A traditional Chinese medicine composition with efficacy of treating pediatric recurrent respiratory tract infection and a preparation method and application thereof

Abstract

The application discloses a traditional Chinese medicine composition with the effect of treating infantile recurrent respiratory tract infection and a preparation method thereof. Through a large amount of clinical practice, the application selects radix pseudostellariae, fried atractylodes, fried rhizoma atractylodis, agastache, levisticus, lonicera, radix scrophulariae, carbonized wheat bran, calcined osseous, ephedra root as raw materials, and is prepared into an oral or external dosage form according to weight ratio. The application has the effects of transporting the spleen, preventing the invasion of pathogenic factors, and consolidating the surface and stopping sweating, and is used for infantile recurrent respiratory tract infection with the syndrome of the spleen failing to transport and the lung and defensive system failing to consolidate. The application is verified by clinical tests, has remarkable curative effect, no toxic side effect, and good safety. Animal experiment researches show that the traditional Chinese medicine composition can effectively relieve the chronic inflammation level of model mice, improve the airway epithelial barrier damage, improve the body's ability to resist pathogenic factors, and reduce the risk of infection. The application can fill the market blank of treating infantile recurrent respiratory tract infection diseases based on the theory of 'four seasons with the spleen being strong and not being invaded by pathogenic factors' and 'the spleen being strong is not about tonifying but about transportation', and has great development prospect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a drug for treating recurrent respiratory infections in children made from Chinese herbal medicines, its preparation method, and its application. Background Technology

[0002] Recurrent respiratory infections are a common pediatric respiratory disease characterized by a high frequency of upper and lower respiratory tract infections within a given period, exceeding the normal range. This disease is characterized by recurrence, a tendency to induce other illnesses, and prolonged illness can damage the immune system. Currently, the pathogenesis of this disease is not fully understood, and Western medicine treatments are complex with unsatisfactory symptom control. Traditional Chinese medicine (TCM) offers advantages and unique approaches to preventing and treating recurrent respiratory infections in children by strengthening the body's resistance and addressing its underlying causes. These approaches can improve the child's constitution, reduce the frequency and severity of infections, shorten the course of the disease, and improve the child's quality of life.

[0003] Developing a traditional Chinese medicine compound for treating recurrent respiratory infections in children is of great significance for the prevention and treatment of these infections. Currently, drug treatment generally involves chemical drugs and traditional Chinese medicine. Chemical drugs are diverse, have numerous adverse reactions, and their efficacy gradually declines with long-term use. Some are also expensive, limiting clinical choices. Traditional Chinese medicine treatment can address both the symptoms and the root cause, is safe and effective, and is less expensive. Currently, there is a lack of pediatric-specific traditional Chinese medicine preparations for treating recurrent respiratory infections on the market. Among these, Huaiqi Huang Granules, Huangqi Jing Oral Liquid, and Yupingfeng Granules are mostly tonifying and primarily used for adults. This invention is based on the traditional Chinese medicine theories of "a strong spleen in all four seasons is immune to pathogens" and "a healthy spleen in children is not about tonification but about proper function," treating recurrent respiratory infections in children from the perspective of the lungs and spleen. It is developed based on years of clinical experience and can effectively overcome the shortcomings of similar products currently on the market. Summary of the Invention

[0004] The purpose of this invention is to provide a safe and effective treatment for recurrent respiratory infections in children, which can effectively reduce the frequency of respiratory infections, shorten the interval between infections and the course of the disease, reduce the severity of infection, improve lung and spleen function, enhance physical fitness, improve immunity and quality of life. Another objective of this invention is to provide a method for preparing and using this drug.

[0005] The etiology of recurrent respiratory infections is generally believed to be related to age, environmental factors, lifestyle habits, dietary structure, and allergic constitution. Clinically, it is mainly characterized by recurrent external pathogens, shortness of breath, lethargy, emaciation, sallow complexion, poor appetite, and excessive sweating. Traditional Chinese medicine believes that the lung, spleen, and kidney functions of children are not yet mature, making them more susceptible to external pathogens, food, and drugs, and thus more prone to illness than adults. If daily dietary care is not properly managed, the spleen and stomach will lose their protective function. The spleen, located in the middle jiao, is the foundation of acquired constitution and the pivot of qi mechanism. Spleen deficiency leads to insufficient lung qi, impaired lung function, and weakened defensive qi, making children susceptible to external pathogens and illness. Therefore, impaired spleen function and weakened lung defense are the key pathogenesis of recurrent respiratory infections in children.

[0006] Western medicine primarily treats illness by regulating the body's immunity, supplementing trace elements and vitamins, and administering microbial preparations. Traditional Chinese medicine (TCM) takes a holistic approach, focusing on strengthening the body's resistance and addressing the root cause of the disease through syndrome differentiation and treatment. It regulates the child's overall physical condition, making it safe and effective.

[0007] This invention's technical solution is based on the classic TCM theory of "a strong spleen in all four seasons prevents the spread of pathogens," grounded in TCM's understanding of the pathogenesis and treatment principles of recurrent respiratory infections in children. It is developed through repeated screening and careful research, combined with years of clinical experience in treating this disease. The spleen governs muscles, and the lungs govern skin and hair. Spleen deficiency leads to insufficient muscle mass, while lung deficiency results in impaired lung function. With both the spleen and lungs deficient, external pathogens can easily invade. This highlights the importance of the spleen and lungs in the pathogenesis of exogenous diseases. The spleen is considered the mother of all things; when spleen qi is deficient, lung qi is the first to be depleted. Many childhood illnesses are closely related to diet and feeding; slight improper feeding can easily damage spleen qi. Spleen deficiency leads to impaired digestion and transformation, insufficient production of qi and blood, and a lack of essential nutrients to nourish the lungs, ultimately resulting in deficiency of both the spleen and lungs. Combined with repeated exposure to pathogens, this leads to the disease. Therefore, the treatment concept focuses on strengthening the spleen, emphasizing its role in nourishing the body's vital energy, strengthening defensive qi, and preventing the spread of pathogens. Ultimately, it achieves the effects of strengthening the spleen to prevent infection, strengthening the exterior, and stopping sweating, and is used to treat recurrent respiratory infections in children.

[0008] The specific technical solution is as follows:

[0009] A traditional Chinese medicine composition effective in treating recurrent respiratory infections in children, made from the following raw materials:

[0010] Codonopsis pilosula, stir-fried Atractylodes macrocephala, stir-fried Atractylodes lancea, Pogostemon cablin, Saposhnikovia divaricata, Magnolia biondii, Scrophularia ningpoensis, charred Shenqu (medicated leaven), calcined dragon bone, Ephedra root.

[0011] As a preferred embodiment, a traditional Chinese medicine composition for treating recurrent respiratory infections in children is made from the following raw materials in the indicated weight ratios:

[0012] Codonopsis pilosula 6-14g, stir-fried Atractylodes macrocephala 6-14g, stir-fried Atractylodes lancea 2-10g, Pogostemon cablin 2-10g, Saposhnikovia divaricata 2-10g, Magnolia biondii 2-10g (wrapped and decocted), Scrophularia ningpoensis 6-14g, charred Shenqu 6-14g, calcined dragon bone 10-25g (decocted first), Ephedra sinica root 2-10g.

[0013] As a more preferred embodiment, the traditional Chinese medicine composition for treating recurrent respiratory infections in children is made from the following raw materials in the preferred weight ratio:

[0014] Codonopsis pilosula 8-12g, stir-fried Atractylodes macrocephala 8-12g, stir-fried Atractylodes lancea 4-8g, Pogostemon cablin 4-8g, Saposhnikovia divaricata 4-8g, Magnolia biondii 4-8g (wrapped and decocted), Scrophularia ningpoensis 8-12g, charred Shenqu 8-12g, calcined dragon bone 12-20g (decocted first), Ephedra sinica root 4-8g.

[0015] As a particularly preferred embodiment, the traditional Chinese medicine composition for treating recurrent respiratory infections in children is made from the following raw materials in the optimal weight ratio:

[0016] 10g of Codonopsis pilosula, 10g of stir-fried Atractylodes macrocephala, 6g of stir-fried Atractylodes lancea, 6g of Pogostemon cablin, 6g of Saposhnikovia divaricata, 6g of Magnolia biondii (wrapped and decocted), 10g of Scrophularia ningpoensis, 10g of charred Shenqu (medicated leaven), 15g of calcined dragon bone (decocted first), and 6g of Ephedra sinica root.

[0017] The TCM syndrome differentiation and treatment explanation of the herbal composition of this invention is as follows:

[0018] The prescription consists of 10 herbs: Codonopsis pilosula, stir-fried Atractylodes macrocephala, stir-fried Atractylodes lancea, Pogostemon cablin, Saposhnikovia divaricata, Magnolia biondii, Scrophularia ningpoensis, charred Shenqu (medicated leaven), calcined dragon bone, and Ephedra sinica root.

[0019] Codonopsis pilosula: Sweet and slightly bitter in taste, neutral in nature, it enters the spleen and lung meridians. Its functions include tonifying qi and strengthening the spleen, generating fluids and moistening the lungs. Children often have deficiencies in their lungs and spleen. Children with recurrent respiratory infections, due to improper care, repeatedly succumb to pathogenic factors, further damaging their lungs and spleen. Prolonged illness leads to impaired spleen function and weakened lung defenses, making them susceptible to pathogenic factors. Using Codonopsis pilosula as the principal herb allows it to directly target the affected area, gently tonifying the lungs and spleen, thus strengthening the body's foundation to resist pathogenic factors.

[0020] Stir-fried Atractylodes macrocephala: Bitter and sweet in taste, warm in nature, enters the spleen and stomach meridians, functions to strengthen the spleen and replenish qi, dry dampness and promote diuresis. Stir-fried Atractylodes lancea: Pungent and bitter in taste, warm in nature, enters the spleen, stomach and liver meridians, functions to dry dampness, strengthen the spleen, and regulate the spleen and stomach. Children often have weak spleens, coupled with improper care, excessive tonification, and prolonged illness damaging the spleen and stomach, resulting in spleen qi deficiency and inability to transform and transport food, leading to stagnation of spleen earth. When the middle jiao is congested, the mother's illness affects the child, earth fails to generate metal, and the lung and wei qi cannot protect the surface of the body, thus easily becoming susceptible to repeated pathogens. Atractylodes macrocephala is most beneficial to spleen essence, and Atractylodes lancea is an essential medicine for regulating the spleen; their combination of dispersing and tonifying effects can nourish the earth to generate metal and protect the lung and wei qi. Patchouli: Pungent in taste, slightly warm in nature, enters the spleen, stomach and lung meridians, functions to aromatically transform turbidity, regulate qi and harmonize the middle jiao, and can disperse and purge. Saposhnikovia divaricata: Pungent and sweet in taste, slightly warm in nature, enters the bladder, liver and spleen meridians, functions to dispel wind and release the exterior, taking its "defense" meaning to consolidate the exterior and dispel pathogens. These four herbs combine the functions of "tonifying, transporting, preventing, and dispersing," serving as auxiliary medicines.

[0021] Magnolia flower bud: pungent in taste, warm in nature, enters the lung and stomach meridians. Its function is to dispel wind-cold and clear nasal passages. Children with recurrent respiratory infections often have rhinitis; adding magnolia flower bud aims to dispel wind and clear nasal passages, calming latent wind within the child's body. Scrophularia root: sweet, bitter, and salty in taste, slightly cold in nature. Enters the lung, stomach, and kidney meridians. Its function is to clear heat and cool the blood, nourish yin and reduce fire, detoxify and dissipate nodules. Adding scrophularia root to the formula can improve the chronic pharyngeal congestion and swollen tonsils in children with this disease, protect the mucous membranes directly connected to the outside world, and also counteract the excessive warmth of other herbs to prevent them from trapping pathogens. Charred Shenqu (medicated leaven): sweet and pungent in taste, warm in nature, enters the spleen and stomach meridians. Its function is to strengthen the spleen and stomach, promote digestion and regulate the middle jiao; simple in formula but highly effective. Calcined dragon bone: sweet and astringent in taste, neutral in nature. Enters the heart, liver, kidney, and large intestine meridians. Its function is to astringe sweat and semen. Ephedra root: sweet and astringent in taste, neutral in nature. Enters the heart and lung meridians. Its function is to consolidate the exterior and stop sweating. Both have astringent and consolidating properties, which can ensure that the body's internal organs open and close normally.

[0022] The above-mentioned drugs are used together to tonify and regulate, and to disperse and astringe, so that tonification does not cause stagnation and dispersion does not harm the body's vital energy. They are based on the principle that "the spleen's health lies not in tonification but in regulation" and "strengthening the earth to generate metal" as the core principle, so that "the spleen is strong in all four seasons and is not susceptible to evil." This achieves the effects of regulating the spleen to prevent colds, consolidating the exterior to stop sweating, and harmonizing yin and yang.

[0023] The method for preparing the traditional Chinese medicine composition provided by the present invention includes the following steps:

[0024] (1) First, place the calcined dragon bone in an extraction tank, add water to soak it, then heat and decoct it, then mix in the previously soaked Codonopsis pilosula, stir-fried Atractylodes macrocephala, stir-fried Atractylodes lancea, Pogostemon cablin, Saposhnikovia divaricata, Magnolia biondii, Scrophularia ningpoensis, charred Shenqu and Ephedra sinica root, then heat and extract, filter, add water to extract again, filter, combine the filtrates, concentrate, and obtain concentrated liquid.

[0025] (2) Add an appropriate amount of ethanol to the concentrate in step (1), stir well, let stand, filter, take the supernatant, recover the ethanol until there is no alcohol taste, concentrate, and use it to prepare various preparations.

[0026] As a preferred embodiment, the preparation method of the traditional Chinese medicine composition of the present invention comprises the following steps:

[0027] (1) According to the weight ratio, add 8-12 times the weight of the Codonopsis pilosula, stir-fried Atractylodes macrocephala, stir-fried Atractylodes lancea, Pogostemon cablin, Saposhnikovia divaricata, Magnolia biondii, Scrophularia ningpoensis, charred Shenqu and Ephedra sinica root to soak for 30 minutes; at the same time, place calcined dragon bone in the extraction tank according to the specific gravity, soak and heat to decoct first, then mix the soaking liquid with the decoction and heat to decoct or reflux extract for 1-2 hours, filter, add 6-10 times the amount of water to the filtrate and decoct or reflux extract for 1-1.5 hours, filter, combine the filtrates and concentrate to 2:1 (medicinal material: medicinal liquid);

[0028] (2) Add 95% ethanol to the drug solution until the alcohol content reaches 70% to 80%, let it stand for 24 to 48 hours, filter, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.1 to 1.3, refrigerate, and use it to prepare various preparations.

[0029] Pharmaceutically acceptable excipients can be added to the concentrated extract obtained by this invention, and then it can be prepared into commonly used oral and external dosage forms, such as oral liquids, granules, tablets, mixtures, powders, capsules, soft capsules, pills, and other oral preparations or throat sprays, using conventional Chinese medicine preparation methods.

[0030] Beneficial effects: The traditional Chinese medicine composition for treating recurrent respiratory infections in children provided by this invention has the following advantages:

[0031] 1. This invention screens the composition and optimal weight ratio of each medicinal ingredient through extensive clinical trials. Experimental studies show that the traditional Chinese medicine composition provided by this invention can effectively alleviate chronic inflammation levels in model mice, improve airway epithelial barrier damage, enhance the body's ability to defend against pathogens, and reduce the risk of infection.

[0032] 2. Furthermore, clinical trials have shown that the herbal composition of this invention has functions such as strengthening the spleen and preventing colds, consolidating the exterior and stopping sweating. It is used to treat recurrent respiratory infections in children, and is particularly suitable for spleen deficiency and lung weakness, achieving good therapeutic effects and high safety. Attached Figure Description

[0033] Figure 1 To investigate the effects of the spleen-tonifying and cold-preventing formula on lung pathology in a mouse model of recurrent respiratory tract infection, note: HE staining (×200); n=3. #: compared with the normal group, ##p<0.01; *: compared with the model group, **p<0.01, ***p<0.001.

[0034] Figure 2 To investigate the effects of the spleen-tonifying and cold-preventing formula on serum cytokines in mice with recurrent respiratory infections, note: compared with the control group,

[0035] #p<0.05; Compared with the model group, *p<0.05, **p<0.01, ***p<0.001.

[0036] Figure 3 The effect of the spleen-tonifying and cold-preventing formula on E-cadherin expression in the airway of mice with recurrent respiratory infections.

[0037] Figure 4 The effect of the spleen-tonifying and cold-preventing formula on the expression of ZO-1 in the airway of mice with recurrent respiratory tract infections. Detailed Implementation

[0038] The present invention can be better understood from the following embodiments. However, those skilled in the art will readily understand that the specific material ratios, process conditions, and results described in the embodiments are for illustrative purposes only and should not, and will not, limit the invention as described in detail in the claims.

[0039] Example 1

[0040] 1. A medicine for treating recurrent respiratory infections in children, which is made from the following raw materials in the indicated weight ratios: Codonopsis pilosula 10g, stir-fried Atractylodes macrocephala 10g, stir-fried Atractylodes lancea 6g, Pogostemon cablin 6g, Saposhnikovia divaricata 6g, Magnolia biondii 6g (wrapped and decocted), Scrophularia ningpoensis 10g, charred Shenqu 10g, calcined dragon bone 15g (decocted first), and Ephedra sinica root 6g.

[0041] 2. A method for preparing a traditional Chinese medicine oral liquid for treating recurrent respiratory infections in children, comprising the following steps:

[0042] (1) Take 10g of Codonopsis pilosula, 10g of stir-fried Atractylodes macrocephala, 6g of stir-fried Atractylodes lancea, 6g of Pogostemon cablin, 6g of Saposhnikovia divaricata, 6g of Magnolia biondii (wrapped and decocted), 10g of Scrophularia ningpoensis, 10g of charred Shenqu (medicated leaven), and 6g of Ephedra sinica root. Place them in an extraction tank and soak them in drinking water with 8 times the weight of the herbs for 30 minutes. At the same time, take 15g of calcined dragon bone and place it in another extraction tank. Add drinking water with 2 times the weight of the herbs and decoct for half an hour. Then combine the calcined dragon bone decoction with the soaking liquid of the Chinese herbal raw materials and decoct for 1 hour. Filter and take the filtrate. Add 8 times the amount of water to the residue and decoct for 1.5 hours. Filter and combine the two filtrates. Concentrate to a weight volume ratio of 2:1 for the herbs and the liquid.

[0043] (2) Take the concentrated medicine solution from step (1), add 95% ethanol to the concentrated medicine solution to make the ethanol content reach 80%, let it stand for 24 hours, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.2, add distilled water to the specified volume, add an appropriate amount of flavoring agent and other excipients, mix well, let it stand for 12 to 24 hours, filter, bottle, sterilize, and the oral liquid is made.

[0044] Example 2

[0045] 1. A medicine for treating recurrent respiratory infections in children, which is made from the following raw materials in the indicated weight ratios: Codonopsis pilosula 10g, stir-fried Atractylodes macrocephala 10g, stir-fried Atractylodes lancea 6g, Pogostemon cablin 6g, Saposhnikovia divaricata 6g, Magnolia biondii 6g (wrapped and decocted), Scrophularia ningpoensis 10g, charred Shenqu 10g, calcined dragon bone 15g (decocted first), and Ephedra sinica root 6g.

[0046] 2. The preparation of a traditional Chinese medicine capsule for treating recurrent respiratory infections in children includes the following steps:

[0047] (1) Take 10g of Codonopsis pilosula, 10g of stir-fried Atractylodes macrocephala, 6g of stir-fried Atractylodes lancea, 6g of Pogostemon cablin, 6g of Saposhnikovia divaricata, 6g of Magnolia biondii (wrapped and decocted), 10g of Scrophularia ningpoensis, 10g of charred Shenqu (medicated leaven), and 6g of Ephedra sinica root. Place them in an extraction tank and add 8 times the weight of the medicines of drinking water to soak for 30 minutes. At the same time, take 15g of calcined dragon bone and place it in another extraction tank. Add 2 times the weight of the medicines of drinking water to decoct and heat for half an hour. Then combine the decoction and the soaking liquid and decoct. Heat and extract for 2 hours. Filter and take the filtrate. Add 8 times the amount of water to the residue and extract for 1 hour. Filter and combine the two filtrates. Concentrate to a weight volume ratio of medicine to liquid of 2:1.

[0048] (2) Add 95% ethanol to the drug solution in step (1) until the alcohol content reaches 75%, let stand for 48 hours, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.3, add dextrin, mix well, vacuum dry, pulverize, granulate, dry, granulate, and encapsulate to make capsules.

[0049] Example 3

[0050] 1. A medicine for treating recurrent respiratory infections in children, comprising the following raw materials in the indicated weight ratios:

[0051] Codonopsis pilosula 12g, stir-fried Atractylodes macrocephala 12g, stir-fried Atractylodes lancea 8g, Pogostemon cablin 8g, Saposhnikovia divaricata 8g, Magnolia biondii 8g (wrapped and decocted), Scrophularia ningpoensis 12g, charred Shenqu 12g, calcined dragon bone 17g (decocted first), Ephedra sinica root 8g.

[0052] 2. Preparation of a traditional Chinese medicine tablet for treating recurrent respiratory infections in children, comprising the following steps:

[0053] (1) Take 12g of Codonopsis pilosula, 12g of stir-fried Atractylodes macrocephala, 8g of stir-fried Atractylodes lancea, 8g of Pogostemon cablin, 8g of Saposhnikovia divaricata, 8g of Magnolia biondii (wrapped and decocted), 12g of Scrophularia ningpoensis, 12g of charred Shenqu (medicated leaven), and 8g of Ephedra sinica root. Place them in an extraction tank and add 10 times the weight of the medicines of drinking water to soak for 30 minutes. At the same time, take 17g of calcined dragon bone and place it in another extraction tank. Add 2 times the weight of the medicines of drinking water and decoct for half an hour. Then combine the decoction and the soaking liquid and decoct for 2 hours. Filter and add 10 times the amount of water to extract for 1.5 hours. Filter and combine the filtrates. Concentrate to a weight volume ratio of medicine to liquid of 2:1.

[0054] (2) Add 95% ethanol to the drug solution in step (1) until the alcohol content reaches 78%, let stand for 48 hours, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.3, add dextrin, mix well, vacuum dry, pulverize, granulate, dry, granulate, compress, and coat to make tablets.

[0055] Example 4

[0056] 1. A medicine for treating recurrent respiratory infections in children, which is made from the following raw materials in the indicated weight ratios: Codonopsis pilosula 8g, stir-fried Atractylodes macrocephala 8g, stir-fried Atractylodes lancea 4g, Pogostemon cablin 4g, Saposhnikovia divaricata 4g, Magnolia biondii 4g (wrapped and decocted), Scrophularia ningpoensis 8g, charred Shenqu 8g, calcined dragon bone 13g (decocted first), and Ephedra sinica root 4g.

[0057] 2. The preparation of a traditional Chinese medicine granule for treating recurrent respiratory infections in children includes the following steps:

[0058] (1) Take 8g of Codonopsis pilosula, 8g of stir-fried Atractylodes macrocephala, 4g of stir-fried Atractylodes lancea, 4g of Pogostemon cablin, 4g of Saposhnikovia divaricata, 4g of Magnolia biondii (wrapped and decocted), 8g of Scrophularia ningpoensis, 8g of charred Shenqu, and 4g of Ephedra sinica root. Place them in an extraction tank and add 10 times the weight of the medicines of drinking water to soak for 30 minutes. At the same time, take 13g of calcined dragon bone and place it in another extraction tank. Add 2 times the weight of the medicines of drinking water and decoct for half an hour. Then combine the decoction and the soaking liquid and decoct. Heat and extract for 1.5 hours. Filter. Add 8 times the amount of water and extract for 1.5 hours. Filter. Combine the filtrates and concentrate to a weight volume ratio of medicine to liquid of 2:1.

[0059] (2) Add 95% ethanol to the drug solution in step (1) until the alcohol content reaches 70%, let stand for 48 hours, filter, take the supernatant to recover ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.1 to 1.2, granulate in one step, granulate, and package to make granules.

[0060] Example 5

[0061] 1. A medicine for treating recurrent respiratory infections in children, which is made from the following raw materials in the indicated weight ratios: Codonopsis pilosula 14g, stir-fried Atractylodes macrocephala 14g, stir-fried Atractylodes lancea 10g, Pogostemon cablin 10g, Saposhnikovia divaricata 10g, Magnolia biondii 10g (wrapped and decocted), Scrophularia ningpoensis 14g, charred Shenqu 14g, calcined dragon bone 19g (decocted first), and Ephedra sinica root 10g.

[0062] 2. A preparation of a traditional Chinese medicine soft capsule for treating recurrent respiratory infections in children, comprising the following steps:

[0063] (1) Take 14g of Codonopsis pilosula, 14g of stir-fried Atractylodes macrocephala, 10g of stir-fried Atractylodes lancea, 10g of Pogostemon cablin, 10g of Saposhnikovia divaricata, 10g of Magnolia biondii (wrapped and decocted), 14g of Scrophularia ningpoensis, 14g of charred Shenqu (medicated leaven), and 10g of Ephedra sinica root. Place them in an extraction tank and add 10 times the weight of the medicines of drinking water to soak for 30 minutes. At the same time, take 19g of calcined dragon bone and place it in another extraction tank. Add 2 times the weight of the medicines of drinking water and decoct for half an hour. Then combine the decoction and the soaking liquid and decoct for 2 hours. Filter and add 10 times the amount of water to extract for 1.5 hours. Filter and combine the filtrates. Concentrate to a weight volume ratio of medicine to liquid of 2:1.

[0064] (2) Add 95% ethanol to the drug solution in step (1) until the alcohol content reaches 75%, let stand for 24 hours, filter, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.1, dry, add an appropriate amount of glycerin, mix well, drip or press into soft capsules, and package to make soft capsules.

[0065] Example 6

[0066] 1. A medicine for treating recurrent respiratory infections in children, comprising the following raw materials in the indicated weight ratios:

[0067] 10g of Codonopsis pilosula, 10g of stir-fried Atractylodes macrocephala, 6g of stir-fried Atractylodes lancea, 6g of Pogostemon cablin, 6g of Saposhnikovia divaricata, 6g of Magnolia biondii (wrapped and decocted), 10g of Scrophularia ningpoensis, 10g of charred Shenqu (medicated leaven), 15g of calcined dragon bone (decocted first), and 6g of Ephedra sinica root.

[0068] 2. The preparation of a traditional Chinese medicine external throat spray for treating recurrent respiratory infections in children includes the following steps:

[0069] (1) Take 10g of Codonopsis pilosula, 10g of stir-fried Atractylodes macrocephala, 6g of stir-fried Atractylodes lancea, 6g of Pogostemon cablin, 6g of Saposhnikovia divaricata, 6g of Magnolia biondii (wrapped and decocted), 10g of Scrophularia ningpoensis, 10g of charred Shenqu (medicated leaven), and 6g of Ephedra sinica root. Place them in an extraction tank and add 10 times the weight of the medicines of drinking water to soak for 30 minutes. At the same time, take 15g of calcined dragon bone and place it in another extraction tank. Add 2 times the weight of the medicines of drinking water and decoct for half an hour. Then combine the decoction and the soaking liquid and decoct for 2 hours. Filter and add 10 times the amount of water to extract for 1.5 hours. Filter and combine the filtrates. Concentrate to a weight volume ratio of medicine to liquid of 2:1.

[0070] (2) Take the medicine solution from step (1), add 95% ethanol to the concentrate to make the ethanol content reach 80%, let it stand for 24 hours, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.2, add distilled water to the specified volume, mix well, let it stand for 12 to 24 hours, filter, bottle, sterilize, and the throat spray is made.

[0071] Example 7: Clinical trial of a traditional Chinese medicine composition for treating recurrent respiratory infections in children with spleen deficiency and weak lung defense.

[0072] (1) Case selection: All cases were children who met the diagnosis of recurrent respiratory tract infection and visited the pediatric outpatient clinic of Jiangsu Provincial Hospital of Traditional Chinese Medicine between July 2021 and November 2023. A total of 73 cases were selected, including 39 males and 34 females. The youngest patient was 1 year and 3 months old and the oldest was 7 years old, with an average age of 4.98 years.

[0073] (2) Treatment drugs and dosage: The drugs are prepared by boiling with water according to the method in step (1) of Example 1. For children aged 1-5, the dosage is 100 mL per day; for children aged 6-10, the dosage is 120 mL per day; and for children aged 11-14, the dosage is 150 mL per day. The drugs are taken orally twice a day, morning and evening.

[0074] (3) Observation of treatment effect:

[0075] The changes in the condition of children with recurrent respiratory infections due to spleen deficiency and lung weakness (including quantitative analysis of the number of attacks, course of disease, and type of disease) and the clinical efficacy (including analysis of symptom scores) before and after treatment with the traditional Chinese medicine composition provided by this invention were observed. The experimental results showed that the total effective rate was 87.671% after 2 weeks of treatment, 94.520% after 1 month, and 98.630% after 2 months, indicating that the traditional Chinese medicine composition of this invention can significantly improve the clinical symptoms of recurrent respiratory infections due to spleen deficiency and lung weakness. After 2 months of treatment, the condition and symptoms of children with recurrent respiratory infections showed significant improvement. Among the secondary symptoms, shortness of breath, sweating, appetite, bowel movements, and sleep showed better improvement (effective rates of 96.429%, 92.593%, 93.478%, 97.297%, and 96.078%, respectively), while physical appearance and complexion were slightly worse than other symptoms (effective rates of 75.758% and 87.719%, respectively). The specific results are shown in Table 1-9.

[0076] Table 1 Changes in the patient's condition before and after treatment.

[0077]

[0078]

[0079] Table 2. Statistical analysis of efficacy before and after treatment.

[0080] therapeutic effect Treatment for 2 weeks Treatment for 1 month Treatment for 2 months invalid 9 / 12.329％ 4 / 5.479％ 1 / 1.370％ efficient 55 / 75.342％ 18 / 24.658％ 5 / 6.849％ Effective 7 / 9.589％ 45 / 61.644％ 30 / 41.096％ get well 2 / 2.740％ 6 / 8.219％ 37 / 50.685％ Overall efficiency 87.671％ 94.520％ 98.630％

[0081] Table 3 Total score after 2 weeks of treatment

[0082] Before treatment Two weeks after treatment t P Total symptom score 6.137±2.705 3.562±2.102 16.513 0.000

[0083] Table 4 Total Score for Treatment in 1 Month

[0084] Before treatment One month after treatment t P Total symptom score 6.137±2.705 2.000±1.518 16.698 0.000

[0085] Table 5 Total Score for Treatment over 2 Months

[0086] Before treatment Two months after treatment t P Total symptom score 6.137±2.705 0.918±1.233 17.867 0.000

[0087] Table 6. Symptom scores after 2 weeks of treatment.

[0088] Before treatment Two weeks after treatment Z P short voice 0.00(0.00，1.00) 0.00(0.00，0.00) －4.491 0.000 Sweating 1.00(0.00，2.00) 1.00(0.00，1.00) －5.794 0.000 Form 0.00(0.00，1.00) 0.00(0.00，1.00) 0.000 1.000 complexion 1.00(1.00，1.00) 1.00(0.00，1.00) －4.243 0.000 diet 1.00(0.00，1.00) 0.00(0.00，1.00) －5.856 0.000 feces 1.00(0.00，1.00) 0.00(0.00，0.00) －4.985 0.000 sleep 1.00(0.00，1.00) 0.00(0.00，1.00) －5.754 0.000

[0089] Table 7. Symptom scores after 1 month of treatment.

[0090] Before treatment One month after treatment Z P short voice 0.00(0.00，1.00) 0.00(0.00，0.00) －4.660 0.000 Sweating 1.00(0.00，2.00) 0.00(0.00，1.00) －6.144 0.000 Form 0.00(0.00，1.00) 0.00(0.00，1.00) －2.646 0.008 complexion 1.00(1.00，1.00) 0.00(0.00，1.00) －6.325 0.000 diet 1.00(0.00，1.00) 0.00(0.00，0.00) －5.998 0.000 feces 1.00(0.00，1.00) 0.00(0.00，0.00) －5.430 0.000 sleep 1.00(0.00，1.00) 0.00(0.00，0.00) －6.058 0.000

[0091] Table 8. Symptom scores after 2 months of treatment.

[0092] Before treatment Two months after treatment Z P short voice 0.00(0.00，1.00) 0.00(0.00，0.00) －4.573 0.000 Sweating 1.00(0.00，2.00) 0.00(0.00，0.00) －6.276 0.000 Form 0.00(0.00，1.00) 0.00(0.00，0.00) －4.123 0.000 complexion 1.00(1.00，1.00) 0.00(0.00，0.00) －6.694 0.000 diet 1.00(0.00，1.00) 0.00(0.00，0.00) －6.184 0.000 feces 1.00(0.00，1.00) 0.00(0.00，0.00) －5.493 0.000 sleep 1.00(0.00，1.00) 0.00(0.00，0.00) －6.151 0.000

[0093] Table 9. Symptom improvement and disappearance after 2 months of treatment.

[0094]

[0095]

[0096] Example 8: Therapeutic Mechanism and Effects of Traditional Chinese Medicine Composition

[0097] (1) Reagents and experimental drugs

[0098] The Chinese herbal composition administration group (hereinafter referred to as the spleen-tonifying and cold-preventing formula): The Chinese herbal decoction pieces of this invention were purchased from Jiangsu Provincial Hospital of Traditional Chinese Medicine and prepared according to the method of Example 1.

[0099] Pidotimod group: Pidotimod tablets, China Resources Sanjiu (Tangshan) Co., Ltd., H20010091.

[0100] Dosage: The conversion formula between experimental animal and human clinical drug dosage proposed in "Methodology of Pharmacological Research of Traditional Chinese Medicine" was used.

[0101] Note: dB is the dose per kilogram of animal B to be calculated; dA is the dose per kilogram of animal A known; WA and WB are the known weights of animals A and B; RA and RB are the body size coefficients of animals A and B.

[0102] (2) Laboratory animals

[0103] Forty-eight healthy male BALB / c mice, SPF grade, 4 weeks old, weighing 14±2g, were purchased from Hangzhou Medical College. Animal qualification certificate number: 20230918Abzz0100000257.

[0104] (3) Experimental methods

[0105] ① Animal model of recurrent respiratory tract infection

[0106] Forty-eight male BALB / c mice were acclimatized for one week. Except for eight randomly selected control mice, the remaining five groups were used to establish a recurrent respiratory infection model using a combination of fatigue, dietary indiscretion, and smoke inhalation. During the experiment, the mice were placed in a 15cm deep pool at 25℃ and allowed to swim until their endurance was exhausted. Endurance exhaustion was defined as the first time the mouse's mouth and nose were submerged in water. Simultaneously, the mice were fed 15g of cabbage daily on odd-numbered days and 10mL / kg of lard via gavage on even-numbered days, with free access to water and feed. On day 15 of the modeling process, the mice were stimulated with cigarette smoke for 30 minutes daily for 15 consecutive days. Successful modeling was indicated by the mice exhibiting symptoms such as lethargy, sluggishness, reduced activity, brittle fur, decreased appetite, slow weight gain, and rapid breathing.

[0107] ②Administration

[0108] After modeling, the model mice were divided into a model group, a low-, medium-, and high-dose Yunpi Fanggan Fang (a traditional Chinese medicine formula) group, and a pidotimod group, with 8 mice in each group. The mice were administered the formula via gavage for 2 weeks. The control group and the model group were administered 1.0 ml / 100 mg of physiological saline. The low-, medium-, and high-dose Yunpi Fanggan Fang groups were administered the formula via gavage at concentrations of 13.01 g / kg, 26.01 g / kg (clinically equivalent dose), and 52.02 g / kg, respectively. The pidotimod group was administered the formula via gavage at a concentration of 0.3 g / kg (clinically equivalent dose), once daily.

[0109] Experimental specimen collection

[0110] Blood collection: 16 hours after the last administration, mice were fasted for 8 hours, followed by intraperitoneal anesthesia with 0.2 mL / 10 g of 0.3% sodium pentobarbital. After intraperitoneal anesthesia, blood was collected by fundus puncture from all mice, allowed to stand for 1 hour, and then centrifuged at 3000 r / min for 10 min at 4°C. The serum was aliquoted and stored at -80°C for later use.

[0111] Lung tissue was collected: lung tissue was washed with phosphate buffer, fixed with 4% formaldehyde at room temperature, dehydrated with ethanol at graded concentrations, and embedded in paraffin. 4 μm thick tissue sections were stained with hematoxylin and eosin (HE) for histopathological examination. Immunohistochemical assay kits were used to observe the expression and distribution of E-cadherin and ZO-1 proteins in the airway.

[0112] (4) Experimental Results

[0113] ① General condition of mice

[0114] After successful modeling, the mice in the recurrent respiratory infection model showed slightly poor mental state, preferred to lie down and had reduced activity, with no significant change in weight. After 14 days of drug administration, the mental state of the mice in the model group and each drug administration group improved to varying degrees, and their activity increased slightly.

[0115] ② Pathological staining of mouse lung tissue

[0116] The study results indicate that chronic airway inflammation is prevalent in recurrent respiratory infections. HE staining was used to observe the extent of airway inflammation. Figure 1 As shown, compared with the normal group, the recurrent respiratory infection model showed a significant increase in peri-airway inflammation, thickening of the airway and vascular walls, local inflammatory infiltration in the lung tissue, and a significantly elevated pathological score (p<0.001). After intervention with low, medium, and high doses of Yunpi Fanggan Fang and pidotimod, peri-airway and vascular inflammation were significantly reduced, alveolar morphology became regular, and the pathological score of airway inflammation was significantly lower (p<0.01, p<0.001, p<0.01, p<0.01). This indicates that Yunpi Fanggan Fang can improve chronic airway inflammation, thereby reducing the frequency of infections.

[0117] ③ Results of mouse serum cytokine detection

[0118] like Figure 2 As shown, compared with the normal control group, the serum levels of IL-4, IL-6, IL-13, and TSLP in the model group mice were significantly increased (P<0.05). Compared with the model group, the serum levels of IL-4, IL-6, IL-13, and TSLP in mice in each dose group of Yunpi Fanggan Fang and the pidotimod tablet group were decreased, and the differences were statistically significant (p<0.05), indicating that Yunpi Fanggan Fang can improve the level of chronic inflammation in the body.

[0119] ④ Expression of E-cadherin and ZO-1 in mouse airway epithelium

[0120] Current research indicates that recurrent respiratory infections may be related to multiple factors, including mucosal barrier disruption, immune damage, genetics, and environment. The airway epithelium, as the first line of defense against harmful environmental damage (such as infectious pathogens and allergens), suffers damage after repeated infections, leading to airway epithelial barrier impairment. This impairment reduces the airway epithelial barrier's ability to defend against external pathogens, increasing the risk of infection. Therefore, this experiment used immunohistochemical microscopy to observe airway epithelial staining and the expression of E-cadherin and Zonula occludens-1 (ZO-1). Figure 3-4 As shown, after repeated respiratory infection modeling, compared with the normal group, the expression levels of E-cadherin and ZO-1 in the airway epithelium of the model group were both decreased. Low, medium, and high doses of Yunpi Fanggan Decoction could increase the expression levels of E-cadherin and ZO-1 in the airway epithelium, indicating that Yunpi Fanggan Decoction can regulate the expression of E-cadherin and ZO-1 in the airway epithelium, and has the function of repairing the integrity of the epithelial barrier, thereby achieving the effects of "preventing infection" and "strengthening the surface".

Claims

1. A traditional Chinese medicine composition having efficacy in treating recurrent respiratory tract infection in children, characterized in that, the composition comprises the following components: It is made of the following raw medicinal materials in the weight ratio: ​ Radix pseudoginseng 6-14g, fried Atractylodes 6-14g, fried Atractylodes 2-10g, Agastache 2-10g, Saposhnikovia 2-10g, Lonicera 2-10g, Scrophularia 6-14g, Six God Medicinal Wheat 6-14g, calcined Ossis 11-19g, Ephedra root 2-10g.

2. The traditional Chinese medicine composition for treating recurrent respiratory infections in children according to claim 1, characterized in that, It is made of the following raw medicinal materials in the weight ratio: Radix pseudoginseng 8-12g, fried Atractylodes 8-12g, fried Atractylodes 4-8g, Agastache 4-8g, Saposhnikovia 4-8g, Lonicera 4-8g, Scrophularia 8-12g, Six God Medicinal Wheat 8-12g, calcined Ossis 13-17g, Ephedra root 4-8g. 3.The traditional Chinese medicine composition with efficacy of treating recurrent respiratory tract infections in children of claim 2, characterized in that, It is made of the following raw medicinal materials in the weight ratio: Radix pseudoginseng 10g, fried Atractylodes 10g, fried Atractylodes 6g, Agastache 6g, Saposhnikovia 6g, Lonicera 6g, Scrophularia 10g, Six God Medicinal Wheat 10g, calcined Ossis 15g, Ephedra root 6g.

4. The preparation method of the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The following steps are included: (1) Put the calcined Ossis in any one of claims 1-3 into an extraction tank, first add water to soak, then heat to decoct, then mix in Radix pseudoginseng, fried Atractylodes, fried Atractylodes, Agastache, Saposhnikovia, Lonicera, Scrophularia, Six God Medicinal Wheat and Ephedra root which have been soaked in water in advance, then heat to extract, filter, then add water to extract, filter, combine the filtrates, concentrate to obtain a concentrated solution; (2) Add an appropriate amount of ethanol to the concentrated solution of step (1), stir well, stand still, filter, take the supernatant, recover ethanol until there is no alcohol taste, concentrate, and use to prepare various preparations.

5. The preparation method of the traditional Chinese medicine composition according to claim 4, characterized in that, In step (1), first add 8-12 times the weight of the raw medicinal materials with water to soak for 30 minutes, then heat to decoct or reflux extract for 1-2 hours, filter to obtain a filtrate, add 6-10 times the amount of water to the filtrate to heat to decoct or reflux extract for 1-1.5 hours, filter to combine the filtrates of the two extractions, and concentrate to a medicinal material: medicinal liquid weight volume ratio of 2:

1.

6. The preparation method of the traditional Chinese medicine composition according to claim 4, characterized in that, In step (2), the concentration of ethanol added is 95%, so that the alcohol content in the concentrated solution reaches 70%-80%, stand still for 24-48 hours, and concentrate to a relative density of 1.1-1.

3.

7. The preparation method of the traditional Chinese medicine composition according to claim 4, characterized in that, Add a pharmaceutically acceptable excipient to the concentrated solution of step (2) to make an oral preparation or an external spray.

8. Use of the traditional Chinese medicine composition of any one of claims 1-3 in the preparation of a medicine for treating pediatric recurrent upper respiratory tract infection.

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