Application of traditional Chinese medicine composition in preparation of medicine for treating persistent pneumonia

Abstract

The invention discloses application of a traditional Chinese medicine composition in preparation of a medicine for treating persistent pneumonia, the composition is prepared from multiple medicinal materials such as fried hawthorn, areca nut and immature bitter orange, the traditional Chinese medicine composition is prepared by adopting a differential extraction process according to the properties of the medicinal materials, and the two components can be mixed or respectively prepared and combined for use. The traditional Chinese medicine composition adapts to physiological characteristics, can relieve respiratory tract symptoms of the persistent pneumonia, improves systemic symptoms such as low fever and anorexia, and reduces repeated upper respiratory tract infection. The traditional Chinese medicine composition is scientific in compatibility, synergistic in effect, remarkable in curative effect, high in safety and suitable for clinical treatment and body conditioning of the persistent pneumonia, achieves consideration of both symptoms and root causes, can reduce the disease recurrence risk and avoid serious complications, and solves many limitations of an existing treatment scheme.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to the use of a traditional Chinese medicine composition in the preparation of a drug for treating persistent pneumonia. Background Technology

[0002] Persistent pneumonia is a common chronic inflammatory lung disease in pediatric clinical practice. Its diagnostic criteria are clearly defined as: pneumonia lasting more than one month but less than three months, with persistent inflammatory infiltration in the lungs, accompanied by recurrent or persistent respiratory symptoms. It is one of the more difficult-to-treat and recurrent types of respiratory diseases in children. Clinical research data shows that its incidence has been slowly increasing in recent years due to the irrational use of antibiotics. The clinical symptoms of this disease are specific, mainly manifested as: persistent cough, mostly paroxysmal dry cough or accompanied by a small amount of thick sputum, which worsens after activity, at night, or after being exposed to cold; some children may experience low-grade fever, wheezing, chest tightness, and moist or dry rales can be heard on lung auscultation; at the same time, due to long-term inflammation and damage to spleen and stomach function, children often experience loss of appetite, indigestion, fatigue, pale complexion, and slow weight gain. In severe cases, anemia and further decline in immunity may occur, even affecting growth and development. Some children may also develop chronic pneumonia and pulmonary fibrosis, bringing a heavy economic burden and mental stress to the children's families.

[0003] Currently, the core treatment plan for persistent pneumonia in Western medicine includes anti-infection, expectoration, cough suppression, bronchodilator, and nutritional support. Specific treatment measures include: selecting appropriate antibiotics (such as cephalosporins and macrolides) based on sputum culture and drug sensitivity test results, combined with expectorants (such as ambroxol and acetylcysteine), bronchodilators, and, when necessary, administering anti-inflammatory corticosteroids and immunomodulators to enhance the body's resistance. However, this treatment plan has many limitations and is difficult to meet clinical treatment needs.

[0004] Currently, commonly used Chinese medicine preparations in clinical practice are mostly divided into two categories: one category focuses on clearing the lungs and eliminating phlegm, clearing heat and relieving cough, emphasizing "eliminating pathogens," and is suitable for the acute phase of pneumonia or phlegm-heat obstructing the lungs. However, long-term use can easily damage the spleen and stomach's vital energy, and is not suitable for the pathogenesis of persistent pneumonia where the body's vital energy is deficient and pathogens linger. The other category focuses on tonifying qi and strengthening the spleen, emphasizing "strengthening the body's vital energy," and is suitable for lung and spleen deficiency syndrome. However, it lacks the effects of eliminating phlegm and dissipating nodules, and clearing residual pathogens, making it difficult to quickly relieve clinical symptoms such as cough and phlegm.

[0005] While some existing compound traditional Chinese medicine formulas have been attempted to treat persistent pneumonia, problems remain, including irrational compatibility, uncertain efficacy, and limited applicability to a single syndrome type. Therefore, developing a scientifically formulated, clearly defined dosage range, highly effective, and safe traditional Chinese medicine composition has become an urgent technical challenge in the field of traditional Chinese medicine. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of existing drugs for treating persistent pneumonia, such as unreasonable drug compatibility, uncertain efficacy, limited applicable syndrome types, limitations of Western medicine treatment plans, and the inability of single Chinese medicine preparations to simultaneously eliminate pathogenic factors and enhance the body's resistance. This invention provides a Chinese medicine composition with scientific compatibility, a clear dosage range, significant efficacy, and high safety. It also discloses the use of this composition in the preparation of drugs for treating persistent pneumonia. This composition can specifically improve the respiratory and systemic symptoms of persistent pneumonia, achieving a therapeutic effect that addresses both the symptoms and the root cause.

[0007] This invention provides a traditional Chinese medicine composition for pneumonia, made from the following raw materials in parts by weight: 80-120 parts of stir-fried hawthorn, 80-120 parts of areca nut, 80-120 parts of immature bitter orange, 80-120 parts of honey-processed loquat leaf, 110-160 parts of trichosanthes fruit, 80-120 parts of stir-fried radish seed, 80-120 parts of stir-fried lepidium seed, 80-120 parts of platycodon root, 80-120 parts of forsythia fruit, and cicada molting. 50–80 parts, Codonopsis pilosula 50–85 parts, stir-fried Atractylodes macrocephala 110–160 parts, roasted Astragalus membranaceus 50–85 parts, roasted Glycyrrhiza uralensis 25–45 parts, Poria cocos 110–160 parts, processed Polygala tenuifolia 110–160 parts, stir-fried Ziziphus jujuba var. spinosa 50–85 parts, longan pulp 110–160 parts, Angelica sinensis 110–160 parts, Aucklandia lappa 25–45 parts, jujube 25–45 parts, fresh ginger 12–22 parts.

[0008] Preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 100 parts of stir-fried hawthorn, 100 parts of areca nut, 100 parts of immature bitter orange, 100 parts of honey loquat leaf, 134 parts of trichosanthes fruit, 100 parts of stir-fried radish seed, 100 parts of stir-fried lepidium seed, 100 parts of platycodon root, 100 parts of forsythia fruit, 66 parts of cicada slough, 68 parts of codonopsis root, 136 parts of stir-fried atractylodes macrocephala, 68 parts of processed astragalus root, 34 parts of processed licorice root, 136 parts of poria cocos, 136 parts of processed polygala root, 68 parts of stir-fried jujube seed, 136 parts of longan pulp, 136 parts of angelica root, 34 parts of costus root, 34 parts of jujube, and 17 parts of ginger.

[0009] Based on the emphasis on the efficacy of medicinal materials and the principles of compatibility, this invention divides the traditional Chinese medicine composition into component A and component B. Component A is made from stir-fried hawthorn, areca nut, immature bitter orange, honey-processed loquat leaf, trichosanthes fruit, stir-fried radish seed, stir-fried lepidium seed, platycodon root, forsythia fruit, and cicada slough. Component B is made from codonopsis root, stir-fried atractylodes rhizome, processed astragalus root, processed licorice root, poria cocos, processed polygala root, stir-fried jujube seed, longan pulp, angelica root, costus root, jujube, and ginger. The combined use of these two components can achieve synergistic effects, addressing both symptom improvement and overall body conditioning.

[0010] This invention further defines the clinical dosage ratio of component A and component B, which is precisely adjusted according to the age stage of the child and adapted to the physiological characteristics of the child: 1-3 years old, component A 5ml each time, 3 times a day, component B 5ml each time, 2 times a day; 3-6 years old, component A 10ml each time, 3 times a day, component B 10ml each time, 2 times a day.

[0011] This formula targets the core pathogenesis of persistent pneumonia, aligning with the physiological characteristics of "delicate internal organs, often deficient spleen, and often weak lungs." Component B serves as the principal ingredient, and component A as the assistant ingredient, supplemented with qi-regulating, phlegm-resolving, and warming / cooling herbs. This approach aims to strengthen the spleen and stomach, harmonize the flavors of all the herbs, and achieve a synergistic combination with clear internal hierarchy of principal, assistant, and adjuvant herbs. This results in a comprehensive effect that addresses both the root cause and the symptoms, eliminating pathogens without harming the body's resistance and supporting the body's resistance without allowing pathogens to linger. Component B is the principal herb for strengthening the body and addressing the root cause. Its core ingredients are Codonopsis pilosula, stir-fried Atractylodes macrocephala, and roasted Astragalus membranaceus, which greatly replenish the Qi of the lungs and spleen to restore organ function and strengthen the exterior to prevent recurrent infections. Poria cocos, Angelica sinensis, longan pulp, and stir-fried Ziziphus jujuba seeds are the assistant herbs, which strengthen the spleen, eliminate dampness, nourish blood, and calm the mind to improve Qi deficiency and blood-related issues such as lethargy and slow weight gain. Prepared Polygala tenuifolia and Aucklandia lappa are the adjuvant herbs, which calm the mind, resolve phlegm, regulate Qi, and harmonize the middle Jiao, preventing the lingering effects of tonifying herbs while mitigating the stomach upset caused by their rich and cloying nature. Roasted Glycyrrhiza uralensis, Ziziphus jujuba, and Zingiber officinale are the guiding herbs, which harmonize the medicinal properties and strengthen the spleen. This formula protects the stomach and also warms and disperses a small amount of cold pathogens in the lungs. Component A acts as the symptom-treating agent, with Trichosanthes kirilowii and stir-fried Lepidium apetalum as the principal ingredients. They moisten and purge, clearing heat and phlegm, purging the lungs and relieving asthma, directly targeting the core symptoms of sticky phlegm, wheezing, and lung rales. Honey loquat leaf, Platycodon grandiflorus, stir-fried radish seed, and Citrus aurantium act as assistant ingredients, promoting lung function, relieving cough, aiding digestion, resolving phlegm, and lowering qi. They assist the principal ingredient in clearing phlegm and preventing the internal generation of phlegm. Stir-fried hawthorn, areca nut, Forsythia suspensa, and Cicadae periostracum act as adjuvant ingredients, eliminating food stagnation, harmonizing the stomach, clearing heat and expelling pathogens, dispelling wind and benefiting the throat. At the same time, the warming and cooling properties balance the bitter and cold nature of the principal ingredient to protect the spleen and stomach. The combined formula works synergistically, with the principal and assistant herbs complementing each other. It takes supporting the body's resistance as the foundation and eliminating pathogens as the means to break the vicious cycle of "pathogens clinging to the body's weakness". Furthermore, the adjuvant herbs are skillfully matched and harmonized, with a balance of cold and heat, and a combination of tonification and purgation. There are no excessively bitter, cold, or greasy herbs, which are suitable for the physiological and pathological characteristics. It is a scientific formula for treating persistent pneumonia.

[0012] This invention also discloses a method for preparing the above-mentioned traditional Chinese medicine composition. This method employs differentiated extraction processes based on the differences in the medicinal properties of components A and B, maximizing the retention of the effective components of each medicinal material and ensuring the efficacy of the preparation. Specifically, the method includes the following steps:

[0013] 1) Preparation of component A: Take roasted hawthorn, areca nut, immature bitter orange, honey loquat leaf, trichosanthes fruit, roasted radish seed, roasted lepidium seed, platycodon root, forsythia fruit, and cicada molting. Add water and decoct twice. Combine the decoctions and filter. Concentrate the filtrate under reduced pressure to an appropriate amount. Add ethanol to make the alcohol content reach 60%. Let stand and filter. Recover the ethanol from the filtrate and concentrate. Add an appropriate amount of water, stir, refrigerate, filter, add β-cyclodextrin to the filtrate, stir to encapsulate, add sucrose, stir well, and add water to an appropriate amount to obtain component A.

[0014] 2) Preparation of component B: Take stir-fried Atractylodes macrocephala, Aucklandia lappa and Angelica sinensis to extract volatile oils by distillation; percolate the Angelica sinensis residue with 50% ethanol as solvent, collect the percolate and recover the ethanol; decoct the residues of Atractylodes macrocephala and Aucklandia lappa with the remaining Codonopsis pilosula, Astragalus membranaceus (processed), Glycyrrhiza uralensis (processed), Poria cocos, Polygala tenuifolia (processed), Ziziphus jujuba (stir-fried), Longan aril, Jujube and ginger three times with water, combine the decoctions, filter, concentrate the filtrate to an appropriate amount, combine with the above percolate, let stand, filter, concentrate the filtrate to an appropriate amount, add sodium benzoate, cool, add the above volatile oil, add water to an appropriate amount to obtain component B;

[0015] 3) Mix component A and component B according to the clinical dosage ratio, or prepare them separately and then use them together to obtain the traditional Chinese medicine composition of the present invention.

[0016] Preferably, in step 1), water is added and decocted twice, each time for 1.5 hours. The filtrate is concentrated under reduced pressure to a clear extract with a relative density of 1.10 to 1.15. The refrigeration time is 24 hours. The amount of β-cyclodextrin added is 10 parts by weight, the amount of sucrose added is 200 parts by weight, and finally water is added to 1000 parts by weight.

[0017] Preferably, in step 2), water is added and decocted three times: the first decoction is 2 hours, the second is 1.5 hours, and the third is 1 hour. The Angelica dregs are soaked in 50% ethanol for 24 hours before percolation. 1000 parts by weight of percolate are collected. 3 parts by weight of sodium benzoate are added. Finally, water is added to 1000 parts by weight.

[0018] This invention also protects the use of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating persistent pneumonia, wherein persistent pneumonia is a pediatric chronic inflammatory lung disease with a course of more than 1 month but less than 3 months, persistent inflammatory infiltration in the lungs, and recurrent or persistent related symptoms.

[0019] This traditional Chinese medicine composition can effectively relieve and treat respiratory symptoms caused by persistent dry cough or with a small amount of phlegm, worsening cough in the morning / night / after activity, wheezing in the airway, and persistent fine moist rales in the lungs. At the same time, it can significantly improve systemic symptoms caused by prolonged illness, such as recurrent low-grade fever, slow weight gain, lethargy, loss of appetite, and fatigue. It can also reduce accompanying symptoms such as recurrent upper respiratory tract infections caused by prolonged illness, thus achieving multi-dimensional treatment and conditioning of persistent pneumonia.

[0020] Compared with the prior art, the present invention has the following significant technical effects:

[0021] (1) Scientific formulation and synergistic effect: This invention divides medicinal materials with different effects into two components for formulation. The two components perform their respective functions and work synergistically. It can not only quickly relieve various respiratory symptoms of persistent pneumonia, but also fundamentally regulate the body condition of the child and enhance the body's own ability. It solves the shortcomings of existing Chinese medicine preparations that only improve symptoms or only regulate the body, and achieves a treatment effect that takes into account both the symptoms and the root cause.

[0022] (2) Significant therapeutic effect, superior to conventional treatment: Clinical efficacy observation shows that the total effective rate of the combined use of the traditional Chinese medicine composition of the present invention is much higher than that of conventional Western medicine treatment, and can significantly improve various clinical symptoms of children. The improvement of symptoms is far greater than that of the Western medicine control group and the single-component drug group. Animal experiments have also confirmed that the composition can quickly relieve respiratory abnormal symptoms, repair airway ventilation function, inhibit lung inflammatory response and improve immune-related indicators. All experimental results are significantly better than those of the Western medicine control group, proving that it has a definite and excellent therapeutic effect on persistent pneumonia.

[0023] (3) Precise dosage, adapted to children’s physiological characteristics: For children aged 1-3 years and 3-6 years, specific clinical dosage and frequency of component A and B have been formulated. The dosage is precisely controlled, which not only ensures the therapeutic effect, but also avoids the metabolic burden on children’s bodies caused by excessive drug use. It is adapted to the physiological characteristics of children’s delicate organs and weak digestive capacity.

[0024] (4) High safety and no obvious adverse reactions: Clinical observation results show that no adverse reactions occurred in children treated with the Chinese medicine composition of the present invention, while a certain proportion of adverse reactions such as gastrointestinal discomfort and rash occurred in the conventional Western medicine treatment group, proving that the Chinese medicine composition is safe and suitable for clinical use and subsequent body conditioning.

[0025] (5) Reduce the risk of recurrence and fundamentally improve the condition of the child: The composition of the present invention can not only quickly relieve the acute symptoms of persistent pneumonia, but also enhance the child's own resistance by regulating the body's condition, improve the child's diet, mental state and other overall condition, fundamentally solve the problem of persistent and recurrent disease, reduce the occurrence of repeated upper respiratory tract infections, and avoid the development of serious complications such as chronic pneumonia and pulmonary fibrosis. Attached Figure Description

[0026] Figure 1 Statistical analysis of clinical efficacy results. Detailed Implementation

[0027] To make the objectives and technical solutions of this invention clearer, the following embodiments are provided for further explanation. However, the scope of protection of this invention is not limited to these embodiments; the embodiments are merely for illustrative purposes. Those skilled in the art should understand that any changes or equivalent substitutions that do not depart from the concept of this invention are included within the scope of protection of this invention.

[0028] Example 1

[0029] Prescription (g):

[0030] 100g of stir-fried hawthorn, 100g of areca nut, 100g of immature bitter orange, 100g of honey-processed loquat leaf, 134g of trichosanthes fruit, 100g of stir-fried radish seed, 100g of stir-fried lepidium seed, 100g of platycodon root, 100g of forsythia fruit, 66g of cicada slough, 68g of codonopsis root, 136g of stir-fried atractylodes macrocephala, 68g of roasted astragalus root, 34g of roasted licorice root, 136g of poria cocos, 136g of prepared polygala tenuifolia, 68g of stir-fried jujube seed, 136g of longan pulp, 136g of angelica sinensis, 34g of costus root, 34g of jujube (pitted), and 17g of fresh ginger.

[0031] Preparation method:

[0032] 1. Preparation of component A:

[0033] Weigh out 100g of roasted hawthorn, 100g of areca nut, 100g of immature bitter orange, 100g of honey-processed loquat leaf, 134g of trichosanthes fruit, 100g of roasted radish seed, 100g of roasted lepidium seed, 100g of platycodon root, 100g of forsythia fruit, and 66g of cicada slough. Add 10 times the amount of water and decoct twice, 1.5 hours each time. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.12 (60℃). Add 95% ethanol to bring the alcohol content to 60%, stir well, and let stand. After 24 hours, filter, recover ethanol from the filtrate and concentrate to a thick paste with a relative density of 1.20 (60℃). Add water to 500ml, stir well, refrigerate for 24 hours, filter, add 10g of betacyclodextrin to the filtrate, stir and mix for 30 minutes, then add 200g of sucrose, stir to dissolve, add water to 1000ml, filter, fill into 10ml / vial tubular bottles, and sterilize with flowing steam at 105℃ for 30 minutes to obtain component A liquid preparation.

[0034] 2. Preparation of component B:

[0035] Weigh out 136g of stir-fried Atractylodes macrocephala, 34g of Aucklandia lappa, and 136g of Angelica sinensis. Extract the volatile oil separately by water distillation and collect the volatile oil for later use. Soak the Angelica sinensis residue in 50% ethanol for 24 hours, then percolate. Collect 1000ml of the percolate, recover the ethanol, and concentrate to a clear extract with a relative density of 1.15 (60℃). Combine the residue of Atractylodes macrocephala and Aucklandia lappa with 68g of Codonopsis pilosula, 68g of processed Astragalus membranaceus, 34g of processed Glycyrrhiza uralensis, 136g of Poria cocos, 136g of processed Polygala tenuifolia, 68g of stir-fried Ziziphus jujuba var. spinosa, 136g of longan pulp, 34g of jujube (pitted), and 17g of ginger. Add 12 times the amount of water and decoct three times: 2 hours the first time, 1.5 hours the second time, and 1 hour the third time. Combine the decoctions, filter, and concentrate the filtrate to a clear extract with a relative density of 1.10 (60℃). Combine this extract with the concentrated extract of Angelica sinensis percolation, let stand for 24 hours, filter, and concentrate the filtrate to about 900ml. Add 3g of sodium benzoate, stir to dissolve, cool to room temperature, add the above volatile oil, add water to 1000ml, mix well, fill into 10ml / vial control bottles, and sterilize with flowing steam at 100℃ for 20 minutes to obtain component B liquid preparation.

[0036] 3. Combine the oral liquid of component A and the compound of component B according to the clinical dosage ratio to obtain the traditional Chinese medicine composition of the present invention.

[0037] Example 2

[0038] Prescription (g):

[0039] 80g of stir-fried hawthorn, 80g of areca nut, 80g of immature bitter orange, 80g of honey-processed loquat leaf, 110g of trichosanthes fruit, 80g of stir-fried radish seed, 80g of stir-fried lepidium seed, 80g of platycodon root, 80g of forsythia fruit, 50g of cicada slough, 50g of codonopsis root, 110g of stir-fried atractylodes macrocephala, 50g of roasted astragalus root, 25g of roasted licorice root, 110g of poria cocos, 110g of prepared polygala tenuifolia, 50g of stir-fried jujube seed, 110g of longan pulp, 110g of angelica sinensis, 25g of costus root, 25g of jujube (pitted), and 12g of fresh ginger.

[0040] Preparation method:

[0041] Similar to Example 1, only the dosage of the ingredients is the same as in Example 1. All other preparation processes and parameters are the same as in Example 1. Component A liquid preparation and component B liquid preparation are prepared separately and used together to obtain the traditional Chinese medicine composition of the present invention.

[0042] Example 3

[0043] Prescription (g):

[0044] 120g of stir-fried hawthorn, 120g of areca nut, 120g of immature bitter orange, 120g of honey-processed loquat leaf, 160g of trichosanthes fruit, 120g of stir-fried radish seed, 120g of stir-fried lepidium seed, 120g of platycodon root, 120g of forsythia fruit, 80g of cicada slough, 85g of codonopsis root, 160g of stir-fried atractylodes macrocephala, 85g of roasted astragalus root, 45g of roasted licorice root, 160g of poria cocos, 160g of prepared polygala tenuifolia, 85g of stir-fried jujube seed, 160g of longan pulp, 160g of angelica sinensis, 45g of costus root, 45g of jujube (pitted), and 22g of fresh ginger.

[0045] Preparation method:

[0046] Similar to Example 1, only the dosage of the ingredients is the same as in Example 1. All other preparation processes and parameters are the same as in Example 1. Component A liquid preparation and component B liquid preparation are prepared separately and used together to obtain the traditional Chinese medicine composition of the present invention.

[0047] Example 4: Clinical efficacy observation

[0048] 1. General Information

[0049] 120 children meeting the diagnostic criteria for persistent pneumonia were randomly divided into 4 groups of 30 each:

[0050] Experimental group: Treatment was administered using a combination of oral solution of component A prepared in Example 1 and compound preparation of component B;

[0051] Western medicine control group: treated with conventional Western medicine regimen;

[0052] Group A: Treatment was administered using only the oral solution of Component A prepared in Example 1;

[0053] Component B: Treatment was performed using only the Component B compound prepared in Example 1.

[0054] There were no statistically significant differences (P>0.05) in general information among the four groups of children regarding gender, age (1–6 years), duration of illness (1–3 months), severity of illness, and clinical symptom scores, indicating comparability. This study was approved by the hospital's ethics committee, and all families of the children signed informed consent forms.

[0055] 2. Treatment methods

[0056] All four groups of children received basic care (such as a light diet, keeping warm, and respiratory care), and in addition to this, they received the following treatments, all for a course of 2 weeks:

[0057] Experimental group: Combination of component A oral liquid and component B compound preparation, with dosage adjusted according to age: 1-3 years old, component A 5ml each time, 3 times a day, component B 5ml each time, 2 times a day; 3-6 years old, component A 10ml each time, 3 times a day, component B 10ml each time, 2 times a day.

[0058] Western medicine control group: Azithromycin dry suspension (10mg / kg·d, once a day, 3 days on, 4 days off) + ambroxol oral solution (2.5ml each time for children aged 1-3 years, 5ml each time for children aged 3-6 years, 3 times a day), treatment course of 2 weeks.

[0059] Group A: Only the oral solution of Component A prepared in Example 1 was administered, with the same dosage and usage as the experimental group.

[0060] Component B group: Only the component B mixture prepared in Example 1 was administered, with the same dosage and usage as the experimental group.

[0061] 3. Criteria for Evaluating Therapeutic Effect

[0062] Based on the "Standards for Diagnosis and Efficacy Evaluation of Diseases and Syndromes in Traditional Chinese Medicine" and the clinical treatment guidelines for pediatric pneumonia, and combined with clinical symptoms, signs, and imaging examinations, a four-level efficacy evaluation standard was established. The disappearance time of cough and sputum symptoms and the incidence of adverse reactions were also statistically analyzed.

[0063] Recovery: Clinical symptoms such as cough and sputum completely disappear, lung rales disappear, chest X-ray shows complete absorption of lung inflammation, and the child's appetite and mental state return to normal.

[0064] Significant effect: Cough and sputum are significantly reduced (symptom score reduced by ≥70%), lung rales are significantly reduced, chest X-ray shows that most of the lung inflammation has been absorbed (≥70%), and the child's appetite and mental state are significantly improved.

[0065] Effective: Cough and sputum production are reduced (symptom score decreases by 30%–69%), lung rales are reduced, chest X-ray shows partial absorption of lung inflammation (30%–69%), and the child's appetite and mental state are slightly improved.

[0066] Ineffective: Symptoms, signs, and chest X-ray examination show no improvement or worsening (symptom score decreases by <30%), or even a deterioration of the condition.

[0067] Overall effective rate = (number of cured cases + number of cases with significant effect + number of cases with effect) / total number of cases × 100%; Improvement rate of TCM syndrome score = (score before treatment - score after treatment) / score before treatment × 100%; Relapse rate = number of cases relapsed within 3 months after treatment / total number of cases × 100%.

[0068] 4. Results

[0069] (1) Comparison of clinical efficacy

[0070] The efficacy results of the four groups of children after 2 weeks of treatment are shown in the table below:

[0071] Table 1. Statistical analysis of clinical efficacy results

[0072] Table 1 shows that the total effective rate of the experimental group treated with the combination of components A and B (93.33%) was significantly higher than that of the Western medicine control group (76.67%), and also significantly higher than that of the single-component A and B treatment groups. Furthermore, the experimental group had the most cured cases and the fewest ineffective cases. Statistical analysis showed that the total effective rate of the experimental group was significantly higher than that of the Western medicine control group, component A group, and component B group (P < 0.05). This demonstrates that the clinical efficacy of this combination of traditional Chinese medicine is significantly better than that of conventional Western medicine regimens and single-component treatments, and the combination of the two is the key to achieving good therapeutic effects.

[0073] (2) Comparison of improvement in TCM syndrome scores

[0074] Referring to the syndrome scoring criteria (5 items: cough, sputum, loss of appetite, fatigue, and pale complexion, each item scored from 0 to 3 points, for a total score of 0 to 15 points; the higher the score, the more severe the syndrome), the syndrome scores and improvement rates of the four groups of children before and 2 weeks after treatment were statistically analyzed. The results are shown in the table below:

[0075] Table 2. Traditional Chinese Medicine Syndrome Scores

[0076] Table 2 shows that the baseline TCM syndrome scores of the four groups of children were consistent before treatment. After combined treatment with components A and B, the syndrome score of the experimental group decreased from 11.2±2.3 to 2.1±1.0, with an improvement rate of 81.2±7.5%, which was much higher than that of the Western medicine control group and the single component treatment group. Moreover, the syndrome improvement rate of component B group was only 10.6±9.0%, indicating that the combined use of this TCM composition can specifically improve the core syndrome of persistent pneumonia in children. In contrast, the Western medicine regimen has limited improvement on systemic syndrome, and a single component cannot achieve a conditioning effect that addresses both the symptoms and the root cause.

[0077] (3) Comparison of adverse reaction rates

[0078] Experimental group: No adverse reactions were observed.

[0079] In the Western medicine control group: 5 children experienced nausea and diarrhea, and 2 children developed rashes, with an adverse reaction rate of 23.33%.

[0080] Group A: No adverse reactions were observed.

[0081] Group B: No adverse reactions were observed.

[0082] Rat experiments on the efficacy of traditional Chinese medicine combinations in treating persistent pneumonia

[0083] laboratory animals

[0084] SPF - level SD rats were selected, with the experimental animal license number: SYXK(Shandong)20230023, weighing 180 - 220 g, with an equal number of males and females; they were housed in an environment with constant temperature (22 ± 2°C) and constant humidity (50 ± 5%), with a 12 - hour light - dark cycle, free access to food and water, and the experiment began after 1 week of adaptive feeding.

[0085] Experimental drugs and reagents

[0086] Test drug: The traditional Chinese medicine composition of the present invention (Component A and Component B of the formulations in Examples 1, 2, and 3, all prepared according to the corresponding example processes, concentrated into an oral liquid with 1 g / ml of crude drug, stored at 4°C, and restored to room temperature before use).

[0087] Positive control drugs: Azithromycin for suspension and Ambroxol Oral Solution (prepared into an oral solution).

[0088] Model - making reagent: Streptococcus pneumoniae (standard strain, concentration 1×10 8 CFU / ml).

[0089] Experimental grouping and specific equivalent dosing

[0090] 160 SD rats were randomly divided into 8 groups, with 10 rats in each group, 5 males and 5 females in each group. The blank group and the model group were gavaged with an equal amount of normal saline (2 ml / rat / day), and the other dosing groups were converted to the clinical equivalent dose according to the body surface area of the rats. The specific grouping and dosing regimens are shown in the following table, and the treatment course for all groups was 14 days:

[0091] Table 3 Grouping and dosing regimens

[0092] Establishment of animal model

[0093] A rat model of protracted pneumonia was established by using the method of Streptococcus pneumoniae infection + low - dose repeated stimulation. The modeling period was 21 days, which conformed to the pathological characteristics of protracted pneumonia with a disease course of 1 - 3 months and persistent inflammation. The modeling steps were as follows:

[0094] Basic pneumonia modeling: On the 1st day, the rats were anesthetized by intraperitoneal injection of 10% chloral hydrate (3 ml / kg), and 0.2 ml / rat of Streptococcus pneumoniae bacterial solution was slowly instilled into the trachea. After the operation, the rats were normally raised for 7 days to establish an acute pneumonia model. Protracted induction: From the 8th day, the rats were instilled with Streptococcus pneumoniae bacterial solution into the trachea again every 2 days (the dose was halved, 0.1 ml / rat), and low - dose repeated stimulation was used to maintain pulmonary inflammation and prevent the inflammation from subsiding spontaneously. During this period, the rats were normally raised for 14 days.

[0095] Experimental indicators and results

[0096] Observation of general conditions

[0097] During the administration period, the general behavior (mental state, activity level, coat gloss), food and water intake (accurately weighing the food bowl / water bottle), weight changes (weighing on Monday and Thursday mornings), and respiratory symptoms (coughing frequency, respiratory rhythm, presence or absence of wheezing and lung rales) of rats in each group were observed and recorded daily from 9:00 to 10:00. The incidence of abnormal symptoms and the time for relief of respiratory symptoms after the administration period were also recorded.

[0098] Table 4. Incidence of abnormal symptoms and time to relief of respiratory symptoms

[0099] Compared with the model group, p < 0.01.

[0100] Table 4 shows that the incidence of abnormal symptoms in the model control group rats exceeded 90%, and the respiratory symptoms were relieved in nearly 13 days, verifying the successful establishment of the persistent pneumonia model and the presence of significant pathological abnormalities and persistent respiratory symptoms in the rats. All treatment groups could improve this condition, but the effects varied significantly. Among them, the combination of component A+B in experimental groups 1, 2, and 3 not only reduced the incidence of abnormal symptoms to less than 15%, but also shortened the time for respiratory symptoms to be relieved. Experimental group 1 showed the best performance, while the improvement effect of the Western medicine control group was second best. The improvement effects of single component A and B groups were limited, and the effect of group B was weaker than that of group A. This result directly proves that the combination of traditional Chinese medicine composition of the present invention can quickly relieve the respiratory symptoms of persistent pneumonia and significantly improve the overall health status of rats, which is far superior to conventional Western medicine regimens and single-component drugs.

[0101] Lung function test

[0102] On day 14 of drug administration, non-invasive pulmonary function tests were performed on rats in each group using a small animal pulmonary function instrument. After anesthesia, the rats were fixed on the testing table, and three core indicators were recorded: forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and maximum expiratory flow (PEF). Each group was tested three times and the average value was taken to reflect airway ventilation function and assess the improvement of symptoms such as wheezing and airway obstruction.

[0103] Table 5 Lung Function Indicators

[0104] Compared with the model group, p < 0.01.

[0105] Table 5 shows that the three core lung function indicators—forced vital capacity, forced expiratory volume in one second, and maximum expiratory flow—were at normal levels in the blank control group, while they were significantly reduced in the model control group, indicating that persistent pneumonia causes severe airway ventilation dysfunction in rats. All treatment groups improved the lung function indicators of the model rats, with the combined treatment regimen of groups 1, 2, and 3 showing the most outstanding effect. All three indicators were close to those of the blank control group. Group 1 showed the best recovery effect, while the Western medicine control group only showed moderate improvement in lung function. The repair effects of single components A and B were relatively limited, with group B showing the weakest improvement. This demonstrates that the combined treatment of components A and B in this invention can effectively repair airway damage caused by persistent pneumonia, efficiently restore airway ventilation function in rats, and address problems such as wheezing and airway obstruction from a pathological perspective. The repair effect is far superior to conventional Western medicine combined treatment regimens.

[0106] Serum marker testing

[0107] On day 14 of drug administration, 5 ml of blood was collected from the orbital venous plexus of rats and placed in a tube without anticoagulant. After standing at room temperature for 30 min, the sample was centrifuged at 3000 r / min for 15 min to separate the supernatant serum, which was then stored at -20℃ for later use. In accordance with the kit instructions, the levels of inflammatory factors (IL-6, TNF-α) and immune function indicators (IgG) in the serum were detected by enzyme-linked immunosorbent assay (ELISA). The OD values ​​were read at a wavelength of 450 nm using an ELISA reader, and the concentrations of each indicator were calculated.

[0108] Table 6 Serum Indicators

[0109] Compared with the model group, p < 0.01.

[0110] Table 6 shows that the serum levels of inflammatory factors IL-6 and TNF-α in the blank control group were low, while the level of the immune indicator IgG was high. In contrast, the model control group showed a significant increase in inflammatory factors and a significant decrease in IgG, which is consistent with the pathogenesis of "deficiency of vital energy and lingering pathogenic factors" in persistent pneumonia. This also confirms that the model rats have severe lung inflammation and low humoral immune function. All treatment groups showed varying degrees of anti-inflammatory and immunomodulatory effects. The combined treatment regimen of groups 1, 2, and 3 significantly reduced the level of inflammatory factors and significantly increased the IgG content. All indicators were close to those of the blank control group. Group 1 showed the best effect. The Western medicine control group could only moderately inhibit inflammation and enhance immunity. The anti-inflammatory effect of the single component A group was slightly better than that of group B, but neither group significantly improved the body's immune function. This molecular-level result indicates that the combined treatment of components A and B in this invention can achieve a dual effect of potent anti-inflammatory and immune function recovery, which is consistent with the TCM treatment principle of "strengthening the body's resistance and eliminating pathogenic factors." Conventional Western medicine regimens and single-component drugs cannot achieve this synergistic effect.

Claims

1. A traditional Chinese medicine composition for pneumonia, characterized in that, Made from the following raw materials in parts by weight: 80–120 parts roasted hawthorn, 80–120 parts areca nut, 80–120 parts immature bitter orange, 80–120 parts honey-processed loquat leaf, 110–160 parts trichosanthes fruit, 80–120 parts roasted radish seed, 80–120 parts roasted lepidium seed, 80–120 parts platycodon root, 80–120 parts forsythia fruit, 50–80 parts cicada slough, and codonopsis root. 50–85 parts, stir-fried Atractylodes macrocephala 110–160 parts, roasted Astragalus membranaceus 50–85 parts, roasted Glycyrrhiza uralensis 25–45 parts, Poria cocos 110–160 parts, processed Polygala tenuifolia 110–160 parts, stir-fried Ziziphus jujuba var. spinosa 50–85 parts, longan pulp 110–160 parts, Angelica sinensis 110–160 parts, Aucklandia lappa 25–45 parts, jujube 25–45 parts, fresh ginger 12–22 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 100 parts of stir-fried hawthorn, 100 parts of areca nut, 100 parts of immature bitter orange, 100 parts of honey loquat leaf, 134 parts of trichosanthes fruit, 100 parts of stir-fried radish seed, 100 parts of stir-fried lepidium seed, 100 parts of platycodon root, 100 parts of forsythia fruit, 66 parts of cicada slough, 68 parts of codonopsis root, 136 parts of stir-fried atractylodes macrocephala, 68 parts of roasted astragalus root, 34 parts of roasted licorice root, 136 parts of poria cocos, 136 parts of roasted polygala root, 68 parts of stir-fried jujube seed, 136 parts of longan pulp, 136 parts of angelica root, 34 parts of costus root, 34 parts of jujube, and 17 parts of ginger.

3. The traditional Chinese medicine composition according to any one of claims 1-2, characterized in that, The traditional Chinese medicine composition is divided into component A and component B. Component A is made from stir-fried hawthorn, areca nut, immature bitter orange, honey loquat leaf, trichosanthes fruit, stir-fried radish seed, stir-fried lepidium seed, platycodon root, forsythia fruit, and cicada slough. Component B is made from codonopsis root, stir-fried atractylodes rhizome, prepared astragalus root, prepared licorice root, poria cocos, prepared polygala root, stir-fried jujube seed, longan pulp, angelica root, costus root, jujube, and ginger.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, The clinical dosage ratio of component A and component B is as follows: 1-3 years old, 5 ml of component A three times a day, and 5 ml of component B twice a day; 3-6 years old, 10 ml of component A three times a day, and 10 ml of component B twice a day; adults, 10-20 ml of component A three times a day, and 10-20 ml of component B three times a day.

5. The traditional Chinese medicine composition according to any one of claims 1-2, characterized in that, Its preparation method includes the following steps: 1) Take stir-fried hawthorn, areca nut, immature bitter orange, honey loquat leaf, trichosanthes fruit, stir-fried radish seed, stir-fried lepidium seed, platycodon root, forsythia fruit, and cicada molting. Add water and decoct twice. Combine the decoctions, filter, concentrate the filtrate under reduced pressure to an appropriate amount, add ethanol to make the alcohol content reach 60%, let stand, filter, recover the ethanol from the filtrate and concentrate, add an appropriate amount of water, stir, refrigerate, filter, add β-cyclodextrin to the filtrate, stir to encapsulate, then add sucrose, stir well, add water to an appropriate amount to obtain component A; 2) Take stir-fried Atractylodes macrocephala, Aucklandia lappa and Angelica sinensis and distill to extract volatile oils respectively; use 50% ethanol as solvent to percolate the Angelica sinensis residue, collect the percolate and recover the ethanol; take the residues of Atractylodes macrocephala and Aucklandia lappa, and decoct with the remaining Codonopsis pilosula, Astragalus membranaceus, Glycyrrhiza uralensis, Poria cocos, Polygala tenuifolia, stir-fried Ziziphus jujuba var. spinosa, Longan aril, Jujube and ginger three times with water, combine the decoctions, filter, concentrate the filtrate to an appropriate amount, combine with the above percolate, let stand, filter, concentrate the filtrate to an appropriate amount, add sodium benzoate, cool, add the above volatile oil, add water to an appropriate amount, and obtain component B; 3) Mix component A and component B according to the clinical dosage ratio, or prepare them separately and then use them together to obtain the final product.

6. The traditional Chinese medicine composition according to claim 5, characterized in that, In step 1), water is added and decocted twice, each time for 1.5 hours. The filtrate is concentrated under reduced pressure to a clear extract with a relative density of 1.10 to 1.

15. The extract is refrigerated for 24 hours. 10 parts by weight of β-cyclodextrin and 200 parts by weight of sucrose are added. Finally, water is added to a final volume of 1000 parts by weight.

7. The traditional Chinese medicine composition according to claim 5, characterized in that, In step 2), add water and decoct three times: the first time for 2 hours, the second time for 1.5 hours, and the third time for 1 hour. Before percolation, soak the Angelica dregs in 50% ethanol for 24 hours, collect 1000 parts by weight of percolate, add 3 parts by weight of sodium benzoate, and finally add water to 1000 parts by weight.

8. Use of the traditional Chinese medicine composition according to claims 1-2 in the preparation of a drug for treating persistent pneumonia.

9. The use of the traditional Chinese medicine composition according to claim 8 in the preparation of a drug for treating persistent pneumonia in children.

10. The use according to claim 8, characterized in that, The herbal composition can relieve / treat persistent dry cough or cough with a small amount of phlegm, worsening cough in the morning / night / after activity, wheezing and persistent fine moist rales in the lungs caused by chronic pneumonia. It can also improve recurrent low-grade fever, slow weight gain, lethargy, loss of appetite, fatigue and other systemic symptoms, and reduce the symptoms of recurrent upper respiratory tract infections caused by the protracted illness.

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