Traditional Chinese medicine composition with effects of warming lung and relieving cough and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicines, and discloses a traditional Chinese medicine composition with effects of warming lung and relieving cough and application thereof. The traditional Chinese medicine composition provided by the invention comprises honey-fried ephedra, tussilago farfara, liquorice tablets, perilla stems, blackberry lily, vinegar-processed schisandra chinensis, fried perilla fruits, fried semen lepidii, rhizoma pinellinae praeparata, loquat leaves, scalded semen armeniacae amarae, pericarpium trichosanthis, pericarpium citri reticulatae and asarum. Wherein the stir-fried ephedra has the effects of dispelling cold and wind and enabling wind-cold evil to come out from the exterior, the stir-fried bitter apricot kernel has the effects of releasing bitter and lowering bitter, externally freeing the exterior of the lung and internally clearing and discharging depression of lung qi, the perilla stem is pungent and slightly warm in taste and has the main effect of lowering, the perilla stem has the effects of relieving chest stuffiness and disinhibiting diaphragm when entering the lung, the fried perilla fruit has the effects of depressing qi and dissolving phlegm and relieving cough and asthma, and the fried semen lepidii has the effects of releasing, dispersing and lowering, and conforms to the physiological functions of releasing, dispersing and lowering of the lung; and the traditional Chinese medicine is also suitable for the pathogenesis of exogenous cough. The flos farfarae has the effects of moistening lung, descending qi, reducing phlegm and stopping cough, the vinegar-processed schisandra chinensis has the effects of astringing lung and stopping cough, the folium eriobotryae has the effects of clearing lung and stopping cough, and the pericarpium trichosanthis has the effects of clearing heat and reducing phlegm; pericarpium citri reticulatae, rhizoma pinellinae praeparata and herba asari have the effects of eliminating dampness and phlegm and regulating qi and middle warmer, rhizoma belamcandae has the effects of dissolving phlegm and relieving sore-throat and are used as adjuvant drugs, and liquorice tablets are used for harmonizing the drugs and have the effects of freeing lung, dispelling cold, eliminating phlegm and stopping coughing through compatibility of the drugs.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition with the effects of warming the lungs and relieving cough, and its application. Background Technology

[0002] Currently, there are various treatment options for cough, but in the management of pediatric cough, due to the difficulty of taking medication and the challenge of controlling drug dosage, the current research and improvement of granule dosage forms have not yet fully met clinical needs.

[0003] Therefore, there is an urgent need for a suitable medication for treating children's coughs. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition with the effect of warming the lungs and relieving cough and its application. The traditional Chinese medicine composition has the effects of warming the lungs and relieving asthma, resolving phlegm and relieving cough. Compared with the prior art, it has a variety of combinations, is less likely to produce drug resistance, and is more suitable for treating children's cough.

[0005] This invention provides a traditional Chinese medicine composition with the effect of warming the lungs and relieving cough, comprising: honey-processed ephedra, coltsfoot flower, licorice root slices, perilla stem, belamcanda rhizome, vinegar-processed schisandra fruit, stir-fried perilla seed, stir-fried lepidium seed, processed pinellia tuber, loquat leaf, scalded bitter almond, trichosanthes peel, tangerine peel, and asarum.

[0006] The following are preferred technical solutions of the present invention, but are not intended to limit the technical solutions provided by the present invention. The purpose and beneficial effects of the present invention can be better achieved and realized through the following preferred technical solutions.

[0007] As a preferred technical solution, the traditional Chinese medicine composition with the effect of warming the lungs and relieving cough is composed of the following raw materials in parts by weight:

[0008] Honey-processed ephedra 1-5 parts, coltsfoot flower 3-7 parts, licorice root slices 3-7 parts, perilla stem 3-7 parts, belamcanda chinensis 3-7 parts, vinegar-processed schisandra chinensis 3-7 parts, stir-fried perilla seed 3-7 parts, stir-fried lepidium seed 3-7 parts, prepared pinellia ternata 3-7 parts, loquat leaf 8-12 parts, blanched bitter almond 3-7 parts, trichosanthes peel 8-12 parts, dried tangerine peel 3-7 parts, asarum 1-3 parts.

[0009] As a preferred technical solution, the traditional Chinese medicine composition with the effect of warming the lungs and relieving cough is composed of the following raw materials in parts by weight:

[0010] 1 part honey-processed ephedra, 3 parts coltsfoot flower, 3 parts licorice root slices, 3 parts perilla stem, 3 parts belamcanda rhizome, 3 parts vinegar-processed schisandra fruit, 3 parts stir-fried perilla seed, 3 parts stir-fried lepidium seed, 3 parts prepared pinellia tuber, 8 parts loquat leaf, 3 parts blanched bitter almond, 8 parts trichosanthes peel, 3 parts dried tangerine peel, 1 part asarum.

[0011] As a preferred technical solution, the traditional Chinese medicine composition with the effect of warming the lungs and relieving cough is composed of the following raw materials in parts by weight:

[0012] 5 parts honey-processed ephedra, 5 parts coltsfoot flower, 5 parts licorice root slices, 5 parts perilla stem, 5 parts belamcanda rhizome, 5 parts vinegar-processed schisandra fruit, 5 parts stir-fried perilla seed, 5 parts stir-fried lepidium seed, 5 parts prepared pinellia tuber, 12 parts loquat leaf, 5 parts blanched bitter almond, 12 parts trichosanthes peel, 5 parts dried tangerine peel, and 3 parts asarum.

[0013] As a preferred technical solution, the traditional Chinese medicine composition with the effect of warming the lungs and relieving cough is composed of the following raw materials in parts by weight:

[0014] Honey-processed ephedra 2-4 parts, coltsfoot flower 4-6 parts, licorice root slices 4-6 parts, perilla stem 4-6 parts, belamcanda chinensis 4-6 parts, vinegar-processed schisandra chinensis 4-6 parts, stir-fried perilla seed 4-6 parts, stir-fried lepidium seed 4-6 parts, prepared pinellia ternata 4-6 parts, loquat leaf 9-11 parts, blanched bitter almond 4-6 parts, trichosanthes peel 9-11 parts, dried tangerine peel 4-6 parts, asarum 2-3 parts.

[0015] As a preferred technical solution, the traditional Chinese medicine composition with the effect of warming the lungs and relieving cough is composed of the following raw materials in parts by weight:

[0016] 2 parts honey-processed ephedra, 4 parts coltsfoot flower, 4 parts licorice root slices, 4 parts perilla stem, 4 parts belamcanda rhizome, 4 parts vinegar-processed schisandra fruit, 4 parts stir-fried perilla seed, 4 parts stir-fried lepidium seed, 4 parts prepared pinellia tuber, 9 parts loquat leaf, 4 parts blanched bitter almond, 9 parts trichosanthes peel, 4 parts dried tangerine peel, 2 parts asarum.

[0017] As a preferred technical solution, the traditional Chinese medicine composition with the effect of warming the lungs and relieving cough is composed of the following raw materials in parts by weight:

[0018] 4 parts honey-processed ephedra, 6 parts coltsfoot flower, 6 parts licorice root slices, 6 parts perilla stem, 6 parts belamcanda rhizome, 6 parts vinegar-processed schisandra fruit, 6 parts stir-fried perilla seed, 6 parts stir-fried lepidium seed, 6 parts prepared pinellia tuber, 11 parts loquat leaf, 6 parts blanched bitter almond, 11 parts trichosanthes peel, 6 parts dried tangerine peel, and 3 parts asarum.

[0019] As a preferred technical solution, the traditional Chinese medicine composition with the effect of warming the lungs and relieving cough is composed of the following raw materials in parts by weight:

[0020] 3 parts honey-processed ephedra, 5 parts coltsfoot flower, 5 parts licorice root slices, 5 parts perilla stem, 5 parts belamcanda rhizome, 5 parts vinegar-processed schisandra fruit, 5 parts stir-fried perilla seed, 5 parts stir-fried lepidium seed, 5 parts prepared pinellia tuber, 10 parts loquat leaf, 5 parts blanched bitter almond, 10 parts trichosanthes peel, 5 parts dried tangerine peel, and 2 parts asarum.

[0021] This invention provides a method for preparing a traditional Chinese medicine composition with the effects of warming the lungs and relieving cough, comprising:

[0022] Weigh out the following ingredients according to the formula: honey-processed ephedra, coltsfoot flower, licorice root slices, perilla stem, belamcanda rhizome, vinegar-processed schisandra fruit, stir-fried perilla seed, stir-fried lepidium seed, prepared pinellia tuber, loquat leaf, scalded bitter almond, trichosanthes peel, dried tangerine peel, and asarum. Add water and decoct, filter, combine the filtrates, and concentrate to obtain the final product.

[0023] As a preferred technical solution, the method for preparing the traditional Chinese medicine composition with the effect of warming the lungs and relieving cough includes the following steps: the decoction is performed 2-3 times, with 8-12 times the amount of water added each time, and the decoction is performed for 0.5-2 hours; the concentration is performed to a density of 1.25-1.30 g / mL.

[0024] This invention provides a medicine with the effect of warming the lungs and relieving cough, comprising the above-mentioned traditional Chinese medicine composition and / or the traditional Chinese medicine composition prepared by the above-mentioned preparation method.

[0025] As a preferred technical solution, the dosage form of the drug includes pills, capsules, granules, oral liquids, tablets, lozenges, powders, ointments, and syrups. Granules are the preferred dosage form. Suitable drug carriers in the art can be selected for different dosage forms.

[0026] As a preferred technical solution, the method for preparing the granules includes:

[0027] Take the prescribed amount of medicinal slices, decoct them, and collect the filtrate.

[0028] The filtrate was concentrated to obtain a clear extract;

[0029] Add excipients to the ointment, mix well, and transfer to a granulator to prepare granules.

[0030] As a preferred technical solution, the excipients are sucrose powder and dextrin, and the mass ratio of the extract to the excipients is 1:2. Among the excipients, the mass ratio of sucrose powder to dextrin is 1:3.

[0031] The present invention provides the application of the above-mentioned traditional Chinese medicine composition and the above-mentioned drug in the preparation of a medicine for treating pediatric cough.

[0032] As a preferred technical solution, childhood cough includes the following symptoms:

[0033] The cough is heavy, paroxysmal, and occasionally short of breath. The sputum is thin, white, or absent. It is often accompanied by nasal congestion, runny nose, headache, or chills, fever, and absence of sweating. The tongue coating is thin and white, and the pulse is floating or floating and tight. It is a cough caused by external wind-cold.

[0034] The properties of the traditional Chinese medicine components used in this invention are further explained below.

[0035] Honey-processed ephedra: Honey-processed ephedra has the effect of moistening the lungs and relieving cough, and is often used for cough with wheezing after the exterior syndrome has been relieved. Ephedra mainly contains alkaloids, phenolic acids, volatile oils, flavonoids, polysaccharides, etc. After being processed with honey, the levels of ephedrine, total flavonoids, and total phenolic acids are significantly reduced, while the levels of volatile components are increased. The metabolic processes by which limonene and α-terpinene participate in the regulation of thyroid hormone signaling pathways and neuroactive ligand-receptor interactions through their interaction with nuclear receptors NCOA1 and NR3C1 may be related to the enhanced cough-relieving and asthma-relieving effects of honey-processed ephedra.

[0036] Coltsfoot flower: pungent, slightly bitter, warm. It enters the lung meridian. It moistens the lungs, lowers qi, relieves cough and resolves phlegm. It is often used for acute and chronic coughs, wheezing cough with excessive phlegm, and cough with hemoptysis due to overwork. Coltsfoot flower mainly contains sesquiterpenes, triterpenes, flavonoids, organic acids, alkaloids, volatile oils, etc., as well as steroids, chromones, trace elements, tannins, amino acids, and other chemical components. Modern research shows that the cough-relieving and phlegm-resolving effects of coltsfoot flower are closely related to the regulation of intestinal flora composition and metabolites. Kaempferol, 3,5-caffeoylquinic acid, and 4,5-caffeoylquinic acid are the main components of coltsfoot flower's antitussive effect, which can relieve bronchospasm caused by acetylcholine or histamine. At the same time, coltsfoot ketones are the main anti-inflammatory active substances in coltsfoot flower, achieving anti-inflammatory effects by inhibiting transcription factors and regulating the balance of inflammatory factors.

[0037] Licorice tablets: They possess the functions of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, alleviating spasms and pain, and harmonizing the effects of other medications. They mainly contain flavonoids and saponins, with the flavonoids primarily being apigenin, glycyrrhizin, apigenin isoglycyrrhizin, and isoglycyrrhizin. These compounds exhibit pharmacological activities such as expectoration, antitussive, anti-inflammatory, antioxidant, and anti-fibrotic effects. The main triterpenoid is glycyrrhizic acid, which has anti-inflammatory, detoxifying, immunomodulatory, and antiviral effects. The pharmacological effects of these components are closely related to the "clearing heat and detoxifying, resolving phlegm and relieving cough" effects of licorice, and are the main active medicinal components in licorice.

[0038] Perilla stem: It has the effects of regulating qi, relieving chest tightness, alleviating pain, and calming the fetus. It can be used for symptoms such as chest tightness and stomach pain. Its main chemical components are volatile oils (perilla ketone, perilla aldehyde, β-caryophyllene), flavonoids (luteolin, luteolin-7-O-diglucuronide), phenolic acids (rosmarinic acid, caffeic acid), and terpenes (oleanolic acid). Perilla stem extract can reduce inflammatory cell infiltration in the lungs of asthmatic tracheal model mice, decrease white blood cell count and inflammatory factor levels, and inhibit the expression of key proteins in inflammatory signaling pathways. Luteolin and perilla aldehyde may be the main components exerting the anti-inflammatory effect.

[0039] Belamcanda chinensis (Belamcanda chinensis): It has the effects of clearing heat and detoxifying, resolving phlegm, and relieving sore throat. It is often used for symptoms such as heat-toxin phlegm-fire stagnation, sore throat, excessive phlegm, cough, and wheezing. Belamcanda chinensis contains a variety of chemical components, mainly including flavonoids, phenolic acids, steroids, volatile oils, and triterpenoids. Among them, flavonoids are the main chemical components of Belamcanda chinensis, including irisinin, irisin, irisin A, and irisin, which are potential quality markers in Belamcanda chinensis. Modern pharmacological studies have shown that Belamcanda chinensis can play an anti-inflammatory role by inhibiting the levels of pro-inflammatory factors and reducing iNOS and COX levels to correct the Th1 / Th2 balance. At the same time, the flavonoid components in Belamcanda chinensis can participate in the regulation of target proteins such as PTGS1, 5lox, PTGS2, RORγt, and NK1, inhibiting the frequency of cough and prolonging the latency of cough, thereby achieving the effect of relieving cough.

[0040] Vinegar-processed Schisandra: Vinegar-processed Schisandra has astringent, qi-tonifying, fluid-generating, kidney-tonifying, and heart-calming effects. It is used for chronic cough and wheezing, nocturnal emission, frequent urination, chronic diarrhea, spontaneous sweating and night sweats, thirst due to fluid depletion, internal heat and thirst, palpitations, and insomnia. The astringent properties of Schisandra are enhanced after vinegar processing. Schisandra mainly contains terpenes, lignans, glycosides, and organic acids. After vinegar processing, the content of lignans schisandrin A, schisandrin B, and schisandrin A, and the content of the organic acid 5-hydroxymethylfurfural are significantly increased, while other contents remain unchanged. Simultaneously, modern pharmacological studies have shown that vinegar processing of Schisandra reduces the degree of lipid peroxidation in the body; it can increase the phagocytic index of peritoneal macrophages in immunocompromised mice, increase the weight of immune organs such as the thymus and spleen, and enhance the body's immunity.

[0041] Fried Lepidium seed: It clears lung heat and relieves asthma, and is often used for symptoms such as phlegm accumulation in the lungs, wheezing, and excessive phlegm. Currently, various chemical components, including glucosinolates, isothiocyanates, flavonoids, lignans, nucleosides, organic acids, and amides, have been isolated from Lepidium seed. Modern research shows that Lepidium seed has effects such as improving cardiovascular function, anti-tumor activity, antitussive, expectorant, and asthma relief. Among them, total flavonoids exert their therapeutic effect on asthma by reducing the proliferation level of lung smooth muscle cells and inhibiting airway remodeling in asthma. Quercetin-3-OBD-gentian disaccharide can inhibit lung tissue cell apoptosis by balancing the Th17 / Treg balance in peripheral blood.

[0042] Processed Pinellia ternata: Dries dampness and resolves phlegm. Used for cough and asthma with excessive phlegm, dizziness and palpitations due to phlegm retention, vertigo due to wind-phlegm, and headache due to phlegm syncope. Pinellia ternata has a high starch content, and other chemical components mainly include alkaloids, organic acids, volatile oils, proteins, flavonoids, sterols, and abundant inorganic elements. After processing, glycyrrhizic acid and ammonium glycyrrhizate can be detected in processed Pinellia ternata. At the same time, the content of calcium oxalate needle crystals and lysophosphatidylcholine is significantly reduced, decreasing the irritation and toxicity of Pinellia ternata. Alkaloids are one of the main active ingredients in Pinellia ternata, possessing antitussive and expectorant effects. Simultaneously, all processed Pinellia ternata products have anti-inflammatory effects, the mechanism of which is related to reducing the secretion of inflammatory factors interleukin-6 and tumor necrosis factor-α, and improving the inflammatory response in a respiratory tract inflammation model mouse by inhibiting p38 and IKB phosphorylation.

[0043] Loquat leaves: Clear the lungs and relieve cough, reduce nausea and vomiting. Used for cough due to lung heat, shortness of breath, vomiting due to stomach heat, and thirst due to fever. Loquat leaves mainly contain triterpenoids, flavonoids, and cyanogenic glycosides, which can clear the lungs and relieve cough, lower blood sugar, and have a certain therapeutic effect on type 2 diabetes. Among them, flavonoids may be the key expectorants, exerting their expectorant effect by inhibiting the action of signal transduction factors, transcription activators, and NF-κB, and significantly reducing the level of inflammatory factors in serum. They can be used as quality markers for cough relief and expectoration in loquat leaves.

[0044] Bitter almonds: Relieve cough and asthma, moisten the intestines and promote bowel movements. Used for cough and asthma, chest fullness with excessive phlegm, and constipation due to intestinal dryness. Bitter almonds mainly contain cyanogenic glycosides, fatty acids, volatile oils, amino acids, flavonoids, etc. Their mechanisms of action for relieving cough and asthma include: 1) inhibiting the inflammatory response of pneumonia tissue, reducing mucoprotein secretion and inflammatory cell infiltration in the pulmonary interstitium; 2) promoting the synthesis of pulmonary surfactant, which is beneficial to lung respiratory function; 3) amygdalin can be enzymatically broken down into hydrocyanic acid, which exerts its antitussive and antiasthmatic effects by inhibiting the respiratory center and relaxing bronchial smooth muscle.

[0045] Trichosanthes peel: Clears heat and resolves phlegm, regulates qi and relieves chest tightness. Used for cough with phlegm and heat, chest tightness and hypochondriac pain. It mainly contains active ingredients such as terpenes and glycosides, flavonoids and flavonoid glycosides, sterols, polysaccharides, and oils. The total amino acids in Trichosanthes peel have a good expectorant effect. Among them, aspartic acid can relieve cellular inflammation, reduce secretions, and enhance cellular immunity; cysteine ​​can dilute phlegm by breaking down mucoproteins in phlegm. These effects correspond to the traditional efficacy of "clearing heat and resolving phlegm".

[0046] Dried tangerine peel: It regulates qi and strengthens the spleen, dries dampness and resolves phlegm. It is used for abdominal distension, poor appetite, vomiting and diarrhea, and cough with excessive phlegm. It mainly contains flavonoids, volatile oils, alkaloids, limonene, and other chemical components. Among them, the volatile oil and water extract of dried tangerine peel can inhibit the spontaneous activity of tracheal smooth muscle, thus playing a role in "regulating qi." Components in dried tangerine peel such as dextrorotatory limonene, volatile oils, and hesperidin can block interleukin-1β signaling, increase bronchial phenol red secretion, and protect lung cells, thus playing a role in "resolving phlegm." Modern research also shows that dried tangerine peel has anti-inflammatory, anti-Alzheimer's disease, anti-Parkinson's disease, and bone-protective effects.

[0047] Asarum: Relieves exterior syndromes and dispels cold, dispels wind and relieves pain, clears the nasal passages, warms the lungs and resolves phlegm. Used for common cold due to wind-cold, headache, toothache, nasal congestion and runny nose, rhinitis, sinusitis, rheumatic pain, and cough with phlegm. Its chemical components mainly include lignans, volatile oils, acids, and glycosides, among which lignans and volatile oils are considered the main active ingredients. Multiple components in Asarum exert their anti-inflammatory and anti-asthmatic effects by acting on various signaling pathways, including anti-inflammatory and airway remodeling inhibition. Methyleugenol is particularly effective. Simultaneously, β-asarone also has beneficial effects, acting directly on bronchial smooth muscle by antagonizing H1 and M receptors, thus treating bronchial asthma holistically, and exerting an anti-asthmatic effect by inhibiting neurotransmission in the medullary respiratory neuronal network.

[0048] Roasted perilla seeds: These seeds have the effects of lowering qi and resolving phlegm, relieving cough and asthma. They can be used for symptoms such as phlegm accumulation, shortness of breath, cough, and wheezing. Perilla seeds contain various chemical components, including volatile oils, fatty acids, flavonoids, phenolic acids, and phytosterols. Modern research shows that phenolic acids are the main water-soluble components of perilla seeds, mostly rosmarinic acid, caffeic acid, and their glycosides and ester derivatives. Rosmarinic acid is a natural oxidant with strong antioxidant activity and is the main active ingredient in perilla seeds, possessing antibacterial, antiviral, and antioxidant physiological effects. Perilla seeds contain a large amount of flavonoids, the main components of which are luteolin and apigenin, exhibiting good antioxidant activity. Treatment with a small dose of perilla seed water extract on the basis of routine symptomatic treatment for asthma patients showed that the total effective rate increased from 78.8% to 90.4%, and it effectively relieved clinical symptoms such as wheezing, shortness of breath, chest tightness, and cough in asthma patients, further confirming the important role of perilla seeds in modern asthma treatment. In addition, perilla seeds also contain some sugars and amino acids, which have pharmacological effects such as anti-aging, sedation, anti-allergy, liver protection, anti-inflammation, blood pressure reduction, antibacterial, and regulation of glucose and lipid metabolism.

[0049] Compared with the prior art, the embodiments of the present invention have the following advantages:

[0050] According to embodiments of the present invention, a traditional Chinese medicine composition with the function of warming the lungs and relieving cough is provided. Honey-processed ephedra dispels cold and wind, allowing the pathogenic wind-cold to be expelled from the surface; roasted bitter apricot kernel disperses and descends, externally clearing the lung surface and internally relieving stagnation of lung qi; perilla stem is pungent and slightly warm, primarily descending, and when it enters the lungs, it widens the chest and benefits the diaphragm; roasted perilla seed descends qi, eliminates phlegm, relieves cough and asthma; roasted lepidium seed clears the lungs and relieves asthma. These five herbs have dispersing, descending, and purging properties, conforming to the physiological functions of the lungs in dispersing and descending, and also conforming to the pathogenesis of exogenous cough, thus serving as the principal herb. Coltsfoot flower moistens the lungs, descends qi, resolves phlegm, and relieves cough; vinegar-processed schisandra fruit astringes the lungs and relieves cough; loquat leaf clears the lungs and relieves cough; trichosanthes peel clears heat and resolves phlegm. These four herbs, combined with the principal herb, assist its dispersing, descending, and purging functions, exerting the effects of moistening the lungs, resolving phlegm, astringing the lungs, and relieving cough, thus serving as the assistant herbs. Tangerine peel, prepared pinellia, and asarum are used to dry dampness, resolve phlegm, regulate qi, and harmonize the middle jiao. Belamcanda chinensis is used to eliminate phlegm and soothe the throat; these are all used as adjuvant herbs. Licorice root slices harmonize the other herbs. Together, these herbs work to promote lung function, dispel cold, resolve phlegm, and stop coughing. Guided by the theory of viscera and bowels, this formula advocates warming the lungs, strengthening the spleen to aid digestion, and resolving phlegm and fluid retention. It treats the lungs from a holistic perspective and has excellent therapeutic effects on children with lung deficiency caused by cold pathogens invading the lungs. Detailed Implementation

[0051] To enable those skilled in the art to better understand the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0052] Example 1

[0053] 1 part honey-processed ephedra, 3 parts coltsfoot flower, 3 parts licorice root slices, 3 parts perilla stem, 3 parts belamcanda rhizome, 3 parts vinegar-processed schisandra fruit, 3 parts stir-fried perilla seed, 3 parts stir-fried lepidium seed, 3 parts prepared pinellia tuber, 8 parts loquat leaf, 3 parts blanched bitter almond, 8 parts trichosanthes peel, 3 parts dried tangerine peel, 1 part asarum.

[0054] Example 2

[0055] 5 parts honey-processed ephedra, 5 parts coltsfoot flower, 5 parts licorice root slices, 5 parts perilla stem, 5 parts belamcanda rhizome, 5 parts vinegar-processed schisandra fruit, 5 parts stir-fried perilla seed, 5 parts stir-fried lepidium seed, 5 parts prepared pinellia tuber, 12 parts loquat leaf, 5 parts blanched bitter almond, 12 parts trichosanthes peel, 5 parts dried tangerine peel, and 3 parts asarum.

[0056] Example 3

[0057] 2 parts honey-processed ephedra, 4 parts coltsfoot flower, 4 parts licorice root slices, 4 parts perilla stem, 4 parts belamcanda rhizome, 4 parts vinegar-processed schisandra fruit, 4 parts stir-fried perilla seed, 4 parts stir-fried lepidium seed, 4 parts prepared pinellia tuber, 9 parts loquat leaf, 4 parts blanched bitter almond, 9 parts trichosanthes peel, 4 parts dried tangerine peel, 2 parts asarum.

[0058] Example 4

[0059] 4 parts honey-processed ephedra, 6 parts coltsfoot flower, 6 parts licorice root slices, 6 parts perilla stem, 6 parts belamcanda rhizome, 6 parts vinegar-processed schisandra fruit, 6 parts stir-fried perilla seed, 6 parts stir-fried lepidium seed, 6 parts prepared pinellia tuber, 11 parts loquat leaf, 6 parts blanched bitter almond, 11 parts trichosanthes peel, 6 parts dried tangerine peel, and 3 parts asarum.

[0060] Example 5

[0061] 3 parts honey-processed ephedra, 5 parts coltsfoot flower, 5 parts licorice root slices, 5 parts perilla stem, 5 parts belamcanda rhizome, 5 parts vinegar-processed schisandra fruit, 5 parts stir-fried perilla seed, 5 parts stir-fried lepidium seed, 5 parts prepared pinellia tuber, 10 parts loquat leaf, 5 parts blanched bitter almond, 10 parts trichosanthes peel, 5 parts dried tangerine peel, and 2 parts asarum.

[0062] Preparation Examples

[0063] The above fourteen ingredients are decocted three times, with 8 times the amount of water added each time, and decocted for 1 hour each time. The decoction is filtered, the filtrates are combined, and the concentrated extract is obtained with a total relative density of about 1.25 to 1.30 (80℃). The extract is cooled, and appropriate amounts of dextrin and sucrose powder are added and mixed well. The extract is then granulated, dried, and sized to obtain the final product.

[0064] Treatment effect:

[0065] The patients ranged in age from 1 to 14 years, including 65 boys and 35 girls, with 100 cases of cough due to wind-cold.

[0066] 1. Treatment Plan

[0067] (1) Diagnostic criteria:

[0068] The diagnostic criteria for cough in Traditional Chinese Medicine are based on the "Standards for Diagnosis and Treatment of Diseases in Traditional Chinese Medicine".

[0069] Formulated with reference to the "Standards for Diagnosis and Efficacy of Diseases in Traditional Chinese Medicine" issued by the State Administration of Traditional Chinese Medicine in 2012 and the national higher education textbook for traditional Chinese medicine (ninth edition) "Pediatrics in Traditional Chinese Medicine" (edited by Wang Shouchuan):

[0070] Diagnostic basis:

[0071] ①The main symptom is cough, which often occurs after a cold and is frequently triggered by changes in weather.

[0072] ② It is most common in winter and spring.

[0073] ③ Cough due to wind-cold attacking the lungs: frequent coughing, expectoration of phlegm, thin and clear white phlegm, nasal congestion with clear runny nose, chills without sweating.

[0074] It may be accompanied by fever, pale red tongue, thin white coating, floating and tight pulse, or floating red finger veins.

[0075] Traditional Chinese Medicine Symptom Scoring Criteria: See the table below

[0076] Traditional Chinese Medicine Symptom Scoring Standards

[0077]

[0078]

[0079] Note: Tongue and pulse are not scored.

[0080] (2) Inclusion criteria:

[0081] ① It meets the diagnostic criteria for pediatric bronchitis in Western medicine (Zhu Futang Practical Pediatrics, 7th Edition, edited by Hu Yamei) and the diagnostic criteria for wind-cold cough in traditional Chinese medicine.

[0082] ② Children aged 1-14 years.

[0083] ③ Informed consent from parents or guardians of the test subjects.

[0084] (3) Exclusion criteria:

[0085] ① Individuals under 6 months of age or over 14 years of age, those with allergies, or those allergic to this drug.

[0086] ② Individuals with severe pulmonary diseases, lung abscesses, and systemic diseases of the heart, brain, respiratory system, liver, kidneys, etc.

[0087] ③ Patients with mental illness or other serious primary diseases.

[0088] ④ Failure to meet inclusion criteria, failure to use medication as prescribed, inability to determine efficacy, or incomplete data, etc., affecting efficacy or

[0089] Safety assessor.

[0090] (4) Treatment methods:

[0091] Prescription: Lung-warming and cough-relieving formula (prescription composition: honey-processed ephedra 3g, coltsfoot flower 5g, licorice root slices 5g, perilla stem 5g, belamcanda rhizome 5g, vinegar-processed schisandra fruit 5g, stir-fried perilla seed 5g, stir-fried lepidium seed 5g, prepared pinellia tuber 5g, loquat leaf 10g, roasted bitter apricot kernel 5g, trichosanthes peel 10g, tangerine peel 5g, asarum 2g), decocted in water and taken orally.

[0092] Dosage and administration: 1-3 years old: 33 ml / dose (1 / 3 of adult dose), 3 times a day; 4-6 years old: 67 ml / dose (2 / 3 of adult dose), 3 times a day; 7-14 years old: 100 ml / dose (adult dose), 3 times a day.

[0093] Treatment course: 1 week is 1 treatment course, and a total of 1 treatment course is required.

[0094] (5) Observation items and indicators:

[0095] 1) Safety indicators

[0096] The routine physical examination includes three routine tests and liver and kidney function tests. (These tests are performed once before and after each group's test.)

[0097] 2) Therapeutic indicators

[0098] ①Symptoms and therapeutic effects of wind-cold attacking the lungs:

[0099] Main symptoms: cough, expectoration of phlegm, thin and white phlegm;

[0100] Secondary symptoms: chills, no sweating, nasal congestion with clear runny nose, fever;

[0101] Tongue and pulse: The tongue is pale red with a thin white coating, and the pulse is floating and tight or the finger veins are floating red.

[0102] ② Changes in physical signs before and after treatment. Based on the severity of the child's various clinical symptoms, scores were assigned as follows: ① Primary symptom scores were 0, 2, 4, and 6 points respectively; ② Secondary symptom scores were 0 and 1 point respectively.

[0103] (6) Efficacy evaluation criteria:

[0104] The efficacy evaluation standards were formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" approved in 2002.

[0105] 1) Disease efficacy evaluation criteria

[0106] Observe the changes in the main symptoms before and after treatment:

[0107] ① Clinically cured: Cough and sputum symptoms disappear, and breath sounds are normal upon auscultation of the lungs;

[0108] ②Significant effect: Cough and sputum production are significantly improved, and lung auscultation reveals a significant reduction in symptoms;

[0109] ③ Effective: Cough and sputum symptoms improve, and lung auscultation reveals relief;

[0110] ④ Ineffective: No change or only slight relief in cough, sputum production, and lung auscultation, or worsening of symptoms and lung auscultation.

[0111] 2) Symptom-based efficacy evaluation criteria

[0112] Therapeutic effect = [(Pre-treatment score - Post-treatment score) / Pre-treatment score] × 100% (Nimodipine method)

[0113] ① Cured: Symptoms and signs disappear or basically disappear, and the syndrome score decreases by ≥95%.

[0114] ②Significant effect: Symptoms and signs are significantly improved, and the syndrome score is reduced by ≥70%.

[0115] ③ Effective: Symptoms and signs improve, and the syndrome score decreases by ≥30%.

[0116] ④ Ineffective: Symptoms and signs show no significant improvement, or even worsen, and the syndrome score decreases by <30%.

[0117] 2. Medical Record Summary

[0118] (1) Clinical efficacy

[0119] Comparison of therapeutic effects [n%]

[0120]

[0121] Note: *P<0.01 for comparison before and after treatment. After treatment, the total symptom scores decreased compared to before treatment, and the main symptoms and signs, including sputum production and lung signs, improved significantly compared to before treatment (P<0.01), indicating that the Wenfei Zhike formula has a certain effect on improving the symptoms of the children.

[0122] Typical case:

[0123] Case 1: A 3-year-9-month-old boy, surnamed Sun, presented with a cough lasting over six months. He was diagnosed with cough due to wind-cold invading the lungs, presenting with recurrent paroxysmal coughing, worse in the morning or at night, without wheezing, accompanied by nasal congestion and runny nose, but without palpitations or shortness of breath. His appetite and energy levels were good, and he had no fever. Bowel and bladder function were normal. Physical examination revealed: clear consciousness, good mental responsiveness, normal breathing, no enlarged superficial lymph nodes, no rash or petechiae, slightly red pharynx, supple neck, coarse breath sounds in both lungs with a few audible rattles, no wheezing or crackles, strong heart sounds, regular heart rhythm, no murmurs, soft abdomen, good limb movement, red tongue with a thick, slightly greasy white coating, and a floating, rapid pulse. The diagnosis was cough (wind-cold invading the lungs). He was prescribed a lung-warming and cough-relieving formula, 33 ml (1 / 3 of the adult dose), 3 times a day, decocted in water. After 7 doses, the cough lessened, with occasional nasal congestion and runny nose, but no vomiting or diarrhea, normal bowel and bladder function, and no other discomfort.

[0124] Case 2: A 5-year-11-month-old boy, Deng, presented with a one-week cough and was diagnosed with bronchitis, wind-cold invading the lungs syndrome, and childhood cough. Symptoms included cough with phlegm, more pronounced in the morning and evening, accompanied by nasal congestion and runny nose. There was no fever, vomiting, or diarrhea. Appetite was poor, and bowel movements were normal. Physical examination revealed: clear consciousness, normal mental responsiveness, stable breathing, no redness in the throat, no enlargement of the tonsils, no yellow or white secretions, supple neck without resistance, coarse breath sounds in both lungs without obvious moist rales, no abnormalities in the heart and abdomen, no neurological abnormalities, red tongue with a thick, slightly greasy white coating, and a floating and rapid pulse. The diagnosis was cough (wind-cold invading the lungs syndrome). He was prescribed a lung-warming and cough-relieving formula, 67 ml (2 / 3 of the adult dose), three times a day, decocted in water. After 7 doses, the cough lessened, with occasional nasal congestion and runny nose, no vomiting or diarrhea, normal bowel movements, and no other discomfort.

[0125] Case 3: A 6-year-old girl, Liu, presented with a 2-day history of cough, diagnosed as cough (wind-cold invading the lungs). Symptoms included cough with phlegm, more pronounced in the morning and evening, accompanied by nasal congestion and runny nose. There was no fever, vomiting, or diarrhea. Appetite was poor, and bowel movements were normal. Physical examination revealed: clear consciousness, normal mental responsiveness, stable breathing, red pharynx, bilateral tonsillar enlargement (Type I), no yellow or white discharge, supple neck without resistance, coarse breath sounds in both lungs without obvious moist rales, no abnormalities in the heart and abdomen, no neurological abnormalities, red tongue with a thick, slightly greasy white coating, and a floating, rapid pulse. The diagnosis was cough (wind-cold invading the lungs). She was prescribed a lung-warming and cough-relieving formula, 67 ml (2 / 3 of the adult dose), 3 times a day, decocted in water. After 7 doses, the cough lessened, with occasional nasal congestion and runny nose, no vomiting or diarrhea, normal bowel movements, and no other discomfort.

[0126] Case 4: A 2-year-4-month-old boy, surnamed Sun, presented with a 2-day history of cough, diagnosed as cough (wind-cold invading the lungs). Symptoms included cough with phlegm, more pronounced in the morning and evening, accompanied by nasal congestion and runny nose. There was no fever, vomiting, or diarrhea. Appetite was poor, and bowel movements were normal. Physical examination revealed: clear consciousness, normal mental responsiveness, stable breathing, red pharynx, no tonsillar enlargement or yellow / white discharge, supple neck without resistance, coarse breath sounds in both lungs without obvious moist rales, no abnormalities in the heart and abdomen, and no neurological abnormalities. Tongue was red with a thick, slightly greasy white coating, and pulse was floating and rapid. The diagnosis was cough (wind-cold invading the lungs). A lung-warming and cough-relieving formula was prescribed, 33 ml (1 / 3 of the adult dose), 3 times daily, decocted in water. After 7 doses, the cough improved, with more white phlegm, occasional nasal congestion and runny nose, no vomiting or diarrhea, normal bowel movements, and no other discomfort.

[0127] Case 5: Patient, Yang, male, 7 years and 4 months old, case number: 1407049566. Presented with a 4-day history of cough, diagnosed as cough (wind-cold invading the lungs syndrome). Symptoms included cough with phlegm, more pronounced in the morning and evening, accompanied by nasal congestion and runny nose, no fever, no vomiting or diarrhea, poor appetite, and normal bowel and bladder function. Physical examination: alert, responsive, breathing stable, pharynx red, tonsils not enlarged, no yellow or white discharge, supple neck without resistance, coarse breath sounds in both lungs without obvious moist rales, no abnormalities in the heart and abdomen, no abnormalities in the nervous system, red tongue with a thick, slightly greasy white coating, and a floating and rapid pulse. The diagnosis was cough (wind-cold invading the lungs syndrome). A lung-warming and cough-relieving formula was prescribed, 100 ml (adult dose), 3 times a day, decocted in water. After 4 doses, the cough improved, with white phlegm remaining, occasional nasal congestion and runny nose, no vomiting or diarrhea, normal bowel and bladder function, and no other discomfort.

[0128] (3) Adverse reactions

[0129] Children with wind-cold cough have a short course of illness, usually 5-7 days. Through observation, no obvious gastrointestinal (dizziness, headache, head distension, vertigo, nausea, vomiting, diarrhea, loss of appetite, etc.), palpitations, skin rash, liver, kidney, and respiratory system adverse reactions were found in the use of Wenfei Zhike Fang in clinical practice, indicating that Wenfei Zhike Fang is safe.

[0130] It should be understood that the present invention is not limited to the precise structure described above, and various modifications and changes can be made without departing from its scope. The scope of the invention is limited only by the appended claims.

[0131] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition with the effect of warming the lungs and relieving cough, characterized in that, By weight, it includes: Honey-processed ephedra 1-5 parts, coltsfoot flower 3-7 parts, licorice root slices 3-7 parts, perilla stem 3-7 parts, belamcanda chinensis 3-7 parts, vinegar-processed schisandra chinensis 3-7 parts, stir-fried perilla seed 3-7 parts, stir-fried lepidium seed 3-7 parts, prepared pinellia ternata 3-7 parts, loquat leaf 8-12 parts, blanched bitter almond 3-7 parts, trichosanthes peel 8-12 parts, dried tangerine peel 3-7 parts, asarum 1-3 parts.

2. The traditional Chinese medicine composition with the function of warming the lungs and relieving cough according to claim 1, characterized in that, By weight, it includes: Honey-processed ephedra 2-4 parts, coltsfoot flower 4-6 parts, licorice root slices 4-6 parts, perilla stem 4-6 parts, belamcanda chinensis 4-6 parts, vinegar-processed schisandra chinensis 4-6 parts, stir-fried perilla seed 4-6 parts, stir-fried lepidium seed 4-6 parts, prepared pinellia ternata 4-6 parts, loquat leaf 9-11 parts, blanched bitter almond 4-6 parts, trichosanthes peel 9-11 parts, dried tangerine peel 4-6 parts, asarum 2-3 parts.

3. The traditional Chinese medicine composition with the function of warming the lungs and relieving cough according to claim 1, characterized in that, By weight, it includes: 3 parts honey-processed ephedra, 5 parts coltsfoot flower, 5 parts licorice root slices, 5 parts perilla stem, 5 parts belamcanda rhizome, 5 parts vinegar-processed schisandra fruit, 5 parts stir-fried perilla seed, 5 parts stir-fried lepidium seed, 5 parts prepared pinellia tuber, 10 parts loquat leaf, 5 parts blanched bitter almond, 10 parts trichosanthes peel, 5 parts dried tangerine peel, and 2 parts asarum.

4. A method for preparing a traditional Chinese medicine composition with the effect of warming the lungs and relieving cough as described in any one of claims 1-3, characterized in that, include: Weigh out the following ingredients according to the formula: honey-processed ephedra, coltsfoot flower, licorice root slices, perilla stem, belamcanda rhizome, vinegar-processed schisandra fruit, stir-fried perilla seed, stir-fried lepidium seed, prepared pinellia tuber, loquat leaf, scalded bitter almond, trichosanthes peel, dried tangerine peel, and asarum. Add water and decoct, filter, combine the filtrates, and concentrate to obtain the final product.

5. The method for preparing the traditional Chinese medicine composition with lung-warming and cough-relieving effects according to claim 5, characterized in that, The decoction is performed 2-3 times, with 8-12 times the amount of water added each time, and the decoction is performed for 0.5-2 hours. The concentration is to concentrate to a density of 1.25-1.30 g / mL.

6. A medicine with the effect of warming the lungs and relieving cough, characterized in that, The traditional Chinese medicine composition comprising any one of claims 1-3 or any one of claims 4-5 prepared by the preparation method.

7. The medicine with the function of warming the lungs and relieving cough according to claim 6, characterized in that, The dosage forms of the drugs include pills, capsules, granules, oral liquids, tablets, lozenges, powders, ointments, and syrups.

8. The medicine with the function of warming the lungs and relieving cough according to claim 7, characterized in that, The drug is in granule form.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-3, or the traditional Chinese medicine composition prepared according to the preparation method according to any one of claims 4-5, or the drug according to any one of claims 6-7, in the preparation of a drug for treating pediatric cough.

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