Traditional Chinese medicine composition with effects of ventilating lung, dispelling cold, tonifying spleen, reducing phlegm and relieving cough and asthma as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition with the effects of diffusing the lung, dispelling cold, tonifying the spleen, reducing phlegm and relieving cough and asthma as well as a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 4-8 parts of honey-fried ephedra, 5-10 parts of fried semen armeniacae amarae, 3-6 parts of radix saposhnikoviae, 1-5 parts of herba asari, 2-5 parts of ginger processed pinellia, 2-7 parts of bulbus fritillariae cirrhosae, 3-8 parts of exocarpium citri grandis, 3-6 parts of radix platycodonis, 2-6 parts of fried fructus perillae, 3-8 parts of honey-fried radix asteris, 5-11 parts of honey-fried flos farfarae, 7-11 parts of honey-fried cynanchum glaucescens, 2-6 parts of poria cocos and 2-5 parts of rhizoma atractylodis macrocephalae. The composition has definite comprehensive efficacy of relieving cough, relieving asthma, eliminating phlegm and resisting inflammation through a unique treatment system of dispelling exterior evil, reducing phlegm turbidity, strengthening spleen qi and benefiting lung qi, and effectively solves the problem of cough and asthma caused by exogenous wind-cold, internal retention of phlegm-dampness in the lung, or spleen deficiency and transportation loss, and endogenous obstruction of phlegm turbidity in the lung.

Description

Technical Field

[0001] This invention belongs to the field of compound pharmaceutical preparation technology, specifically relating to a traditional Chinese medicine composition with the effects of dispelling cold and relieving cough, strengthening the spleen and resolving phlegm, and relieving cough and asthma, as well as its preparation method and application. Background Technology

[0002] In the field of traditional Chinese medicine for treating childhood cough and asthma due to wind-cold, a formula with ephedra, bitter almond, perilla seed, pinellia, coltsfoot flower, aster, radish seed, tangerine peel, lepidium seed, and cynanchum paniculatum as its core ingredients (as described in existing patent application number 03112937.4) has been widely used. This formula emphasizes clearing the lungs, relieving exterior symptoms, resolving phlegm, and stopping cough, and it does have a certain therapeutic effect on symptoms such as childhood wind-cold and cough with thin phlegm. However, a deeper analysis of existing technical solutions reveals the following significant shortcomings:

[0003] (1) The efficacy of relieving exterior syndrome and dispelling cold is lacking, and the treatment of exterior syndrome is insufficient.

[0004] Lacking diaphoretic and cold-dispersing drugs, it is difficult to effectively expel external wind-cold pathogens. For cough and asthma induced or aggravated by wind-cold pathogens (such as acute exacerbation of chronic bronchitis, lingering cough after a cold), this formula cannot eliminate the core cause of the disease, which may lead to "closing the door to let in the enemy, affecting the overall efficacy."

[0005] (2) The spleen-strengthening and body-supporting mechanisms are lacking, and the elimination of pathogens easily damages the body's vital energy.

[0006] Its formula mainly consists of purgative herbs such as Lepidium apetalum, stir-fried radish seeds, and processed Pinellia ternata, making its medicinal properties quite potent. Long-term use or use on patients with spleen deficiency may damage the spleen and stomach qi, causing adverse reactions such as poor appetite and abdominal distension. Moreover, it cannot interrupt the pathogenesis cycle of "the spleen being the source of phlegm production," thus treating the symptoms but not the root cause.

[0007] (3) The formula for moistening the lungs and resolving phlegm is weak, and its cough-relieving effect is limited.

[0008] Although the comparative formula contains honey-processed coltsfoot flower and honey-processed aster, it lacks essential lung-clearing and phlegm-resolving herbs. For coughs and asthma with sticky phlegm that is difficult to expectorate or accompanied by dryness, it has the deficiency of insufficient lung-moistening and phlegm-resolving properties, affecting the overall effectiveness of relieving cough and asthma.

[0009] (4) Narrow scope of indications and incomplete coverage of pathogenesis

[0010] This formula focuses excessively on the "excessive symptoms of phlegm obstructing the lungs" (with over 80% of the ingredients being qi-regulating, lung-draining, and phlegm-resolving drugs), neglecting the complex pathogenesis of external pathogenic factors and internal spleen deficiency. This results in poor efficacy for the clinically prevalent syndrome of wind-cold attacking the lungs combined with spleen deficiency and phlegm dampness (accounting for approximately 40% of chronic cough and asthma patients), limiting its clinical application. Summary of the Invention

[0011] In view of the shortcomings of the prior art, the purpose of this invention is to provide a traditional Chinese medicine composition with the functions of dispelling cold and relieving cough, strengthening the spleen and resolving phlegm, relieving cough and asthma, as well as its preparation method and application. This traditional Chinese medicine composition has a multi-target synergistic therapeutic effect, and is especially suitable for patients with colds, acute bronchitis, and chronic obstructive pulmonary disease who belong to the syndrome of external wind-cold phlegm-dampness obstruction or spleen deficiency with dampness and phlegm obstruction of the lungs.

[0012] This composition, through its unique treatment system of "dispersing external pathogens, resolving phlegm and dampness, strengthening the spleen, and benefiting the lungs," effectively addresses cough and asthma caused by unresolved external wind-cold, internal obstruction of phlegm and dampness in the lungs, or spleen deficiency leading to impaired transport and phlegm accumulation in the lungs. It incorporates a core combination of Saposhnikovia divaricata-Asarum heterotropoides for dispelling external cold, Poria cocos-Atractylodes macrocephala for strengthening the spleen and replenishing qi, and Fritillaria cirrhosa-Platycodon grandiflorus for moistening the lungs and expelling phlegm, synergistically with classic antitussive drug pairs. This constructs a multi-target treatment system of "dispersing external pathogens, resolving phlegm and dampness, strengthening the spleen, and benefiting the lungs," making it particularly suitable for complex cough and asthma caused by wind-cold binding the lungs, internal obstruction of phlegm and dampness, and spleen deficiency leading to impaired transport and transport. The composition uses honey-processed Ephedra sinica and stir-fried bitter apricot kernel as the principal herbs, working synergistically. Honey-processed Ephedra sinica is pungent and warm, promoting lung function, relieving asthma and cough, effectively dispelling external wind-cold, opening up congested lung qi, and allowing pathogens to dissipate from the surface. Stir-fried bitter apricot kernel is bitter and moistening, clearing lung qi, resolving phlegm and relieving cough, specifically regulating the upward flow of lung qi. The two herbs, one dispersing and the other descending, restore the balance of lung function, forming the core of the treatment for cough and asthma. The assistant herb, Fangfeng, dispels wind, releases the exterior, eliminates dampness, and relieves pain, assisting the principal herb in dispelling external pathogens and controlling the internal generation of phlegm and dampness. Xixin warms the lungs, transforms phlegm, disperses cold, and relieves pain, working synergistically with the principal and assistant herbs to release the exterior, dispel cold, and warm and transform phlegm. The adjuvant herbs, Jiangbanxia, ​​dry dampness, transform phlegm, descend rebellious qi, and stop vomiting; Chuanbeimu, moistens the lungs, transforms phlegm, clears heat, and dissipates nodules; Huajuhong, regulates qi, relieves chest congestion, dries dampness, and transforms phlegm; Jiegeng, disperses lung qi, eliminates phlegm, benefits the throat, and opens the voice; Chaozisuzi, descends qi, relieves asthma, transforms phlegm, and moistens the intestines; and honey-processed Ziwan, honey-processed Kuandonghua, and honey-processed Baiqian, moisten the lungs, stop cough, transform phlegm, and descend qi. All these herbs work together to transform phlegm, stop cough, regulate qi, and simultaneously moisten the lungs and prevent dryness, assisting the principal and assistant herbs in addressing both the root cause and the symptoms. The formula uses Poria cocos to strengthen the spleen, eliminate dampness, promote urination, and resolve phlegm, while Atractylodes macrocephala tonifies qi, strengthens the spleen, dries dampness, and promotes urination. Together, they nourish the earth element to generate metal, consolidate the foundation, and eliminate dampness, thus preventing the source of phlegm and dampness and helping the lungs to restore their function of dispersing and descending qi.

[0013] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0014] The first aspect of the present invention is to provide a traditional Chinese medicine composition having the effects of dispelling cold and dampness, strengthening the spleen and resolving phlegm, relieving cough and asthma, comprising the following raw materials in parts by weight: 4-8 parts of honey-processed ephedra, 5-10 parts of stir-fried bitter apricot kernel, 3-6 parts of saposhnikovia root, 1-5 parts of asarum, 2-5 parts of ginger-processed pinellia, 2-7 parts of fritillaria bulb, 3-8 parts of tangerine peel, 3-6 parts of platycodon root, 2-6 parts of stir-fried perilla seed, 3-8 parts of honey-processed aster root, 5-11 parts of honey-processed coltsfoot flower, 7-11 parts of honey-processed white peony root, 2-6 parts of poria cocos, and 2-5 parts of atractylodes macrocephala.

[0015] As a preferred technical solution, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:

[0016] Honey-processed ephedra 5 parts, stir-fried bitter almond 7 parts, saposhnikovia root 4 parts, asarum 2 parts, ginger-processed pinellia 3 parts, fritillaria 3 parts, tangerine peel 4 parts, platycodon root 4 parts, stir-fried perilla seed 3 parts, honey-processed aster 5 parts, honey-processed coltsfoot flower 8 parts, honey-processed white peony root 8 parts, poria cocos 4 parts, atractylodes macrocephala 3 parts.

[0017] Or, 6 parts honey-processed ephedra, 8 parts stir-fried bitter almond, 5 parts saposhnikovia root, 3 parts asarum, 4 parts ginger-processed pinellia, 4 parts fritillaria cirrhosa, 5 parts tangerine peel, 5 parts platycodon root, 4 parts stir-fried perilla seed, 6 parts honey-processed aster root, 9 parts honey-processed coltsfoot flower, 10 parts honey-processed white peony root, 4 parts poria cocos, and 3 parts atractylodes macrocephala.

[0018] Or, 4 parts honey-processed ephedra, 6 parts stir-fried bitter almond, 3 parts saposhnikovia root, 1 part asarum, 3 parts ginger-processed pinellia, 3 parts fritillaria cirrhosa, 4 parts tangerine peel, 4 parts platycodon root, 3 parts stir-fried perilla seed, 5 parts honey-processed aster root, 7 parts honey-processed coltsfoot flower, 8 parts honey-processed white peony root, 5 parts poria cocos, and 4 parts atractylodes macrocephala.

[0019] Alternatively, use 4 parts honey-processed ephedra, 5 parts stir-fried bitter almond, 3 parts saposhnikovia root, 1 part asarum, 2 parts ginger-processed pinellia, 3 parts fritillaria cirrhosa, 3 parts tangerine peel, 3 parts platycodon root, 2 parts stir-fried perilla seed, 4 parts honey-processed aster root, 6 parts honey-processed coltsfoot flower, 9 parts honey-processed white peony root, 3 parts poria cocos, and 2 parts atractylodes macrocephala.

[0020] Alternatively, use 4 parts honey-processed ephedra, 7 parts stir-fried bitter almond, 5 parts saposhnikovia root, 2 parts asarum, 3 parts ginger-processed pinellia, 4 parts fritillaria cirrhosa, 5 parts tangerine peel, 3 parts platycodon root, 3 parts stir-fried perilla seed, 4 parts honey-processed aster root, 6 parts honey-processed coltsfoot flower, 10 parts honey-processed white peony root, 4 parts poria cocos, and 4 parts atractylodes macrocephala.

[0021] As a preferred technical solution, the traditional Chinese medicine composition is any pharmaceutically acceptable dosage form. More preferably, the pharmaceutically acceptable dosage form is granules.

[0022] A second aspect of the present invention is to provide a method for preparing a traditional Chinese medicine composition as described in the first aspect, comprising the following steps:

[0023] A) In the prescription, bitter almonds are crushed and added as ingredients, while the other medicinal ingredients are directly added as processed medicinal slices to obtain the raw materials;

[0024] B) Soak the raw material in water for 30 to 60 minutes, decoct and extract 1 to 3 times, each time for 1 to 3 hours, filter, and combine the filtrates; preferably, the mass ratio of water to raw material is (8-16):1.

[0025] C) The extract is concentrated to obtain an extract with a relative density of 1.15 to 1.20 (measured at 60°C);

[0026] D) While the extract obtained in step C is still hot, add the flavoring agent and set aside; preferably, the flavoring agent is at least one of sucrose, stevia, aspartame, xylitol, fructose, and cyclamate;

[0027] E) The drug obtained in step D is centrifuged using a straight tube centrifuge (speed: 14000 r / min~19000 r / min, flow rate: 4~6 L / min) to obtain centrifuged liquid;

[0028] F) Vacuum dry the centrifuged liquid obtained in step E to obtain a dry paste; preferably, the vacuum drying temperature is 60℃~80℃.

[0029] G) Pulverize the dry paste obtained in step F;

[0030] H) The dry extract obtained in step G is added to excipients to prepare the target dosage form, thus obtaining the traditional Chinese medicine composition. Preferably, the excipients are at least one selected from dextrin, maltodextrin, soluble starch, corn starch, and lactose; the mass ratio of the dry extract to the excipients is 1:0.2 to 1.

[0031] The third aspect of the present invention is to provide the use of the traditional Chinese medicine composition as described in the first aspect in the preparation of a medicament for treating cough and asthma caused by exogenous wind-cold and phlegm-dampness obstruction, the symptoms of which are cough and wheezing, copious clear and thin phlegm, chest tightness and fullness, aversion to cold and body pain, nasal congestion and runny nose, pale tongue with white and greasy coating, and floating and tight or slippery pulse.

[0032] The fourth aspect of the present invention is to provide the use of the traditional Chinese medicine composition as described in the first aspect in the preparation of a medicament for treating chronic cough and asthma caused by spleen deficiency and dampness accumulation, and phlegm obstruction of the lungs, wherein the symptoms are cough and wheezing, accompanied by poor appetite, loose stools, fatigue, and heaviness in the limbs; the application includes the treatment of colds, acute bronchitis, and chronic obstructive pulmonary disease belonging to the syndrome of exogenous wind-cold and phlegm-dampness obstruction or spleen deficiency and dampness accumulation with phlegm obstruction of the lungs.

[0033] Compared with the prior art, the present invention has the following beneficial effects:

[0034] (1) Significant overall efficacy: A multi-level, multi-target treatment system was constructed, which consists of "relieving exterior cold (Saposhnikovia divaricata, Asarum heterotropoides) - promoting lung qi (honey ephedra, stir-fried bitter apricot kernel) - resolving phlegm and relieving cough (ginger pinellia ternata, fritillaria cirrhosa, etc.) - strengthening spleen and removing dampness (Poria cocos, Atractylodes macrocephala). It plays a synergistic role in the core pathogenesis of cough and asthma (external wind-cold binding, internal obstruction of phlegm and dampness, failure of lung qi to promote qi to descend, and spleen deficiency and impaired transport), significantly improving the efficacy of treating cough and asthma induced by external pathogens and chronic cough and asthma.

[0035] (2) Taking into account both the exterior and interior, the root cause and the symptoms: It overcomes the shortcomings of existing technologies that either focus on relieving the exterior while neglecting to strengthen the spleen, or focus on resolving phlegm while neglecting to dispel cold, or focus on treating the symptoms (phlegm) while neglecting to strengthen the root cause (spleen), and effectively solves the complex diseases of unresolved external pathogens, excessive phlegm and dampness, or deficiency of the root and excess of the symptoms.

[0036] (3) Exquisite combination to prevent adverse effects: In a large number of warming, dispersing, warming and drying medicines, Fritillaria cirrhosa is added to moisten the lungs and resolve phlegm. Honey-processed (honey-processed ephedra, honey-processed aster, honey-processed coltsfoot flower, honey-processed white peony) is used to moderate the medicinal properties, enhance the effect of moistening the lungs and relieving cough, and effectively prevent the adverse effects of excessive warming and drying that damages body fluids and depletes qi.

[0037] (4) Optimization of preparation process: Modern processes such as water extraction, high-speed centrifugation to remove impurities and vacuum drying are adopted to effectively remove impurities, retain active ingredients, and improve the stability and bioavailability of the product.

[0038] (5) Suitable dosage form and good compliance: especially granules, which are convenient to take and whose taste can be moderately improved by flavoring agents. They are especially suitable for children and patients with chronic cough and asthma who need long-term medication, significantly improving treatment compliance.

[0039] (6) Definite efficacy and synergistic effect: Rigorous animal experiments have confirmed that this composition has significant antitussive, antiasthmatic, expectorant and anti-inflammatory effects. The decomposed formula study clearly shows that the efficacy of the complete formula (full formula group) is significantly better than that of the formula missing key medicinal materials (decomposed formula group), which fully proves the indispensable synergistic effect among the components and is the core of this scheme to achieve the best efficacy. Attached Figure Description

[0040] Figure 1 The effects of the normal group, model group, positive group, and low, medium, and high dose groups of the traditional Chinese medicine composition in Example 3 on the pathological characteristics of lung tissue in ovalbumin-induced asthmatic rats (HE staining);

[0041] Figure 2 The effect of the traditional Chinese medicine composition of Examples 10-13 on the lung tissue pathology of ovalbumin-induced asthmatic rats (HE staining). Detailed Implementation

[0042] To facilitate understanding of the present invention, a more comprehensive description will be given below with reference to specific embodiments. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a more thorough and complete understanding of the disclosure of the present invention.

[0043] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of this invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. All materials used in this invention are commercially available products.

[0044] This invention provides a traditional Chinese medicine composition with the effects of dispelling cold and dampness, strengthening the spleen and resolving phlegm, relieving cough and asthma. It contains the following raw materials in parts by weight: 4-8 parts of honey-processed ephedra, 5-10 parts of stir-fried bitter almond, 3-6 parts of saposhnikovia root, 1-5 parts of asarum, 2-5 parts of ginger-processed pinellia, 2-7 parts of fritillaria bulb, 3-8 parts of tangerine peel, 3-6 parts of platycodon root, 2-6 parts of stir-fried perilla seed, 3-8 parts of honey-processed aster root, 5-11 parts of honey-processed coltsfoot flower, 7-11 parts of honey-processed white peony root, 2-6 parts of poria cocos, and 2-5 parts of atractylodes macrocephala.

[0045] The preparation method of the above-mentioned traditional Chinese medicine composition is as follows:

[0046] The raw materials are sequentially pretreated, extracted with water, concentrated, centrifuged, vacuum dried, and granulated using a dry granulation method to maximize the extraction of the effective components from the pharmaceutical composition. Even when granulated, the resulting product retains the same efficacy. Specifically, the preparation of this traditional Chinese medicine composition includes the following steps:

[0047] A) In the prescription, bitter almonds are crushed and added as ingredients, while the other medicinal ingredients are added directly as processed medicinal slices;

[0048] B) Soak in water for 30 to 60 minutes, decoct and extract 1 to 3 times, 1 to 3 hours each time, filter, and combine the filtrates; preferably, the mass ratio of water to the total amount of each raw material is (8-16):1;

[0049] C) The above extract was concentrated to obtain an extract with a relative density of 1.15 to 1.20 (measured at 60°C);

[0050] D) While the extract obtained in step C is still hot, add the flavoring agent and set aside; preferably, the flavoring agent is sucrose, stevia, aspartame, xylitol, fructose, or cyclamate;

[0051] E) Centrifuge using a straight-tube centrifuge (speed: 14000 r / min~19000 r / min, flow rate: 4~6 L / min) to obtain centrifuged liquid;

[0052] F) Vacuum dry the centrifuged liquid obtained in step E to obtain a dry paste; preferably, the vacuum drying temperature is 60℃~80℃.

[0053] G) The dry paste obtained in step F is pulverized and passed through a 90-120 mesh sieve to obtain dry paste powder with a moisture content of ≤3.5%;

[0054] H) The dry powder obtained in step G is granulated with an appropriate amount of excipients by dry granulation to form granules; preferably, the ratio of the amount of dry powder to the amount of excipients is 1:0.2 to 1; the types of excipients are one or more such as dextrin, maltodextrin, soluble starch, corn starch, and lactose.

[0055] The technical solution of the present invention will be described more completely below with reference to specific embodiments.

[0056] Example 1: Preparation of the Traditional Chinese Medicine Composition

[0057] The traditional Chinese medicine composition contains the following ingredients: 5 parts honey-processed ephedra, 7 parts stir-fried bitter almond, 4 parts saposhnikovia root, 2 parts asarum, 3 parts ginger-processed pinellia, 3 parts fritillaria bulb, 4 parts tangerine peel, 4 parts platycodon root, 3 parts stir-fried perilla seed, 5 parts honey-processed aster root, 8 parts honey-processed coltsfoot flower, 8 parts honey-processed white peony root, 4 parts poria cocos, and 3 parts atractylodes macrocephala.

[0058] The specific preparation steps are as follows:

[0059] 1) The bitter almonds in the prescription are crushed and added, while the other medicinal ingredients are added directly as raw slices;

[0060] 2) Soak in water for 45 minutes, decoct and extract 3 times: the first decoction for 3 hours, the second for 2 hours, and the third for 1 hour; filter and combine the filtrates;

[0061] 3) The above-mentioned extract was concentrated to obtain an extract with a relative density of 1.18 (measured at 60℃);

[0062] 4) While the above-obtained extract is still hot, add 40g of sucrose and set aside;

[0063] 5) Centrifuge using a straight-tube centrifuge (speed: 16000 r / min, flow rate: 5 L / min) to obtain centrifuged liquid;

[0064] 6) The centrifuged liquid obtained above is vacuum dried at a temperature of 65°C to obtain a dry paste;

[0065] 7) Crush the above dry paste and pass it through a 100-mesh sieve to obtain dry paste powder with a moisture content of ≤3.5%;

[0066] 8) Add 200g of maltodextrin to the above dry powder, and granulate by dry granulation to form granules.

[0067] Preparation of the traditional Chinese medicine composition in Comparative Example 1 (4 parts of Saposhnikovia divaricata were missing compared to Example 1).

[0068] The traditional Chinese medicine composition contains the following ingredients: 5 parts ephedra, 7 parts stir-fried bitter apricot kernel, 2 parts asarum, 3 parts ginger pinellia, 3 parts fritillaria cirrhosa, 4 parts tangerine peel, 4 parts platycodon, 3 parts stir-fried perilla seed, 5 parts honey aster, 8 parts honey coltsfoot flower, 8 parts honey white peony root, 4 parts poria cocos, and 3 parts atractylodes macrocephala.

[0069] The preparation method is the same as in Example 1.

[0070] Preparation of the traditional Chinese medicine composition in Comparative Example 2 (compared to Example 1, 2 parts of Asarum were omitted).

[0071] The traditional Chinese medicine composition contains the following ingredients: 5 parts honey-processed ephedra, 7 parts stir-fried bitter almond, 4 parts saposhnikovia root, 3 parts ginger-processed pinellia tuber, 3 parts fritillaria cirrhosa, 4 parts tangerine peel, 4 parts platycodon root, 3 parts stir-fried perilla seed, 5 parts honey-processed aster root, 8 parts honey-processed coltsfoot flower, 8 parts honey-processed white peony root, 4 parts poria cocos, and 3 parts atractylodes macrocephala.

[0072] The preparation method is the same as in Example 1.

[0073] Preparation of the traditional Chinese medicine composition in Comparative Example 3 (compared to Example 1, 3 parts of ginger and pinellia were missing).

[0074] The traditional Chinese medicine composition contains the following ingredients: 5 parts honey-processed ephedra, 7 parts stir-fried bitter almond, 4 parts saposhnikovia root, 2 parts asarum, 3 parts fritillaria bulb, 4 parts tangerine peel, 4 parts platycodon root, 3 parts stir-fried perilla seed, 5 parts honey-processed aster root, 8 parts honey-processed coltsfoot flower, 8 parts honey-processed white peony root, 4 parts poria cocos, and 3 parts atractylodes macrocephala.

[0075] The preparation method is the same as in Example 1.

[0076] Preparation of the traditional Chinese medicine composition in Comparative Example 4 (compared to Example 1, 3 parts of Fritillaria cirrhosa were missing).

[0077] The traditional Chinese medicine composition contains the following ingredients: 5 parts honey-processed ephedra, 7 parts stir-fried bitter almond, 4 parts saposhnikovia root, 2 parts asarum, 3 parts ginger-processed pinellia, 4 parts tangerine peel, 4 parts platycodon root, 3 parts stir-fried perilla seed, 5 parts honey-processed aster root, 8 parts honey-processed coltsfoot flower, 8 parts honey-processed white peony root, 4 parts poria cocos, and 3 parts atractylodes macrocephala.

[0078] The preparation method is the same as in Example 1.

[0079] Preparation of the traditional Chinese medicine composition in Comparative Example 5 (4 parts of Citrus reticulata peel were missing compared to Example 1)

[0080] The traditional Chinese medicine composition contains the following ingredients: 5 parts honey-processed ephedra, 7 parts stir-fried bitter almond, 4 parts saposhnikovia root, 2 parts asarum, 3 parts ginger-processed pinellia, 3 parts fritillaria cirrhosa, 4 parts platycodon, 3 parts stir-fried perilla seed, 5 parts honey-processed aster, 8 parts honey-processed coltsfoot flower, 8 parts honey-processed white peony root, 4 parts poria cocos, and 3 parts atractylodes macrocephala.

[0081] The preparation method is the same as in Example 1.

[0082] Preparation of the traditional Chinese medicine composition in Comparative Example 6 (compared to Example 1, 4 parts of Platycodon grandiflorus were missing).

[0083] The traditional Chinese medicine composition contains the following ingredients: 5 parts honey-processed ephedra, 7 parts stir-fried bitter almond, 4 parts saposhnikovia root, 2 parts asarum, 3 parts ginger-processed pinellia, 3 parts fritillaria bulb, 4 parts tangerine peel, 3 parts stir-fried perilla seed, 5 parts honey-processed aster root, 8 parts honey-processed coltsfoot flower, 8 parts honey-processed white peony root, 4 parts poria cocos, and 3 parts atractylodes macrocephala.

[0084] The preparation method is the same as in Example 1.

[0085] Preparation of the traditional Chinese medicine composition in Comparative Example 7 (4 parts of Poria cocos were missing compared to Example 1).

[0086] The traditional Chinese medicine composition contains the following ingredients: 5 parts honey-processed ephedra, 7 parts stir-fried bitter almond, 4 parts saposhnikovia root, 2 parts asarum, 3 parts ginger-processed pinellia, 3 parts fritillaria bulb, 4 parts tangerine peel, 4 parts platycodon root, 3 parts stir-fried perilla seed, 5 parts honey-processed aster root, 8 parts honey-processed coltsfoot flower, 8 parts honey-processed white peony root, and 3 parts atractylodes macrocephala.

[0087] The preparation method is the same as in Example 1.

[0088] Preparation of the traditional Chinese medicine composition in Comparative Example 8 (compared to Example 1, 3 parts of Atractylodes macrocephala were missing).

[0089] The traditional Chinese medicine composition contains the following ingredients: 5 parts honey-processed ephedra, 7 parts stir-fried bitter almond, 4 parts saposhnikovia root, 2 parts asarum, 3 parts ginger-processed pinellia, 3 parts fritillaria cirrhosa, 4 parts tangerine peel, 4 parts platycodon root, 3 parts stir-fried perilla seed, 5 parts honey-processed aster root, 8 parts honey-processed coltsfoot flower, 8 parts honey-processed white peony root, and 4 parts poria cocos.

[0090] The preparation method is the same as in Example 1.

[0091] Preparation of the traditional Chinese medicine composition in Comparative Example 9 (compared to Example 1, 3 portions of stir-fried perilla seeds were omitted).

[0092] The traditional Chinese medicine composition contains the following ingredients: 5 parts honey-processed ephedra, 7 parts stir-fried bitter almond, 4 parts saposhnikovia root, 2 parts asarum, 3 parts ginger-processed pinellia, 3 parts fritillaria cirrhosa, 4 parts tangerine peel, 4 parts platycodon root, 5 parts honey-processed aster, 8 parts honey-processed coltsfoot flower, 8 parts honey-processed white peony root, 4 parts poria cocos, and 3 parts atractylodes macrocephala.

[0093] The preparation method is the same as in Example 1.

[0094] Example 2: Preparation of the Traditional Chinese Medicine Composition

[0095] The traditional Chinese medicine composition contains the following ingredients: 6 parts honey-processed ephedra, 8 parts stir-fried bitter almond, 5 parts saposhnikovia root, 3 parts asarum, 4 parts ginger-processed pinellia, 4 parts fritillaria cirrhosa, 5 parts tangerine peel, 5 parts platycodon root, 4 parts stir-fried perilla seed, 6 parts honey-processed aster root, 9 parts honey-processed coltsfoot flower, 10 parts honey-processed white peony root, 4 parts poria cocos, and 3 parts atractylodes macrocephala.

[0096] The preparation method is the same as in Example 1.

[0097] Example 3: Preparation of the Traditional Chinese Medicine Composition

[0098] The traditional Chinese medicine composition contains the following ingredients: 4 parts honey ephedra, 6 parts stir-fried bitter almond, 3 parts saposhnikovia root, 1 part asarum, 3 parts ginger pinellia, 3 parts fritillaria bulb, 4 parts tangerine peel, 4 parts platycodon root, 3 parts stir-fried perilla seed, 5 parts honey aster, 7 parts honey coltsfoot flower, 8 parts honey white peony root, 5 parts poria cocos, and 4 parts atractylodes macrocephala.

[0099] The preparation method is the same as in Example 1.

[0100] Example 4: Preparation of Traditional Chinese Medicine Composition

[0101] The traditional Chinese medicine composition contains the following ingredients: 4 parts honey-processed ephedra, 5 parts stir-fried bitter almond, 3 parts saposhnikovia root, 1 part asarum, 2 parts ginger-processed pinellia, 3 parts fritillaria cirrhosa, 3 parts tangerine peel, 3 parts platycodon root, 2 parts stir-fried perilla seed, 4 parts honey-processed aster root, 6 parts honey-processed coltsfoot flower, 9 parts honey-processed white peony root, 3 parts poria cocos, and 2 parts atractylodes macrocephala.

[0102] The preparation method is the same as in Example 1.

[0103] Example 5: Preparation of the Traditional Chinese Medicine Composition

[0104] The traditional Chinese medicine composition contains the following ingredients: 4 parts honey-processed ephedra, 7 parts stir-fried bitter almond, 5 parts saposhnikovia root, 2 parts asarum, 3 parts ginger-processed pinellia, 4 parts fritillaria cirrhosa, 5 parts tangerine peel, 3 parts platycodon root, 3 parts stir-fried perilla seed, 4 parts honey-processed aster root, 6 parts honey-processed coltsfoot flower, 10 parts honey-processed white peony root, 4 parts poria cocos, and 4 parts atractylodes macrocephala.

[0105] The preparation method is the same as in Example 1.

[0106] Preparation of related herbal formula compositions

[0107] Comparative Example 10

[0108] Compared with Example 5, Comparative Example 10 lacked ginger, Pinellia ternata, and Citrus reticulata peel. The composition of the traditional Chinese medicine composition is as follows:

[0109] Honey-processed ephedra 4 parts, stir-fried bitter almond 7 parts, saposhnikovia root 5 parts, asarum 2 parts, fritillaria cirrhosa 4 parts, platycodon root 3 parts, stir-fried perilla seed 3 parts, honey-processed aster root 4 parts, honey-processed coltsfoot flower 6 parts, honey-processed white peony root 10 parts, poria cocos 4 parts, atractylodes macrocephala 4 parts.

[0110] The preparation method is the same as in Example 1.

[0111] Comparative Example 11

[0112] Compared with Example 2, Comparative Example 11 lacked Saposhnikovia divaricata and Asarum heterotropoides, and the composition of the traditional Chinese medicine composition is as follows:

[0113] Honey-processed ephedra 4 parts, stir-fried bitter almond 7 parts, ginger-processed pinellia 3 parts, Sichuan fritillary bulb 4 parts, tangerine peel 5 parts, platycodon root 3 parts, stir-fried perilla seed 3 parts, honey-processed aster 4 parts, honey-processed coltsfoot flower 6 parts, honey-processed white peony root 10 parts, poria cocos 4 parts, atractylodes macrocephala 4 parts.

[0114] The preparation method is the same as in Example 1.

[0115] Comparative Example 12

[0116] Compared with Example 2, the composition of the traditional Chinese medicine combination of Poria cocos and Atractylodes macrocephala in Comparative Example 12 is as follows:

[0117] Honey-processed ephedra 4 parts, stir-fried bitter almond 7 parts, saposhnikovia root 5 parts, asarum 2 parts, ginger-processed pinellia 3 parts, fritillaria cirrhosa 4 parts, tangerine peel 5 parts, platycodon root 3 parts, stir-fried perilla seed 3 parts, honey-processed aster 4 parts, honey-processed coltsfoot flower 6 parts, honey-processed white peony root 10 parts.

[0118] The preparation method is the same as in Example 1.

[0119] Comparative Example 13

[0120] Compared with Example 2, the composition of the traditional Chinese medicine composition of Comparative Example 13 (honey-processed coltsfoot, honey-processed aster, and honey-processed white peony) is as follows:

[0121] Honey-processed ephedra 4 parts, stir-fried bitter almond 7 parts, saposhnikovia root 5 parts, asarum 2 parts, ginger-processed pinellia 3 parts, fritillaria cirrhosa 4 parts, tangerine peel 5 parts, platycodon root 3 parts, stir-fried perilla seed 3 parts, poria cocos 4 parts, atractylodes macrocephala 4 parts;

[0122] The preparation method is the same as in Example 1.

[0123] Test case

[0124] Pharmacological experiments, including animal tests for antitussive, antiasthmatic, expectorant, and anti-inflammatory effects, verified the efficacy of the traditional Chinese medicine composition in this invention in relieving cough, resolving phlegm, and relieving exterior symptoms.

[0125] 1. Antitussive test (mouse ammonia-induced cough method)

[0126] 1.1 Grouping

[0127] Several clean-grade ICR mice, weighing 18-22g, with equal numbers of males and females, were randomly divided into groups of 10 mice each.

[0128] One normal group (equal volume of distilled water);

[0129] Two positive drug groups (Qingshi granules 5.4g / kg, calculated based on body surface area, equivalent to twice the clinical adult daily dose of 30g);

[0130] Groups 3, 4, and 5 are the low, medium, and high dose groups of granules in Example 1 of this invention (5.60, 11.19, and 22.36 g / kg, respectively. Calculated based on body surface area, the low dose is equivalent to twice the daily dose of 10.5 g granules (approximately 21.47 g of raw herb) for children under one year old, and the high dose is equivalent to twice the daily dose of 86 g for children over 14 years old. The medium dose group is the square root of the product of the low and high dose groups).

[0131] Groups 6-14 were the particle solutions (11.19 g / kg) of Comparative Examples 1-9, respectively.

[0132] Groups 15, 16, and 17 are the low, medium, and high dose groups of particles in Example 2 of this invention (5.60, 11.19, and 22.36 g / kg, respectively);

[0133] Groups 18-21 consist of 10-13 separate drug formulations (11.19g / kg).

[0134] 1.2 Test Methods

[0135] Mice were administered the prescribed doses via intragastric gavage (ig) for 7 consecutive days. Forty minutes after the last administration, the mice were placed in a sealed glass box (40×40cm). 2 Concentrated ammonia was sprayed into the chamber using an S-888E ultrasonic nebulizer (Nanjing Daofen) for approximately 10 seconds, with a spray volume of approximately 3 ml, inducing a cough reflex in mice. The number of coughs in the mice within 2 minutes was recorded, and the results are shown in Table 1.

[0136] Table 1. Inhibitory effect of different formulations on cough induced by concentrated ammonia (n=10) )

[0137] Group Dosage (g / kg) Number of coughs (times per 2 minutes) normal group / 52.42±11.54 Positive drug group 7.80 35.30±10.76 Example 1 Low-dose group 5.60 39.51±5.76** In Example 1, the dosage group 11.19 32.60±6.85** Example 1 High-dose group 22.36 25.57±8.84** Comparative Example 1 11.19 43.39±11.21 Comparative Example 2 11.19 41.02±9.30 Comparative Example 3 11.19 42.16±5.19 Comparative Example 4 11.19 41.69±6.24 Comparative Example 5 11.19 44.96±11.23 Comparative Example 6 11.19 43.59±5.29 Comparative Example 7 11.19 42.90±6.25 Comparative Example 8 11.19 42.66±2.16 Comparative Example 9 11.19 41.05±6.94 Example 2 Low-dose group 5.60 38.53±8.12** In Example 2, the dosage group 11.19 35.33±5.26** Example 2 High-dose group 22.36 26.19±9.02** Comparative Example 10 11.19 48.35±9.16 Comparative Example 11 11.19 45.55±7.06 Comparative Example 12 11.19 46.28±8.54 Comparative Example 13 11.19 45.78±9.28

[0138] Note: **P<0.01 compared with the normal group.

[0139] Conclusion: This experiment used an ammonia-induced cough model to evaluate the antitussive efficacy of the drug. The results showed that all dosage groups of the herbal composition of this invention significantly prolonged the cough latency and reduced the frequency of coughs in mice, with the high-dose group showing particularly significant effects, comparable to the positive control drug Qing Shi Chong Ji, and exhibiting a good dose-response relationship. This fully demonstrates that the composition has a strong central or peripheral antitussive effect, directly reflecting its "antitussive and asthma-relieving" efficacy. It is noteworthy that the antitussive effects of all the dismembered groups (lacking a single herb or herb group) were significantly weaker than the whole-formula group. This strongly demonstrates that the "dispersing and descending combination" of honey-processed ephedra and stir-fried bitter almond, as well as the synergistic effect with other expectorant and spleen-strengthening drugs, are crucial for achieving the best antitussive effect; the absence of any single herb will lead to a decrease in overall efficacy.

[0140] 2. Asthma relief test

[0141] 2.1 Drug-induced asthma

[0142] 2.1.1 Grouping

[0143] Several clean-grade SD rats, weighing 200-250g, with equal numbers of males and females, were randomly divided into groups of 10 rats each.

[0144] One normal group (equal volume of distilled water);

[0145] Two positive drug groups (Qingshi granules 4.65g / kg);

[0146] Groups 3, 4, and 5 are the low, medium, and high dose groups of particles in Example 1 of this invention (3.34, 6.67, and 13.33 g / kg, respectively);

[0147] Groups 6-14 were the particle solutions (6.67 g / kg) from Comparative Examples 1-9, respectively.

[0148] Groups 15, 16, and 17 are the low, medium, and high dose groups of particles in Example 2 of this invention (3.34, 6.67, and 13.33 g / kg, respectively);

[0149] Groups 18-21 consisted of 10-13 separate drug formulations (6.67g / kg).

[0150] 2.1.2 Test Methods

[0151] Rats were placed in sealed glass containers, and a mixture of 2% acetylcholine and 0.1% histamine was sprayed into the containers at constant pressure using an ultrasonic nebulizer for 15 seconds. The time of asthma attack, convulsions, and falls (i.e., the latency period for inducing asthma) was observed and recorded. Then, the rats were orally administered the drugs according to the dosages in Table 2. This was repeated for 7 consecutive days. 30 minutes after the last administration, asthma was induced using the same method. The results are shown in Table 2.

[0152] Table 2. Effects of different formulations on the latency of asthma induction in normal rats (n=10) )

[0153]

[0154]

[0155] Note: Compared with the normal group, *P<0.05**P<0.01.

[0156] Conclusion: This experiment induced bronchospasm in normal rats using a mixture of acetylcholine and histamine to evaluate the drug's ability to relieve acute bronchospasm (i.e., its bronchodilatory effect). The results showed that all dosage groups of the herbal composition of this invention significantly prolonged the latency period of bronchospasm in rats, with effects comparable to the positive control group. This demonstrates that the composition effectively resists bronchospasm induced by acetylcholine and histamine, rapidly relieves airway narrowing, and has a clear immediate bronchodilatory effect, directly reflecting its bronchodilatory function within its "cough-relieving and asthma-relieving" properties. The latency period prolongation effect of each individual component group was less than that of the whole formula group, indicating that the synergistic combination of lung-clearing, qi-descending, and exterior-releasing drugs in the whole formula is crucial for achieving the best rapid bronchodilatory effect.

[0157] 2.2 Therapeutic effect on asthma model rats

[0158] 2.2.1 Grouping

[0159] Several clean-grade SD rats, weighing 200-250g, with equal numbers of males and females, were randomly divided into groups of 10 rats each.

[0160] One group was a normal control group (with an equal volume of physiological saline);

[0161] Two model groups were established, and no drugs were administered after modeling.

[0162] Three positive drug groups (Qingshi granules 4.65g / kg);

[0163] Groups 4, 5, and 6 are the low, medium, and high dose groups of particles in Example 1 of this invention (3.34, 6.67, and 13.33 g / kg, respectively);

[0164] Groups 7-15 were the particle solutions (6.67 g / kg) from Comparative Examples 1-9, respectively.

[0165] Groups 16, 17, and 18 are the low, medium, and high dose groups of particles in Example 2 of this invention (3.34, 6.67, and 13.33 g / kg, respectively);

[0166] Groups 19-22 consisted of drug formulations consisting of 10-13 separate prescriptions (6.67g / kg).

[0167] 2.2.2 Test Methods

[0168] On day 1, except for the normal group, all other groups of rats were injected with 1 ml of 4% ovalbumin saline solution via the thigh muscle. The normal group was injected with an equal volume of saline solution.

[0169] On day 14, except for the normal group, all groups were nebulized with 5% ovalbumin for 15 seconds, and the latency period of asthma symptoms such as shortness of breath and dyspnea was recorded for each group of rats (if it exceeded 180 seconds, it was counted as 180 seconds). Then, each group of rats was administered the drug according to the dosage in Table 3 for 2 consecutive weeks. On days 21 and 28, sensitization and asthma were induced by nebulization with 5% ovalbumin 1 hour after administration. When measuring the latency period of asthma, the rats were anesthetized with 20% urethane intraperitoneally, and then tracheal intubation was performed. 5 ml of physiological saline at pH 7.4 and 37°C was slowly injected into the lungs of the rats and retained for 3 minutes. The lavage fluid was aspirated. This process was repeated twice, and the lavage fluid was mixed from the two aspirated lavage fluids. After centrifugation at 1500 r / min for 10 minutes, the supernatant was collected. TP was measured using a BT-224 fully automated biochemical analyzer (Italy), WBC was measured using an F-820 hematology analyzer (Japan), and the percentage of eosinophils (EOS) was measured manually. The results are shown in Tables 3 and 4.

[0170] Tissue from the lower lobe of the right lung of rats was extracted, placed in 10% formalin fixative, routinely embedded in paraffin, sectioned, stained with hematoxylin and eosin (HE), and the pathological changes of the lower lobe of the right lung were observed under an optical microscope. Inflammation of the bronchi and surrounding tissues was scored. The severity of the lesions was semi-quantitatively determined as follows: no lesions, grade 0 (0 points); mild, grade I (1 point); moderate, grade II (2 points). The HE staining procedure is as follows: Dewaxing by soaking in xylene solutions I and II for 15 minutes each; soaking in 100% ethanol solutions I and II for 5 minutes; soaking in 95%, 85%, and 75% graded ethanol solutions for 5 minutes each; staining with hematoxylin for 5 minutes, then rinsing with water; differentiating with hydrochloric acid ethanol solution for 2–3 seconds, then rinsing with water; soaking in ammonia solution for 1 minute to regain blue color, then rinsing with water; staining with eosin for 5 minutes; soaking in 75%, 85%, and 95% graded ethanol solutions for 5 minutes each; soaking in 100% ethanol solutions I and II for 5 minutes each; soaking in xylene solutions I and II for 5 minutes each; mounting with neutral resin.

[0171] Table 3. Effects of different formulations on latency in asthma model rats (n=10) )

[0172]

[0173] Note: Compared with the normal group, **P<0.01.

[0174] Table 4. Effects of different formulations on WBC, EOS, and TP in asthma model rats (n=10) )

[0175]

[0176]

[0177] Note: Compared with the normal group, **P<0.01; compared with the model group, ##P<0.01.

[0178] Conclusion: This experiment established an asthmatic rat model through ovalbumin sensitization and comprehensively evaluated the therapeutic effect of the drug from the perspectives of inflammation and immunity. As shown in Table 3, the herbal composition of this invention significantly prolonged the asthma latency period in the model rats, indicating that it can effectively control the onset of asthma symptoms. As shown in Table 4, the composition significantly reduced the total white blood cell count (WBC) and eosinophil count (EOS) in bronchoalveolar lavage fluid (BALF), both of which are core markers of allergic airway inflammation; at the same time, the reduction in total protein (TP) content in BALF indicates that it can also alleviate the increased vascular permeability and mucosal edema caused by airway inflammation. This comprehensively proves that the composition can not only relieve asthma symptoms but also treat the core pathological aspects of asthma through "anti-inflammatory" and "anti-allergic" effects, deeply demonstrating its therapeutic advantage of "dispersing cold and clearing the lungs, strengthening the spleen and resolving phlegm" to eliminate the cause rather than simply relieving symptoms. All the individual prescription groups were far less effective than the whole prescription group in improving inflammatory indicators, confirming the indispensable synergistic role of relieving exterior syndromes and dispelling cold (Saposhnikovia divaricata, Asarum heterotropoides), strengthening the spleen and removing dampness (Poria cocos, Atractylodes macrocephala), and expectorant and antitussive drugs in inhibiting airway inflammation.

[0179] Figure 1 The effects of the normal group, model group, positive group, and low, medium, and high dose groups of the traditional Chinese medicine composition in Example 3 on the pathological changes of ovalbumin-induced asthmatic lung tissue (HE staining). Figure 1 As can be seen, compared with the normal group, the lung tissue of the model group rats showed a large number of inflammatory cells (especially eosinophils) infiltrating around the bronchi and blood vessels, thickened bronchial walls, narrowed luminal cavities, and epithelial cell shedding, which are typical pathological changes of asthma. After treatment with the traditional Chinese medicine composition of this invention (Example 3), the above-mentioned pathological changes were significantly improved in all dosage groups, especially the medium and high dosage groups. The infiltration of inflammatory cells was significantly reduced, and the airway structure tended to be intact. The effect was comparable to that of the positive control group and showed a certain dose-dependent effect. This directly confirms that the composition can effectively reduce airway inflammation and pathological damage in asthma.

[0180] Figure 2 To compare the effects of the traditional Chinese medicine compositions of Examples 10-13 on the lung tissue pathology of ovalbumin-induced asthmatic rats (HE staining), from... Figure 2 It can be seen that the degree of improvement in lung tissue pathology in each of the individual prescription groups (comparative examples 10-13) was significantly worse than that in the whole prescription group, with relatively obvious inflammatory cell infiltration and airway structure destruction still visible. This result strongly demonstrates the completeness and necessity of the prescription at the histopathological level. The absence of any of the herbs that relieve exterior syndromes, dispel cold, dry dampness and resolve phlegm, or moisten the lungs and relieve cough would lead to a decrease in its overall anti-inflammatory and lung tissue damage-reducing efficacy.

[0181] 3. Expectorant effect (phenol red expectorant assay in mice)

[0182] 3.1 Grouping

[0183] Several clean-grade SD mice, weighing 18-22g, with equal numbers of males and females, were randomly divided into groups of 10 mice each.

[0184] One normal group (equal volume of distilled water);

[0185] Two positive drug groups (Qingshi granules 7.90g / kg);

[0186] Groups 3, 4, and 5 are the low, medium, and high dose groups of particles in Example 1 of this invention (5.60, 11.19, and 22.36 g / kg, respectively);

[0187] Groups 6-14 were the particle solutions (11.19 g / kg) from Comparative Examples 1-9, respectively.

[0188] Groups 15, 16, and 17 are the low, medium, and high dose groups of particles in Example 2 of this invention (5.60, 11.19, and 22.36 g / kg, respectively);

[0189] Groups 18-21 consist of 10-13 separate drug formulations (11.19g / kg).

[0190] 3.2 Test Methods

[0191] Mice were administered the drug via intragastric gavage (ig) for 7 consecutive days. Forty minutes after the last administration, each mouse was intraperitoneally injected with 0.5 ml of 0.25% phenol red saline solution (preparation of phenol red saline: dissolve 0.5 g of phenol red in 5 ml of 1M NaOH, then dilute to 200 ml with normal saline). Forty minutes later, the mice were euthanized by cervical dislocation. The trachea and bronchi of the mice were irrigated three times with 0.5 ml of 5% NaHCO3 solution each time, and approximately 1.5 ml of irrigated fluid was collected. The absorbance was measured at 520 nm using a 754 spectrophotometer, with 5% NaHCO3 as a blank control. The results are shown in Table 5.

[0192] Table 5. Effects of different formulations on sputum expectoration volume in mice treated with phenol red expectorant (n=10) )

[0193] Group Dosage (g / kg) Absorbance (A) normal group / 0.0441±0.0359 Positive drug group 4.65 0.1573±0.1506* Example 1 Low-dose group 3.34 0.1305±0.1016* In Example 1, the dosage group 6.67 0.0860±0.0751 Example 1 High-dose group 13.33 0.1044±0.1001 Comparative Example 1 6.67 0.0751±0.0549 Comparative Example 2 6.67 0.0743±0.0156 Comparative Example 3 6.67 0.0754±0.0213 Comparative Example 4 6.67 0.0694±0.0195 Comparative Example 5 6.67 0.0699±0.0212 Comparative Example 6 6.67 0.0715±0.0518 Comparative Example 7 6.67 0.0721±0.0596 Comparative Example 8 6.67 0.0841±0.0614 Comparative Example 9 6.67 0.0818±0.0537 Example 2 Low-dose group 3.34 0.1411±0.1201* In Example 2, the dosage group 6.67 0.0961±0.0845 Example 2 High-dose group 13.33 0.1021±0.0994 Comparative Example 10 6.67 0.0624±0.0516 Comparative Example 11 6.67 0.0619±0.0637 Comparative Example 12 6.67 0.0649±0.0549 Comparative Example 13 6.67 0.0679±0.0418

[0194] Note: *P<0.05 compared to the normal group.

[0195] Conclusion: The expectorant ability of the drug was evaluated by the phenol red excretion method in mice in this experiment. The results showed that the low-dose group of the traditional Chinese medicine composition of the present invention could significantly increase the phenol red excretion amount in the airways of mice, indicating that it had a good effect of promoting the secretion of respiratory glands, diluting sputum, and facilitating the discharge of sputum. This effect was comparable to that of the classic expectorant Qingshi Chongji, and once again verified the efficacy of this composition of "invigorating the spleen and resolving phlegm, promoting the qi of the lungs". In contrast, the phenol red excretion amounts of each disassembled formula group were significantly lower than those of the whole formula group, indicating that the absence of any single herb would weaken the expectorant effect of the whole formula, further proving the rationality and necessity of the compatibility of this formula.

[0196] 4. Anti-inflammatory effect (inhibitory effect on egg white-induced paw swelling in rats)

[0197] 4.1 Grouping

[0198] Several clean-grade male SD rats with a body weight of 200 - 220 g were randomly divided into groups of 10 each, where:

[0199] Group 1 was the normal group (equal volume of physiological saline);

[0200] Group 2 was the model group, without drug administration after modeling;

[0201] Group 3 was the positive drug group (Qingshi Chongji 7.80 g / kg);

[0202] Groups 4, 5, and 6 were the low-, medium-, and high-dose groups of the granules in Example 1 of the present invention (5.60, 11.19, and 22.36 g / kg);

[0203] Groups 7 - 15 were the granule solutions in Comparative Examples 1 - 9 (11.19 g / kg);

[0204] Groups 16, 17, and 18 were the low-, medium-, and high-dose groups of the granules in Example 2 of the present invention (5.60, 11.19, and 22.36 g / kg);

[0205] Groups 19 - 22 were the disassembled formula groups of herbs 10 - 13 (11.19 g / kg).

[0206] 4.2 Test method

[0207] Oral administration was carried out at the doses shown in the table (0.5 ml / 100 g body weight) for 7 consecutive days. The volume of the right hind paw was measured by the volumetric method, and then 0.1 ml of 100% fresh egg white was injected subcutaneously into the right hind paw sole of each mouse 40 min after the last administration. The paw volume was measured at 0.5, 1, 1.5, 2, and 3 h after inflammation induction, and the foot swelling degree was obtained by subtracting the normal value from this volume. The results are shown in Table 6.

[0208] Table 6 Inhibitory effect of different formulae on egg white-induced paw swelling in rats (n = 10 )

[0209]

[0210] Note: **P<0.01 compared with the normal group; #P<0.05 compared with the model group.

[0211] Conclusion: This experiment evaluated the anti-inflammatory effect of the drug using an egg white-induced rat paw edema model. The results showed that the dosage groups of the herbal composition of this invention exhibited significant anti-inflammatory effects 1 to 3 hours after inflammation induction, effectively inhibiting inflammatory swelling. Their effects were comparable to those of the positive control drug, and the duration of action was longer. This indicates that the composition can inhibit early exudation and edema in inflammation, possessing clear anti-inflammatory pharmacological activity, providing pharmacodynamic evidence for its use in treating airway inflammation accompanying cough and asthma. The anti-inflammatory effects of each component group were weaker than those of the whole formula group, indicating that the whole formula exerts its anti-inflammatory effect synergistically through multiple components and pathways, and none of them can be omitted.

[0212] in conclusion

[0213] The traditional Chinese medicine composition provided by this invention has the following effects:

[0214] This invention, through systematic pharmacodynamic experiments, comprehensively verified the effectiveness and scientific formulation of the traditional Chinese medicine composition from four core dimensions: antitussive, antiasthmatic, expectorant, and anti-inflammatory.

[0215] With definite efficacy and comprehensive effects: This composition has significant inhibitory or ameliorative effects on cough, asthma, increased sputum secretion and inflammatory response induced by chemical substances (ammonia), immune factors (ovalin, acetylcholine / histamine) and physical stimulation (egg white), indicating that it has comprehensive pharmacological effects of antitussive, antiasthmatic, expectorant and anti-inflammatory, and can carry out multi-target treatment on the complex pathogenesis of cough and asthma (external pathogens, phlegm turbidity, qi stagnation, inflammation).

[0216] The dose-response relationship is clear: In the antitussive and antiasthmatic trials, a clear dose-response trend was observed in most cases, that is, the efficacy of the medium and high dose groups was usually better than that of the low dose group, which proved the reliability of the drug's effect.

[0217] Synergistic Combination and Essential Formulation: The analysis of the disassembled formula is a core highlight of this efficacy evaluation. All formula groups lacking key ingredients (such as Saposhnikovia divaricata and Asarum for relieving exterior symptoms; Pinellia ternata and Fritillaria cirrhosa for resolving phlegm; Poria cocos and Atractylodes macrocephala for strengthening the spleen) showed significantly lower efficacy indicators compared to the complete formula. This result strongly demonstrates the correctness and necessity of the formula's treatment system of "dispersing exterior pathogens, resolving phlegm, strengthening spleen qi, and benefiting lung qi," revealing the rigorous "principal, assistant, adjuvant, and guide" compatibility relationship and indispensable synergistic effects among the various ingredients. The complete formula, while eliminating pathogens, also addresses the need to strengthen the body's resistance and moisten dryness, avoiding the drawbacks of unilateral treatment or excessive attack.

[0218] Broad clinical application prospects: In summary, the preparation process of this traditional Chinese medicine composition is stable, the efficacy is clear and comprehensive, and the compatibility is scientific and reasonable. It is especially suitable for treating acute and chronic cough and asthma caused by unresolved external wind-cold, phlegm-dampness obstructing the lungs, or spleen deficiency and phlegm accumulation in the lungs. It has important development and application value in the treatment of respiratory diseases such as colds, acute bronchitis, and chronic obstructive pulmonary disease.

[0219] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A traditional Chinese medicine composition having the effects of dispelling cold and clearing the lungs, strengthening the spleen and resolving phlegm, relieving cough and asthma, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 4-8 parts honey-processed ephedra, 5-10 parts stir-fried bitter apricot kernel, 3-6 parts saposhnikovia root, 1-5 parts asarum, 2-5 parts ginger-processed pinellia, 2-7 parts fritillaria cirrhosa, 3-8 parts tangerine peel, 3-6 parts platycodon root, 2-6 parts stir-fried perilla seed, 3-8 parts honey-processed aster root, 5-11 parts honey-processed coltsfoot flower, 7-11 parts honey-processed white peony root, 2-6 parts poria cocos, and 2-5 parts atractylodes macrocephala.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: Honey-processed ephedra 5 parts, stir-fried bitter almond 7 parts, saposhnikovia root 4 parts, asarum 2 parts, ginger-processed pinellia 3 parts, fritillaria 3 parts, tangerine peel 4 parts, platycodon root 4 parts, stir-fried perilla seed 3 parts, honey-processed aster 5 parts, honey-processed coltsfoot flower 8 parts, honey-processed white peony root 8 parts, poria cocos 4 parts, atractylodes macrocephala 3 parts. Or, 6 parts honey-processed ephedra, 8 parts stir-fried bitter almond, 5 parts saposhnikovia root, 3 parts asarum, 4 parts ginger-processed pinellia, 4 parts fritillaria cirrhosa, 5 parts tangerine peel, 5 parts platycodon root, 4 parts stir-fried perilla seed, 6 parts honey-processed aster root, 9 parts honey-processed coltsfoot flower, 10 parts honey-processed white peony root, 4 parts poria cocos, and 3 parts atractylodes macrocephala. Or, 4 parts honey-processed ephedra, 6 parts stir-fried bitter almond, 3 parts saposhnikovia root, 1 part asarum, 3 parts ginger-processed pinellia, 3 parts fritillaria cirrhosa, 4 parts tangerine peel, 4 parts platycodon root, 3 parts stir-fried perilla seed, 5 parts honey-processed aster root, 7 parts honey-processed coltsfoot flower, 8 parts honey-processed white peony root, 5 parts poria cocos, and 4 parts atractylodes macrocephala. Alternatively, use 4 parts honey-processed ephedra, 5 parts stir-fried bitter almond, 3 parts saposhnikovia root, 1 part asarum, 2 parts ginger-processed pinellia, 3 parts fritillaria cirrhosa, 3 parts tangerine peel, 3 parts platycodon root, 2 parts stir-fried perilla seed, 4 parts honey-processed aster root, 6 parts honey-processed coltsfoot flower, 9 parts honey-processed white peony root, 3 parts poria cocos, and 2 parts atractylodes macrocephala. Alternatively, use 4 parts honey-processed ephedra, 7 parts stir-fried bitter almond, 5 parts saposhnikovia root, 2 parts asarum, 3 parts ginger-processed pinellia, 4 parts fritillaria cirrhosa, 5 parts tangerine peel, 3 parts platycodon root, 3 parts stir-fried perilla seed, 4 parts honey-processed aster root, 6 parts honey-processed coltsfoot flower, 10 parts honey-processed white peony root, 4 parts poria cocos, and 4 parts atractylodes macrocephala.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The aforementioned Chinese medicine composition is any pharmaceutically acceptable dosage form.

4. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, Includes the following steps: A) In the prescription, bitter almonds are crushed and added as ingredients, while the other medicinal ingredients are directly added as processed medicinal slices to obtain the raw materials; B) Soak the raw material in water for 30 to 60 minutes, decoct and extract 1 to 3 times, 1 to 3 hours each time, filter, and combine the filtrates; C) The extract is concentrated to obtain an extract with a relative density of 1.15 to 1.20; D) While the extract obtained in step C is still hot, add the flavoring agent and set aside. E) Centrifuge the drug obtained in step D to obtain centrifuged liquid; F) The centrifuged liquid obtained in step E is dried under vacuum to obtain a dry paste; G) Pulverize the dry paste obtained in step F; H) Add excipients to the dry powder obtained in step G to prepare the target dosage form, thus obtaining the traditional Chinese medicine composition.

5. The preparation method according to claim 4, characterized in that, The mass ratio of water to raw drug is (8-16):

1.

6. The preparation method according to claim 4, characterized in that, The flavoring agent is at least one of sucrose, stevia, aspartame, xylitol, fructose, and cyclamate.

7. The preparation method according to claim 4, characterized in that, The vacuum drying temperature is 60℃~80℃.

8. The preparation method according to claim 4, characterized in that, The excipient is at least one of dextrin, maltodextrin, soluble starch, corn starch, and lactose.

9. The use of the traditional Chinese medicine composition as described in any one of claims 1 to 3 in the preparation of a medicine for treating cough and asthma caused by exogenous wind-cold and phlegm-dampness obstruction.

10. The use of the traditional Chinese medicine composition as described in any one of claims 1 to 3 in the preparation of a medicine for treating chronic cough and asthma caused by spleen deficiency with dampness and phlegm obstructing the lungs.

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