Chinese medicine composition for treating chronic obstructive pulmonary disease, preparation method and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease (COPD), which is composed of the following components in parts of mass: reed stem 10-20 parts, wax gourd seed 15-30 parts, caulis sargentodoxae 20-40 parts, luffa 10-20 parts, salvia miltiorrhiza 10-20 parts, rhodiola 6-15 parts, belamcanda 8-15 parts, ephedra 3-9 parts, radix pini 6-15 parts, forsythia suspensa 6-15 parts, mulberry bark 10-20 parts, rehmannia 10-20 parts, astragalus 15-30 parts, and licorice 3-9 parts. The application further discloses a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition is capable of clearing heat, activating blood and promoting lung, and at the same time, the astragalus and rehmannia are used to tonify the lung and kidney, support the healthy qi and eliminate the pathogenic factors, so that the traditional Chinese medicine composition is suitable for long-term treatment of COPD.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, specifically relating to a traditional Chinese medicine composition for treating COPD. This invention also relates to the preparation method and application of the traditional Chinese medicine composition. Background Technology

[0002] Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease characterized by persistent airflow limitation. It has a long course, recurrent acute exacerbations, and is often accompanied by multiple comorbidities, severely impacting patients' ability to work and their quality of life, and has become a significant public health burden globally. Currently, Western medicine treatment mainly relies on bronchodilators (such as β2-receptor agonists and anticholinergic drugs) and glucocorticoids to relieve airway spasm and control acute inflammation. However, long-term clinical practice has shown that Western medicine treatment alone has significant limitations: on the one hand, bronchodilators may cause side effects such as palpitations and skeletal muscle tremors, while long-term inhaled hormones may lead to oral candidiasis, osteoporosis, and decreased immunity; on the other hand, Western medicine treatment focuses primarily on symptomatic relief, which, while quickly alleviating acute symptoms, has limited effect on the structural repair of lung tissue, long-term protection of lung function, and improvement of the patient's overall health, making it difficult to fundamentally block the pathological process of progressive decline in lung function.

[0003] In contrast, Traditional Chinese Medicine (TCM) treatment of COPD follows the core principles of "holistic view" and "treatment based on syndrome differentiation," emphasizing "treating the symptoms in acute cases and addressing the root cause in chronic cases," demonstrating unique advantages in the full-cycle management of the disease. TCM views the pathogenesis of COPD as "deficiency of the root and excess of the branch," meaning that the root cause is the deficiency of the functions of the lungs, spleen, and kidneys, while the branch causes are the mutual binding of phlegm, blood stasis, and qi stagnation. During acute exacerbations, TCM effectively improves symptoms such as cough, phlegm, and wheezing through methods such as clearing heat, resolving phlegm, promoting blood circulation, and relieving asthma, while reducing the use of antibiotics and hormones. During stable periods, the focus is on tonifying qi, nourishing yin, tonifying the kidneys, and strengthening the spleen to consolidate the body's foundation, improve immune function, reduce the frequency of acute exacerbations, and delay lung function decline. Furthermore, TCM plays an irreplaceable role in improving patients' overall condition, such as appetite and weight, and in promoting recovery through non-drug therapies such as Tai Chi and breathing exercises.

[0004] Despite the immense potential of Traditional Chinese Medicine (TCM) in COPD treatment, current techniques still suffer from several shortcomings: First, some TCM diagnoses lack quantitative support from modern medical indicators, and the subjective nature of syndrome differentiation leads to insufficient treatment precision; second, many TCM compound formulas have complex compositions, unclear pharmacodynamic material bases, and lack systematic research on formula breakdown and compatibility analysis, making it difficult to elucidate the synergistic effects between individual herbs; furthermore... Therefore, developing a TCM compound formula based on modern pathological mechanisms, with rigorous compatibility, definite efficacy, and clear synergistic effects is of great significance for overcoming the current bottlenecks in COPD treatment. Summary of the Invention

[0005] The first objective of this invention is to provide a traditional Chinese medicine composition for treating COPD. This composition, while clearing heat, promoting blood circulation, and ventilating the lungs, also uses Astragalus membranaceus and Rehmannia glutinosa to tonify the lungs and kidneys, strengthen the body's resistance, and eliminate pathogenic factors, making it suitable for long-term treatment of COPD.

[0006] The second objective of this invention is to provide a method for preparing the traditional Chinese medicine composition.

[0007] A third objective of this invention is to provide the application of this traditional Chinese medicine composition in the preparation of a medicament for treating COPD.

[0008] The first technical solution adopted in this invention is: a traditional Chinese medicine composition for treating COPD, which is composed of the following components in parts by weight: 10-20 parts of reed stem, 15-30 parts of winter melon seed, 20-40 parts of chicken blood vine, 10-20 parts of loofah sponge, 10-20 parts of salvia miltiorrhiza, 6-15 parts of rhodiola rosea, 8-15 parts of belamcanda chinensis, 3-9 parts of ephedra, 6-15 parts of aster, 6-15 parts of coltsfoot flower, 10-20 parts of mulberry bark, 10-20 parts of prepared rehmannia root, 15-30 parts of astragalus root, and 3-9 parts of licorice root.

[0009] The second technical solution adopted in this invention is: a method for preparing a traditional Chinese medicine composition for treating COPD, comprising the following steps: Step 1, Pre-processing of medicinal materials: Weigh each medicinal material according to the formula, mix them, and then grind them into coarse powder for later use; Step 2, Water decoction extraction: Add water to the above-mentioned crude Chinese herbal medicine powder and decoct to extract. After the extraction is completed, combine the filtrates to obtain the Chinese herbal medicine extract. Step 3, Concentration: Concentrate the herbal extract from Step 2 to a relative density of 1.10. 1.20 thick extract; Step 4, freeze-drying: Freeze-dry the thick extract from step 3 to obtain freeze-dried Chinese medicine powder, which is the above-mentioned Chinese medicine composition.

[0010] The second technical solution adopted in this invention is further characterized in that: In step 2, the number of simmering times is 1. Three times; each time, add water equal to 6% of the total weight of the medicinal materials. 10 times the volume, each simmering time is 30 minutes. 60 minutes.

[0011] In step 3, at a vacuum level of 0.05 0.09 MPa, temperature 50 Concentration was carried out by rotary evaporation at 60°C.

[0012] Step 4 is as follows: Step 4.1, Pre-freezing: Place the thick extract in an ultra-low temperature environment below -80℃ and freeze rapidly for more than 4-6 hours until it is completely solidified.

[0013] Step 4.2, freeze drying: Transfer the pre-frozen solid Chinese medicine to a freeze dryer and first dry it for 24-48 hours at a temperature below -50℃ and a vacuum degree below 10Pa. Then slowly raise the temperature to 20-30℃ and continue drying for 6-12 hours to obtain freeze-dried Chinese medicine powder.

[0014] The third technical solution adopted in this invention is: the application of the above-mentioned traditional Chinese medicine composition for treating COPD in the preparation of drugs for treating COPD.

[0015] The third technical solution adopted in this invention is further characterized by: The above-mentioned drugs are any one of the following: decoction, powder, pill, ointment, tablet, capsule, lyophilized powder, granule, or oral liquid.

[0016] The beneficial effects of this invention are: The herbal composition of this invention emphasizes both clearing heat and promoting blood circulation. The combination of reed stems and winter melon seeds with chicken blood vine and salvia miltiorrhiza achieves the goal of treating both phlegm and blood stasis. The combined use of loofah sponge and rhodiola rosea can improve microcirculation by clearing the meridians, while belamcanda chinensis, ephedra, and mulberry bark disperse lung qi and relieve airway obstruction, achieving a synergistic effect of clearing the meridians and relieving asthma. Furthermore, while clearing heat, promoting blood circulation, and clearing the lungs, this formula also uses astragalus and rehmannia to tonify the lungs and kidneys, supporting the body's resistance and eliminating pathogenic factors, making it suitable for long-term treatment of COPD.

[0017] The traditional Chinese medicine composition of this invention exhibits significant therapeutic effects in improving lung function, inhibiting pulmonary inflammation, and repairing pathological damage to lung tissue in COPD rats. Furthermore, the drug pairs in the traditional Chinese medicine composition provided by this invention do not simply have additive effects, but rather exhibit close synergistic effects. Comprehensive formulation is crucial to ensuring the optimal therapeutic efficacy of this traditional Chinese medicine compound; each component is indispensable. Attached Figure Description

[0018] Figure 1 A schematic diagram showing the FEV0.3 / FVC measurement results of rats in each group; Figure 2a A schematic diagram showing the TNF-α concentration in the BALF of rats in each group; Figure 2b A schematic diagram showing the IL-6 concentration in the BALF of rats in each group; Figure 2c A schematic diagram showing the IL-1β concentration in the BALF of rats in each group; Figure 3a This is a schematic diagram showing the HE staining results of lung tissue from rats in the blank control group. Figure 3bThis is a schematic diagram showing the HE staining results of lung tissue from rats in the model group. Figure 3c This is a schematic diagram showing the HE staining results of lung tissue from rats in the positive control group. Figure 3d Schematic diagram of HE staining results of rat lung tissue in Example 1 group; Figure 4a A schematic diagram showing the MAN measurement results of rats in each group; Figure 4b This is a schematic diagram showing the MLI measurement results for each group of rats. Detailed Implementation

[0019] The present invention will now be described in detail with reference to specific embodiments.

[0020] This invention provides a traditional Chinese medicine compound for COPD, which consists of the following ingredients: 10-20 parts of reed stem, 15-30 parts of winter melon seed, 20-40 parts of chicken blood vine, 10-20 parts of loofah sponge, 10-20 parts of salvia miltiorrhiza, 6-15 parts of rhodiola rosea, 8-15 parts of belamcanda chinensis, 3-9 parts of ephedra, 6-15 parts of aster root, 6-15 parts of coltsfoot flower, 10-20 parts of mulberry bark, 10-20 parts of prepared rehmannia root, 15-30 parts of astragalus root, and 3-9 parts of licorice root.

[0021] This compound formula takes clearing heat and promoting blood circulation, unblocking the meridians and relieving asthma, and tonifying the lungs and kidneys as its core treatment principles. The entire formula embodies the modern TCM pathological thought of treating lung diseases by addressing the meridians and the mutual binding of phlegm and blood stasis. It organically combines phlegm-resolving, blood-activating, and meridian-unblocking methods, aiming to control inflammation, slow fibrosis, and improve lung function. The principal herbs in the formula are reed stem, winter melon seed, chicken blood vine, and salvia miltiorrhiza. Among them, reed stem and winter melon seed clear heat, resolve phlegm, and drain pus; chicken blood vine and salvia miltiorrhiza activate blood circulation, remove blood stasis, and unblock the meridians. These four herbs together address the core pathogenesis of COPD, namely lung heat, phlegm stasis, and blood stasis obstructing the meridians. The assistant herbs are loofah sponge, rhodiola rosea, belamcanda chinensis, ephedra, and mulberry bark. Among them, loofah sponge unblocks the meridians and disperses nodules; rhodiola rosea invigorates qi and promotes blood circulation; belamcanda chinensis clears heat, detoxifies, resolves phlegm, and soothes the throat; ephedra disperses lung heat and relieves asthma; and mulberry bark drains lung heat and relieves asthma. The combined effects of these herbs enhance the effects of clearing heat, activating blood circulation, and relieving asthma. The adjuvant herbs are Aster tataricus, Coltsfoot flower, Rehmannia glutinosa, and Astragalus membranaceus. Aster tataricus and Coltsfoot flower moisten the lungs, relieve cough, and resolve phlegm; Rehmannia glutinosa tonifies the kidneys and nourishes yin; Astragalus membranaceus tonifies qi and strengthens the exterior, assisting the principal and assistant herbs and preventing the heat-clearing and blood-activating herbs from harming the body's vital energy. The guiding herb is Glycyrrhiza uralensis, which harmonizes the herbs and also has the effects of relieving cough, resolving phlegm, tonifying qi, and harmonizing the middle jiao, guiding the herbs to their respective meridians. This formula emphasizes both clearing heat and activating blood. Reed stem and winter melon seed are combined with Spatholobus suberectus and Salvia miltiorrhiza to achieve the goal of treating both phlegm and blood stasis. The combination of Luffa cylindrica and Rhodiola rosea can unblock the meridians and improve microcirculation, while Belamcanda chinensis, Ephedra sinica, and Morus alba root bark can disperse lung qi and relieve airway obstruction, achieving the goal of synergistically unblocking the meridians and relieving asthma. In addition, while clearing heat, activating blood, and activating the lungs, this formula uses Astragalus membranaceus and Rehmannia glutinosa to tonify the lungs and kidneys, supporting the body's vital energy and eliminating pathogens, making it suitable for long-term treatment of COPD.

[0022] The properties, channels, effects, and modern pharmacological effects of each herb in the formula are as follows: Reed stem (reed rhizome): Properties and channels: Sweet, cold. Enters the lung and stomach channels. Functions: Clears heat and generates fluids, relieves irritability, stops vomiting, and promotes urination. In this formula, it is used as the principal herb, taking advantage of its effects of clearing lung heat and promoting pus drainage; it is an essential medicine for treating lung abscess. Modern pharmacology: It has antipyretic, analgesic, and sedative effects; it can inhibit harmful bacteria in the intestines and promote intestinal peristalsis; it has certain antioxidant and immunomodulatory effects.

[0023] Winter melon seeds: Properties and channels: Sweet, slightly cold. Enters the lung, large intestine, and small intestine channels. Functions: Clears lung heat and resolves phlegm, promotes diuresis and drains pus. When combined with reed stems, it enhances the lung-clearing, phlegm-resolving, and pus-draining effects. Modern pharmacology: Contains saponins and fatty oils, possessing antitussive and expectorant effects; can inhibit fat synthesis and lower blood lipids; has a regulatory effect on the immune system.

[0024] Chicken Blood Vine: Properties and Channels Entered: Bitter, sweet, warm. Enters the Liver and Kidney channels. Functions: Invigorates blood circulation, nourishes blood, regulates menstruation, relieves pain, relaxes muscles and tendons. Modern Pharmacology: Promotes hematopoietic function, increases red blood cells and hemoglobin; has anti-inflammatory, antioxidant, and antiviral effects; improves microcirculation and inhibits platelet aggregation.

[0025] Danshen (Salvia miltiorrhiza): Properties and Channels Entered: Bitter, slightly cold. Enters the Heart and Liver channels. Functions: Activates blood circulation and removes blood stasis, unblocks meridians and relieves pain, clears the heart and relieves irritability, cools the blood and reduces swelling. Modern Pharmacology: Dilates coronary arteries, increases blood flow, and improves microcirculation; anti-thrombotic; anti-inflammatory, antioxidant, and anti-fibrotic; inhibits various bacteria.

[0026] Loofah sponge: Properties and channels: Sweet, neutral. Enters the lung, stomach, and liver channels. Functions: Dispels wind, unblocks channels, invigorates blood, and promotes lactation. In this formula, it is used to unblock channels and disperse nodules, improving pulmonary microcirculation. Modern pharmacology: It has anti-inflammatory and analgesic effects; contains xylan and other components that can enhance the body's immunity; and has hepatoprotective and choleretic effects.

[0027] Rhodiola Rosea: Properties and Channels Entered: Sweet, astringent, cold. Enters the Lung and Heart channels. Functions: Invigorates Qi and blood, unblocks meridians and relieves asthma. Modern Pharmacology: Has significant anti-hypoxia and anti-fatigue effects; bidirectionally regulates the immune system; has antioxidant and anti-aging effects; protects the cardiovascular system and improves blood circulation.

[0028] Belamcanda chinensis: Properties and Channels: Bitter, cold. Enters the Lung Channel. Functions: Clears heat and detoxifies, resolves phlegm, and soothes the throat. Modern Pharmacology: It has significant anti-inflammatory and antiviral effects; it inhibits influenza virus and herpes virus; it can clear respiratory secretions and relieve sore throat.

[0029] Ephedra: Properties and Channels Entered: Pungent, slightly bitter, warm. Enters the Lung and Bladder channels. Functions: Induces sweating to relieve exterior syndromes, clears the lungs and relieves asthma, promotes diuresis and reduces edema. Modern Pharmacology: Contains ephedrine, which can relax bronchial smooth muscle (relieving asthma); stimulate the central nervous system; constrict blood vessels (raising blood pressure); and has anti-inflammatory, anti-allergic, and antipyretic effects.

[0030] Mulberry bark: Properties and channels: Sweet, cold. Enters the Lung channel. Functions: Clears lung heat and relieves asthma, promotes diuresis and reduces edema. Modern pharmacology: Has antihypertensive and diuretic effects; has sedative and anticonvulsant effects; has inhibitory effects on Staphylococcus aureus and Salmonella typhi; has anti-inflammatory and immunomodulatory functions.

[0031] Aster tataricus: Properties and Channels Entered: Bitter, pungent, sweet, slightly warm. Enters the Lung Channel. Functions: Moistens the lungs and lowers qi, resolves phlegm and relieves cough. Mainly treats cough with phlegm, chronic cough due to lung deficiency. Modern Pharmacology: Contains aster saponins, which have significant expectorant effects; inhibits Escherichia coli and Shigella dysenteriae; possesses anti-tumor, antioxidant, and diuretic effects.

[0032] Coltsfoot flower: Properties and channels: Pungent, slightly bitter, warm. Enters the Lung channel. Functions: Moistens the lungs, lowers qi, relieves cough and resolves phlegm. Often used in combination with Aster tataricus. Modern pharmacology: Has antitussive and expectorant effects; can stimulate the respiratory center; has a pressor effect; has an antispasmodic effect on gastrointestinal smooth muscle; has antiplatelet-activating factor activity.

[0033] Rehmannia glutinosa (processed Rehmannia root): Properties and Channels Entered: Sweet, slightly warm. Enters the Liver and Kidney channels. Functions: Nourishes blood and Yin, replenishes essence and marrow. Modern Pharmacology: Promotes hematopoietic function; enhances immune function; lowers blood sugar; has antioxidant and anti-aging effects; has cardiotonic and diuretic effects.

[0034] Astragalus: Properties and Channels Entered: Sweet, slightly warm. Enters the Spleen and Lung channels. Functions: Tonifies Qi and strengthens the exterior, promotes diuresis and eliminates toxins, drains pus, and promotes wound healing and tissue regeneration. Modern Pharmacology: Enhances the body's immune function (bidirectional regulation); protects the cardiovascular system; protects the liver and promotes diuresis; has anti-aging, anti-stress, and broad-spectrum antibacterial effects.

[0035] Licorice: Properties and Channels Entered: Sweet, neutral. Enters the Heart, Lung, Spleen, and Stomach channels. Functions: Tonifies the spleen and replenishes qi, clears heat and detoxifies, resolves phlegm and relieves cough, alleviates spasms and pain, and harmonizes other herbs. Modern Pharmacology: Has adrenocortical hormone-like effects (anti-inflammatory, anti-allergic); protects the gastric mucosa; detoxifies (adsorbs toxins); relieves cough and expectorates phlegm; has antiviral and immunomodulatory effects.

[0036] The traditional Chinese medicine compound provided by this invention can be made into conventional traditional Chinese medicine preparations such as decoctions, powders, pills, ointments, tablets, capsules, freeze-dried powders, granules, and oral liquids by adding medical excipients.

[0037] The following specific embodiments describe the preparation process of the freeze-dried Chinese medicine powder used in animal experiments: (1) Pre-treatment of medicinal materials: Weigh each medicinal material according to the formula, mix them and crush them into coarse powder for later use.

[0038] (2) Water decoction extraction: Add water to the above-mentioned crude Chinese herbal powder and decoct for extraction. The decoction is carried out 1-3 times. The amount of water added each time is 6-10 times the total weight of the herbs, and the decoction time is 30-60 minutes each time. After the extraction is completed, combine the filtrates to obtain the Chinese herbal extract.

[0039] (3) Concentration: The herbal extract is concentrated to a thick paste with a relative density of 1.10-1.20. Concentration is carried out by rotary evaporation under vacuum conditions of 0.05-0.09 MPa and temperature of 50-60℃.

[0040] (4) Freeze-drying: Pre-freezing: Place the thick extract in an ultra-low temperature environment below -80℃ and freeze rapidly for more than 4-6 hours until it is completely solidified.

[0041] Freeze-drying: The pre-frozen solid Chinese medicine is transferred to a freeze dryer and initially dried for 24-48 hours at a temperature below -50°C and a vacuum degree below 10Pa. Then, the temperature is slowly raised to 20-30°C and dried for another 6-12 hours to obtain freeze-dried Chinese medicine powder.

[0042] The technical solution of the present invention will be further described below with reference to the accompanying drawings and embodiments.

[0043] Example 1 This embodiment provides a processing technology for freeze-dried powder of traditional Chinese medicine, the core steps of which include raw material processing, extraction, concentration and freeze-drying, as detailed below: 1. Raw material pretreatment: Weigh out the following ingredients according to the prescription: 15g of reed stem, 20g of winter melon seed, 30g of chicken blood vine, 15g of loofah sponge, 15g of salvia miltiorrhiza, 10g of rhodiola rosea, 12g of belamcanda chinensis, 6g of ephedra, 10g of aster tataricus, 10g of coltsfoot flower, 15g of mulberry bark, 15g of prepared rehmannia root, 20g of astragalus membranaceus, and 6g of licorice root. Mix the above-mentioned medicinal materials and pulverize them to obtain coarse Chinese medicine powder for later use.

[0044] 2. Water decoction extraction: Place the coarse powdered Chinese herbs in a decoction pot, add drinking water equivalent to 10 times the total weight of the herbs, and soak for 40 minutes. Then heat over high heat to a boil, reduce to a simmer and cook for 60 minutes. After decoction, filter through gauze and collect the filtrate (labeled as filtrate A). Add water equivalent to 6 times the weight of the herbs to the remaining dregs, decoct again in the same manner for 45 minutes, and filter to obtain filtrate B. Combine the two filtrates and filter through multiple layers of gauze to remove residual impurities to obtain the Chinese herbal extract.

[0045] 3. Concentration: The obtained herbal extract was transferred to a rotary evaporator and concentrated under reduced pressure at a vacuum of 0.08 MPa and a temperature of 55°C. The concentration endpoint was determined by measuring the relative density of the extract at 60°C, concentrating it to a thick paste with a relative density of approximately 1.10.

[0046] 4. Freeze-drying: The thick extract is evenly spread in a freeze-drying container, with the layer thickness controlled within 1 cm. It is then placed in an ultra-low temperature environment below -80°C for rapid freezing for at least 5 hours to completely solidify the extract. The frozen solid is transferred to a freeze dryer and dried in the first stage at -50°C and a vacuum degree below 10 Pa for 24 hours. The temperature is then slowly increased to 25°C, and drying continues for another 8 hours to obtain a loosely structured freeze-dried block product.

[0047] 5. Grinding and Storage: Grind the freeze-dried block product into powder, pass it through an 80-mesh sieve, and obtain a uniform and fine freeze-dried powder of traditional Chinese medicine. The final product should be sealed and protected from light, and stored at -80℃ for later use.

[0048] Example 2 This embodiment provides a processing technology for freeze-dried powder of traditional Chinese medicine, the core steps of which include raw material processing, extraction, concentration and freeze-drying, as detailed below: 1. Raw material pretreatment: Weigh out the following ingredients according to the prescription: 10g of reed stem, 20g of winter melon seed, 20g of chicken blood vine, 15g of loofah sponge, 10g of salvia miltiorrhiza, 10g of rhodiola rosea, 8g of belamcanda chinensis, 6g of ephedra, 6g of aster, 10g of coltsfoot flower, 10g of mulberry bark, 15g of prepared rehmannia root, 15g of astragalus root, and 6g of licorice root. Mix the above-mentioned medicinal materials and pulverize them to obtain coarse Chinese medicine powder for later use.

[0049] 2. Water decoction extraction: Place the coarse powdered Chinese herbs in a decoction pot, add drinking water equivalent to 8 times the total weight of the herbs, and soak for 30 minutes. Then heat over high heat to a boil, reduce to a simmer and cook for 40 minutes. After decoction, filter through gauze and collect the filtrate (labeled as filtrate A). Add water equivalent to 6 times the weight of the herbs to the remaining dregs, decoct again in the same manner for 35 minutes, and filter to obtain filtrate B. Combine the two filtrates and filter through multiple layers of gauze to remove residual impurities to obtain the Chinese herbal extract.

[0050] 3. Concentration: The obtained herbal extract was transferred to a rotary evaporator and concentrated under reduced pressure at a vacuum of 0.05 MPa and a temperature of 50°C. The concentration endpoint was determined by measuring the relative density of the extract at 60°C, concentrating it to a thick paste with a relative density of approximately 1.15.

[0051] 4. Freeze-drying: The thick extract is evenly spread in a freeze-drying container, with the layer thickness controlled within 1 cm. It is then rapidly frozen in an ultra-low temperature environment below -80°C for at least 4 hours to completely solidify the extract. The frozen solid is transferred to a freeze dryer and dried in the first stage at -50°C and a vacuum degree below 10 Pa for 32 hours. The temperature is then slowly increased to 20°C, and drying continues for 6 hours to obtain a loosely structured freeze-dried block product.

[0052] 5. Grinding and Storage: Grind the freeze-dried block product into powder, pass it through an 80-mesh sieve, and obtain a uniform and fine freeze-dried powder of traditional Chinese medicine. The final product should be sealed and protected from light, and stored at -80℃ for later use.

[0053] Example 3 This embodiment provides a processing technology for freeze-dried powder of traditional Chinese medicine, the core steps of which include raw material processing, extraction, concentration and freeze-drying, as detailed below: 1. Raw material pretreatment: Weigh out the following ingredients according to the prescription: 15g of reed stem, 15g of winter melon seed, 30g of chicken blood vine, 10g of loofah sponge, 15g of salvia miltiorrhiza, 6g of rhodiola rosea, 12g of belamcanda chinensis, 3g of ephedra, 10g of aster tataricus, 6g of coltsfoot flower, 15g of mulberry bark, 10g of prepared rehmannia root, 20g of astragalus membranaceus, and 3g of licorice root. Mix the above-mentioned medicinal materials and pulverize them to obtain coarse Chinese medicine powder for later use.

[0054] 2. Decoction Extraction: Place the coarse powdered Chinese herbs in a decoction pot, add drinking water equivalent to 9 times the total weight of the herbs, and soak for 40 minutes. Then heat over high heat to a boil, reduce to a simmer and cook for 60 minutes. After decoction, filter through gauze and collect the filtrate (labeled as filtrate A). Add water equivalent to 7 times the weight of the herbs to the remaining dregs, decoct again in the same manner for 45 minutes, and filter to obtain filtrate B. Combine the two filtrates and filter through multiple layers of gauze to remove residual impurities to obtain the Chinese herbal extract.

[0055] 3. Concentration: The obtained herbal extract was transferred to a rotary evaporator and concentrated under reduced pressure at a vacuum of 0.09 MPa and a temperature of 60°C. The concentration endpoint was determined by measuring the relative density of the extract at 60°C, and the extract was concentrated to a thick paste with a relative density of approximately 1.12.

[0056] 4. Freeze-drying: The thick extract is evenly spread in a freeze-drying container, with the layer thickness controlled within 1 cm. It is then rapidly cooled in an ultra-low temperature environment below -80°C for at least 6 hours to completely solidify the extract. The frozen solid is transferred to a freeze dryer and dried in the first stage at -50°C and a vacuum degree below 10 Pa for 48 hours. The temperature is then slowly increased to 30°C, and drying continues for 12 hours to obtain a loosely structured freeze-dried block product.

[0057] 5. Grinding and Storage: Grind the freeze-dried block product into powder, pass it through an 80-mesh sieve, and obtain a uniform and fine freeze-dried powder of traditional Chinese medicine. The final product should be sealed and protected from light, and stored at -80℃ for later use.

[0058] Example 4 This embodiment provides a processing technology for oral preparations of traditional Chinese medicine, the core steps of which include raw material processing, extraction, concentration and freeze-drying, as detailed below: 1. Raw material pretreatment: Weigh out the following ingredients according to the prescription: 20g of reed stem, 20g of winter melon seed, 40g of chicken blood vine, 15g of loofah sponge, 20g of salvia miltiorrhiza, 10g of rhodiola rosea, 15g of belamcanda chinensis, 6g of ephedra, 15g of aster tataricus, 10g of coltsfoot flower, 20g of mulberry bark, 15g of prepared rehmannia root, 30g of astragalus membranaceus, and 6g of licorice root. Mix the above-mentioned medicinal materials and pulverize them to obtain coarse Chinese medicine powder for later use.

[0059] 2. Water decoction extraction: Place the coarse powdered Chinese herbs in a decoction pot, add drinking water equivalent to 10 times the total weight of the herbs, and soak for 40 minutes. Then heat over high heat to a boil, reduce to a simmer and cook for 60 minutes. After decoction, filter through gauze and collect the filtrate (labeled as filtrate A). Add water equivalent to 8 times the weight of the herbs to the remaining dregs, decoct again in the same manner for 45 minutes, and filter to obtain filtrate B. Combine the two filtrates and filter through multiple layers of gauze to remove residual impurities to obtain the Chinese herbal extract.

[0060] 3. Concentration: The obtained herbal extract was transferred to a rotary evaporator and concentrated under reduced pressure at a vacuum of 0.08 MPa and a temperature of 55°C. The concentration endpoint was determined by measuring the relative density of the extract at 60°C, concentrating it to a thick paste with a relative density of approximately 1.10.

[0061] 4. Freeze-drying: The thick extract is evenly spread in a freeze-drying container, with the layer thickness controlled within 1 cm. It is then placed in an ultra-low temperature environment below -80°C for rapid freezing for at least 5 hours to completely solidify the extract. The frozen solid is transferred to a freeze dryer and dried in the first stage at -50°C and a vacuum degree below 10 Pa for 24 hours. The temperature is then slowly increased to 25°C, and drying continues for another 8 hours to obtain a loosely structured freeze-dried block product.

[0062] 5. Grinding and Storage: Grind the freeze-dried block product into powder, pass it through an 80-mesh sieve, and obtain a uniform and fine freeze-dried powder of traditional Chinese medicine. The final product should be sealed and protected from light, and stored at -80℃ for later use.

[0063] 6. Traditional Chinese medicine freeze-dried powder is prepared into commonly used oral preparations by adding pharmaceutically acceptable excipients or auxiliary ingredients.

[0064] Example 5 This embodiment provides a processing technology for traditional Chinese medicine decoctions, the core steps of which include raw material processing, extraction, concentration, and freeze-drying, as detailed below: 1. Raw material pretreatment: Weigh out the following ingredients according to the prescription: 15g of reed stem, 30g of winter melon seed, 30g of chicken blood vine, 20g of loofah sponge, 15g of salvia miltiorrhiza, 15g of rhodiola rosea, 12g of belamcanda chinensis, 9g of ephedra, 10g of aster tataricus, 15g of coltsfoot flower, 15g of mulberry bark, 20g of prepared rehmannia root, 20g of astragalus root, and 9g of licorice root. Mix the above-mentioned medicinal materials and pulverize them to obtain coarse Chinese medicine powder for later use.

[0065] 2. Decoction Extraction: Place the coarse powdered Chinese herbs in a decoction pot, add drinking water equivalent to 8 times the total weight of the herbs, and soak for 40 minutes. Then heat over high heat to a boil, reduce to a simmer and cook for 60 minutes. After decoction, filter through gauze and collect the filtrate (labeled as filtrate A). Add water equivalent to 6 times the weight of the herbs to the remaining dregs, decoct again in the same manner for 45 minutes, and filter to obtain filtrate B. Combine the two filtrates and filter through multiple layers of gauze to remove residual impurities to obtain the Chinese herbal decoction.

[0066] Example 6 This embodiment provides a processing technology for traditional Chinese medicine granules, the core steps of which include raw material processing, extraction, concentration and freeze-drying, as detailed below: 1. Raw material pretreatment: Weigh out the following ingredients according to the prescription: 15g of reed stem, 30g of winter melon seed, 30g of chicken blood vine, 20g of loofah sponge, 15g of salvia miltiorrhiza, 15g of rhodiola rosea, 12g of belamcanda chinensis, 9g of ephedra, 10g of aster tataricus, 15g of coltsfoot flower, 15g of mulberry bark, 20g of prepared rehmannia root, 20g of astragalus root, and 9g of licorice root. Mix the above-mentioned medicinal materials and pulverize them to obtain coarse Chinese medicine powder for later use.

[0067] 2. Decoction Extraction: Place the coarse powdered Chinese herbs in a decoction pot, add drinking water equivalent to 8 times the total weight of the herbs, and soak for 40 minutes. Then heat over high heat to a boil, reduce to a simmer and cook for 60 minutes. After decoction, filter through gauze and collect the filtrate (labeled as filtrate A). Add water equivalent to 6 times the weight of the herbs to the remaining dregs, decoct again in the same manner for 45 minutes, and filter to obtain filtrate B. Combine the two filtrates and filter through multiple layers of gauze to remove residual impurities to obtain the Chinese herbal extract.

[0068] 3. Concentration: The obtained herbal extract was transferred to a rotary evaporator and concentrated under reduced pressure at a vacuum of 0.08 MPa and a temperature of 55°C. The concentration endpoint was determined by measuring the relative density of the extract at 60°C, concentrating it to a thick paste with a relative density of approximately 1.20.

[0069] 4. Freeze-drying: The thick extract is evenly spread in a freeze-drying container, with the layer thickness controlled within 1 cm. It is then placed in an ultra-low temperature environment below -80°C for rapid freezing for at least 5 hours to completely solidify the extract. The frozen solid is transferred to a freeze dryer and dried in the first stage at -50°C and a vacuum degree below 10 Pa for 24 hours. The temperature is then slowly increased to 25°C, and drying continues for another 8 hours to obtain a loosely structured freeze-dried block product.

[0070] 5. Crushing and storage: The freeze-dried block product is crushed into fine particles and packaged to obtain granules of the traditional Chinese medicine composition.

[0071] Comparative Example 1 This comparative example provides a processing technology for freeze-dried Chinese medicine powder. The specific preparation process differs from that of Example 1 only in that the reed stem and winter melon seed are omitted in step 1.

[0072] Comparative Example 2 This comparative example provides a processing technology for freeze-dried Chinese medicine powder. The specific preparation process differs from that of Example 1 only in that the two herbs, chicken blood vine and loofah, are omitted in step 1.

[0073] Comparative Example 3 This comparative example provides a processing technology for freeze-dried Chinese medicine powder. The specific preparation process differs from that of Example 1 only in that the two herbs, Danshen and Rhodiola rosea, are omitted in step 1.

[0074] Comparative Example 4 This comparative example provides a processing technology for freeze-dried Chinese medicine powder. The specific preparation process differs from that of Example 1 only in that the three herbs, Belamcanda chinensis, Ephedra sinica, and Morus alba root bark, are omitted in step 1. Comparative Example 5 This comparative example provides a processing technology for freeze-dried Chinese medicine powder. The specific preparation process differs from that of Example 1 only in that the two herbs, Aster tataricus and Tussilago farfara, are omitted in step 1.

[0075] Comparative Example 6 This comparative example provides a processing technology for freeze-dried Chinese medicine powder. The specific preparation process differs from that of Example 1 only in that Rehmannia glutinosa and Astragalus membranaceus are omitted in step 1.

[0076] The following animal experiments were used to verify the therapeutic effect of the lyophilized powder provided in Example 1 and Comparative Examples 1-6 of this invention on COPD.

[0077] 1. Experimental materials: 1.1 Laboratory Animals This experiment used SPF-grade male SD rats, aged 6-8 weeks and weighing 180-220g, all of which were obtained from the Experimental Animal Center of Xi'an Peihua University. All rats were acclimatized in the laboratory for one week before the formal experiment began.

[0078] 1.2 Experimental reagents: Aminophylline tablets: Manufacturer: Tianjin Lisheng Pharmaceutical Co., Ltd.; Approval number: National Drug Approval Number: H2020118; Specification: 0.1mg*100 tablets.

[0079] The lyophilized powders prepared in the above embodiments and comparative examples.

[0080] 2. Experimental Methods 2.1 Animal model establishment, grouping, and drug administration COPD Model Establishment: LPS was administered via tracheal instillation on days 1 and 14 of the experiment. Rats were anesthetized (by inhaling isoflurane) and fixed on the operating table, exposing the trachea. 0.2 ml of an aqueous solution containing 200 μg of lipopolysaccharide (1 g / L) was drawn into a syringe, and the LPS solution was injected by obliquely inserting a needle into the tracheal lumen. The rats were then immediately upright and rotated to ensure even distribution of the drug in both lungs. The needle was removed, and the muscles and skin were sutured layer by layer.

[0081] From days 2 to 13 and from days 15 to 28 of the experiment, rats were subjected to cigarette smoke treatment: except for days 1 and 14, rats were placed in a smoke chamber each day, and 10 unfiltered cigarettes were lit. Smoke was applied twice daily for one hour each time, with a four-hour interval. After smoke treatment, the activity and mental state of the rats in each group were observed and recorded. After the rats naturally recovered, they were returned to their original cages. This process was repeated five days a week for four consecutive weeks. The normal control group rats were exposed to clean air and did not undergo the above-mentioned cigarette smoke treatment.

[0082] Grouping: After successful modeling, the model rats were randomly divided into 9 groups of 8 rats each: model group, positive control group, Example 1 group, comparative example 1 group, comparative example 2 group, comparative example 3 group, comparative example 4 group, comparative example 5 group, and comparative example 6 group. Eight normal control rats were also used as blank controls.

[0083] Drug administration: After grouping, rats in each group began receiving oral administration of the traditional Chinese medicine prepared in Example 1 daily at a dose of 3.15 g / kg. Comparative groups 1 to 6 received the corresponding comparative group's prepared traditional Chinese medicine lyophilized powder at a dose of 3.15 g / kg. The positive control group received aminophylline tablets daily at a dose of 3.15 mg / kg, dissolved in 2 mL of physiological saline before administration. The model group and the blank control group received 2 mL of physiological saline daily via oral administration.

[0084] 2.2 Detection Indicators and Methods 2.2.1 Lung function test Twenty-four hours after the last administration, pulmonary function was assessed using a small animal pulmonary function analyzer. Rats were anesthetized, intubated, and connected to the pulmonary function analyzer. After standard tidal volume ventilation via mechanical ventilation, pulmonary function was measured: forced expiratory volume in 0.3 seconds / forced vital capacity (FEV0.3 / FVC).

[0085] 2.2.2 Levels of inflammatory factors in BALF Rats were euthanized, and bronchoalveolar lavage was performed with sterile PBS. The collected BALF was centrifuged to separate the supernatant, and the concentrations of tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-1β (IL-1β) in BALF were detected using an ELISA kit.

[0086] 2.2.3 Pathological assessment of lung tissue The left lung was harvested and fixed in 4% paraformaldehyde for 24 hours. After standard dehydration, clearing, and paraffin embedding, it was embedded in paraffin. Serial sections were prepared with a thickness of 4-5 μm, and all sections were routinely stained with hematoxylin and eosin (HE). Five non-overlapping fields were randomly selected from each HE-stained section and preserved.

[0087] Mean Lining Spacing (MLI) Measurement: Using image analysis software, a clear "X" shaped cross line was drawn at the center of each acquired image. The total length (L) of the "X" shaped cross line was measured using the ranging tool of the image analysis software. The number of alveolar septa crossed by the "X" shaped cross line (Ns) was counted. The counting rule was: the intersection of the cross line and the alveolar septum wall was counted as 1. The MLI value (in μm / n) was calculated using the formula MLI = L / Ns. The average MLI value of 5 fields of view was taken as the final MLI of the rat lung tissue.

[0088] Mean alveolar number (MAN) measurement: Image analysis software is used to calibrate the actual tissue area (S) corresponding to each acquired field of view. Within the same acquired field of view, the total number of intact alveoli (Na) is counted. The counting rule is: only alveoli with intact structure and clear outlines are counted. The result is calculated using the formula MAN = Na / S, and is the MAN value for that field of view (unit: n / μm). 2 The average MAN value of the five visual fields was taken as the final MAN of the rat lung tissue.

[0089] 3. Statistical Analysis All data were statistically analyzed using SPSS 22.0 software. Quantitative data conformed to a normal distribution, and the mean ± standard deviation was used. The mean ± standard deviation (±s) was used to compare the two groups using the independent samples t-test, and the chi-square test was used for count data. P < 0.05 or P < 0.01 was used as the criteria for statistical significance.

[0090] 4. Experimental Results 4.1 Comparison of lung function in rats of different groups.

[0091] Lung function is a core indicator for assessing the severity of COPD. In this experiment, the ratio of forced expiratory volume in 0.3 seconds to forced vital capacity (FEV0.3 / FVC) was used to reflect airway obstruction in rats. Figure 1 The FEV0.3 / FVC ratios of rats in each group are shown in the figure. As can be seen from the figure, the FEV0.3 / FVC ratio of the model group rats was significantly lower than that of the control group, indicating that the COPD model was successfully established and the rats had severe ventilatory dysfunction. After 28 days of treatment, the FEV0.3 / FVC ratios of the positive control group and all traditional Chinese medicine treatment groups (Example 1 group and Comparative Examples 1-6 groups) were significantly higher than those of the model group, indicating that all treatment regimens could improve lung function in COPD rats. Furthermore, the FEV0.3 / FVC ratio of Example 1 group (complete formula) was significantly higher than that of all comparative examples, and the difference was statistically significant (P<0.05). This indicates that the complete traditional Chinese medicine compound provided in Example 1 can most effectively improve lung ventilation function in COPD rats. While removing any drug pair from the compound (as shown in Comparative Examples 1-6) still maintained some efficacy, the ability to improve lung function significantly decreased.

[0092] 4.2 Comparison of inflammatory factor levels in BALF of rats in each group.

[0093] Inflammation is a key component of COPD pathogenesis. This experiment measured the concentrations of three key pro-inflammatory factors—TNF-α, IL-6, and IL-1β—in bronchoalveolar lavage fluid (BALF). Figure 2 shows the levels of inflammatory factors in the BALF of rats in each group. Figure 2a , Figure 2b and Figure 2c The figures show the concentrations of TNF-α, IL-6, and IL-1β in the bronchoalveolar lavage fluid (BALF) of rats in each group. The figures show that the levels of TNF-α, IL-6, and IL-1β in the model group were significantly higher than those in the control group (P<0.01), indicating a severe inflammatory response in the lungs of COPD model rats. The Example 1 group showed the strongest effect in inhibiting inflammatory factors. Its TNF-α, IL-6, and IL-1β levels were significantly lower than those in the positive control group and all comparative groups. The inflammatory factor levels in all comparative groups were significantly higher than those in the Example 1 group, indicating that the absence of specific drug pairs leads to a significant reduction in the ability of the compound to inhibit the inflammatory cascade.

[0094] 4.3 Pathological evaluation results of lung tissue in each group of rats.

[0095] Figure 3 shows the HE staining results of some rat lung tissues. Figure 3a , Figure 3b , Figure 3c , Figure 3d The staining results are shown for the blank group, model group, positive control group, and Example 1 group, respectively. The figures show that the lung tissue structure of the rats in the blank group was basically normal, with clear alveolar septa and no obvious inflammatory cell infiltration. Compared with the blank group, the lung tissue of the rats in the model group exhibited typical COPD pathological features: significant alveolar dilation, multiple ruptures and fusions of alveolar walls forming bullae, accompanied by a large number of inflammatory cell infiltrations. After intervention with the traditional Chinese medicine compound provided in Example 1, the above-mentioned pathological damage in the rat lung tissue was significantly improved.

[0096] This experiment quantified the degree of lung tissue damage using mean alveolar number (MAN) and mean lining space (MLI). Lower MAN and higher MLI indicate more severe alveolar damage and more pronounced emphysema. Figure 4 shows the semi-quantitative pathological assessment results of lung tissue from each group of rats. Figure 4a and Figure 4b The MAN and MLI measurements for each group of rats are shown below. Compared with the control group, the model group showed a significant decrease in MAN and a significant increase in MLI, indicating severe alveolar structural damage and alveolar fusion to form bullae. The Example 1 group exhibited the best lung tissue protection effect, with the highest MAN value and the lowest MLI value, significantly superior to the positive control group and all comparative groups (P<0.05). This demonstrates that the compound provided in Example 1 can most effectively prevent alveolar wall rupture and fusion. Comparing the comparative groups, the removal of any drug pair resulted in varying degrees of decrease in MAN values ​​and an increase in MLI values. This indicates that the absence of any component of the medicinal material weakens the compound's ability to protect the lung parenchyma and maintain alveolar structural integrity.

[0097] The animal experiments described above showed that the traditional Chinese medicine compound provided in Example 1 exhibited significant therapeutic effects in improving lung function, inhibiting pulmonary inflammation, and repairing pathological damage in COPD rats, with its overall efficacy superior to the positive control drug (aminophylline). Analysis of the compound by dissecting the ingredients (Comparative Examples 1-6) revealed that the absence of any specific drug pair significantly reduced the efficacy in improving lung function indicators (FEV0.3 / FVC), decreasing inflammatory factor levels (TNF-α, IL-6, IL-1β), and improving lung tissue structure (MAN, MLI) (P<0.05 or P<0.01). This result confirms that the drug pairs in the compound of Example 1 do not simply exhibit additive effects, but rather a close synergistic effect. The optimal combination of all components is crucial to ensuring the best therapeutic efficacy of this traditional Chinese medicine compound; each component is indispensable.

[0098] It should be noted that, in this document, terms such as “comprising,” “including,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0099] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for treating COPD, characterized in that, The ingredients are composed of the following components by weight: 10-20 parts of reed stem, 15-30 parts of winter melon seed, 20-40 parts of chicken blood vine, 10-20 parts of loofah sponge, 10-20 parts of salvia miltiorrhiza, 6-15 parts of rhodiola rosea, 8-15 parts of belamcanda chinensis, 3-9 parts of ephedra, 6-15 parts of aster, 6-15 parts of coltsfoot flower, 10-20 parts of mulberry bark, 10-20 parts of prepared rehmannia root, 15-30 parts of astragalus root, and 3-9 parts of licorice root.

2. The traditional Chinese medicine composition for treating COPD according to claim 1, characterized in that, The ingredients are composed of the following components by weight: 15 parts reed stem, 20 parts winter melon seed, 30 parts chicken blood vine, 15 parts loofah sponge, 15 parts salvia miltiorrhiza, 10 parts rhodiola rosea, 12 parts belamcanda chinensis, 6 parts ephedra, 10 parts aster, 10 parts coltsfoot flower, 15 parts mulberry bark, 15 parts prepared rehmannia root, 20 parts astragalus root, and 6 parts licorice root.

3. The method for preparing the traditional Chinese medicine composition for treating COPD according to claim 1 or 2, characterized in that, Includes the following steps: Step 1, Pre-processing of medicinal materials: Weigh each medicinal material according to the formula, mix them, and then grind them into coarse powder for later use; Step 2, Water decoction extraction: Add water to the above-mentioned crude Chinese herbal medicine powder and decoct to extract. After the extraction is completed, combine the filtrates to obtain the Chinese herbal medicine extract. Step 3, Concentration: Concentrate the herbal extract from Step 2 to a relative density of 1.

10. 1.20 thick extract; Step 4, freeze-drying: Freeze-dry the thick extract from step 3 to obtain freeze-dried Chinese medicine powder, which is the Chinese medicine composition.

4. The preparation method according to claim 2, characterized in that, In step 2, the number of decoctions is 1. Three times; each time, add water equal to 6-10 times the total weight of the herbs, and decoct for 30-60 minutes each time.

5. The preparation method according to claim 2, characterized in that, In step 3, concentration is carried out by rotary evaporation under vacuum conditions of 0.05-0.09 MPa and temperature of 50-60℃.

6. The preparation method according to claim 2, characterized in that, Step 4 is as follows: Step 4.1, Pre-freezing: Place the thick extract in an ultra-low temperature environment below -80℃ for rapid freezing for 4-6 hours to completely solidify it; Step 4.2, freeze drying: Transfer the pre-frozen solid Chinese medicine to a freeze dryer and first dry it for 24-48 hours at a temperature below -50℃ and a vacuum degree below 10Pa. Then slowly raise the temperature to 20-30℃ and continue drying for 6-12 hours to obtain freeze-dried Chinese medicine powder.

7. The use of the traditional Chinese medicine composition for treating COPD according to claim 1 or 2 in the preparation of drugs for treating COPD.

8. The application according to claim 7, characterized in that, The drug is any one of the following: decoction, powder, pill, ointment, tablet, capsule, freeze-dried powder, granule, or oral liquid.

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