A pharmaceutical composition for treating respiratory diseases and a preparation method and use thereof

Abstract

The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a medicinal composition for treating respiratory diseases and a preparation method and use thereof. The medicinal composition is prepared from raw medicinal materials of white mustard seed, asarum, cassia bark, corydalis, dried tangerine or orange peel, Szechuan lovage root, ginger and green onion white, and the components are combined to have a remarkable effect on treating respiratory diseases, and the incidence of skin discomfort or adverse reactions is significantly reduced after use. The traditional Chinese medicinal composition has a remarkable effect on treating respiratory diseases, and the incidence of skin discomfort or adverse reactions is significantly reduced after use, which is specifically manifested in that most cases do not foam after use, and only a few cases will have slight foaming, thereby reducing the risk of scarring. In particular, the safety of the medicinal composition for children is unanimously affirmed by the families of patients. In addition, the ginger and green onion white in the traditional Chinese medicinal composition can improve the absorption capacity of the medicinal composition through acupoints, and the moxibustion feeling is better, and the qi is easier to obtain and the feeling of obtaining qi is better.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a pharmaceutical composition for treating respiratory diseases, its preparation method, and its uses. Background Technology

[0002] Sanfu Patch is a traditional Chinese medicine external therapy. Its therapeutic principle comes from the description of "nourishing yang in spring and summer, and nourishing yin in autumn and winter" in the "Suwen·Siqi Tiaoshen Dalun" chapter. During the Sanfu period when yang energy is abundant, yang-positive and hot medicines are applied to acupoints such as Feishu, Gaohuang, Tanzhong, Tiantu, and Dingchuan. The medicines are then transported to the affected area through the meridians and blood to regulate the balance of yin and yang and expel external pathogens. Currently, the Sanfu Patch method is largely based on the medical text *Zhang's Medical Treatise* by Zhang Lu, a renowned physician of the Qing Dynasty. The book explicitly states: "For cold asthma, moxibustion at Feishu (BL13), Gaoyu (BL20), and Tiantu (CV22) may or may not be effective. Applying white mustard seed paste during the Sanfu period in summer often yields good results. The formula uses one ounce of pure white mustard seed powder, one ounce of Corydalis rhizome, and half an ounce each of Euphorbia kansui and Asarum, all ground into a fine powder. Add half a mace of fennel seeds, mix well, and apply with ginger juice to acupoints such as Feishu (BL13), Gaoyu (BL20), and Bailao (BL10). After application, there will be numbness and pain; do not remove it immediately. Wait until the incense smoke has burned for three hours before removing it." This text is the first to elucidate the basic composition of this formula, with white mustard seed and Corydalis rhizome as the principal ingredients, Asarum as the assistant ingredient, and Euphorbia kansui as the adjuvant ingredient. Modern medicine, combining the clinical characteristics of different diseases and seasonal changes, modifies the formula, primarily using it to treat respiratory diseases such as bronchial asthma and allergic rhinitis, with significant efficacy.

[0003] Traditional Sanfu Patch treatments may cause mild skin reactions such as burning, itching, redness, small blisters, and pigmentation after application. Some patients may experience severe adverse reactions such as large blisters, skin ulceration, and unbearable burning pain. The highly irritating ingredients, white mustard seed and the toxic herb, Euphorbia kansui, are contraindicated or have limited use in children, those with thin skin, or those with sensitive constitutions. Therefore, the innovative development of traditional Chinese medicine requires both inheriting and promoting its culture while simultaneously exploring new avenues based on clinical and theoretical practice to address the problems associated with traditional Sanfu Patch treatments and meet the modern demands for both safety and effectiveness. Summary of the Invention

[0004] The technical problem solved by the present invention is to provide a pharmaceutical composition for treating respiratory diseases in the form of Sanfu Patch.

[0005] The pharmaceutical composition of this invention uses white mustard seed, asarum, cinnamon, corydalis, tangerine peel, chuanxiong, ginger, and scallion as raw materials. The components work together to not only significantly treat respiratory diseases, but also significantly reduce the incidence of skin discomfort or adverse reactions after use.

[0006] The active pharmaceutical ingredient of the present invention is composed of the following ingredients in the indicated weight ratios: 20-40 parts white mustard seed, 10-20 parts asarum, 10-20 parts cinnamon, 25-40 parts corydalis, 10-25 parts dried tangerine peel, 15-30 parts chuanxiong rhizome, 30-60 parts fresh ginger, and 30-60 parts scallion.

[0007] More preferably, the active pharmaceutical ingredient of the pharmaceutical composition of the present invention is composed of the following raw materials in the indicated weight ratios: 30 parts white mustard seed, 15 parts asarum, 15 parts cinnamon, 30 parts corydalis, 15 parts dried tangerine peel, 15 parts chuanxiong rhizome, 50 parts ginger, and 50 parts scallion.

[0008] The ginger is any one of small yellow ginger, white ginger, or broad ginger, or a mixture thereof; small yellow ginger is preferred.

[0009] The white part of the scallion can be any one of scallions, onions, or green onions, or a mixture thereof; preferably, the white part of scallions is used.

[0010] Based on the above-mentioned components as active pharmaceutical ingredients, the present invention achieves its objective by employing the following preparation method, which includes the following steps:

[0011] (1) Take the white mustard seed, asarum, cinnamon, corydalis rhizome, tangerine peel and chuanxiong rhizome from the raw materials, crush them and set aside;

[0012] (2) Ginger and scallion whites shall be processed using at least one of the following methods:

[0013] (2a) Take fresh ginger and scallion whites, crush, grind or juice them, collect the juice, filter it and set it aside;

[0014] (2b) Take freeze-dried ginger and scallion whites, crush them, and mix with water;

[0015] (2c) Crush dried ginger and scallion whites and mix with water.

[0016] In practical applications, the powder obtained in step (1) is mixed with the ginger and scallion obtained in step (2) to make a paste for application.

[0017] In the above preparation method:

[0018] The pulverization in step (1) yields a fine powder of the raw material.

[0019] The pulverization mentioned in step (1) involves pulverizing each raw material into fine powder separately and then mixing them according to the weight ratio; alternatively, the raw materials can be mixed according to the weight ratio and then pulverized together into fine powder.

[0020] The pulverization described in step (1) is as follows: first pulverize into coarse powder and pass through a 20-40 mesh sieve; then pulverize again and pass through a 100-200 mesh sieve;

[0021] Preferably, the pulverization in step (1) is as follows: first pulverize into coarse powder and pass through a 40-mesh sieve; then pulverize again and pass through a 100-120-mesh sieve.

[0022] In step (2a), the ginger and scallion whites are juiced separately and then mixed, or they are juiced together.

[0023] Step (2a) involves collecting ginger juice and scallion juice and filtering them through an 80-300 mesh sieve;

[0024] Preferably, the ginger juice and scallion juice collected in step (2a) are filtered through a 100-200 mesh sieve;

[0025] Furthermore, since ginger juice will produce sediment after filtration and standing, possibly due to the precipitation of certain substances during the process, a finer mesh is used for filtration; therefore, the following filtration parameters can also be used:

[0026] Step (2a) Ginger Juice Preparation: The filtration process involves first coarse filtration using an 80-100 mesh sieve, followed by fine filtration using a 200-300 mesh filter cloth.

[0027] Preferably, the filtration of ginger juice in step (2a) involves first coarse filtration using a 100-mesh sieve, and then fine filtration using a 200-mesh filter cloth;

[0028] Step (2a) Preparation of scallion juice: filtration using a 100-300 mesh filter cloth;

[0029] Preferably, the scallion juice in step (2a) is filtered using a 200-mesh filter cloth;

[0030] Alternatively, in step (2a) of preparing scallion juice, the filtration process involves first coarse filtration using an 80-100 mesh sieve, followed by fine filtration using a 200-300 mesh filter cloth.

[0031] Preferably, in step (2a) the preparation of scallion juice, the filtration is first coarsely filtered using a 100-mesh sieve, and then finely filtered using a 200-mesh filter cloth.

[0032] The pulverization described in steps (2b) and (2c) is pulverization into fine powder.

[0033] Furthermore, the process of pulverizing into fine powder in steps (2b) and (2c) involves first pulverizing into coarse powder and then pulverizing into fine powder.

[0034] Furthermore, the pulverization into fine powder described in steps (2b) and (2c) involves first pulverizing into coarse powder and passing it through a 20-40 mesh sieve; then pulverizing again and passing it through a 100-200 mesh sieve.

[0035] Furthermore, the process of pulverizing into fine powder in steps (2b) and (2c) involves first pulverizing into coarse powder and passing it through a 40-mesh sieve; then pulverizing again and passing it through a 100-120-mesh sieve.

[0036] The pharmaceutical composition of this invention is primarily used in the preparation of drugs for external application. Specifically, it can be used for acupoint application; the acupoints are selected from one or more of the following: Dazhui (GV14), Dingchuan (EX-B1), Feishu (BL13), Shenzhu (GV12), Shenshu (BL23), and Gaohuang (BL43).

[0037] The external preparations are medicated pastes, moxibustion plasters, ointments, and blank medicated patches or non-woven fabrics loaded with medicated pastes, moxibustion plasters, or ointments; preferably, medicated pastes or blank medicated patches or non-woven fabrics loaded with medicated pastes are used. The application time for each acupoint is 4-8 hours, preferably 6 hours; the amount of medicated paste used for each acupoint is 3-5g.

[0038] The pharmaceutical use of the pharmaceutical composition of the present invention is in the preparation of remedies for treating and / or preventing respiratory diseases. These respiratory diseases include one or more of the following: chronic cough, chronic bronchitis, bronchial asthma, chronic obstructive pulmonary disease, susceptibility to colds in children with weak constitutions, rhinitis, and recurrent respiratory infections.

[0039] Through long-term clinical practice and application, the traditional Chinese medicine composition of this invention has demonstrated significant efficacy in treating respiratory diseases. Furthermore, it significantly reduces the incidence of skin discomfort or adverse reactions in patients. Specifically, in most cases, blistering does not occur, and in a few cases, only mild blistering occurs, reducing the risk of scarring. Its safety, especially in pediatric use, has been consistently affirmed by patients and their families. In addition, the ginger and scallion whites in this composition enhance the drug's absorption through acupoints, resulting in better moxibustion sensations during application, making it easier to achieve the desired Qi flow. Attached Figure Description

[0040] Figure 1 In vitro release curve (cumulative release rate of sinigrin thiocyanate - time curve). Detailed Implementation

[0041] The present invention will be explained and described below with reference to embodiments. Those skilled in the art will understand that the following embodiments are for illustrative purposes only and should not be considered as limiting the scope of the invention. Where specific techniques or conditions are not specified in the embodiments, they are performed according to the techniques or conditions described in the literature in the field or according to the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be obtained commercially.

[0042] Traditional Sanfu Patch treatments can cause mild skin reactions such as burning, itching, redness, small blisters, and pigmentation after application. In some cases, severe adverse reactions include large blisters, skin ulceration, and unbearable burning pain. The highly irritating ingredients, such as white mustard seed and the toxic ingredient Euphorbia kansui, make the patch unsuitable or limiting for use in children, those with thin skin, or those with sensitive constitutions. Therefore, the innovation of traditional Chinese medicine (TCM) requires both inheriting and promoting its culture and combining clinical and theoretical practice to address the problems of traditional Sanfu Patch treatments while ensuring both safety and effectiveness. Against this backdrop, the inventors have provided the TCM composition and its preparation method of this invention.

[0043] Example 1: The traditional Chinese medicine composition of the present invention

[0044] The raw materials for the traditional Chinese medicine composition of this invention are weighed according to the following weight ratio: 50 parts ginger, 50 parts scallion, 30 parts white mustard seed, 15 parts asarum, 15 parts cinnamon, 30 parts corydalis, 15 parts tangerine peel, and 15 parts chuanxiong.

[0045] Among them, ginger includes small yellow ginger, white ginger, scallion, and large ginger, with small yellow ginger being preferred. Among them, scallion whites include the white parts of scallions, onions, and green onions, with the white parts of scallions being preferred.

[0046] Example 2 Preparation of powder (fine powder)

[0047] Except for ginger and scallion, the following raw materials are weighed by weight: 30 parts white mustard seed, 15 parts asarum, 15 parts cinnamon, 30 parts corydalis, 15 parts dried tangerine peel, and 15 parts chuanxiong. They are then put into a pulverizing device and pulverized first into coarse powder, which is then passed through a 40-mesh sieve. After that, they are pulverized again and passed through a 100-120-mesh sieve.

[0048] Example 3: Preparation of ginger and scallion juice

[0049] Take 50 portions each of fresh ginger and scallion whites, wash them, slice them, put them in a juicer to extract the juice, collect the juice, first coarsely filter it through a 100-mesh sieve, then finely filter it through a 200-mesh filter cloth, and set the filtrate aside.

[0050] In practical use, the powder prepared in Example 2 can be mixed with the juice prepared in Example 3 to form a paste, which can be placed on non-woven fabric or in a blank medicated patch and applied to acupoints for 4-8 hours, once a day.

[0051] Preferably, each acupoint uses 3-5g of medicated paste per patch, applied to Dazhui, Dingchuan, Feishu, Shenzhu, Shenshu, and Gaohuang for 6 hours, once daily.

[0052] The following experimental examples use the medicated paste prepared in the foregoing embodiments to load blank medicated patches to prepare acupoint patch formulations to illustrate the beneficial effects of the present invention.

[0053] Experiment Example 1: Skin Irritation Test

[0054] The traditional method for preparing the control group sample for Sanfu Patch involves grinding one ounce of pure white mustard seed powder, one ounce of Corydalis rhizome, and half an ounce each of Euphorbia kansui and Asarum root into a fine powder, mixing well, and then mixing with ginger juice to form a paste. Here, "one ounce" refers to a Qing Dynasty unit of weight; it should be converted to the current weight for experimental calculations.

[0055] Thirty male guinea pigs were randomly divided into five groups of six each: a blank control group, a single-dose traditional Sanfu Patch control group, a continuous-dose traditional Sanfu Patch control group, a single-dose traditional Chinese medicine composition experimental group, and a continuous-dose traditional Chinese medicine composition experimental group. The experiment used a self-control method with left and right sides of the same animal. Twenty-four hours before administration, the guinea pigs' backs were shaved on both sides, with a shaving area of ​​5 cm × 5 cm on each side. An appropriate amount of depilatory cream was evenly applied to the exposed area, and after standing, it was gently wiped away with a cotton ball soaked in PBS buffer to thoroughly remove any residue, ensuring full skin exposure. Subsequent procedures are shown in Table 1. Visual observation was performed at 30 min, 24 h, and 48 h after the last application to check for erythema, edema, blistering, etc. The experimental results are shown in Table 2.

[0056] Table 1. Procedure for Skin Irritation Tests

[0057]

[0058] Table 2 Results of skin irritation test

[0059]

[0060] Conclusion: Compared with traditional Sanfu Patch, the herbal composition of this invention has lower skin irritation and exhibits better medication safety.

[0061] Experimental Example 2: Transdermal Absorption Experiment

[0062] The Franz in vitro transdermal diffusion method was used to compare the in vitro release of traditional Chinese medicine (TCM) compositions and traditional Sanfu Patch. The experiment consisted of four groups: a TCM composition with ginger, a TCM composition with scallion, a TCM composition with both ginger and scallion, and a traditional Sanfu Patch group. 1g of the herbal powder was weighed and mixed with the same weight of herbal decoction from each group to form a paste. A Franz vertical diffusion cell was used, with PBS as the receiving medium. A 1µm FES biomembrane was cut into circular pieces approximately 2 cm in diameter and fixed between the diffusion cell and the sample cell. The receiving cell contained a magnetic stirring bead, and 15.5mL of the receiving medium was injected, with air bubbles removed. The slanted opening of the receiving cell was sealed with aluminum foil to prevent leakage of the test solution. The water bath temperature was maintained at 33.0±0.5℃, and the mixture was stirred at a constant speed (300rpm). After the transdermal test stabilized for 30 min, 1 mL samples were taken from the slanted opening of the receiving cell at 1, 2, 4, 6, 8, 10, and 12 h, and an equal volume of blank receiving medium at the same temperature was added. Each test was performed in triplicate. The sample solution was pretreated, and 20 µL was automatically injected for HPLC analysis of the sinapicin concentration in the sample solution. The peak area was measured, and the cumulative release rate was calculated by substituting it into the linear regression equation. The formula is as follows:

[0063]

[0064] Parameter description:

[0065] Qn%: Cumulative release rate (%) at time point n

[0066] V: Total volume of the receiving liquid in the receiving chamber (mL)

[0067] Cn: Drug concentration (ug / mL) measured at the nth time point

[0068] Vs: Volume of each sample taken (mL, 1 mL in the text).

[0069] Ci: Drug concentration at time point i (ug / mL)

[0070] W: Total mass of medication contained in the patch (ug)

[0071] The in vitro release curve (cumulative release rate of sinigrin thiocyanate - time curve) is shown in the figure. Figure 1 The results showed that the cumulative permeability of sinigrin thiocyanate in the herbal composition of this invention after 12 hours was comparable to that of traditional Sanfu Patch, while the permeability of ginger and scallion alone was significantly lower than that of the combination of the two. The results indicate that the combination of scallion and ginger in the herbal composition of this invention can achieve a synergistic effect, while simultaneously achieving the same transdermal release efficiency as traditional Sanfu Patch.

[0072] Example 3: Pharmacological Experiment

[0073] To verify the therapeutic effect of the traditional Chinese medicine composition of the present invention, animal efficacy experiments were conducted on the four groups described in Example 6.

[0074] Experimental Model and Methods: A bronchitis animal model was established using healthy male SD rats, which were randomly divided into 6 groups: normal group, model group, traditional Sanfu Patch group, traditional Chinese medicine combination with ginger group, traditional Chinese medicine combination with scallion group, and traditional Chinese medicine combination with ginger and scallion group. There were 6 rats in each group.

[0075] Application method: Apply the corresponding medicated paste to the Feishu acupoint daily for 6 hours each time, for 5 consecutive days. The amount of paste used is 0.5-1g, with approximately the same thickness and area. During the experiment, the following indicators were monitored: FVC (vital capacity), FeV 0.1%, FeV 0.3%, FeV 0.10 / FVC%, and FeV 0.30 / FVC%. The experimental results are shown in Table 3.

[0076] Table 3. Improvement rate of lung function in different groups

[0077]

[0078] Note: Compared with the normal group, Compared with the model group, #P < 0.05; compared with the traditional Chinese medicine combination of ginger and scallion, △P < 0.05; compared with the traditional Sanfu Patch group, †P < 0.05 (used for comparison between the single-use group and the traditional Sanfu Patch group).

[0079] Experimental results showed that, in terms of improving lung function, the combination of ginger and scallion in the traditional Chinese medicine composition was superior to that in the traditional Sanfu Patch group. This result fully demonstrates that the combination of ginger and scallion produced a significant synergistic effect, making the Chinese medicine composition of this invention the best among all groups in improving lung ventilation function in bronchitis model rats.

[0080] Example 4: Clinical efficacy observation

[0081] To observe the effect of the traditional Chinese medicine composition of the present invention on children with chronic pulmonary diseases, we observed the effects before and after treatment in 50 children with chronic pulmonary diseases (including chronic cough, chronic bronchitis, bronchial asthma, chronic obstructive pulmonary disease, children with weak constitution who are prone to colds, and children with recurrent respiratory infections) who received Sanfu Sanjiu Tiefa at Mingde Traditional Chinese Medicine Clinic in Qingyang District from July to August 2025.

[0082] Traditional Chinese Medicine Diagnostic Methods: Combining past clinical experience and a summary of literature, the diagnostic criteria are based on lung qi deficiency syndrome. Main symptoms: aversion to wind, susceptibility to colds; Accompanying symptoms: ① persistent cough and wheezing, with thin, clear sputum. ② weak cough. ③ shortness of breath. ④ spontaneous sweating. ⑤ fatigue, weakness, and reluctance to speak. ⑥ pale tongue with a white coating. ⑦ weak pulse.

[0083] Inclusion criteria: Individuals aged 5 to 14 years who meet the diagnostic criteria of traditional Chinese medicine.

[0084] Exclusion criteria: Children with abnormal liver and kidney function, congenital heart disease, and coagulation disorders; children with congenital diseases such as immune deficiency; children with other respiratory diseases such as rhinitis and pharyngitis; and children who are allergic to the patch or adhesive tape.

[0085] Application to acupoints: Apply the plaster prepared in Example 4 to the acupoints Dazhui, Dingchuan, Feishu, Shenzhu, Shenshu, and Gaohuang for 6 hours, once a day, and once every 3-5 days.

[0086] Efficacy assessment: Symptoms such as cough, sputum production, and wheezing are classified into four levels: severe, moderate, mild, and none. A TCM syndrome efficacy index is established based on a scoring system. Changes in patients' symptoms before and after treatment are observed.

[0087] Percentage improvement in symptom and sign scores (N) = (Pre-treatment score - Post-treatment score) / Pre-treatment score × 100%. Cure: Clinical symptoms and signs disappear or essentially disappear, with a ≥95% reduction in syndrome score. Significant effect: Clinical symptoms and signs show significant improvement, with 95% > syndrome score reduction ≥70%. Effective: Clinical symptoms and signs improve, with 70% > syndrome score reduction ≥30%. Ineffective: Clinical symptoms and signs show no significant change, or even worsen, with a syndrome score reduction of less than 30%. Results are shown in Table 4.

[0088] Table 4 Comparison of effective rates after treatment (%)

[0089] The observation results show that the traditional Chinese medicine composition of the present invention has a good effect on the prevention and treatment of chronic pulmonary diseases.

[0090] In summary, the composition of this invention demonstrates significant efficacy in treating respiratory diseases, with a markedly reduced incidence of skin discomfort or adverse reactions in patients. Specifically, blistering does not occur in most cases, and only mild blistering occurs in a few, thus reducing the risk of scarring. In particular, the safety of this pharmaceutical composition in children has been consistently affirmed by patients' families. Furthermore, the combined use of ginger and scallion in this traditional Chinese medicine composition enhances the drug's absorption through acupoints, resulting in a better moxibustion sensation during application, making it easier to achieve the desired Qi flow, and providing a novel option for clinical application of topical plaster preparations.

Claims

1. A pharmaceutical composition, characterized in that: The active pharmaceutical ingredient of the pharmaceutical composition is composed of the following ingredients in the indicated weight ratios: 20-40 parts white mustard seed, 10-20 parts asarum, 10-20 parts cinnamon, 25-40 parts corydalis, 10-25 parts dried tangerine peel, 15-30 parts chuanxiong rhizome, 30-60 parts fresh ginger, and 30-60 parts scallion.

2. The pharmaceutical composition according to claim 1, characterized in that: The active pharmaceutical ingredient of the pharmaceutical composition is composed of the following ingredients in the indicated weight ratios: 30 parts white mustard seed, 15 parts asarum, 15 parts cinnamon, 30 parts corydalis, 15 parts dried tangerine peel, 15 parts chuanxiong rhizome, 50 parts fresh ginger, and 50 parts scallion.

3. The pharmaceutical composition according to claim 1 or 2, characterized in that: At least one of the following must be met: The ginger is any one of small yellow ginger, white ginger, scallion ginger, or large ginger, or a mixture thereof; Preferably, the ginger is small yellow ginger; The white part of the scallion can be any one of scallions, onions, or green onions, or a mixture thereof; Preferably, the white part of the scallion is the white part of a scallion.

4. A method for preparing the pharmaceutical composition according to any one of claims 1-3, characterized in that: It includes the following steps: (1) Take the white mustard seed, asarum, cinnamon, corydalis rhizome, tangerine peel and chuanxiong rhizome from the raw materials, crush them and set aside; (2) Ginger and scallion whites shall be processed using at least one of the following methods: (2a) Take fresh ginger and scallion whites, crush, grind or juice them, collect the juice, filter it and set it aside; (2b) Take freeze-dried ginger and scallion whites, crush them, add water and mix, set aside; (2c) Crush dried ginger and scallion whites, mix with water, and set aside.

5. The method for preparing the pharmaceutical composition according to claim 4, characterized in that: Step (1) must satisfy at least one of the following conditions: The pulverization described in step (1) yields a fine powder of the active pharmaceutical ingredient; The pulverization mentioned in step (1) involves pulverizing each raw material into fine powder separately and then mixing them according to the weight ratio; alternatively, the raw materials can be mixed according to the weight ratio and then pulverized together into fine powder. The pulverization described in step (1) is as follows: first pulverize into coarse powder and pass through a 20-40 mesh sieve; then pulverize again and pass through a 100-200 mesh sieve; Preferably, the pulverization in step (1) is as follows: first pulverize into coarse powder and pass through a 40-mesh sieve; then pulverize again and pass through a 100-120-mesh sieve.

6. The method for preparing the pharmaceutical composition according to claim 4, characterized in that: Step (2) must satisfy at least one of the following conditions: In step (2a), the ginger and scallion whites are juiced separately and then mixed, or they are juiced together. Alternatively, the ginger juice and scallion juice collected in step (2a) can be filtered through an 80-300 mesh sieve; Alternatively, preferably, the ginger juice and scallion juice obtained in step (2a) are filtered through a 100-200 mesh sieve; Alternatively, in step (2a) of preparing ginger juice, the filtration process involves first coarse filtration using an 80-100 mesh sieve, followed by fine filtration using a 200-300 mesh filter cloth. Alternatively, preferably, the filtration of ginger juice in step (2a) is to first coarsely filter it with a 100-mesh sieve, and then finely filter it with a 200-mesh filter cloth; Alternatively, in step (2a), the preparation of scallion juice involves filtering with a 100-300 mesh filter cloth. Alternatively, preferably, the scallion juice in step (2a) is filtered using a 200-mesh filter cloth; Alternatively, in step (2a) of preparing scallion juice, the filtration process involves first coarse filtration using an 80-100 mesh sieve, followed by fine filtration using a 200-300 mesh filter cloth. Alternatively, preferably, in step (2a) the preparation of scallion juice, the filtration is first coarsely filtered through a 100-mesh sieve, and then finely filtered through a 200-mesh filter cloth; Alternatively, the pulverization described in steps (2b) and (2c) may be pulverization into fine powder; Alternatively, further, the grinding into fine powder described in steps (2b) and (2c) is to first grind into coarse powder and then grind into fine powder; Alternatively, further, the grinding into fine powder described in steps (2b) and (2c) is to first grind into coarse powder and pass it through a 20-40 mesh sieve; and then grind it again and pass it through a 100-200 mesh sieve. Alternatively, in steps (2b) and (2c), the process of pulverizing the material into fine powder involves first pulverizing it into coarse powder and passing it through a 40-mesh sieve; then pulverizing it again and passing it through a 100-120-mesh sieve.

7. The use of the pharmaceutical composition according to any one of claims 1-3 in the preparation of a topical formulation, characterized in that: Topical preparations are used for acupoint application; Preferably, the acupoints are selected from one or more of the following: Dazhui, Dingchuan, Feishu, Shenzhu, Shenshu, and Gaohuang. Preferably, the external preparation is a medicated paste, moxibustion plaster, ointment, or a blank medicated patch or non-woven fabric loaded with the medicated paste, moxibustion plaster, or ointment. Most preferably, the topical preparation is a medicated paste or a blank medicated patch loaded with medicated paste or a non-woven fabric; Alternatively, the acupoint patch can be applied for 4-8 hours each time; Preferably, the acupoint patch is applied for 6 hours each time; Alternatively, the amount of medicated paste used for each acupoint patch is 3-5g.

8. The use of the pharmaceutical composition prepared by the method according to any one of claims 4-6 in the preparation of a topical formulation, characterized in that: The topical preparation is made by mixing the powder obtained in step (1) with the ginger and scallion obtained in step (2) to form a paste for application, or by making a blank patch or non-woven fabric loaded with the paste for application.

9. Use of the pharmaceutical composition according to any one of claims 1-3, or the pharmaceutical composition prepared by the preparation method according to any one of claims 4-6, in the preparation of a medicament for treating and / or preventing respiratory diseases.

10. The use according to claim 9, characterized in that: The respiratory diseases include one or more of the following: chronic cough, chronic bronchitis, bronchial asthma, chronic obstructive pulmonary disease, children with weak constitutions who are prone to colds, rhinitis, and recurrent respiratory infections.

Images