A traditional Chinese medicine preparation composition, a preparation method and application thereof

Abstract

This invention provides a traditional Chinese medicine preparation composition, its preparation method, and its application, belonging to the field of pharmaceutical preparation technology. It is composed of component (i) and component (ii), wherein component (i) is an extract obtained from the following raw materials: ephedra, pinellia, dried ginger, bitter almond, scutellaria, chlorite, gypsum, peach kernel, polygonatum, trichosanthes, glehnia, and licorice. The preparation composition provided by this invention has a good therapeutic effect on phlegm-heat obstructing the lungs syndrome of pneumonia caused by mycoplasma pneumoniae infection in children. Furthermore, the raw materials used are inexpensive, the preparation is simple, the use is convenient, the side effects are minimal, and it can be taken long-term, showing good application prospects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparations, specifically relating to a traditional Chinese medicine preparation composition, its preparation method, and its application. Background Technology

[0002] Mycoplasma pneumoniae pneumonia (MPP) in children is an inflammation of the lungs caused by Mycoplasma pneumoniae infection, and is one of the important types of community-acquired pneumonia (CAP) in children. The main clinical manifestations of the disease are fever and cough. The cough is mostly a severe dry cough, which may turn into a wet cough in the later stages. Some children also have symptoms such as wheezing, shortness of breath, and chest pain. Severe cases may develop respiratory distress, hypoxemia, and extrapulmonary complications.

[0003] In terms of treatment, while a certain system of treatment protocols for mycoplasma pneumoniae pneumonia (MPP) in children has been established, it has not yet reached an ideal state. Western medicine treatment focuses on antimicrobial therapy, supplemented by symptomatic support, immune modulation, and management of complications. Macrolide antibiotics (such as azithromycin and clarithromycin) remain the first-line treatment. Mild cases are often treated orally or with short-term intravenous administration. Severe or refractory cases require the combination of glucocorticoids (such as methylprednisolone) to suppress excessive inflammatory responses. When complications such as pleural effusion and plastic bronchitis occur, thoracic drainage and bronchoscopic intervention to remove mucus plugs are also necessary. In recent years, with the increase in macrolide-resistant strains (MRMP), the incidence of refractory MPP (RMPP) and severe MPP (SMPP) has risen, leading to prolonged disease course, increased treatment difficulty, and some children may suffer from sequelae such as obliterative bronchiolitis and bronchiectasis, severely impacting their quality of life. It is evident that the overall treatment has not yet fully achieved the unity of "precision" and "long-term effectiveness" and still needs further optimization.

[0004] Traditional Chinese medicine (TCM) categorizes childhood mycoplasma pneumoniae infection under the categories of "pneumonia with wheezing and cough" and "wind-heat syndrome." The core pathogenesis is the invasion of external pathogens into the lung's defensive qi, leading to impaired lung function. During the course of the disease, it can evolve into various syndromes such as wind-heat invading the lungs, phlegm-heat obstructing the lungs, and yin deficiency with lung heat. Some children also experience blood stasis and obstruction of the lung collaterals. Phlegm-heat obstructing the lungs syndrome belongs to the acute or severe stage of MPP, often progressing from wind-heat obstructing the lungs syndrome. Its pathogenesis involves phlegm-heat congesting the lungs and stagnation of lung qi. At this stage, the heat pathogens remain, condensing fluids into phlegm, and the phlegm and heat mutually bind, obstructing lung qi, belonging to the category of internal excess heat syndrome.

[0005] The advantages of traditional Chinese medicine (TCM) in treating mycoplasma pneumonia (MPP) lie in its multi-target effects. It can directly inhibit mycoplasma, regulate immunity, improve pulmonary microcirculation, and repair respiratory epithelium, with fewer adverse reactions and reduced drug resistance and relapse. Treatment is based on syndrome differentiation and treatment principles, commonly employing methods such as clearing the lungs and resolving phlegm, clearing heat and detoxifying, clearing the lungs and unblocking the meridians, and nourishing yin and moistening the lungs. It is often combined with Western medicine to enhance efficacy, making it superior to Western medicine alone.

[0006] Chinese Patent CN111714597A discloses a traditional Chinese medicine composition for treating lobar pneumonia, which is made from the following raw materials in parts by weight: Ephedra 6-12 parts, Bitter Almond 10-15 parts, Gypsum 15-30 parts, Licorice 3-6 parts, Reed Rhizome 10-30 parts, Peach Kernel 10-15 parts, Coix Seed 10-20 parts, Winter Melon Seed 10-15 parts, Prepared Pinellia 6-9 parts, Platycodon 6-12 parts, Trichosanthes Fruit 6-10 parts, Scutellaria 3-6 parts, Fritillaria thunbergii 10-15 parts, and Houttuynia cordata 10-20 parts. This traditional Chinese medicine composition for treating lobar pneumonia provides a better therapeutic effect on acute lobar pneumonia in children, and is lower in cost and has fewer side effects compared to Western medicine treatments.

[0007] Chinese patent CN102743714A discloses a traditional Chinese medicine composition for treating pneumonia by invigorating qi and nourishing yin. This composition consists of the following ingredients in parts by weight: 5-7 parts of processed ephedra, 28-32 parts of raw gypsum, 8-10 parts of stir-fried apricot kernel, 8-12 parts of lily bulb, 13-17 parts of ophiopogon japonicus, 13-17 parts of scutellaria baicalensis, 8-12 parts of fritillaria cirrhosa, 30 parts of trichosanthes kirilowii, 13-17 parts of codonopsis pilosula, 13-17 parts of mulberry bark, 13-17 parts of astragalus membranaceus, 13-17 parts of reed rhizome, 13-17 parts of polygonatum odoratum, 13-17 parts of codonopsis pilosula, 13-17 parts of glehnia littoralis, 5-7 parts of artemisia annua, 8-10 parts of bamboo shavings, 4-6 parts of processed pinellia ternata, 8-10 parts of red poria cocos, 8-10 parts of scutellaria baicalensis, 4-6 parts of immature bitter orange peel, 4-6 parts of dried ginger, 4-6 parts of asarum heterotropoides, and 4-6 parts of hawthorn root. This invention has a significant therapeutic effect on pneumonia, with a total effective rate of 98%.

[0008] However, there are currently no reports of traditional Chinese medicine specifically treating phlegm-heat obstructing the lungs in children with mycoplasma pneumoniae, either domestically or internationally. Furthermore, herbs such as ephedra, pinellia, and apricot kernel may irritate the gastrointestinal mucosa, causing nausea, vomiting, abdominal pain, and diarrhea. Therefore, it is necessary to develop a lung-clearing, phlegm-resolving, fluid-generating, and cough-relieving composition that addresses the pathological characteristics of mycoplasma pneumoniae in children—"deep-seated pathogenic factors, phlegm and blood stasis, and deficiency of both qi and yin"—with minimal gastrointestinal side effects, adhering to the treatment principles of "clearing heat and resolving phlegm, promoting lung function and relieving cough" for the "phlegm-heat obstructing the lungs" syndrome. The preparation method and application of this composition are also needed. Summary of the Invention

[0009] Based on the shortcomings of existing technologies, this invention aims to provide a traditional Chinese medicine preparation composition, its preparation method, and its application. This traditional Chinese medicine composition follows the treatment principle of "clearing heat and eliminating phlegm, promoting lung function and relieving cough" in the "phlegm-heat obstructing the lungs syndrome". It can take into account the physiological characteristics of children, pay attention to eliminating pathogens without harming the body's vital energy, and regulate both cold and heat. The overall formula takes into account clearing heat and eliminating phlegm, moistening dryness and nourishing yin, which reflects the flexibility of traditional Chinese medicine diagnosis and treatment and has good efficacy.

[0010] To achieve the above objectives, the present invention provides the following technical solutions.

[0011] In a first aspect, the present invention provides a traditional Chinese medicine composition.

[0012] The aforementioned traditional Chinese medicine composition is made from the following raw materials in parts by weight: 4-8 parts ephedra, 3-10 parts pinellia, 2-5 parts dried ginger, 7-13 parts bitter apricot kernel, 7-13 parts scutellaria, 7-13 parts chlorite, 21-39 parts gypsum, 7-13 parts peach kernel, 7-13 parts polygonatum, 7-13 parts trichosanthes, 11-20 parts north ginseng, and 4-8 parts licorice.

[0013] This composition can be prepared by mixing relevant raw material components. After mixing, it can also be pulverized or further extracted.

[0014] As one embodiment, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 5-7 parts ephedra, 5-10 parts pinellia, 2-5 parts dried ginger, 8-12 parts bitter almond, 8-12 parts scutellaria, 8-12 parts chlorite, 25-35 parts gypsum, 8-12 parts peach kernel, 8-12 parts polygonatum, 8-12 parts trichosanthes, 13-18 parts glehnia littoralis, and 5-7 parts licorice.

[0015] As one embodiment, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 6-7 parts ephedra, 5-10 parts pinellia, 3-4 parts dried ginger, 9-11 parts bitter apricot kernel, 9-11 parts scutellaria, 9-11 parts chlorite, 28-32 parts gypsum, 9-11 parts peach kernel, 9-10 parts polygonatum, 9-11 parts trichosanthes, 14-16 parts glehnia littoralis, and 6-7 parts licorice.

[0016] Furthermore, as a specific implementation scheme, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 6 parts ephedra, 5-9 parts pinellia, 3 parts dried ginger, 10 parts bitter almond, 10 parts scutellaria, 10 parts chlorite, 30 parts gypsum, 10 parts peach kernel, 10 parts polygonatum, 10 parts trichosanthes, 15 parts glehnia littoralis, and 6 parts licorice.

[0017] As a specific implementation plan, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 6 parts ephedra, 9 parts pinellia, 3 parts dried ginger, 10 parts bitter almond, 10 parts scutellaria, 10 parts chlorite, 30 parts gypsum, 10 parts peach kernel, 10 parts polygonatum, 10 parts trichosanthes, 15 parts glehnia littoralis, and 6 parts licorice.

[0018] This composition can be prepared by mixing relevant raw material components, and the mixture can be further processed such as extraction. In some cases, the extraction is water extraction.

[0019] Secondly, the present invention also provides a traditional Chinese medicine extract.

[0020] The aforementioned herbal extract is prepared from the following raw materials in parts by weight: Ephedra 4-8 parts, Pinellia ternata 3-10 parts, Dried ginger 2-5 parts, Bitter almond 7-13 parts, Scutellaria baicalensis 7-13 parts, Chlorite 7-13 parts, Gypsum 21-39 parts, Peach kernel 7-13 parts, Polygonatum odoratum 7-13 parts, Trichosanthes kirilowii 7-13 parts, Adenophora stricta 11-20 parts, and Licorice 4-8 parts. The extract is prepared by solvent extraction. The extraction, as defined in the field of traditional Chinese medicine, refers to the process of extracting effective components or effective parts from medicinal materials using suitable solvents and methods.

[0021] As some implementation schemes, the herbal extract is prepared from raw materials comprising the following parts by weight: 5-7 parts ephedra, 5-10 parts pinellia, 2-5 parts dried ginger, 8-12 parts bitter almond, 8-12 parts scutellaria, 8-12 parts chlorite, 25-35 parts gypsum, 8-12 parts peach kernel, 8-12 parts polygonatum, 8-12 parts trichosanthes, 13-18 parts glehnia littoralis, and 5-7 parts licorice.

[0022] In some other embodiments, the herbal extract is prepared from raw materials comprising the following parts by weight: 6-7 parts ephedra, 5-10 parts pinellia, 3-4 parts dried ginger, 9-11 parts bitter almond, 9-11 parts scutellaria, 9-11 parts chlorite, 28-32 parts gypsum, 9-11 parts peach kernel, 9-10 parts polygonatum, 9-11 parts trichosanthes, 14-16 parts glehnia littoralis, and 6-7 parts licorice.

[0023] As a preferred embodiment, the herbal extract is prepared by extracting the following raw materials in parts by weight: 6 parts ephedra, 5-9 parts pinellia, 3 parts dried ginger, 10 parts bitter almond, 10 parts scutellaria, 10 parts chlorite, 30 parts gypsum, 10 parts peach kernel, 10 parts polygonatum, 10 parts trichosanthes, 15 parts glehnia littoralis, and 6 parts licorice.

[0024] As a preferred embodiment, the herbal extract is prepared by extracting the following raw materials in parts by weight: 6 parts ephedra, 9 parts pinellia, 3 parts dried ginger, 10 parts bitter almond, 10 parts scutellaria, 10 parts chlorite, 30 parts gypsum, 10 parts peach kernel, 10 parts polygonatum, 10 parts trichosanthes, 15 parts glehnia littoralis, and 6 parts licorice.

[0025] Thirdly, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition.

[0026] Weigh out the following ingredients according to the weight proportions of the traditional Chinese medicine composition described in the first aspect above: ephedra, pinellia, dried ginger, bitter almond, scutellaria, chlorite, gypsum, peach kernel, polygonatum, trichosanthes, north ginseng, and licorice, and mix them to obtain the traditional Chinese medicine composition.

[0027] As one implementation method, the raw materials are pulverized after mixing to obtain the final product. Further extraction is then performed.

[0028] Fourthly, the present invention provides a method for preparing the above-mentioned Chinese herbal extract.

[0029] As one implementation scheme, ephedra, pinellia, dried ginger, bitter almond, scutellaria, chlorite, gypsum, peach kernel, polygonatum, trichosanthes, glehnia littoralis, and licorice are weighed according to the weight proportions of the traditional Chinese medicine extract described in the second aspect above. Solvents are added separately, and the extracts are extracted and filtered. The resulting filtrates are then processed and combined or the filtrates are directly combined to obtain the extract.

[0030] As one implementation method, ephedra, pinellia, dried ginger, bitter almond, scutellaria, chlorite, gypsum, peach kernel, polygonatum, trichosanthes fruit, glehnia root, and licorice are weighed according to the specified weight proportions. The raw materials are then mixed, and a solvent is added for extraction. The mixture is filtered, and the filtrate is collected to obtain a filtrate containing the extract. The obtained filtrate can be further concentrated and dried using conventional methods to prepare an extract, thus obtaining the dried product of the traditional Chinese medicine extract.

[0031] As one implementation method, ephedra, pinellia, dried ginger, bitter almond, scutellaria, chlorite, gypsum, peach kernel, polygonatum, trichosanthes, glehnia littoralis, and licorice are weighed according to the specified weight proportions. A solvent is added to the raw materials, and extraction is performed to obtain the extract.

[0032] As one implementation method, ephedra, pinellia, dried ginger, bitter almond, scutellaria, chlorite, gypsum, peach kernel, polygonatum, trichosanthes, glehnia littoralis, and licorice are weighed according to the formula dosage. Solvents are added to each raw material separately, and the extracts are extracted, filtered, and the filtrates are combined to obtain the extract. As a further processing method, the obtained filtrate is further concentrated and dried to prepare an extract, thus obtaining the Chinese herbal extract.

[0033] As one implementation method, ephedra, pinellia, dried ginger, bitter almond, scutellaria, chlorite, gypsum, peach kernel, polygonatum, trichosanthes, glehnia littoralis, and licorice are weighed according to the specified weight proportions. A solvent is added to the raw materials, and extraction is performed to obtain the extract.

[0034] In the preparation method of the present invention, as a preferred embodiment, the solvent is water, and the extraction method is decoction.

[0035] Preferably, during water extraction, the total mass of the water is 8-20 times the total mass of the raw material being extracted; the number of decoctions is 1-3; and the decoction time is 1-3 hours.

[0036] Fifthly, the present invention provides a pharmaceutical preparation.

[0037] The pharmaceutical preparations provided by the present invention include (i) the above-mentioned traditional Chinese medicine composition and / or traditional Chinese medicine extract; and (ii) a pharmaceutically acceptable carrier.

[0038] The aforementioned traditional Chinese medicine composition refers to the traditional Chinese medicine composition provided in the first aspect or the traditional Chinese medicine composition prepared by the method in the third aspect.

[0039] The aforementioned Chinese medicine extracts refer to the Chinese medicine extracts provided in the second aspect above or the Chinese medicine extracts prepared by the method in the fourth aspect above.

[0040] As one implementation, the pharmaceutical formulation provided by the present invention includes macrolide antibiotics as a pharmaceutically acceptable carrier.

[0041] As one specific implementation, the pharmaceutical preparation provided by the present invention contains a macrolide antibiotic selected from azithromycin.

[0042] In a sixth aspect, the present invention provides the application of the above-mentioned traditional Chinese medicine composition, and / or traditional Chinese medicine extract, and / or pharmaceutical preparation.

[0043] As one embodiment, the present invention provides the use of the pharmaceutical composition described in the first aspect or / and the traditional Chinese medicine extract described in the second aspect or / and the pharmaceutical preparation described in the fifth aspect in the preparation of a product having the functions of clearing heat, resolving phlegm, ventilating the lungs, and relieving cough; the pharmaceutical composition has good effects of clearing heat, resolving phlegm, ventilating the lungs, and relieving cough, especially with significant efficacy in phlegm-heat obstructing the lungs syndrome.

[0044] As one embodiment, the present invention provides the use of the pharmaceutical composition described in the first aspect and / or the traditional Chinese medicine extract described in the second aspect and / or the pharmaceutical preparation described in the fifth aspect in the preparation of a product for treating pneumonia caused by Mycoplasma pneumoniae infection.

[0045] As one embodiment, the present invention provides the use of the pharmaceutical composition described in the first aspect and / or the traditional Chinese medicine extract described in the second aspect and / or the pharmaceutical preparation described in the fifth aspect in the preparation of a product for treating pneumonia caused by Mycoplasma pneumoniae infection with phlegm-heat obstructing the lungs.

[0046] As one embodiment, the present invention provides the use of the pharmaceutical composition described in the first aspect or / and the traditional Chinese medicine extract described in the second aspect or / and the pharmaceutical preparation described in the fifth aspect in the preparation of a drug for inhibiting mycoplasma.

[0047] In this embodiment of the invention, the mycoplasma is *Mycoplasma pneumoniae*, and the product is a drug or health food. Alternatively, the *Mycoplasma pneumoniae* is *Mycoplasma pneumoniae pediatricis*.

[0048] As one embodiment, the present invention provides the use of the above-mentioned traditional Chinese medicine composition, and / or traditional Chinese medicine extract, and / or pharmaceutical preparation in the preparation of products for treating pneumonia caused by Mycoplasma pneumoniae infection in children.

[0049] The traditional Chinese medicine composition, and / or traditional Chinese medicine extract, and / or pharmaceutical preparation described in this invention have good therapeutic effects on mycoplasma pneumoniae-associated pneumonia.

[0050] As one embodiment, the present invention provides a traditional Chinese medicine composition, extract, pharmaceutical preparation, or product that has a synergistic effect with azithromycin. The invention also provides the use of said traditional Chinese medicine composition, extract, pharmaceutical preparation, or product in preparing a formulation that enhances the inhibitory effect of azithromycin on mycoplasma or its therapeutic effect on mycoplasma pneumonia. Their combined use results in better therapeutic effects.

[0051] The present invention relates to pediatric phlegm-heat obstructing the lungs syndrome, with symptoms including: fever, cough, thick yellow phlegm or rattling in the throat, shortness of breath, poor appetite, dry stools, scanty yellow urine, red tongue, yellow and greasy tongue coating, and slippery and rapid pulse.

[0052] In a seventh aspect, the present invention provides a product for treating phlegm-heat obstructing the lungs syndrome of pneumonia caused by Mycoplasma pneumoniae infection in children. The product comprises the above-mentioned traditional Chinese medicine composition, and / or traditional Chinese medicine extract, and / or pharmaceutical preparation; preferably, the product is selected from drugs or health foods; preferably, the target of treatment of the product is children.

[0053] Eighthly, the present invention provides a medicament for treating pneumonia caused by Mycoplasma pneumoniae infection with phlegm-heat obstructing the lungs, wherein the medicament uses the above-mentioned traditional Chinese medicine composition and / or traditional Chinese medicine extract as active ingredients. The preferred target group for treatment of the product is children.

[0054] Ninthly, the present invention provides a composition for clearing heat, resolving phlegm, ventilating the lungs, and relieving cough, wherein the composition comprises the following raw materials: ephedra, pinellia, dried ginger, bitter almond, scutellaria, chlorite, gypsum, peach kernel, polygonatum, trichosanthes, glehnia littoralis, and licorice.

[0055] In a tenth aspect, the present invention provides a traditional Chinese medicine extract.

[0056] The extract comprises an extract made from the following raw materials in parts by weight: Ephedra 4-8 parts, Pinellia ternata 3-10 parts, Dried ginger 2-4 parts, Bitter almond 7-13 parts, Scutellaria baicalensis 7-13 parts, Chlorite 7-13 parts, Gypsum 21-39 parts, Peach kernel 7-13 parts, Polygonatum odoratum 7-13 parts, Trichosanthes kirilowii 7-13 parts, Adenophora stricta 11-20 parts, and Licorice 4-8 parts. The preparation method is water extraction. As a preferred embodiment, the raw material composition of the above-mentioned traditional Chinese medicine composition or extract is: Ephedra 6 parts, Pinellia ternata 5-9 parts, Dried ginger 3 parts, Bitter almond 10 parts, Scutellaria baicalensis 10 parts, Chlorite 10 parts, Gypsum 30 parts, Peach kernel 10 parts, Polygonatum odoratum 10 parts, Trichosanthes kirilowii 10 parts, Adenophora stricta 15 parts, and Licorice 6 parts. This component has definite efficacy in clinical applications.

[0057] Eleventhly, the present invention provides a traditional Chinese medicine preparation composition, which is made of component (i) and component (ii), wherein component (i) is an extract obtained from raw materials comprising the following parts by weight: 4-8 parts of ephedra, 3-10 parts of pinellia, 2-5 parts of dried ginger, 7-13 parts of bitter almond, 7-13 parts of scutellaria, 7-13 parts of chlorite, 21-39 parts of gypsum, 7-13 parts of peach kernel, 7-13 parts of polygonatum, 7-13 parts of trichosanthes, 11-20 parts of glehnia littoralis, and 4-8 parts of licorice; component (ii) is a pharmaceutically acceptable excipient; and the mass content of component (ii) in the preparation composition is 0.5%-99.5%.

[0058] Twelfthly, a traditional Chinese medicine preparation, characterized in that it contains a traditional Chinese medicine preparation composition, said traditional Chinese medicine preparation composition being made of component (i) and component (ii), wherein component (i) is an extract obtained from raw materials comprising the following parts by weight: ephedra 4-8 parts, pinellia 3-10 parts, dried ginger 2-5 parts, bitter almond 7-13 parts, scutellaria baicalensis 7-13 parts, chlorite 7-13 parts, gypsum 21-39 parts, peach kernel 7-13 parts, polygonatum odoratum 7-13 parts, trichosanthes kirilowii 7-13 parts, glehnia littoralis 11-20 parts, and licorice 4-8 parts; component (ii) is a pharmaceutically acceptable excipient; the preparation is a solid preparation, preferably granules, tablets, or capsules, and further, the mass content of component (ii) in the preparation composition is 0.1%-99.8%. The traditional Chinese medicine preparation composition or preparation according to the eleventh and twelfth aspects of the present invention, wherein the component (i) comprises the following raw materials in parts by weight: Ephedra 5-7 parts, Pinellia ternata 5-10 parts, dried ginger 2-5 parts, bitter apricot kernel 8-12 parts, Scutellaria baicalensis 8-12 parts, chlorite 8-12 parts, gypsum 25-35 parts, peach kernel 8-12 parts, Polygonatum odoratum 8-12 parts, Trichosanthes kirilowii 8-12 parts, Adenophora stricta 13-18 parts, and licorice 5-7 parts; or, preferably, Ephedra 6-7 parts, Pinellia ternata 5-10 parts, dried ginger 3-4 parts, bitter apricot kernel 9-11 parts, Scutellaria baicalensis 9-11 parts, chlorite 9-11 parts, and gypsum 28- 32 parts, peach kernel 9-11 parts, Solomon's seal 9-10 parts, trichosanthes fruit 9-11 parts, north ginseng 14-16 parts and licorice 6-7 parts; or, more preferably, ephedra 6 parts, pinellia 5-9 parts, dried ginger 3 parts, bitter almond 10 parts, scutellaria 10 parts, chlorite 10 parts, gypsum 30 parts, peach kernel 10 parts, Solomon's seal 10 parts, trichosanthes fruit 10 parts, north ginseng 15 parts and licorice 6 parts; or, even more preferably, ephedra 6 parts, pinellia 9 parts, dried ginger 3 parts, bitter almond 10 parts, scutellaria 10 parts, chlorite 10 parts, gypsum 30 parts, peach kernel 10 parts, Solomon's seal 10 parts, trichosanthes fruit 10 parts, north ginseng 15 parts and licorice 6 parts.

[0059] The component (ii) has a mass content of 1.0%-99.0%, more preferably 2.5%-95.0%, and more preferably 5.0%-90.0% in the formulation composition.

[0060] The traditional Chinese medicine preparation composition is prepared by the following method: Ephedra, Pinellia, dried ginger, bitter almond, Scutellaria baicalensis, chlorite, gypsum, peach kernel, Polygonatum odoratum, Trichosanthes kirilowii, Adenophora stricta and licorice are weighed according to the weight parts, solvent is added to each, extraction is performed, and filtration is carried out. The filtrates are then treated and combined or directly combined, concentrated and mixed with component (ii) to obtain the final product. Alternatively, weigh out ephedra, pinellia, dried ginger, bitter almond, scutellaria, chlorite, gypsum, peach kernel, polygonatum, trichosanthes, north ginseng and licorice according to the weight proportions, mix the raw materials, add solvent, extract, filter, and collect the filtrate to obtain the product; or further concentrate and dry the filtrate to make an extract, and mix it with component (ii) to obtain the product. Alternatively, weigh out ephedra, pinellia, dried ginger, bitter almond, scutellaria, chlorite, gypsum, peach kernel, polygonatum, trichosanthes, glehnia littoralis, and licorice according to the weight proportions, add solvent to the raw materials, extract, concentrate and mix with component (ii) to obtain the final product; Furthermore, the solvent is water, the extraction method is decoction, the total mass of the water is 8-20 times the total mass of the raw material being extracted, the number of decoctions is 1-3, and the decoction time is 1-3 hours.

[0061] In a thirteenth aspect, a method for preparing the traditional Chinese medicine preparation composition or preparation described in the eleventh and twelfth aspects is provided, characterized in that it comprises: weighing ephedra, pinellia, dried ginger, bitter almond, scutellaria, chlorite, gypsum, peach kernel, polygonatum, trichosanthes, north ginseng, and licorice according to the weight proportions; adding a solvent to the raw materials; extracting; concentrating; and mixing with component (ii) to obtain the preparation; further, the solvent is water; the extraction method is decoction; the total mass of the water is 8-20 times the total mass of the extracted raw materials; the number of decoctions is 1-3 times; and the decoction time is 1-3 hours.

[0062] In a fourteenth aspect, the present invention provides a combination or combination therapy of drugs.

[0063] The pharmaceutical composition provided by this invention comprises component 1 and component 2, wherein component 1 is selected from the traditional Chinese medicine composition described in the first aspect or the heat-clearing, phlegm-resolving, lung-ventilating, and cough-relieving composition described in the ninth aspect, or the traditional Chinese medicine extract described in the second or tenth aspect, or the traditional Chinese medicine extract prepared by the method described in the third aspect, or the pharmaceutical preparation described in the fifth aspect, or the traditional Chinese medicine composition described in the eleventh aspect, or the traditional Chinese medicine preparation described in the twelfth aspect. Component 2 is selected from macrolide antibiotics. Preferably, the macrolide antibiotic is selected from azithromycin; as some embodiments, the two components are packaged independently or together, or packaged after mixing.

[0064] The combined treatment provided by this invention includes therapeutically effective amounts of component 1 and component 2, wherein component 1 is selected from the traditional Chinese medicine composition described in the first aspect or the heat-clearing, phlegm-resolving, lung-ventilating, and cough-relieving composition described in the ninth aspect, or the traditional Chinese medicine extract described in the second or tenth aspect, or the traditional Chinese medicine extract prepared by the method described in the third aspect, or the pharmaceutical preparation described in the fifth aspect, or the traditional Chinese medicine composition described in the eleventh aspect, or the traditional Chinese medicine preparation described in the twelfth aspect. Component 2 is selected from macrolide antibiotics. Preferably, the macrolide antibiotic is selected from azithromycin; as some embodiments, the two components are packaged independently or together, or packaged after mixing.

[0065] In the aforementioned drug combination and combination therapy regimen, the dosage ratio of component 1 to component 2 is 10-150 g of crude drug: 1 mg. As a practical regimen, the daily dosage of component 1 to component 2 is 2.79-25.11 kg of crude drug: 150-200 mg.

[0066] In the first to fourteenth aspects of the present invention, as a preferred embodiment, the ephedra is honey-processed ephedra; the bitter almond is stir-fried bitter almond; the pinellia is processed pinellia; the peach kernel is stir-fried peach kernel; the chlorite is calcined chlorite; the gypsum is raw gypsum; and the licorice is prepared licorice. Further, it contains an extract prepared from the following raw materials in parts by weight: 4-8 parts ephedra, 3-10 parts pinellia, 2-4 parts dried ginger, 7-13 parts bitter almond, 7-13 parts scutellaria, 7-13 parts chlorite, 21-39 parts gypsum, 7-13 parts peach kernel, 7-13 parts polygonatum, 7-13 parts trichosanthes, 11-20 parts glehnia littoralis, and 4-8 parts licorice, wherein the preparation method is water extraction.

[0067] In the first to fourteenth aspects of the present invention, the use of the raw materials is in accordance with the principles of monarch-minister-assistant-guide combination and the treatment principles of diseases.

[0068] Traditional Chinese medicine (TCM) categorizes childhood mycoplasma pneumoniae infection under the categories of "pneumonia with wheezing and cough" and "wind-heat syndrome," with the core pathogenesis being the invasion of external pathogens into the lung's defensive qi, leading to impaired lung function. Phlegm-heat obstructing the lungs is considered the acute or severe stage of mycoplasma pneumoniae, often progressing from wind-heat obstructing the lungs. The pathogenesis involves phlegm-heat congesting the lungs and stagnation of lung qi. At this stage, the lingering heat pathogens condense into phlegm, and the phlegm and heat combine, obstructing lung qi, thus belonging to the category of internal heat excess syndrome.

[0069] The traditional Chinese medicine composition, extract, preparation, or product described in this invention is designed for the pathological characteristics of mycoplasma pneumoniae in children, namely "deep-seated pathogenic factors, phlegm and blood stasis, and damage to both qi and yin." It is based on the classic formula Ma Xing Shi Gan Tang from Zhang Zhongjing's *Treatise on Febrile and Miscellaneous Diseases*, which is modified by incorporating Xiao Xian Xiong Tang, Qing Qi Hua Tan Wan, and Xie Xin Tang. Following the treatment principle of "clearing heat and eliminating phlegm, opening the lungs and relieving asthma" for "phlegm-heat obstructing the lungs," it particularly emphasizes eliminating pathogenic factors without harming the body's vital energy, and harmonizing cold and heat. The overall formula takes into account clearing heat and eliminating phlegm, moistening dryness and nourishing yin, reflecting the flexibility of TCM syndrome differentiation and treatment, and has good therapeutic effects.

[0070] In the first to fourteenth aspects of this invention, the traditional Chinese medicine composition, extract, preparation, or product of this invention comprises and / or uses raw materials including ephedra, pinellia, dried ginger, bitter almond, scutellaria, chlorite, gypsum, peach kernel, polygonatum, trichosanthes, glehnia littoralis, and licorice. In this traditional Chinese medicine composition, extract, preparation, or product, ephedra and gypsum are the principal herbs, used in combination to balance cold and warm properties, combining dispersing and clearing effects, aligning with the principle of "clearing heat and transforming qi" in febrile diseases, targeting the main symptoms of fever, cough, and asthma in MPP (metastatic phlegm-phlegm). Trichosanthes, pinellia, peach kernel, and chlorite are the assistant herbs, resolving phlegm, removing blood stasis, clearing heat, and dissipating nodules. Scutellaria, dried ginger, glehnia littoralis, and polygonatum are the adjuvant herbs, using pungent and bitter herbs to open and descend, nourishing yin and protecting the body's vital energy. Fried bitter almond and licorice are the guiding herbs, relieving cough and harmonizing the effects of the other herbs.

[0071] The effects of these Chinese medicinal herbs are as follows: Ephedra: It is pungent, warm, and slightly bitter. It can relieve lung congestion and asthma, and open up the obstruction of lung qi. The "Correct Interpretation of Materia Medica" states that it "specifically relieves lung stagnation and promotes the smooth flow of qi."

[0072] Gypsum: It is pungent, sweet, and extremely cold. It clears and drains excess heat in the lungs and stomach. The "Records of Integrating Chinese and Western Medicine" states that it "cools and disperses, and relieves muscle tension by penetrating the exterior."

[0073] Trichosanthes kirilowii and Pinellia ternata: Trichosanthes kirilowii is sweet and cold, moistens the lungs, resolves phlegm and relieves chest congestion; Pinellia ternata is pungent and warm, dries dampness, relieves nausea and resolves phlegm. The combination of the two resolves phlegm and disperses nodules, targeting the syndrome of phlegm-heat obstructing the lungs.

[0074] Peach kernel: It promotes blood circulation, removes blood stasis, moistens the intestines and relieves constipation. According to the "Medicinal Properties of Chinese Medicine", it "disperses stagnant qi in the blood and breaks up blood stasis and heat accumulation", and improves the exudation and microcirculation disorders of MPP lung inflammation.

[0075] Qingmengshi: Salty, neutral, and heavy, it helps to expel phlegm and lower qi. The Compendium of Materia Medica states that it "treats phlegm and saliva accumulation, cough, asthma, and shortness of breath," and assists Trichosanthes kirilowii and Pinellia ternata in clearing away phlegm and turbidity.

[0076] Scutellaria baicalensis and dried ginger: Scutellaria baicalensis is bitter and cold, clearing heat, while dried ginger is pungent and warm, protecting the stomach. Following the "pungent opening and bitter descending" method of Banxia Xiexin Decoction, it harmonizes the Qi of the lungs and stomach, preventing gypsum and Scutellaria baicalensis from being too cold and damaging the middle Jiao.

[0077] North American ginseng and Solomon's seal: sweet and cool, they moisten the lungs, replenish qi and nourish yin. Based on the approach of the "Wenbing Tiaobian" (Treatise on Warm Diseases) and the "Shashen Maidong Decoction", it is used to treat symptoms of heat evil damaging body fluids and chronic cough depleting qi.

[0078] Bitter almonds: bitterness lowers lung qi, moistens the intestines and promotes bowel movement. The "Compendium of Materia Medica" states that it "lowers qi and resolves phlegm, moistens dryness and promotes bowel movement," assisting ephedra in its function of dispersing and descending qi.

[0079] Licorice: It is sweet and mild, harmonizing the cold and hot properties of various herbs, and can also stop coughing and resolve phlegm.

[0080] For the raw materials of traditional Chinese medicine, the ephedra, pinellia, dried ginger, bitter almond, scutellaria, chlorite, gypsum, peach kernel, polygonatum, trichosanthes, glehnia littoralis, and licorice mentioned in this invention meet the quality requirements of the current 2025 edition of the Chinese Pharmacopoeia.

[0081] As the preferred embodiment, in the first to tenth aspects of this invention, the ephedra is honey-processed ephedra, the bitter apricot kernel is stir-fried bitter apricot kernel, the pinellia is processed pinellia, the peach kernel is stir-fried peach kernel, the chlorite is calcined chlorite, the gypsum is raw gypsum, and the licorice is processed licorice. All raw materials meet the quality requirements of the current 2025 edition of the Chinese Pharmacopoeia.

[0082] The dosage of the pharmaceutical preparation described in this invention can be determined based on the amount of drug contained in the final preparation to achieve the required effective therapeutic dose and complete the preventive and / or therapeutic effects of this invention.

[0083] The traditional Chinese medicine composition described in this invention is a traditional Chinese medicine composition used to treat phlegm-heat obstructing the lungs syndrome of pneumonia caused by Mycoplasma pneumoniae infection in children.

[0084] The herbal extract described in this invention is a herbal extract used to treat phlegm-heat obstructing the lungs syndrome of pneumonia caused by Mycoplasma pneumoniae infection in children.

[0085] The pharmaceutical preparation described in this invention is a pharmaceutical preparation for treating phlegm-heat obstructing the lungs syndrome of pneumonia caused by Mycoplasma pneumoniae infection in children.

[0086] Compared with the prior art, the beneficial effects of the present invention are as follows: (1) The results of the Mycoplasma pneumoniae infection experiment using rats as a model showed that the Chinese herbal composition, extract, preparation or product provided by the present invention was significantly more effective than the product without the use of Adenophora stricta. This indicates that the addition of Adenophora stricta greatly enhances the mycoplasma inhibition ability of the product. In addition, the use of the traditional Chinese medicine compound with the combination of principal, assistant, adjuvant and guide herbs of the present invention can help improve the therapeutic effect of azithromycin.

[0087] (2) The heat-clearing, phlegm-resolving, lung-ventilating, and cough-relieving composition and related products provided by the present invention can be used specifically to treat phlegm-heat obstructing the lungs in children with pneumonia caused by Mycoplasma pneumoniae infection, filling the gap in clinical drugs.

[0088] (3) The heat-clearing, phlegm-resolving, lung-ventilating, and cough-relieving composition and related products provided by the present invention have no drug resistance and few side effects, thus avoiding the problem and sequelae of the increase in the incidence of refractory MPP and severe MPP caused by the current increase in macrolide drug resistant strains (MRMP) in clinical practice.

[0089] (4) The pharmaceutical composition and related products provided by this invention for treating phlegm-heat obstructing the lungs in children with pneumonia caused by Mycoplasma pneumoniae infection use inexpensive raw materials, are easy to prepare, convenient to use, have few side effects, and can be taken for a long time. After years of clinical application research, it has shown good efficacy in treating phlegm-heat obstructing the lungs in children with pneumonia caused by Mycoplasma pneumoniae infection. Given the large number of children suffering from phlegm-heat obstructing the lungs in pneumonia caused by Mycoplasma pneumoniae infection, and the current clinical treatment with Western medicine is prone to drug resistance, this invention has good application prospects.

[0090] (2) The traditional Chinese medicine composition, or / and traditional Chinese medicine extract, or / and pharmaceutical preparation provided by the present invention have a better synergistic effect when used in combination with macrolide antibiotics such as azithromycin.

[0091] Terminology Explanation: Unless otherwise defined, all technical terms in this document have the same meanings as commonly understood by one of ordinary skill in the art to which the subject matter of the claims pertains. Unless otherwise stated, all patents, patent inventions, and publications cited in this document are incorporated herein by reference in their entirety. If multiple definitions exist for terms in this document, the definitions in this chapter shall prevail.

[0092] It should be understood that the above brief description and the following detailed description are exemplary and for illustrative purposes only, and do not limit the subject matter of the invention in any way. In this invention, the singular is used in conjunction with the plural unless otherwise specifically stated. It should also be noted that, unless otherwise stated, the use of “or” or “or” means “and / or”. Furthermore, the use of the term “comprising” and other forms such as “including,” “containing,” and “contains” are not limiting.

[0093] Unless specifically defined herein, the use of all commercially available products herein employs standard techniques. For example, it may be carried out using the manufacturer's instructions for use with the kit, or in accordance with methods known in the art or the description of this invention. The techniques and methods described herein can generally be implemented according to conventional methods well known in the art, based on the descriptions in the various summary and more specific documents cited and discussed in this specification.

[0094] The terms “optional / arbitrary” or “optionally / arbitrarily” mean that the event or situation described below may or may not occur, including both the occurrence and non-occurrence of the event or situation.

[0095] The term "treatment" generally refers to achieving a desired pharmacological and / or physiological effect. An effect may be preventative, but not necessarily preventative, in relation to the prevention or partial prevention of a disease, symptom, or condition (such as dermatitis). An effect may be therapeutic in relation to the partial or complete cure of a disease, condition, symptom, or adverse reaction attributable to that disease, condition, or condition. Specifically, the term "treatment" can include any treatment of a subject's (especially a human) relevant symptom or disease, and may include any one or more of the following: (a) preventing the disease from occurring in subjects who may be susceptible to the disease but have not yet been diagnosed with it; (b) suppressing the disease, i.e., preventing its development; and (c) alleviating the disease, i.e., reducing or improving the disease and / or its symptoms or condition.

[0096] The term "pharmaceutically acceptable" means a substance (such as a carrier or diluent) that does not significantly affect the biological activity or properties of the compounds of the present invention and is relatively non-toxic, i.e., the substance can be administered to an individual without causing an adverse biological reaction or interacting adversely with any component contained in the composition.

[0097] The term "carrier" refers to a relatively non-toxic substance.

[0098] The term "portion" refers to a unit of weight. Attached Figure Description

[0099] Figure 1 Graphs showing changes in body weight of rats in each group; Figure 2 HE staining of rat ovarian lung tissue; Figure 3 Mycoplasma load in rat lung tissue; P<0.05, P<0.01 (X±S, n=6) Figure 4 Results of rat inflammatory factor detection; P<0.05, P<0.01 (X±S, n=6) Figure 5 Figure showing the results of detecting oxidative stress damage indicators in rats; P<0.05, P<0.01 (X±S, n=6) Figure 6 Figure showing the effect of each drug treatment group on cell apoptosis in lung tissue of mycoplasma pneumoniae; P<0.05, P<0.01 (X±S, n=6) Figure 7 Chart showing changes in rat body weight. Detailed Implementation

[0100] Unless otherwise specified, the experimental methods described in the following examples are conventional methods; the reagents and materials described are commercially available unless otherwise specified. The units of measurement for raw materials, "parts" and "g", are interchangeable.

[0101] Unless otherwise specified, all the medicinal materials mentioned are processed Chinese medicinal herbs, which can be obtained from sales companies or processed from cultivated and harvested herbs, all meeting the requirements of the 2025 edition of the Chinese Pharmacopoeia. Specifically, the ephedra is honey-processed ephedra, the bitter apricot kernel is stir-fried bitter apricot kernel, the pinellia is processed pinellia, the peach kernel is stir-fried peach kernel, the chlorite is calcined chlorite, the gypsum is raw gypsum, and the licorice is prepared licorice. For herbs with multiple origins, honey-processed ephedra is *Ephedra sinica*, a plant in the Ephedraceae family. Ephedra sinica Stapf refers to the dried herbaceous stems; Trichosanthes kirilowii Maxim. is the dried, mature fruit of the Cucurbitaceae plant; and Prunus persica kernel is the fruit of the Rosaceae plant Prunus persica. Prunus davidiana The dried, mature seeds of (Carr.) Franch.; bitter almonds are the seeds of the wild apricot tree (Prunus armeniaca) belonging to the Rosaceae family. Prunus armeniaca L. var.ansu The dried, mature seeds of Maxim., licorice is the licorice plant of the legume family. Glycyrrhiza uralensis The dried roots and rhizomes of Fisch.

[0102] Example 1: A traditional Chinese medicine composition and its preparation method The composition is made up of the following raw materials in parts by weight: Ephedra 6g, Pinellia 9g, Dried Ginger 3g, Bitter Almond 10g, Scutellaria 10g, Chlorite 7g, Gypsum 30g, Peach Kernel 10g, Polygonatum odoratum 10g, Trichosanthes Root 10g, North American Ginseng 15g, and Licorice 6g.

[0103] The preparation method is as follows: weigh each component according to the formula, crush and mix them to obtain the final product.

[0104] Example 2: A Traditional Chinese Medicine Extract and Its Preparation Method The extract is formulated with the following raw materials in parts by weight: 6g of honey-processed ephedra, 9g of processed pinellia, 3g of dried ginger, 10g of stir-fried bitter almond, 10g of scutellaria, 10g of calcined chlorite, 30g of raw gypsum, 10g of stir-fried peach kernel, 10g of polygonatum, 10g of trichosanthes, 15g of glehnia littoralis, and 6g of prepared licorice.

[0105] The preparation method is as follows: Weigh each component according to the formula, add water at 10 times the mass of all raw materials (total mass of raw materials), decoct twice, decoct for 1 hour each time, filter to obtain filtrate; concentrate the obtained filtrate to obtain concentrated solution, further concentrate and dry the concentrated solution to make dry extract.

[0106] Example 3: A Traditional Chinese Medicine Extract and Its Preparation Method The extract is formulated with the following raw materials in parts by weight: 6g of honey-processed ephedra, 5g of processed pinellia, 3g of dried ginger, 10g of stir-fried bitter almond, 10g of scutellaria, 10g of calcined chlorite, 30g of raw gypsum, 10g of stir-fried peach kernel, 10g of polygonatum, 10g of trichosanthes, 15g of glehnia littoralis, and 6g of prepared licorice.

[0107] The preparation method is as follows: Weigh each component according to the formula, add water at 20 times the total mass of the raw materials, decoct twice, each time for 0.8 hours, filter, and obtain the filtrate; concentrate the obtained filtrate to obtain the concentrate, and further concentrate and dry the concentrate to make the dry extract.

[0108] Example 4: A Traditional Chinese Medicine Extract and Its Preparation Method The extract is formulated with the following raw materials in parts by weight: 7g of honey-processed ephedra, 5g of processed pinellia, 3g of dried ginger, 9g of stir-fried bitter almond, 11g of scutellaria, 11g of calcined chlorite, 28g of raw gypsum, 11g of stir-fried peach kernel, 9g of polygonatum, 9g of trichosanthes, 16g of glehnia littoralis, and 7g of prepared licorice.

[0109] The preparation method is as follows: Weigh each component according to the formula, add water at 10 times the total mass of the raw materials, decoct twice, decoct for 1 hour each time, filter to obtain filtrate; concentrate the obtained filtrate to obtain concentrated solution, further concentrate and dry the concentrated solution to make dry extract.

[0110] Example 5: A Traditional Chinese Medicine Extract and Its Preparation Method The extract is formulated with the following raw materials in parts by weight: 5g of honey-processed ephedra, 10g of processed pinellia, 3g of dried ginger, 12g of stir-fried bitter almond, 8g of scutellaria, 8g of calcined chlorite, 34g of raw gypsum, 8g of stir-fried peach kernel, 12g of polygonatum, 12g of trichosanthes, 18g of glehnia littoralis, and 5g of prepared licorice.

[0111] The preparation method is as follows: Weigh each component according to the formula, add water at 10 times the total mass of the raw materials, decoct twice, decoct for 1 hour each time, filter to obtain filtrate; concentrate the obtained filtrate to obtain concentrated solution, further concentrate and dry the concentrated solution to make dry extract.

[0112] Example 6: A Traditional Chinese Medicine Extract and Its Preparation Method The extract is formulated with the following raw materials in parts by weight: 5g of honey-processed ephedra, 5g of processed pinellia, 4g of dried ginger, 12g of stir-fried bitter almond, 9g of scutellaria, 12g of calcined chlorite, 35g of raw gypsum, 8g of stir-fried peach kernel, 7g of polygonatum, 8g of trichosanthes, 13g of glehnia littoralis, and 7g of prepared licorice.

[0113] The preparation method is as follows: Weigh each component according to the formula, add water at 10 times the total mass of the raw materials, decoct twice, decoct for 1 hour each time, filter to obtain filtrate; concentrate the obtained filtrate to obtain concentrated solution, further concentrate and dry the concentrated solution to make dry extract.

[0114] Example 7: Preparation of Granules Granules were prepared according to the following formula: 5.00 g dextrin, 20.00 g extract powder obtained in Example 2, and an appropriate amount of 85% ethanol.

[0115] Mix dextrin and extract powder evenly, add an appropriate amount of 85% ethanol and knead evenly, squeeze through a 20-mesh sieve, dry in an oven at 60℃, and clean with a 16-mesh sieve to obtain granules.

[0116] Example 8: Preparation of capsules and tablets The filtrate obtained in Example 3 was concentrated to obtain a concentrate. Starch with an extract mass ratio of 1:9 was added to make granules. A portion of the granules were filled into capsule shells to obtain capsules, and a portion of the granules were compressed into tablets.

[0117] Example 9: Preparation of Granules The filtrate obtained in Example 3 was concentrated to obtain a concentrate. Starch with an extract mass ratio of 9:1 was added to the concentrate and granulated.

[0118] Comparative Example 1: An extract and its preparation method Formula: 6g of processed ephedra, 10g of stir-fried bitter almond, 30g of raw gypsum, 10g of whole trichosanthes fruit, 9g of processed pinellia, 10g of scutellaria, 10g of stir-fried peach kernel, 3g of dried ginger, 10g of calcined chlorite, 10g of polygonatum, and 6g of processed licorice.

[0119] Preparation process: Weigh each component according to the formula, add water at 10 times the total mass of raw materials, decoct twice, 1 hour each time, filter to obtain filtrate; concentrate the obtained filtrate to obtain concentrated solution, further concentrate and dry the concentrated solution to prepare the dry extract of the decomposed group intermediate.

[0120] Comparative Example 2 Prescription: Ephedra 50g, bitter almond 100g, gypsum 300g, licorice 50g, anemarrhena 83.5g, scutellaria 100g, isatis root 167g, ophiopogon 167g, forsythia 83.5g, houttuynia 167g.

[0121] Preparation method: Preparation process: Weigh each component according to the formula, add water at 10 times the total mass of raw materials, decoct twice, 1 hour each time, filter to obtain filtrate; concentrate the obtained filtrate to obtain concentrated solution, further concentrate and dry the concentrated solution to prepare the dry extract of the decomposed group intermediate.

[0122] Comparative Example 3: An extract of traditional Chinese medicine and its preparation method Ingredients: 6g honey-processed ephedra, 5g processed pinellia, 6g dried ginger, 10g stir-fried bitter almond, 4g scutellaria, 15g calcined chlorite, 29g raw gypsum, 6g stir-fried peach kernel, 17g polygonatum, 17g trichosanthes, 5g north ginseng, and 9g prepared licorice.

[0123] The preparation method is as follows: Weigh each component according to the formula, add water at 20 times the total mass of the raw materials, decoct twice, each time for 0.8 hours, filter, and obtain the filtrate; concentrate the obtained filtrate to obtain the concentrate, and further concentrate and dry the concentrate to make the dry extract.

[0124] Comparative Example 4: An extract and its preparation method Formula: Prepared ephedra 7g, stir-fried bitter apricot kernel 12g, raw gypsum 30g, whole trichosanthes fruit 14g, prepared pinellia 9g, scutellaria baicalensis 12g, stir-fried peach kernel 10g, dried ginger 5g, calcined chlorite 10g, polygonatum odoratum 14g, prepared licorice root 6g Preparation process: Weigh each component according to the formula, add water at 10 times the total mass of raw materials, decoct twice, decoct for 1 hour each time, filter to obtain filtrate; concentrate the obtained filtrate to obtain concentrated solution, further concentrate and dry the concentrated solution to make dry extract.

[0125] Effect test: I. Efficacy test of mycoplasma pneumonia in rats 1.1 Test substance Traditional Chinese Medicine Group: The dry extract prepared using the method in Example 2; The fractionated group: the dry extract prepared using the method of Comparative Example 1; Positive control group: Azithromycin tablets (0.25g) purchased commercially available were used. 12 tablets / box, batch number: 2742401201, CSPC Ouyi Pharmaceutical Co., Ltd., positive drug group); Control group: Dry extract prepared using the method of Comparative Example 2; Combination group: The dry extract prepared by the method in Example 2 above was used in combination with commercially available azithromycin tablets.

[0126] 1.2 Reagents Table 1 Main Reagents List

[0127] 1.3 Instruments Table 2. List of Main Instruments and Equipment

[0128] 1.4 Experimental Animals Seventy-two male SPF-grade SD rats, weighing 180-200g, were acclimatized for 7 days at a room temperature of 20±2℃ with alternating light and dark lighting for 12 hours, and were provided with regular feed and their own drinking water.

[0129] 2. Experimental Design 2.1 Grouping of experimental animals and dosage design In this experiment, 72 SPF-grade female SD rats were randomly divided into 9 groups, with 8 rats in each group.

[0130] Positive control group: Azithromycin group, administered by gavage at a dose of 189.2 mg / kg / day; Traditional Chinese medicine groups: low concentration group: 2.79 g crude drug / kg / day; medium concentration group: 8.37 g crude drug / kg / day (compound group data); high concentration group: 25.11 g crude drug / kg / day. The dosage group consisted of 7.39g of raw medicinal materials per kg per day. Combination therapy group: Azithromycin 189.2 mg / kg / d + medium concentration of traditional Chinese medicine group 8.37 g crude drug / kg / d; Comparative Example 2: 8.37 g crude drug / kg / d (data from the medium concentration group); A blank control group and a model control group were also set up.

[0131] d is a unit of days.

[0132] 2.2 Preparation of experimental drugs The test substance was prepared into a solution daily using drinking water.

[0133] Positive control group (yxy): Azithromycin solution was prepared, with a dosage of 1 ml / 100 g for rats. 378.4 mg of the positive control drug was dissolved in 20 ml of water.

[0134] Low-concentration traditional Chinese medicine group (zyd): The low-concentration solution of the traditional Chinese medicine test substance was prepared by dissolving the test substance in 20 ml of water at a dose of 1 ml / 100 g for rats.

[0135] Medium-concentration traditional Chinese medicine group (zyz): Medium-concentration solution of traditional Chinese medicine test substance was prepared by dissolving the test substance in 20ml of water according to the rat administration solution volume of 1ml / 100g.

[0136] High-concentration traditional Chinese medicine group (zyg): A high-concentration solution of the traditional Chinese medicine test substance was prepared by dissolving the test substance in 20 ml of water at a dose of 1 ml / 100 g for rat administration.

[0137] Fragmented formulation group (cfz): The test substance solution of the fragmented formulation group was prepared by dissolving the test substance of the fragmented formulation group in 20 ml of water at a rat administration volume of 1 ml / 100 g.

[0138] Combination group (lyz): Azithromycin and the test Chinese medicine Preparation: Based on a rat administration solution volume of 1 ml / 100 g, dissolve 378.4 mg of the positive control drug and the corresponding dose of the medium-concentration traditional Chinese medicine group in 20 ml of water.

[0139] Comparative Example 2 (ffz): The concentration solution of the Chinese herbal medicine test substance was prepared by dissolving the test substance in 20 ml of water at a dose of 1 ml / 100 g for rat administration.

[0140] Storage conditions for all test substances and preparations: cool and sealed.

[0141] 3. Test Procedure 3.1 Test Methods Seventy-two male SD rats were acclimatized for 7 days and then randomly divided into four groups using a random number table: a blank control group, a model control group, a positive control group, a low-concentration traditional Chinese medicine (TCM) group, a medium-concentration TCM group, a high-concentration TCM group, a prescription-splitting group, a combination group, and a control group, with eight rats in each group. The rats were anesthetized by intraperitoneal injection of chloral hydrate. Except for the blank control group, all other groups received 10... 6 100 μL of CCU / mL Mycoplasma pneumoniae strain was administered intranasally for 4 consecutive days. The control group received an equal volume of physiological saline intranasally. The rats' mental state, food and water intake, and body weight were closely monitored. Successful modeling was confirmed by clinical symptoms (weight loss, rapid breathing). Oral administration of the experimental drug was initiated on day 8 post-modeling, administered once daily at the prepared dosage for 2 weeks.

[0142] 3.2 Observation of rat weight gain and general condition From the start of drug administration, daily changes in body weight were recorded, and the general condition and behavioral characteristics of the rats were observed and recorded.

[0143] The general condition of rats was scored and statistically analyzed according to the scoring criteria in Table 3 below.

[0144] Table 3. Rats' General Condition Scoring Criteria

[0145] 3.3 Serum inflammatory factor detection After the last administration, rats in each group were fasted but allowed free access to water for 12 hours. Rats were then anesthetized with 10% chloral hydrate, and blood was collected from the abdominal aorta. The blood was allowed to stand for 1 hour, then centrifuged at 3500 rpm for 15 minutes at 4°C. Serum was collected and used for ELISA to detect inflammatory factors IL-6, TNF-α, IL-1β, and IL-10.

[0146] 3.4 Mycoplasma load detection After the last administration, rats in each group were fasted but allowed free access to water for 12 hours. They were then anesthetized and sacrificed. Lung tissue was collected, and the M. pneumoniae DNA load in the lung tissue was detected by qPCR.

[0147] 3.5 Lung tissue pathological examination Lung tissue fixed in formalin was removed, embedded, cut into uniform sections of 3 µm thickness, dewaxed to water, stained with hematoxylin and eosin (HE) and turbinates (TUNEL), dehydrated, mounted, and observed under a microscope for pathological and apoptotic observation.

[0148] 3.6 Detection of Oxidative Stress Indicators After the last administration, rats in each group were fasted for 12 hours but allowed free access to water. They were then anesthetized and sacrificed, and lung tissue was collected to detect the levels of biochemical indicators SOD and MDA.

[0149] 3.7 Statistical Analysis All data were statistically analyzed using GraphPad Prism (10.1.2) software, and the results are presented in the form of... Mean ± s. One-way ANOVA was used to compare the differences between groups. P < 0.05 and P < 0.01 were considered statistically significant.

[0150] 4. Test Results 4.1 Effects on rat body weight and general condition Weight information: Rat body weight during administration Figure 1 As shown, there was no significant difference in weight gain among the groups, indicating that the administration of the heat-clearing, phlegm-resolving, lung-ventilating, and cough-relieving formula of this invention has no significant effect on the weight of rats.

[0151] General condition: The model group rats exhibited reduced food and water intake; dull and disheveled fur; reduced stool output; and significant sneezing. The rats' condition was scored according to Table 3, and the general condition of each group is summarized in Table 4. After 14 days of drug treatment, food and water intake fully recovered, fur regained its smoothness and shine, and sneezing symptoms resolved. The combined treatment group showed the fastest recovery, with all rats scoring 0 on day 11. The positive control group followed, with all rats scoring 0 on day 12. The medium- and high-concentration traditional Chinese medicine groups also showed a significantly better recovery trend than the control group.

[0152] Table 4. General condition scoring table for each rat in each group.

[0153] 4.2 Impact on inflammation and etiology like Figure 2 Pathological examination of lung tissue and HE staining results showed that, compared with the control group, the model control group exhibited alveolar epithelial hyperplasia, alveolar septal thickening, alveolar atrophy, and inflammatory cell infiltration. The Qingre Ditan Xuanfei Zhike formula alleviated pathological symptoms in a dose-dependent manner. The formula-individualized group showed slight therapeutic effect, while the positive control group and the medium-to-high concentration group showed significant therapeutic effects. Among all treatment groups, the high-concentration traditional Chinese medicine group and the combined treatment group showed better alveolar recovery than other groups.

[0154] To investigate the therapeutic effect of the heat-clearing, phlegm-resolving, lung-ventilating, and cough-relieving composition on mycoplasma pneumoniae pneumonia, the viral load of mycoplasma pneumoniae was detected by qPCR, as shown above. Figure 3 The results showed that the positive control group significantly reduced mycoplasma load in rat lung tissue after treatment. The dosage-related reduction of mycoplasma load in each group of the heat-clearing, phlegm-resolving, lung-ventilating, and cough-relieving composition was observed, with the medium and high concentrations of traditional Chinese medicine significantly reducing mycoplasma load in rat lung tissue. No significant reduction in mycoplasma levels was observed in the individual formula groups. The combined treatment group showed the lowest mycoplasma load and the best therapeutic effect after administration. The experimental results indicated that omitting North American ginseng in the individual formula groups significantly reduced the mycoplasma treatment effect compared to the group without omitting it; no significant reduction in mycoplasma levels was observed at 7.39 g crude drug / kg / d, while the heat-clearing, phlegm-resolving, lung-ventilating, and cough-relieving composition of this invention showed a significant effect at 8.37 g crude drug / kg / d.

[0155] The essence of mycoplasma pneumonia is not only the damage directly caused by the pathogen, but more importantly, the "immune inflammatory storm" triggered by the body's immune system response. Therefore, detection was performed on the main inflammatory factors. Figure 4 In the study, regarding pro-inflammatory factors IL-6, TNF-α, and IL-1β, the levels of inflammatory factors were significantly increased in the model control group compared to the blank control group, while they were significantly reduced in the positive control group after treatment. Among the various treatment groups using the heat-clearing, phlegm-resolving, lung-ventilating, and cough-relieving combination, the medium- and high-concentration traditional Chinese medicine groups significantly reduced the levels of inflammatory factors. The combined treatment group significantly reduced the levels of pro-inflammatory factors in serum, showing the best therapeutic effect among all treatment groups. Regarding the anti-inflammatory factor IL-10, the level was significantly lower in the model control group compared to the blank control group, but it significantly rebounded after treatment in all treatment groups. The medium-concentration traditional Chinese medicine group, high-concentration traditional Chinese medicine group, and positive control group showed significant efficacy, and the combined treatment group still exhibited the best therapeutic effect among all groups.

[0156] 4.3 Effects on lung function and injury indicators Mycoplasma pneumoniae-induced damage involves two key stages: oxidative stress imbalance and apoptosis. Activated immune cells (such as macrophages and neutrophils) produce large amounts of reactive oxygen species (ROS) during the phagocytosis and clearance of pathogens, leading to oxidative stress. This can cause severe damage to lung tissue cells. SOD (superoxide dismutase) and MDA (malondialdehyde) are important indicators for detecting the degree of oxidative stress in the body, and the results are as follows: Figure 5 As shown, compared with the blank control group, the SOD value in the model control group decreased, indicating an aggravated oxidative stress state and increased susceptibility of lung tissue to oxidative damage. The SOD values ​​of the positive control group, high-concentration traditional Chinese medicine group, combined treatment group, and medium-concentration traditional Chinese medicine group significantly rebounded after treatment, with the combined treatment group showing the best effect. For MDA, the induction of mycoplasma pneumonia significantly increased the level of MDA in lung tissue. Treatment of the positive control group, high-concentration traditional Chinese medicine group, combined treatment group, and medium-concentration treatment group significantly reduced this trend, with the combined treatment group showing the most significant therapeutic effect.

[0157] Next, the TUNEL assay was used to investigate the effects of different drug treatments on apoptosis in lung tissue of mycoplasma pneumoniae. Figure 6 As can be seen, the number of apoptotic cells in the model group increased significantly. The positive control group, the high-concentration traditional Chinese medicine group, the combined treatment group, and the medium-concentration treatment group all had a significant effect on reducing lung tissue cell apoptosis. Among them, the effect of the high-concentration traditional Chinese medicine group was basically the same as that of the combined treatment group. Figure 6 B is a statistical graph showing the number of apoptotic cells, which expresses similar results.

[0158] 5. Conclusion The heat-clearing, phlegm-resolving, lung-ventilating, and cough-relieving composition of this invention effectively alleviates histopathological damage and inflammatory infiltration caused by mycoplasma pneumonia, reduces the mycoplasma load in lung tissue, and improves lung function and oxidative damage. It exhibits significant therapeutic effects, particularly in regulating inflammatory factors, oxidative stress, and apoptosis. In restoring the pathological state of lung tissue and reducing lung cell apoptosis, the therapeutic effect of the herbal group of this invention is superior to the split-formula group and the control group. Among the various herbal groups, the combination of the heat-clearing, phlegm-resolving, lung-ventilating, and cough-relieving composition and azithromycin showed outstanding therapeutic effects, exhibiting optimal therapeutic efficacy in terms of pathological damage and various indicator detection. The low-concentration herbal group also had a certain therapeutic effect, alleviating symptoms to some extent.

[0159] To further screen and optimize the formulation, the extracts prepared in Examples 3-6 and Comparative Example 4 were tested for efficacy at a dose of 8.37 g crude drug / kg / d using the same experimental method. The results showed that the extracts prepared in Examples 3-6 had similar efficacy to the extracts prepared in Example 2 and could effectively inhibit mycoplasma pneumoniae-related pneumonia. The extracts prepared in Comparative Example 4 had similar efficacy to the extracts in the disassembled formulation group, but the effect was not obvious at this dose.

[0160] II. Gastrointestinal adverse reaction experiment in rats 1. Laboratory animals Twenty-seven male SPF-grade SD rats, weighing 200-220g, were kept at room temperature of 20±2℃ with alternating light and dark lighting for 12 hours, and were provided with regular feed and their own drinking water.

[0161] 2. Test substance and grouping In this experiment, 27 SPF-grade female SD rats were randomly divided into 3 groups, with 9 rats in each group.

[0162] Group 1 of traditional Chinese medicine: dry extract prepared using the method in Example 5, 100g crude drug / kg / d.

[0163] Comparative Example 2: Dry extracts of the herbal formula obtained using the method of Comparative Example 3, 100g crude drug / kg / d Blank group: Normal drinking water.

[0164] For the preparation of experimental drugs, a suspension was made using drinking water, and 2 ml was administered each time.

[0165] 3. Test methods Male SD rats were acclimatized for 7 days and then randomly divided into a blank control group, a traditional Chinese medicine (TCM) group 1, and a control group (TCM) group 2) using a random number table. The experimental TCM drugs were administered once daily for 14 consecutive days at the prepared dosage. The rats' mental state, food and water intake, stool characteristics, and body weight were closely monitored.

[0166] 4. Test Results 4.1 Diarrhea in rats In the control group, there were no significant changes in food and water intake, no diarrhea, and normal feces. In the herbal medicine group 1, there were no significant changes in food and water intake, and no obvious diarrhea. In the control group (herbal medicine group 2), there was a decrease in food and water intake, with some rats experiencing diarrhea, loose yellow feces, and reduced activity.

[0167] 4.2 Changes in rat body weight like Figure 7 As shown, after 14 days of administration, the body weight of the blank group increased significantly, there was no significant difference between the Chinese medicine group 1 and the blank group, and the body weight of rats in the comparative Chinese medicine group 2 decreased significantly, which may be related to the decrease in food intake caused by gastrointestinal reactions.

[0168] Verification Experiment: The gastrointestinal adverse reaction experiment in rats was repeatedly verified using the dry extract prepared by the method of Example 5, the dry extract prepared by the method of Example 2, and the glycoside extract prepared by the method of Comparative Example 2. The dosage was 100g crude drug / kg / d. The results showed that the food intake and water intake of the dry extract prepared by the method of Example 5 and the dry extract prepared by the method of Example 2 did not change significantly, and no diarrhea was observed. However, the rats using the glycoside extract prepared by the method of Comparative Example 2 showed a significant decrease in body weight, and some rats experienced diarrhea, which may be related to the decrease in food intake caused by gastrointestinal reactions.

[0169] III. Clinical Trials 1.1 Experimental Design This study is a single-center, randomized, controlled trial conducted in accordance with the Declaration of Helsinki.

[0170] 1.2 Subjects The subjects were 16 hospitalized children from the First Affiliated Hospital of Henan University of Traditional Chinese Medicine.

[0171] 1.3 Inclusion Criteria (1) Inpatients who meet the diagnostic criteria for MPP in Western medicine and the diagnostic criteria for acute phlegm-heat obstructing the lungs in traditional Chinese medicine are enrolled within a time window of ≤72 hours throughout the course of the disease. (2) Age 1-16 years old; (3) Parents are informed, voluntarily sign consent forms, and are able to cooperate throughout the research period; (4) No serious damage to the heart, brain, kidneys, circulatory system, or nervous system.

[0172] 1.4 Exclusion Criteria (1) The researchers determined that the patient had a combined bacterial or viral infection, and the blood routine test showed a white blood cell count ≥13×10⁻⁶. 9 / L, with neutrophils predominating or positive for respiratory virus nucleic acid testing; (2) Individuals known to be allergic to the treatment drugs used in the study protocol; (3) Before seeking medical treatment, other anti-mycoplasma drugs, or similar Chinese medicines for treating this disease, including Chinese patent medicine injections, or non-drug treatments of traditional Chinese medicine (including massage, Chinese medicine plasters, lung physiotherapy, etc.) have been used; (4) Life-threatening critical complications, such as serious intrapulmonary complications such as empyema, pneumothorax, lung abscess, necrotizing pneumonia, and acute respiratory failure, or serious extrapulmonary complications such as septic shock, viral encephalopathy, and persistent lesions. (5) Diseases that need to be differentiated from MPP, such as tuberculosis and pneumonia caused by other uncommon fungal pathogens; (6) Lung infection secondary to underlying diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory tract malformation, lung developmental abnormalities, aspiration pneumonia, and malignant lung tumors.

[0173] 1.5 Randomization Methods A random number table is used for grouping.

[0174] The control group consisted of 8 cases: 4 cases aged 1-3 years, 2 cases aged 4-6 years, and 2 cases aged 7 years and older.

[0175] The treatment group consisted of 8 patients, including 4 aged 1-3 years, 2 aged 4-6 years, and 2 aged 7 years and older.

[0176] 1.6 Intervention Measures The treatment group received treatment with the decoction obtained from the formula of this invention and Western medicine (the administration regimen of the Western medicine was the same as that of the control group). The specific usage and dosage of the formula of this invention are as follows: 6g of processed ephedra, 10g of stir-fried bitter apricot kernel, 30g of raw gypsum (decocted first), 10g of whole trichosanthes fruit, 5-6g of processed pinellia, 10g of scutellaria, 10g of stir-fried peach kernel, 15g of north ginseng, 3g of dried ginger, 10g of chlorite (decocted first), 10g of polygonatum, and 6g of processed licorice. Administration: Decocted in water. For children aged 1-3 years, half a dose daily, divided into two doses; for children aged 4-6 years, two-thirds of a dose daily, divided into two doses; for children over 7 years old, one dose daily, divided into two doses.

[0177] The control group (Western medicine group) followed the "Guidelines for the Diagnosis and Treatment of Mycoplasma Pneumonia in Children (2023 Edition)" and the "Expert Consensus on the Clinical Application of Tetracycline Antibiotics in Pediatrics (2024 Edition)". Initial treatment for both groups involved intravenous azithromycin at 10 mg / (kg·d), with a daily dose not exceeding 500 mg, once daily (qd), for approximately 7 days. A second course of treatment began after a 3-day interval, for a total treatment duration of 14 days. Treatment ended when the researchers determined the patient to be cured during the treatment process. Both groups received general and symptomatic treatment, including adequate rest and energy intake, and maintenance of fluid and electrolyte balance. Appropriate oxygen therapy was administered based on the patient's condition. Antipyretics (acetaminophen, administered according to the instructions) were administered correctly. All expectorant and antitussive Western medicines and related nebulizers were contraindicated.

[0178] 1.7 Outcome Indicators Traditional Chinese medicine syndrome scoring, comparison before and after treatment; clinical efficacy, comparison after treatment.

[0179] 1.8 Statistical Analysis SPSS 26.0 software was used for analysis. Measurement data in the experiment were described using mean ± standard deviation. Paired t-tests and independent samples t-tests were performed on changes before and after treatment within groups and differences between groups, respectively. The χ² test was used for comparisons between groups. The rank-sum test was used for stratified data. All tests were two-tailed. P <0.05 indicates a statistically significant difference.

[0180] 1.9 Results This study included 16 eligible participants, all of whom completed all treatments and follow-ups. No drug-related adverse events occurred during the study period, and all safety tests, including complete blood counts and liver and kidney function tests, were normal after treatment.

[0181] (1) Comparison of TCM syndrome scores before and after treatment in the two groups of children According to the data in Table 5, compared with the pre-treatment scores, the scores of primary and secondary syndromes in TCM were significantly lower in both groups after treatment (P<0.05). Furthermore, the scores of primary and secondary syndromes in the treatment group (combined drug administration group) were significantly lower than those in the Western medicine group after treatment (P<0.05).

[0182] Table 5 Comparison of TCM syndrome scores before and after treatment in the two groups of patients ( x±s )

[0183] Note: Compared with the pre-treatment level in this group 1） P <0.05; compared with the Western medicine group after treatment 2） P <0.05.

[0184] (2) Comparison of clinical efficacy between the two groups of patients after treatment As shown in Table 6, after 14 days of treatment, the total effective rate in the treatment group (combined medication group) was 100% (8 / 8), while the total effective rate in the conventional medication group (control group) was 87.5% (7 / 8). The difference between the two groups was not statistically significant (χ²). 2 =12.25, P <0.05), see Table 6.

[0185] Table 6

[0186] (3) Adverse reactions No adverse reactions such as abnormal liver or kidney function occurred in either group of children during treatment. This indicates that the formula of this invention has good safety.

[0187] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the present invention. 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 modifications and improvements all fall within the scope of protection of the present invention. Therefore, the scope of protection of this patent should be determined by the appended claims.

Claims

1. A traditional Chinese medicine preparation composition, characterized in that, It is made from component (i) and component (ii), wherein component (i) is an extract made from raw materials comprising the following parts by weight: 4-8 parts of ephedra, 3-10 parts of pinellia, 2-5 parts of dried ginger, 7-13 parts of bitter almond, 7-13 parts of scutellaria, 7-13 parts of chlorite, 21-39 parts of gypsum, 7-13 parts of peach kernel, 7-13 parts of polygonatum, 7-13 parts of trichosanthes, 11-20 parts of glehnia littoralis, and 4-8 parts of licorice; component (ii) is a pharmaceutically acceptable excipient; and the mass content of component (ii) in the pharmaceutical composition is 0.5%-99.5%.

2. A traditional Chinese medicine preparation, characterized in that, The preparation comprises a traditional Chinese medicine composition, which is made of component (i) and component (ii), wherein component (i) is an extract prepared from raw materials comprising the following parts by weight: ephedra 4-8 parts, pinellia 3-10 parts, dried ginger 2-5 parts, bitter almond 7-13 parts, scutellaria baicalensis 7-13 parts, chlorite 7-13 parts, gypsum 21-39 parts, peach kernel 7-13 parts, polygonatum odoratum 7-13 parts, trichosanthes kirilowii 7-13 parts, glehnia littoralis 11-20 parts, and licorice 4-8 parts; component (ii) is a pharmaceutically acceptable excipient; the preparation is a solid preparation, preferably granules, tablets, or capsules, and further, the mass content of component (ii) in the preparation composition is 0.1%-99.8%.

3. The traditional Chinese medicine preparation composition according to claim 1 or the traditional Chinese medicine preparation according to claim 2, characterized in that, The components (i) are raw materials in parts by weight: Ephedra 5-7 parts, Pinellia 5-10 parts, Dried Ginger 2-5 parts, Bitter Almond 8-12 parts, Scutellaria 8-12 parts, Chlorite 8-12 parts, Gypsum 25-35 parts, Peach Kernel 8-12 parts, Polygonatum 8-12 parts, Trichosanthes 8-12 parts, North American Ginseng 13-18 parts, and Licorice 5-7 parts; Alternatively, the raw materials of component (i) by weight are: 6-7 parts of ephedra, 5-10 parts of pinellia, 3-4 parts of dried ginger, 9-11 parts of bitter almond, 9-11 parts of scutellaria, 9-11 parts of chlorite, 28-32 parts of gypsum, 9-11 parts of peach kernel, 9-10 parts of polygonatum, 9-11 parts of trichosanthes, 14-16 parts of glehnia littoralis, and 6-7 parts of licorice. Alternatively, the raw materials of component (i) by weight are: 6 parts of ephedra, 5-9 parts of pinellia, 3 parts of dried ginger, 10 parts of bitter almond, 10 parts of scutellaria, 10 parts of chlorite, 30 parts of gypsum, 10 parts of peach kernel, 10 parts of polygonatum, 10 parts of trichosanthes, 15 parts of glehnia littoralis and 6 parts of licorice. Alternatively, the raw materials of component (i) by weight are: 6 parts ephedra, 9 parts pinellia, 3 parts dried ginger, 10 parts bitter almond, 10 parts scutellaria, 10 parts chlorite, 30 parts gypsum, 10 parts peach kernel, 10 parts polygonatum, 10 parts trichosanthes, 15 parts glehnia littoralis, and 6 parts licorice.

4. The traditional Chinese medicine preparation composition according to claim 1 or the traditional Chinese medicine preparation according to claim 2, characterized in that: The component (ii) has a mass content of 1.0%-99.0%, more preferably 2.5%-95.0%, and more preferably 5.0%-90.0% in the formulation composition.

5. The traditional Chinese medicine preparation composition according to claim 1 or the traditional Chinese medicine preparation according to claim 2, characterized in that: The traditional Chinese medicine preparation composition is prepared by the following method: Ephedra, Pinellia, dried ginger, bitter almond, Scutellaria baicalensis, chlorite, gypsum, peach kernel, Polygonatum odoratum, Trichosanthes kirilowii, Adenophora stricta and licorice are weighed according to the weight parts, solvent is added to each, extraction is performed, and filtration is carried out. The filtrates are then treated and combined or directly combined, concentrated and mixed with component (ii) to obtain the final product. Alternatively, weigh out ephedra, pinellia, dried ginger, bitter almond, scutellaria, chlorite, gypsum, peach kernel, polygonatum, trichosanthes, north ginseng and licorice according to the weight proportions, mix the raw materials, add solvent, extract, filter, and collect the filtrate to obtain the product; or further concentrate and dry the filtrate to make an extract, and mix it with component (ii) to obtain the product. Alternatively, weigh out ephedra, pinellia, dried ginger, bitter almond, scutellaria, chlorite, gypsum, peach kernel, polygonatum, trichosanthes, glehnia littoralis, and licorice according to the weight proportions, add solvent to the raw materials, extract, concentrate and mix with component (ii) to obtain the final product; The solvent is water, and the extraction method is decoction; the total mass of the water is 8-20 times the total mass of the raw material being extracted; the number of decoctions is 1-3 times; and the decoction time is 1-3 hours.

6. A method for preparing a traditional Chinese medicine preparation composition according to claim 1 or a traditional Chinese medicine preparation according to claim 2, characterized in that, include: Weigh out the following ingredients according to their weight proportions: ephedra, pinellia, dried ginger, bitter almond, scutellaria, chlorite, gypsum, peach kernel, polygonatum, trichosanthes, north ginseng, and licorice. Add solvent to the raw materials, extract, concentrate, and then mix with component (ii) to obtain the final product. The solvent is water, and the extraction method is decoction. The total mass of the water is 8-20 times the total mass of the extracted raw materials. The number of decoctions is 1-3 times, and the decoction time is 1-3 hours.

7. The use of the traditional Chinese medicine preparation composition of claim 1 or the traditional Chinese medicine preparation of claim 2 in the preparation of a product having the functions of clearing heat, resolving phlegm, ventilating the lungs, and relieving cough; or, in the preparation of a product for treating pneumonia caused by Mycoplasma pneumoniae infection; or, in the preparation of a product for treating phlegm-heat obstructing the lungs syndrome of pneumonia caused by Mycoplasma pneumoniae infection; or, in the preparation of a drug for inhibiting mycoplasma; or, in the preparation of a drug for improving the efficacy of azithromycin in treating pneumonia; wherein the mycoplasma is Mycoplasma pneumoniae, and the product is a drug or health food.

8. A product for treating phlegm-heat obstructing the lungs syndrome in pneumonia caused by Mycoplasma pneumoniae infection, characterized in that, The product includes the traditional Chinese medicine preparation composition of claim 1 or the traditional Chinese medicine preparation of claim 2; the product is a drug or health food; the Mycoplasma pneumoniae is Mycoplasma pneumoniae in children; further, the target of treatment for the product is children.

9. The traditional Chinese medicine preparation composition according to claim 1, or the traditional Chinese medicine preparation according to claim 2, or the product according to claim 8, characterized in that, The ephedra is honey-processed ephedra; the bitter apricot kernel is stir-fried bitter apricot kernel; the pinellia is processed pinellia; the peach kernel is stir-fried peach kernel; the chlorite is calcined chlorite; the gypsum is raw gypsum; and the licorice is prepared licorice.

10. A pharmaceutical composition comprising component 1 selected from the traditional Chinese medicine preparation composition of claim 1, the traditional Chinese medicine preparation of claim 2, or the product of claim 8, and component 2 selected from macrolide antibiotics; preferably, the macrolide antibiotic is selected from azithromycin; preferably, the two components are packaged separately or together, or packaged together.

Images