Application ointment for chronic cough and asthma diseases as well as preparation method and use method of application ointment

Abstract

The invention discloses an application ointment for chronic cough and asthma diseases, a preparation method and a use method, which can effectively treat chronic respiratory diseases such as asthma, chronic obstructive pulmonary disease, bronchiectasis, chronic cough, pulmonary fibrosis and the like with cough and asthma as main symptoms, and is non-invasive, convenient and non-irritant to skin. The application ointment for treating the chronic cough and asthma diseases is prepared from the following raw materials in percentage by mass: 12 to 13 percent of herba ephedrae, 12 to 13 percent of semen armeniacae amarae, 24 to 26 percent of perillaseed, 12 to 13 percent of semen brassicae, 12 to 13 percent of semen raphani, 5 to 7 percent of datura seed, 12 to 13 percent of earthworm, 1 percent of sesame oil and 2 percent of ginger juice.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a patch ointment for chronic cough and asthma diseases, a preparation method of the patch ointment for chronic cough and asthma diseases, and a method for using the patch ointment for chronic cough and asthma diseases. Background Art

[0002] Modern medicine believes that the main pathogenesis of chronic cough and asthma is the change in cough reflex sensitivity under the influence of various stimuli. Common causes include upper airway cough syndrome (postnasal drip syndrome), cough variant asthma, eosinophilic bronchitis, gastroesophageal reflux cough, and allergic cough. Etiological treatment is mainly aimed at the underlying disease that causes upper airway cough syndrome. Taking cough variant asthma as an example, the "Guidelines for the Diagnosis and Treatment of Cough (2021)" recommends the use of ICS (glucocorticoids) + LABA (β2 receptor agonists). The drugs mainly act on bronchial smooth muscles to dilate the airways and relieve airway spasms.

[0003] From the perspective of Traditional Chinese Medicine (TCM), cough and asthma manifest as paroxysmal dysfunction of the lung's defensive qi (wei qi stagnation). The "Lingshu" (Lingshu) states: "Defensive qi retention in the abdomen, twitching and stagnating, and accumulation of qi lost in its proper place, causing sciatica, fullness in the stomach, wheezing, and shortness of breath." TCM believes that chronic cough and asthma are caused by a combination of internal and external factors, with phlegm as the internal cause and wind as the external cause. Phlegm forms due to spleen deficiency, which prevents digestion of food and water, leading to the accumulation of accumulated phlegm. External pathogens, such as fatigue, cold, or a strange smell, mobilize these pathogens. Wind, the root of all diseases, can easily be accompanied by phlegm and damage the lungs. Zhang Jiebin explained, "Asthma caused by excess qi is caused by pathogenic factors, which are excess qi. Asthma caused by deficiency qi is not caused by pathogenic factors, which are deficiency qi." Wind and phlegm damage the lungs, leading to poor lung qi function. Over time, this leads to poor collateral circulation, dysfunctional lung qi distribution, and wheezing and shortness of breath. In TCM, decoctions, acupuncture, cupping, and acupoint application are commonly used to treat chronic cough and asthma.

[0004] Acupoint patching is a complex intervention method that combines medication, acupoints, stimulation dose, and application timing. Based on Traditional Chinese Medicine (TCM) meridian theory, this method utilizes both medication and acupoints for dual therapeutic effects. Through transdermal absorption of the medication, it stimulates local meridian acupoints and stimulates systemic Qi, thereby enhancing the body's ability to prevent and combat disease and reducing the recurrence of illness (particularly chronic lung disease) during the autumn and winter seasons. Modern pharmacy, also known as transdermal drug delivery, avoids the "first-pass elimination" and "gastrointestinal inactivation" effects of oral administration, improving bioavailability. By synergizing the medication and acupoints, a holistic effect is generated. Experimental studies have shown that acupoints, compared to non-acupoint areas, have a thinner stratum corneum and more abundant nerve endings, resulting in exo-sensitivity and amplification effects. These unique physiological functions can produce effects unattainable by non-acupoint drug delivery. Currently, the clinical application of acupoint patching varies, often based on physicians' clinical experience. There are variations in the composition of the medicinal ingredients, preparation methods, acupoint selection, application timing, duration of action, dosage form, and the presence of foaming. In recent years, new dosage forms, such as film-coated and plastered medications, have improved the efficacy of acupuncture. Clinical observations have shown that a 4-hour application duration consistently improves patient symptoms, with greater efficacy during the dog days of summer. Acupoints such as Feishu, Dingchuan, Geshu, Tanzhong, and Tiantu are the most frequently used and most effective for the treatment of respiratory diseases. Acupoint application for cough and asthma has become widely accepted, and each summer, more and more people queue up at hospitals for treatment with acupuncture. However, the three-fu stickers suffer from inconsistent efficacy and a limited application time. Summary of the Invention

[0005] In order to overcome the defects of the existing technology, the technical problem to be solved by the present invention is to provide a patch ointment for chronic cough and asthma diseases, which can effectively treat chronic respiratory diseases with cough and asthma as the main symptoms, including asthma, chronic obstructive pulmonary disease, bronchiectasis, chronic cough, pulmonary fibrosis, etc., which is non-invasive, convenient, and non-irritating to the skin.

[0006] The technical solution of the present invention is that the ointment for chronic cough and asthma diseases contains the following raw materials in percentage by mass: 12-13% of ephedra, 12-13% of apricot kernel, 24-26% of perilla seed, 12-13% of white mustard seed, 12-13% of radish seed, 5-7% of datura seed, 12-13% of earthworm, 1% of sesame oil and 2% of ginger juice.

[0007] The patch ointment of the present invention can effectively treat chronic respiratory diseases with cough and wheezing as main symptoms, including asthma, chronic obstructive pulmonary disease, bronchiectasis, chronic cough, pulmonary fibrosis, etc. It is non-invasive, convenient, and non-irritating to the skin.

[0008] The preparation method of the patch ointment for chronic cough and asthma diseases comprises the following steps:

[0009] (1) crushing and grinding ephedra, apricot kernel, perilla seed, white mustard seed, radish seed, kelp seed and earthworm into 100 mesh fine powder;

[0010] (2) Add the percentage of sesame oil and ginger juice and mix evenly to make a paste, which is placed in a blank non-woven fabric sheet to obtain a Chinese medicine acupoint application ointment.

[0011] Also provided is a method for using the patch ointment for chronic cough and asthma diseases, which includes applying the patch ointment on the Tanzhong point, Dingchuan point, and Feishu point. DETAILED DESCRIPTION

[0012] The ointment for chronic cough and asthma contains the following raw materials by mass percentage: 12-13% ephedra, 12-13% almond, 24-26% perilla seed, 12-13% white mustard seed, 12-13% radish seed, 5-7% datura seed, 12-13% earthworm, 10% sesame oil and 2% ginger juice.

[0013] The patch ointment of the present invention can effectively treat chronic respiratory diseases with cough and wheezing as main symptoms, including asthma, chronic obstructive pulmonary disease, bronchiectasis, chronic cough, pulmonary fibrosis, etc. It is non-invasive, convenient, and non-irritating to the skin.

[0014] Preferably, the ointment for chronic cough and asthma is characterized by comprising the following raw materials: 300g of ephedra, 300g of apricot kernel, 600g of perilla seed, 300g of white mustard seed, 300g of radish seed, 100g of datura seed, 300g of earthworm, 30g of sesame oil, and 50g of ginger juice.

[0015] Preferably, it is used in asthma, chronic obstructive pulmonary disease, bronchiectasis, chronic cough, pulmonary fibrosis.

[0016] Also provided is a method for preparing the ointment for treating chronic cough and asthma, comprising the following steps:

[0017] (1) crushing and grinding ephedra, apricot kernel, perilla seed, white mustard seed, radish seed, kelp seed and earthworm into 100 mesh fine powder;

[0018] (2) Add the percentage of sesame oil and ginger juice and mix evenly to make a paste, which is placed in a blank non-woven fabric sheet to obtain a Chinese medicine acupoint application ointment.

[0019] Preferably, the preparation method further comprises step (3), cutting the blank non-woven fabric patch into a size suitable for application to a designated acupuncture point.

[0020] Preferably, in step (2), the stability and skin penetration of the active ingredients of the drug are ensured by modern pharmaceutical technology.

[0021] Preferably, in step (2), 5 g of the medicine paste is used per patch and is used in combination with a special Sanfutie non-woven fabric.

[0022] The invention also provides a method for using the patch ointment for chronic cough and asthma diseases, which comprises applying the patch ointment on the Tanzhong point, Dingchuan point and Feishu point.

[0023] The embodiments of the present invention are described in detail below.

[0024] Crush 300g of ephedra, 300g of apricot kernel, 600g of perilla seed, 300g of white mustard seed, 300g of radish seed, 100g of datura seed and 300g of earthworm into 100-mesh fine powder, and mix them with 30g of sesame oil and 50g of ginger juice to form a paste to obtain the ointment of the present invention. 5g of the paste is used for each patch and is used in combination with a special Sanfu patch non-woven fabric.

[0025] Applying the above-mentioned drug to the Tanzhong, Dingchuan, and Feishu points in patients with chronic cough and asthma diagnosed with "wind-phlegm-involved lung syndrome" according to Traditional Chinese Medicine (TCM) has shown to effectively improve clinical cough and asthma scores without side effects. Related clinical trials have been completed, and the detailed data are attached below.

[0026] 1. Methods: Sixty patients meeting the Western medical diagnosis of AECOPD and the Traditional Chinese Medicine diagnosis of wind-phlegm obstruction of the lung syndrome were randomly divided into two groups: an experimental group of 30 and a control group of 30. Patients' gender, age, height, weight, duration of COPD, medical history, medication history, the four diagnostic methods of Traditional Chinese Medicine, and current symptoms were recorded at admission. The control group received conventional Western medication, including oxygen therapy, bronchodilators, antibiotics, expectorants, and symptomatic supportive care. The experimental group received Jinlong Huatan Pingchuan acupoint application in addition to conventional treatment.

[0027] 2. Acupoint application: Tiantu point and bilateral Feishu points, once a day, 3-6 hours each time, for a course of 7 days. Blood samples were collected from patients on the first and seventh days after enrollment, and serological indicators such as white blood cell count (WBC), neutrophil percentage (NE%), neutrophil absolute value (NE#), eosinophil percentage (EO%), eosinophil absolute value (EO#), red blood cell mean distribution width (RDW), and C-reactive protein (CRP) levels were recorded. The TCM symptom scores of cough, sputum, chest tightness, and asthma were recorded before treatment, 6 hours after treatment, 1 day after treatment, 3 days after treatment, and 7 days after treatment. The improvement rate of the score was used as the evaluation standard for whether the treatment was effective. The red blood cell count (RBC), hemoglobin (HGB), platelet count (PLT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA) levels, as well as vital signs and adverse reactions were recorded as safety indicators. After the experiment, the data were summarized and analyzed using SPSS22.0. The differences were considered statistically significant when P < 0.05.

[0028] 3. Results:

[0029] 3.1 Comparison of baseline data between the experimental group and the control group:

[0030] (1) There was no statistical difference in demographic data such as gender and age between the two groups of patients (P>0.05).

[0031] (2) There was no statistical difference in the course of COPD and the time of acute exacerbation between the two groups of patients (P>0.05).

[0032] (3) The main comorbidities between the two groups were cardiovascular disease and diabetes, and there was no statistical difference in the incidence of comorbidities (P>0.05).

[0033] (4) There was no statistical difference in TCM syndrome scores and serological indices (WBC, NE%, NE#, EO, EO#, CRP, RDW) (P>0.05). Baseline data showed that the two groups were well comparable.

[0034] 3.2 Comparison of serological indicators before and after treatment:

[0035] (1) The mean WBC values of the two groups were within the normal range. After treatment, the WBC values of the two groups decreased compared with those before treatment, with no statistically significant difference (P>0.05). There was no significant difference in WBC values between the two groups (P>0.05). (2) The NE% and NE# of the two groups were above the upper limit of normal. After treatment, the NE% and NE# decreased, with no statistically significant difference (P>0.05). There was no statistically significant difference in NE% and NE# between the two groups (P>0.05). (3) The EO% and EO# of the two groups were within the normal range before treatment. After treatment, the EO% of the two groups increased compared with those before treatment. There was no statistically significant difference between the two groups before and after treatment (P>0.05). The EO# value of the experimental group decreased compared with that before treatment, while the EO# of the control group increased compared with that before treatment, with no statistically significant difference. There was no statistically significant difference in EO# between the two groups (P>0.05).

[0036] (4) Before treatment, CRP levels in both groups were higher than the upper limit of normal. After treatment, CRP levels decreased compared with those before treatment, with a statistically significant difference (P < 0.05). There was no statistically significant difference in CRP values between the two groups (P > 0.05). (5) Before treatment, RDW levels in both groups were within the normal range. After treatment, RDW levels in both groups decreased compared with those before treatment, with no statistically significant difference (P > 0.05).

[0037] 3.3 Effectiveness evaluation:

[0038] (1) There was no statistical difference in TCM syndrome scores between the experimental and control groups at enrollment (P>0.05). Intra-group comparison showed that the scores of both the experimental and control groups decreased after treatment, with statistical differences (P<0.001). After treatment, the TCM syndrome scores of the experimental group were lower than those of the control group, but there was no statistical difference (P>0.05).

[0039] (2) The effectiveness was evaluated based on the improvement rate of TCM syndrome scores at 6 hours, 1 day, 3 days, and 7 days after treatment. The effectiveness of the experimental group (46.7%-63.3%-73.3%-83.3%) was higher than that of the control group (26.7%-46.7%-63.3%-70%), but there was no statistical difference (P>0.05).

[0040] (3) Before treatment, there was no significant difference in cough scores between the two groups (P>0.05). After treatment, cough scores decreased significantly in both groups, with a significant difference in the experimental group 6 hours after treatment (P<0.05) and in the control group 1 day after treatment (P<0.05). After treatment, cough scores in the experimental group were lower than those in the control group, and the differences between the two groups were statistically significant 6 hours, 3 days, and 7 days after treatment (P<0.05).

[0041] (4) Before treatment, there was no significant difference in the expectoration scores between the two groups. After treatment, the expectoration scores of both groups decreased, and the difference was statistically significant (P < 0.05). Seven days after treatment, the expectoration scores of the experimental group were lower than those of the control group, and the difference was statistically significant (P < 0.05).

[0042] (5) After treatment, the chest tightness and breathlessness scores of the patients were improved compared with those before treatment (P < 0.05). There was no significant difference in the scores between the two groups (P > 0.05).

[0043] 4. Test conclusion:

[0044] (1) Jinlong Huatan Pingchuan Patch can help improve the symptoms of patients with AECOPD of the wind-phlegm obstruction type. It is significantly better than the Western medicine control group in improving cough and sputum symptoms, and the effect is faster.

[0045] (2) The safety evaluation of Jinlong Huatan Pingchuan Patch was good, and no serious adverse events occurred during the trial.

[0046] The medicine of the present invention is applied to specific acupuncture points, and the purpose of preventing and treating diseases is achieved through the combined effect of drug skin absorption and local stimulation of acupuncture points. Clinical trials show that the present invention has outstanding therapeutic effects for treating chronic cough and asthma of "wind-phlegm-involved lung syndrome", and is a breakthrough in the treatment of chronic cough and asthma by combining acupuncture points and meridians with medicine. The treatment of chronic cough and asthma by acupuncture point application is based on the theories of "strengthening the body's resistance and eliminating pathogenic factors", "regulating ascending and descending", and "dispersing blood stasis and unblocking meridians". The acupuncture points enter the internal organs through the meridians through the smell of different medicines, achieving the functions of resisting the body's resistance and eliminating pathogenic factors, coordinating yin and yang, and pivoting ascending and descending. As everyone knows, meridians are an important component of human tissues, the channels for the circulation of human qi and blood, and the independent systems that connect the inside and outside of the human body, connect the internal organs and tissues, and circulate qi and blood. The human body connects the whole body tissues such as the five internal organs, six bowels, five limbs, five sense organs, nine orifices, and four limbs and bones into an organic whole through the meridian system, and completes the functional activities of the body through the effects of essence, qi, blood, and body fluids. Meridians are also a multifunctional, multi-layered, and multi-modal regulatory system, enabling physiological functions at all levels to be stimulated, coordinated, and superimposed, thereby amplifying physiological effects. Therefore, regulating the deficiency and excess of meridians can cure a wide range of ailments. Meridians exhibit unique sensing phenomena, and the meridian system acts as a low-resistance pathway. Therefore, applying effective medications to specific acupuncture points can rapidly produce strong pharmacological effects in the corresponding tissues and organs, exerting a single-phase or biphasic regulatory effect. Therefore, it is effective in treating chronic cough and asthma. The combination of medications and acupuncture points and meridians in treating chronic cough and asthma has significant clinical significance and outstanding economic and social benefits.

[0047] The above description is merely a preferred embodiment of the present invention and does not constitute any form of limitation to the present invention. Any simple modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention are still within the scope of protection of the technical solution of the present invention.

Claims

1. A patch ointment for chronic cough and asthma, characterized in that: Calculated by mass percentage, the invention comprises the following raw materials: 12-13% of ephedra, 12-13% of apricot kernel, 24-26% of perilla seed, 12-13% of white mustard seed, 12-13% of radish seed, 5-7% of datura seed, 12-13% of earthworm, 1% of sesame oil and 2% of ginger juice.

2. The ointment for treating chronic cough and asthma according to claim 1, characterized in that: Contains the following ingredients: ephedra 300g, almond 300g, perilla seed 600g, white mustard seed 300g, radish seed 300g, datura seed 100g, earthworm 300g, sesame oil 30g, ginger juice 50g.

3. The ointment for treating chronic cough and asthma according to claim 1, characterized in that: It is used in asthma, chronic obstructive pulmonary disease, bronchiectasis, chronic cough, and pulmonary fibrosis.

4. The method for preparing the ointment for treating chronic cough and asthma according to any one of claims 1 to 3, characterized in that: It includes the following steps: (1) crushing and grinding ephedra, apricot kernel, perilla seed, white mustard seed, radish seed, kelp seed and earthworm into 100 mesh fine powder; (2) Add the percentage of sesame oil and ginger juice and mix evenly to make a paste, which is placed in a blank non-woven fabric sheet to obtain a Chinese medicine acupoint application ointment.

5. The method for preparing the ointment for treating chronic cough and asthma according to claim 4, wherein: The method also includes step (3), cutting the blank non-woven fabric patch into a size suitable for application to a designated acupuncture point.

6. The method for preparing the ointment for treating chronic cough and asthma according to claim 5, wherein: In the step (2), the stability and skin penetration of the active ingredients of the drug are ensured by modern pharmaceutical technology.

7. The method for preparing the ointment for treating chronic cough and asthma according to claim 4, wherein: In the step (2), 5 g of the medicine paste is used for each patch and is combined with a special Sanfutie non-woven fabric.

8. The method for using the ointment for treating chronic cough and asthma according to claim 1, characterized in that: Apply the ointment on the Tanzhong point, Dingchuan point, and Feishu point.