A traditional Chinese medicine composition for treating or improving asthma

Abstract

This invention provides a traditional Chinese medicine composition for treating or improving asthma, relating to the field of traditional Chinese medicine pharmaceutical technology. The composition comprises the following raw materials: Inula japonica, Bambusa textilis, Lysimachia christinae, Rutaecarpa, Ligusticum striatum, Pyrrosia lingua, Chaenomeles speciosa, Dioscorea hypoglauca, Atractylodes lancea, walnut kernel, maltose, Citronella arvense, and Glycyrrhiza uralensis. In this invention, each ingredient in the composition fulfills its specific function, addressing both the symptoms of asthma (phlegm and qi stagnation, and upward flow of lung qi) and the underlying causes (spleen strengthening, kidney tonification, and liver soothing). This achieves the combined effects of dispelling wind and clearing the lungs, resolving phlegm and descending rebellious qi, strengthening the spleen and resolving dampness, warming the kidneys and promoting qi circulation, and regulating liver qi. It treats both the symptoms and the root cause. This invention's composition effectively inhibits airway inflammation in asthma model mice, improves clinical symptoms, and demonstrates significant therapeutic effects. The composition exhibits a high overall effective rate in treating asthma, with particular advantages in alleviating clinical symptoms and improving lung function in asthma patients.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine manufacturing technology, specifically to a traditional Chinese medicine composition for treating or improving asthma. Background Technology

[0002] Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation, airway remodeling, and airway hyperresponsiveness, and it is closely related to allergic reactions. Western medicine treatment typically involves inhaled corticosteroids and beta-agonists. While these medications can alleviate symptoms to some extent, they are insufficient for achieving complete recovery and improving prognosis, and the relapse rate is high. Furthermore, long-term use of corticosteroids can cause various adverse reactions, potentially leading to more serious complications.

[0003] Bronchial asthma falls under the categories of "asthma," "wheezing," "phlegm retention," and "dyspnea" in Traditional Chinese Medicine (TCM). TCM considers the etiology and pathogenesis of asthma to be complex, often stemming from dysfunction of the internal organs, external pathogenic factors, and internal injuries. Many well-known asthma treatment formulas, such as Xiao Qinglong Tang, Yu Ping Feng San, and She Gan Ma Huang Tang, play a significant role in clinical treatment. TCM treatment for asthma has fewer adverse reactions and better efficacy, showing good therapeutic effects at different stages of asthma attacks. Summary of the Invention

[0004] (a) Technical problems to be solved

[0005] In view of the shortcomings of the prior art, the present invention provides a traditional Chinese medicine composition for treating or improving asthma.

[0006] (II) Technical Solution

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] First, the present invention provides a traditional Chinese medicine composition for treating or improving asthma, the traditional Chinese medicine composition being composed of the following traditional Chinese medicine raw materials: Inula japonica, Bambusa textilis, Lysimachia christinae, Rutaecarpa, Ligusticum striatum, Pyrrosia lingua, Chaenomeles speciosa, Dioscorea hypoglauca, Atractylodes lancea, walnut kernels, maltose, Citronella arvense, and Glycyrrhiza uralensis.

[0009] Furthermore, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 5-25 parts of Inula japonica, 5-25 parts of Bambusa textilis, 5-25 parts of Lysimachia christinae, 5-25 parts of Rutaecarpa, 5-25 parts of Ligusticum striatum, 5-25 parts of Pyrrosia lingua, 5-25 parts of Chaenomeles speciosa, 5-25 parts of Dioscorea hypoglauca, 5-25 parts of Atractylodes lancea, 5-25 parts of walnut kernels, 5-25 parts of maltose, 5-25 parts of Citronella foenum-graecum, and 5-25 parts of Glycyrrhiza uralensis.

[0010] Furthermore, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-20 parts of Inula japonica, 10-20 parts of Bambusa textilis, 10-20 parts of Lysimachia christinae, 10-20 parts of Rutaecarpa, 10-20 parts of Ligusticum striatum, 10-20 parts of Pyrrosia lingua, 5-15 parts of Chaenomeles speciosa, 5-15 parts of Dioscorea hypoglauca, 5-15 parts of Atractylodes lancea, 5-15 parts of walnut kernels, 5-15 parts of maltose, 5-15 parts of Citronella arvense, and 5-15 parts of Glycyrrhiza uralensis.

[0011] Furthermore, the traditional Chinese medicine composition consists of the following raw materials in parts by weight: 16 parts of Inula japonica, 12 parts of Bambusa textilis, 14 parts of Lysimachia christinae, 12 parts of Rutaecarpa, 12 parts of Ligusticum striatum, 14 parts of Pyrrosia lingua, 10 parts of Chaenomeles speciosa, 8 parts of Dioscorea hypoglauca, 10 parts of Atractylodes lancea, 10 parts of walnut kernels, 6 parts of maltose, 8 parts of Citronella arvense, and 6 parts of Glycyrrhiza uralensis.

[0012] Furthermore, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 18 parts of Inula japonica, 14 parts of Bambusa textilis, 14 parts of Lysimachia christinae, 14 parts of Rutaecarpa, 14 parts of Ligusticum striatum, 14 parts of Pyrrosia lingua, 8 parts of Chaenomeles speciosa, 10 parts of Dioscorea hypoglauca, 12 parts of Atractylodes lancea, 8 parts of walnut kernels, 8 parts of maltose, 6 parts of Citronella foenum-graecum, and 6 parts of Glycyrrhiza uralensis.

[0013] Furthermore, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 20 parts of Inula japonica, 18 parts of Bambusa textilis, 16 parts of Lysimachia christinae, 14 parts of Rutaecarpa, 14 parts of Ligusticum striatum, 14 parts of Pyrrosia lingua, 12 parts of Chaenomeles speciosa, 10 parts of Dioscorea hypoglauca, 14 parts of Atractylodes lancea, 12 parts of walnut kernels, 10 parts of maltose, 8 parts of Citronella arvense, and 6 parts of Glycyrrhiza uralensis.

[0014] Furthermore, the traditional Chinese medicine composition provided by the present invention is used to prepare a drug for treating or improving asthma. The drug is made from the above-mentioned parts by weight as raw materials, with the addition of medically acceptable excipients, and is prepared into an oral dosage form, including oral liquid, pills, granules, powders, decoctions, ointments, capsules, lyophilized powders, and tablets.

[0015] In this invention, the herbal composition uses Inula japonica and Bambusa textilis as the principal herbs. Inula japonica is bitter, pungent, salty, and warm in nature, and is good at lowering qi, eliminating phlegm, relieving asthma, and stopping cough. Its nature is mainly downward, which can purify the qi of the lungs and stomach, and is especially good at dissolving stubborn phlegm, so that the upward rebellious lung qi can be lowered. It is an essential medicine for relieving asthma with qi rebellion and phlegm obstruction. Bambusa textilis is sweet and cold in nature, and has the effects of clearing heat, eliminating phlegm, cooling the heart, and calming fright. It can clear lung heat and eliminate thick phlegm, and is especially suitable for wheezing, coughing, phlegm, chest tightness, and restlessness caused by phlegm and heat obstructing the lungs. When Bambusa textilis and Inula japonica are combined, one lowers and the other clears, directly targeting the core pathogenesis of asthma with phlegm and qi obstruction and upward rebellious lung qi. Together, they achieve the effects of eliminating phlegm, lowering rebellious qi, clearing heat, and relieving asthma. They are both principal herbs.

[0016] The herb *Dwarf ground tea* is bitter, pungent, and neutral, and it resolves phlegm, stops coughs, and invigorates blood circulation. *Rubus idaeus* is bitter, pungent, and cool, and it resolves phlegm, stops coughs, and has a strong effect on relieving asthma. It also detoxifies and promotes diuresis. These two herbs help the principal herb enhance its effects in resolving phlegm and relieving coughs and asthma. *Ligusticum striatum* is pungent and warm, enters the Taiyang meridian, dispels wind and cold, and can remove wind-cold-dampness from the lung and wei qi, clearing the lung orifices. From an external perspective, it eliminates the inducing factors of external wind-cold, and helps the lung qi to disperse wind and cold. *Pyrrosia lingua* is bitter, sweet, and slightly cold, and enters the lung and bladder meridians. It can promote urination, clear the lungs, and stop coughs. It can reduce phlegm production through diuresis and clear lung heat, helping the principal herb to clear phlegm and heat. These four herbs are the assistant herbs, assisting the principal herb from different angles to strengthen its ability to resolve phlegm, relieve asthma, and regulate lung qi.

[0017] Papaya, Dioscorea hypoglauca, Atractylodes lancea, walnut kernels, maltose, and citron are used as adjuvant herbs. Papaya is sour and warm, and can relax muscles and tendons, harmonize the stomach and eliminate dampness. The spleen is the source of phlegm, and harmonizing the stomach and eliminating dampness can prevent the root cause of phlegm production. Its muscle-relaxing effect can also relieve spasms in the airways and tendons. Dioscorea hypoglauca is bitter and neutral, and can eliminate dampness and turbidity, dispel wind and relieve numbness. It can remove dampness and turbidity from the body and reduce the basis for phlegm production. Atractylodes lancea is bitter, pungent, and warm, and can dry dampness, strengthen the spleen, dispel wind and cold. Strengthening the spleen and drying dampness can normalize spleen function, thus preventing phlegm production. Papaya, Dioscorea hypoglauca, and Atractylodes lancea work together to strengthen the spleen, eliminate dampness and turbidity, and are key adjuvant herbs for treating the root cause. Walnut kernels are sweet and warm, and can tonify the kidneys and lungs, and warm the kidneys and promote digestion. Asthma, if prolonged, affects the kidneys. When the kidneys fail to receive qi, wheezing worsens. Walnut kernels can replenish the qi of the lungs and kidneys and help the kidneys receive qi. Maltose is sweet and warm, replenishing the middle jiao and benefiting qi, moistening the lungs and relieving cough. Prolonged asthma depletes lung qi and weakens the spleen and stomach. Maltose can replenish the qi of the spleen and stomach to provide the source of transformation, moisten the lungs to nourish lung fluids, relieve dryness in the airways, protect the middle jiao, and ensure that the elimination of pathogens does not harm the body's vital energy. Citron is pungent, slightly bitter, sour, and warm. It soothes the liver, regulates qi, harmonizes the middle jiao, and resolves phlegm. When liver wood attacks the lungs, lung qi becomes impaired. Citron soothes the liver to regulate lung qi and also helps resolve phlegm. All of the above herbs are adjuvant herbs, either to eliminate pathogens, to support the body's vital energy, or to regulate the related organs, assisting the principal and assistant herbs in exerting their effects.

[0018] Licorice is sweet and neutral, invigorating qi and replenishing the middle jiao, resolving phlegm and relieving cough, relieving spasms and pain, and harmonizing the effects of other herbs. It can help maltose replenish the middle jiao qi, strengthen the earth element and generate metal element, and also has the effects of resolving phlegm and relieving cough, as well as synergistically relieving asthma. Its sweet and mild nature can harmonize the biases of the cold, warm, ascending and descending herbs in the formula, so that the whole formula can work together to enhance the effect, and the medicinal power can be sustained and mild. Therefore, it is the guiding herb.

[0019] In this invention, the traditional Chinese medicine composition utilizes the respective functions of the principal, assistant, adjuvant, and guiding herbs to address both the symptoms of asthma—phlegm and qi stagnation, and upward reversal of lung qi—and the underlying causes—supplementing the spleen, tonifying the kidneys, and soothing the liver. This achieves the combined effects of dispelling wind and clearing the lungs, resolving phlegm and reversing reversal, strengthening the spleen and resolving dampness, warming the kidneys and promoting qi circulation, and regulating liver qi. It combines tonification and purgation, treating both the symptoms and the root cause. Furthermore, animal experiments and observations on the effects on patients with bronchial asthma demonstrate that the traditional Chinese medicine composition of this invention has outstanding therapeutic effects on asthma, specifically reflected in the following aspects:

[0020] 1. The herbal composition of this invention has an effect similar to that of dexamethasone, a clinical asthma drug, and can effectively alleviate typical clinical manifestations such as wheezing, coughing, chest tightness, and shortness of breath in asthmatic mouse models. It can significantly reduce the white blood cell count, eosinophil count, and neutrophil count in the bronchoalveolar lavage fluid of asthmatic mice, and also significantly reduce the content of inflammatory factors IL-4, IL-5, and IL-13 in the bronchoalveolar lavage fluid. The herbal composition of this invention can effectively inhibit the airway inflammatory response in asthma, improve the clinical symptoms of asthmatic mice, and has a significant therapeutic effect on asthmatic mice.

[0021] 2. The total effective rate of the traditional Chinese medicine composition of the present invention in the treatment of asthma is significantly higher than that of clinical asthma medications. It has a greater advantage in relieving clinical symptoms and improving lung function in asthma patients. The traditional Chinese medicine composition provided by the present invention offers a new treatment approach and direction for asthma. Attached Figure Description

[0022] Figure 1 Results of the improvement effect of the traditional Chinese medicine composition of the present invention on typical symptoms of asthmatic mice; A: number of coughs; B: cough latency; C: number of wheezing; D: wheezing latency; **P<0.01; ****P<0.0001.

[0023] Figure 2 The total white blood cell count (A), eosinophil (B), neutrophil (C), and lymphocyte (D) counts in BALF of mice in each group were compared. *P<0.05; **P<0.01; ****P<0.0001.

[0024] Figure 3 The levels of inflammatory factors IL-4 (A), IL-5 (B), and IL-13 (C) in the BALF of mice in each group were compared; **P<0.01; ***P<0.001; ****P<0.0001. Detailed Implementation

[0025] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0026] Example 1

[0027] A traditional Chinese medicine composition for treating or improving asthma, the composition comprising the following raw materials in parts by weight: 16 parts of Inula japonica, 12 parts of Bambusa textilis, 14 parts of Lysimachia christinae, 12 parts of Rutaecarpa, 12 parts of Ligusticum striatum, 14 parts of Pyrrosia lingua, 10 parts of Chaenomeles speciosa, 8 parts of Dioscorea hypoglauca, 10 parts of Atractylodes lancea, 10 parts of walnut kernels, 6 parts of maltose, 8 parts of Citronella arvense, and 6 parts of Glycyrrhiza uralensis.

[0028] The above-mentioned traditional Chinese medicine composition is used to prepare a drug for treating or improving asthma. The drug is made from the above-mentioned parts by weight as raw materials, with the addition of medically acceptable excipients, and is prepared into an oral dosage form, including oral liquid, pills, granules, powders, decoctions, ointments, capsules, lyophilized powders, and tablets.

[0029] Example 2

[0030] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 18 parts of Inula japonica, 14 parts of Bambusa textilis, 14 parts of Lysimachia christinae, 14 parts of Rutaecarpa, 14 parts of Ligusticum striatum, 14 parts of Pyrrosia lingua, 8 parts of Chaenomeles speciosa, 10 parts of Dioscorea hypoglauca, 12 parts of Atractylodes lancea, 8 parts of walnut kernels, 8 parts of maltose, 6 parts of Citronella foenum-graecum, and 6 parts of Glycyrrhiza uralensis.

[0031] Example 3

[0032] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 20 parts of Inula japonica, 18 parts of Bambusa textilis, 16 parts of Lysimachia christinae, 14 parts of Rutaecarpa, 14 parts of Ligusticum striatum, 14 parts of Pyrrosia lingua, 12 parts of Chaenomeles speciosa, 10 parts of Dioscorea hypoglauca, 14 parts of Atractylodes lancea, 12 parts of walnut kernels, 10 parts of maltose, 8 parts of Citronella foenum-graecum, and 6 parts of Glycyrrhiza uralensis.

[0033] Example 4

[0034] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Inula japonica, 10 parts of Bambusa textilis, 10 parts of Lysimachia christinae, 10 parts of Rutaecarpa, 10 parts of Ligusticum striatum, 10 parts of Pyrrosia lingua, 5 parts of Chaenomeles speciosa, 5 parts of Dioscorea hypoglauca, 5 parts of Atractylodes lancea, 5 parts of walnut kernels, 5 parts of maltose, 5 parts of Citronella arvense, and 5 parts of Glycyrrhiza uralensis.

[0035] Example 5

[0036] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 22 parts of Inula japonica, 22 parts of Bambusa textilis, 20 parts of Lysimachia christinae, 20 parts of Rutaecarpa, 20 parts of Ligusticum striatum, 20 parts of Pyrrosia lingua, 18 parts of Chaenomeles speciosa, 16 parts of Dioscorea hypoglauca, 20 parts of Atractylodes lancea, 18 parts of walnut kernels, 16 parts of maltose, 16 parts of Citronella arvense, and 15 parts of Glycyrrhiza uralensis.

[0037] Example 6

[0038] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 12 parts of Inula japonica, 10 parts of Bambusa textilis, 12 parts of Lysimachia christinae, 12 parts of Rutaecarpa, 10 parts of Ligusticum striatum, 10 parts of Pyrrosia lingua, 6 parts of Chaenomeles speciosa, 8 parts of Dioscorea hypoglauca, 8 parts of Atractylodes lancea, 6 parts of walnut kernels, 6 parts of maltose, 6 parts of Citronella foenum-graecum, and 6 parts of Glycyrrhiza uralensis.

[0039] Example 7

[0040] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 20 parts of Inula japonica, 20 parts of Bambusa textilis, 20 parts of Lysimachia christinae, 20 parts of Rutaecarpa, 20 parts of Ligusticum striatum, 20 parts of Pyrrosia lingua, 15 parts of Chaenomeles speciosa, 15 parts of Dioscorea hypoglauca, 15 parts of Atractylodes lancea, 15 parts of walnut kernels, 15 parts of maltose, 15 parts of Citronella arvense, and 15 parts of Glycyrrhiza uralensis.

[0041] Example 8

[0042] The therapeutic effect of the traditional Chinese medicine composition of this invention on asthma model mice was investigated.

[0043] 1. Materials and Methods

[0044] 1.1 Laboratory Animals

[0045] Fifty SPF-grade 6-8 week old female BALB / C mice, weighing 18-20g, were selected and acclimatized for 1 week before the experiment.

[0046] 1.2 Experimental Drugs

[0047] The original Chinese medicine extract of this invention consists of: 16 parts of Inula japonica, 12 parts of Bambusa textilis, 14 parts of Lysimachia christinae, 12 parts of Rutaecarpa, 12 parts of Ligusticum striatum, 14 parts of Pyrrosia lingua, 10 parts of Chaenomeles speciosa, 8 parts of Dioscorea hypoglauca, 10 parts of Atractylodes lancea, 10 parts of walnut kernels, 6 parts of maltose, 8 parts of Citronella arvense, and 6 parts of Glycyrrhiza uralensis.

[0048] The original Chinese medicine extract 2 of this invention consists of: 18 parts of Inula japonica, 14 parts of Bambusa textilis, 14 parts of Lysimachia christinae, 14 parts of Rutaecarpa, 14 parts of Ligusticum striatum, 14 parts of Pyrrosia lingua, 8 parts of Chaenomeles speciosa, 10 parts of Dioscorea hypoglauca, 12 parts of Atractylodes lancea, 8 parts of walnut kernels, 8 parts of maltose, 6 parts of Citronella foenum-graecum, and 6 parts of Glycyrrhiza uralensis.

[0049] The original Chinese medicine extract 3 of this invention consists of: 20 parts of Inula japonica, 18 parts of Bambusa textilis, 16 parts of Lysimachia christinae, 14 parts of Rutaecarpa, 14 parts of Ligusticum striatum, 14 parts of Pyrrosia lingua, 12 parts of Chaenomeles speciosa, 10 parts of Dioscorea hypoglauca, 14 parts of Atractylodes lancea, 12 parts of walnut kernels, 10 parts of maltose, 8 parts of Citronella arvense, and 6 parts of Glycyrrhiza uralensis.

[0050] Preparation method of the Chinese herbal extract 1-3 of the present invention: Weigh each raw material according to the above weight proportions, add 4 times the amount of water and decoct over high heat for 30 minutes, repeat the decoction twice, filter, concentrate the filtrate to 1g / mL (each milliliter contains 1g of raw herb), refrigerate, and use for later use.

[0051] Dexamethasone, 2 g / L.

[0052] 1.3 Test Methods

[0053] 1.3.1 Preparation and grouping of asthma mouse models

[0054] Fifty mice were randomly divided into five groups: control group (BC group), model group (Mod group), dexamethasone group (Dex group, dexamethasone 2 mg / kg), experimental group 1 (Test-1 group, Chinese herbal medicine 1, 300 mg / kg), experimental group 2 (Test-2 group, Chinese herbal medicine 2, 300 mg / kg), and experimental group 3 (Test-3 group, Chinese herbal medicine 3, 300 mg / kg). Except for the BC group, the other groups of mice were used to establish an asthma mouse model by intraperitoneal injection of OVA / AL2(OH)3 suspension combined with OVA nebulization challenge. Specifically, 50 µg of OVA and 2 mg of Al2(OH)3 were dissolved in 0.2 mL of sterile saline to prepare a suspension, which was then injected subcutaneously at multiple points on days 0, 7, and 14 for sensitization. The nebulization challenge period was from day 21 to 27, using a 1% grade II OVA challenge solution prepared with saline for nebulization challenge, 30 min / time, once daily. Each treatment group was administered the corresponding dose by gavage 30 minutes before the challenge. The BC group and the Mod group were given physiological saline by gavage according to body weight, once a day, for 7 consecutive days.

[0055] 1.3.2 Cough and wheezing index detection

[0056] Mice were placed in the aerosol chamber of a multifunctional cough-inducing and asthma-inducing device and sprayed with 25% ammonia water for 15 seconds to induce coughing. The time from the start of the spray to the first cough was observed, defined as the contraction of the mouse's abdominal muscles and the opening of its mouth. This time was the cough latency period. The cough latency period and the number of coughs within 2 minutes were recorded.

[0057] Mice were induced to breathe by spraying a mixture of equal volumes of 0.1% histamine phosphate and 2% acetylcholine chloride. The time from the start of spraying to the onset of shortness of breath and wheezing was observed; this was the latency period for induced breathing. The latency period and the number of wheezes within 2 minutes were recorded.

[0058] 1.3.3 Bronchoalveolar perfusion fluid (BALF) white blood cell and differential count

[0059] On the last day of the experiment, mice were sacrificed, and BALF (basal body fluid) was collected from each group. 10 μL of BALF was taken, and the red blood cell membranes were ruptured with 2% glacial acetic acid. The treated BALF was then placed below the level of a cell counting plate, and the cells were counted using a low-power microscope. 200 white blood cells were then counted under an oil immersion microscope, and the proportions of eosinophils, lymphocytes, and neutrophils in each group were statistically analyzed.

[0060] 1.3.4 Detection of inflammatory factors in bronchoalveolar perfusion fluid (BALF)

[0061] The levels of inflammatory factors IL-4, IL-5, and IL-13 in BALF were measured according to the ELISA kit instructions.

[0062] 1.4 Statistical Analysis

[0063] One-way ANOVA was performed on multiple groups of data using Prism 8.0.2 software. The data are expressed as mean ± standard deviation.

[0064] 2 Results

[0065] 2.1 The effect of the traditional Chinese medicine composition of the present invention on the improvement of typical symptoms in asthmatic mice

[0066] Compared with the control group, the number of coughs and wheezes in the model group was significantly higher than that in the control group (P<0.0001), while the cough latency and wheezing latency were significantly lower (P<0.0001). Compared with the model group, the number of coughs and wheezes in each treatment group was significantly lower (P<0.0001), while the cough latency and wheezing latency were significantly increased (P<0.0001). There were no significant differences in the number of wheezes, cough latency, and wheezing latency between the dexamethasone group and experimental groups 1-3 (P>0.05). The number of coughs in experimental groups 1-3 was significantly lower than that in the dexamethasone group (P<0.01), while there were no significant differences among the experimental groups 1-3 (P>0.05). Results are as follows. Figure 1 As shown.

[0067] 2.2 Effects of the herbal composition of the present invention on airway inflammation in mice

[0068] 2.2.1 Total and differential white blood cell counts in BALF of mice in each group

[0069] Compared with the control group, the model group mice showed a significant increase in the total number of white blood cells, eosinophils, and neutrophils in their BALF (P<0.0001), while the number of lymphocytes decreased but without significant difference (P>0.05). Compared with the model group, the total number of white blood cells, eosinophils, and neutrophils in the BALF of mice in each treatment group was significantly decreased (P<0.0001). Specifically, the total number of white blood cells in the BALF of mice in experimental groups 1-3 was significantly lower than that in the dexamethasone group (P<0.0001), with no significant difference among the groups (P>0.05); the number of neutrophils in the BALF of mice in experimental group 3 was significantly lower than that in the dexamethasone group (P<0.01). The number of lymphocytes in the BALF of mice in experimental group 1 was significantly increased compared with the model group (P<0.05), while the number of lymphocytes in the BALF of mice in the other treatment groups was slightly increased compared with the model group but without significant difference (P>0.05). Results are as follows. Figure 2 As shown.

[0070] 2.2.2 Levels of inflammatory factors IL-4, IL-5, and IL-13 in BALF of mice in each group

[0071] Compared with the control group, the levels of inflammatory factors IL-4, IL-5, and IL-13 in the BALF of mice in the model group were significantly increased (P<0.0001). Compared with the model group, the levels of inflammatory factors IL-4, IL-5, and IL-13 in the BALF of mice in each treatment group were significantly decreased (P<0.0001). Among them, the levels of inflammatory factors IL-4 and IL-13 in the BALF of mice in experimental groups 1-3 were significantly lower than those in the dexamethasone group (P<0.01, P<0.001), and there were no significant differences among the experimental groups 1-3.

[0072] 3. Conclusion

[0073] This experiment used an OVA-sensitized asthmatic mouse model to verify that the effects of the traditional Chinese medicine composition of this invention are similar to those of dexamethasone, a clinical asthma drug, and can effectively alleviate typical clinical manifestations such as wheezing, coughing, chest tightness, and shortness of breath in the asthmatic mouse model.

[0074] Airway inflammation is a good indicator of the severity of asthma. This experiment used it as an evaluation index, assessing changes in airway inflammation in each group of mice by measuring the total white blood cell count and the number of eosinophils and other differentially expressed cells in the bronchoalveolar lavage fluid (BALF), as well as the levels of inflammatory factors IL-4, IL-5, and IL-13 in the BALF. The results showed that the herbal composition of this invention significantly reduced the white blood cell count, eosinophil count, and neutrophil count in the BALF of asthmatic mice, and also significantly reduced the levels of inflammatory factors IL-4, IL-5, and IL-13 in the BALF.

[0075] The above results indicate that the herbal composition of the present invention can effectively inhibit the airway inflammatory response in asthma, improve the clinical symptoms of asthmatic mice, and has a significant therapeutic effect on asthmatic mice.

[0076] Example 9

[0077] Observation on the effects of the traditional Chinese medicine composition of the present invention on patients with bronchial asthma

[0078] 1. Materials and Methods

[0079] 1.1 General Information

[0080] Ninety patients with bronchial asthma admitted between July 2022 and December 2024 were randomly divided into a control group and an observation group according to the treatment plan, with 45 patients in each group. There were no statistically significant differences in the general information of the two groups (Table 1) (P>0.05), and they were comparable.

[0081] Table 1 Comparison of general information between the two groups of patients

[0082]

[0083] 1.2 Inclusion Criteria

[0084] The patient meets the diagnostic criteria for bronchial asthma and is in the chronic persistent phase. According to the "Guidelines for the Prevention and Treatment of Bronchial Asthma", (1) clinical manifestations include recurrent wheezing, shortness of breath, chest tightness or cough, which are more severe in the morning or at night; (2) wheezing or coughing is accompanied by obvious diffuse wheezing and a long expiration time; (3) the bronchodilator test or bronchial provocation test results are positive; (4) 18 years old ≤ age ≤ 60 years old; (5) the patient has signed an informed consent form.

[0085] 1.3 Exclusion Criteria

[0086] (1) Patients with other pulmonary diseases such as pulmonary infection, pulmonary tuberculosis, cor pulmonale, COPD, bronchiectasis, lung tumors, etc.; (2) Patients in the acute phase or severe persistent phase; (3) Patients with solid organ dysfunction; (4) Pregnant or lactating women; (5) Hormone-dependent asthma.

[0087] 2 methods

[0088] Control group: Administered salmeterol / fluticasone powder inhaler (Seretide, 50 μg / 250 μg), twice daily, one inhalation each time.

[0089] Observation group: The following ingredients were weighed according to the following proportions: 20 parts of Inula japonica, 18 parts of Bambusa textilis, 16 parts of Lysimachia christinae, 14 parts of Rutaecarpa, 14 parts of Ligusticum striatum, 14 parts of Pyrrosia lingua, 12 parts of Chaenomeles speciosa, 10 parts of Dioscorea hypoglauca, 14 parts of Atractylodes lancea, 12 parts of walnut kernels, 10 parts of maltose, 8 parts of Citronella foenum-graecum, and 6 parts of Glycyrrhiza uralensis. They were washed, soaked in 4 times their weight of water for 30 minutes, then boiled over high heat for 30 minutes, filtered, and then boiled in 3 times their weight of water for 20 minutes. The filtrates were then combined and concentrated to about 400 mL. The decoction was taken twice a day, morning and evening, one dose per day.

[0090] Both groups were treated continuously for 2 months to determine the efficacy.

[0091] 3. Evaluation of therapeutic effect

[0092] Clinical control: Symptoms and signs disappear or basically disappear, and the syndrome score decreases by ≥95%;

[0093] Significant improvement: Symptoms and signs are significantly improved, with a reduction in syndrome score of 70% ≤ < 95%;

[0094] Effective: Symptoms and signs improved, with a decrease in syndrome score of 30% ≤ < 70%;

[0095] Ineffective: Symptoms and signs show no significant improvement or even worsen, and the syndrome score decreases by <30%.

[0096] Overall effective rate = (Number of cases with clinical control + number of cases with significant effect + number of cases with effect) / total number of cases × 100%

[0097] 4. Observation Indicators and Methods

[0098] 4.1 Asthma Control Test (ACT) score

[0099] Record the following scores before and after treatment: impairment of daily activities, number of times of dyspnea, number of times the patient wakes up at night, number of times emergency medications are used, and self-assessment scores. Each score ranges from 1 to 5 points, with a total score of 25 points. A score of 20 to 25 points indicates good asthma control; 16 to 19 points indicates poor asthma control; and 5 to 15 points indicates very poor asthma control.

[0100] 4.2 Lung function indicators

[0101] Forced expiratory volume in one second (FEV1), forced vital capacity ratio (FVC), and peak expiratory flow (PEF) were measured using a pulmonary function testing device.

[0102] 5 Statistical Methods

[0103] SPSS 24.0 statistical analysis software was used for data processing. Quantitative data are expressed as mean ± standard deviation, and t-tests were used for comparisons between groups; χ² tests were used for comparisons between groups of categorical data. 2 Test. P < 0.05 indicates a significant difference.

[0104] 6 Results

[0105] 6.1 Comparison of therapeutic effects between the two groups of patients

[0106] The results are shown in Table 2. The total effective rate of treatment in the control group was 75.56%, and the total effective rate of treatment in the observation group was 88.88%. The difference between the two groups was statistically significant (P<0.05).

[0107] Table 2 Comparison of treatment efficacy between the two groups [n(%)]

[0108]

[0109] Note: *P<0.05 compared with the control group.

[0110] 6.2 Asthma Control Test (ACT) scores of the two groups of patients

[0111] The results are shown in Table 3. Before treatment, there was no statistically significant difference in ACT scores between the two groups (P>0.05). After treatment, the CAT scores of both the control group and the observation group were significantly higher than before treatment (P<0.05). Among them, the ACT score of the observation group was significantly higher than that of the control group (P<0.05).

[0112] Table 3 ACT scores of the two groups of patients

[0113]

[0114] Note: Compared with the group before treatment, *P<0.05; compared with the control group after treatment, # P<0.05.

[0115] 6.3 Comparison of pulmonary function between the two groups of patients

[0116] The results are shown in Table 4. Before treatment, there were no statistically significant differences in FEV1, FVC, and PEF between the two groups (P>0.05). After treatment, FEV1, FVC, and PEF in both groups increased significantly compared to before treatment (P<0.05); among them, FEV1, FVC, and PEF in the observation group were significantly higher than those in the control group (P<0.05).

[0117] Table 4. Lung function indicators of the two groups of patients

[0118]

[0119] Note: Compared with the group before treatment, *P<0.05; compared with the control group after treatment, # P<0.05.

[0120] 7 Summary

[0121] According to the above results, it can be seen that after treatment, the total effective rate of the observation group is higher than that of the control group. The ACT scores and various indexes of lung function in both groups increased, and those in the observation group were significantly higher than those in the control group. The above results indicate that the traditional Chinese medicine composition of the present invention has a significant therapeutic effect on asthma, effectively relieves the clinical symptoms of asthma patients, and improves lung function.

[0122] In the traditional Chinese medicine composition of the present invention, Inula britannica is good at descending qi to eliminate phlegm, relieving asthma and stopping cough. Its nature is mainly descending, and it can purge the qi of the lung and stomach, especially good at resolving stubborn phlegm. It can make the rebellious lung qi descend, and is the key medicine for calming asthma with qi rebellion and phlegm obstruction; Tianzhu Huang has the effects of clearing away heat and resolving phlegm, cooling the heart and calming fright. It can clear away the heat of the lung and resolve thick phlegm, and is especially suitable for asthma with wheezing, coughing and rattling phlegm, chest tightness and uneasiness caused by phlegm-heat congesting the lung; When Tianzhu Huang and Inula britannica are used together, they are the monarch drugs. One is for descending and the other is for clearing, directly hitting the core pathogenesis of asthma with phlegm qi obstruction and lung qi reversal, and jointly achieving the effects of resolving phlegm and descending adverse qi, clearing heat and relieving asthma. Ardisia japonica can resolve phlegm and stop cough and promote blood circulation; Cymbopogon distans can resolve phlegm and stop cough, has a strong effect on relieving asthma, and can also detoxify and promote diuresis. The two help the monarch drugs enhance the effects of resolving phlegm turbidity and calming wheezing and coughing; Ligusticum sinense can dispel wind-cold-damp pathogens in the lung and defense, dredge the lung orifices, and relieve the inducing factors of exogenous wind pathogens from the external cause perspective, helping the lung qi to disperse wind and cold; Pyrrosia lingua can promote diuresis and relieve stranguria, clear the lung and stop cough, can reduce the generation of phlegm retention by promoting diuresis, and clear away the heat of the lung, helping the monarch drugs to clear and resolve phlegm-heat; These four herbs are the ministerial drugs in total, assisting the monarch drugs to strengthen the functions of resolving phlegm and relieving asthma, and regulating lung qi. Chinese flowering quince can soothe the muscles and tendons, activate collaterals, harmonize the stomach and resolve dampness. The spleen is the source of phlegm production, and harmonizing the stomach and resolving dampness can cut off the root of phlegm production. The effect of soothing the muscles of Chinese flowering quince can also relieve the spasm of airway tendons; Dioscorea septemloba can promote diuresis and remove turbidity, dispel wind and relieve arthralgia, can dispel internal damp turbidity and reduce the basis of phlegm retention generation; Atractylodes lancea can dry dampness and strengthen the spleen to make the spleen function normally, then phlegm will not be produced; Chinese flowering quince, Dioscorea septemloba and Atractylodes lancea together achieve the effects of strengthening the spleen, resolving dampness and removing turbidity, which are the key assistants for treating the root cause; Asthma involves the kidney over time, and the kidney failing to receive qi will exacerbate wheezing. Semen juglandis can tonify the qi of the lung and kidney and help the kidney receive qi; Maltose can replenish the middle qi, moisten the lung and stop cough. Asthma consumes the lung qi and weakens the spleen and stomach over time. Maltose can replenish the qi of the spleen and stomach to provide the source of transformation, moisten the lung to nourish the lung fluid, soothe the dryness of the airway, protect the middle jiao, and make the pathogenic factors eliminated without damaging the healthy qi; Citrus medica var. sarcodactylis can soothe the liver, regulate qi, harmonize the middle and resolve phlegm. When the liver wood invades the lung, the lung qi will be unfavorable. Citrus medica var. sarcodactylis soothes the liver to regulate the lung qi and helps resolve phlegm; The above herbs are the adjuvant drugs in total, either expelling pathogenic factors, strengthening healthy qi, or regulating relevant zang-fu organs, assisting the monarch and ministerial drugs to exert their effects. Licorice is sweet and flat, can replenish qi and invigorate the middle, eliminate phlegm and stop cough, relieve spasm and pain, and harmonize all herbs; It can help maltose tonify the middle qi, strengthen the earth to generate metal, and has the effects of eliminating phlegm and stopping cough, synergistically relieving asthma. Its sweet and slow nature can reconcile the biases of cold, warm, ascending and descending herbs in the formula, making the whole formula synergistic and the medicinal power last and be mild. It is the guiding drug. In the whole formula, the monarch, ministerial, adjuvant and guiding drugs each fulfill their responsibilities, jointly achieving the effects of expelling wind and diffusing the lung, resolving phlegm and descending adverse qi, strengthening the spleen and resolving dampness, warming the kidney and receiving qi, soothing the liver and regulating qi, treating both the principal and secondary aspects of the disease with both attacking and tonifying methods.

[0123] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for treating or improving asthma, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 5-25 parts of Inula japonica, 5-25 parts of Bambusa textilis, 5-25 parts of Lysimachia christinae, 5-25 parts of Rutaecarpa, 5-25 parts of Ligusticum striatum, 5-25 parts of Pyrrosia lingua, 5-25 parts of Chaenomeles speciosa, 5-25 parts of Dioscorea hypoglauca, 5-25 parts of Atractylodes lancea, 5-25 parts of walnut kernels, 5-25 parts of maltose, 5-25 parts of Citronella foenum-graecum, and 5-25 parts of Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition for treating or improving asthma as described in claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10-20 parts of Inula japonica, 10-20 parts of Bambusa textilis, 10-20 parts of Lysimachia christinae, 10-20 parts of Rutaecarpa, 10-20 parts of Ligusticum striatum, 10-20 parts of Pyrrosia lingua, 5-15 parts of Chaenomeles speciosa, 5-15 parts of Dioscorea hypoglauca, 5-15 parts of Atractylodes lancea, 5-15 parts of walnut kernels, 5-15 parts of maltose, 5-15 parts of Citronella arvense, and 5-15 parts of Glycyrrhiza uralensis.

3. The traditional Chinese medicine composition for treating or improving asthma as described in claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 16 parts of Inula japonica, 12 parts of Bambusa textilis, 14 parts of Lysimachia christinae, 12 parts of Rutaecarpa, 12 parts of Ligusticum striatum, 14 parts of Pyrrosia lingua, 10 parts of Chaenomeles speciosa, 8 parts of Dioscorea hypoglauca, 10 parts of Atractylodes lancea, 10 parts of walnut kernels, 6 parts of maltose, 8 parts of Citronella arvense, and 6 parts of Glycyrrhiza uralensis.

4. The traditional Chinese medicine composition for treating or improving asthma as described in claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 18 parts of Inula japonica, 14 parts of Bambusa textilis, 14 parts of Lysimachia christinae, 14 parts of Rutaecarpa, 14 parts of Ligusticum striatum, 14 parts of Pyrrosia lingua, 8 parts of Chaenomeles speciosa, 10 parts of Dioscorea hypoglauca, 12 parts of Atractylodes lancea, 8 parts of walnut kernels, 8 parts of maltose, 6 parts of Citronella foenum-graecum, and 6 parts of Glycyrrhiza uralensis.

5. A traditional Chinese medicine composition for treating or improving asthma as described in claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 20 parts of Inula japonica, 18 parts of Bambusa textilis, 16 parts of Lysimachia christinae, 14 parts of Rutaecarpa, 14 parts of Ligusticum striatum, 14 parts of Pyrrosia lingua, 12 parts of Chaenomeles speciosa, 10 parts of Dioscorea hypoglauca, 14 parts of Atractylodes lancea, 12 parts of walnut kernels, 10 parts of maltose, 8 parts of Citronella arvense, and 6 parts of Glycyrrhiza uralensis.

6. The use of the traditional Chinese medicine composition according to any one of claims 1 to 5 in the preparation of a medicament for treating or improving asthma, characterized in that, The drug is made from the above-mentioned parts by weight as raw materials, with the addition of medically acceptable excipients, and is formulated into an oral dosage form, including oral liquid, pills, granules, powders, decoctions, ointments, capsules, lyophilized powders, and tablets.

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