A pharmafood composition and its use in the preparation of a medicament or food for improving chronic pulmonary disease

Abstract

This invention discloses a medicinal and edible homologous composition and its application in the preparation of drugs or foods for improving chronic lung diseases, belonging to the field of pharmaceutical technology. The medicinal and edible homologous composition of this invention uses donkey-hide gelatin and astragalus as the principal ingredient, apricot kernel and burdock seed as the assistant ingredient, loquat leaf as the adjuvant ingredient, and platycodon and licorice as the auxiliary and guiding ingredients. Through the use of volatile oil extraction and re-addition techniques, as well as the separate "melting" of donkey-hide gelatin, the heat-sensitive volatile oil components in the raw medicinal materials are preserved, and a networked regulatory mode of "synthesis promotion-degradation inhibition-signal enhancement" is constructed, achieving deep activation of the cAMP pathway. The medicinal and edible homologous composition has pharmacological activities that improve lung function and inhibit airway inflammation. The activity is significantly superior to that of donkey-hide gelatin, roflumilast, and hormones used alone; the medicinal and edible homologous composition exhibits excellent synergistic effects in the treatment of COPD and asthma, and has improving and therapeutic effects on chronic lung diseases induced by inflammation, bronchoconstriction, and mucus secretion, and can delay the progression of COPD and asthma, providing a new approach and direction for the preparation of drugs or foods that improve chronic lung diseases; this invention can provide core technical support for the secondary development of traditional Chinese medicine compound prescriptions and the creation of new drugs, thereby effectively promoting the modernization of traditional Chinese medicine.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to a food-medicine homology composition and its application in the preparation of drugs or foods that improve chronic lung diseases. Background Technology

[0002] Chronic lung diseases are common and prevalent diseases that seriously threaten public health. Among them, chronic obstructive pulmonary disease (COPD) and bronchial asthma are the most common clinical types. Both are characterized by respiratory system dysfunction, significantly affecting patients' quality of life and even endangering their lives. COPD mainly affects the trachea, bronchi, lungs, and pleural cavity, and is characterized by airflow limitation. It includes pathological states such as chronic bronchitis and emphysema with airflow obstruction. Disease progression can lead to dyspnea, and in severe cases, death due to respiratory failure. Bronchial asthma, on the other hand, is characterized by chronic airway inflammation, airway hyperresponsiveness, and reversible airflow limitation. Clinical manifestations include recurrent episodes of wheezing, shortness of breath, chest tightness, and cough. Severe attacks can directly endanger life. From a pathological perspective, both diseases are closely related to abnormal infiltration or activation of immune cells: COPD is characterized by chronic inflammation of the airways and lung parenchyma, accompanied by infiltration of neutrophils, monocytes and lymphocytes in multiple regions of the lungs; asthma involves the abnormal activation and interaction of various immune cells such as eosinophils, mast cells and T lymphocytes, and its pathological mechanism is complex and not yet fully understood.

[0003] The high incidence and mortality rates of two types of chronic lung diseases constitute a major global public health challenge. Chronic obstructive pulmonary disease (COPD) is particularly harmful, while bronchial asthma shows a continuously increasing global prevalence, placing a heavy burden on patient populations and social healthcare systems worldwide. With the increasing aging population and environmental factors, the number of people affected by these two diseases continues to expand, and their negative impacts on individual health, family well-being, and socio-economic development are becoming increasingly prominent, making them urgent public health challenges that need to be addressed.

[0004] Current clinical treatments for chronic lung diseases still have significant limitations, making complete cure difficult and carrying high risks with long-term medication. For chronic obstructive pulmonary disease (COPD), clinical treatment primarily relies on Western medicine, mainly using bronchodilators such as theophylline, β2-receptor agonists, and anticholinergic drugs, supplemented by symptomatic supportive care including oxygen therapy, antibiotics, glucocorticoids, and mechanical ventilation. However, these therapies have significant drawbacks: long-term antibiotic use easily induces drug-resistant strains and may cause various toxic side effects; high-level antibiotics for patients with recurrent infections are expensive, further increasing the financial burden on patients; and long-term use of glucocorticoids is accompanied by severe systemic side effects, damaging the patient's overall health. For bronchial asthma, the first-line clinical treatment is glucocorticoids combined with long-acting β2-receptor agonists, but long-term use can also cause adverse reactions, and some patients experience insufficient efficacy or drug resistance, making it difficult to effectively control recurrent attacks.

[0005] In summary, chronic lung diseases have a persistently high incidence rate and cause far-reaching harm. However, existing treatments have many limitations, including limited efficacy, high safety risks, and heavy economic burdens, failing to meet clinical needs. Therefore, developing safe and effective new treatment strategies to overcome existing treatment bottlenecks, improve patient prognosis, and enhance quality of life has become an urgent need in the global healthcare field, possessing significant clinical value and social significance.

[0006] Against this backdrop, natural products and traditional Chinese medicine formulas, adhering to the concept of "medicine and food sharing the same origin," have shown unique potential and broad prospects in the prevention and treatment of respiratory diseases due to their high safety, wide range of effects, and good long-term tolerability. Formulas based on this concept not only possess multiple biological activities such as anti-inflammatory, immunomodulatory, and antioxidant effects, but also regulate complex disease networks through multi-target synergistic effects, providing innovative ideas for developing intervention programs that combine therapeutic and health-preserving functions.

[0007] Traditional Chinese medicine believes that lung qi deficiency is the fundamental pathogenesis of lung-related diseases. Prolonged illness depletes vital energy, leading to lung and kidney qi deficiency, which in turn causes the lung to lose its regulatory function and the kidney to lose its ability to store fluids. Without sufficient qi to propel blood, blood stasis occurs due to irregular blood circulation; abnormal fluid metabolism leads to the accumulation of phlegm. Ultimately, this results in a complex pathological state where blood stasis, phlegm, and fluid retention intertwine and cause disease. Based on the principle of "suppressing cough and moistening the lungs" in syndrome differentiation and treatment, this invention establishes a treatment strategy primarily focused on tonifying the qi of the lungs, spleen, and kidneys. The donkey-hide gelatin compound preparation developed using this strategy precisely targets the above-mentioned pathogenesis and has shown definite efficacy in treating COPD, asthma, and other lung-related diseases.

[0008] Traditional Chinese medicine research, based on the principles of TCM syndrome differentiation, primarily relies on the extraction and separation of effective components or monomeric compounds, as well as pharmacological and clinical validation. However, due to the diversity of chemical components in TCM compound formulas and the complexity of their pharmacodynamic material basis, their specific therapeutic mechanisms have long remained largely unexplained.

[0009] Existing research confirms that dysregulation of the cAMP signaling pathway is a core driver of the progression of COPD and asthma. In healthy organisms, the cAMP-PKA signaling axis maintains airway diastole and immune homeostasis. However, in COPD and asthma patients, downregulation of β2 receptor function and overexpression of PDE4 disrupt cAMP metabolic balance, leading to decreased cAMP concentration levels. This molecular-level defect manifests at the tissue and organ level as persistent airflow limitation, uncontrolled airway inflammation, and increased mucus secretion. Furthermore, low cAMP levels further exacerbate airway remodeling and oxidative damage. Based on these mechanisms, restoring or increasing intracellular cAMP concentration has been identified as an important approach for etiological treatment of chronic lung diseases.

[0010] However, despite the potential of Traditional Chinese Medicine (TCM) in treating chronic lung diseases, the modernization of traditional formulas faces severe technical bottlenecks. Their mechanisms of action are unclear, and their effects remain unproven. Traditional formulas are mostly based on empirical treatment, and the principles of "principal, assistant, adjuvant, and guide" in their formulation lack modern molecular biological evidence. The pathways through which they exert their effects and whether there is synergistic synergy among their components are still unclear. This leads to difficulties in quality control and reproducibility of therapeutic effects, hindering true modernization. Therefore, there is an urgent need in this field for a technological solution that can address the shortcomings of traditional formulas, elucidate their synergistic mechanisms, and, based on this, provide an improved approach with superior efficacy compared to existing technologies. Summary of the Invention

[0011] Based on the above-mentioned technical requirements, the purpose of this invention is to provide a medicinal and edible homology composition and its application in the preparation of drugs or foods for improving chronic lung diseases. The medicinal and edible homology composition of this invention uses donkey-hide gelatin and astragalus as the principal drug, apricot kernel and burdock seed as the assistant drug, loquat leaf as the adjuvant drug, and platycodon and licorice as the active and auxiliary drugs. By employing volatile oil extraction and re-addition technology, as well as the separate "melting" of donkey-hide gelatin, the heat-sensitive volatile oil components in the raw materials are preserved, and a networked regulatory mode of "synthesis promotion-degradation inhibition-signal enhancement" is constructed, achieving deep activation of the cAMP pathway. The medicinal and edible homology composition shows excellent synergistic effects in the treatment of COPD and asthma and has promotional value.

[0012] While existing technologies disclose the use of single or partial combinations of ingredients such as donkey-hide gelatin, almonds, burdock seeds, loquat leaves, platycodon, astragalus, and licorice for the treatment of cough, asthma, and lung deficiency, there is no complete technical solution for combining donkey-hide gelatin, burdock seeds, licorice, loquat leaves, almonds, platycodon, and astragalus according to the weight range and compatibility relationships shown in this invention. By reorganizing the efficacy, properties, and compatibility of each herb, a novel traditional Chinese medicine composition is formed that nourishes Qi and Yin, clears the lungs and resolves phlegm, promotes the downward flow of lung Qi, and relieves cough and asthma. Donkey-hide gelatin nourishes Yin and moistens the lungs, nourishes blood and moistens dryness, targeting the pathogenesis of lung Yin deficiency; Astragalus membranaceus invigorates Qi and strengthens the spleen, tonifies the lungs and consolidates the exterior, embodying the principle of simultaneously tonifying Qi and Yin and nourishing the earth to generate metal; Burdock seed clears and disperses lung heat, resolves phlegm and soothes the throat; Loquat leaf clears the lungs and lowers Qi, harmonizes the stomach and stops vomiting; Apricot kernel descends lung Qi, stops cough and relieves asthma; Platycodon grandiflorus promotes lung function and soothes the throat, carrying the medicine upwards, collectively achieving the effects of clearing, dispersing, descending, resolving phlegm and stopping cough; Licorice root invigorates Qi, tonifies the middle Jiao, clears heat and detoxifies, and harmonizes the other herbs. The entire formula tonifies without stagnation, clears without being cold, promotes and descends in a complementary manner, and addresses both Qi and Yin, with a clear compatibility strategy and a rigorous formulation structure.

[0013] Existing prescriptions for treating cough and asthma mostly focus on nourishing yin and moistening the lungs, clearing the lungs and resolving phlegm, or simply tonifying qi and consolidating the exterior. Few organically integrate tonifying qi, nourishing yin, promoting lung function, reducing lung heat, and clearing phlegm and heat. This invention combines the qi-tonifying and exterior-consolidating properties of Astragalus membranaceus with the yin-nourishing and lung-moistening properties of donkey-hide gelatin to achieve dual tonification of qi and yin. Simultaneously, it incorporates herbs that promote lung function, reduce phlegm, and resolve phlegm, thus tonifying the body's vital energy, clearing pathogenic heat, resolving phlegm, and restoring normal lung function. This provides a more comprehensive, gentle, and lasting therapeutic effect on chronic cough, asthma, thick phlegm, sore throat, shortness of breath, and fatigue caused by deficiency of both qi and yin in the lungs, internal accumulation of phlegm and heat, and impaired lung function. The therapeutic effects are synergistic and the advantages are significant.

[0014] The ingredients in this invention are all commonly used, low-toxicity, and safe traditional Chinese medicines. They do not contain toxic herbs such as aristolochic acid. The combination is mild and does not harm the body's vital energy or the spleen and stomach. It is suitable for people with chronic cough, weak constitution, elderly people, and those with recurrent respiratory discomfort. This expands the clinically applicable population and improves the safety and practicality of the medication.

[0015] To achieve the above-mentioned objectives, the present invention employs the following technical solution:

[0016] This invention provides a food-medicine composition comprising, by weight, 5-20 parts of donkey-hide gelatin, 5-20 parts of burdock seed, 1-10 parts of licorice root, 5-15 parts of loquat leaf, 5-15 parts of apricot kernel, 1-10 parts of platycodon root, and 10-20 parts of astragalus root.

[0017] Furthermore, the formula for the food-medicine homology composition described in this invention is as follows: The principal ingredient is donkey-hide gelatin plus astragalus root; The donkey-hide gelatin mentioned above is sweet, neutral, and moistening, directly entering the lung meridian to nourish yin and moisten dryness, nourish blood and stop bleeding, targeting the root cause of lung yin deficiency; Astragalus is sweet and warm, and greatly tonifies the Qi of the spleen and lungs. It strengthens Qi, consolidates the exterior, strengthens the Wei Qi, and stops sweating. When the lung Qi is deficient, the Wei Qi is not consolidated, making it easy to be infected by external pathogens and induce asthma. When the Zong Qi is weak, breathing becomes weak and shortness of breath worsens. Astragalus can not only tonify lung Qi to relieve asthma, but also strengthen the exterior of the body and reduce recurrence. The combination of donkey-hide gelatin and astragalus: When the two are combined, astragalus invigorates qi and generates yin, while donkey-hide gelatin nourishes yin and replenishes qi. Together, they work to invigorate qi and nourish yin, strengthen the body's resistance and consolidate the foundation. This combination is especially suitable for those with long-term asthma who have depleted qi and yin, and who have symptoms such as weak cough and wheezing, shortness of breath and reluctance to speak, spontaneous sweating and aversion to wind, and dry mouth and throat.

[0018] The accompanying medicine: apricot kernels plus burdock seeds; The almond described: bitter, it lowers lung qi, stops cough and relieves asthma, and also moistens the intestines and promotes bowel movement, guiding lung heat downward; The burdock seed described is pungent and bitter, and its cold nature can clear heat, soothe the throat, and resolve phlegm and nodules; its slippery nature helps to expel sticky phlegm. The combination of almonds and burdock seeds: one mainly lowers qi, and the other mainly clears heat and resolves phlegm, together solving the problems of lung qi rising upward and phlegm and heat obstructing the lungs; Medicinal ingredient: Loquat leaf; The adjuvant herbs are: Platycodon grandiflorus and Glycyrrhiza uralensis; Platycodon grandiflorus: bitter, pungent and neutral, enters the lung meridian, and has three functions: (1) promote lung qi and relieve sore throat: open up lung qi and disperse pathogenic qi. For asthma patients with sore throat and phlegm retention, it has the effect of "lifting the lid of the pot" to facilitate expectoration; (2) carry medicine upward: as a "boat", it guides the power of various medicines to the chest and lungs, so that the medicinal power is concentrated in the disease area; (3) when paired with apricot kernel: one promotes and the other descends, restoring the lung's function of promoting and descending, which is a classic drug pair for regulating the lung qi mechanism. The licorice root has the following effects: it invigorates qi and strengthens the middle jiao (spleen and stomach), assisting astragalus in nourishing the earth element and generating metal (metal); it also relieves phlegm and stops coughs, as licorice root itself has the function of relieving coughs and relieving phlegm. Harmonizing the herbs: It moderates the extreme properties of the herbs (especially the warming properties of Astragalus membranaceus and the cold properties of Arctium lappa and Eriobotrya japonica), making the overall prescription more balanced. Eriobotrya japonica is bitter and slightly cold, enters the lung and stomach meridians, and is good at clearing the lungs and relieving cough, as well as suppressing nausea and vomiting.

[0019] Furthermore, the preparation of the medicinal and edible homology composition includes the following steps: (1) Mix burdock seed, apricot kernel, loquat leaf, licorice, platycodon root and astragalus root and decoct with water, collect the volatile components to obtain volatile oil; (2) The decoction after the first decoction is decocted 1 to 3 times, the decoction is collected and mixed to obtain a medicinal liquid, the medicinal liquid is filtered and concentrated to obtain an extract; (3) Place the donkey-hide gelatin in a container, add rice wine or water, heat it in a water bath or steam it to dissolve it, and obtain a melted donkey-hide gelatin liquid; (4) Mix the extract, the melted donkey-hide gelatin solution and the volatile oil evenly to obtain a food-medicine homology composition.

[0020] Furthermore, the weight of the water is 6 to 10 times the total weight of burdock seed, almond, loquat leaf, licorice, platycodon and astragalus, and the total decoction time is 1 to 3 hours.

[0021] Furthermore, during the preparation of the medicinal and edible composition, pharmaceutically and food-acceptable excipients are added, including one or more of the following: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and matrices.

[0022] Furthermore, the filler includes one or more of starch, pregelatinized starch, lactose, mannitol, chitosan, microcrystalline cellulose, and sucrose.

[0023] Furthermore, the disintegrant includes one or more of starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, croscarmellose, low-substituted hydroxypropyl cellulose, and croscarmellose sodium.

[0024] Furthermore, the lubricant includes one or more of magnesium stearate, sodium dodecyl sulfate, talc, and silica.

[0025] Furthermore, the suspending agent includes one or more of the following: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, and hydroxypropyl methylcellulose.

[0026] Furthermore, the adhesive comprises one or more of starch paste, polyvinylpyrrolidone, and hydroxypropyl methylcellulose.

[0027] The present invention also provides the application of the aforementioned food-medicine homology composition in the preparation of drugs or foods that improve chronic lung diseases.

[0028] Furthermore, the chronic lung diseases include chronic obstructive pulmonary disease and / or bronchial asthma.

[0029] Furthermore, the symptoms of the chronic lung disease include at least one of decreased lung function, airway inflammation, bronchitis, excessive sputum and cough, granulocytosis, and hypermucus secretion.

[0030] Furthermore, the medicinal and edible homology composition can regulate the cAMP signaling pathway to exert its function.

[0031] Furthermore, the medicinal and edible composition can effectively enhance lung function in COPD animal models, reduce the number of neutrophils in the alveoli, reduce mucus secretion in the trachea, inhibit the secretion of inflammatory factors in bronchoalveolar lavage fluid, promote the release of intracellular signaling molecule cAMP, and increase the activity of PKA kinase.

[0032] Furthermore, using a mouse disease model, this invention first verified the synergistic function of donkey-hide gelatin with other components, and further verified that the medicinal and edible homology composition is superior to donkey-hide gelatin alone, significantly reducing the serum IgE content and the content of inflammatory factors such as IL-4, 5, 6, and 1β in bronchoalveolar lavage fluid in asthma animal models, as well as the number of leukocytes, eosinophils, and lymphocytes in the airway; at the same time, the medicinal and edible homology composition can alleviate airway constriction in mice, effectively inhibit airway hyperresponsiveness, and significantly reduce inflammatory cell aggregation, goblet cell hyperplasia, and excessive mucus secretion.

[0033] Furthermore, the components of the medicinal and edible composition include, by weight, 10 parts of donkey-hide gelatin, 10 parts of burdock seed, 6 parts of licorice, 9 parts of loquat leaf, 10 parts of apricot kernel, 6 parts of platycodon root, and 15 parts of astragalus root.

[0034] Furthermore, based on body weight, the drug or food for improving chronic lung disease contains a medicinal and edible composition at a mass content of 0.1~10g / kg.

[0035] Furthermore, based on body weight, the drug or food for improving chronic lung disease contains a medicinal and edible composition at a mass content of 0.1~2g / kg.

[0036] Furthermore, based on body weight, the drug or food for improving chronic lung disease contains a medicinal and edible composition at a mass content of 8-9 g / kg.

[0037] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0038] 1. The food-medicine homology composition provided by this invention, through specific formulation, exhibits excellent synergistic effects in the treatment of COPD and asthma. This food-medicine homology composition significantly reduces inflammation-related pathological indicators, effectively reduces the inflammatory area in lung tissue, protects the morphology and function of the lungs, improves and treats inflammation-induced chronic lung diseases, and has a significant effect on treating bronchoconstriction and mucus secretion, thus slowing the progression of COPD and asthma.

[0039] 2. Experimental data from this invention demonstrate that the improved composition exhibits statistically significant differences in improving lung function indicators and inhibiting the expression of key inflammatory cells and core inflammatory factors. It is not only superior to the single-component donkey-hide gelatin group but also outperforms the existing first-line clinical drug roflumilast in several key efficacy indicators. This comprehensive efficacy, superior to single-component drugs and existing positive control drugs, confirms a non-obvious synergistic effect among the components of this invention, rather than a simple additive effect of their individual efficacy.

[0040] 3. This invention further verifies the mechanism by which the drug composition exerts its therapeutic effect through multi-level regulation of the cAMP signaling pathway, overcoming the limitations of the prior art in understanding the mechanism of action of compound drugs: the active ingredient collagen peptides derived from donkey-hide gelatin in the drug-food homology composition combine with the anti-inflammatory activities of components such as burdock seed and almond, which may act as ligands on Gs protein-coupled receptors on the one hand, and alleviate the desensitization phenomenon of β-adrenergic receptors on the other hand, synergistically promote the endogenous production of cAMP and enhance downstream signal transduction. The above effects together maintain a high level of intracellular cAMP, thereby effectively activating the downstream PKA / CREB signaling pathway and restoring the body's anti-inflammatory, anti-apoptotic and smooth muscle relaxation functions.

[0041] The above mechanism shows that the present invention achieves deep activation of the cAMP pathway by constructing a networked regulatory model of "synthesis promotion-degradation inhibition-signal enhancement".

[0042] 4. This invention employs an optimized preparation process, targeting the specific physicochemical properties of different medicinal materials. Specifically, a separate "melting" process is used for donkey-hide gelatin, effectively avoiding the denaturation of large molecular proteins or loss of active ingredients that might occur with co-decoction. Simultaneously, volatile oil extraction and re-addition techniques are used to maximize the retention of heat-sensitive volatile oil components in raw materials such as almonds and burdock seeds. The preparation method of the medicinal and edible homologous composition described in this invention not only solves the technical challenge of simultaneously extracting components with different properties from compound formulas, but also ensures the full realization of the synergistic efficacy of the composition from a process perspective.

[0043] 5. This invention provides a comprehensive analysis of the mechanism of action of food-medicine homology compositions in the treatment of related diseases, and has important clinical application prospects. In particular, the clarification of their key pharmacodynamic targets and pathways of action can provide core technical support for the secondary development of traditional Chinese medicine compound prescriptions and the creation of new drugs, thereby effectively promoting the modernization of traditional Chinese medicine. Attached Figure Description

[0044] Figure 1 The effects of nine different formulations on TNF-α levels in an inflammatory cell model;

[0045] Figure 2 The effects of drug-containing serum containing components 1 and 2 and the total components extracted from Formula 9 on the TNF-α level in an inflammatory cell model. Detailed Implementation

[0046] To make the application objectives, technical solutions, and beneficial technical effects of this invention clearer, the following detailed description of this invention is provided in conjunction with specific embodiments. However, those skilled in the art will understand that the following embodiments are for illustrative purposes only and should not be considered as limiting the scope of this invention. Where specific conditions are not specified in the embodiments, conventional conditions or manufacturer-suggested conditions are followed. Where the manufacturers of reagents or instruments are not specified, they are all commercially available conventional products.

[0047] Based on the analysis of drug associations using Apriori association rules, this invention employs complex system entropy clustering analysis and unsupervised entropy hierarchical clustering analysis to identify and screen potential new drug combinations into the following nine groups: Formula 1: Donkey-hide gelatin, licorice root, apricot kernel, pinellia tuber, poria cocos, ephedra; Formula 2: Donkey-hide gelatin, dried tangerine peel, poria cocos, licorice root, apricot kernel, and scutellaria baicalensis; Formula 3: Donkey-hide gelatin, Atractylodes macrocephala, Poria cocos, Glycyrrhiza uralensis, Astragalus membranaceus, Dioscorea opposita; Formula 4: Donkey-hide gelatin, Scutellaria baicalensis, Gardenia jasminoides, Anemarrhena asphodeloides, Fritillaria cirrhosa, Ophiopogon japonicus; Formula 5: Donkey-hide gelatin, Ophiopogon japonicus, lily bulb, mulberry bark, Scrophularia ningpoensis, and Fritillaria cirrhosa; Formula 6: Donkey-hide gelatin, Ophiopogon japonicus, lily bulb, Scrophularia ningpoensis, apricot kernel, mulberry leaf; Formula 7: Donkey-hide gelatin, ephedra, cinnamon twig, asarum, apricot kernel, licorice, and jujube; Formula 8: Donkey-hide gelatin, angelica sinensis, chuanxiong rhizome, white peony root, rehmannia root, astragalus root, and atractylodes macrocephala rhizome; Formula 9: Donkey-hide gelatin, burdock fruit, licorice root, loquat leaf, apricot kernel, platycodon root, astragalus root; Furthermore, this invention conducted animal-level drug-containing serum collection and cellular-level verification studies on the nine combined prescriptions, combined with... Figure 1 As shown in the experimental results, formulation 9 had the best effect.

[0048] This invention extracts Formula 9 into two parts: Component 1 is a single donkey-hide gelatin group, and Component 2 is a group containing six other traditional Chinese medicines. The total components of Formula 9 are compared, and experiments are conducted on cells using animal serum containing the drug. The results are as follows... Figure 2 As shown, serum containing components 1, 2, and the total components of formulation 9 significantly increased TNF-α levels in the inflammatory cell model. Therefore, formulation 9 was selected for subsequent experiments.

[0049] Based on the foregoing, this invention uses Formula 9: donkey-hide gelatin, burdock seed, licorice, loquat leaf, apricot kernel, platycodon root, and astragalus root as a compound for donkey-hide gelatin, which is a novel food and medicine homology composition. This invention provides the preparation of the food and medicine homology composition, as detailed in Examples 1 to 4.

[0050] Example 1

[0051] This embodiment provides the preparation of a medicinal and edible homology composition 1, specifically including the following:

[0052] 1. Prescription: 5 parts donkey-hide gelatin, 5 parts burdock fruit, 5 parts licorice root, 5 parts loquat leaf, 5 parts apricot kernel, 3 parts platycodon root, and 10 parts astragalus root.

[0053] 2. Preparation method: Mix burdock seed, apricot kernel, loquat leaf, licorice, platycodon root, and astragalus root from the prescription and decoct with water. The weight of the water is 6 times the total weight of the raw materials in the above prescription. Collect the volatile components during the first decoction to obtain volatile oil. Continue to decoct twice for a total of 3 hours. Combine the decoctions to obtain a medicinal liquid. Filter and concentrate the medicinal liquid to obtain an extract. Melt the donkey-hide gelatin in the prescription and mix it evenly with the obtained extract and volatile oil to obtain the food-medicine homologous composition 1.

[0054] Example 2

[0055] This embodiment provides the preparation of food-medicine homology composition 2, specifically including the following:

[0056] 1. Prescription: 10 parts donkey-hide gelatin, 10 parts burdock fruit, 6 parts licorice root, 9 parts loquat leaf, 10 parts apricot kernel, 6 parts platycodon root, and 15 parts astragalus root.

[0057] 2. Preparation method: Mix burdock seed, apricot kernel, loquat leaf, licorice, platycodon root, and astragalus root from the prescription and decoct with water. The weight of the water is 6 times the total weight of the raw materials in the above prescription. Collect the volatile components during the first decoction to obtain volatile oil. Continue to decoct twice for a total of 3 hours. Combine the decoctions to obtain a medicinal liquid. Filter and concentrate the medicinal liquid to obtain an extract. Melt the donkey-hide gelatin in the prescription and mix it evenly with the obtained extract and volatile oil to obtain the food-medicine homologous composition 2.

[0058] Example 3

[0059] This embodiment provides the preparation of the food-medicine homology composition 3, specifically including the following:

[0060] 1. Prescription: 15 parts donkey-hide gelatin, 15 parts burdock fruit, 8 parts licorice root, 15 parts loquat leaf, 15 parts apricot kernel, 8 parts platycodon root, and 18 parts astragalus root.

[0061] 2. Preparation method: Mix burdock seed, apricot kernel, loquat leaf, licorice, platycodon root, and astragalus root from the prescription and decoct with water. Collect volatile components during the first decoction. The weight of the water is 6 times the total weight of the raw materials in the above prescription to obtain volatile oil. Continue to decoct twice for a total of 3 hours. Combine the decoctions to obtain a medicinal liquid. Filter and concentrate the medicinal liquid to obtain an extract. Melt the donkey-hide gelatin in the prescription and mix it evenly with the obtained extract and volatile oil to obtain the food-medicine homology composition 3.

[0062] Example 4

[0063] This embodiment provides the preparation of the medicinal and edible homology composition 4, specifically including the following:

[0064] 1. Prescription: 20 parts donkey-hide gelatin, 20 parts burdock fruit, 10 parts licorice root, 15 parts loquat leaf, 15 parts apricot kernel, 10 parts platycodon root, and 20 parts astragalus root.

[0065] 2. Preparation method: Boil the burdock seed, apricot kernel, loquat leaf, licorice, platycodon root, and astragalus root in the prescription with water. Collect the volatile components during the first decoction. The weight of the water is 6 times the total weight of the raw materials in the above prescription to obtain volatile oil. Continue to decoct twice for a total of 3 hours. Combine the decoction liquids from each decoction, filter, and concentrate to obtain an extract. Melt the donkey-hide gelatin in the prescription and mix it evenly with the obtained extract and the obtained volatile oil to obtain the food-medicine homology composition 4.

[0066] Example 5

[0067] This embodiment provides the effects of the food-medicine homology compositions prepared in Examples 1-4 on COPD induced by smoking combined with LPS respiratory tract.

[0068] 1. Experimental Methods

[0069] Forty-eight mice were randomly divided into eight groups of six each: a control group, a model group, a positive control group, a compound donkey-hide gelatin group (compositions 1, 2, 3, and 4), and a donkey-hide gelatin group. Before the experiment, cigarettes (30 cigarettes per session) were placed in a smoke generator, and all mice were placed in a poisoning chamber (80 cm × 80 cm × 80 cm). Except for the control group, in the other groups, cigarettes were lit, and smoke was injected into the poisoning chamber using an automatic syringe. The mice were exposed to the smoke twice daily, morning and evening, for 30 minutes each time, with an interval of at least four hours, for 60 consecutive days. During this process, it was ensured that all cigarettes burned out within five minutes. On days 14 and 46 of smoking, except for the control group, all mice in the other groups were anesthetized by intraperitoneal injection of 10% chloral hydrate solution. After anesthesia, 0.75 mg / kg of LPS was rapidly injected into the trachea of ​​the mice using a nebulizer. After the injection, the mice were quickly rotated upright for 20 seconds to distribute the LPS solution evenly in the lung lobes. Then the mice were sutured.

[0070] The donkey-hide gelatin compound group was fed the corresponding donkey-hide gelatin compound at a dose of 500 mg / kg daily from day 46 of nebulization, while the positive control group was fed roflumilast at a dose of 5 mg / kg (body weight) daily for 14 consecutive days. All mice were fed normally. One hour after administration on day 60, all test animals were placed in a whole-body plethysmography system for non-invasive pulmonary function testing. Subsequently, after anesthesia with intraperitoneal injection of sodium pentobarbital solution, the neck skin was quickly cut open, the trachea was separated, a small incision was made in the trachea, a cannula was inserted, endotracheal intubation was performed, and lung perfusion was performed. The perfusion fluid was collected and stored for later analysis.

[0071] 2. Determination of Experimental Results

[0072] (1) Measurement of lung function

[0073] On days 55 and 58, four mice from each group were randomly selected and placed in the chamber of the WBP whole-body volume plethysmography system. The biased air supply was turned on, and the mice were allowed to acclimatize in the chamber for 10 minutes. After the last administration, the mice's Penh (airway constriction index), Mv (minute volume), and PEF (peak expiratory flow rate) were measured.

[0074] Table 1. Results of lung function tests on COPD mice using compound donkey-hide gelatin formula.

[0075]

[0076] Note: Compared with the model group: P < 0.05 p < 0.01, p < 0.001; compared with the control group: ### P < 0.001.

[0077] As shown in Table 1, compared with the control group, the Mv and PEF of the model group mice were significantly decreased; the Mv and PEF of each treatment group mice were increased compared with the model group, and the growth effect of the food-medicine homology composition 2 was better than that of the positive drug roflumilast and the donkey-hide gelatin group alone; compared with the control group, the Penh of the model group mice was significantly increased, and the donkey-hide gelatin compound can effectively enhance the lung function of COPD mouse model, and the effect of the food-medicine homology composition 2 is significantly better than that of the donkey-hide gelatin group alone in multiple indicators, and even better than that of the positive drug roflumilast; PEF refers to peak expiratory flow rate, that is, the maximum airflow velocity during the expiratory phase in one respiratory cycle. It mainly reflects the patency of small airways and the elastic recoil force of the lungs. Exhalation is a passive process that relies on the elastic recoil of the lung tissue itself to drive the gas outflow. If the small airways are narrowed, blocked, or the elastic tissue of the lungs is damaged, PEF will be significantly reduced. The results show that the donkey-hide gelatin compound can effectively enhance the lung function of COPD mouse model.

[0078] (2) Detection of neutrophils in bronchoalveolar lavage fluid

[0079] After euthanizing the mouse, place it supine on the operating table, fix its limbs, disinfect its neck with 75% alcohol, then fully expose the mouse's trachea, insert a tracheal intubation needle near the larynx, inserting the needle to a certain position, but not beyond the bifurcation of the trachea; irrigate the mouse three times repeatedly with sterile saline at 4°C, collect the irrigating fluid, centrifuge at 1800 rpm / min for 5 min, suspend the precipitate in PBS, smear it, and observe and count the neutrophils using a hematology typing instrument to calculate the number of neutrophils.

[0080] In the pathogenesis of COPD, various mediators can promote the migration and aggregation of neutrophils. At the same time, neutrophils release oxidative metabolites, proteases, and cytokines. These substances cause damage to local tissues, resulting in chronic damage to the peripheral airways. They also lead to an imbalance between proteases and antiproteases, causing emphysema, thereby promoting the occurrence and development of COPD. Therefore, neutrophils are an important indicator for evaluating COPD.

[0081] As shown in Table 2, compared with the blank group, the number of neutrophils in the lung lavage fluid of the model group mice increased significantly. Each compound of donkey-hide gelatin could significantly reduce the number of neutrophils, and the positive drug group could also significantly reduce the number. Among the four drug treatments, the combination of food and medicine homology 2 was the best, and its effect was far better than the almost ineffective simple donkey-hide gelatin group. This once again proves that the efficacy of the present invention comes from its unique compatibility and synergy, rather than the effect of a single principal drug.

[0082] Table 2. Effects of donkey-hide gelatin compound on neutrophils in COPD mice.

[0083]

[0084] Note: Compared with the model group: P < 0.05 p < 0.01; Compared with the blank group: ###P < 0.001.

[0085] (3) Determination of the content of inflammatory factors

[0086] The collected irrigation fluid was tested for the content of inflammatory factors, and the results are shown in Table 3.

[0087] Table 3. Effects of donkey-hide gelatin compound on alveolar secretion of inflammatory factors in COPD mice.

[0088]

[0089] Note: Compared with the model group: P < 0.05 p < 0.01, p < 0.001; compared with the control group: # P < 0.05## P < 0.01, ### P < 0.001.

[0090] TNF-α and IL-1β, as key initiation signals, drive intense neutrophilic inflammation and tissue destruction; IL-6 is associated with acute-phase responses and systemic manifestations; IL-17 further enhances neutrophil recruitment and connects to the adaptive immune response. Meanwhile, elevated TGF-β levels predict the initiation of pathological repair, namely, small airway fibrotic remodeling.

[0091] As shown in Table 3, compared with the control group, the levels of inflammatory factors in the model group mice were significantly increased. All drug treatments effectively reversed the tracheal sensitivity to cigarette smoke and LPS. Among the four drug treatments, the combination of medicinal and edible ingredients 2 was the most effective, far surpassing the almost ineffective treatment of the simple donkey-hide gelatin group. This indicates that the donkey-hide gelatin compound can reduce the secretion of inflammatory factors leading to airway remodeling and inflammatory responses in COPD animal models.

[0092] (4) Detection of phosphorylation expression of PKA and CREB proteins

[0093] Mouse lung tissue was collected to detect the phosphorylation expression of PKA and CREB proteins, and the effect of donkey-hide gelatin compound on the cAMP-PKA-CREB signaling pathway in COPD mouse lung tissue was investigated. The results are shown in Table 4.

[0094] Table 4. Effects of donkey-hide gelatin compound on the cAMP-PKA-CREB signaling pathway in lung tissue of COPD mice.

[0095]

[0096] Table 4 shows that both p-PKA and p-CREB were significantly reduced in the model group, with statistically significant differences compared to the control group. Cigarette smoke (CS) and inflammatory factors disrupt the homeostasis of alveolar epithelial cells and airway cells, leading to inhibited PKA activation and consequently reduced CREB phosphorylation levels. This weakening of a key signal indicates a weakening of the cell's anti-inflammatory barrier. Under normal circumstances, activated p-CREB can inhibit pro-inflammatory signaling pathways such as NF-κB, while the reduction of p-CREB directly leads to the massive release of pro-inflammatory cytokines such as IL-6 and TNF-α, exacerbating chronic inflammation. Furthermore, it disrupts cell survival mechanisms. p-CREB is a key transcription factor regulating anti-apoptotic genes; its decreased level makes alveolar epithelial cells and endothelial cells more sensitive to CS-induced oxidative stress, accelerating apoptosis and thus promoting the formation and development of emphysema. In addition, inhibition of this pathway also affects the relaxation function of airway smooth muscle and reduces mitochondrial biosynthesis, leading to cellular energy metabolism disorders and increased oxidative stress. Compared to the model group, the protein phosphorylation level in the drug group was increased, indicating that the compound donkey-hide gelatin can activate the expression of proteins in this pathway and thus exert an anti-COPD effect.

[0097] Example 6

[0098] This embodiment investigates the effects of donkey-hide gelatin compound on lung function, alveolar neutrophil percentage, and inflammatory factors in asthmatic mice.

[0099] 1. Experimental Materials and Methods

[0100] (1) Animals: Seventy female SPF-grade Balb / c mice, 8 weeks old and weighing 18-22g, were purchased from Jinan Pengyue Company, animal license number: SCXK (Lu) 2022 0006. Before the formal start of the experiment, all mice were acclimatized in an SPF-grade environment for 3 days with free access to water and food. The indoor temperature was 20±2℃, the relative humidity was 70%, and the environment was free of specific pathogens.

[0101] (2) Drugs and reagents: The food-medicine homologous compositions 1-4 described in this invention were prepared according to Examples 1-4. Based on the "Equivalent dose ratio table for humans and animals calculated by body surface area", the dosage for mice was converted from the clinical dose to 8.14 g / kg, which was used as the dosage in this experiment.

[0102] Aluminum hydroxide (Wuhan Sewell Biotechnology Co., Ltd.); OVA (Beijing Solarbio Biotechnology Co., Ltd.); PBS buffer (Wuhan Sewell Biotechnology Co., Ltd.); 0.9% sodium chloride solution (Chenxin Pharmaceutical Co., Ltd.); Mouse interleukin-6 (IL-6) ELISA kit, mouse interleukin-4 (IL-4) ELISA kit, mouse interleukin-5 (IL-5) ELISA kit, mouse interleukin-13 (IL-13) ELISA kit, mouse interleukin-1β (IL-1β) ELISA kit, and mouse ovalbumin-specific IgE (OVA-IgE) ELISA kit were all purchased from Jianglai Biotechnology.

[0103] (3) Grouping and modeling: Balb / c mice were randomly divided into 7 groups according to the random number table method, namely, normal control group, model group, food and medicine homology composition group 1, food and medicine homology composition group 2, food and medicine homology composition group 3, food and medicine homology composition group 4 and positive drug group, with 10 mice in each group.

[0104] Except for the control group, animals in other groups were intraperitoneally injected with 200 μl / animal of the sensitizing agent (20 μg OVA + 2 mg Al(OH)3) on days 0, 7, and 14, respectively. The control group was given the same concentration of Al(OH)3 in PBS buffer instead. From days 21 to 23, the model mice were nebulized with 5% OVA (PBS) for 30 min daily, while the control group mice were nebulized with PBS for the same duration. The animals' condition, respiration, and duration of abnormal respiratory reactions were closely observed after each nebulization.

[0105] (4) Intervention and administration method: The dosage for mice was calculated based on the "Equivalent dose ratio table for humans and animals based on body surface area". The normal control group and the model group were administered physiological saline by gavage at the same dose, while the positive control group was administered dexamethasone by gavage at 3 mg / kg. All groups were administered the drug 14 days after modeling, once a day, until the end of the experiment, a total of 10 days.

[0106] (5) Detection indicators and methods

[0107] To assess respiratory function in mice, this embodiment utilizes a non-invasive whole-body plethysmograph (WBP) for non-invasive pulmonary function testing. During the experiment, the animal is placed inside a closed plethysmograph connected to sensors leading to the outside. As the animal breathes, the rise and fall of its chest changes the volume within the plethysmograph. This volume change is converted into an electrical signal by a pressure transducer and amplifier. After computer processing, the respiratory curve is displayed on a computer screen. Software processing of the graph allows for the calculation of respiratory parameters such as penH (bronchoconstriction index), tidal volume (VT), peak expiratory flow (PEF), and respiratory rate. Three days prior to the experiment, the mice to be measured are placed in the closed plethysmograph for half an hour each day to acclimatize and ensure accurate measurement results.

[0108] (6) The basal respiratory status of mice was detected before administration on day 20; the respiratory status of mice was detected 30 minutes after nebulization on days 21 and 22; and the respiratory status of mice during the stable period was detected on day 23.

[0109] (7) Twenty-four hours after the last OVA challenge in mice, the mice were anesthetized with 1% sodium pentobarbital. After exposing the trachea, endotracheal intubation was performed, and the lungs were lavaged twice with 0.7 mL of PBS buffer. BALF was collected. The BALF was centrifuged at 1500 rpm for 10 minutes at 4℃. After centrifugation, the supernatant was separated. The OVA-sIgE content in the collected serum samples and the IL-4, 5, 6, 13, and 1β content in the BALF supernatant were detected by enzyme-linked immunosorbent assay (ELISA) according to the kit manufacturer's instructions. The cell pellet was resuspended with an equal volume of PBS buffer, and then the total white blood cell count and differential count of neutrophils, lymphocytes, monocytes, and eosinophils were performed using a hematology analyzer.

[0110] (8) Total protein was extracted from the tissue using a protein extraction reagent. The homogenate was then centrifuged at 12,000 rpm for 10 min at 4°C, and the supernatant was collected. The protein concentration was determined using the BCA protein assay. Proteins were separated by 10% sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) and 5% concentrated gel, and transferred to a polyvinylidene fluoride (PVDF) membrane at appropriate current and time. The PVDF membrane was then blocked in approximately 5% BSA for 2 hours. After blocking, the membrane was washed with phosphate-buffered saline containing Tween-20 (TBST) for 30 min, and then incubated overnight on a shaker at 4°C with an appropriate primary antibody. The primary antibodies used were p-PI3K, PI3K, p-AKT, AKT, and GAPDH. The next day, the membrane was washed with PBST and incubated on a shaker with an appropriate secondary antibody for 1 hour. After incubation, the membrane was washed three times with TBST, and then the proteins in the membrane were visualized using enhanced chemiluminescence (ECL) in a Western blotting detection system. ImageJ was used to analyze the protein bands.

[0111] (9) All experimental data were analyzed using GraphPad Prism 8.0.2 (GraphPad InStat Software, San Diego, CA, United States). One-way ANOVA or t-tests were used to compare the groups. All experimental data are expressed as mean ± standard deviation (SD). p < 0.05 is statistically significant.

[0112] 2. Experimental Results and Discussion

[0113] (1) Penh value measurement results

[0114] Penh is considered an empirical parameter for judging the degree of bronchial constriction, reflecting changes in the pressure signal waveform within the measurement container. As shown in Table 5, an asthma model was constructed using OVA induction to observe the effects of donkey-hide gelatin compound on respiratory function-related indicators in mice.

[0115] Mice in the model group, due to their asthmatic pathological state, exhibited a significantly elevated mean Penh value, reflecting increased airway resistance and respiratory limitation. After intervention with the medicinal and edible homologous compositions 1-4, compared to the model group, the mean Penh value of mice in the donkey-hide gelatin compound group was significantly reduced (p < 0.05). Furthermore, compared to the positive control drug dexamethasone (DEX) group, medicinal and edible homologous compositions 2 and 4 showed comparable effects in improving respiratory function and lowering the mean Penh value. The donkey-hide gelatin alone group showed improvement in respiratory function, but not as effectively as the compound group. This indicates that the donkey-hide gelatin compound can effectively alleviate the adverse respiratory state in asthmatic mice, and that the respiratory function-improving effects of medicinal and edible homologous compositions 2 and 4 are comparable to those of the classic treatment drug dexamethasone. (See Table 5)

[0116] Table 5. Results of Penh value detection in asthmatic mice using compound donkey-hide gelatin.

[0117]

[0118] Note: Compared with the normal control group ### p < 0.001; compared with the model group p<0.05, p<0.01, p<0.001.

[0119] (2) Determination of total white blood cell count, neutrophil count, lymphocyte count and eosinophil count in bronchoalveolar lavage fluid of mice

[0120] The effects of donkey-hide gelatin compound on anti-allergic asthma in asthmatic mice were investigated by measuring the total number of white blood cells, neutrophils, lymphocytes and eosinophils in the bronchoalveolar lavage fluid of mice.

[0121] The cell counting results are shown in Table 6. Compared with the control group, the number of leukocytes, neutrophils, lymphocytes, and eosinophils in the BALF of the model group mice was significantly increased, directly demonstrating that OVA successfully induced strong lung inflammation and promoted the recruitment of a large number of inflammatory cells. After intervention with the food-medicine homology compositions 1-4, the number of the above-mentioned inflammatory cells in the BALF of mice was significantly reduced compared with the model group, and all were significantly better than the groups treated with donkey-hide gelatin alone, proving that the synergistic effect of the compound of this invention is far beyond that of donkey-hide gelatin alone. Among them, food-medicine homology composition 2 had the best effect. The above results indicate that the donkey-hide gelatin compound can effectively reduce the infiltration of inflammatory cells in the lungs of asthmatic mice and play a positive role in alleviating lung inflammation and improving the pathological process of asthma.

[0122] Table 6. Number of white blood cells, neutrophils, lymphocytes and eosinophils in mouse BALF

[0123]

[0124] Note: Compared with the normal control group ### p < 0.001; compared with the model group, p<0.05, p<0.01, p<0.001.

[0125] (3) Detection of inflammatory factors in bronchoalveolar lavage fluid

[0126] As shown in Tables 7 and 8, compared with the normal control group, the levels of IL-4, IL-5, IL-13, IL-1β, and IL-6 in the BALF of the model group mice were significantly increased, reflecting that the OVA-induced asthma model successfully triggered a strong inflammatory response and abnormal secretion of a large number of pro-inflammatory cytokines. After intervention with the medicinal and edible homologous compositions 1-4, the levels of IL-4, IL-5, IL-13, IL-1β, and IL-6 in the BALF of mice were reduced to varying degrees, and all were significantly better than those of the group treated with donkey-hide gelatin alone, proving that the synergistic effect of the compound of this invention is far beyond that of donkey-hide gelatin alone. This indicates that the donkey-hide gelatin compound can effectively inhibit the overexpression of inflammatory factors in the BALF of asthmatic mice and alleviate the pulmonary inflammation state, among which the medicinal and edible homologous composition 2 has the best effect. The above results indicate that the donkey-hide gelatin compound can reduce the level of Th2 cytokines in the BALF of mice, thereby inhibiting the type II inflammatory response.

[0127] The level of allergen-specific IgE can reflect the severity of asthma. As shown in Table 8, compared with the control group, the serum OVA-IgE level in the model group was significantly increased, indicating successful modeling. After intervention with the medicinal and edible homologous compositions 1-4, the serum OVA-IgE level in mice was significantly lower than that in the model group and significantly better than that in the group treated with donkey-hide gelatin alone. The experimental results indicate that the donkey-hide gelatin compound can reduce the production of OVA-IgE, among which the medicinal and edible homologous composition 2 has the best effect, reducing the severity of asthma by alleviating allergic reactions.

[0128] Table 7. Detection of inflammatory factor concentrations in mouse BALF

[0129]

[0130] Note: Compared with the normal control group ### p < 0.001; compared with the model group p<0.05, p<0.01, p<0.001.

[0131] Table 8. OVA-IgE levels in mouse serum and inflammatory factor levels in BALF

[0132]

[0133] Note: Compared with the normal control group ### p < 0.001; compared with the model group p<0.05, p<0.01, p<0.001.

[0134] In summary, compound donkey-hide gelatin does not act on a single target through a single component, but rather through its complex group of active ingredients (especially glycine and collagen-derived peptides) to intervene and repair the damaged cAMP-PKA signaling pathway from three levels: "inhibiting inflammatory interference, directly activating pathways, and providing a foundation for repair." This not only profoundly explains the core position of donkey-hide gelatin in compound donkey-hide gelatin formulations, but also provides modern molecular biology evidence for the treatment of complex diseases through the synergistic effects of multiple components and multiple targets described in this invention.

[0135] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions claimed by the present invention.

Claims

1. A medicinal and edible composition, characterized in that, The medicinal and edible composition comprises the following components: by weight, 5-20 parts of donkey-hide gelatin, 5-20 parts of burdock seed, 1-10 parts of licorice root, 5-15 parts of loquat leaf, 5-15 parts of apricot kernel, 1-10 parts of platycodon root, and 10-20 parts of astragalus root.

2. The medicinal and edible composition according to claim 1, characterized in that, The preparation method of the medicinal and edible homology composition includes the following steps: (1) Mix burdock seed, apricot kernel, loquat leaf, licorice, platycodon root and astragalus root and decoct with water, collect the volatile components to obtain volatile oil; (2) The decoction after the first decoction is decocted 1 to 3 times, the decoction is collected and mixed to obtain a medicinal liquid, the medicinal liquid is filtered and concentrated to obtain an extract; (3) Place the donkey-hide gelatin in a container, add rice wine or water, heat it in a water bath or steam it to dissolve it, and obtain a melted donkey-hide gelatin liquid; (4) Mix the extract, the melted donkey-hide gelatin solution and the volatile oil evenly to obtain a food-medicine homology composition.

3. The medicinal and edible composition according to claim 1, characterized in that, In step (1), the weight of water is 6 to 10 times the total weight of burdock seed, apricot kernel, loquat leaf, licorice, platycodon and astragalus, and the total decoction time is 1 to 3 hours.

4. The use of the medicinal and edible composition according to claim 1 in the preparation of a medicine or food for improving chronic lung disease.

5. The application according to claim 4, characterized in that, The chronic lung diseases include chronic obstructive pulmonary disease and / or bronchial asthma.

6. The application according to claim 4, characterized in that, The symptoms of the chronic lung disease include at least one of the following: decreased lung function, airway inflammation, bronchitis, excessive sputum and cough, granulocytosis, and hypermucus secretion.

7. The application according to claim 4, characterized in that, The medicinal and edible homology composition can regulate the cAMP signaling pathway to exert its function.

8. The application according to any one of claims 4 to 7, characterized in that, The mass content of the drug or food containing the same medicinal and edible composition in the drug or food for improving chronic lung disease is 0.1~10g / kg, based on body weight.

9. The application according to any one of claims 4 to 7, characterized in that, The components of the medicinal and edible composition include, by weight, 10 parts of donkey-hide gelatin, 10 parts of burdock seed, 6 parts of licorice, 9 parts of loquat leaf, 10 parts of apricot kernel, 6 parts of platycodon root, and 15 parts of astragalus root.

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