Application of traditional Chinese medicine composition in preparation of medicine for preventing and / or treating chronic obstructive pulmonary disease

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to application of a traditional Chinese medicine composition in preparation of a medicine for preventing and / or treating chronic obstructive pulmonary disease. The traditional Chinese medicine composition comprises antelope horn powder, pearl powder, bezoar, stiff silkworm, cinnabar, amber, arisaema cum bile, borneol and rhizoma acori graminei oil. The traditional Chinese medicine composition provided by the invention can be used for remarkably enhancing the lung function, improving the airway limitation condition and improving the symptoms such as tachypnea, irregular rhythm, cough and asthma; the total number of leukocytes, the number of lymphocytes, the number of neutrophils and expression of inflammatory factors are reduced, airway inflammation is improved, and therefore the chronic obstructive pulmonary disease is treated in a multi-target mode.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to the use of a traditional Chinese medicine composition in the preparation of a medicament for the prevention and / or treatment of chronic obstructive pulmonary disease. Background Technology

[0002] Chronic obstructive pulmonary disease (COPD) is the most common chronic respiratory disease. In my country, it is characterized by high prevalence, high mortality, and high disease burden. Due to the continued existence of factors such as population aging, a large number of smokers and secondhand smoke exposure, indoor and outdoor air pollution, and tuberculosis infection, the prevention and control of COPD is very challenging.

[0003] Chronic obstructive pulmonary disease (COPD) is a common lung disease that causes airflow limitation and breathing problems. It is characterized by persistent airflow limitation and corresponding respiratory symptoms (dyspnea, cough, sputum production); its pathological changes are primarily airway and / or alveolar abnormalities, usually associated with significant exposure to harmful particles or gases. Numerous host factors, including genetic susceptibility, abnormal inflammatory responses, and abnormal lung development, are involved in the pathogenesis; severe comorbidities can affect disease presentation and mortality.

[0004] Lingzhu Powder is composed of antelope horn powder, pearl powder, bezoar, silkworm pupae, cinnabar, amber, chopped arisaema, borneol, and acorus tatarinowii oil. Lingzhu Powder has antipyretic, sedative, and calming effects, and is used for children with exogenous fever, restlessness, and cough with phlegm. It is particularly effective for viral infections such as wind-heat colds, tonsillitis, measles, chickenpox, and mumps. However, there are no current reports indicating that Lingzhu Powder has a therapeutic effect on chronic obstructive pulmonary disease (COPD).

[0005] In recent years, the focus of COPD prevention and treatment has shifted to early prevention, early treatment, and treatment during the stable phase, with the primary goal of improving patients' quality of life and reducing the frequency of acute exacerbations. Traditional Chinese medicine (TCM) has certain advantages in improving clinical symptoms, enhancing quality of life, and reducing acute exacerbations. Therefore, providing a new and reliable TCM treatment for COPD is urgently needed. Summary of the Invention

[0006] In view of this, the purpose of the present invention is to provide an application of a traditional Chinese medicine composition in the preparation of a medicament for the prevention and / or treatment of chronic obstructive pulmonary disease.

[0007] To achieve the above-mentioned objectives, the technical solution of this invention is as follows: On one hand, the present invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for the prevention and / or treatment of chronic obstructive pulmonary disease, characterized in that the traditional Chinese medicine composition is composed of the following raw materials: antelope horn powder, pearl powder, bezoar, silkworm, cinnabar, amber, arisaema cum bile, borneol, and acorus tatarinowii oil; Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 100-190 parts by weight of antelope horn powder, 100-200 parts by weight of pearl powder, 200-400 parts by weight of bezoar, 200-400 parts by weight of silkworm pupae, 100-200 parts by weight of cinnabar, 200-400 parts by weight of amber, 500-700 parts by weight of Arisaema cum Bile, 5-50 parts by weight of borneol, and 5-50 parts by weight of Acorus tatarinowii oil. More preferably, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 150 parts antelope horn powder, 150 parts pearl powder, 300 parts bezoar, 300 parts silkworm, 150 parts cinnabar, 300 parts amber, 600 parts Arisaema cum Bile, 30 parts borneol, and 20 parts Acorus tatarinowii oil.

[0008] As a preferred embodiment, the preparation method of the traditional Chinese medicine composition includes the following steps: Place the sweet flag in a multi-functional water extraction tank, moisten it with drinking water, pass in direct steam, and distill for 4-6 hours until all the volatile oil is extracted. Set aside for later use.

[0009] In addition to antelope horn powder, pearl powder, silkworm pupae, arisaema cum bile, and calamus oil, cinnabar is water-milled or pulverized into fine powder. Bezoar, amber, and borneol are separately ground into fine powders of bezoar, amber, and borneol, and then sieved. Arisaema cum bile and silkworm pupae are decocted with water 1-5 times, each time for 0.2-4 hours. The decoctions are combined, allowed to stand, and the supernatant is concentrated into a thick paste. This paste is mixed with antelope horn powder, pearl powder, fine powder of bezoar, and fine powder of amber, dried, and pulverized into fine powder A. Fine powder A is then ground with fine powder of cinnabar and fine powder of borneol, sprayed with calamus oil, sieved, and mixed well to obtain the final product.

[0010] Preferably, the bezoar includes artificial bezoar and / or in vitro cultured bezoar.

[0011] Preferably, the chronic obstructive pulmonary disease (COPD) is either stable COPD or acute exacerbation COPD.

[0012] Preferably, the symptoms of the chronic obstructive pulmonary disease include one or more of the following: airway restriction, decreased lung function, shortness of breath, irregular breathing, cough, wheezing, and abnormal airway inflammation.

[0013] Preferably, the traditional Chinese medicine composition is prepared into one or more of the following: tablets, capsules, granules, powders, liquid preparations, ointments, injections, and sprays.

[0014] Preferably, the drug further includes pharmaceutically acceptable excipients.

[0015] On the other hand, an application of Lingzhu San in the preparation of drugs for the prevention and treatment of chronic obstructive pulmonary disease is provided, comprising the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0016] In the composition of this invention, antelope horn powder, pearl powder, and bezoar are the principal ingredients, which have the effects of clearing heat and detoxifying, calming wind and relieving convulsions; silkworm and arisaema cum bile are the assistant ingredients, which have the effects of dispelling wind and relieving spasms, clearing heat and resolving phlegm; cinnabar and amber are the adjuvant ingredients, which have the effects of calming the nerves, relieving cough and resolving phlegm; borneol and acorus tatarinowii are the guiding ingredients, which have the effects of aromatic opening of the orifices, and invigorating the brain and refreshing the mind.

[0017] The beneficial effects of this invention are as follows: This invention discovers the application of a traditional Chinese medicine composition in the preparation of drugs for the prevention and / or treatment of chronic obstructive pulmonary disease (COPD). Experiments show that the traditional Chinese medicine composition can effectively improve the survival status of COPD rats and significantly increase FEV1. FVC FEV1 / FVC levels improve airway limitation, enhance lung function, and alleviate symptoms such as shortness of breath, irregular breathing, cough, and wheezing. They also significantly reduce the total white blood cell count, lymphocyte count, neutrophil count, and expression of inflammatory factors, thus improving airway inflammation and providing a new direction for the treatment of chronic obstructive pulmonary disease. Detailed Implementation

[0018] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the invention based on the disclosed content, which should also fall within the scope of protection claimed in this application.

[0019] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all chemical reagents used in the embodiments of the present invention were obtained through conventional commercial means. Unless otherwise specified, all contents mentioned below are mass contents. Unless otherwise specified, it is understood that the process was carried out at room temperature.

[0020] Preparation Example Example 1: 100 parts antelope horn powder, 200 parts pearl powder, 200 parts bezoar, 400 parts silkworm, 100 parts cinnabar, 400 parts amber, 500 parts arisaema cum bile, 50 parts borneol, and 50 parts acorus calamus oil.

[0021] Preparation method: Place the sweet flag in a multi-functional water extraction tank, moisten it with drinking water, pass in direct steam, and distill for 4 hours until all the volatile oil is extracted. Set aside for later use.

[0022] In addition to antelope horn powder, pearl powder, silkworm pupae, arisaema cum bile, and calamus oil, cinnabar is pulverized into fine powder. Bezoar, amber, and borneol are separately ground into fine powders of bezoar, amber, and borneol, and then sieved. Arisaema cum bile and silkworm pupae are decocted with water five times, 0.2 hours each time. The decoctions are combined, allowed to stand, and the supernatant is concentrated into a thick paste. This paste is mixed with antelope horn powder, pearl powder, fine powder of bezoar, and fine powder of amber, dried, and pulverized into fine powder A. Fine powder A is then ground with fine powder of cinnabar and fine powder of borneol, sprayed with calamus oil, sieved, and mixed well to obtain the final product.

[0023] Example 2: 150 parts antelope horn powder, 150 parts pearl powder, 300 parts bezoar, 300 parts silkworm, 150 parts cinnabar, 300 parts amber, 600 parts Arisaema cum Bile, 30 parts borneol, and 20 parts Acorus tatarinowii oil.

[0024] Preparation method: Place the sweet flag in a multi-functional water extraction tank, moisten it with drinking water, pass in direct steam, and distill for 5 hours until all the volatile oil is extracted. Set aside for later use.

[0025] In addition to antelope horn powder, pearl powder, silkworm pupae, arisaema cum bile, and calamus oil, cinnabar is pulverized into fine powder. Bezoar, amber, and borneol are separately ground into fine powders of bezoar, amber, and borneol, and then sieved. Arisaema cum bile and silkworm pupae are decocted twice with water, one hour each time. The decoctions are combined, allowed to stand, and the supernatant is concentrated into a thick paste. This paste is then mixed with antelope horn powder, pearl powder, fine powder of bezoar, and fine powder of amber, dried, and pulverized into fine powder A. Fine powder A is then ground with fine powder of cinnabar and fine powder of borneol, sprayed with calamus oil, sieved, and mixed well to obtain the final product.

[0026] Example 3: 190 parts antelope horn powder, 100 parts pearl powder, 400 parts bezoar, 200 parts silkworm, 200 parts cinnabar, 200 parts amber, 700 parts Arisaema cum Bile, 5 parts borneol, and 5 parts Acorus tatarinowii oil.

[0027] Preparation method: Place the sweet flag in a multi-functional water extraction tank, moisten it with drinking water, pass in direct steam, and distill for 6 hours until all the volatile oil is extracted. Set aside for later use.

[0028] In addition to antelope horn powder, pearl powder, silkworm pupae, arisaema cum bile, and calamus oil, cinnabar is pulverized into a fine powder. Bezoar, amber, and borneol are separately ground into fine powders of bezoar, amber, and borneol, and then sieved. Arisaema cum bile and silkworm pupae are decocted once with water for 4 hours each time, allowed to stand, and the supernatant is concentrated into a thick paste. This paste is then mixed with antelope horn powder, pearl powder, fine powder of bezoar, and fine powder of amber, dried, and pulverized into fine powder A. Fine powder A is then ground together with fine powder of cinnabar and fine powder of borneol, sprayed with calamus oil, sieved, and mixed evenly to obtain the final product.

[0029] Comparative Example 1: 90 parts antelope horn powder, 210 parts pearl powder, 190 parts bezoar, 465 parts silkworm, 90 parts cinnabar, 410 parts amber, 490 parts bile arisaema, 2 parts borneol, and 53 parts calamus oil.

[0030] Preparation method: Place the sweet flag in a multi-functional water extraction tank, moisten it with drinking water, pass in direct steam, and distill for 5 hours until all the volatile oil is extracted. Set aside for later use.

[0031] In addition to antelope horn powder, pearl powder, silkworm pupae, arisaema cum bile, and calamus oil, cinnabar is pulverized into fine powder. Bezoar, amber, and borneol are separately ground into fine powders of bezoar, amber, and borneol, and then sieved. Arisaema cum bile and silkworm pupae are decocted twice with water, one hour each time. The decoctions are combined, allowed to stand, and the supernatant is concentrated into a thick paste. This paste is then mixed with antelope horn powder, pearl powder, fine powder of bezoar, and fine powder of amber, dried, and pulverized into fine powder A. Fine powder A is then ground with fine powder of cinnabar and fine powder of borneol, sprayed with calamus oil, sieved, and mixed well to obtain the final product.

[0032] Comparative Example 2: 210 parts antelope horn powder, 90 parts pearl powder, 410 parts bezoar, 160 parts silkworm, 210 parts cinnabar, 155 parts amber, 710 parts Arisaema cum Bile, 53 parts borneol, and 2 parts Acorus tatarinowii oil.

[0033] Preparation method: Place the sweet flag in a multi-functional water extraction tank, moisten it with drinking water, pass in direct steam, and distill for 5 hours until all the volatile oil is extracted. Set aside for later use.

[0034] In addition to antelope horn powder, pearl powder, silkworm pupae, arisaema cum bile, and calamus oil, cinnabar is pulverized into a fine powder. Bezoar, amber, and borneol are separately ground into fine powders of bezoar, amber, and borneol, and then sieved. Arisaema cum bile and silkworm pupae are decocted twice with water, one hour each time. The decoctions are combined, allowed to stand, and the supernatant is concentrated into a thick paste. This paste is then mixed with antelope horn powder, pearl powder, fine powder of bezoar, and fine powder of amber, dried, and pulverized into fine powder A. Fine powder A is then ground with fine powders of cinnabar and borneol, sprayed with calamus oil, sieved, and mixed well to obtain the final product.

[0035] Comparative Example 3: 980 parts of Arisaema cum Bile, 40 parts of Acorus tatarinowii oil, 490 parts of Bombyx mori, and 490 parts of Calculus bovis.

[0036] Preparation method: Place the sweet flag in a multi-functional water extraction tank, moisten it with drinking water, pass in direct steam, and distill for 5 hours until all the volatile oil is extracted. Set aside for later use.

[0037] Except for silkworm pupae, arisaema cum bile, and calamus oil, bezoar is ground into fine powder and sieved. Arisaema cum bile and silkworm pupae are decocted twice with water, one hour each time. The decoctions are combined, left to stand, and the supernatant is concentrated into a thick paste. This paste is mixed with the fine bezoar powder, dried, and pulverized into fine powder A. The fine powder is then sprayed into calamus oil, sieved, and mixed to obtain the final product.

[0038] Effect example: Animal experiment 1. Materials 1.1 Animals Male 6-week-old specific pathogen free (SPF) Wistar rats, weighing 180 - 220 g, were provided by Jinan Pengyue Laboratory Animal Breeding Co., Ltd., with the animal license number: SCXK(Lu)2023 - 0002

[0039] 1.2 Reagents Dexamethasone acetate tablets: Each tablet is 0.75 mg, batch number 2022081, purchased from Zhejiang Xianju Pharmaceutical Co., Ltd.; Rat neutrophil elastase (NE) kit: RX302063R, purchased from Quanzhou Ruixin Biotechnology Co., Ltd.; Tumor necrosis factor α (TNF-α) kit: H052 - 1 - 2, purchased from Nanjing Jiancheng Bioengineering Institute; Interleukin - 1β (IL - 1β) kit: ml106733, purchased from Shanghai Enzyme-linked Biology; Interleukin - 6 (IL - 6) kit: H007 - 1 - 1, purchased from Nanjing Jiancheng Bioengineering Institute; Wright-Giemsa composite staining solution: G1020, purchased from Beijing Solarbio Science & Technology Co., Ltd.

[0040] 1.3 Instruments AniRes 2005 type animal lung function detection and analysis instrument (Beijing Beilanbo Co., Ltd.); LW3000T biological microscope (product of Shanghai Optoelectronics Co., Ltd.).

[0041] 2. Experimental methods 2.1 Drug preparation method Example 1: Take the composition of Example 1, add 0.5% CMC - Na and suspend it, vortex to mix evenly, and the dosing dose is 0.5 g / kg, prepared and used immediately.

[0042] Example 2: Take the composition of Example 2, add 0.5% CMC - Na and suspend it, vortex to mix evenly, and the dosing dose is 0.5 g / kg, prepared and used immediately.

[0043] Example 3: Take the composition of Example 3, dissolve it, add 0.5% CMC - Na and suspend it, vortex to mix evenly, and the dosing dose is 0.5 g / kg, prepared and used immediately.

[0044] Control Example 1: Take the composition of Control Example 1, dissolve it, add 0.5% CMC - Na and suspend it, vortex to mix evenly, and the dosing dose is 0.5 g / kg, prepared and used immediately.

[0045] Comparative Example 2: Take the composition of Comparative Example 2 and add 0.5% CMC-Na suspension, vortex mix thoroughly and evenly, and administer at a dose of 0.5 g / kg. Prepare and use immediately.

[0046] Comparative Example 3: Take the composition of Comparative Example 3 and add 0.5% CMC-Na suspension, vortex mix thoroughly and evenly, and administer at a dose of 0.5 g / kg. Prepare and use immediately.

[0047] Positive drug group: Dexamethasone acetate tablets. Take dexamethasone acetate tablets and add 0.5% CMC-Na suspension, vortex to mix thoroughly and evenly. The dosage is 1 mg / kg, and it should be prepared and used immediately.

[0048] 2.2 Constructing a chronic obstructive pulmonary disease (COPD) model Except for the normal control group, all other groups of rats underwent COPD modeling using a combination of cigarette smoke and lipopolysaccharide (LPS) induction. The smoke chamber was sealed with cotton blankets, and 20 cigarettes were smoked each time, twice daily for 1 hour each time. On days 7, 14, and 21 of the smoke exposure, rats were injected intratracheally with LPS at 1 mg / kg (no smoke exposure was performed on the day of LPS injection). The model was established for a total of 8 weeks. A COPD model was considered successfully established when rats exhibited signs such as rapid breathing, exacerbated by exertion, elevated body temperature, moist nose, and sneezing, combined with pulmonary function indicators of the model group.

[0049] 2.3 Grouping and Administration Methods Rats were randomly divided into 9 groups, with 10 rats in each group. After successful model establishment, the corresponding drugs were administered by gavage once a day for 14 consecutive days. Rats in the control group and the model group were administered the same amount of 0.5% CMC-Na by gavage. The specific grouping and drug administration are shown in Table 1 below.

[0050] Table 1 Group Dosing Table

[0051] 2.4 Detection Indicators ① General condition and weight observation Observe the rats daily for their fur luster, eating habits, mental state, activity, urination and defecation, and death, while also observing physical signs such as changes in weight.

[0052] ② Rat lung function test The relevant lung function indicators of rats in each group were measured using a rat pulmonary function testing instrument, including forced vital capacity in 1 second (FEV1), forced vital capacity (FVC), and forced vital capacity in 1 second / forced vital capacity (FEV1 / FVC).

[0053] ③ Detect the total white blood cell count, neutrophil count, and lymphocyte count in the bronchoalveolar lavage fluid. After the pulmonary function test, phosphate-buffered saline (PBS) was slowly injected into the endotracheal intubation site of each group of rats to lavage the left lung. Subsequently, 2 mL of the corresponding bronchoalveolar lavage fluid (BALF) was collected, centrifuged at 2000 rpm for 10 min, and the supernatant was collected. The total white blood cell count, lymphocyte count, and neutrophil count were observed and recorded using an optical microscope.

[0054] ④ Detect the expression of serum neutrophil elastase (NE) and inflammatory factors. Blood samples were collected from rats in each group and subjected to an injection at 3000 r·min. -1 After centrifugation for 10 min, the supernatant was collected, and the serum levels of NE, TNF-α, IL-1β, and IL-6 were detected by ELISA according to the kit instructions.

[0055] 2.5 Statistical Methods All data were analyzed using the GraphPad Prism 6.0 statistical software package. One-way ANOVA was used for comparisons among multiple groups, and pairwise comparisons between groups were performed using... Student’s -t test, P <0.05 indicates a statistically significant difference.

[0056] 3. Experimental Results 3.1 Effects of Traditional Chinese Medicine Composition on the General Condition and Body Weight of COPD Rats The control group rats had shiny fur, moved freely, ate normally, and breathed steadily without any symptoms such as shortness of breath or wheezing; their general condition was good. Compared with the control group, the model rats gradually became hyperactive, their fur became dull and lackluster, they lost hair, their appetite decreased, their stools became hard, their breathing became rapid and irregular, they coughed, wheezed, and had rattling sounds in their sputum, and their respiratory tract secretions were thick and yellow. These conditions gradually worsened with the extension of the modeling time. After 14 days of drug administration, the symptoms in the positive drug group and all other drug administration groups were less severe than those in the model group, with the best results observed in groups 1-3 of Examples.

[0057] Regarding body weight, compared with the normal group, the body weight of rats in the model group was significantly lower, while the body weight of rats in Examples 1-3 and the positive drug group was significantly higher. P <0.01), with comparable effects; comparative groups 1-3 showed no significant weight gain, while compared to examples 1-3, the weight gain was significantly reduced ( P <0.05). See Table 2 for detailed data.

[0058] Table 2. Effects of traditional Chinese medicine composition on body weight in COPD rats (mean ± SD, n =10)

[0059] Note: aa: p <0.01 vs. Blank group; a: p <0.05 vs. Blank group; ##: p <0.01 vs. Model group; #: p <0.05 vs. Model group; **: p <0.01 vs. Mean values ​​of Examples 1-3; *: p <0.05 vs. The mean of Examples 1-3.

[0060] 3.2 Effects of Traditional Chinese Medicine Combinations on Lung Function in COPD Rats Lung function tests are currently the most widely accepted objective indicator for detecting airflow limitation and are considered the "gold standard" for diagnosing COPD. Forced vital capacity (FVC) refers to the total amount of air that can be exhaled as quickly as possible after a maximal inspiration; forced vital capacity in one second (FEV1) is the maximum forced expiratory volume in one second.

[0061] Compared with the control group, the lung function parameters FEV1, FVC, and FEV1 / FVC in the model group rats were significantly reduced. P <0.01), indicating limited lung function in COPD model rats. After 14 days of administration, compared with the model group, the lung function parameters FEV1, FVC, and FEV1 / FVC in the positive control group and Examples 1-3 groups were significantly increased ( P <0.01), the effects of the Example 1-3 groups were comparable to those of the positive control group, suggesting that the composition can significantly enhance the vital capacity of COPD rats, improve airflow limitation, and improve lung function. The Comparative Examples 1-3 groups showed no significant improvement in FEV1, FVC, and FEV1 / FVC, but were significantly lower than those of the Example 1-3 groups ( P <0.05) indicates a significant improvement in efficacy within the range of the composition ratio. See Table 3 for detailed data.

[0062] Table 3. Effects of traditional Chinese medicine composition on lung function in COPD rats (mean±SD, n=10)

[0063] Note: aa: p <0.01 vs. Control group; a: p <0.05 vs. Control group; ##: p <0.01 vs. Model group; #:p <0.05 vs. Model group; **: p <0.01 vs. Mean values ​​of Examples 1-3; *: p <0.05 vs. The mean of Examples 1-3.

[0064] 3.3 Effects of Traditional Chinese Medicine Composition on the Number of Inflammatory Cells in BALF of COPD Rats Airway inflammation is a key pathological feature of COPD and is closely related to disease development and progression. Neutrophils, lymphocytes, and white blood cells are important biomarkers for monitoring inflammation in COPD. White blood cell count (WBC) is correlated with forced vital capacity and forced ventricular volume in one second and can serve as a biomarker for evaluating the diagnosis and treatment of COPD. Neutrophils play an important role in the initial inflammatory response of COPD and are associated with decreased lung function, impaired gas exchange, and alveolar destruction. Abnormal function of CD8+ T cells in lymphocytes promotes the development of emphysema.

[0065] Compared with the control group, the total number of white blood cells, lymphocytes, and neutrophils in the BALF of rats in the model group were significantly increased. P <0.01), indicating elevated inflammation levels and worsened lung function impairment in COPD model rats. After 14 days of administration, compared with the model group, the total white blood cell count, lymphocyte count, and neutrophil count were significantly reduced in the positive drug group and the groups described in Examples 1-3. P <0.01), the effects of groups 1-3 in Examples were comparable to those in the positive control group, suggesting that the composition can significantly inhibit the inflammatory response in COPD rats and improve lung function damage. In comparative groups 1-3, some indicators such as total white blood cell count, lymphocyte count, and neutrophil count showed some effect, but overall there was no significant improvement, and they were significantly higher than those in groups 1-3 in Examples (<0.01). P <0.05) indicates a significant improvement in efficacy within the range of the composition ratio. See Table 4 for detailed data.

[0066] Table 4. Effects of traditional Chinese medicine composition on the number of inflammatory cells in BALF of COPD rats (mean ± SD, n = 10, × 10⁻⁶) 6 L －1 )

[0067] Note: aa: p <0.01 vs. Control group; a: p <0.05 vs. Control group; ##: p <0.01 vs. Model group; #: p <0.05 vs. Model group; **: p <0.01 vs. Mean values ​​of Examples 1-3; *: p <0.05 vs. The mean of Examples 1-3.

[0068] 3.4 Effects of Traditional Chinese Medicine Combination on Serum Inflammatory Factor Levels and NE Expression in COPD Rats Neutrophil elastase (NE) is involved in airway inflammation and airway remodeling in COPD and causes airflow obstruction.

[0069] Compared with the blank group, the levels of NE, TNF-α, IL-1β, and IL-6 in the BALF of rats in the model group were significantly increased. P <0.01), indicating elevated inflammation levels and worsened lung function impairment in COPD model rats. After 14 days of administration, compared with the model group, the positive control group and the groups in Examples 1-3 all showed significantly reduced levels of NE, TNF-α, IL-1β, and IL-6 ( P <0.05), the effects of the Example 1-3 groups were comparable to those of the positive control group, suggesting that the composition can significantly inhibit the inflammatory response and improve airway obstruction in COPD rats. In the Comparative Groups 1-3, some indicators such as NE, TNF-α, IL-1β, and IL-6 showed effects, but overall there was no significant improvement, and they were significantly higher than those in the Example 1-3 groups ( P <0.05), indicating a significant improvement in efficacy within the range of the composition ratio. See Table 5 for detailed data.

[0070] Table 5. Effects of traditional Chinese medicine composition on serum inflammatory factor levels and NE expression in COPD rats (mean±SD, n=10)

[0071] Note: aa: p <0.01 vs. Control group; a: p <0.05 vs. Control group; ##: p <0.01 vs. Model group; #: p <0.05 vs. Model group; **: p <0.01 vs. Mean values ​​of Examples 1-3; *: p <0.05 vs. The mean of Examples 1-3.

[0072] Experimental results showed that the traditional Chinese medicine composition could significantly improve the general condition of COPD rats and significantly increase FEV1. FVC FEV1 / FVC levels improve airway limitation, enhance lung function, and alleviate symptoms such as shortness of breath, irregular breathing, cough, wheezing, and sputum production. They also significantly reduce total white blood cell count, lymphocyte count, neutrophil count, and inflammatory factors, thereby improving airway inflammation.

[0073] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. All embodiments of this composition are applicable. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. The use of a traditional Chinese medicine composition in the preparation of a medicament for the prevention and / or treatment of chronic obstructive pulmonary disease, characterized in that, The traditional Chinese medicine composition consists of the following raw materials: antelope horn powder, pearl powder, bezoar, silkworm, cinnabar, amber, arisaema cum bile, borneol, and acorus tatarinowii oil.

2. The application according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials: 100-190 parts by weight of antelope horn powder, 100-200 parts by weight of pearl powder, 200-400 parts by weight of bezoar, 200-400 parts by weight of silkworm, 100-200 parts by weight of cinnabar, 200-400 parts by weight of amber, 500-700 parts by weight of Arisaema cum Bile, 5-50 parts by weight of borneol, and 5-50 parts by weight of Acorus tatarinowii oil.

3. The application according to claim 2, characterized in that, The traditional Chinese medicine composition consists of the following raw materials: 150 parts antelope horn powder, 150 parts pearl powder, 300 parts bezoar, 300 parts silkworm, 150 parts cinnabar, 300 parts amber, 600 parts arisaema cum bile, 30 parts borneol, and 20 parts acorus tatarinowii oil.

4. The application according to any one of claims 1-3, characterized in that, The bezoar includes artificial bezoar and / or in vitro cultured bezoar.

5. The application according to any one of claims 1-3, characterized in that, The chronic obstructive pulmonary disease (COPD) mentioned refers to either stable COPD or COPD in the acute exacerbation phase.

6. The application according to any one of claims 1-3, characterized in that, The symptoms of chronic obstructive pulmonary disease include one or more of the following: airway restriction, decreased lung function, shortness of breath, irregular breathing, cough, wheezing, and abnormal airway inflammation.

7. The application according to any one of claims 1-3, characterized in that, The traditional Chinese medicine composition is prepared into one or more of the following forms: tablets, capsules, granules, powders, liquid preparations, ointments, injections, and sprays.

8. The application according to claim 7, characterized in that, The preparations made from the traditional Chinese medicine composition also include pharmaceutically acceptable excipients.

9. The application of Lingzhu Powder in the preparation of drugs for the prevention and treatment of chronic obstructive pulmonary disease, characterized in that... It includes the traditional Chinese medicine composition and pharmaceutically acceptable excipients used in any one of claims 1-3.

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