Use of a traditional Chinese medicine composition in the preparation of a medicine for viral pneumonia

Abstract

The application relates to an application of a traditional Chinese medicine composition in a drug for viral pneumonia, which comprises 10-15 parts of wind-preventing, 10-15 parts of perilla leaf, 2-6 parts of Ephedra, 7-9 parts of Schisandra chinensis, 7-9 parts of white ginkgo, 7-9 parts of bitter almond, 7-9 parts of purple aster, 7-9 parts of dogwood fruit and 7-9 parts of lily of the valley. The traditional Chinese medicine composition can obviously inhibit the increase of the lung index of respiratory syncytial virus (RSV) infected mice and has a better treatment effect on viral pneumonia.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology and relates to a new use of a traditional Chinese medicine composition, specifically the application of a traditional Chinese medicine composition in the preparation of a drug for viral pneumonia. Background Technology

[0002] Viral pneumonia is an inflammation of the lungs caused by a viral infection. The most common virus causing pneumonia is the influenza virus, followed by parainfluenza virus, cytomegalovirus, adenovirus, rhinovirus, coronavirus, and certain enteroviruses such as Coxsackievirus and echovirus. Infants and young children are also frequently infected with respiratory syncytial virus (RSV). Viral pneumonia occurs more frequently in winter and spring, and can occur sporadically, in epidemics, or outbreaks. Infants, the elderly, pregnant women, and those with weakened immune systems are more susceptible to the disease, which can be more severe and even fatal.

[0003] Viral pneumonia generally presents with milder clinical manifestations, similar to those of mycoplasma pneumonia. The onset is slow, with symptoms including headache, fatigue, fever, cough, and small amounts of sticky sputum. Physical examination is often absent. X-ray examination reveals patchy, patchy, or uniform shadows of lung inflammation. The white blood cell count may be normal, decreased, or slightly increased. The course of the disease is generally 1-2 weeks. In immunocompromised patients, viral pneumonia is often more severe, with persistent high fever, palpitations, shortness of breath, cyanosis, and extreme exhaustion, which may be accompanied by shock, heart failure, and azotemia. Due to alveolar interstitial and alveolar edema, severe cases may develop acute respiratory distress syndrome. Bacterial pneumonia is a lung disease caused by bacterial infection. Patients typically present with symptoms such as fever, cough, chest pain, and dyspnea. Bacterial pneumonia can be transmitted through the air, direct contact, or blood. Treatment methods include antibiotic therapy, rest, adequate hydration, and nutritional support. Summary of the Invention

[0004] To solve the above-mentioned technical problems, the present invention provides an application of a traditional Chinese medicine composition in the preparation of drugs for viral or bacterial pneumonia. The traditional Chinese medicine composition includes: 10-15 parts of Saposhnikovia divaricata, 10-15 parts of Perilla frutescens leaf, 2-6 parts of Ephedra sinica, 7-9 parts of Schisandra chinensis, 7-9 parts of Ginkgo biloba, 7-9 parts of Prunus armeniaca, 7-9 parts of Aster tataricus, 7-9 parts of Cornus officinalis, and 7-9 parts of Magnolia biondii.

[0005] Preferably, the traditional Chinese medicine composition includes: 10-12 parts of Saposhnikovia divaricata, 10-12 parts of Perilla frutescens leaf, 4-6 parts of Ephedra sinica, 7-8 parts of Schisandra chinensis, 7-8 parts of Ginkgo biloba, 7-8 parts of bitter apricot kernel, 7-8 parts of Aster tataricus, 7-8 parts of Cornus officinalis, and 7-8 parts of Magnolia biondii.

[0006] Most preferably, the traditional Chinese medicine composition includes: 10 parts of Saposhnikovia divaricata, 10 parts of Perilla frutescens leaf, 6 parts of Ephedra sinica, 8 parts of Schisandra chinensis, 8 parts of Ginkgo biloba, 8 parts of bitter apricot kernel, 8 parts of Aster tataricus, 8 parts of Cornus officinalis, and 8 parts of Magnolia biondii.

[0007] The viral pneumonia may be pneumonia caused by respiratory syncytial virus infection, and the bacterial pneumonia may be pneumonia caused by mixed infection of Streptococcus pneumoniae and Staphylococcus aureus.

[0008] The term "used" can refer to any method beneficial to improving the patient's corresponding symptoms, including treatment or prevention. The composition can be made by directly grinding raw materials into powder, or by extracts or other forms obtained through conventional methods. The raw materials used can also be used by directly grinding into powder, extracts, or other processed forms.

[0009] The present invention also proposes the application of any of the aforementioned traditional Chinese medicine compositions in the preparation of anti-respiratory syncytial virus drugs.

[0010] This invention also proposes the application of any of the aforementioned traditional Chinese medicine compositions in the preparation of antibacterial infection drugs. Specifically, the bacterial infection can be Streptococcus pneumoniae or Staphylococcus aureus or a mixed infection thereof.

[0011] Specifically, the aforementioned drugs include oral dosage forms, injectable dosage forms, or topical dosage forms.

[0012] The present invention relates to a traditional Chinese medicine composition for viral pneumonia, which is prepared into granules, capsules, tablets or pills by adding pharmaceutically permissible excipients.

[0013] The preparation method of the traditional Chinese medicine composition of the present invention includes the following steps: the above nine ingredients (bitter almonds added to boiling water) are decocted twice with 8 times the amount of water, each time for 2 hours, filtered, the filtrates are combined, and concentrated under reduced pressure to an extract with a relative density of 1.10 to 1.15 (50±5℃).

[0014] Preferably, the preparation of the traditional Chinese medicine composition includes the following steps: volatile components of Perilla frutescens leaves and Magnolia biondii are extracted by steam distillation, encapsulated with β-cyclodextrin, and set aside. The residue is combined with Saposhnikovia divaricata, Ephedra sinica, and Prunus armeniaca, and decocted separately with water 1-3 times, 1-3 hours each time. The extracts are combined and concentrated to a clear extract with a relative density of 1.10-1.15 at 50°C. The extract is then precipitated with alcohol until the alcohol content reaches 60%-70%. The supernatant is concentrated to a clear extract with a relative density of 1.25-1.30 at 50°C for later use. Schisandra chinensis, Ginkgo biloba, Aster tataricus, and Cornus officinalis are extracted with 60%-70% ethanol 1-3 times, 1-3 hours each time. The ethanol extracts are combined and concentrated to a clear extract with a relative density of 1.25-1.30 at 50°C. The above clear extracts are combined, dried, pulverized, and the volatile oil inclusion complex is added and mixed well to obtain the final product.

[0015] Furthermore, the preparation method of the above-mentioned traditional Chinese medicine composition specifically includes the following steps: Volatile components of Perilla frutescens leaves and Magnolia biondii are extracted by steam distillation, encapsulated with β-cyclodextrin, and set aside. The residue is combined with Saposhnikovia divaricata, Ephedra sinica, and Prunus armeniaca, and decocted three times with 10 times the amount of water, each time for 1.5 hours. The extracts are combined and concentrated into a clear extract with a relative density of 1.10–1.15 at 50°C. The extract is precipitated with alcohol until the alcohol content reaches 70%. The supernatant is then concentrated to prepare a clear extract with a relative density of 1.25–1.30 at 50°C for later use. Schisandra chinensis, Ginkgo biloba, Aster tataricus, and Cornus officinalis are extracted three times with 60% ethanol, each time for 2.5 hours. The ethanol extracts are combined and concentrated to prepare a clear extract with a relative density of 1.25–1.30 at 50°C. The above clear extracts are combined, dried, pulverized, and the volatile oil inclusion complex is added and mixed well to obtain the final product.

[0016] Specifically, the aforementioned drug is selected from granules, and its preparation method includes:

[0017] Volatile components were extracted from 277.8g of Perilla frutescens leaves and 222.2g of Magnolia biondii using steam distillation. These components were then encapsulated with β-cyclodextrin for later use. The residue was combined with 277.8g of Saposhnikovia divaricata, 166.7g of Ephedra sinica, and 222.2g of Prunus armeniaca. Each was decocted separately with 10 times the amount of water three times, 1.5 hours each time. The extracts were combined and concentrated to a clear extract with a relative density of 1.10–1.15 at 50°C. Alcohol precipitation was performed until the alcohol content reached 70%. The supernatant was then concentrated to a concentration suitable for 50°C. Prepare a clear extract with a relative density of 1.25–1.30. Extract 222.2g of Schisandra chinensis, 222.2g of Ginkgo biloba, 222.2g of Aster tataricus, and 222.2g of Cornus officinalis with 60% ethanol three times, 2.5 hours each time. Combine the ethanol extracts and concentrate them to prepare a clear extract with a relative density of 1.25–1.30 at 50℃. Combine the above clear extracts, dry them, pulverize them, add volatile oil inclusion complexes, mix well, add appropriate amounts of dextrin and sucralose, mix well, and make granules.

[0018] The composition of this invention can significantly reduce the increase in lung index in mice infected with respiratory syncytial virus (RSV); it can also significantly reduce the increase in lung index in mice with mixed infections of Streptococcus pneumoniae and Staphylococcus aureus. This indicates that the traditional Chinese medicine composition has a good therapeutic effect on viral or bacterial infections and the resulting pneumonia. Detailed Implementation

[0019] As mentioned above, the present invention aims to provide an application of a traditional Chinese medicine composition in the preparation of drugs for viral or bacterial pneumonia. The following will describe this in detail with reference to specific experiments.

[0020] Unless otherwise specified, all experiments in the following experiments were conducted under standard conditions or conditions recommended by the manufacturer. Active pharmaceutical ingredients (APIs) or excipients, as well as reagents or instruments whose manufacturers are not specified, are all commercially available products. Unless otherwise stated, all percentages, ratios, proportions, or parts are by weight.

[0021] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as are familiar to those skilled in the art. Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to this invention.

[0022] Example 1: Preparation of the traditional Chinese medicine composition granules of the present invention

[0023] In this embodiment, the traditional Chinese medicine composition is made from the following raw materials: Saposhnikovia divaricata 277.8g, Perilla frutescens leaf 277.8g, Ephedra sinica 166.7g, Schisandra chinensis 222.2g, Ginkgo biloba 222.2g, Prunus armeniaca 222.2g, Aster tataricus 222.2g, Cornus officinalis 222.2g, and Magnolia biondii 222.2g.

[0024] The traditional Chinese medicine composition granules are prepared according to the following method:

[0025] Volatile components of Perilla frutescens leaves and Magnolia biondii were extracted by steam distillation and encapsulated with β-cyclodextrin for later use. The residue was combined with Saposhnikovia divaricata, Ephedra sinica, and Prunus armeniaca, and decocted three times with 10 times the amount of water, each time for 1.5 hours. The extracts were combined and concentrated to a clear extract with a relative density of 1.10–1.15 at 50°C. The extract was then precipitated with alcohol until the alcohol content reached 70%. The supernatant was concentrated to a clear extract with a relative density of 1.25–1.30 at 50°C for later use. Schisandra chinensis, Ginkgo biloba, Aster tataricus, and Cornus officinalis were extracted three times with 60% ethanol, each time for 2.5 hours. The ethanol extracts were combined and concentrated to a clear extract with a relative density of 1.25–1.30 at 50°C. The above extracts were combined, dried, pulverized, and encapsulated with volatile oils. The mixture was then mixed to obtain the herbal composition. Appropriate amounts of dextrin and sucralose were added to the herbal composition, mixed well, and granulated to obtain 1000g of granules.

[0026] Experimental Example 2: Therapeutic effect of traditional Chinese medicine composition on a mouse model of respiratory syncytial virus (RSV) induced pneumonia.

[0027] 1. Experimental Materials

[0028] 1.1 Animals

[0029] BALB / C mice, SPF grade, 36 mice, weighing 12-14g, half male and half female.

[0030] Rearing environment: Room temperature 20-26℃, relative humidity controlled at 40-70%. Females and males are housed separately, with 3 individuals / sex per cage / group.

[0031] 1.2 Drugs

[0032] The traditional Chinese medicine composition prepared in Example 1 was from Jiangsu Kangyuan Pharmaceutical Co., Ltd.; ribavirin granules (Kuihua Pharmaceutical Group (Hengshui) Defeier Co., Ltd., batch number 23041304); and isoflurane (Shenzhen Ruiwode Life Science Co., Ltd., batch number 10090310918).

[0033] 1.3 Instruments

[0034] Electronic balance (Shanghai Yueping Scientific Instruments Co., Ltd., model: YP1002 MAX100g); Electronic balance (Mettler-Toledo Instruments, model: AL204 MAX210g).

[0035] 2. Dosage design

[0036] The daily dosage of the herbal composition is 123g of raw drug / day. Based on the body surface area calculation, the equivalent dose for mice is 123g / 60kg * 12.3 = 25.22g of raw drug / kg. Following a 1 / 2:1:2 dosing regimen, the low dose is 12.61g of raw drug / kg, the medium dose is 25.22g of raw drug / kg, and the high dose is 50.44g of raw drug / kg. Administered by gavage, 0.2mL / 10g, once daily.

[0037] The daily dosage of ribavirin granules is 450 mg / day. Based on the body surface area reduction method, the equivalent dose for mice is 450 mg / 60 kg * 12.3 = 92.3 mg / kg.

[0038] 3. Experimental Methods

[0039] BALB / c mice were acclimatized for 3 days with free access to feed and water. They were then randomly divided into four groups according to body weight: a normal control group, a model control group, a ribavirin granule control group, and high, medium, and low dose groups of the traditional Chinese medicine combination, with 6 mice in each group.

[0040] Except for the normal control group, mice in each group were lightly anesthetized with isoflurane and administered 100 TCID45. 50 RSV virus solution was administered via nasal instillation to each mouse, at a dose of 45 μl. One hour after infection, mice in each group were administered the solution via gavage at a dose of 0.1 ml / 10 g, once daily for 5 consecutive days. The normal control group and the model control group were given distilled water under the same conditions. On day 5, mice in each group were weighed one hour after administration, and their lungs were dissected, removed, and weighed. The lung index and inhibition rate were calculated.

[0041] Lung index (%) = Lung wet weight (g) / Body weight (g) × 100;

[0042] Lung index inhibition rate (%) = (lung weight of model control group - average lung weight of drug group) / (lung weight of model control group - lung weight of normal control group) × 100.

[0043] 4. Statistical Methods

[0044] Results are expressed as mean ± standard deviation. The data were analyzed using GraphPad Prism 10 statistical software, employing a combination of one-way ANOVA and Dunnett's multiple comparison test. A p-value < 0.05 was considered statistically significant.

[0045] 5. Experimental Results

[0046] After mice were infected with RSV virus fluid, their lung index was significantly increased compared with the normal control group (P<0.01). Five days after treatment with the traditional Chinese medicine composition starting on the day of infection, the lung index of the high, medium, and low dose groups of the traditional Chinese medicine composition was significantly decreased compared with the model control group (P<0.01). The lung index inhibition rates of the high, medium, and low dose groups of the traditional Chinese medicine composition were 67.61%, 61.96%, and 47.87%, respectively. (See Table 1).

[0047] Table 1: Therapeutic effect on RSV-infected mouse pneumonia model

[0048]

[0049] Note: Compared with the normal control group, ## P<0.01; compared with the model control group, *P<0.05, **P<0.01.

[0050] 6. Experimental Conclusions

[0051] The traditional Chinese medicine composition at concentrations of 50.44, 25.22, and 12.61 g crude drug / kg significantly inhibited the increase in lung index in infected mice, suggesting that the traditional Chinese medicine composition has a certain therapeutic effect on respiratory syncytial virus infection and the resulting pneumonia in mice.

[0052] Example 3: Protective effect of traditional Chinese medicine composition on a mouse pneumonia model of mixed infection with Streptococcus pneumoniae and Staphylococcus aureus.

[0053] 1. Experimental Materials

[0054] 1.1 Animals

[0055] ICR mice, SPF grade, 36 mice, weighing 12-14g, half male and half female. Housing environment: room temperature 20-26℃, relative humidity controlled at 40-70%. Separate males and females into different cages, 3 mice / sex / group per cage.

[0056] 1.2 Drugs

[0057] The traditional Chinese medicine composition was prepared according to the method in Example 1 and was provided by Jiangsu Kangyuan Pharmaceutical Co., Ltd.; amoxicillin capsules (Shijiazhuang Zhongnuo Pharmaceutical Co., Ltd., batch number 324230203); isoflurane (Shenzhen Ruiwode Life Science Co., Ltd., batch number 10090310918).

[0058] 1.3 Instruments

[0059] Electronic balance (Shanghai Yueping Scientific Instruments Co., Ltd., model: YP1002 MAX100g); Electronic balance (Mettler-Toledo Instruments, model: AL204 MAX210g).

[0060] 2. Dosage design

[0061] The daily dosage of the herbal composition is 123g of raw drug / day. Based on the body surface area calculation, the equivalent dose for mice is 123g / 60kg * 12.3 = 25.22g of raw drug / kg. Following a 1 / 2:1:2 dosing regimen, the low dose is 12.61g of raw drug / kg, the medium dose is 25.22g of raw drug / kg, and the high dose is 50.44g of raw drug / kg. Administered by gavage, 0.2mL / 10g, once daily.

[0062] The daily dose of amoxicillin capsules is 500 mg / day. Based on the body surface area calculation method, the equivalent dose for mice is 500 mg / 60 kg * 12.3 = 102.5 mg / kg.

[0063] 3. Experimental Methods

[0064] Staphylococcus aureus and Streptococcus pneumoniae were inoculated separately into nutrient broth and incubated at 37°C for 16 hours. The bacterial turbidity concentration was 9 × 10⁻⁶. 8 bacteria / ml.

[0065] ICR mice were acclimatized for 3 days with free access to feed and water. They were then randomly divided into four groups according to body weight: a normal control group, a model control group, an amoxicillin capsule control group, and high, medium, and low dose groups of the traditional Chinese medicine combination, with 6 mice in each group.

[0066] Except for the normal control group, mice in each group were lightly anesthetized with ether at a concentration of 9 × 10⁻⁶. 8Mice were infected with a bacterial solution of 1000 bacteria / ml via nasal drops. Each mouse received 20 μl of Staphylococcus aureus and 20 μl of Streptococcus pneumoniae bacterial solution. One hour after infection, all groups were administered the solution via gavage at a dose of 0.2 ml / 10 g, once daily for 5 consecutive days. The normal control group and the model control group received distilled water under the same conditions. On day 5, one hour after administration, mice in each group were weighed, dissected, and their lungs were removed and weighed. The lung index and inhibition rate were calculated.

[0067] Lung Index (%) = Lung wet weight (g) / Body weight (g) × 100

[0068] Lung index inhibition rate (%) = (lung weight of model control group - average lung weight of drug group) / (lung weight of model control group - lung weight of normal control group) × 100.

[0069] 4. Statistical Methods

[0070] Results are expressed as mean ± standard deviation. The data were analyzed using GraphPad Prism 10 statistical software, employing a combination of one-way ANOVA and Dunnett's multiple comparison test. A p-value < 0.05 was considered statistically significant. 5. Experimental Results

[0071] 5.1 Effects on lung index and lung index inhibition rate

[0072] Mice infected with Staphylococcus aureus and Streptococcus pneumoniae bacterial suspensions showed a significantly increased lung index compared to the normal control group (P<0.01). Five days after treatment with the traditional Chinese medicine (TCM) composition starting on the day of infection, the lung index of the high, medium, and low dose groups of the TCM composition significantly decreased compared to the model control group (P<0.05, P<0.01). The lung index inhibition rates of the high, medium, and low dose groups of the TCM composition were 93.48%, 79.22%, and 50.68%, respectively. (See Table 2).

[0073] Table 2: Therapeutic effect on mouse pneumonia model of mixed infection with Streptococcus pneumoniae and Staphylococcus aureus

[0074]

[0075] Note: Compared with the normal control group, ## P<0.01; compared with the model control group, **P<0.01.

[0076] 6. Experimental Conclusions

[0077] The traditional Chinese medicine composition at concentrations of 50.44, 25.22, and 12.61 g crude drug / kg significantly inhibited the increase in lung index in infected mice, indicating that the traditional Chinese medicine composition has a certain therapeutic effect on Staphylococcus aureus and Streptococcus pneumoniae infection and the pneumonia induced in mice.

[0078] The above embodiments of the present invention are merely examples to clearly illustrate the present invention and are not intended to limit the implementation of the present invention. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. The application of a traditional Chinese medicine composition in the preparation of a drug for treating viral or bacterial pneumonia, characterized in that, By weight, the traditional Chinese medicine composition is made from the following raw materials: 10-15 parts of Saposhnikovia divaricata, 10-15 parts of Perilla frutescens leaf, 2-6 parts of Ephedra sinica, 7-9 parts of Schisandra chinensis, 7-9 parts of Ginkgo biloba, 7-9 parts of Prunus armeniaca, 7-9 parts of Aster tataricus, 7-9 parts of Cornus officinalis, and 7-9 parts of Magnolia biondii; the viral pneumonia is pneumonia caused by respiratory syncytial virus infection, and the bacterial pneumonia is pneumonia caused by mixed infection of Streptococcus pneumoniae and Staphylococcus aureus.

2. The application according to claim 1, characterized in that, By weight, the traditional Chinese medicine composition is made from the following raw materials: 10-12 parts of Saposhnikovia divaricata, 10-12 parts of Perilla frutescens leaf, 4-6 parts of Ephedra sinica, 7-8 parts of Schisandra chinensis, 7-8 parts of Ginkgo biloba, 7-8 parts of bitter apricot kernel, 7-8 parts of Aster tataricus, 7-8 parts of Cornus officinalis, and 7-8 parts of Magnolia biondii.

3. The application according to claim 1, characterized in that, This traditional Chinese medicine composition is made from the following raw materials: 10 parts of Saposhnikovia divaricata, 10 parts of Perilla frutescens leaf, 6 parts of Ephedra sinica, 8 parts of Schisandra chinensis, 8 parts of Ginkgo biloba, 8 parts of bitter apricot kernel, 8 parts of Aster tataricus, 8 parts of Cornus officinalis, and 8 parts of Magnolia biondii.

4. The application according to claim 1, 2 or 3, characterized in that... This traditional Chinese medicine composition can be prepared into decoctions, granules, capsules, tablets or pills by adding pharmaceutically permissible excipients.

5. The application according to claim 1, 2 or 3, characterized in that, The preparation of the traditional Chinese medicine composition includes the following steps: Volatile components of Perilla frutescens leaves and Magnolia biondii were extracted by steam distillation and encapsulated with β-cyclodextrin for later use. The residue was combined with Saposhnikovia divaricata, Ephedra sinica, and Prunus armeniaca, and decocted separately with water 2-3 times, 1-3 hours each time. The extracts were combined and concentrated to a clear extract with a relative density of 1.10-1.15 at 50℃. The extract was then precipitated with alcohol until the alcohol content reached 60%-70%. The supernatant was concentrated to a clear extract with a relative density of 1.25-1.30 at 50℃ for later use. Schisandra chinensis, Ginkgo biloba, Aster tataricus, and Cornus officinalis were extracted with 60%-70% ethanol 2-3 times, 1-3 hours each time. The alcohol extracts were combined and concentrated to a clear extract with a relative density of 1.25-1.30 at 50℃. The above extracts were combined, dried, pulverized, and the volatile oil encapsulation compound was added and mixed well to obtain the final product.

6. The application according to claim 1, 2 or 3, characterized in that, The preparation of the traditional Chinese medicine composition includes the following steps: Volatile components of Perilla frutescens leaves and Magnolia biondii were extracted by steam distillation and encapsulated with β-cyclodextrin for later use. The residue was combined with Saposhnikovia divaricata, Ephedra sinica, and Prunus armeniaca, and decocted three times with 10 times the amount of water, each time for 1.5 hours. The extracts were combined and concentrated to a clear extract with a relative density of 1.10-1.15 at 50°C. The extract was then precipitated with alcohol until the alcohol content reached 70%. The supernatant was concentrated to a clear extract with a relative density of 1.25-1.30 at 50°C for later use. Schisandra chinensis, Ginkgo biloba, Aster tataricus, and Cornus officinalis were extracted three times with 60% ethanol, each time for 2.5 hours. The ethanol extracts were combined and concentrated to a clear extract with a relative density of 1.25-1.30 at 50°C. The above extracts were combined, dried, pulverized, and the volatile oil encapsulation compound was added and mixed well to obtain the final product.

7. The application according to claim 1, 2 or 3, characterized in that, The drug is selected from granules, and its preparation method includes the following steps: Volatile components were extracted from 277.8g of Perilla frutescens leaves and 222.2g of Magnolia biondii using steam distillation. These components were then encapsulated with β-cyclodextrin for later use. The residue was combined with 277.8g of Saposhnikovia divaricata, 166.7g of Ephedra sinica, and 222.2g of Prunus armeniaca. Each was decocted separately with 10 times the amount of water three times, 1.5 hours each time. The extracts were combined and concentrated to a clear extract with a relative density of 1.10–1.15 at 50°C. Alcohol precipitation was performed until the alcohol content reached 70%. The supernatant was then concentrated to a concentration suitable for 50°C. Prepare a clear extract with a relative density of 1.25–1.

30. Extract 222.2g of Schisandra chinensis, 222.2g of Ginkgo biloba, 222.2g of Aster tataricus, and 222.2g of Cornus officinalis with 60% ethanol three times, 2.5 hours each time. Combine the ethanol extracts and concentrate them to prepare a clear extract with a relative density of 1.25–1.30 at 50℃. Combine the above clear extracts, dry them, pulverize them, add volatile oil inclusion complexes, mix well, add appropriate amounts of dextrin and sucralose, mix well, and make granules.

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