention can effectively improve the symptoms of cough, sputum, wheezing, fatigue, chest tightness and rib pain, aversion to wind, loss of appetite, abdominal distension and spontaneous sweating in patients with chronic obstructive pulmonary disease.

[0073] The cough symptom scores of the patients on days 1, 3, 5, and 7 of treatment are shown in Table 2.

[0074] Table 2. Cough symptom scores of patients on days 1, 3, 5, and 7 of treatment ( ±s)

[0075]

[0076] Note: In the table, P indicates that the difference between day 7 and day 1 is statistically significant.

[0077] As can be seen from Table 2, the cough symptom scores of patients after 7 days of treatment were significantly lower than those on day 1 (P<0.001), indicating that the cough-relieving and asthma-relieving traditional Chinese medicine composition of the present invention can effectively improve the cough symptoms of patients with chronic obstructive pulmonary disease.

[0078] The mMRC scores of the patients before and after treatment are shown in Table 3.

[0079] Table 3. mMRC scores of patients before and after treatment ( ±s)

[0080]

[0081] As can be seen from Table 3, the patients' mMRC scores after 7 days of treatment were significantly lower than those on day 1 (P < 0.001), indicating that the antitussive and asthma-relieving traditional Chinese medicine composition of the present invention can effectively improve the dyspnea in patients with chronic obstructive pulmonary disease.

[0082] The CAT scores of the patients before and after treatment are shown in Table 4.

[0083] Table 4. Patients' CAT scores before and after treatment ( ±s)

[0084]

[0085] As can be seen from Table 4, the CAT scores of patients after 7 days of treatment were significantly lower than those on day 1 (P < 0.001), indicating that the antitussive and antiasthmatic traditional Chinese medicine composition of the present invention can effectively improve the impact of chronic obstructive pulmonary disease symptoms on patients' lives.

[0086] In summary, the antitussive and antiasthmatic traditional Chinese medicine composition of the present invention can effectively improve the clinical symptoms of cough, sputum production, and wheezing in patients with chronic obstructive pulmonary disease, promote lung recovery, alleviate patients' breathing difficulties, and improve patients' quality of life.

[0087] 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 patch for relieving cough and asthma, characterized in that, It is made from the following raw materials in parts by weight: 5-15 parts perilla seed, 5-15 parts radish seed, 5-15 parts mulberry bark, 5-15 parts tangerine peel, and 5-15 parts cinnamon.

2. The traditional Chinese medicine patch for relieving cough and asthma according to claim 1, characterized in that, The orange-red color mentioned is citrus red.

3. The traditional Chinese medicine patch for relieving cough and asthma according to claim 1 or 2, characterized in that, Pharmaceutically acceptable excipients can also be added.

4. The method for preparing the antitussive and asthma-relieving traditional Chinese medicine patch according to any one of claims 1-3, characterized in that, 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.

5. The use of the antitussive and asthma-relieving traditional Chinese medicine patch according to any one of claims 1-3 in the preparation of a medicament for treating chronic obstructive pulmonary disease.

6. The use of the traditional Chinese medicine patch for relieving cough and asthma according to any one of claims 1-3 in the preparation of a medicine for relieving cough and asthma.

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