A cough and asthma relieving patch containing guettarda speciosa and a preparation method thereof

Abstract

The application discloses a cough and asthma relieving patch containing Borneol, which is prepared from the following traditional Chinese medicine decoction pieces: 30-40 parts of Borneol, 20-30 parts of Platycodon Grandiflorum, 18-22 parts of Allium bidentatum, 20-30 parts of Ephedra and the like, and has good effects on treating asthma of the external cold and internal fluid syndrome type by the following functions: warming lung and reducing phlegm, dispersing cold and reducing fluid, invigorating spleen and benefiting qi, warming and tonifying kidney yang, promoting blood circulation to remove blood stasis, reducing fluid to reduce phlegm, promoting qi and relieving depression, and the application further discloses a preparation method of the cough and asthma relieving patch.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and in particular relates to a cough-relieving and asthma-relieving patch containing broadleaf azalea and its preparation method. Background Technology

[0002] Asthma is a chronic airway inflammation involving various cells, such as eosinophils, mast cells, T lymphocytes, neutrophils, and airway epithelial cells, as well as cellular components. This chronic inflammation leads to increased airway hyperresponsiveness, typically resulting in widespread, variable, reversible airflow limitation, and causing recurrent episodes of wheezing, shortness of breath, chest tightness, or cough. These symptoms often occur and worsen at night and / or in the early morning, and most patients experience spontaneous remission or relief with treatment. Based on clinical manifestations, asthma can be divided into acute exacerbation, chronic persistent, and remission phases. The chronic persistent phase refers to the occurrence of symptoms with varying frequency and / or severity each week for a considerable period. In the remission phase, symptoms and signs disappear with or without treatment, and lung function returns to pre-acute exacerbation levels and remains elevated for more than four weeks.

[0003] Traditional Chinese medicine (TCM) believes that asthma is caused by phlegm accumulating in the lungs, which, when triggered by external factors or pathogenic factors, obstructs the airways, impairs the lung's descending function, and leads to paroxysmal wheezing and shortness of breath due to the struggle between phlegm and qi. During an attack, the main symptoms are wheezing in the throat, shortness of breath, difficulty breathing, and even inability to lie flat due to wheezing. It is a common internal medicine condition, more prevalent in northern my country, with an estimated incidence of about 2% of the population. TCM has accumulated rich experience in treating this disease, employing diverse methods with significant efficacy. It not only alleviates symptoms during attacks but also aims to eliminate the root cause and control recurrence through strengthening the body's resistance. Although the *Neijing* (Inner Canon of Medicine) does not use the name "asthma," it mentions terms like "wheezing," which are similar to the characteristics of this disease. TCM classifies asthma into several patterns, including: wind-cold binding the lungs, external cold with internal phlegm, external cold with internal heat, wind-heat invading the lungs, dryness damaging the lungs, summer heat damaging the lung collaterals, pathogenic heat obstructing the lungs, phlegm-heat stagnating in the lungs, phlegm-dampness accumulating in the lungs, and liver fire invading the lungs. External cold with internal phlegm is the most common pattern. The clinical manifestations are: wheezing and coughing, copious thin and frothy sputum, aversion to cold and cold limbs, cold back, no thirst or thirst with a preference for hot drinks, aversion to cold and fever without sweating, pale tongue, white and slippery coating, and wiry and tight pulse. Internal cold phlegm causes aversion to cold and cold limbs, cold back, and no thirst; the internal phlegm is aroused by external cold, obstructing the airways and preventing the lung qi from circulating properly, hence the cough and wheezing, copious thin and frothy sputum; external wind-cold binds the body, hence the aversion to cold and fever, and no sweating; the pale tongue, white and slippery coating, and wiry and slippery pulse are all signs of cold phlegm. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a cough-relieving and asthma-relieving patch containing broadleaf azalea, which has significant curative effect and no side effects.

[0005] To achieve the objectives of this invention, a cough-relieving and asthma-relieving patch containing *Rhodiola rosea* is provided, prepared from the following parts by weight of traditional Chinese medicinal herbs: 30-40 parts of *Rhodiola rosea*, 20-30 parts of *Platycodon grandiflorus*, 18-22 parts of *Aster tataricus*, 20-30 parts of *Ephedra sinica*, 20-30 parts of *Perilla frutescens*, 15-25 parts of *Cinnamomum cassia*, 20-30 parts of dried ginger, 20-30 parts of *Codonopsis pilosula*, 15-35 parts of *Atractylodes macrocephala*, and 20-30 parts of *Astragalus membranaceus*. 20-30 parts of Dioscorea opposita, 18-22 parts of Epimedium, 15-25 parts of Curculigo orchioides, 20-30 parts of Eucommia ulmoides, 25-35 parts of Cuscuta chinensis, 20-30 parts of Angelica sinensis, 18-22 parts of Ligusticum chuanxiong, 15-25 parts of Curcuma zedoaria, 20-30 parts of Salvia miltiorrhiza, 18-22 parts of Prunus armeniaca, 20-30 parts of Eriobotrya japonica leaf, 15-25 parts of Bupleurum chinense, 18-22 parts of Curcuma longa, 20-30 parts of Citronella foenum-graecum, and 28-33 parts of Citrus medica.

[0006] The cough-relieving and asthma-relieving patch containing broadleaf agastache is prepared from the following Chinese herbal medicines in parts by weight: broadleaf agastache 35 parts, platycodon 25 parts, aster 20 parts, ephedra 25 parts, perilla seed 25 parts, cinnamon twig 20 parts, dried ginger 25 parts, codonopsis 25 parts, atractylodes macrocephala 25 parts, astragalus 25 parts, yam 25 parts, epimedium 20 parts, curculigo orchioides 20 parts, eucommia ulmoides 25 parts, dodder seed 30 parts, angelica sinensis 25 parts, chuanxiong rhizome 20 parts, turmeric 20 parts, salvia miltiorrhiza 25 parts, apricot kernel 20 parts, loquat leaf 25 parts, bupleurum 20 parts, turmeric 20 parts, citron 25 parts, and citron 30 parts.

[0007] The cough-relieving and asthma-relieving patch containing *Rhodiola rosea* is prepared from the following parts by weight of traditional Chinese medicine: 30 parts *Rhodiola rosea*, 30 parts *Platycodon grandiflorus*, 18 parts *Aster tataricus*, 30 parts *Ephedra sinica*, 20 parts *Perilla frutescens*, 25 parts *Cinnamomum cassia*, 20 parts *Zingiber officinale*, 30 parts *Codonopsis pilosula*, 15 parts *Atractylodes macrocephala*, 30 parts *Astragalus membranaceus*, 20 parts *Dioscorea opposita*, 22 parts *Epimedium brevicornu*, 15 parts *Curculigo orchioides*, 30 parts *Eucommia ulmoides*, 25 parts *Cuscuta chinensis*, 30 parts *Angelica sinensis*, 18 parts *Ligusticum chuanxiong*, 25 parts *Curcuma zedoaria*, 20 parts *Salvia miltiorrhiza*, 22 parts *Prunus armeniaca*, 20 parts *Eriobotrya japonica*, 25 parts *Bupleurum chinense*, 18 parts *Curcuma longa*, 30 parts *Citrus medica*, and 28 parts *Citrus medica*.

[0008] The cough-relieving and asthma-relieving patch containing broadleaf agastache is prepared from the following Chinese herbal medicines in parts by weight: broadleaf agastache 40 parts, platycodon 20 parts, aster 22 parts, ephedra 20 parts, perilla seed 30 parts, cinnamon twig 15 parts, dried ginger 30 parts, codonopsis 20 parts, atractylodes macrocephala 35 parts, astragalus 20 parts, yam 30 parts, epimedium 18 parts, curculigo orchioides 25 parts, eucommia ulmoides 20 parts, cuscuta 35 parts, angelica sinensis 20 parts, chuanxiong rhizome 22 parts, turmeric 15 parts, salvia miltiorrhiza 30 parts, apricot kernel 18 parts, loquat leaf 30 parts, bupleurum 15 parts, turmeric 22 parts, citron 20 parts, and citron 33 parts.

[0009] The preparation method of the cough-relieving and asthma-relieving patch containing broadleaf agastache is as follows: The broadleaf agastache, ephedra, perilla seed, angelica, chuanxiong rhizome, salvia miltiorrhiza, apricot kernel, bupleurum root, turmeric, citron, and citron are pulverized into fine powder, extracted three times by heating and reflux with 85% ethanol, the extracts are combined, and the ethanol is recovered from the filtrate under reduced pressure. The residue after ethanol extraction is decocted three times with water along with other Chinese herbs, the filtrates are combined, concentrated, and the ethanol concentration is adjusted to 80% with 95% ethanol. After ethanol precipitation for 24 hours, the supernatant is combined with the above-mentioned concentrated ethanol extract, and concentrated to a clear paste with a relative density of 1.30 at 80℃. Excipients are added, and the paste is placed on a carrier to prepare the patch.

[0010] The preparation method of the cough and asthma relief patch containing broadleaf agastache involves three extractions by heating and reflux with 85% ethanol, adding 10 times the weight of the Chinese herbal medicine slices of ethanol each time, and decocting with water three times, adding 10 times the weight of the Chinese herbal medicine slices of water each time, and decocting with ...

[0011] The cough-relieving and asthma-relieving patch containing broadleaf agastache is prepared by using one or more of the following excipients: honey, vinegar, sesame oil, petrolatum, paraffin oil, and rice wine.

[0012] The cough-relieving and asthma-relieving patch containing broadleaf azalea is prepared by using a carrier made of one of the following: non-woven fabric, gauze, adhesive tape, plaster, or medical rubber.

[0013] The application of the cough-relieving and asthma-relieving patch containing broadleaf azalea in the preparation of asthma treatment patches.

[0014] The application of the cough-relieving and asthma-relieving patch containing broadleaf agastache in the preparation of a patch for treating asthma, where asthma belongs to the external cold and internal phlegm syndrome type.

[0015] The application of the cough-relieving and asthma-relieving patch containing broadleaf azalea in the preparation of asthma treatment patches, wherein the patch is applied to the Tanzhong, Tiantu, and Feishu acupoints respectively.

[0016] The ingredients listed, including Platycodon grandiflorus, Aster tataricus, Ephedra sinica, Perilla frutescens, Cinnamomum cassia, Zingiber officinale, Codonopsis pilosula, Atractylodes macrocephala, Astragalus membranaceus, Dioscorea opposita, Epimedium brevicornu, Curculigo orchioides, Eucommia ulmoides, Cuscuta chinensis, Angelica sinensis, Ligusticum chuanxiong, Curcuma zedoaria, Salvia miltiorrhiza, Prunus armeniaca, Eriobotrya japonica, Bupleurum chinense, Curcuma longa, Citrus medica, and Citrus medica, all conform to the Chinese Pharmacopoeia.

[0017] The clinical manifestations of external cold and internal phlegm retention are: wheezing and coughing, copious thin and frothy sputum, aversion to cold and cold limbs, cold back, no thirst or thirst with a preference for hot drinks, aversion to cold and fever without sweating, pale tongue, white and slippery coating, and wiry and tight pulse. The internal cold and phlegm retention cause aversion to cold and cold limbs, cold back, and no thirst; the internal phlegm retention is triggered by external cold, obstructing the airways and preventing the lung qi from circulating properly, hence the cough, wheezing, and copious thin and frothy sputum; the external wind-cold binding the body causes aversion to cold and fever without sweating; the pale tongue, white and slippery coating, and wiry and slippery pulse are all signs of cold and phlegm retention. First, internal dampness and phlegm accumulate, and exposure to wind and cold triggers the internal dampness, obstructing the airways and preventing the lung qi from descending. The treatment should focus on warming the lungs and resolving phlegm. Simultaneously, external cold and internal dampness are often accompanied by chills, fever, and lack of sweating, requiring the use of pungent and cold-dispersing herbs. Second, spleen deficiency leads to impaired function, resulting in internal dampness and phlegm accumulation, affecting the airways and causing recurrent coughs, wheezing, and phlegm. Therefore, it is necessary to strengthen the spleen and replenish qi, nourishing the earth element to generate metal. Third, the lungs govern qi and respiration; insufficient lung qi leads to respiratory dysfunction. Regular fatigue and sweating, persistent cough, lingering phlegm and heat, internal retention of fluids, frequent exposure to external pathogens, or chronic illness can all cause lung qi and yin deficiency, leading to shortness of breath and wheezing. As stated in the *Suwen* (Plain Questions) chapter "On the True Organs and Viscera," "In autumn, if the pulse is insufficient, it causes wheezing, shortness of breath, and coughing." The *Zhengzhi Zhunsheng* (Standards of Diagnosis and Treatment) also states, "Lung deficiency causes shortness of breath and wheezing." The kidneys, located in the lower jiao (lower burner), are the root of qi and govern the intake of qi. Excessive sexual activity can damage the kidneys, or prolonged illness can affect the kidneys, leading to kidney deficiency and impaired kidney function, resulting in more exhalation than inhalation and shortness of breath upon exertion. As Zhao Xianke of the Ming Dynasty stated in his *Medical Treatise on Asthma*, "When the true essence is depleted, shortness of breath arises from the upward rushing of kidney qi… and the qi fails to return to its origin." Furthermore, the kidneys govern water and the fire of the gate of life (mingmen). When the fire weakens and cannot warm the earth (earth element), water loses its control and rises, forming phlegm and fluid retention. In addition, when the heart yang is weak and cannot descend to the kidneys, leading to heart and kidney yang deficiency, water loses its control and can rise with the lung qi, attacking the heart and lungs, causing shortness of breath and palpitations. Therefore, in addition to strengthening the spleen and benefiting the kidneys, warming and tonifying kidney yang is essential. Fourth, Li Dan of the Ming Dynasty recognized a certain relationship between this disease and blood stasis in his *Introduction to Medicine*, pointing out that "lung distension, caused by phlegm and blood stasis obstructing qi, results in shortness of breath upon exertion." The *Suwen* (Plain Questions) states, "When evil enters the vessels, cold causes blood to congeal," indicating that using blood-activating and stasis-removing drugs is helpful in treating asthma. Fifth, external pathogenic wind and cold can bind the lung qi, causing it to rise and reverse upwards, requiring the resolution of phlegm and the downward flow of qi. Sixth, asthma is often affected by emotions. The *Miscellaneous Diseases: Origins and Development* states, "Worry is a disease of the lungs and glands… It is sometimes called Taiyin along with the spleen, circulating qi to nourish all organs. When the lungs become diseased by worry, the qi becomes blocked and cannot be released. The qi is trapped internally and cannot flow, leading to constipation and damage to the spleen. Therefore, worry is also a disease of the spleen." Excessive worry causes stagnation of lung and spleen qi, resulting in blocked qi flow, hence symptoms such as depression, chest tightness, and shortness of breath; impaired spleen qi flow leads to abdominal distension, poor appetite, and constipation; a choppy pulse is a sign of qi stagnation; anger can trigger asthma attacks, requiring the promotion of qi and the release of stagnation.

[0018] This invention employs broadleaf atractylodes, platycodon, aster, ephedra, and perilla seed to warm the lungs and resolve phlegm, combined with cinnamon twig and dried ginger to dispel cold phlegm, serving as the principal herbs; codonopsis, atractylodes, astragalus, and yam to invigorate the spleen and replenish qi, nourishing earth to generate metal; epimedium, curculigo, eucommia, and cuscuta to invigorate the spleen and kidneys, warming and tonifying kidney yang, serving as the assistant herbs; angelica, chuanxiong, turmeric, and salvia miltiorrhiza to promote blood circulation and remove blood stasis, serving as the adjuvant herbs; apricot kernel and loquat leaf to descend rebellious qi and resolve phlegm; bupleurum, turmeric, citron, and citron to regulate qi and relieve stagnation, serving as the adjuvant herbs. The formula contains Platycodon grandiflorus, Aster tataricus, Ephedra sinica, Perilla frutescens, Cinnamomum cassia, Zingiber officinale, Codonopsis pilosula, Atractylodes macrocephala, Astragalus membranaceus, Dioscorea opposita, Epimedium brevicornu, Curculigo orchioides, Eucommia ulmoides, Cuscuta chinensis, Angelica sinensis, Ligusticum chuanxiong, Curcuma zedoaria, Salvia miltiorrhiza, Prunus armeniaca, Eriobotrya japonica, Bupleurum chinense, Curcuma longa, Citrus medica, and Citrus medica. It works by warming the lungs and resolving phlegm, dispersing cold phlegm, strengthening the spleen and replenishing qi, warming and tonifying kidney yang, promoting blood circulation and removing blood stasis, lowering adverse qi and resolving phlegm, and regulating qi and relieving stagnation. When prepared as a patch, it has a good effect on treating asthma with external cold and internal phlegm syndrome. Detailed Implementation

[0019] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the description of this invention, those skilled in the art can make various alterations or modifications to the invention, but these equivalent forms also fall within the scope defined by the appended claims.

[0020] Example 1: Take 35g of broadleaf agastache, 25g of platycodon, 20g of aster, 25g of ephedra, 25g of perilla seed, 20g of cinnamon twig, 25g of dried ginger, 25g of codonopsis, 25g of atractylodes macrocephala, 25g of astragalus, 25g of yam, 20g of epimedium, 20g of curculigo orchioides, 25g of eucommia, 30g of cuscuta, 25g of angelica sinensis, 20g of chuanxiong rhizome, 20g of turmeric, 25g of salvia miltiorrhiza, 20g of apricot kernel, 25g of loquat leaf, 20g of bupleurum, 20g of turmeric, 25g of citron, and 30g of bergamot. The preparation method is as follows: the above broadleaf agastache, ephedra, perilla seed, angelica sinensis, chuanxiong rhizome, salvia miltiorrhiza, apricot kernel, and bupleurum... Turmeric, citron, and Buddha's hand are pulverized into a fine powder and extracted three times by heating and reflux with 85% ethanol. Each time, 10 times the weight of the medicinal herbs in ethanol is added, and the extraction time is 2 hours each time. The extracts are combined, and the ethanol is recovered from the filtrate under reduced pressure. The residue after ethanol extraction is decocted three times with water along with other medicinal herbs. Each time, 10 times the weight of the medicinal herbs in water is added, and the extraction time is 2 hours each time. The filtrates are combined, concentrated, and the alcohol concentration is adjusted to 80% with 95% ethanol. The precipitate is allowed to stand for 24 hours. The supernatant is then combined with the above concentrated ethanol extract and concentrated to a clear paste with a relative density of 1.30 at 80°C. Honey is added, and the paste is placed on gauze to prepare a patch.

[0021] Example 2: Take 30g of broadleaf azalea, 30g of platycodon, 18g of aster, 30g of ephedra, 20g of perilla seed, 25g of cinnamon twig, 20g of dried ginger, 30g of codonopsis, 15g of atractylodes macrocephala, 30g of astragalus, 20g of yam, 22g of epimedium, 15g of curculigo orchioides, 30g of eucommia, 25g of cuscuta seed, 30g of angelica sinensis, 18g of chuanxiong rhizome, 25g of turmeric, 20g of salvia miltiorrhiza, 22g of apricot kernel, 20g of loquat leaf, 25g of bupleurum root, 18g of turmeric, 30g of citron, and 28g of bergamot. The preparation method is as follows: the above broadleaf azalea, ephedra, perilla seed, angelica sinensis, chuanxiong rhizome, salvia miltiorrhiza, apricot kernel, bupleurum root, Turmeric, citron, and Buddha's hand were pulverized into a fine powder and extracted three times by heating and reflux with 85% ethanol. Each time, 10 times the weight of the medicinal herbs in ethanol was added, and the extraction time was 2 hours each time. The extracts were combined, and the ethanol was recovered from the filtrate under reduced pressure. The residue after the ethanol extraction was decocted three times with water along with other medicinal herbs. Each time, 10 times the weight of the medicinal herbs in water was added, and the extraction time was 2 hours each time. The filtrates were combined, concentrated, and the alcohol concentration was adjusted to 80% with 95% ethanol. After ethanol precipitation for 24 hours, the supernatant was collected and combined with the above concentrated ethanol extract. The extract was concentrated to 80°C, and a clear paste with a relative density of 1.30 was obtained. Vaseline was added, and the paste was placed on a plaster to prepare a patch.

[0022] Example 3: Take 40g of broadleaf agastache, 20g of platycodon, 22g of aster, 20g of ephedra, 30g of perilla seed, 15g of cinnamon twig, 30g of dried ginger, 20g of codonopsis, 35g of atractylodes macrocephala, 20g of astragalus, 30g of yam, 18g of epimedium, 25g of curculigo orchioides, 20g of eucommia, 35g of cuscuta, 20g of angelica sinensis, 22g of chuanxiong rhizome, 15g of turmeric, 30g of salvia miltiorrhiza, 18g of apricot kernel, 30g of loquat leaf, 15g of bupleurum, 22g of turmeric, 20g of citron, and 33g of citron. The preparation method is as follows: the above broadleaf agastache, ephedra, perilla seed, angelica sinensis, chuanxiong rhizome, salvia miltiorrhiza, apricot kernel, and bupleurum... Turmeric, citron, and Buddha's hand are pulverized into fine powder and extracted three times by heating and reflux with 85% ethanol. Each time, 10 times the weight of the Chinese medicinal herbs in ethanol is added, and the extraction time is 2 hours each time. The extracts are combined, and the ethanol is recovered from the filtrate under reduced pressure. The residue after ethanol extraction is decocted three times with water along with other Chinese medicinal herbs. Each time, 10 times the weight of the Chinese medicinal herbs in water is added, and the extraction time is 2 hours each time. The filtrates are combined, concentrated, and the alcohol concentration is adjusted to 80% with 95% ethanol. The alcohol is precipitated for 24 hours, and the supernatant is combined with the above concentrated ethanol extract. The extract is concentrated to a clear paste with a relative density of 1.30 at 80°C. Sesame oil is added, and the paste is placed on non-woven fabric to prepare a patch.

[0023] Example 4: The antitussive effect of the present invention on ammonia-induced cough mice

[0024] Thirty Kunming mice, half male and half female, were randomly divided into three groups according to body weight: a blank control group, a positive control group (approval number: Z12020200, manufacturer: Tianjin Tongrentang Group Co., Ltd.), and the first embodiment of this invention group, with 10 mice in each group. One day before administration, the fur on the abdomen and back of the mice was shaved to an area of ​​2cm × 2cm. The test drug solution was evenly applied to the shaved areas on the back and abdomen of the mice. The blank control group received 0.4mL of physiological saline per mouse, the positive control group received 2cm × 2cm pieces of cough and asthma ointment (one piece each for the abdomen and back), and the first embodiment of this invention group received 2cm × 2cm pieces (one piece each for the abdomen and back). After administration, the drug was fixed using a self-made tool. After 7 consecutive days of administration, 4 hours after the last administration, mice were placed in a glass jar with filter paper containing 0.5 ml of concentrated ammonia suspended inside to induce coughing for 30 seconds. The mice were then quickly removed and placed in a beaker. The presence or absence of coughing was used as the standard for observing the appearance of abdominal muscle contraction, chest retraction, and mouth opening (whether or not there was a cough). The number of coughs and latency (in seconds) were recorded over 5 minutes.

[0025] The antitussive effect of this invention on mice is shown in Table 1.

[0026] Table 1. Effect of the present invention on the antitussive effect of ammonia-induced cough in mice (x±s, n=10)

[0027] Group Number of coughs (times / 5 minutes) Incubation period (s) Blank control 29.45±18.73 15.73±7.34 Example 1 Group 12.90±6.18*# 23.32±16.56*# Positive drug group 16.49±8.93* 14.36±9.04*

[0028] Compared with the control group, *<0.05; compared with the positive control group, #<0.05

[0029] Table 1 shows that, compared with the control group, the group treated with the present invention (Example 1) significantly inhibited the number of coughs in mice (P < 0.05) and showed a trend of increasing the latency period of cough in mice, with better effects than the positive control group. This indicates that the present invention has a certain antitussive effect.

[0030] Example 5: The antiasthmatic effect of the present invention

[0031] Guinea pig acetylcholine and histamine phosphate induced asthma method. Fifty healthy guinea pigs were pre-selected. Each guinea pig was placed in a 4L sealed glass bell jar. After calming down, an equal volume mixture of 2% acetylcholine chloride and 0.1% histamine phosphate was sprayed at a pressure of 400 mmHg for 15 seconds for pre-selection. After the spraying stopped, the latency period for asthma induction was observed within 6 minutes, i.e., the time from when the asthma-induced convulsions appeared after the spraying stopped. Insensitive guinea pigs with a latency period exceeding 120 seconds were not selected. On the second day, 30 pre-selected guinea pigs were randomly divided into 4 groups according to weight: a blank control group, a positive drug cough and asthma ointment group (approval number: Z12020200, manufacturer: Tianjin Tongrentang Group Co., Ltd.), and the first example of this invention group, with 10 guinea pigs in each group. Before administration, the fur on the abdomen and back of guinea pigs was shaved to an area of ​​3cm × 4cm. The test drug solution was evenly applied to the shaved areas on the back and abdomen of the mice. The positive control group (3cm × 4cm patches, one for the abdomen and one for the back) and the first group of this invention (3cm × 4cm patches, one for the abdomen and one for the back) were treated. After administration, the drug was fixed using a self-made tool. Each group was administered the patch once daily for two consecutive days. Two hours and four hours after the last administration, the above method of inducing asthma was repeated, and the latency period of asthma induction in the guinea pigs within 6 minutes was recorded (if the latency period exceeded 6 minutes, the latency period was calculated as 360 seconds).

[0032] The results of the antiasthmatic effect of this invention on guinea pigs are shown in Table 2.

[0033] Table 2. Effects of this invention on the latency period of guinea pig asthma (x±s, n=10)

[0034] Group Latent period (S) before medication-induced asthma Latency period (S) for asthma induction 2 hours after drug administration 4-hour latency period (S) for asthma induction after drug administration Blank control 62.86±17.45 61.64±14.72 62.20±15.51 Example 1 Group 61.54±16.43 74.33±16.86 89.72±19.32*# Positive drug group 61.74±18.04 65.92±15.29 67.51±16.09

[0035] Compared with the control group, *<0.05; compared with the positive control group, #<0.05

[0036] The results in Table 2 show that, compared with the latency period of asthma induction before drug administration, there was no significant change in the blank control group; 2 hours after drug administration, all drug administration groups showed an increasing trend, but there was no significant difference (P>0.05); 4 hours after drug administration, the latency period of asthma in the group of Example 1 of this invention was significantly prolonged (P<0.05), and the effect was better than that of the positive drug group, indicating that this invention has a certain antiasthmatic effect.

[0037] Example 6: Clinical Study

[0038] One hundred patients with bronchial asthma exhibiting external cold and internal phlegm syndrome admitted between January 2022 and April 2023 were selected and randomly divided into a control group and a study group, with 50 patients in each group. The control group consisted of 30 males and 20 females, aged 28-65 years, with a disease duration of 2-9 years. The study group consisted of 28 males and 22 females, aged 25-67 years, with a disease duration of 2-10 years. There were no statistically significant differences in general characteristics between the two groups (P>0.05), indicating comparability.

[0039] Inclusion and Exclusion Criteria Inclusion Criteria: (1) Meets the relevant diagnostic criteria of both Traditional Chinese Medicine and Western Medicine. (2) According to TCM syndrome differentiation, the patient is diagnosed with external cold and internal phlegm retention syndrome (wheezing and coughing, copious thin and frothy sputum, cold limbs, cold back, no thirst, or thirst with preference for hot drinks, aversion to cold, fever without sweating, pale tongue, white and slippery coating, and wiry and tight pulse). (3) Good treatment compliance. (4) No abnormalities in consciousness and mental state, able to communicate normally, and actively cooperate with the research. (5) Informed and voluntary participation in the research. Exclusion Criteria: (1) Patients with other types of respiratory diseases. (2) Patients with severe organ dysfunction. (3) Patients who have received related drug treatment within one month prior to treatment. (4) Patients in special periods such as pregnancy or lactation. (5) Patients allergic to the research drug.

[0040] The control group received a cough and asthma plaster (approval number: Z12020200, manufacturer: Tianjin Tongrentang Group Co., Ltd.), applied to the Tanzhong, Tiantu, and Feishu acupoints for 2 hours each time, 3 times a day. The group receiving Example 1 of this invention received the plaster prepared according to the method of Example 1, applied to the Tanzhong, Tiantu, and Feishu acupoints for 2 hours each time, 3 times a day. Both groups were treated continuously for 4 weeks.

[0041] Clinical observation indicators: (1) TCM syndrome score. Before and after treatment, cough, sputum, wheezing, chest tightness and wheezing were scored on both groups using a 0-4 scale. The higher the score, the more severe the symptoms. (2) Lung function index level. Before and after treatment, forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and peak expiratory flow (PEF) of both groups were measured using a pulmonary function testing instrument, and their percentages relative to predicted values ​​were compared, i.e., FEV1%, FVC%, and PEF%. (3) Efficacy. The efficacy was evaluated based on the efficacy rate of the symptoms, signs and TCM syndrome scores of the two groups. The efficacy rate of TCM syndrome score = (total score before treatment - total score after treatment) / total score before treatment × 100%. Cured: Symptoms and signs completely or basically disappeared after treatment, and the efficacy rate was not less than 95%. Significantly effective: Symptoms and signs significantly improved after treatment, and the efficacy rate was between 70% and 95%. Effective: Symptoms and signs were relieved after treatment, and the efficacy rate was between 30% and 70%. Ineffective: Symptoms and signs did not improve significantly or worsened after treatment, and the efficacy rate was less than 30%. The total effective rate was the sum of the proportions of the remaining patients excluding the ineffective patients. (4) Adverse reactions: Record the adverse reactions of the two groups.

[0042] 2.1 Comparison of TCM syndrome scores between the two groups, see Table 3.

[0043] Table 3 Comparison of TCM syndrome scores between the two groups

[0044]

[0045] Compared with pre-treatment levels, *<0.05; compared with the control group, #<0.05

[0046] As shown in Table 3, after treatment, the scores of all TCM syndromes in both groups were lower than before treatment, and the scores of Example 1 group were lower than those in the control group (P<0.05).

[0047] Table 4 shows a comparison of the lung function index levels between the two groups.

[0048] Table 4 Comparison of pulmonary function index levels between the two groups

[0049]

[0050] Compared with pre-treatment levels, *<0.05; compared with the control group, #<0.05

[0051] After treatment, FEV1%, FVC%, and PEF% in both groups were higher than before treatment, and the values ​​in Example 1 group were higher than those in the control group (P < 0.05).

[0052] Comparison of clinical efficacy between the two groups: In Example 1 group (n=50), 10 cases were cured, 15 cases showed significant improvement, 21 cases showed improvement, and 4 cases were ineffective, with a total effective rate of 92.00%; in the control group (n=50), 5 cases were cured, 18 cases showed significant improvement, 14 cases showed improvement, and 13 cases were ineffective, with a total effective rate of 74.00%. The difference in clinical efficacy between the two groups was statistically significant (P<0.05), indicating that the efficacy of the present invention is better than that of the control group.

[0053] In summary, this invention can effectively relieve symptoms and improve lung function in patients with asthma due to external cold and internal phlegm retention, with definite efficacy and high safety.

[0054] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A cough-relieving and asthma-relieving patch containing Rhododendron macrophylla, characterized in that, It is prepared from the following parts by weight of Chinese medicinal herbs: 30-40 parts of broadleaf atractylodes, 20-30 parts of platycodon, 18-22 parts of aster, 20-30 parts of ephedra, 20-30 parts of perilla seed, 15-25 parts of cinnamon twig, 20-30 parts of dried ginger, 20-30 parts of codonopsis, 15-35 parts of atractylodes macrocephala, 20-30 parts of astragalus, 20-30 parts of dioscorea opposita, and 18 parts of epimedium. -22 parts, Curculigo orchioides 15-25 parts, Eucommia ulmoides 20-30 parts, Cuscuta chinensis 25-35 parts, Angelica sinensis 20-30 parts, Ligusticum chuanxiong 18-22 parts, Curcuma zedoaria 15-25 parts, Salvia miltiorrhiza 20-30 parts, Prunus armeniaca 18-22 parts, Eriobotrya japonica 20-30 parts, Bupleurum chinense 15-25 parts, Curcuma longa 18-22 parts, Citronella tamariscina 20-30 parts, Citrus medica 28-33 parts.

2. The cough-relieving and asthma-relieving patch containing Rhododendron simsii as described in claim 1, characterized in that, This medicine was prepared by extracting the following parts by weight of Chinese medicinal herbs: 35 parts of broadleaf atractylodes, 25 parts of platycodon, 20 parts of aster, 25 parts of ephedra, 25 parts of perilla seed, 20 parts of cinnamon twig, 25 parts of dried ginger, 25 parts of codonopsis, 25 parts of atractylodes macrocephala, 25 parts of astragalus, 25 parts of yam, 20 parts of epimedium, 20 parts of curculigo orchioides, 25 parts of eucommia, 30 parts of cuscuta, 25 parts of angelica sinensis, 20 parts of chuanxiong rhizome, 20 parts of turmeric, 25 parts of salvia miltiorrhiza, 20 parts of apricot kernel, 25 parts of loquat leaf, 20 parts of bupleurum, 20 parts of turmeric, 25 parts of citron, and 30 parts of citron.

3. The cough-relieving and asthma-relieving patch containing Rhododendron simsii as described in claim 1, characterized in that, This medicine was prepared by extracting the following parts by weight of Chinese medicinal herbs: 30 parts of broadleaf atractylodes, 30 parts of platycodon, 18 parts of aster, 30 parts of ephedra, 20 parts of perilla seed, 25 parts of cinnamon twig, 20 parts of dried ginger, 30 parts of codonopsis, 15 parts of atractylodes macrocephala, 30 parts of astragalus, 20 parts of yam, 22 parts of epimedium, 15 parts of curculigo orchioides, 30 parts of eucommia, 25 parts of cuscuta seed, 30 parts of angelica sinensis, 18 parts of chuanxiong rhizome, 25 parts of turmeric, 20 parts of salvia miltiorrhiza, 22 parts of apricot kernel, 20 parts of loquat leaf, 25 parts of bupleurum root, 18 parts of turmeric, 30 parts of citron, and 28 parts of citron.

4. The cough-relieving and asthma-relieving patch containing Rhododendron simsii as described in claim 1, characterized in that, It is prepared by extracting the following Chinese medicinal herbs in parts by weight: 40 parts of broadleaf atractylodes, 20 parts of platycodon, 22 parts of aster, 20 parts of ephedra, 30 parts of perilla seed, 15 parts of cinnamon twig, 30 parts of dried ginger, 20 parts of codonopsis, 35 parts of atractylodes macrocephala, 20 parts of astragalus, 30 parts of yam, 18 parts of epimedium, 25 parts of curculigo orchioides, 20 parts of eucommia, 35 parts of cuscuta seed, 20 parts of angelica sinensis, 22 parts of chuanxiong rhizome, 15 parts of turmeric, 30 parts of salvia miltiorrhiza, 18 parts of apricot kernel, 30 parts of loquat leaf, 15 parts of bupleurum, 22 parts of turmeric, 20 parts of citron, and 33 parts of citron.

5. The cough-relieving and asthma-relieving patch containing Rhododendron simsii as described in claim 1, characterized in that, The preparation method is as follows: The above-mentioned herbs, including broadleaf azalea, ephedra, perilla seed, angelica, chuanxiong rhizome, salvia miltiorrhiza, apricot kernel, bupleurum root, turmeric, citron, and citron, are pulverized into fine powder and extracted three times by heating and reflux with 85% ethanol. The extracts are combined, and the ethanol is recovered from the filtrate under reduced pressure. The residue after ethanol extraction is decocted three times with water along with other Chinese herbs. The filtrates are combined, concentrated, and the alcohol concentration is adjusted to 80% with 95% ethanol. After ethanol precipitation for 24 hours, the supernatant is taken and combined with the above-mentioned concentrated ethanol extract. The extract is concentrated to a clear paste with a relative density of 1.30 at 80℃. Excipients are added, and the paste is placed on a carrier to prepare a patch.

6. The cough-relieving and asthma-relieving patch containing Rhododendron simsii as described in claim 5, characterized in that, The preparation method involves three extractions using 85% ethanol under reflux, with 10 times the weight of the Chinese medicinal herbs added each time, and each extraction lasting 2 hours; and three decoctions using water, with 10 times the weight of the Chinese medicinal herbs added each time, and each decoction lasting 2 hours.

7. The cough-relieving and asthma-relieving patch containing Rhododendron simsii as described in claim 5, characterized in that, The auxiliary materials used in the preparation method are one or more of the following: honey, vinegar, sesame oil, petrolatum, paraffin oil, and rice wine.

8. The cough-relieving and asthma-relieving patch containing Rhododendron simsii as described in claim 5, characterized in that, In the preparation method, the carrier is one of non-woven fabric, gauze, or adhesive plaster.

9. The application of the cough-relieving and asthma-relieving patch containing Rhododendron simsii as described in claim 1 in the preparation of an asthma treatment patch.

10. The application of the cough-relieving and asthma-relieving patch containing *Rhodiola rosea* as described in claim 1 in the preparation of an asthma treatment patch, characterized in that, Asthma belongs to the syndrome of external cold and internal phlegm retention.

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