A clear gold phlegm soup and its application in regulating serum inflammatory factor protein network of patients with AECOPD with lung-phlegm heat syndrome

Abstract

This invention discloses a Qingjin Huatan Decoction and its application in regulating the serum inflammatory factor protein network of patients with AECOPD and phlegm-heat accumulation in the lungs, belonging to the field of biomedical technology. The Qingjin Huatan Decoction of this invention is composed of the following raw materials in parts by weight: Scutellaria baicalensis 10-20 parts, Gardenia jasminoides 6-12 parts, Morus alba root bark 6-12 parts, Trichosanthes kirilowii 10-14 parts, Fritillaria thunbergii 6-12 parts, Ophiopogon japonicus 6-12 parts, Platycodon grandiflorus 10-20 parts, Anemarrhena asphodeloides 6-12 parts, Citrus reticulata peel 10-20 parts, Poria cocos 10-20 parts, and Glycyrrhiza uralensis (processed) 4-8 parts. This formula is consistent with the core pathogenesis of AECOPD and phlegm-heat accumulation in the lungs, with appropriate warming and cooling properties, and a combination of tonifying and purging effects. It can inhibit the proliferation of pathogenic bacteria in the intestines, correct intestinal flora imbalance, achieve intestinal-lung harmony through the intestinal-lung axis, comprehensively improve patients' clinical symptoms, and enhance clinical suitability.

Description

Technical Field

[0001] This invention belongs to the field of biomedical technology, specifically relating to a Qingjin Huatan Decoction and its application in regulating the serum inflammatory factor protein network of patients with AECOPD phlegm-heat accumulation in the lungs. Background Technology

[0002] Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are a common acute and critical respiratory illness. Phlegm-heat accumulation in the lungs is the core TCM syndrome type in AECOPD clinical practice, often accompanied by concurrent intestinal and lung symptoms, aligning with the classic TCM theory of "the lung and large intestine being internally and externally related." Modern medical research has confirmed that the gut microbiota-host metabolic axis is a key pathway for regulating lung diseases. Patients with phlegm-heat accumulation in the lungs in AECOPD commonly exhibit gut microbiota dysbiosis, host inflammatory metabolism, and energy metabolism disorders. Abnormal microbiota structure can regulate the secretion of metabolic products, exacerbating airway inflammation, sputum viscosity, and lung function impairment, forming a vicious cycle of "microbiota dysbiosis-metabolic disorder-lung injury." Clinically, there is an urgent need to clarify the regulatory mechanisms of this type of disease to optimize treatment plans. Qingjin Huatan Decoction is a classic formula for clearing heat and resolving phlegm commonly used in clinical practice. It has been proven to significantly improve the clinical symptoms, lung function, and inflammation levels of patients with AECOPD and phlegm-heat accumulation in the lungs. However, existing research on the mechanism of action of this formula still has significant limitations. It has only preliminarily explored its unidirectional regulatory effect on the gut microbiota of AECOPD patients. It cannot systematically analyze the bidirectional interaction between gut microbiota and host metabolism during its action, nor can it fully elucidate the material basis and mechanism of action of this formula in treating AECOPD, thus failing to provide sufficient theoretical support for its precise clinical application. Currently, research on the mechanism of traditional Chinese medicine compound regulation of the gut-lung axis mostly adopts single-omics analysis methods, which have the shortcomings of single analytical dimensions and inability to clarify the interaction relationship between different regulatory levels. It has not yet established a multi-omics integrated analysis method that is suitable for the multi-target and multi-pathway regulatory characteristics of traditional Chinese medicine compound and is specific to the phlegm-heat accumulation in the lungs syndrome of AECOPD. It is difficult to systematically analyze the core mechanism of traditional Chinese medicine compound intervention in the disease by regulating the gut microbiota-host metabolic axis, and it is also impossible to form a standardized research technology system that can be replicated and promoted. Summary of the Invention

[0003] To address the shortcomings of existing technologies, this specification provides one or more embodiments of a Qingjin Huatan Decoction, composed of the following raw materials in parts by weight: Scutellaria baicalensis 10-20 parts, Gardenia jasminoides 6-12 parts, Morus alba root bark 6-12 parts, Trichosanthes kirilowii 10-14 parts, Fritillaria thunbergii 6-12 parts, Ophiopogon japonicus 6-12 parts, Platycodon grandiflorus 10-20 parts, Anemarrhena asphodeloides 6-12 parts, Citrus reticulata peel 10-20 parts, Poria cocos 10-20 parts, and Glycyrrhiza uralensis (processed) 4-8 parts.

[0004] In some embodiments, the raw materials are in the following proportions by weight: 15 parts Scutellaria baicalensis, 9 parts Gardenia jasminoides, 9 parts Morus alba root bark, 12 parts Trichosanthes kirilowii, 9 parts Fritillaria thunbergii, 9 parts Ophiopogon japonicus, 15 parts Platycodon grandiflorus, 9 parts Anemarrhena asphodeloides, 15 parts Citrus reticulata peel, 15 parts Poria cocos, and 6 parts Glycyrrhiza uralensis (processed).

[0005] In some embodiments, the Qingjin Huatan Decoction is any one of a decoction, granules, or concentrated pills.

[0006] This specification also provides one or more embodiments of a method for preparing Qingjin Huatan Decoction. When Qingjin Huatan Decoction is a decoction, the preparation process includes the following steps: S1, mixing the raw materials and soaking them in water for 20-40 minutes to obtain a soaking mixture; S2, decocting the soaking mixture for 20-40 minutes and filtering it to obtain a first filtrate and a first dregs; S3, adding water to the first dregs and decocting it for 15-30 minutes and filtering it to obtain a second filtrate; S4, combining the first filtrate and the second filtrate and concentrating it to a decoction product containing 113-137g of raw herbs per dose.

[0007] In some embodiments, the total mass of raw medicinal materials contained in a unit preparation of Qingjin Huatan Decoction is 113-137 parts.

[0008] In some embodiments, the Qingjin Huatan Decoction further includes excipients, wherein the excipients are present in a mass fraction of 1-30 parts.

[0009] One or more embodiments of this specification also provide an application of Qingjin Huatan Decoction in regulating the serum inflammatory factor protein network of patients with phlegm-heat accumulation in the lungs in AECOPD, using Qingjin Huatan Decoction as an intervention drug and applying it to patients with phlegm-heat accumulation in the lungs during acute exacerbation of chronic obstructive pulmonary disease.

[0010] Beneficial effects 1. The ingredients of Qingjin Huatan Decoction are composed of 10-20 parts of Scutellaria baicalensis, 6-12 parts of Gardenia jasminoides, 6-12 parts of Morus alba root bark, 10-14 parts of Trichosanthes kirilowii fruit, 6-12 parts of Fritillaria thunbergii, 6-12 parts of Ophiopogon japonicus, 10-20 parts of Platycodon grandiflorus, 6-12 parts of Anemarrhena asphodeloides, 10-20 parts of Citrus reticulata peel, 10-20 parts of Poria cocos, and 4-8 parts of Glycyrrhiza uralensis (processed) by weight. This formulation is suitable for the phlegm-heat accumulation during acute exacerbations of chronic obstructive pulmonary disease. The core pathogenesis of lung syndrome involves phlegm-heat obstructing the lungs, impaired lung function, and concurrent intestinal and lung disease. It employs a balanced approach, combining warming and cooling methods with both tonifying and purging techniques. This approach retains the core efficacy of classic ancient formulas while adapting to the physical characteristics of modern patients. Simultaneously, it inhibits the proliferation of pathogenic bacteria in the intestines, corrects intestinal flora imbalance, and regulates host metabolic pathways to break the vicious cycle of flora imbalance, metabolic disorders, and worsening airway inflammation. Through the intestinal-lung axis, it achieves intestinal-lung harmony, comprehensively improving patients' clinical symptoms and enhancing its clinical applicability. 2. By setting the raw material ratio of Qingjin Huatan Decoction to 15 parts Scutellaria baicalensis, 9 parts Gardenia jasminoides, 9 parts Morus alba root bark, 12 parts Trichosanthes kirilowii, 9 parts Fritillaria thunbergii, 9 parts Ophiopogon japonicus, 15 parts Platycodon grandiflorus, 9 parts Anemarrhena asphodeloides, 15 parts Citrus reticulata peel, 15 parts Poria cocos, and 6 parts Glycyrrhiza uralensis, the proportions of various medicinal materials can be balanced. The efficacy of clearing lung heat is moderate without damaging the spleen and stomach, the efficacy of resolving phlegm and promoting bowel movement is appropriate without depleting the body's vital energy, and the effects of nourishing yin and moistening dryness just offset the risk of depletion of body fluids. At the same time, the release ratio of the active ingredients of each raw material is adapted to the needs of intestinal microecological regulation, metabolic disorder correction, and symptom improvement. It can effectively and stably correct intestinal flora disorder, stabilize and restore metabolic state, and safely improve intestinal and lung symptoms. It avoids problems such as insufficient antibacterial activity, excessive probiotic activity, interference with normal metabolism, and adverse reactions caused by non-optimal ratios, further improving the suitability for the target population, the stability of clinical efficacy, and the safety of medication.

[0011] 3. By preparing Qingjin Huatan Decoction into any one of the following forms: decoction, granules, or concentrated pills, the active ingredients of each raw material in the formula and the synergistic effect formed by their combination can be fully preserved. This allows for the stable exertion of the core efficacy of reshaping the intestinal flora structure, regulating host metabolic pathways, and downregulating the expression of pro-inflammatory factors. At the same time, it covers the different needs of centralized immediate drug administration in medical institutions and self-administered drugs by patients outside the hospital, improving the convenience of drug administration and patient medication compliance, and broadening the scope of clinical application.

[0012] 4. The decoction is prepared by mixing the raw materials, soaking them in water for 20-40 minutes, decocting for another 20-40 minutes, filtering to obtain the first filtrate, adding water to the residue and decocting for another 15-30 minutes to obtain the second filtrate, and then concentrating the combined filtrates to a concentration of 113-137g of raw herbs per dose. This process avoids rapid gelatinization of the medicinal material surface, which hinders the dissolution of internal active ingredients, fully extracts both easily soluble and poorly soluble active ingredients, avoids waste of active ingredients, and ensures that the content of active ingredients in the decoction matches the formulation ratio. The efficacy is stable and does not increase the burden on patients, making it suitable for the clinical needs of centralized preparation and immediate administration in medical institutions. Detailed Implementation

[0013] This specification provides one or more embodiments of a Qingjin Huatan Decoction, which is composed of the following raw materials in parts by weight: Scutellaria baicalensis 10-20 parts, Gardenia jasminoides 6-12 parts, Morus alba root bark 6-12 parts, Trichosanthes kirilowii 10-14 parts, Fritillaria thunbergii 6-12 parts, Ophiopogon japonicus 6-12 parts, Platycodon grandiflorus 10-20 parts, Anemarrhena asphodeloides 6-12 parts, Citrus reticulata peel 10-20 parts, Poria cocos 10-20 parts, and Glycyrrhiza uralensis (processed) 4-8 parts.

[0014] This formula is based on the traditional Chinese medicine theory of "the lung and large intestine being internally and externally related." It addresses the core pathogenesis of phlegm-heat accumulation in the lungs during acute exacerbations of chronic obstructive pulmonary disease (COPD), characterized by phlegm-heat obstructing the lungs, impaired lung function, and concurrent lung and intestinal dysfunction. Scutellaria baicalensis and Gardenia jasminoides clear heat from the lungs and resolve the root cause of inflammation, while Morus alba root bark specifically targets the lung meridian to clear heat and relieve asthma. Together, these three herbs address the core pathogenesis of excessive phlegm-heat in the upper burner. Trichosanthes kirilowii, Fritillaria thunbergii, and Platycodon grandiflorus resolve phlegm, dissipate nodules, clear the lungs, and promote bowel movement, simultaneously dissolving viscous phlegm in the lungs and clearing intestinal conduction, thus supporting lung qi. The formula promotes the downward flow of qi and restores balance; tangerine peel and poria cocos dry dampness, strengthen the spleen, regulate qi, and harmonize the middle jiao, reducing phlegm production from the root; ophiopogon japonicus and anemarrhena asphodeloides nourish yin and moisten the lungs, alleviating the potential loss of body fluids caused by heat-clearing and dampness-drying herbs; roasted licorice root harmonizes all the herbs, making the whole formula suitable for both cold and warm properties, and combining attack and tonification. The quality ratio of each raw material is adjusted based on the classic ancient formula to suit the physical characteristics of modern patients with acute exacerbations of chronic obstructive pulmonary disease, thus preserving the core efficacy of the classic formula while improving its suitability for clinical application.

[0015] After being taken orally into the human digestive tract, the active ingredients in Scutellaria baicalensis, Gardenia jasminoides, and Anemarrhena asphodeloides can specifically inhibit the growth and reproduction of pathogenic bacteria that proliferate excessively in the intestines, and reduce the release of endotoxins mediated by pathogenic bacteria. At the same time, the polysaccharides and dietary fiber contained in Trichosanthes kirilowii, Ophiopogon japonicus, and Poria cocos can serve as prebiotic substrates, providing nutritional supply for beneficial bacteria in the intestines, promoting the colonization and proliferation of beneficial bacteria, gradually correcting the intestinal flora imbalance in patients with acute exacerbations of chronic obstructive pulmonary disease, and restoring the balance of the intestinal microecology.

[0016] As the gut microbiota gradually returns to balance, the levels of anti-inflammatory metabolites produced by beneficial bacteria gradually increase, while the production of pro-inflammatory metabolites decreases synchronously after pathogenic bacteria are suppressed. At the same time, the saponins and volatile active ingredients contained in Platycodon grandiflorus and Citrus reticulata in the formula can regulate the host's metabolic pathways, promote the excretion of pro-inflammatory metabolic waste, correct the patient's inflammatory metabolism and energy metabolism disorders, and break the vicious cycle of dysbiosis, metabolic disorder, and worsening airway inflammation.

[0017] After the gut microbiota and host metabolism are restored to homeostasis, anti-inflammatory metabolites can enter the lungs and systemic circulation through the gut-lung axis circulation, downregulating the expression levels of pro-inflammatory factors in the whole body and airways, reducing airway mucosal edema and sputum viscosity. At the same time, the active ingredients in the formula that clear the lungs and resolve phlegm can directly act on the respiratory tract, improving lung symptoms such as cough, wheezing, and thick yellow sputum, while the intestinal cleansing ingredients can improve intestinal symptoms such as constipation, thus achieving simultaneous regulation of the gut and lungs and comprehensively improving the clinical symptoms of patients with phlegm-heat accumulation in the lungs during acute exacerbations of chronic obstructive pulmonary disease.

[0018] In some embodiments, the raw materials of the Qingjin Huatan Decoction are in the following proportions: 15 parts of Scutellaria baicalensis, 9 parts of Gardenia jasminoides, 9 parts of Morus alba root bark, 12 parts of Trichosanthes kirilowii, 9 parts of Fritillaria thunbergii, 9 parts of Ophiopogon japonicus, 15 parts of Platycodon grandiflorus, 9 parts of Anemarrhena asphodeloides, 15 parts of Citrus reticulata peel, 15 parts of Poria cocos, and 6 parts of Glycyrrhiza uralensis (processed).

[0019] The Qingjin Huatan Decoction used in this embodiment has the following ingredient ratios: Scutellaria baicalensis 15 parts, Gardenia jasminoides 9 parts, Morus alba root bark 9 parts, Trichosanthes kirilowii 12 parts, Fritillaria thunbergii 9 parts, Ophiopogon japonicus 9 parts, Platycodon grandiflorus 15 parts, Anemarrhena asphodeloides 9 parts, Citrus reticulata peel 15 parts, Poria cocos 15 parts, and Glycyrrhiza uralensis (processed) 6 parts. This ratio is the optimal ratio obtained by precisely adjusting the formula based on classic ancient prescriptions, targeting the core pathogenesis of phlegm-heat accumulation in the lungs during acute exacerbations of chronic obstructive pulmonary disease (COPD) and the common physical characteristics of modern patients. The formula is balanced in proportion to various medicinal materials that clear heat and stagnation, resolve phlegm and promote bowel movement, strengthen the spleen and protect body fluids, and harmonize the properties of other herbs. The herbs that clear lung heat are strong enough to eliminate the root cause of inflammation without being too cold and damaging to the spleen and stomach. The herbs that resolve phlegm and promote bowel movement are strong enough to resolve phlegm and clear the intestines without excessively damaging the body's vital energy. The herbs that nourish yin and moisten dryness just offset the potential loss of body fluids caused by the heat-clearing and dampness-drying herbs. The formula is suitable for both cold and warm properties and combines attack and tonification. Compared to a wide range of proportions, it is more suitable for the pathological and physical characteristics of the target population, and has better suitability and safety for clinical application.

[0020] Under this formulation, the release ratio of the active ingredients of each raw material is adapted to the needs of intestinal microecological regulation. The content of active ingredients that inhibit pathogenic bacteria in Scutellaria baicalensis, Gardenia jasminoides, and Anemarrhena asphodeloides is moderate, which can specifically inhibit the growth and reproduction of pathogenic bacteria that proliferate excessively in the intestines of patients with acute exacerbations of chronic obstructive pulmonary disease and reduce the release of endotoxins. At the same time, the release of polysaccharides and dietary fiber prebiotics in Trichosanthes kirilowii, Ophiopogon japonicus, and Poria cocos is sufficient and moderate, which can provide sufficient nutrition for beneficial bacteria in the intestines, promote the colonization and proliferation of beneficial bacteria, and will not cause excessive proliferation or new structural disorders of the intestinal flora. It can more efficiently and steadily correct the intestinal flora structure disorder in patients, restore the balance of the intestinal microecology more quickly, and avoid the problems of insufficient antibacterial efficacy or excessive probiotic effect that may occur with non-optimal formulations.

[0021] Under this formulation, the adjustment range of the intestinal flora structure is adapted to the degree of metabolic disorder in patients. The content of anti-inflammatory metabolites produced after the proliferation of beneficial bacteria is sufficient to exert an anti-inflammatory effect. After the pathogenic bacteria are inhibited, the reduction in the production of pro-inflammatory metabolites is just right to match the need to correct metabolic disorders. At the same time, the release ratio of saponins and volatile active ingredients that regulate metabolic pathways in Platycodon grandiflorus and Citrus reticulata is appropriate, which can precisely regulate the host's inflammatory metabolism and energy metabolism pathways, promote the excretion of pro-inflammatory metabolic waste, and will not interfere with the normal metabolic homeostasis of the human body. It can more thoroughly break the vicious cycle of dysbiosis, metabolic disorder, and aggravation of airway inflammation, and the recovery efficiency of metabolic disorder is more stable.

[0022] This formulation achieves a higher efficiency in restoring homeostasis of gut microbiota and host metabolism. The concentration of anti-inflammatory metabolites after entering the lungs and systemic circulation through the gut-lung axis is just right to effectively downregulate the expression levels of pro-inflammatory factors in the whole body and airways, and the effect of reducing airway mucosal edema and sputum viscosity is more stable. At the same time, the content of lung-clearing and phlegm-resolving active ingredients in the formula is adapted to the needs of respiratory symptom improvement, and can directly act on the respiratory tract to relieve symptoms such as cough, wheezing, and yellow and sticky sputum. The content of bowel-clearing ingredients is just right to improve intestinal symptoms such as constipation, without causing adverse reactions such as diarrhea. While achieving gut-lung coordination and comprehensively improving the patient's clinical symptoms, the overall safety is higher and the efficacy is more stable.

[0023] In some embodiments, the Qingjin Huatan Decoction is any one of a decoction, granules, or concentrated pills.

[0024] In some embodiments, the Qingjin Huatan Decoction can be prepared as a decoction, granules, or concentrated pills. The preparation processes of these three dosage forms can completely preserve the active ingredients of each raw material in the formula, without disrupting the synergistic balance of clearing lung heat, resolving phlegm and promoting bowel movement, and strengthening the spleen and protecting body fluids formed by the proportion of each herb. It can stably exert the core efficacy of reshaping the intestinal flora structure, regulating host metabolic pathways, and downregulating the expression of pro-inflammatory factors. The decoction is suitable for the clinical intervention needs of standardized centralized preparation and immediate administration in medical institutions, while the granules and concentrated pills are suitable for the portability needs of patients who self-administer the medication outside the hospital and for long-term sequential treatment. Under the premise of ensuring stable and consistent efficacy, it covers the applicable populations with different medical scenarios and different medication habits, effectively improving the convenience of administration and patient medication compliance, and broadening the clinical application scope of the formula.

[0025] This specification also provides one or more embodiments of a method for preparing Qingjin Huatan Decoction. When Qingjin Huatan Decoction is a decoction, the preparation process includes the following steps: S1, mixing the raw materials and soaking them in water for 20-40 minutes to obtain a soaking mixture; S2, decocting the soaking mixture for 20-40 minutes and filtering it to obtain a first filtrate and a first dregs; S3, adding water to the first dregs and decocting it for 15-30 minutes and filtering it to obtain a second filtrate; S4, combining the first filtrate and the second filtrate and concentrating it to a decoction product containing 113-137g of raw herbs per dose.

[0026] In some embodiments, when the Qingjin Huatan Decoction is a decoction, the raw materials are first mixed and soaked in water for 20-40 minutes. This allows the dried herbs to fully absorb water and swell, preventing rapid gelatinization of the surface of the herbs during decoction and hindering the dissolution of internal active ingredients, thus ensuring the extraction efficiency of subsequent active ingredients. The soaked mixture is then decocted for 20-40 minutes and filtered to allow easily soluble active ingredients such as flavonoids and saponins to fully dissolve and obtain the first filtrate. The remaining dregs are then decocted in water for 15-30 minutes to further extract the insoluble alkaloids and polysaccharides from the herbs, avoiding waste of active ingredients. The two filtrates are combined and concentrated to each dose containing 113-137g of raw herbs. This ensures that the content of active ingredients in each decoction is completely matched with the formulation ratio, guaranteeing stable and consistent efficacy, and avoids increasing the burden on patients due to excessive concentration. This approach is suitable for the clinical application needs of centralized preparation and immediate administration in medical institutions.

[0027] In some embodiments, the total mass of raw medicinal materials contained in a unit preparation of Qingjin Huatan Decoction is 113-137 parts.

[0028] In some embodiments, the total mass of raw medicinal materials contained in a unit preparation of Qingjin Huatan Decoction is 113-137 parts. This range is an appropriate dosage range obtained by superimposing the mass part ranges of each raw material in the formula. This ensures that the proportion of each raw material in the unit preparation always conforms to the compatibility rules of the original formula, and there will be no deviation of the proportion of a single herb from the compatibility requirements. This ensures that the efficacy of the whole formula in clearing heat and resolving phlegm, purifying the lungs and regulating the intestines is stable and controllable. At the same time, this range matches the appropriate daily dosage for patients with phlegm-heat accumulation in the lungs during the acute exacerbation of chronic obstructive pulmonary disease. It will not lead to insufficient intervention due to too low a amount of raw medicinal materials, nor will it increase the metabolic burden on the patient's gastrointestinal tract due to too high a amount of raw medicinal materials. It can also be adapted to the preparation requirements of different dosage forms such as decoction, granules, and concentrated pills, which facilitates the precise control of clinical dosage and the large-scale quality control of the preparation.

[0029] In some embodiments, Qingjin Huatan Decoction further includes excipients, wherein the excipients are in the form of 1-30 parts by weight.

[0030] In some embodiments, Qingjin Huatan Decoction also adds 1-30 parts by weight of pharmaceutically acceptable excipients. This addition range is adapted to the total mass range of 113-137 parts of raw herbs in Qingjin Huatan Decoction. By adding excipients such as flavoring agents, binders, disintegrants, and suspending agents required for the corresponding dosage form, it can meet the needs of different dosage forms such as decoction, granules, and concentrated pills in terms of shaping, flavor adjustment, and stability control. It can also avoid the problems of diluting the effective components of raw herbs due to excessive excipient proportions or failing to meet the requirements of the formulation process due to excessively low proportions. It will not interfere with the compatibility ratio and efficacy of the raw materials in the original formula, ensuring the stability of the whole formula's effects of clearing heat and resolving phlegm, purifying the lungs and regulating the intestines. It can also improve the patient's compliance with the formulation and facilitate the large-scale production, storage and transportation of the formulation and the precise control of clinical dosage.

[0031] One or more embodiments of this specification also provide an application of Qingjin Huatan Decoction in regulating the serum inflammatory factor protein network of patients with phlegm-heat accumulation in the lungs in AECOPD. Any of the above-mentioned Qingjin Huatan Decoctions is used as an intervention drug and applied to patients with phlegm-heat accumulation in the lungs during the acute exacerbation of chronic obstructive pulmonary disease.

[0032] In some embodiments, when Qingjin Huatan Decoction is applied to patients with phlegm-heat accumulation in the lungs during acute exacerbations of chronic obstructive pulmonary disease (COPD) to regulate their serum inflammatory factor protein network, relying on the formula's combined effects of clearing heat and resolving phlegm, purifying the lungs and regulating the intestines, it can first reshape the patient's intestinal flora structure, increase the abundance of beneficial bacteria and reduce the abundance of pathogenic bacteria, then regulate the host's metabolic pathways, promote the synthesis of anti-inflammatory metabolites and inhibit the production of pro-inflammatory metabolites, and finally downregulate the expression level of pro-inflammatory factors and upregulate the expression level of anti-inflammatory factors in the serum, thereby regulating the serum inflammatory factor protein network, breaking the vicious cycle of "dysbiosis-metabolic disorder-airway inflammation". This not only conforms to the core theory of "the lung and large intestine are internally and externally related" in traditional Chinese medicine, but also matches the pathogenesis characteristics of phlegm-heat accumulation in the lungs and impaired lung function in this type of patient, and can simultaneously improve various clinical symptoms of concurrent intestinal and lung diseases, improving the accuracy and safety of intervention.

[0033] The method of the present invention will now be described in detail with reference to embodiments, comparative examples and experimental data.

[0034] Example 1 In this embodiment, the decoction of Qingjin Huatan Decoction was prepared. All the raw materials used were qualified medicinal materials that met the national standards for processing Chinese medicinal materials. The weighing amounts of each raw material were as follows: Scutellaria baicalensis 15g, Gardenia jasminoides 9g, Morus alba root bark 9g, Trichosanthes kirilowii 12g, Fritillaria thunbergii 9g, Ophiopogon japonicus 9g, Platycodon grandiflorus 15g, Anemarrhena asphodeloides 9g, Citrus reticulata peel 15g, Poria cocos 15g, and Glycyrrhiza uralensis 6g.

[0035] The preparation process of the decoction is carried out according to the following steps: S1. Mix all weighed raw materials evenly, add 8-10 times the amount of purified water, soak for 30 minutes to obtain a soaking mixture; S2. Transfer the soaking mixture to a decoction equipment that meets the medical decoction specifications, heat to a boil, and then maintain a simmer for 30 minutes. Filter with 4 layers of medical gauze to obtain the first filtrate and the first residue; S3. Add 6-8 times the amount of purified water to the first residue, heat to a boil, and then maintain a simmer for 20 minutes. Filter with 4 layers of medical gauze to obtain the second filtrate; S4. Combine the first filtrate and the second filtrate, concentrate under normal pressure to a decoction product containing 125g of raw herbs per dose, dispense and seal in 200mL portions per dose, store at 4℃, and heat to a suitable temperature before use.

[0036] The Qingjin Huatan Decoction prepared in this embodiment can be used to regulate the serum inflammatory factor protein network in patients with phlegm-heat accumulation in the lungs during acute exacerbations of chronic obstructive pulmonary disease (COPD). The applicable population is patients who meet the following inclusion criteria: age 45-75 years, duration of acute exacerbation ≤7 days, no use of antibiotics, probiotics, or systemic glucocorticoids in the past 30 days, and who meet both the Western medicine diagnostic criteria for acute exacerbations of COPD and the TCM diagnostic criteria for phlegm-heat accumulation in the lungs. They also have no serious primary diseases of the heart, liver, kidneys, or digestive system, no allergic reactions to the medicinal materials used in the formula, and are able to cooperate in completing the entire intervention process.

[0037] The medication is administered orally once daily, with each dose consisting of 125g of raw herbs. This means that each dose is a pre-packaged decoction, which can be taken twice daily, morning and evening. The treatment period is 7 days. During the treatment period, patients should avoid taking other traditional Chinese medicines, probiotics, and prebiotic preparations to prevent interference with the intervention effect.

[0038] The Qingjin Huatan Decoction regulates the serum inflammatory factor protein network through the following steps: S1, reshaping the patient's intestinal flora structure, increasing the abundance of beneficial bacteria and reducing the abundance of pathogenic bacteria; S2, regulating host metabolic pathways, promoting the synthesis of anti-inflammatory metabolites and inhibiting the production of pro-inflammatory metabolites; S3, downregulating the expression level of pro-inflammatory factors in serum and upregulating the expression level of anti-inflammatory factors in serum, thereby completing the regulation of the serum inflammatory factor protein network.

[0039] Example 2 In this embodiment, the decoction of Qingjin Huatan Decoction was prepared. All the raw materials used were qualified medicinal materials that met the national standards for processing Chinese medicinal materials. The weighing amounts of each raw material were as follows: Scutellaria baicalensis 15g, Gardenia jasminoides 9g, Morus alba root bark 9g, Trichosanthes kirilowii 12g, Fritillaria thunbergii 9g, Ophiopogon japonicus 9g, Platycodon grandiflorus 15g, Anemarrhena asphodeloides 9g, Citrus reticulata peel 15g, Poria cocos 15g, and Glycyrrhiza uralensis 6g.

[0040] The preparation process of the decoction is carried out according to the following steps: S1. Mix all the weighed raw materials evenly, add 9 times the amount of purified water, soak for 30 minutes to obtain a soaking mixture; S2. Transfer the soaking mixture to a decoction equipment that meets the medical decoction specifications, heat to a boil and then maintain a simmer for 30 minutes, filter with 4 layers of medical gauze to obtain the first filtrate and the first residue; S3. Add 7 times the amount of purified water to the first residue, heat to a boil and then maintain a simmer for 20 minutes, filter with 4 layers of medical gauze to obtain the second filtrate; S4. Combine the first filtrate and the second filtrate, concentrate under normal pressure to a decoction product containing 125g of raw herbs per dose, dispense and seal in 200mL per dose, store at 4℃, and heat to a suitable temperature before use.

[0041] The Qingjin Huatan Decoction prepared in this embodiment can be used to regulate the serum inflammatory factor protein network in patients with phlegm-heat accumulation in the lungs during acute exacerbations of chronic obstructive pulmonary disease (COPD). The applicable population is patients who meet the following inclusion criteria: age 45-75 years, duration of acute exacerbation ≤7 days, no use of antibiotics, probiotics, or systemic glucocorticoids in the past 30 days, and who meet both the Western medicine diagnostic criteria for acute exacerbations of COPD and the TCM diagnostic criteria for phlegm-heat accumulation in the lungs. They also have no serious primary diseases of the heart, liver, kidneys, or digestive system, no allergic reactions to the medicinal materials used in the formula, and are able to cooperate in completing the entire intervention process.

[0042] The medication is administered orally once daily, with each dose consisting of 125g of raw herbs. This means that each dose is a pre-packaged decoction, which can be taken twice daily, morning and evening. The treatment period is 7 days. During the treatment period, patients should avoid taking other traditional Chinese medicines, probiotics, and prebiotic preparations to prevent interference with the intervention effect.

[0043] The Qingjin Huatan Decoction regulates the serum inflammatory factor protein network through the following steps: S1, reshaping the patient's intestinal flora structure, increasing the abundance of beneficial bacteria and reducing the abundance of pathogenic bacteria; S2, regulating host metabolic pathways, promoting the synthesis of anti-inflammatory metabolites and inhibiting the production of pro-inflammatory metabolites; S3, downregulating the expression level of pro-inflammatory factors in serum and upregulating the expression level of anti-inflammatory factors in serum, thereby completing the regulation of the serum inflammatory factor protein network.

[0044] Example 3 In this embodiment, the decoction of Qingjin Huatan Decoction was prepared. All the raw materials used were qualified medicinal materials that met the national standards for processing Chinese medicinal materials. The weighing amounts of each raw material were as follows: Scutellaria baicalensis 15g, Gardenia jasminoides 9g, Morus alba root bark 9g, Trichosanthes kirilowii 12g, Fritillaria thunbergii 9g, Ophiopogon japonicus 9g, Platycodon grandiflorus 15g, Anemarrhena asphodeloides 9g, Citrus reticulata peel 15g, Poria cocos 15g, and Glycyrrhiza uralensis 6g.

[0045] The preparation process of the decoction is carried out according to the following steps: S1. Mix all weighed raw materials evenly, add 10 times the amount of purified water, soak for 30 minutes to obtain a soaking mixture; S2. Transfer the soaking mixture to a decoction equipment that meets the medical decoction specifications, heat to a boil, and then maintain a simmer for 30 minutes. Filter with 4 layers of medical gauze to obtain the first filtrate and the first residue; S3. Add 8 times the amount of purified water to the first residue, heat to a boil, and then maintain a simmer for 20 minutes. Filter with 4 layers of medical gauze to obtain the second filtrate; S4. Combine the first filtrate and the second filtrate, concentrate under normal pressure to a decoction product containing 125g of raw herbs per dose, dispense and seal in 200mL portions per dose, store at 4℃, and heat to a suitable temperature before use.

[0046] The Qingjin Huatan Decoction prepared in this embodiment can be used to regulate the serum inflammatory factor protein network in patients with phlegm-heat accumulation in the lungs during acute exacerbations of chronic obstructive pulmonary disease (COPD). The applicable population is patients who meet the following inclusion criteria: age 45-75 years, duration of acute exacerbation ≤7 days, no use of antibiotics, probiotics, or systemic glucocorticoids in the past 30 days, and who meet both the Western medicine diagnostic criteria for acute exacerbations of COPD and the TCM diagnostic criteria for phlegm-heat accumulation in the lungs. They also have no serious primary diseases of the heart, liver, kidneys, or digestive system, no allergic reactions to the medicinal materials used in the formula, and are able to cooperate in completing the entire intervention process.

[0047] The medication is administered orally once daily, with each dose consisting of 125g of raw herbs. This means that each dose is a pre-packaged decoction, which can be taken twice daily, morning and evening. The treatment period is 7 days. During the treatment period, patients should avoid taking other traditional Chinese medicines, probiotics, and prebiotic preparations to prevent interference with the intervention effect.

[0048] The Qingjin Huatan Decoction regulates the serum inflammatory factor protein network through the following steps: S1, reshaping the patient's intestinal flora structure, increasing the abundance of beneficial bacteria and reducing the abundance of pathogenic bacteria; S2, regulating host metabolic pathways, promoting the synthesis of anti-inflammatory metabolites and inhibiting the production of pro-inflammatory metabolites; S3, downregulating the expression level of pro-inflammatory factors in serum and upregulating the expression level of anti-inflammatory factors in serum, thereby completing the regulation of the serum inflammatory factor protein network.

[0049] Comparative Example 1 This comparative example provides a decoction of Qingjin Huatan Decoction, which differs from Example 1 in that: the amount of Scutellaria baicalensis in the raw materials is 22g, while the amount of other raw materials, preparation process, and administration regimen are completely consistent with Example 1.

[0050] Comparative Example 2 This comparative example provides a decoction of Qingjin Huatan Decoction, which differs from Example 1 in that: Trichosanthes kirilowii is not added to the raw materials, while the weighing, preparation process, and administration regimen of the other raw materials are completely consistent with Example 1.

[0051] Comparative Example 3 This comparative example provides a decoction of Qingjin Huatan Decoction, which differs from Example 1 in that: in preparation step S1, the time for soaking the raw materials in purified water after mixing is 10 minutes. The remaining preparation steps, raw material ratios, and administration methods are completely consistent with Example 1.

[0052] Comparative Example 4 This comparative example provides a decoction of Qingjin Huatan Decoction, which differs from Example 1 in that step S3 is omitted in the preparation process. It is not necessary to add water to the first dregs to decoct and prepare the second filtrate. Instead, the first filtrate obtained in step S2 is directly concentrated at normal pressure to a decoction product containing 125g of raw herbs per dose. The remaining raw material ratios, preparation parameters, and administration methods are completely consistent with Example 1.

[0053] Comparative Example 5 This comparative example provides a decoction of Qingjin Huatan Decoction, which differs from Example 1 in that: in preparation step S4, the filtrates are combined and concentrated under normal pressure to a decoction containing 100g of raw herbs per dose. The remaining preparation steps, raw material ratios, and administration regimens are completely consistent with Example 1.

[0054] Comparative Example 6 This comparative example provides a decoction of Qingjin Huatan Decoction, which differs from Example 1 in that the continuous dosing cycle is 7 days, while the other raw material ratios, preparation process, dosing method, and single dose are completely consistent with Example 1.

[0055] Comparative Example 7 This comparative example provides a decoction of Qingjin Huatan Decoction, which differs from Example 1 in that the subjects administered the decoction were patients with phlegm-heat accumulation in the lungs during the acute exacerbation of chronic obstructive pulmonary disease who had used systemic glucocorticoids in the past 30 days. The inclusion criteria, raw material ratios, preparation process, and administration regimens for the remaining patients were completely consistent with those of Example 1.

[0056] The products corresponding to the above embodiments and comparative examples were tested using the following methods: Traditional Chinese Medicine (TCM) syndrome score: A quantitative score was assigned to symptoms such as cough, sputum production, chest tightness, and dry mouth related to the phlegm-heat accumulation in the lungs syndrome during acute exacerbations of chronic obstructive pulmonary disease (COPD). This score can be obtained through a clinical physician's face-to-face assessment and requires no sophisticated instruments. Clinical treatment effectiveness rate: The efficacy level was determined based on the degree of improvement in the TCM syndrome score, and the proportion of effective cases to the total number of subjects was calculated. This calculation is simple and requires no instruments. Adverse reaction incidence rate: The occurrence of adverse reactions such as rash, gastrointestinal discomfort, and dizziness during the treatment period was recorded, and the incidence rate was calculated. This can be obtained directly through observation and inquiry. Core symptom relief time: The number of days after significant relief of core discomfort symptoms such as cough, sputum production, and chest tightness was recorded. This requires no testing instruments and is easy to statistically analyze.

[0057] The products corresponding to the above embodiments and comparative examples were tested using the following methods: Traditional Chinese Medicine Syndrome Score: This score quantifies symptoms such as cough, sputum production, chest tightness, and dry mouth associated with the phlegm-heat accumulation in the lungs syndrome during acute exacerbations of chronic obstructive pulmonary disease. Clinical treatment effectiveness rate: The efficacy level is determined based on the degree of improvement in TCM syndrome scores; Adverse reaction incidence: Record the occurrence of adverse reactions such as rash, gastrointestinal discomfort, and dizziness during the dosing period and calculate the incidence rate; Time to relief of core symptoms: Record the number of days that the patient’s core discomfort symptoms such as cough, sputum, and chest tightness are significantly relieved.

[0058] Table 1 Test Results

[0059] Analysis of Experimental Results Example 1 uses a defined ratio of raw materials and a decoction process to prepare Qingjin Huatan Decoction. After intervention with a predetermined dosing regimen for patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) and phlegm-heat accumulation in the lungs who meet the specified inclusion criteria, the TCM syndrome score decreased to 4.2 points, the clinical treatment effectiveness rate reached 92.5%, the incidence of adverse reactions was only 2.5%, the core symptom relief time was 5.2 days, and the overall intervention effect was excellent.

[0060] Example 2 used the same raw material ratio and administration regimen as Example 1, only adjusting the amount of water added during the first decoction to 9 times and the amount of water added during the second decoction to 7 times. After the intervention, the TCM syndrome score dropped to 4.0 points, the clinical treatment effectiveness rate reached 95.0%, the incidence of adverse reactions was 2.5%, and the time to relief of core symptoms was 5.0 days. All indicators were better than those in Example 1, indicating that the preparation with the added water parameters had a better intervention effect.

[0061] Example 3 used the same raw material ratio and administration regimen as Example 1, only adjusting the amount of water added during the first decoction to 10 times and the amount of water added during the second decoction to 8 times. After the intervention, the TCM syndrome score dropped to 4.1 points, the clinical treatment effectiveness rate reached 93.8%, the incidence of adverse reactions was 2.5%, and the core symptom relief time was 5.1 days. The performance of each indicator was slightly better than that of Example 1 and was also at an excellent level.

[0062] The only difference between Comparative Example 1 and Example 1 was that the amount of Scutellaria baicalensis in the raw material was adjusted to 22g, while all other conditions were exactly the same. After intervention, the TCM syndrome score was 7.8, the clinical treatment effectiveness rate was 77.5%, the incidence of adverse reactions increased to 5.0%, and the time to relief of core symptoms was 7.6 days. All indicators were significantly worse than those in Example 1, indicating that deviation from the specified range of Scutellaria baicalensis dosage will significantly reduce the intervention effect of the preparation and increase the risk of adverse reactions.

[0063] The only difference between Comparative Example 2 and Example 1 is that Trichosanthes kirilowii was not added to the raw materials. All other conditions were exactly the same. After the intervention, the TCM syndrome score was 10.3 points, the clinical treatment effectiveness rate was only 62.5%, the incidence of adverse reactions was 2.5%, and the time to relief of core symptoms was 9.2 days. The intervention effect was significantly lower than that of Example 1, indicating that Trichosanthes kirilowii is a key ingredient in the formula to ensure the intervention effect and cannot be omitted.

[0064] The only difference between Comparative Example 3 and Example 1 is that the soaking time of the raw material in the preparation step was shortened to 10 minutes. All other conditions were completely the same. After the intervention, the TCM syndrome score was 8.5 points, the clinical treatment effectiveness rate was 72.5%, the adverse reaction rate was 2.5%, and the core symptom relief time was 8.1 days. The intervention effect was significantly worse than that of Example 1, indicating that sufficient soaking time is a necessary condition to ensure the full dissolution of the effective components of the medicinal materials and improve the intervention effect of the preparation.

[0065] The only difference between Comparative Example 4 and Example 1 is that the second decoction step was omitted in the preparation process, and the first filtrate was directly concentrated to obtain the preparation. All other conditions were completely the same. After the intervention, the TCM syndrome score was 9.1 points, the clinical treatment effectiveness rate was 67.5%, the adverse reaction rate was 2.5%, and the core symptom relief time was 8.7 days. The intervention effect was significantly lower than that of Example 1, indicating that the second decoction step can fully extract the effective components remaining in the dregs, which is crucial to ensuring the intervention effect of the preparation.

[0066] The only difference between Comparative Example 5 and Example 1 is that the filtrates were combined and concentrated to contain 100g of raw medicinal material per dose during the preparation process. All other conditions were exactly the same. After the intervention, the TCM syndrome score was 8.9, the clinical treatment effectiveness rate was 70.0%, the adverse reaction rate was 2.5%, and the core symptom relief time was 8.4 days. The intervention effect was significantly worse than that of Example 1, indicating that the dosage corresponding to the limited raw medicinal material content per dose is the key parameter to ensure the intervention effect. Too low a dosage of raw medicinal material cannot achieve the ideal intervention effect.

[0067] The only difference between Comparative Example 6 and Example 1 is that the continuous dosing period was shortened to 7 days. All other conditions were completely the same. After the intervention, the TCM syndrome score was 7.4 points, the clinical treatment effectiveness rate was 75.0%, the incidence of adverse reactions was 2.5%, and the core symptom relief time was 7.2 days. The intervention effect was inferior to that of Example 1, indicating that a sufficient dosing period is a necessary condition to ensure that the preparation can fully exert its intervention effect. If the dosing period is too short, the ideal therapeutic effect cannot be achieved.

[0068] The only difference between Comparative Example 7 and Example 1 was that the subjects were patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) and phlegm-heat accumulation in the lungs who had used systemic glucocorticoids within the past 30 days. All other conditions were identical. After the intervention, the TCM syndrome score was 11.2 points, the clinical treatment effectiveness rate was only 57.5%, the incidence of adverse reactions increased to 7.5%, and the time to relief of core symptoms was 10.3 days. The intervention effect was significantly lower than that of Example 1, and the risk of adverse reactions was significantly increased. This indicates that patients who have used systemic glucocorticoids within the past 30 days will significantly interfere with the intervention effect of the preparation and increase the medication safety risk.

[0069] In summary, intervention with patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) exhibiting phlegm-heat accumulation in the lungs, meeting the specified inclusion criteria, using a limited formula and dosage, preparation process, and administration regimen, can achieve excellent therapeutic effects, effectively reduce the risk of adverse reactions, and shorten the remission time of core symptoms; the formula and dosage of the prescribed herbs and dosages, preparation process, and administration regimen can achieve excellent therapeutic effects, effectively reduce the risk of adverse reactions, and shorten the remission time of core symptoms; Dosage, soaking time of medicinal materials, second decoction steps, content of raw medicinal materials per dose, dosing cycle, and inclusion criteria of the subject population are all key factors affecting the intervention effect. Any deviation from the limit range will lead to a decrease in the intervention effect, and deviation of some parameters will also increase the risk of adverse reactions.

[0070] The applicant declares that the detailed process flow of this invention is illustrated by the above embodiments, but this invention is not limited to the above detailed process flow, that is, it does not mean that this invention must rely on the above detailed process flow to be implemented. Those skilled in the art should understand that any improvements to this invention, equivalent substitutions of raw materials for the product of this invention, addition of auxiliary components, and selection of specific methods, etc., all fall within the protection scope and disclosure scope of this invention.

Claims

1. Qingjin Huatan Decoction, characterized in that, It is composed of the following raw materials in parts by weight: Scutellaria baicalensis 10-20 parts, Gardenia jasminoides 6-12 parts, Morus alba root bark 6-12 parts, Trichosanthes kirilowii 10-14 parts, Fritillaria thunbergii 6-12 parts, Ophiopogon japonicus 6-12 parts, Platycodon grandiflorus 10-20 parts, Anemarrhena asphodeloides 6-12 parts, Citrus reticulata peel 10-20 parts, Poria cocos 10-20 parts, and Glycyrrhiza uralensis (processed) 4-8 parts.

2. The Qingjin Huatan Tang according to claim 1, characterized in that, The raw materials are in the following proportions by weight: Scutellaria baicalensis 15 parts, Gardenia jasminoides 9 parts, Morus alba root bark 9 parts, Trichosanthes kirilowii 12 parts, Fritillaria thunbergii 9 parts, Ophiopogon japonicus 9 parts, Platycodon grandiflorus 15 parts, Anemarrhena asphodeloides 9 parts, Citrus reticulata peel 15 parts, Poria cocos 15 parts, and Glycyrrhiza uralensis (processed) 6 parts.

3. The Qingjin Huatan Tang according to claim 1, characterized in that, The Qingjin Huatan Decoction can be any one of the following: decoction, granules, or concentrated pills.

4. A method for preparing Qingjin Huatan Tang, characterized in that, When the Qingjin Huatan Decoction is a decoction, the preparation process includes the following steps: S1. Mix the raw materials and soak them in water for 20-40 minutes to obtain a soaking mixture; S2. After decocting the soaking mixture for 20-40 minutes, filter to obtain the first filtrate and the first dregs. S3. Add water to the first dregs and boil for 15-30 minutes, then filter to obtain the second filtrate. S4. Combine the first and second filtrates and concentrate them into a decoction containing 113-137g of raw herbs per dose.

5. The Qingjin Huatan Tang of claim 1, wherein, The total mass of raw medicinal materials contained in a unit preparation of the Qingjin Huatan Decoction is 113-137 parts.

6. The Qingjin Huatan Tang of claim 1, wherein, It also includes excipients, wherein the excipients are present in parts by weight of 1-30 parts.

7. An application of the Qingjin Huatan Decoction according to any one of claims 1 to 3 to regulate the serum inflammatory factor protein network in patients with AECOPD phlegm-heat accumulation in the lungs.

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