Traditional Chinese medicine decoction for treating phlegm heat and viscera excess syndrome in acute exacerbation stage of chronic obstructive pulmonary disease and preparation method of traditional Chinese medicine decoction

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine decoction for treating phlegm heat and viscera excess syndromes in the acute exacerbation stage of chronic obstructive pulmonary diseases and a preparation method of the traditional Chinese medicine decoction. The traditional Chinese medicine composition for preparing the traditional Chinese medicine decoction is prepared from, by mass, 10-12 parts of radix bupleuri, 8-15 parts of gypsum, 5-8 parts of fructus aurantii immaturus, 5-8 parts of radix scutellariae, 5-8 parts of radix paeoniae alba, 4-8 parts of rheum officinale, 5-8 parts of peach kernels, 5-10 parts of pericarpium trichosanthis, 5-8 parts of almonds and 4-5 parts of cassia twigs. Aiming at the core pathogenesis of phlegm heat and viscera excess, the traditional Chinese medicine decoction synchronously exerts the effects of clearing heat and eliminating phlegm, purging heat and relaxing the viscera, and freeing lung and relieving asthma, realizes multi-target integral regulation, and directly attacks the root of the disease; core symptoms can be quickly improved, the disease course is shortened, the recurrence probability is reduced, long-term prognosis is effectively improved, and the safety is high; and the preparation is convenient to use and suitable for being popularized as a traditional Chinese and western medicine combined scheme.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and more specifically, to a traditional Chinese medicine decoction and its preparation method for treating phlegm-heat obstruction syndrome during acute exacerbations of chronic obstructive pulmonary disease. Background Technology

[0002] Chronic obstructive pulmonary disease (COPD) is a major global public health problem. It is a common and frequently occurring disease that seriously endangers human health, with high morbidity and mortality rates. The global prevalence of COPD in people aged ≥40 years reaches 9% to 10%.

[0003] Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are common and serious clinical events in COPD patients, characterized by a sudden worsening of airway inflammation, leading to a significant deterioration of respiratory symptoms. These symptoms primarily manifest as increased shortness of breath, increased sputum production, purulent sputum, and fever. Systemic inflammatory responses and multi-system dysfunction are also frequently present, with inflammatory markers (neutrophils, eosinophils, white blood cells, etc.) often showing significant abnormalities. The pathophysiological mechanisms of AECOPD involve airway infection, activation of inflammatory cells, enhanced oxidative stress, and accelerated airway remodeling, resulting in a further decline in lung function.

[0004] Currently, Western medicine treatments for AECOPD include bronchodilators, glucocorticoids, anti-infective therapy, respiratory support (non-invasive mechanical ventilation, invasive mechanical ventilation), oxygen therapy, and rehabilitation therapy.

[0005] However, the following limitations still exist in clinical practice: (1) Difficulty in diagnosing the cause: The cause of about one-third of acute exacerbations could not be determined, resulting in insufficient targeted treatment.

[0006] (2) Oxidative stress and systemic inflammation are difficult to control effectively, especially after repeated acute exacerbations, which can easily lead to complications such as respiratory failure and pulmonary hypertension.

[0007] (3) Limited improvement in prognosis: Despite the use of advanced treatment methods, the in-hospital mortality rate of patients with severe AECOPD is still as high as 15%–20%.

[0008] Overall, the treatment of AECOPD still mainly relies on Western medicine's bronchiectasis and anti-inflammatory measures, but further optimization and integration of treatment strategies are needed to improve systemic inflammation, protect lung function, and improve long-term prognosis. Summary of the Invention

[0009] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine decoction for treating phlegm-heat obstruction syndrome in the acute exacerbation of chronic obstructive pulmonary disease and its preparation method.

[0010] The technical solution of the present invention to solve the above-mentioned technical problems is as follows: This invention provides a traditional Chinese medicine composition, wherein the medicinal materials and their mass parts are as follows: Bupleurum chinense 10-12 parts, Gypsum fibrosum 8-15 parts, Citrus aurantium 5-8 parts, Scutellaria baicalensis 5-8 parts, Paeonia lactiflora 5-8 parts, Rheum palmatum 4-8 parts, Prunus persica 5-8 parts, Trichosanthes kirilowii peel 5-10 parts, Prunus armeniaca 5-8 parts, and Cinnamomum cassia 4-5 parts.

[0011] The present invention also provides the application of the above-described traditional Chinese medicine composition in the preparation of a traditional Chinese medicine decoction for treating phlegm-heat obstruction syndrome during acute exacerbation of chronic obstructive pulmonary disease.

[0012] The present invention also provides a traditional Chinese medicine decoction for treating phlegm-heat obstruction syndrome during acute exacerbation of chronic obstructive pulmonary disease, which is prepared using the traditional Chinese medicine composition described above.

[0013] This invention provides a method for preparing a traditional Chinese medicine decoction for treating phlegm-heat obstruction syndrome during acute exacerbations of chronic obstructive pulmonary disease, as described above, comprising the following steps: S1. Weigh each medicinal material in the Chinese herbal composition according to the mass fractions; S2. Soak each medicinal herb in water; S3. Add water directly to the soaked herbs for the first decoction to obtain the first decoction, then add water for the second decoction to obtain the second decoction. S4. Combine the first decoction and the second decoction, filter, and concentrate the filtrate to obtain the traditional Chinese medicine decoction.

[0014] Preferably, in step S2, the soaking time is 0.25-0.5 hours, and during soaking, the soaking water level is 2-3 cm above all the medicinal materials.

[0015] Preferably, in step S3, each time the food is simmered, it is first brought to a boil over high heat, and then the heat is reduced to a simmer.

[0016] Preferably, the simmering time is 0.5-1 hour each time.

[0017] Preferably, the two decoctions are performed using the same amount of room temperature water.

[0018] The beneficial effects of this invention are as follows: (1) The Chinese herbal decoction of the present invention for treating the acute exacerbation of chronic obstructive pulmonary disease with phlegm-heat and bowel obstruction syndrome targets the core pathogenesis of "phlegm-heat and bowel obstruction", and simultaneously exerts the effects of clearing heat and resolving phlegm, purging heat and clearing the bowels, and relieving asthma, thereby achieving overall regulation of the target and directly addressing the root cause of the disease. (2) The traditional Chinese medicine decoction of the present invention for treating phlegm-heat and bowel obstruction syndrome during acute exacerbation of chronic obstructive pulmonary disease can effectively relieve cough, wheezing, excessive phlegm, fever, abdominal distension, constipation and other symptoms in patients with AECOPD, rapidly improve core symptoms and reduce patient suffering; (3) The traditional Chinese medicine decoction of the present invention for treating phlegm-heat and visceral obstruction syndrome during acute exacerbation of chronic obstructive pulmonary disease can be used in combination with conventional treatment to achieve synergistic effect with Western medicine, and can accelerate the reduction of key inflammatory markers such as CRP and PCT, and shorten the course of disease. (4) The traditional Chinese medicine decoction of the present invention for treating phlegm-heat and visceral obstruction syndrome during acute exacerbation of chronic obstructive pulmonary disease can effectively improve long-term prognosis by regulating the body's immune status, reducing the frequency of acute exacerbations of AECOPD, lowering the probability of recurrence. (5) The traditional Chinese medicine decoction of the present invention for treating phlegm-heat and visceral obstruction syndrome during acute exacerbation of chronic obstructive pulmonary disease has a balanced formula, does not damage liver and kidney function, has high safety, and some components have clear protective effects on the lungs, heart and kidneys. (6) The method for preparing a traditional Chinese medicine decoction for treating acute exacerbation of chronic obstructive pulmonary disease with phlegm-heat and visceral obstruction is simple in preparation process and convenient in dosage form, and is suitable for promotion as a traditional Chinese and Western medicine combination in primary medical units. Attached Figure Description

[0019] Figure 1 This is a flowchart of the method for preparing a traditional Chinese medicine decoction for treating phlegm-heat obstruction syndrome during acute exacerbation of chronic obstructive pulmonary disease according to the present invention. Detailed Implementation

[0020] The principles and features of the present invention are described below. The examples given are only for explaining the present invention and are not intended to limit the scope of the present invention.

[0021] The traditional Chinese medicine composition of the present invention comprises the following ingredients and their weight proportions: Bupleurum chinense 10-12 parts, Gypsum fibrosum 8-15 parts, Citrus aurantium 5-8 parts, Scutellaria baicalensis 5-8 parts, Paeonia lactiflora 5-8 parts, Rheum palmatum 4-8 parts, Prunus persica 5-8 parts, Trichosanthes kirilowii peel 5-10 parts, Prunus armeniaca 5-8 parts, and Cinnamomum cassia 4-5 parts.

[0022] The traditional Chinese medicine composition of the present invention can be used to prepare a traditional Chinese medicine decoction for treating phlegm-heat obstruction syndrome in the acute exacerbation of chronic obstructive pulmonary disease, namely Chai Shi Xie Re Tang.

[0023] The Chai Shi Xie Re Tang of this invention is based on the systematic understanding of the pathogenesis of "phlegm-heat accumulation in the viscera" in traditional Chinese medicine, and is applicable to acute exacerbation of chronic obstructive pulmonary disease (AECOPD).

[0024] The etiology and pathogenesis of AECOPD are analyzed as follows: First, external pathogenic factors, especially wind-cold, wind-heat, and dryness, invade the lungs, causing stagnant heat and phlegm, which in turn triggers pre-existing phlegm, leading to a sudden onset of cough and wheezing. Second, impaired spleen function leads to the internal generation of dampness and phlegm, which, along with the upward flow of qi, obstructs the lungs. Heat easily combines with phlegm and dampness to form a "phlegm-heat stagnation." Third, obstructed intestinal qi flow causes heat and phlegm to stagnate in the intestines, forming a "visceral fullness," further hindering the ascent of clear yang and the descent of turbid yin, impairing lung function and worsening cough, wheezing, and abdominal distension. The inducing factors are often related to external pathogen infection, sudden temperature changes, overwork, emotional imbalance, alcohol consumption, spicy foods, and constipation, with "external pathogens triggering phlegm" and "pre-existing phlegm accumulating due to heat" being key. Traditional Chinese medicine believes that acute exacerbations often present with thick yellow phlegm, cough, wheezing, shortness of breath, chest tightness, a red tongue with a yellow, greasy coating, constipation, and scanty dark urine, which are comprehensive results of lung and spleen dysfunction. In summary, the pathogenesis of AECOPD is essentially the mutual binding of phlegm and heat, impaired lung function, and obstructed bowel movement. The treatment should focus on clearing heat and resolving phlegm, promoting lung function and relieving adverse flow, and clearing the bowels to release heat, so as to restore the smooth flow of Qi and clear the internal organs.

[0025] The pathogenesis of phlegm-heat obstruction in the internal organs: "Phlegm-heat obstruction in the internal organs" is an important pathological syndrome in Traditional Chinese Medicine (TCM), characterized by the mutual binding of phlegm-dampness and stagnant heat, which stagnates in the internal organs, obstructing the flow of Qi and affecting organ function. Its main pathogenesis includes: Phlegm-heat binding: Phlegm-dampness and heat adhere to each other, obstructing the flow of Qi, and heat transforms into phlegm-turbidity, which then accumulates with the heat. Obstruction of Qi in the internal organs: Heat, phlegm-turbidity, and blood stasis obstruct the internal organs, leading to obstruction of Qi in the internal organs, resulting in symptoms such as "wheezing, fullness in the chest, excessive phlegm, constipation, and dark yellow urine." Deficiency of vital Qi and excess of pathogenic factors: Accompanied by physical weakness and insufficient vital Qi, the body is susceptible to pathogenic factors, with the excess of pathogenic factors obstructing the internal flow while the deficiency of vital Qi makes it difficult to expel the pathogenic factors.

[0026] Typical manifestations of phlegm-heat accumulation in AECOPD: Common causes of AECOPD include infection, which leads to a significant aggravation of airway inflammation, manifesting as respiratory symptoms: cough, wheezing, copious yellow and sticky sputum, or blood in the sputum, chest tightness, shortness of breath, rattling in the throat, red tongue with yellow and greasy coating; digestive symptoms: abdominal distension and constipation, or dry and difficult bowel movements, abdominal distension and tenderness, foul-smelling belching, and slippery and rapid pulse; systemic symptoms: fever (worsening in the afternoon or at night), dry mouth and bitter taste, irritability, and scanty and yellow urine.

[0027] The treatment principles for AECOPD with phlegm-heat and bowel obstruction are as follows: Clearing heat and resolving phlegm: using herbs such as gypsum, bupleurum, and scutellaria to clear heat, detoxify, and harmonize the Shao Yang. Purging heat and unblocking the bowels: using herbs such as rhubarb and peach kernel to purge heat and remove obstruction. Promoting lung function and relieving asthma: combining herbs such as apricot kernel and trichosanthes fruit to promote lung function, resolve phlegm, relieve asthma, and stop coughing. This treatment method reflects the holistic approach emphasized in Traditional Chinese Medicine, using the synergistic effects of "clearing heat, resolving phlegm, and unblocking the bowels" to regulate bowel function, detoxify, eliminate pathogens, and restore vital energy, ultimately eliminating the pathological factors of infection and improving clinical symptoms.

[0028] Generally speaking, traditional Chinese medicine believes that phlegm-heat obstructing the fu-organs is an important pathogenesis in the acute exacerbation stage of chronic obstructive pulmonary disease. The core pathogenesis lies in phlegm-heat congesting the lungs, toxic pathogens blocking the qi movement of the fu-organs, clear yang failing to ascend, and turbid yin failing to descend, resulting in symptoms such as coughing and wheezing, copious yellow and sticky phlegm, chest distress and shortness of breath, gurgling of phlegm in the throat, abdominal distension and constipation, or dry and hard stools that are difficult to pass, abdominal distension with resistance to pressure, fetid eructation, fever, dry mouth and bitter taste, restlessness and irritability, short and yellow urine, red tongue with yellow and greasy coating, slippery and rapid pulse, etc. The treatment should mainly focus on "clearing heat and resolving phlegm, purging heat and dredging the fu-organs, and dispersing the lung qi and relieving asthma". On this basis, combined with the clinical experience of the Traditional Chinese Medicine Classics Department of Chongqing Traditional Chinese Medicine Hospital in treating the acute exacerbation stage of chronic obstructive pulmonary disease, the Chai Shi Xie Re Decoction of the present invention is summarized and induced.

[0029] For the traditional Chinese medicine composition of the present invention, the monarch drugs in the formula are: Bupleurum chinense and Gypsum fibrosum. Bupleurum chinense: Bitter, pungent and slightly cold, dispersing the Shaoyang meridian and dispelling stagnant heat, being the core of the monarch drug, targeting qi stagnation and internal accumulation of heat pathogen caused by exogenous or endogenous factors. Gypsum fibrosum: Pungent, sweet and大寒, clearing heat and purging fire, removing vexation and promoting fluid production, assisting Bupleurum chinense to enhance the power of clearing heat, especially targeting symptoms such as restlessness and fever caused by intense heat pathogen.

[0030] The ministerial drugs are: Scutellaria baicalensis, Rheum palmatum, Aurantii Fructus Immaturus and Paeonia lactiflora. Scutellaria baicalensis: Bitter and cold, clearing heat and purging the Shaoyang meridian and the lung heat, being used in combination with Bupleurum chinense to strengthen the effect of "reconciling the Shaoyang meridian and clearing heat pathogen". Rheum palmatum: Bitter and cold, purging accumulation and clearing heat and cooling blood, targeting heat constipation and stasis-heat intermingling, assisting Gypsum fibrosum and Scutellaria baicalensis to clear excessive heat. Aurantii Fructus Immaturus: Bitter, pungent and slightly cold, breaking qi and reducing accumulation, resolving phlegm and dissipating stagnation, not only assisting Rheum palmatum to purge heat and dredge the fu-organs, but also resolving qi stagnation, enhancing the effect of the monarch drug in promoting qi and clearing heat. Paeonia lactiflora: Bitter, sour and slightly cold, nourishing the liver and softening the liver, relieving spasm and pain, relieving the distending pain caused by qi stagnation.

[0031] The adjuvant drugs are: Prunus persica, Trichosanthis Pericarpium and Armeniacae Semen. Prunus persica: Bitter, sweet and flat, promoting blood circulation and removing stasis, targeting heat pathogen scorching collaterals and blood stasis blocking the interior, assisting Rheum palmatum and Scutellaria baicalensis to clear stasis-heat. Trichosanthis Pericarpium: Sweet, slightly bitter and cold, clearing heat and resolving phlegm, widening the chest and dissipating stagnation, targeting heat pathogen transforming phlegm and chest oppression and stuffiness, assisting Aurantii Fructus Immaturus to resolve phlegm and dissipate stagnation. Armeniacae Semen: Bitter and warm, descending qi and relieving cough and asthma, being used in combination with Trichosanthis Pericarpium to enhance the power of resolving phlegm and relieving cough, taking into account the symptoms of coughing and wheezing caused by heat pathogen invading the lungs.

[0032] The guiding drug is: Cinnamomum cassia, pungent, sweet and warm in nature, warming the meridians and promoting qi transformation. Its role in this formula is very delicate. Among a large number of cold drugs (such as Gypsum fibrosum, Scutellaria baicalensis, Rheum palmatum, etc.), adding a warm drug of Cinnamomum cassia can prevent the cold drugs from being too stagnant in qi and blood and hindering the qi movement, just like "putting firewood into the fire", which helps the medicinal power to spread and has a hidden effect of "regulating the properties of the medicine".

[0033] The above traditional Chinese medicine components of the present invention have shown potential value in experimental and clinical studies, as follows: (1) Saikosaponin A in Bupleurum chinense can significantly improve LPS-induced lung inflammatory response and reduce oxidative stress injury by inhibiting NF-κB and MAPK signaling pathways.

[0034] (2)Calcium sulfate, the main component of gypsum, has been shown in animal experiments to relieve high fever symptoms and contribute to synergistic anti-inflammatory and antipyretic mechanisms, enhancing the ability of patients to respond to heat-toxicity during respiratory tract infections.

[0035] (3)Immature bitter orange contains components such as naringin, which has the effects of promoting gastrointestinal motility, breaking up stagnation and promoting qi movement, and anti-inflammation, and can promote the smooth flow of qi in the intestines of patients with phlegm-heat obstructing the intestines.

[0036] (4)Trichosanthes kirilowii Maxim. pericarp is rich in saponin components, which have the effects of resolving phlegm and widening the chest, anti-inflammation and anti-asthma. Animal experiments have shown that the total amino acids extracted from Trichosanthes kirilowii Maxim. pericarp have good expectorant effects. Aspartic acid among them can promote cellular immunity, help reduce the degree of inflammation, and decrease secretions; cysteine can cleave the mucoprotein in sputum, making the sputum thinner and easier to cough out.

[0037] (5)Emodin in rhubarb can improve the pathological changes and inflammatory cell infiltration in rats with lipopolysaccharide-induced acute lung injury, significantly reduce inflammatory indicators, alleviate tissue damage caused by inflammation, and has multi-organ protective effects on infectious pneumonia, urinary tract infections, etc.

[0038] (6)Baicalin, the main component of Scutellaria baicalensis Georgi, has been shown in research to inhibit oxidative stress and inflammation by activating the Nrf2-mediated HO-1 signaling pathway, and improve lung or myocardial tissue damage caused by infection.

[0039] (7)Peach kernels and apricot kernels are rich in amygdalin, which has anticoagulant, anti-inflammatory, and antioxidant effects, and can improve microcirculation disorders and tissue stasis caused by infection.

[0040] (8)The combination of white peony root and cassia twig can significantly inhibit the increase in malondialdehyde levels and can also inhibit the activity of CAMP-PDE in inflammatory cells to a certain extent, thus inhibiting the ability of inflammatory cells to a certain extent.

[0041] In summary, the Chai Shi Xie Re Decoction of the present invention targets the core pathogenesis of "phlegm-heat obstructing the intestines", can simultaneously play the roles of clearing heat and resolving phlegm, purging heat and dredging the intestines, and dispersing the lung qi and relieving asthma, directly hitting the root cause of the disease, and can effectively relieve the symptoms of coughing, excessive phlegm, fever, abdominal distension, constipation, etc. in AECOPD patients, reducing pain.

[0042] At the same time, the Chai Shi Xie Re Decoction can be used in combination with conventional treatments to accelerate the reduction of key inflammatory indicators such as CRP and PCT, shorten the course of the disease. By regulating the immune status of the body, it can reduce the frequency of acute exacerbations of AECOPD and improve the long-term prognosis.

[0043] The Chai Shi Xie Re Decoction of the present invention has a balanced compatibility of various medicinal materials, causes no significant damage to liver and kidney functions, and some components have definite protective effects on the lungs, heart, and kidneys.

[0044] Preferably, the Chai Shi Xie Re Tang is composed of the following Chinese herbs in the following weight ratios: Bupleurum 10g, Gypsum 10g, Fructus Aurantii Immaturus 5g, Radix Scutellariae 5g, Radix Paeoniae Alba 5g, Radix Rhei 5g, Semen Persicae 5g, Pericarpium Trichosanthis 5g, Semen Apricotii 5g, and Rhizoma Cinnamomi 5g.

[0045] In addition, the formula of the Chinese herbal decoction of the present invention may also be: Bupleurum 12g, Gypsum 15g, Fructus Aurantii Immaturus 5g, Radix Scutellariae 8g, Radix Paeoniae Alba 8g, Rhizoma Rhei 4g, Semen Persicae 5g, Pericarpium Trichosanthis 10g, Semen Apricot 8g, and Rhizoma Cinnamomi 4g; this formula focuses on clearing heat and resolving phlegm, and relieving asthma by promoting lung function.

[0046] In the traditional Chinese medicine decoction of the present invention, the formula of the traditional Chinese medicine composition may also be: Bupleurum 10g, Gypsum 8g, Fructus Aurantii Immaturus 8g, Radix Scutellariae 5g, Radix Paeoniae Alba 8g, Rhizoma Rhei 8g, Semen Persicae 8g, Pericarpium Trichosanthis 5g, Semen Apricotii 5g, and Twigs Cinnamomi 5g; this formula focuses on purging and clearing the bowels, promoting qi circulation and relieving stagnation.

[0047] The present invention relates to a method for preparing a traditional Chinese medicine decoction for treating phlegm-heat obstruction syndrome during acute exacerbations of chronic obstructive pulmonary disease, such as... Figure 1 As shown, it includes the following steps: S1. Weigh each medicinal material in the Chinese herbal composition according to the mass fractions.

[0048] S2. Soak all the medicinal herbs in water for 30 minutes; Use room temperature water for soaking, with the water level 2-3 cm above all the herbs.

[0049] S3. Boil the soaked herbs twice with water. Each time you fry or boil, first bring it to a boil over high heat, then reduce to a simmer.

[0050] Each simmering time is 0.5-1 hour; the optimal time is 1 hour.

[0051] The amount of water added for both decoctions is equal, and room temperature water is used for both.

[0052] Specifically, this step involves simmering the ingredients twice with room temperature water. Each time, first bring the mixture to a rapid boil over high heat, then reduce to a simmer and maintain a gentle boil. Each simmer lasts for one hour, using the same amount of room temperature water for both simmerings.

[0053] S4. Combine the decoctions obtained from the two decoctions, filter them, and concentrate the filtrate to 300ml to obtain the traditional Chinese medicine decoction.

[0054] Preferably, the filtration method can be conventional filter paper filtration, filter screen filtration, or vacuum filtration; the concentration method can be rotary evaporation.

[0055] The Chai Shi Xie Re Tang of this invention is taken three times a day, morning, noon and evening, 100 mL each time, warm after meals. During the medication period, spicy and cold foods should be avoided, and one should avoid wind and cold, regulate emotions, and be careful with daily life.

[0056] The effects of the present invention will be illustrated below through specific embodiments.

[0057] Example 1: Clinical observation of the treatment of patients with AECOPD of phlegm-heat and bowel obstruction syndrome by Chai Shi Xie Re Tang. This study selected 120 patients with phlegm-heat accumulation syndrome of acute exacerbation of COPD (AECOPD) admitted between January 2024 and September 2025. These patients were randomly divided into a control group and three experimental groups (n=30 each). There were no statistically significant differences between the two groups in terms of gender, age, disease duration, and baseline inflammatory markers (P>0.05), making them comparable. Statistical analysis was performed using SPSS 26.0 software. Quantitative data were expressed as mean ± standard deviation. The t-test was used for comparisons between groups, and P<0.05 was considered statistically significant.

[0058] This embodiment uses the traditional Chinese medicine decoction of the present invention for treatment. The specific treatment method is as follows: The control group received standardized comprehensive treatment for AECOPD, including medication to control inflammation and airway spasm, respiratory support to correct hypoxia, and ventilation.

[0059] In addition to the above-mentioned standardized AECOPD comprehensive treatment, experimental group 1 was given oral Chai Shi Xie Re Tang, each dose containing 10g of Bupleurum, 10g of Gypsum, 5g of Fructus Aurantii Immaturus, 5g of Radix Scutellariae, 5g of Radix Paeoniae Alba, 5g of Radix Rhei, 5g of Semen Persicae, 5g of Semen Trichosanthis, 5g of Semen Apricot, and 5g of Twigs Cinnamomi. The decoction was prepared twice and concentrated to 300 mL, and divided into three doses (100 mL each time) in the morning, noon and evening for 10 days.

[0060] In addition to the above-mentioned standardized AECOPD comprehensive treatment, experimental group 2 was given oral Chai Shi Xie Re Tang formula B, each dose containing Bupleurum chinense 12g, Gypsum fibrosum 15g, Citrus aurantium 5g, Scutellaria baicalensis 8g, Paeonia lactiflora 8g, Rheum palmatum 4g, Prunus persica 5g, Trichosanthes kirilowii peel 10g, Prunus armeniaca 8g, and Cinnamomum cassia 4g. The decoction was prepared twice and concentrated to 300 mL, and divided into three doses (100 mL each time) in the morning, noon and evening, for a course of 10 days.

[0061] In addition to the above-mentioned standardized AECOPD comprehensive treatment, experimental group 3 was given oral Chai Shi Xie Re Tang formula C, each dose containing Bupleurum chinense 10g, Gypsum fibrosum 8g, Citrus aurantium 8g, Scutellaria baicalensis 5g, Paeonia lactiflora 8g, Rheum palmatum 8g, Prunus persica 8g, Trichosanthes kirilowii peel 5g, Prunus armeniaca 5g, and Cinnamomum cassia 5g. The decoction was prepared twice and concentrated to 300 mL, and divided into three doses (100 mL each time) in the morning, noon and evening, for a course of 10 days.

[0062] No other traditional Chinese medicine preparations were used in any of the above groups during the treatment period.

[0063] After the treatment course, the indicators and testing methods of each group of patients were observed, and the specific results are as follows: (1) Chest imaging examination: Records were made on enrollment and on the 10th day of treatment, and scores were made according to the chest imaging improvement assessment criteria table in Table 1.

[0064] Table 1. Assessment Criteria for Improvement in Chest Imaging

[0065] Calculation method: Total score: The total score is obtained by adding up the scores of each patient before and after treatment.

[0066] Efficacy assessment (based on the rate of change of total score): Significant improvement: Total score decreased by ≥70% after treatment; Improvement: Total score decreased by ≥30% and <70% after treatment; No change: Total score decreased by <30% or increased by <10% after treatment; Worsening: Total score increases by ≥10% after treatment.

[0067] Table 2 shows the comparison of chest imaging results before and after treatment in each group: Table 2 Comparison of chest imaging before and after treatment in each group of patients The above results show that the Chai Shi Xie Re Tang provided by the present invention can significantly promote the absorption of lung inflammation and improve chest imaging scores in patients with AECOPD, indicating that it can effectively improve airway inflammation and lung ventilation function. Its efficacy is clearly superior to the existing standard Western medicine treatment plan, providing objective and strong imaging evidence for the beneficial effects of the present invention.

[0068] (2) Test of relevant indicators: The specific test indicators are white blood cell count (WBC), neutrophil percentage (NEUT%), C-reactive protein (CRP) and procalcitonin (PCT). The test results are shown in Table 3.

[0069] Table 3 Comparison of various test indicators before and after treatment The results above show that all experimental groups showed better improvement than the control group, indicating that Chai Shi Xie Re Tang has a strong anti-inflammatory and immunomodulatory overall therapeutic effect.

[0070] (3) Safety evaluation: Safety evaluation is conducted by monitoring liver and kidney function, electrolytes and adverse reactions.

[0071] Tests showed that no significant abnormalities were observed in liver and kidney function or electrolyte levels in either the control group or the experimental groups during the treatment period. No significant adverse reactions such as gastrointestinal discomfort were observed in either group.

[0072] It is evident that the Chai Shi Xie Re Tang of this invention, through its multi-target regulatory mechanism of "clearing heat and resolving phlegm, purging heat and unblocking the bowels, and ventilating the lungs and relieving asthma," effectively improves the inflammatory state and abnormal lung imaging in patients with AECOPD phlegm-heat-abdominal excess syndrome, which is significantly superior to simple Western medicine comprehensive treatment and is worthy of promotion and application in clinical practice.

[0073] The following is detailed information about a typical case: Case 1 Patient: Mr. Li, male, 63 years old Chief complaint: Worsening cough, wheezing, and phlegm, accompanied by fever, chest tightness, and abdominal distension for 5 days.

[0074] Physical examination: body temperature 38.6℃, rapid breathing, moist rales audible in both lungs, red tongue with yellow and greasy coating, and rapid and forceful pulse.

[0075] Auxiliary examination: WBC: 13.2×10 9 / L, Neut%: 81.0%, CRP: 46.2 mg / L, PCT: 1.30 ng / mL Chest imaging (before treatment): Increased lung markings (2 points), moderate patchy infiltrates (2 points), mild emphysema (1 point), total score 5 points.

[0076] Diagnosis: AECOPD (phlegm-heat obstruction syndrome), lung infection.

[0077] Treatment: In addition to standard AECOPD Western medicine treatment, take the original formula of Chai Shi Xie Re Tang orally (Bupleurum 10g, Gypsum 10g, Fructus Aurantii Immaturus 5g, Radix Scutellariae 5g, Radix Paeoniae Alba 5g, Radix Rhei 5g, Semen Persicae 5g, Pericarpium Trichosanthis 5g, Semen Apricot 5g, Rhizoma Cinnamomi 5g), 1 dose per day, divided into 3 doses.

[0078] Follow-up examination 10 days later: WBC: 9.0×10 9 / L, Neut%: 63.2%, CRP: 20.5 mg / L, PCT: 0.58 ng / mL.

[0079] Chest imaging (post-treatment): Increased lung markings have been reduced (1 point), patchy exudates have been largely absorbed (1 point), emphysema has not progressed significantly (1 point), total score 3 points.

[0080] Therapeutic effects: Cough and wheezing were significantly relieved, sputum production was reduced, body temperature returned to normal, chest tightness improved, tongue coating turned thin and yellow, abdominal distension was reduced, bowel movements became regular, and inflammation and chest imaging showed significant improvement.

[0081] Case 2 Patient: Mr. Wang, male, 70 years old Chief complaint: Worsening shortness of breath accompanied by high fever and cough with sputum for 4 days.

[0082] Physical examination: body temperature 39.2℃, rapid breathing, obvious wheezing in both lungs, red tongue with thick yellow and greasy coating, and slippery and rapid pulse.

[0083] Auxiliary examination: WBC: 14.0×10 9 / L, Neut%: 84.5%, CRP: 52.8 mg / L, PCT: 1.45 ng / mL.

[0084] Chest imaging (before treatment): Significantly increased lung markings (3 points), large areas of consolidation, inflammation covering 2 / 3 of the lung fields (3 points), mild hyperinflation of both lungs (2 points), total score 8 points.

[0085] Diagnosis: AECOPD (phlegm-heat obstructing the lungs, with excessive heat and toxicity).

[0086] Treatment: Based on Western medicine, take the following oral formula B of Chai Shi Xie Re Tang (Bupleurum 12g, Gypsum 15g, Fructus Aurantii Immaturus 5g, Radix Scutellariae 8g, Radix Paeoniae Alba 8g, Radix Rhei 4g, Semen Persicae 5g, Pericarpium Trichosanthis 10g, Semen Apricot 8g, Rhizoma Cinnamomi 4g), one dose per day, divided into three administrations.

[0087] Follow-up examination 10 days later: WBC: 8.5×10 9 / L, Neut%: 58.5%, CRP: 16.8 mg / L, PCT: 0.55 ng / mL.

[0088] Chest imaging (post-treatment): Significant reduction in increased lung markings (1 point), absorption of large areas of consolidation with only a few patches (1 point), stable emphysema (1 point), total score 3 points.

[0089] Treatment efficacy: Shortness of breath significantly improved, sputum volume decreased and color lightened, body temperature returned to normal, and the patient reported feeling comfortable breathing. Chest imaging showed significant absorption of inflammation.

[0090] Case 3 Patient: Zhao, male, 58 years old.

[0091] Chief complaint: Coughing, wheezing, expectoration, fever, abdominal distension, and constipation for 6 days.

[0092] Physical examination: body temperature 38.4℃, significant abdominal distension, difficulty in defecation, red tongue with little saliva, thick and greasy coating, and deep and rapid pulse.

[0093] Auxiliary examination: WBC: 12.8×10 9 / L, Neut%: 79.2%, CRP: 44.6 mg / L, PCT: 1.20 ng / mL.

[0094] Chest imaging (before treatment): Increased lung markings (2 points), multiple patchy exudates (2 points), slightly increased translucency in both lungs (1 point), total score 5 points.

[0095] Diagnosis: AECOPD (phlegm-heat accumulation, obstruction of bowel function).

[0096] Treatment: Western medicine treatment combined with oral administration of Chai Shi Xie Re Tang formula C (Bupleurum 10g, Gypsum 8g, Fructus Aurantii Immaturus 8g, Radix Scutellariae 5g, Radix Paeoniae Alba 8g, Radix Rhei 8g, Semen Persicae 8g, Pericarpium Trichosanthis 5g, Semen Apricot 5g, Rhizoma Cinnamomi 5g), 1 dose per day, divided into 3 doses.

[0097] Follow-up examination 10 days later: WBC: 8.8×10 9 / L, Neut%: 60.0%, CRP: 18.5 mg / L, PCT: 0.57 ng / mL.

[0098] Chest imaging (post-treatment): Lung markings improved to slightly thickened (1 point), exudates decreased and were mostly absorbed (1 point), emphysema did not change much (1 point), total score 3 points.

[0099] Therapeutic effects: Cough and wheezing are relieved, bowel movements are regular, abdominal distension disappears, phlegm is reduced and easier to cough up, and lung inflammation is significantly absorbed.

[0100] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, The composition of the traditional Chinese medicine contains the following ingredients and their proportions by weight: Bupleurum chinense 10-12 parts, Gypsum 8-15 parts, Citrus aurantium 5-8 parts, Scutellaria baicalensis 5-8 parts, Paeonia lactiflora 5-8 parts, Rheum palmatum 4-8 parts, Prunus persica 5-8 parts, Trichosanthes kirilowii peel 5-10 parts, Prunus armeniaca 5-8 parts, and Cinnamomum cassia twig 4-5 parts.

2. The application of the traditional Chinese medicine composition as described in claim 1 in the preparation of a traditional Chinese medicine decoction for treating phlegm-heat obstruction syndrome during acute exacerbation of chronic obstructive pulmonary disease.

3. A traditional Chinese medicine decoction for treating phlegm-heat obstruction syndrome during acute exacerbations of chronic obstructive pulmonary disease, characterized in that... It is prepared using the traditional Chinese medicine composition as described in claim 1.

4. A method for preparing a traditional Chinese medicine decoction as described in claim 3 for treating phlegm-heat obstruction syndrome during acute exacerbation of chronic obstructive pulmonary disease, characterized in that, Includes the following steps: S1. Weigh each medicinal material in the Chinese herbal composition according to the mass fractions; S2. Soak each medicinal herb in water; S3. Add water directly to the soaked herbs for the first decoction to obtain the first decoction, then add water for the second decoction to obtain the second decoction. S4. Combine the first decoction and the second decoction, filter, and concentrate the filtrate to obtain the traditional Chinese medicine decoction.

5. A method for preparing a traditional Chinese medicine decoction for treating phlegm-heat obstruction syndrome during acute exacerbation of chronic obstructive pulmonary disease according to claim 4, characterized in that, In step S2, the soaking time is 0.25-0.5 hours, and during the soaking, the water level is 2-3 cm above all the medicinal materials.

6. A method for preparing a traditional Chinese medicine decoction for treating phlegm-heat obstruction syndrome during acute exacerbation of chronic obstructive pulmonary disease according to claim 4, characterized in that, In step S3, each time you fry, first bring it to a boil over high heat, then reduce to a simmer and maintain a gentle boil.

7. A method for preparing a traditional Chinese medicine decoction for treating phlegm-heat obstruction syndrome during acute exacerbation of chronic obstructive pulmonary disease according to claim 6, characterized in that, Each simmering time is 0.5-1 hour.

8. A method for preparing a traditional Chinese medicine decoction for treating phlegm-heat obstruction syndrome during acute exacerbation of chronic obstructive pulmonary disease according to claim 6, characterized in that, Both decoctions are performed using the same amount of room temperature water.

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