A Chinese medicine navel patch for treating chronic cough and preparation method thereof

Abstract

The invention relates to a Chinese medicine navel patch for treating chronic cough and a preparation method thereof. The Chinese medicine navel patch is prepared from the following Chinese medicine composition: 7-9 parts by weight of ephedra, 1.3-1.7 parts by weight of asarum, 7-9 parts by weight of ginger, 1.7-2.3 parts by weight of cynomorium songaricum, 7-9 parts by weight of pinellia tuber, 7-9 parts by weight of aster, 7-9 parts by weight of coltsfoot flower, 8.7-11.3 parts by weight of ebony root, 7-9 parts by weight of bergenia, 4.3-5.7 parts by weight of bombyx batryticatus, 4.3-5.7 parts by weight of earthworm, 17.5-22.5 parts by weight of dwarf tea, 2.6-3.4 parts by weight of gallnut, 2.6-3.4 parts by weight of schisandra chinensis, 4.3-5.7 parts by weight of radix platycodonis, 5.2-6.8 parts by weight of platycodon, 7-9 parts by weight of white mulberry bark, 5.2-6.8 parts by weight of liquorice and 7-9 parts by weight of vaccaria segetalis. The Chinese medicine navel patch of the present invention takes replenishing kidney yang as the fundamental principle and warms and regulates the lung as the surface, harmonizes the inside and outside, and achieves the effect of treating both the symptoms and the root cause of chronic cough.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine navel patch for treating chronic cough and a preparation method thereof. Background Art

[0002] Chronic cough is a common chronic disease of the respiratory system, with cough as the only (or main) symptom, a course of cough > 8 weeks, no obvious abnormalities in imaging, but repeated attacks and prolonged illness. Modern medicine believes that chronic cough is not only a persistent symptom of some diseases, but also a disease with specific pathophysiology, that is, it manifests in the high sensitivity of the respiratory tract to endogenous or exogenous stimuli. In terms of treatment, Western medicine will give antibiotics, glucocorticoids, antitussives or antihistamines and other drugs according to the different causes of chronic cough, or use non-drug therapies such as staying away from allergens, but the long-term clinical efficacy is poor, and it also causes great psychological and economic pressure on patients. There is no name for chronic cough in traditional Chinese medicine, and it is now mostly classified as "cough" or "long-term cough". Traditional Chinese medicine has rich experience in treating chronic cough, or "stubborn cough", with various methods, focusing on syndrome differentiation and treatment and individualized diagnosis and treatment, and has unique advantages in controlling cough symptoms and improving the quality of life of patients.

[0003] At present, the relevant technology of Chinese medicine navel patch for treating chronic cough, such as Chinese patent application CN118021925A, discloses a Chinese medicine composition for treating refractory chronic cough, which is a decoction, tablet, pill, powder, capsule granule, and its treatment principle is mainly to take cold phlegm in the lung as the main pathogenesis, and also has wind evil internal disturbance, internal heat caused by body fluid injury, etc., and is composed of classical Chinese medicine prescriptions such as Linggan Wuwei Jiangxin Decoction and Guomin Jian, and is combined with additions and subtractions, and the purpose of treating refractory chronic cough patients is achieved by warming the lungs and transforming phlegm, dispersing wind and cold, and nourishing yin and clearing heat. Chinese patent application CN118078947A discloses a Chinese medicine preparation for treating refractory chronic cough and its preparation method, which is a decoction or oral granule, which is mainly aimed at the problems of coughing leading to weakness, coughing due to weakness, long-term cough, stubborn cough that will hurt the lungs, and the dissipation of old lung qi, and adopts three medicines such as green fruit charcoal, black plum charcoal, and yam to astringe lung qi to assist the medicine in astringing the lungs and relieving cough. Chinese patent application CN117427132A is a Chinese medicine composition for treating chronic cough and its application in dogs. It is an oral preparation, which is made up of stewed kudzu root powder, celandine, smilax glabra, flax seeds, etc., with the liver as the fundamental, taking into account the kidney and spleen, and supplemented by removing dampness and expelling evil to achieve the cough-relieving effect. Chinese patent application CN115554382A is a Chinese medicine composition for treating chronic cough of phlegm and fluid, which achieves therapeutic effects from the aspects of warming phlegm and fluid, relieving cough and relieving asthma, and expelling wind and clearing the bowels. However, the above schemes all belong to oral preparations, which have the problems of poor convenience of medication (water decoction needs to be decocted before use), first-pass effect affecting the efficacy, and medication brings a certain burden to the digestive system. In addition, since some Chinese medicines themselves have strong medicinal properties or taste bitter, they may affect people's (especially young patients) taste and appetite as well as medication compliance. Summary of the invention

[0004] 1. Technical issues to be resolved

[0005] In view of the above-mentioned shortcomings and deficiencies of the prior art, the present invention provides a Chinese medicine navel patch for treating chronic cough and a preparation method thereof. The navel patch is made of ephedra, asarum, ginger, pinellia, aster and the like, and takes sufficient kidney yang as the fundamental purpose while taking warming and regulating the lung as the exterior, so as to coordinate the inside and the outside, achieve the effect of treating both the symptoms and the root cause, and adopts navel administration to solve the problems of poor convenience of oral administration, first-pass effect affecting the efficacy and negative impact on the digestive system, thereby improving the patient's medication compliance and medication efficacy.

[0006] (II) Technical solution

[0007] In a first aspect, the present invention provides a Chinese medicine navel patch for treating chronic cough, which is made of the following Chinese medicine composition: 7-9 parts by weight of ephedra, 1.3-1.7 parts by weight of asarum, 7-9 parts by weight of ginger, 1.7-2.3 parts by weight of cynomorium songaricum, 7-9 parts by weight of pinellia, 7-9 parts by weight of aster, 7-9 parts by weight of coltsfoot, 8.7-11.3 parts by weight of ebony, 7-9 parts by weight of stemona, 7-9 parts by weight of bergenia, 4.3-5.7 parts by weight of bombyx batryticatus, 4.3-5.7 parts by weight of earthworm, 17.5-22.5 parts by weight of dwarf tea, 2.6-3.4 parts by weight of gallnut, 2.6-3.4 parts by weight of schisandra, 4.3-5.7 parts by weight of scutellaria baicalensis, 5.2-6.8 parts by weight of platycodon, 7-9 parts by weight of mulberry bark, 5.2-6.8 parts by weight of licorice and 7-9 parts by weight of fenugreek.

[0008] According to a preferred embodiment of the present invention, the composition of the Chinese medicine composition is: 8 parts by weight of ephedra, 1.5 parts by weight of asarum, 8 parts by weight of ginger, 2 parts by weight of Cynomorium songaricum, 8 parts by weight of Pinellia ternata, 8 parts by weight of Aster tataricus, 8 parts by weight of Coltsfoot Flos, 10 parts by weight of Plum, 8 parts by weight of Stemona, 8 parts by weight of Bergenia, 5 parts by weight of Bombyx batryticatus, 5 parts by weight of Pheretima, 20 parts by weight of Camellia sinensis, 3 parts by weight of Galla chinensis, 3 parts by weight of Schisandra chinensis, 5 parts by weight of Radix Phellodendri, 6 parts by weight of Platycodon grandiflorum, 8 parts by weight of Morus alba, 6 parts by weight of Licorice and 8 parts by weight of Vaccaria segetalis.

[0009] In a second aspect, the present invention provides a method for preparing the above-mentioned Chinese medicine navel patch for treating chronic cough, which comprises:

[0010] S1. Powdering a Chinese medicine composition, wherein the composition comprises: 7-9 parts by weight of ephedra, 1.3-1.7 parts by weight of asarum, 7-9 parts by weight of ginger, 1.7-2.3 parts by weight of cynomorium songaricum, 7-9 parts by weight of pinellia tuber, 7-9 parts by weight of aster, 7-9 parts by weight of coltsfoot flower, 8.7-11.3 parts by weight of ebony root, 7-9 parts by weight of bergenia, 4.3-5.7 parts by weight of bombyx batryticatus, 4.3-5.7 parts by weight of earthworm, 17.5-22.5 parts by weight of dwarf tea, 2.6-3.4 parts by weight of gallnut, 2.6-3.4 parts by weight of schisandra chinensis, 4.3-5.7 parts by weight of scutellaria baicalensis, 5.2-6.8 parts by weight of platycodon, 7-9 parts by weight of mulberry bark, 5.2-6.8 parts by weight of liquorice and 7-9 parts by weight of vaccaria segetalis;

[0011] S2, decoction: put the remaining powder except fenugreek into a casserole, add 6-10 times water and decoct, first boil over high heat for 6-8 minutes and then simmer over low heat for 25-35 minutes, stir constantly during the decoction process to prevent the bottom from getting sticky and to heat it evenly, to obtain a decoction (containing the powder);

[0012] S3, low temperature distillation: use a rotary evaporator to low temperature distill the decoction of S2 at 60-70°C, evaporate excess water, and obtain a paste-like liquid medicine (including powder residue and extract) with a water content of 200%±5%. Add fenugreek powder to the paste-like liquid medicine, stir evenly, and obtain a paste-like ointment;

[0013] S4. Shaping: Melt the beeswax and slowly add it to the paste ointment at a mass ratio of 2.9-3.1:1. After stirring evenly, pour it into a mold to shape it to obtain a Chinese medicine navel patch.

[0014] According to a preferred embodiment of the present invention, in S1, the composition of the Chinese medicine composition is: 8 weight parts of ephedra, 1.5 weight parts of asarum, 8 weight parts of ginger, 2 weight parts of Cynomorium songaricum, 8 weight parts of Pinellia ternata, 8 weight parts of Aster tataricus, 8 weight parts of Coltsfoot Flos, 10 weight parts of Prunus mume, 8 weight parts of Stemona bulbs, 8 weight parts of Bergenia rapa, 5 weight parts of Bombyx batryticatus, 5 weight parts of Pheretima, 20 weight parts of Camellia sinensis, 3 weight parts of Galla chinensis, 3 weight parts of Schisandra chinensis, 5 weight parts of Radix Phellodendri, 6 weight parts of Platycodon grandiflorum, 8 weight parts of Morus alba, 6 weight parts of Licorice and 8 weight parts of Vaccaria segetalis.

[0015] According to a preferred embodiment of the present invention, in S1, fenugreek is ground into powder and passed through an 80-mesh sieve, and the remaining medicinal materials are ground into powder and passed through a 40-mesh sieve for later use.

[0016] According to a preferred embodiment of the present invention, in S2, 8 times of water is added for decoction, firstly boiled over high heat for 6-8 minutes and then decocted over low heat for 30 minutes.

[0017] According to a preferred embodiment of the present invention, in S3, the decoction of S2 is low-temperature distilled at 60-65°C using a rotary evaporator.

[0018] According to a preferred embodiment of the present invention, in S4, the melted beeswax and the paste ointment are evenly mixed in a mass ratio of 3:1.

[0019] According to a preferred embodiment of the present invention, in S4, the mold is a flat mold, a lining cloth is provided at the bottom of the mold, and the lining cloth is round or square; the beeswax and the paste ointment are evenly mixed and poured into the middle of the lining cloth, and the Chinese medicine navel patch is obtained after cooling; or, the mold is a spherical mold, the beeswax and the paste ointment are evenly mixed and poured into the mold, and the navel-filling pills are obtained after cooling, and the navel-filling pills are used in conjunction with the sticky lining cloth.

[0020] The backing cloth is one or more of non-woven fabric, cotton cloth, medical tape, hydrogel matrix sheet, silicone sheet. The adhesive layer on the backing cloth is any one of acrylic adhesive, polyisobutylene adhesive or silicone adhesive, and pressure-sensitive adhesive (adhesion is achieved by light pressure) can also be used, and the pressure-sensitive adhesive can be acrylic, silicone and rubber-based adhesive.

[0021] (III) Beneficial effects

[0022] 1. The present invention provides a Chinese medicine navel patch for treating chronic cough, the treatment principle of which is: taking sufficient kidney yang as the fundamental, taking warming and regulating the lung as the surface, carrying out internal and external coordination, treating both the lung and kidney, achieving the effect of treating both the symptoms and the root cause, and embodying the viewpoint of "mutual generation of gold and water" in traditional Chinese medicine.

[0023] 2. The navel is where the vital energy gathers. Modern research shows that in addition to the microcirculatory network of the general skin, the subumbilical peritoneum has a super-rich and dense venous network. The superficial part is the anastomosis between the superficial abdominal wall veins and the thoracic and abdominal wall veins; the deep part is the anastomosis between the upper and lower abdominal wall veins. Most of the branches of the hypogastric artery also pass around the navel. Modern medicine believes that after the drug penetrates the navel skin, it directly diffuses to the venous network and (or) most of the branches of the hypogastric artery and penetrates into the systemic circulation. Therefore, the drug absorbed through the navel skin is more effective than that administered to other parts, with high bioavailability and fast drug absorption.

[0024] Therefore, the medicine for treating chronic cough of the present invention adopts navel administration, which solves the problems of poor convenience of oral administration, first-pass effect affecting drug efficacy and negative impact on the digestive system, and improves the patient's medication compliance and drug efficacy; in addition, the navel is close to the waist and kidney, chronic cough affects the kidney over time, and the active ingredients quickly enter the hypogastric artery, which can not only quickly achieve warming and replenishing kidney yang, stimulate kidney qi, and enhance the function of receiving qi; and the lung belongs to gold, the kidney belongs to water, and the vigorous kidney essence can nourish the lung defense, which should be the meaning of "gold and water are born together". Cynomorium songaricum has the effect of warming yang and replenishing the lung, replenishing lung yang qi on the basis of replenishing yang, and helping ephedra to evacuate wind and cold evil qi.

[0025] The present invention adopts external application on the navel as a treatment method, which is more friendly to young patients with chronic cough. The navel administration has good permeability, high bioavailability, and more obvious effect of warming yang and kidney qi. It avoids the dependence and addiction of traditional Chinese and Western medicine administration methods, has the characteristics of safety and effectiveness, and also avoids the problems of inconvenience of taking medicine, medicine loss, taste and smell affecting the patient's appetite, and a certain burden on the digestive tract such as the stomach and intestines caused by the use of oral Chinese medicine.

[0026] 3. When preparing the Chinese medicine navel patch of the present invention, the medicinal materials are first ground into powder and then boiled, so that the degree of drug mixing is higher, the heating during boiling is more uniform, and the molding is more delicate; then, low-temperature distillation technology is adopted to avoid the influence of high-temperature heating on the efficacy of the Chinese medicine, and while retaining the efficacy, excess water is distilled off to obtain a paste-like liquid medicine; then, fenugreek is added to the paste-like liquid medicine, and fenugreek is a roving product, which is more uniform after being ground into fine powder, which is conducive to the diffusion of the efficacy; finally, beeswax is used as a shaping agent, which avoids the toxicity of traditional excipients, and beeswax is a lipid, which is more friendly to the skin and non-irritating, and beeswax itself has a bactericidal effect, which can preserve the medicine for a long time, and because beeswax has a low melting point, after being applied to the navel, the closed internal environment makes the temperature higher than the skin temperature, and this temperature can change the shape of the beeswax, so that it fits better to the human body.

[0027] 4. The medicinal material composition and preparation process of the medicated navel patch of the present invention do not involve toxic medicinal materials or auxiliary materials, nor do they involve red lead components, and the medicinal ingredients are safe; and the medicine is an external medicine, which further improves the safety of the medicine, and meets the needs of chronic cough patients who have a long-term cough and need long-term medication. DETAILED DESCRIPTION

[0028] In order to better explain the present invention and facilitate understanding, the present invention is described in detail below in conjunction with specific implementation methods.

[0029] The applicant believes that the kidney stores essence and is responsible for receiving qi, which is the root of qi and the foundation of the five internal organs. If the kidney qi is sufficient and the yang qi is abundant, phlegm will not be generated and breathing will be smooth; if the kidney yang is insufficient, it loses warmth, the qi intake is powerless, and the water metabolism is impaired, phlegm will grow, and the cough will not heal for a long time. Therefore, chronic cough is mostly internal and external coordination, and the treatment should focus on the lungs and kidneys. Therefore, the present invention provides a Chinese medicine navel patch for treating chronic cough, and its treatment principle is: taking sufficient kidney yang as the fundamental and taking into account warming and regulating the lungs as the surface, performing internal and external coordination, treating the lungs and kidneys at the same time, achieving the effect of treating both the symptoms and the root causes, and embodying the view of "gold and water coexistence" in traditional Chinese medicine.

[0030] The Chinese medicine navel patch for treating chronic cough of the present invention is prepared from the following Chinese medicine composition: 7-9 parts by weight of ephedra, 1.3-1.7 parts by weight of asarum, 7-9 parts by weight of ginger, 1.7-2.3 parts by weight of cynomorium songaricum, 7-9 parts by weight of pinellia, 7-9 parts by weight of aster, 7-9 parts by weight of coltsfoot, 8.7-11.3 parts by weight of ebony, 7-9 parts by weight of stemona, 7-9 parts by weight of bergenia, 4.3-5.7 parts by weight of bombyx batryticatus, 4.3-5.7 parts by weight of earthworm, 17.5-22.5 parts by weight of dwarf tea, 2.6-3.4 parts by weight of gallnut, 2.6-3.4 parts by weight of schisandra, 4.3-5.7 parts by weight of radix platycodonis, 5.2-6.8 parts by weight of platycodon, 7-9 parts by weight of white mulberry bark, 5.2-6.8 parts by weight of liquorice and 7-9 parts by weight of fenugreek.

[0031] In the above-mentioned Chinese medicine composition, ephedra and asarum are the main medicines, which can eliminate external pathogens.

[0032] In the above-mentioned Chinese medicine composition, ginger and Pinellia ternata are assistant medicines. Using asarum, ginger and Pinellia ternata together can warm the internal yang, stimulate kidney yang, absorb qi and reduce adverse effects, which corresponds to the main medicine inside and outside.

[0033] In the above-mentioned Chinese medicine composition, Aster, Coltsfoot, Plum, Stemona, Bergenia, Morus alba, Camellia sinensis, Gallnut, Schisandra chinensis, Rhizoma Cynomorii, and Cynomorium songaricum are adjuvants, which assist the monarch and minister in warming and dispersing the lungs, relieving cough and reducing phlegm. Gallnut and Schisandra chinensis have the effect of nourishing the kidney, harmonizing the lungs and kidneys, astringing and nourishing, and are particularly suitable for chronic coughs caused by lung deficiency. The above-mentioned adjuvants are assisted by Cynomorium songaricum, which is used for coughs caused by yang deficiency and exogenous factors, to achieve warming yang and nourishing the lungs (replenishing lung yang qi on the basis of tonifying yang), and to help Ephedra dispel wind and cold evil qi; a small amount of Cynomorium songaricum can avoid aggravating the heat condition in the body.

[0034] In the above-mentioned Chinese medicine composition, Bombyx Batryticatus, Pheretima, Platycodon grandiflorum, Vaccaria segetalis, and Licorice are guiding drugs, which can clear the lungs and dredge the meridians, help the drugs return to the meridians, harmonize the drugs, alleviate the drug properties, and reduce the irritation to the skin caused by direct contact and the induction of allergies (such as the volatile oil contained in Asarum and the gingerol component of ginger may be irritating to some people, and the gallic acid is strong). Vaccaria segetalis is a guiding drug, which is a wandering product and helps the active ingredients to spread quickly through the navel to the hypogastric artery.

[0035] The effects of the various medicinal materials in the Chinese medicine navel patch for treating chronic cough of the present invention are as follows:

[0036] Ephedra: induces sweat and relieves exterior symptoms, clears the lungs and relieves asthma.

[0037] Asarum: It can dispel cold, warm and transform the cold phlegm in the lungs. It can not only help ephedra to dispel cold phlegm, but also stimulate the true yang energy in the kidneys, and cooperate with ginger to warm and eliminate the cold phlegm inside the body.

[0038] Ginger: induces sweat and relieves exterior symptoms, dispels wind and cold, and has a pungent and warming effect.

[0039] Banxia: Combined with ginger, it warms the yang and dispels cold, transforms turbidity and dries up dampness, and has the effect of replenishing the deficiency of yang, the excess of cold turbidity, and the accumulation of phlegm and dampness. Both are pungent and warm, and ginger can control the toxicity of Banxia, ​​making the effect of reducing adverse effects and stopping vomiting more significant and safe.

[0040] Aster and Coltsfoot: According to Ben Jing Shu Zheng, "Nine out of ten prescriptions for treating cough, adverse reaction and chronic cough use Aster and Coltsfoot." Aster tastes sweet, bitter and spicy, can moisten and purge, warm but not dry, tends to moisten the lungs, lower qi, resolve phlegm and relieve depression, while Coltsfoot tastes spicy, warm but not dry, tends to suppress cough, lower qi, moisten the lungs and resolve phlegm. Aster and Coltsfoot are used together to resolve phlegm and stop cough, and are especially suitable for chronic cough due to deficiency and cold.

[0041] Black plum can regulate the liver's function of dispersing qi, so as to promote the flow of qi throughout the body. It has the functions of moistening the lungs, relieving cough, promoting fluid production and astringing. It is also combined with Stemona, Aster, Platycodon and Morus alba bark to relieve cough by regulating the rise and fall of lung qi. Bombyx batryticatus is added to relieve spasms, cough and phlegm. Dwarf tea is then added to harmonize the liver and lungs, so that the qi flow is smooth, cough can be stopped and phlegm can be resolved. Earthworm is then added to dredge the meridians, activate the collaterals, clear the lungs and relieve asthma, so that the qi flow is smooth and the efficacy of the medicine is improved.

[0042] Both Chinese gallnut and Schisandra have the effect of astringing the lungs and relieving coughs. However, Chinese gallnut focuses on astringing the lungs, while Schisandra also has the effect of nourishing the kidneys. It can regulate the lungs and kidneys, astringe and replenish, and is especially suitable for chronic coughs caused by lung deficiency.

[0043] Cynomorium songaricum has the function of warming yang and nourishing the lungs, and helps ephedra dispel wind and cold evil spirits. Chronic cough affects the kidneys over time, and adding Cynomorium songaricum can warm and nourish the kidney yang, stimulate the kidney qi, and enhance the function of receiving qi. The lungs belong to metal, and the kidneys belong to water. The vigorous kidney essence can nourish the lung defense, which corresponds to the meaning of "metal and water are mutually beneficial".

[0044] Rock cabbage has the function of nourishing and strengthening, relieving cough and stopping bleeding, and can enhance the main function of nourishing deficiency and relieving cough.

[0045] Baiqian is slightly warm in nature and not dry, so it is good at removing phlegm and relieving cough. It is an important medicine for lung cough and asthma, and is suitable for patients with a lot of phlegm. It is combined with medicines such as Pinellia and Perilla that warm the lungs, resolve phlegm, and relieve cough. Licorice itself has the effects of clearing away heat and detoxifying, removing phlegm and relieving cough, and it also has the effects of tonifying the spleen and replenishing qi, harmonizing the effects of various medicines, and Vaccariae liuli can promote blood circulation and promote drug absorption.

[0046] The following are preferred embodiments of the present invention.

[0047] Example 1

[0048] This embodiment provides a Chinese medicine navel patch for treating chronic cough, and the preparation method is as follows:

[0049] (1) Preparation of medicinal materials: 80g of Ephedra, 15g of Asarum, 80g of Ginger, 20g of Cynomorium songaricum, 80g of Pinellia ternata, 80g of Aster tataricus, 80g of Coltsfoot Flos, 100g of Prunus mume, 80g of Stemona, 80g of Bergenia, 50g of Bombyx batryticatus, 50g of Pheretima, 200g of Camellia sinensis, 30g of Galla chinensis, 30g of Schisandra chinensis, 50g of Radix Phellodendri, 60g of Platycodon grandiflorum, 80g of Morus alba, 60g of Licorice, and 80g of Vaccaria segetalis. Grind Vaccaria segetalis into powder and pass through an 80-mesh sieve. Grind the remaining medicinal materials into powder and pass through a 40-mesh sieve for later use.

[0050] (2) Decoction: Put the remaining powder except fenugreek into a casserole, add 8 times the amount of water and boil. Boil over high heat for 8 minutes and then simmer over low heat for 30 minutes. Stir constantly with a bamboo spatula during the decoction process to prevent the bottom from getting stuck. Heat the mixture evenly and do not filter. A decoction containing the powder is obtained.

[0051] (3) Low-temperature distillation: Use a rotary evaporator to distill the decoction at 65°C to evaporate excess water to obtain a paste-like liquid medicine with a water content of 200% (including powder residue and extract). Add fenugreek powder to the paste-like liquid medicine and stir evenly to obtain a paste-like ointment.

[0052] (4) Shaping: Melt the beeswax and slowly add it to the paste at a mass ratio of 3:1. Stir well and pour it into a mold to shape it. The mold is a spherical mold. Stir the beeswax and paste well and pour them into the mold. After cooling, you will get a navel-filling pill with a diameter of about 1.3-1.4 cm. Use it with a non-woven lining cloth with adhesive coated on the edges.

[0053] Example 2

[0054] This embodiment provides a Chinese medicine navel patch for treating chronic cough, and the medicinal materials are as follows: 84g of ephedra, 16g of asarum, 84g of ginger, 22g of cynomorium songaricum, 84g of pinellia tuber, 84g of aster, 84g of coltsfoot flower, 106g of black plum, 84g of stemona, 84g of bergenia, 52g of bombyx batryticatus, 52g of earthworm, 210g of dwarf tea, 32g of gallnut, 32g of schisandra, 52g of radix platycodonis, 65g of platycodon, 84g of mulberry bark, 65g of licorice and 84g of fenugreek. The preparation process of the Chinese medicine navel patch is the same as that of Example 1.

[0055] Comparative Example 1

[0056] In this comparative example, when preparing the Chinese medicine navel patch for treating chronic cough, three medicinal materials including "gallanthus, schisandra and cynomorium songaricum" are removed from the Chinese medicine composition used. The preparation process is shown in Example 1.

[0057] Clinical trials

[0058] 1. Research Methods

[0059] 1. General Information

[0060] A total of 126 patients with chronic cough admitted to the outpatient and inpatient departments of the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine from October 2023 to April 2024 were selected as the research subjects. The patients were divided into three groups according to the random number table method, with 42 cases in each group. In the control group, 1 case voluntarily withdrew, 2 cases had poor compliance, and 3 cases dropped out in total, and 39 cases completed the trial; 3 cases were lost to follow-up in the experimental group, 1 case had poor compliance, and 4 cases dropped out in total, and 38 cases completed the trial; 2 cases were lost to follow-up in the comparison group, 1 case voluntarily withdrew, 1 case had poor compliance, and 4 cases dropped out in total, and 38 cases completed the trial.

[0061] 2. Diagnostic criteria

[0062] Western medicine diagnosis refers to the diagnostic criteria for chronic cough in the "Guidelines for the Diagnosis and Treatment of Cough (2015)": cough is the main symptom or the only symptom; the course of disease is ≥ 8 weeks; CT or chest X-ray examinations show no abnormalities.

[0063] The diagnosis of traditional Chinese medicine refers to the diagnostic criteria in the "Guidelines for the Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine Internal Medicine•Cough ZYYXH / T4-2008": cough, sputum or no sputum; course of disease ≥ 8 weeks; caused by repeated attacks of exogenous infection or organ dysfunction, and may be accompanied by symptoms of other organ dysfunction.

[0064] 3. Inclusion criteria

[0065] Patients with chronic cough who meet the diagnostic criteria of Western medicine; patients who meet the diagnosis criteria of chronic cough according to traditional Chinese medicine; patients aged between 18 and 80 years old without serious underlying diseases, who are tolerant to the drugs and treatment methods designed for this study; voluntarily participate in this clinical study and sign the informed consent form.

[0066] 4. Exclusion criteria

[0067] Patients who have been confirmed to have major diseases such as cardiovascular, cerebrovascular, lung, liver, kidney, and endocrine diseases; patients with acute and subacute cough; patients with chronic cough caused by diseases such as bronchiectasis, lung abscess, pneumonia, tuberculosis, and asthma; those with allergic constitution, drug allergy or skin sensitivity; those with a history of abdominal surgery; those with ulcers on the skin corresponding to the acupoints; pregnant and lactating women; those with mental disorders, cognitive disorders and other diseases; those who are participating in other trials or research.

[0068] 5. Elimination criteria

[0069] Those who did not meet the criteria and were mistakenly included; those whose statistical or evaluation data were missing or errors affected the efficacy assessment; those who developed other diseases that affected treatment during the trial; those who underwent other treatment interventions during the experiment; those who developed serious adverse reactions during the trial; those who developed other serious complications during the trial or whose condition worsened and may lead to dangerous events.

[0070] 6. Shedding Standard

[0071] Subjects with poor compliance, who did not strictly follow the prescribed treatment, thus affecting the efficacy assessment; those who voluntarily withdrew from the study; and those who were lost to follow-up.

[0072] 7. Intervention measures

[0073] Control group: Compound methoxyphenamine capsules (Shanghai Sankyo Pharmaceutical Co., Ltd., national medicine standard H20033669) were taken orally, 3 times a day, 2 capsules each time, for 4 weeks.

[0074] Experimental group: on the basis of the control group, the umbilical patch of Example 1 was additionally used for treatment, 1 patch / time, 1 time / day, the application time was more than 8 hours per day, and the treatment lasted for 4 weeks.

[0075] Comparative group: On the basis of the control group, the patch of comparative example 1 was additionally used for treatment, 1 patch / time, 1 time / day, the application time was more than 8 hours per day, and the treatment lasted for 4 weeks.

[0076] The three groups were treated for 2 weeks as one course of treatment, with a total of 2 courses of treatment.

[0077] 8. Observation indicators

[0078] (1) TCM syndrome score: According to the Guidelines for Clinical Research of New Chinese Medicines (2002 edition), cough is the main symptom and is assigned different scores according to absence, mild, moderate, and severe, from low to high, 0, 2, 4, and 6 points. The three secondary symptoms of expectoration, itchy throat, and chest tightness are scored as 0, 1, 2, and 3 points according to absence, mild, moderate, and severe. The tongue and pulse are recorded truthfully and are not used as scoring items. The researchers evaluated the TCM syndrome score once before treatment and once after the treatment cycle.

[0079] (2) Cough Visual Analog Scale (VAS) score: A linear scoring method is used. A ruler with intervals of 1 cm is marked on a straight line, with the two ends at 0 cm and 10 cm respectively. The 0 cm end indicates no cough, and the 10 cm end indicates severe cough; the middle part indicates different degrees of cough. During the evaluation process, the patient is asked to mark the horizontal line according to his or her subjective feelings to indicate the degree of cough.

[0080] (3) Cough quality of life score: The Leicester Cough Questionnaire (LCQ) was used to evaluate the improvement of cough quality of life in the three groups of patients before and after treatment. The score specifically included the impact of cough on the patient's physical, psychological, and social aspects. The higher the score, the better the health status.

[0081] (4) Cough relief time and cure time: According to the daily cough VAS score, if the subject's cough VAS score decreases by ≥ 2 points and lasts for 2 days, the day the score starts to decrease is the cough relief time; according to the daily cough VAS score, if the subject's cough VAS score becomes 0 and does not increase until the last day of observation, the day it begins to become 0 is the time required for the cough to be cured.

[0082] (5) Evaluation of main pulmonary function indicators: Pulmonary function measuring instruments were used to measure the maximum expiratory flow (PEF), forced expiratory volume in one second (FEV1), and forced vital capacity (FVC) of the three groups of patients before and after treatment, and the FEV1 / FVC ratio was calculated.

[0083] 9. Safety indicators:

[0084] (1) General physical examination items (body temperature, heart rate, blood pressure, pulse, etc.);

[0085] (2) Electrocardiogram; routine blood, urine and stool tests; liver and kidney function tests, etc.;

[0086] (3) Observe possible adverse reactions, including local skin reactions and systemic reactions, such as general rashes, allergic reactions, and gastrointestinal reactions. Pay attention to analyzing the causes of adverse reactions, make accurate judgments in a timely manner, and truthfully record the treatment process and results.

[0087] 10. Criteria for determining efficacy

[0088] The efficacy determination criteria are determined in accordance with the Guiding Principles for Clinical Research of New Chinese Medicines (2002 edition), as follows:

[0089] Clinical control: clinical symptoms disappear or almost disappear, lung function indexes are normal, and syndrome score decreases by ≥90%;

[0090] Markedly effective: clinical symptoms were significantly improved, lung function indicators were basically normal, and the syndrome score was reduced by 70%≤<90%;

[0091] Effective: clinical symptoms improved, lung function indexes improved, 30%≤symptom score decreased <70%;

[0092] Ineffective: There is no significant improvement in clinical symptoms, or they even get worse, lung function indicators do not return to normal, and the syndrome score decreases by less than 30%.

[0093] Calculation formula (Nimodipine method): TCM syndrome score reduction rate = (total score before treatment - total score after treatment) / total score before treatment × 100%

[0094] Total effective rate = (clinical control + marked effect + effective) number of cases / total number of cases × 100%.

[0095] 11. Statistical analysis

[0096] SPSS 26.0 software was used to input and analyze data. For measurement data, mean ± standard deviation (x(_) ± s) was used to describe the data. For data that met the normal distribution and variance homogeneity, paired sample t test was used for intra-group comparison, and independent sample t test was used for inter-group comparison; otherwise, rank sum test was used. For count data, frequency or percentage (%) was used to express it, and X-test was used for inter-group comparison. 2 For graded data, the rank sum test was used for comparison between groups. The difference between the two groups was considered statistically significant when P < 0.05.

[0097] 2. Research Results

[0098] 1. Statistical analysis of general data

[0099] (1) Comparison of gender among the three groups of patients

[0100] See Table 1. A total of 115 patients were included in this study, including 59 males and 56 females. There were 38 patients in the experimental group, including 19 males, accounting for 50.00%, and 19 females, accounting for 50.00%. There were 38 patients in the experimental comparison group, including 20 males, accounting for 52.63%, and 18 females, accounting for 47.37%. There were 39 patients in the control group, including 20 males, accounting for 51.28%, and 19 females, accounting for 48.72%.2 Check and get X 2 =0.053, P=0.974>0.05, indicating that there was no statistically significant difference in gender among the three groups of patients, indicating that the gender data of the three groups were comparable.

[0101] Table 1: Comparison of gender ratio among the three groups of patients

[0102] .

[0103] (2) Comparison of the ages of the three groups of patients

[0104] See Table 2 for a comparison of the ages of the three groups of patients. The oldest patient in the experimental group was 75 years old, the youngest was 24 years old, and the average age was 52.55±16.48 years old; the oldest patient in the comparison group was 74 years old, the youngest was 23 years old, and the average age was 51.71±17.35 years old; the oldest patient in the control group was 75 years old, the youngest was 23 years old, and the average age was 51.49±13.44 years old. After the rank sum test, H c =0.227, P=0.893>0.05, indicating that there was no statistically significant difference in age among the three groups of patients, indicating that the age data of the three groups were comparable.

[0105] Table 2: Comparison of age of patients in the three groups

[0106] .

[0107] (3) Comparison of disease course among the three groups

[0108] See Table 3, the course of the three groups of patients was compared. The longest course of the experimental group was 9 months, the shortest course was 2 months, and the average course was 6.21±2.20 months; the longest course of the comparison group was 10 months, the shortest course was 2 months, and the average course was 6.34±2.27 months; the longest course of the control group was 10 months, the shortest course was 2 months, and the average course was 6.33±2.35 months. After the rank sum test, H c =0.086, P=0.958>0.05, indicating that there was no statistically significant difference in the course of disease among the three groups of patients, indicating that the course of disease data of the three groups were comparable.

[0109] Table 3: Comparison of disease course among three groups of patients

[0110] .

[0111] 2. Comparison of TCM syndrome scores among the three groups of patients

[0112] See Table 4 for comparison of intra-group data: After treatment, the TCM syndrome scores of the three groups all decreased. The t-test showed that the experimental group t=15.797, P<0.001, and the control group t=13.051, P<0.001; the rank sum test showed that the control group Z=-5.140, P<0.001, indicating that the differences in the TCM syndrome scores of the three groups of patients before and after treatment were statistically significant, suggesting that the interventions in the three groups were effective. Comparison of inter-group data: One-way ANOVA showed that there was no statistically significant difference in the TCM syndrome scores of the three groups of patients before treatment (F=0.040, P=0.961>0.05), indicating that the TCM syndrome score data of the three groups before treatment were comparable; the rank sum test showed that there was a statistically significant difference in the TCM syndrome scores of the three groups of patients after treatment (H c =31.903, P<0.001), indicating that in terms of improving TCM symptoms such as cough, sputum, throat itching, and chest tightness, the experimental group > the comparison group > the control group.

[0113] Table 4: Comparison of TCM syndrome scores among the three groups of patients before and after treatment (points)

[0114] .

[0115] 3. Comparison of cough visual analogue scale (VAS) scores among the three groups of patients

[0116] See Table 5 for comparison of intra-group data: After treatment, the VAS scores of the three groups all decreased. The rank sum test showed that the experimental group Z=-5.325, P<0.001, the comparison group Z=-5.400, P<0.001, and the control group Z=-4.634, P<0.001, indicating that the differences in VAS scores before and after treatment among the three groups of patients were statistically significant, suggesting that the interventions in the three groups were effective. Comparison of inter-group data: The rank sum test showed that there was no statistically significant difference in VAS scores before treatment among the three groups of patients (H c =0.037, P=0.982>0.05), indicating that the VAS score data of the three groups before treatment were comparable; the VAS score differences among the three groups after treatment were statistically significant (H c =52.765, P<0.001), indicating that the experimental group was more effective in improving the cough severity of patients than the comparison group and the control group.

[0117] Table 5: Comparison of VAS scores of the three groups of patients before and after treatment (points)

[0118] .

[0119] 4. Comparison of cough life quality (LCQ) scores among the three groups of patients

[0120] See Table 6 for comparison of intra-group data: After treatment, the LCQ scores of the three groups were all improved. The rank sum test showed that the experimental group Z = -5.384, P < 0.001, the comparison group Z = -5.321, P < 0.001, and the control group Z = -5.308, P < 0.001, indicating that the differences in VAS scores before and after treatment among the three groups of patients were statistically significant, suggesting that the interventions in the three groups were effective. Comparison of inter-group data: The rank sum test showed that there was no statistically significant difference in the LCQ scores of the three groups of patients before treatment (H c =0.258, P=0.879>0.05), indicating that the LCQ score data of the three groups before treatment were comparable; the LCQ score differences among the three groups after treatment were statistically significant (H c =65.019, P<0.001), indicating that the experimental group was more effective in improving the quality of life of patients than the comparison group and the control group.

[0121] Table 6: Comparison of LCQ scores among the three groups of patients before and after treatment (points)

[0122] .

[0123] 5. Comparison of maximum expiratory flow (PEF) levels among the three groups of patients

[0124] See Table 7 for comparison of intra-group data: After treatment, the PEF levels of the three groups were all improved. The t-test showed that the experimental group t=-9.166, P<0.001; the rank sum test showed that the comparison group Z=-5.378, P<0.001, and the control group Z=-2.512, P=0.012<0.05, indicating that the differences in PEF levels before and after treatment among the three groups of patients were statistically significant, suggesting that the interventions in the three groups were effective. Comparison of inter-group data: The rank sum test showed that there was no statistically significant difference in PEF levels among the three groups of patients before treatment (H c =0.090, P=0.956>0.05), indicating that the PEF data of the three groups before treatment were comparable; the differences in PEF levels among the three groups after treatment were statistically significant (H c =25.782, P<0.001), indicating that the experimental group was more effective in improving the patients' maximum expiratory flow rate than the comparison group and the control group.

[0125] Table 7: Comparison of maximum expiratory flow (PEF) among the three groups of patients before and after treatment (L / S)

[0126] .

[0127] 6. Comparison of forced expiratory volume in one second (FEV1) levels among the three groups of patients

[0128] See Table 8 for comparison of intra-group data: After treatment, the FEV1 levels of the three groups were all improved. The rank sum test showed that the experimental group Z=-5.228, P<0.001, and the control group Z=-2.058, P=0.040<0.05; the t test showed that the comparison group t=-11.615, P<0.001, indicating that the differences in FEV1 levels before and after treatment among the three groups of patients were statistically significant, suggesting that the interventions in the three groups were effective. Comparison of inter-group data: One-way ANOVA showed that there was no statistically significant difference in FEV1 levels among the three groups of patients before treatment (F=0.183, P=0.833>0.05), indicating that the FEV1 data before treatment among the three groups were comparable; the rank sum test showed that there was a statistically significant difference in FEV1 levels among the three groups of patients after treatment (H c =30.684, P<0.001), indicating that the experimental group was more effective than the comparison group and the control group in improving the forced expiratory volume in one second.

[0129] Table 8: Comparison of forced expiratory volume in one second (FEV1) among the three groups of patients before and after treatment (L / S)

[0130] .

[0131] 7. Comparison of FEV1 / FVC levels among the three groups of patients

[0132] See Table 9 for comparison of intra-group data: After treatment, the FEV1 / FVC levels of the three groups were all improved. The rank sum test showed that the experimental group Z=-5.373, P<0.001, the comparison group Z=-5.522, P<0.001, and the control group Z=-4.194, P<0.001, indicating that there were statistically significant differences in the FEV1 / FVC levels of the three groups before and after treatment, suggesting that the interventions in the three groups were effective. Comparison of inter-group data: The rank sum test showed that there was no statistically significant difference in the FEV1 / FVC levels of the three groups before treatment (H c =0.160, P=0.923>0.05), indicating that the FEV1 data of the three groups before treatment were comparable; the differences in FEV1 / FVC levels among the three groups after treatment were statistically significant (H c =30.683, P<0.001), indicating that the experimental group was more effective in improving the FEV1 / FVC of patients than the comparison group and the control group.

[0133] Table 9: Comparison of FEV1 / FVC among the three groups of patients before and after treatment (%)

[0134] .

[0135] 8. Comparison of cough relief time and cure time among the three groups of patients

[0136] As shown in Table 10, the cough relief time of the three groups of patients was compared. The average cough relief time of the experimental group was 6.95±2.50 days, the average cough relief time of the comparison group was 9.13±3.71 days, and the average cough relief time of the control group was 11.26±3.84 days. After the rank sum test, H c =22.883, P<0.001, indicating that the experimental group was more effective than the control group and the comparison group in shortening the cough relief time of patients. The cough cure time of the three groups of patients was compared. The average cough cure time of the experimental group was 16.32±3.53 days, the average cough cure time of the comparison group was 19.66±4.13 days, and the average cough cure time of the control group was 23.13±4.18 days. After the rank sum test, H c =38.352, P<0.001, indicating that the experimental group was more effective in shortening the time of cough cure than the comparison group and the control group.

[0137] Table 10: Comparison of cough relief time and cure time among three groups of patients

[0138] .

[0139] 9. Comparison of efficacy among three groups of patients

[0140] See Table 11. After the treatment course of this study was completed, there were 38 patients in the experimental group, of which 6 were clinically controlled, 15 were markedly effective, 14 were effective, and 3 were ineffective, with a total effective rate of 92.11%; there were 38 patients in the comparison group, of which 3 were clinically controlled, 9 were markedly effective, 21 were effective, and 5 were ineffective, with a total effective rate of 86.84%; there were 39 patients in the control group, of which 1 was clinically controlled, 4 were markedly effective, 25 were effective, and 9 were ineffective, with a total effective rate of 76.92%. The rank sum test was used to analyze the total effective rate of the three groups. After the rank sum test, H c =15.069, P=0.001<0.05, indicating that there were statistically significant differences in the total effective rates among the three groups, suggesting that the total effective rate of the experimental group was higher than that of the comparison group and the control group.

[0141] Table 11: Comparison of the efficacy of the three groups of patients after treatment (cases)

[0142] .

[0143] Note: Total effective rate (%) = (clinical control + marked effect + effectiveness) / number of patients × 100%.

[0144] 10. Safety Assessment

[0145] (1) Drug safety assessment

[0146] Before, during and after treatment, the three groups of patients underwent routine examinations of vital signs, blood, urine, and stool, as well as liver and kidney function, electrocardiogram and other examinations to evaluate the safety of the drug. No normal results before treatment were found but abnormal results after treatment, indicating that the drug is safe.

[0147] (2) Comparison of adverse reactions among the three groups of patients

[0148] See Table 12. In terms of adverse reactions, 3 patients in the experimental group, 3 patients in the comparative group, and 2 patients in the control group experienced discomfort symptoms such as itching and gastrointestinal reactions during the treatment. After timely symptomatic treatment intervention, the discomfort symptoms disappeared, and the treatment was not interrupted during this study. 2 The incidence of adverse reactions in the three groups of patients was analyzed and X 2 =0.305, P = 0.859>0.05, indicating that there was no statistically significant difference in the incidence of adverse reactions among the three groups of patients.

[0149] Table 12: Comparison of the incidence of adverse reactions among the three groups of patients (cases)

[0150] .

[0151] Through this clinical trial study, the efficacy and safety of the Chinese medicine patch prepared by the present invention combined with compound methoxyphenamine capsules in the treatment of chronic cough were preliminarily explored. The results showed that the patch can significantly improve the clinical symptoms of patients, and has obvious advantages in improving cough, sputum, throat itching, chest tightness, etc. It has significant therapeutic effects in shortening the patient's cough relief time and cure time, and improving the patient's quality of life and lung function indicators. It has a high total effective rate and reliable safety, without obvious adverse reactions, and is worthy of clinical promotion.

[0152] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A Chinese medicine navel patch for treating chronic cough, characterized in that: The invention is prepared from the following traditional Chinese medicine composition: 8 parts by weight of ephedra, 1.5 parts by weight of asarum, 8 parts by weight of ginger, 2 parts by weight of cynomorium songaricum, 8 parts by weight of pinellia tuber, 8 parts by weight of aster, 8 parts by weight of coltsfoot flower, 10 parts by weight of ebony, 8 parts by weight of stemona, 8 parts by weight of bergenia, 5 parts by weight of bombyx batryticatus, 5 parts by weight of earthworm, 20 parts by weight of dwarf camellia sinensis, 3 parts by weight of gallnut, 3 parts by weight of schisandra chinensis, 5 parts by weight of scutellaria baicalensis, 6 parts by weight of platycodon, 8 parts by weight of mulberry bark, 6 parts by weight of liquorice and 8 parts by weight of fenugreek.

2. A method for preparing a Chinese medicine navel patch for treating chronic cough, characterized in that: It includes the following steps: S1. Powdering a Chinese medicine composition, the composition of which is: 8 parts by weight of ephedra, 1.5 parts by weight of asarum, 8 parts by weight of ginger, 2 parts by weight of cynomorium songaricum, 8 parts by weight of pinellia tuber, 8 parts by weight of aster, 8 parts by weight of coltsfoot flower, 10 parts by weight of ebony, 8 parts by weight of stemona, 8 parts by weight of bergenia, 5 parts by weight of bombyx batryticatus, 5 parts by weight of earthworm, 20 parts by weight of dwarf tea, 3 parts by weight of gallnut, 3 parts by weight of schisandra, 5 parts by weight of radix scutellariae, 6 parts by weight of platycodon, 8 parts by weight of mulberry bark, 6 parts by weight of liquorice and 8 parts by weight of fenugreek; S2, decoction: put the remaining powder except fenugreek into a casserole, add 6-10 times water and decoct, first boil over high heat for 6-8 minutes and then simmer over low heat for 25-35 minutes to obtain a decoction, stir constantly during the decoction process to prevent the bottom from getting sticky and to ensure that it is evenly heated; S3, low temperature distillation: using a rotary evaporator to low temperature distill the decoction obtained in step S2 at 60-70°C to evaporate excess water to obtain a paste-like liquid medicine with a water content of 200%±5%, adding fenugreek powder to the paste-like liquid medicine, stirring evenly to obtain a paste-like ointment; S4, shaping: melt the beeswax, and slowly add it to the paste ointment obtained in step S3 at a mass ratio of 2.9-3.1:1, stir evenly, pour into a mold and shape to obtain a Chinese medicine navel patch.

3. The preparation method according to claim 2, characterized in that: In step S1, fenugreek is ground into powder and passed through an 80-mesh sieve, and the other medicinal materials are ground into powder and passed through a 40-mesh sieve for later use.

4. The preparation method according to claim 2, characterized in that: In step S2, add 8 times the amount of water and boil for 6-8 minutes over high heat and then simmer for 30 minutes over low heat.

5. The preparation method according to claim 2, characterized in that: In step S3, the decoction of S2 is low-temperature distilled at 60-65° C. using a rotary evaporator.

6. The preparation method according to claim 2, characterized in that: In step S4, the melted beeswax and the paste ointment are evenly mixed in a mass ratio of 3:

1.

7. The preparation method according to claim 2, characterized in that: In step S4, the mold is a flat mold, and a lining cloth is provided at the bottom of the mold, and the lining cloth is round or square; beeswax and the paste ointment are mixed evenly and poured into the middle of the lining cloth, and the Chinese medicine navel patch is obtained after cooling; or, the mold is a spherical mold, beeswax and the paste ointment are mixed evenly and poured into the mold, and the navel-filling pills are obtained after cooling, and the navel-filling pills are used in conjunction with the sticky lining cloth.