Traditional Chinese medicine composition for improving allergic asthma and preparation method thereof

Abstract

The invention belongs to the technical field of respiratory system disease medicines and fermentation engineering, and particularly relates to a traditional Chinese medicine composition for improving allergic asthma and a preparation method thereof. The traditional Chinese medicine composition for improving allergic asthma comprises the following components in parts by weight: 10-20 parts of ephedra, 1-10 parts of earthworm, 3-17 parts of white mulberry root-bark, 6-17 parts of poria cocos, 4-15 parts of schisandra chinensis, 8-18 parts of cassia twig and 1-10 parts of perilla leaf. The traditional Chinese medicine composition with a synergistic effect is formed by screening various high-quality traditional Chinese medicinal raw materials and through reasonable formula compatibility; the composition is refined by a specific preparation process, effectively retains active ingredients in the medicinal materials, shows a remarkable effect in the aspect of treating and improving allergic asthma, and also has the advantages of high safety, small side effect, suitability for long-term use and the like.

Description

Technical Field

[0001] The present invention belongs to the technical fields of drugs for respiratory diseases and fermentation engineering, and particularly relates to a traditional Chinese medicine composition for improving allergic asthma and a preparation method thereof. Background Art

[0002] Allergic asthma (also known as allergic bronchial asthma) is a common respiratory disease, an IgE-mediated allergic asthma disease triggered by allergens. Susceptible populations are prone to symptoms caused by inflammation such as wheezing, shortness of breath, chest tightness, and coughing.

[0003] Therapeutic drugs for respiratory diseases generally involve two different drug systems: Western medicine and traditional Chinese medicine. Currently, glucocorticoids (commonly known as "hormones") are still one of the main means in modern medicine for clinically treating allergic asthma. However, with the in-depth clinical research, people have gradually found that long-term use of hormones may bring a series of systemic or local adverse reactions. Allergic asthma is a chronic and recurrent respiratory disease. In the process of prevention and treatment, simply controlling symptoms in the short term is far from enough. Fundamentally conditioning the allergic constitution of patients and enhancing the body's tolerance to external allergens are the keys to achieving long-term stable control and reducing recurrence. While relieving symptoms, traditional Chinese medicine pays attention to adjusting the overall function of the human body and improving the constitution. At the same time, it can also be used as a supplement to Western medicine treatment, especially in reducing the side effects of Western medicine.

[0004] The application of fermentation engineering in traditional Chinese medicine extracts is a new and rapidly developing field, which combines the advantages of traditional Chinese medicine and modern biotechnology, aiming to increase the content of active ingredients in traditional Chinese medicine, improve the medicinal effect, reduce toxicity, and develop new drug resources. However, in the current research and production practice of traditional Chinese medicine fermentation, the control of key parameters in the fermentation process is often not given enough attention. For example, factors such as temperature, pH value, dissolved oxygen, inoculum size, fermentation time, and medium composition will significantly affect the metabolic activity of microorganisms and the production of target products. Without systematic research and standardized operation procedures, it may lead to unstable product quality between batches, large fluctuations in medicinal effects, and even potential safety hazards.

[0005] Therefore, there is an urgent need for a respiratory disease drug specifically for allergic asthma. Summary of the Invention

[0006] The object of the present invention is to provide a traditional Chinese medicine composition for improving allergic asthma and a preparation method thereof.

[0007] To achieve the above object, the present invention provides the following technical solutions:

[0008] In the first aspect of the present invention, a traditional Chinese medicine composition for improving allergic asthma is provided, which comprises the following components in parts by weight: 10 - 20 parts of Ephedrae Herba, 1 - 10 parts of Pheretima, 3 - 17 parts of Mori Cortex, 6 - 17 parts of Poria, 4 - 15 parts of Schisandrae Chinensis Fructus, 8 - 18 parts of Cinnamomi Ramulus, 1 - 10 parts of Perillae Folium.

[0009] Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 10 - 14 parts of Ephedrae Herba, 3 - 8 parts of Pheretima, 7 - 12 parts of Mori Cortex, 11 - 17 parts of Poria, 10 - 15 parts of Schisandrae Chinensis Fructus, 8 - 12 parts of Cinnamomi Ramulus, 1 - 5 parts of Perillae Folium.

[0010] Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 12 parts of Ephedrae Herba, 5 parts of Pheretima, 9 parts of Mori Cortex, 14 parts of Poria, 13 parts of Schisandrae Chinensis Fructus, 10 parts of Cinnamomi Ramulus, 3 parts of Perillae Folium.

[0011] The monarch drug is Ephedrae Herba, which is pungent and warm, dispersing the lung qi, dispelling cold and relieving the exterior syndrome, and mainly promoting the dispersing function of the lung qi and relieving airway spasm.

[0012] The ministerial drugs are Pheretima, which dredges collaterals and relieves spasm, and synergistically relieves dyspnea with Ephedrae Herba; Cinnamomi Ramulus, which warms and dredges yang qi and can also transform fluid retention.

[0013] The adjuvant drugs are Mori Cortex, which clears heat and purges the lung, reduces phlegm and relieves cough; Poria, which strengthens the spleen and promotes diuresis, cutting off the source of fluid retention and phlegm production; Schisandrae Chinensis Fructus, which astringes the lung and nourishes the kidney, regulating the balance of opening and closing.

[0014] The messenger drug is Perillae Folium, which gently disperses the lung qi, dispels wind and relieves the exterior syndrome, leading all the drugs upward to the lung meridian and also harmonizing the properties of the drugs.

[0015] In the second aspect of the present invention, a preparation method of the traditional Chinese medicine composition for improving allergic asthma is provided, which comprises the following steps:

[0016] (1) Mix Ephedrae Herba, Pheretima and Cinnamomi Ramulus, pulverize them, add water, heat and soak; cool down, add Lactobacillus delbrueckii, carry out anaerobic fermentation, sterilize after fermentation ends, filter to obtain extract A, concentrate extract A and then spray dry to obtain extract A;

[0017] (2) Mix Mori Cortex, Schisandrae Chinensis Fructus, Poria and Perillae Folium, pulverize them, add ethanol aqueous solution, carry out extraction, filter after extraction ends to obtain extract B1 and extraction residue, concentrate extract B1 and then spray dry to obtain extract B1;

[0018] (3) Add water and Phaffia rhodozyma to the extraction residue in step (2), carry out aerobic fermentation, sterilize after fermentation ends, filter to obtain extract B2, concentrate extract B2 and then spray dry to obtain extract B2;

[0019] (4) Mix extract A, extract B1, and extract B2 to obtain a traditional Chinese medicine composition for improving allergic asthma.

[0020] Preferably, the conditions for anaerobic fermentation in step (1) are anaerobic fermentation at 35 - 40 °C for 30 - 40 h.

[0021] Preferably, the dosage of Lactobacillus delbrueckii is 10 7 -10 9 CFU / mL of water.

[0022] More preferably, the dosage of Lactobacillus delbrueckii is 10 8 CFU / mL of water.

[0023] Preferably, in step (1), ephedra, earthworm, and cassia twig are mixed and then crushed to less than 60 mesh.

[0024] Preferably, in step (2), the volume concentration of the ethanol aqueous solution is 80 - 90%, and extraction is carried out at 60 - 65 °C for 4 - 7 h.

[0025] Preferably, in step (2), mulberry bark, schisandra fruit, poria cocos, and perilla leaf are mixed and then crushed to less than 60 mesh.

[0026] Preferably, in step (3), the time for aerobic fermentation is 25 - 30 h, the fermentation temperature is 20 - 25 °C, and the aeration rate is controlled at 1.0 - 1.3 vvm. vvm is a key parameter used to measure the aeration rate in fermentation industry, which refers to the ratio of the volume of gas introduced into the fermentation tank per minute to the actual volume of the liquid in the tank, and its unit is cubic meters / (cubic meters * minute).

[0027] Preferably, the dosage of Rhodotorula rubra in step (3) is 10 8 -10 10 CFU / mL of water.

[0028] More preferably, the dosage of Rhodotorula rubra in step (3) is 10 9 CFU / mL of water.

[0029] The third aspect of the present invention provides a pharmaceutical preparation for improving allergic asthma, and the pharmaceutical preparation includes the above traditional Chinese medicine composition.

[0030] Preferably, the pharmaceutical preparation further includes pharmaceutically acceptable excipients.

[0031] Preferably, the excipients include one or more of disintegrants, lubricants, fillers, flavoring agents, binders, sweeteners, and stabilizers.

[0032] Compared with the prior art, the advantages and beneficial effects of the present invention are:

[0033] 1. The present invention forms a traditional Chinese medicine composition with synergistic effect by screening a variety of high-quality traditional Chinese medicine raw materials and through reasonable formula compatibility. The compatibility principle of the present invention is: using warming and clearing herbs together, and combining dispersing and astringing herbs. Through the reasonable compatibility of monarch, minister, assistant, and envoy herbs, the characteristics of each herb are fully exerted, achieving an all-round therapeutic effect from dispelling cold and relieving exterior syndrome, dredging collaterals and relieving spasm, clearing heat and resolving phlegm to regulating the balance of yin and yang, aiming to fundamentally improve the physical condition of patients, relieve symptoms and prevent recurrence.

[0034] 2. The traditional Chinese medicine composition of the present invention is refined through a specific preparation process, effectively retaining the active ingredients in the herbs, enhancing the bioavailability and stability of the drug. Verified by experiments, the traditional Chinese medicine composition shows significant effects in the treatment and improvement of allergic asthma, can effectively relieve airway inflammation, reduce airway hyperresponsiveness, regulate immune function, thus fundamentally improving asthma symptoms and reducing the attack frequency. In addition, the present invention also has the advantages of high safety, small side effects, being suitable for long-term use, etc., and is applicable to allergic asthma patients of different age groups.

[0035] 3. The present invention realizes precise control by optimizing the strains and their fermentation conditions. By precisely controlling the key parameters such as temperature, pH value, dissolved oxygen content, etc. during the fermentation process, it can ensure the consistency and stability of the product quality of each batch, avoiding the differences in product effects caused by fluctuations in fermentation conditions. By accurately regulating the fermentation conditions, the yield of the target active ingredient can be maximized, and at the same time, the generation of new active metabolites can be promoted, thereby enhancing the overall medicinal effect of the traditional Chinese medicine extract and making the therapeutic effect more significant. By establishing a set of scientific and reasonable fermentation condition control standards, the present invention helps to promote the standardization process of traditional Chinese medicine fermentation production. Detailed implementation manners

[0036] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without making creative efforts belong to the scope of protection of the present invention.

[0037] The raw materials used in the following embodiments of the present invention are all commercially available products:

[0038] Lactobacillus delbrueckii, product number TS289314, Ningbo Taisituo Biotechnology Co., Ltd.

[0039] Aspergillus oryzae, product number TS284177, Ningbo Taisituo Biotechnology Co., Ltd.

[0040] Lactobacillus plantarum, product number TS279067, Ningbo Taisituo Biotechnology Co., Ltd.

[0041] Rhodotorula rubra, product number TS274931, Ningbo Taisituo Biotechnology Co., Ltd.

[0042] Example 1

[0043] This example provides a traditional Chinese medicine composition for improving allergic asthma, comprising the following components in parts by weight: 12 parts of Ephedra sinica, 5 parts of Pheretima aspergillum, 9 parts of Mori Cortex, 14 parts of Poria cocos, 13 parts of Schisandra chinensis, 10 parts of Cinnamomi Ramulus, and 3 parts of Perilla leaf.

[0044] The preparation method of the traditional Chinese medicine composition for improving allergic asthma comprises the following steps:

[0045] (1) Mix Ephedra sinica, Pheretima aspergillum, and Cinnamomi Ramulus and pulverize them to less than 60 mesh to obtain mixture A. Add water to mixture A, and the volume-mass ratio of water to mixture A is 22 mL:1 g. Heat to 95 °C and soak for 7 h. Cool to 32 °C, add Lactobacillus delbrueckii, and the dosage of Lactobacillus delbrueckii is 10 8 CFU / mL of water, anaerobically ferment at 37 °C for 36 h, sterilize, filter with a 0.45 μm filter membrane to obtain extract A. Concentrate extract A and then spray dry it to obtain extract A;

[0046] (2) Mix Mori Cortex, Schisandra chinensis, Poria cocos, and Perilla leaf and pulverize them to obtain mixture B. Add an ethanol aqueous solution with a volume concentration of 85%, extract at 62 °C for 6 h, and the volume-mass ratio of the ethanol aqueous solution to mixture A is 22 mL:1 g. Filter with a 0.45 μm filter membrane to obtain extract B1. Concentrate extract B1 and then spray dry it to obtain extract B1 and extraction residue;

[0047] (3) Add water and Rhodotorula rubra to the extraction residue, and the dosage of Rhodotorula rubra is 10 9 CFU / mL of water, the volume-mass ratio of water to the extraction residue is 20 mL:1 g, the aerobic fermentation time is 27 h, the fermentation temperature is 22 °C, and the ventilation rate is controlled at 1.2 vvm. Sterilize, filter with a 0.45 μm filter membrane to obtain extract B2. Concentrate extract B2 and then spray dry it to obtain extract B2;

[0048] (4) Mix extract A, extract B1, and extract B2 to obtain the traditional Chinese medicine composition for improving allergic asthma.

[0049] Example 2

[0050] This example provides a traditional Chinese medicine composition for improving allergic asthma, comprising the following components in parts by weight: 10 parts of Ephedra sinica, 8 parts of Pheretima aspergillum, 7 parts of Mori Cortex, 17 parts of Poria cocos, 10 parts of Schisandra chinensis, 12 parts of Cinnamomi Ramulus, and 1 part of Perilla leaf.

[0051] The preparation method of the traditional Chinese medicine composition for improving allergic asthma comprises the following steps:

[0052] (1) Mix ephedra, earthworm, and cassia twig, and then crush them to less than 60 mesh to obtain mixture A. Add water to mixture A, and the volume-mass ratio of water to mixture A is 22 mL:1 g. Heat it up to 95°C and soak for 6 h. Cool it down to 35°C, add Lactobacillus delbrueckii, and the dosage of Lactobacillus delbrueckii is 10 8 CFU / mL of water, anaerobically ferment at 30°C for 40 h, sterilize, and filter with a 0.45 μm filter membrane to obtain extract A. Concentrate extract A and then spray-dry it to obtain extract A;

[0053] (2) Mix cortex mori, schisandra chinensis, poria cocos, and perilla leaf, and then crush them to obtain mixture B. Add an ethanol aqueous solution with a volume concentration of 80%, extract at 65°C for 4 h, and the volume-mass ratio of the ethanol aqueous solution to mixture A is 22 mL:1 g. Filter with a 0.45 μm filter membrane to obtain extract B1. Concentrate extract B1 and then spray-dry it to obtain extract B1 and extraction residue;

[0054] (3) Add water and Rhodotorula rubra to the extraction residue, and the dosage of Rhodotorula rubra is 10 9 CFU / mL of water, the volume-mass ratio of water to the extraction residue is 20 mL:1 g, the aerobic fermentation time is 30 h, the fermentation temperature is 20°C, and the ventilation rate is controlled at 1.3 vvm. Sterilize, and filter with a 0.45 μm filter membrane to obtain extract B2. Concentrate extract B2 and then spray-dry it to obtain extract B2;

[0055] (4) Mix extract A, extract B1, and extract B2 to obtain the traditional Chinese medicine composition for improving allergic asthma.

[0056] Example 3

[0057] This example provides a traditional Chinese medicine composition for improving allergic asthma, which comprises the following components in parts by weight: 14 parts of ephedra, 3 parts of earthworm, 12 parts of cortex mori, 11 parts of poria cocos, 15 parts of schisandra chinensis, 8 parts of cassia twig, and 5 parts of perilla leaf.

[0058] The preparation method of the traditional Chinese medicine composition for improving allergic asthma comprises the following steps:

[0059] (1) Mix ephedra, earthworm, and cassia twig, and then crush them to less than 60 mesh to obtain mixture A. Add water to mixture A, and the volume-mass ratio of water to mixture A is 22 mL:1 g. Heat it up to 95°C and soak for 8 h. Cool it down to 30°C, add Lactobacillus delbrueckii, and the dosage of Lactobacillus delbrueckii is 10 8CFU / mL of water, anaerobic fermentation at 38°C for 30 h, sterilization, filtration using a 0.45 μm filter membrane to obtain extract A. After concentrating extract A, it is spray-dried to obtain extract A;

[0060] (2) Cortex Mori, Schisandra chinensis, Poria cocos, and Perilla leaf are mixed and pulverized to obtain mixture B. An ethanol aqueous solution with a volume concentration of 90% is added, and extraction is carried out at 60°C for 7 h. The volume-mass ratio of the ethanol aqueous solution to mixture A is 22 mL:1 g. Filtration is carried out using a 0.45 μm filter membrane to obtain extract B1. After concentrating extract B1, it is spray-dried to obtain extract B1 and extraction residue;

[0061] (3) Water and Rhodotorula rubra are added to the extraction residue. The dosage of Rhodotorula rubra is 10 9 CFU / mL of water. The volume-mass ratio of water to the extraction residue is 20 mL:1 g. The aerobic fermentation time is 25 h, the fermentation temperature is 25°C, and the aeration rate is controlled at 1.0 vvm. Sterilization is carried out, and filtration is carried out using a 0.45 μm filter membrane to obtain extract B2. After concentrating extract B2, it is spray-dried to obtain extract B2;

[0062] (4) Extract A, extract B1, and extract B2 are mixed to obtain a traditional Chinese medicine composition for improving allergic asthma.

[0063] Comparative Example 1

[0064] The difference between this comparative example and Example 1 is only the dosage ratio of each component, and the other conditions are the same. Specifically as follows:

[0065] The traditional Chinese medicine composition for improving allergic asthma includes the following components in parts by weight: 25 parts of Ephedra sinica, 13 parts of Pheretima aspergillum, 2 parts of Cortex Mori, 1 part of Poria cocos, 18 parts of Schisandra chinensis, 3 parts of Ramulus Cinnamomi, and 15 parts of Perilla leaf.

[0066] Comparative Example 2

[0067] The difference between this comparative example and Example 1 is only that the total mass of Ephedra sinica, Pheretima aspergillum, and Ramulus Cinnamomi remains unchanged, Ramulus Cinnamomi is not included, and the mass ratio of Ephedra sinica and Pheretima aspergillum remains unchanged. Specifically as follows:

[0068] The traditional Chinese medicine composition for improving allergic asthma includes the following components in parts by weight: 19 parts of Ephedra sinica, 8 parts of Pheretima aspergillum, 9 parts of Cortex Mori, 14 parts of Poria cocos, 13 parts of Schisandra chinensis, and 3 parts of Perilla leaf.

[0069] Comparative Example 3

[0070] The difference between this comparative example and Example 1 is only that the total mass of Cortex Mori, Poria cocos, and Schisandra chinensis remains unchanged, but the mass ratio of the three changes. Specifically as follows:

[0071] Traditional Chinese medicine composition for improving allergic asthma, comprising the following components in parts by weight: Ephedra 12 parts, Pheretima aspergillum 5 parts, Cortex Mori 14 parts, Poria cocos 21 parts, Schisandra chinensis 1 part, Ramulus Cinnamomi 10 parts, Folium Perillae 3 parts.

[0072] Comparative Example 4

[0073] The difference between this comparative example and Example 1 is only that: the preparation methods are different. Specifically as follows:

[0074] The preparation method of the traditional Chinese medicine composition for improving allergic asthma comprises the following steps: Mix Ephedra, Pheretima aspergillum, Cortex Mori, Poria cocos, Schisandra chinensis, Ramulus Cinnamomi, and Folium Perillae and crush them to less than 60 mesh to obtain a mixture. Add water to the mixture, and the volume-mass ratio of water to mixture A is 22 mL: 1 g. Heat up to 95 °C and soak for 7 h; cool down to 32 °C, add Lactobacillus delbrueckii, and the dosage of Lactobacillus delbrueckii is 10 8 CFU / mL water, anaerobically ferment at 32 °C for 36 h, sterilize, filter with a 0.45 μm filter membrane to obtain an extract. Concentrate the extract and then spray-dry to obtain the traditional Chinese medicine composition for improving allergic asthma.

[0075] Comparative Example 5

[0076] The difference between this comparative example and Example 1 is only that: Lactobacillus delbrueckii is replaced with Lactobacillus plantarum. The dosage of Lactobacillus plantarum is 10 8 CFU / mL water. Other conditions are the same.

[0077] Comparative Example 6

[0078] The difference between this comparative example and Example 1 is only that: Rhodotorula rubra is replaced with Aspergillus oryzae, and the dosage of Aspergillus oryzae is 10 9 CFU / mL water. Other conditions are the same.

[0079] Performance test

[0080] Establish an ovalbumin (OVA)-induced asthma model: When the allergen ovalbumin is injected into a mouse, its soluble antigen components stimulate the body to produce IgE, making the body in a sensitized state. When the animal comes into contact with this antigen again, an antigen-antibody reaction mediated by IgE occurs, causing cell degranulation and releasing active chemical substances such as histamine and eosinophil chemotactic factor, etc., which act on the bronchi to cause airway hyperresponsiveness and lead to asthma.

[0081] Select 18 - 22g SPF - level female BALB / c mice (6 - 8 weeks old); the mice are housed in an animal room where the room temperature is maintained at 22 ± 2°C, the relative humidity is kept at 50 - 60%, and the light cycle is controlled by an automatic timer with 07:00 to 19:00 being the dark period and 19:00 to 07:00 being the light period. Feed and sterile reverse osmosis water are available for the mice to eat freely. The mice are allowed to adapt to the environment for 2 weeks before the experiment begins. The experimental animals are randomly divided into groups of 6 each, including: Examples 1 - 3 and Comparative Examples 1 - 6 as the sample groups, a control group (not sensitized with OVA), and a model group (only sensitized with OVA, without treatment), and the mice are treated accordingly.

[0082] Method for constructing the animal model: Sample groups and model group: On the 0th day and the 14th day of the start of the experiment, each group is sensitized by intraperitoneal injection, and the injection dose is 0.2 mL / mouse (a mixture of 20 μg OVA + 2 mg aluminum hydroxide adjuvant). Control group: Intraperitoneally inject 0.2 mL / mouse of PBS (a mixture of PBS + 2 mg aluminum hydroxide adjuvant).

[0083] On the 20th, 21st, 22nd, 23rd, 24th, and 25th days, the mice in the model group and the sample groups are challenged by atomization with 1 wt% OVA once a day for 25 minutes each time. Control group: Atomize with PBS in the same way.

[0084] Administration method: Starting from the 14th day, the animals are given intragastric treatment respectively. Intragastric administration is carried out 1 hour before atomization challenge. The administration method is as follows: The sample groups intragastrically administer 0.30 g of the traditional Chinese medicine composition per kg of body weight in combination with 0.2 mL of normal saline to the mice. The control group and the model group mice are intragastrically administered an equal amount of normal saline. After 3 weeks of administration, the mice are euthanized by injecting sodium pentobarbital at 240 mg / kg. The contents of IL - 5 and IL - 13 in the bronchoalveolar lavage fluid of the mice and the content of specific IgE antibody in the serum are measured. The experimental results are expressed as mean ± SD, and the judgment criterion for significant difference is p < 0.05.

[0085] The body weight of the mice is measured every day during the experiment, and the body weight of the mice is finally measured before the end of the experiment. The finally measured body weight of the mice is used as the experimental statistical data, and the body weight differences of the mice in each group are statistically analyzed.

[0086] The results are shown in Table 1.

[0087] Table 1 Test results of the traditional Chinese medicine composition on the mouse asthma model

[0088]

[0089] As can be seen from the data in Table 1, the traditional Chinese medicine compositions used in Examples 1-3 showed significant effects in reducing inflammatory responses and regulating immune responses. This traditional Chinese medicine composition can effectively reduce the expression levels of inflammatory cytokines in bronchoalveolar lavage fluid, including IL-5 and IL-13. These two cytokines are crucial mediators in the pathological process of allergic asthma, and their reduction indicates that the drug plays an important role in reducing airway inflammation and inhibiting allergic reactions.

[0090] In addition, the experimental results also showed that the traditional Chinese medicine compositions of Examples 1-3 could significantly reduce the concentration of specific IgE antibodies in plasma. IgE antibodies play a key role in allergic diseases, and an increase in their levels is usually positively correlated with the severity of allergic symptoms. Therefore, by reducing the level of IgE antibodies, this traditional Chinese medicine composition can not only relieve the clinical symptoms of asthma patients, but also help improve the overall quality of life of patients and may reduce the frequency and intensity of asthma attacks.

[0091] Compared with the control group, the traditional Chinese medicine compositions of Examples 1-3 had no significant effect on the body weight of mice, indicating that the traditional Chinese medicine composition did not have a negative impact on the normal growth and development of mice at the experimental dose.

[0092] Through the above experiments, not only the effectiveness of the traditional Chinese medicine compositions of Examples 1-3 in treating allergic asthma was verified, but also important clues were provided for further understanding its mechanism of action. By regulating key inflammatory factors and immune indicators, this traditional Chinese medicine composition provides a new, potentially safer and more effective treatment method for allergic asthma. This lays a solid foundation for subsequent in-depth research and clinical application, and at the same time provides valuable experience and directions for the development of more new therapies based on traditional Chinese medicine theory.

[0093] The above is the preferred embodiment of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle described in the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A Chinese medicine composition for improving allergic asthma, characterized in that: The traditional Chinese medicine composition comprises the following components in parts by weight: 10-20 parts of ephedra, 1-10 parts of earthworm, 3-17 parts of mulberry bark, 6-17 parts of tuckahoe, 4-15 parts of schisandra chinensis, 8-18 parts of cassia twig and 1-10 parts of perilla leaf.

2. The Chinese medicine composition for improving allergic asthma according to claim 1, characterized in that: The traditional Chinese medicine composition comprises the following components in parts by weight: 10-14 parts of ephedra, 3-8 parts of earthworm, 7-12 parts of mulberry bark, 11-17 parts of tuckahoe, 10-15 parts of schisandra chinensis, 8-12 parts of cassia twig and 1-5 parts of perilla leaf.

3. The Chinese medicine composition for improving allergic asthma according to claim 2, characterized in that: The traditional Chinese medicine composition comprises the following components in parts by weight: the traditional Chinese medicine composition comprises the following components in parts by weight: 12 parts of ephedra, 5 parts of earthworm, 9 parts of mulberry bark, 14 parts of poria, 13 parts of schisandra, 10 parts of cassia twig, and 3 parts of perilla leaf.

4. A method for preparing the Chinese medicine composition for improving allergic asthma according to any one of claims 1 to 3, characterized in that: The following steps are involved: (1) mixing ephedra, earthworm and cassia twig, crushing the mixture, adding water, heating and soaking the mixture; cooling the mixture, adding Lactobacillus delbrueckii, performing anaerobic fermentation, sterilizing the mixture after the fermentation, filtering the mixture to obtain an extract A, concentrating the extract A, and spray drying the mixture to obtain an extract A; (2) Mixing the mulberry bark, schisandra chinensis, poria cocos, and perilla leaf, crushing the mixture, adding ethanol aqueous solution, and extracting the mixture. After the extraction, filtering is performed to obtain an extract B1 and an extract residue. After the extract B1 is concentrated, spray drying is performed to obtain an extract B1; (3) adding water and red yeast to the extract residue of step (2) for aerobic fermentation, sterilizing and filtering after the fermentation to obtain extract B2, concentrating the extract B2, and spray drying to obtain extract B2; (4) Extract A, extract B1 and extract B2 are mixed to obtain a Chinese medicinal composition for improving allergic asthma.

5. The method for preparing the Chinese medicine composition for improving allergic asthma according to claim 4, characterized in that: The anaerobic fermentation conditions in step (1) are anaerobic fermentation at 35-40° C. for 30-40 hours.

6. The method for preparing the Chinese medicine composition for improving allergic asthma according to claim 5, characterized in that: In the step (2), the volume concentration of the ethanol aqueous solution is 80-90%, and the extraction is carried out at 60-65° C. for 4-7 hours.

7. The method for preparing the Chinese medicine composition for improving allergic asthma according to claim 5, characterized in that: In the step (3), the aerobic fermentation time is 25-30 hours, the fermentation temperature is 20-25° C., and the ventilation volume is controlled at 1.0-1.3 vvm.

8. A pharmaceutical preparation comprising the Chinese medicine composition for improving allergic asthma according to any one of claims 1 to 3.

9. The pharmaceutical preparation according to claim 8, characterized in that The pharmaceutical preparation also includes pharmaceutically acceptable excipients.

10. The pharmaceutical preparation according to claim 9, characterized in that The auxiliary materials include at least one of a disintegrant, a lubricant, a filler, a flavoring agent, a binder, a sweetener, and a stabilizer.

Images