Traditional Chinese medicine composition for treating acute and chronic bronchitis of children

Abstract

The invention relates to the technical field of medicines, and discloses a traditional Chinese medicine composition for treating acute and chronic bronchitis in children, which is prepared by processing the following raw materials: 3 parts of ephedra, 3 parts of almond, 15 parts of honeysuckle, 15 parts of lysimachia christinae hance, 5 parts of gastrodia elata, 5 parts of tendril-leaved fritillary bulb, 5 parts of pericarpium citri reticulatae, 5 parts of uncaria, 10 parts of poria cocos and 6 parts of liquorice. The composition is prepared according to the following steps: S1, decocting: weighing the medicinal materials according to a prescription proportion, putting the medicinal materials into a container, adding water for soaking, decocting the soaked medicinal materials twice, combining the two decoctions, standing and filtering to obtain a medicine juice; s2, concentration: concentrating the medicine juice to obtain medicine liquid; s3, sub-packaging: sub-packaging the liquid medicine by using a clean and dry glass bottle, and sealing the glass bottle; and S4, sterilization: putting the subpackaged liquid medicine into a high-pressure steam sterilizer for sterilization treatment. The traditional Chinese medicine composition not only can quickly relieve symptoms such as cough and expectoration, but also can regulate lung functions and reduce repeated attack of inflammation.

Description

Technical Field

[0001] The invention relates to the technical field of medicines, and in particular to a traditional Chinese medicine composition for treating acute and chronic bronchitis in children. Background Art

[0002] Acute and chronic bronchitis in children is a common respiratory disease characterized by inflammation of the tracheal and bronchial mucosa, leading to symptoms such as coughing and sputum. Depending on the duration of the disease, it can be divided into acute and chronic types.

[0003] Acute bronchitis often occurs secondary to upper respiratory tract infections, such as measles, whooping cough, etc. The course of the disease generally lasts for 7-10 days, and in some cases it may last for 2-3 weeks, and it is easy to relapse. Cough and sputum are the main manifestations, and the nature of the sputum may vary depending on the cause. It is often accompanied by fever, as well as gastrointestinal symptoms such as poor appetite, vomiting, abdominal pain, diarrhea, etc. Auscultation of the lungs can reveal coarse breath sounds in both lungs, with scattered, irregular dry and wet rales. X-ray examinations may show thickened and disordered lung texture. The number of white blood cells may be normal or low in viral infections, while bacterial infections will lead to an increase in the number of white blood cells and neutrophils.

[0004] Chronic bronchitis is less common in children and is mostly caused by severe viral pneumonia, respiratory allergic diseases, etc. The course of the disease is more than 2 months, and it may recur. Symptoms include long-term cough and sputum, with or without wheezing. It may cause serious complications such as emphysema and atelectasis.

[0005] Among the existing treatment technologies, the treatment of acute and chronic bronchitis in children mainly focuses on the following issues: children's ability to metabolize and excrete drugs is different from that of adults, so they are more likely to have drug side effects; since acute bronchitis is mostly caused by viruses, antibiotics have limited effect on it. However, in clinical practice, antibiotics are widely used, leading to drug resistance problems; although non-drug treatments such as traditional Chinese medicine have certain effects in relieving symptoms and improving physical fitness, their application in the treatment of acute and chronic bronchitis in children is not yet widespread, and the efficacy evaluation standards are inconsistent. Summary of the invention

[0006] In view of the above-mentioned deficiencies in the prior art, the present invention provides a traditional Chinese medicine composition for treating acute and chronic bronchitis in children, which solves the problems of abuse of antibiotics and drug side effects in the prior art for treating acute and chronic bronchitis in children.

[0007] In order to achieve the above-mentioned purpose of the invention, the technical solution adopted by the present invention is: a traditional Chinese medicine composition for treating acute and chronic bronchitis in children, the composition is processed from the following raw materials: 3 parts of ephedra, 3 parts of apricot kernel, 15 parts of honeysuckle, 15 parts of desmodium, 5 parts of gastrodia, 5 parts of fritillaria cirrhosa, 5 parts of tangerine peel, 5 parts of Uncaria rhynchophylla, 10 parts of Poria, and 6 parts of licorice.

[0008] Furthermore, the above-mentioned Chinese medicine composition for treating acute and chronic bronchitis in children is prepared according to the following steps:

[0009] S1, decoction: weigh the above medicinal materials according to the prescription ratio, put the medicinal materials into a container and soak them in water, decoct the soaked medicinal materials twice, combine the two decoctions, let them stand and filter them to obtain medicinal juice;

[0010] S2, concentration: concentrating the medicinal juice to obtain a medicinal solution;

[0011] S3, packaging: Pack the liquid medicine into clean and dry glass bottles and seal them;

[0012] S4, Sterilization: Place the packaged liquid medicine into a high-pressure steam sterilizer for sterilization for 30 minutes.

[0013] Furthermore, the above-mentioned Chinese medicine composition for treating acute and chronic bronchitis in children, S1 is specifically: take 30g of ephedra, 30g of almond, 150g of honeysuckle, 150g of desmodium, 50g of gastrodia, 50g of fritillaria, 50g of tangerine peel, 50g of Uncaria rhynchophylla, 100g of Poria and 60g of liquorice, put the medicinal materials into a container and add 5760ml of water, soak them for 30 minutes, boil the soaked medicinal materials and water for 30 minutes, separate the decoction from the residue; add 5760ml of water to the residue, boil it for 30 minutes, obtain a second separated decoction and residue, combine the two decoctions, let them stand and filter them, and obtain a medicinal juice.

[0014] Furthermore, the above-mentioned Chinese medicine composition for treating acute and chronic bronchitis in children, S2 specifically comprises: concentrating the medicinal juice to 2500 ml to obtain a medicinal solution.

[0015] Furthermore, the above-mentioned Chinese medicine composition for treating acute and chronic bronchitis in children, S3 specifically comprises: packaging the medicinal liquid into clean and dry glass bottles according to a dosage of 250 ml per bottle, and sealing them.

[0016] The beneficial effects of the present invention are as follows: the Chinese medicine composition includes products such as ephedra, apricot kernel, etc. that can clear away heat and relieve toxicity, such as honeysuckle, Lysimachia chinensis, etc., and medicines such as gastrodia elata, fritillaria cirrhosa, and dried orange peel that can moisten the lungs and resolve phlegm, regulate qi and relieve cough. These medicines work synergistically, can quickly relieve symptoms such as cough and sputum, can regulate lung function, and reduce repeated inflammation. All medicinal materials are natural plants, do not contain chemically synthesized ingredients, avoid the side effects such as drug resistance and intestinal flora imbalance that may be caused by drugs such as antibiotics, are particularly suitable for children's physique, and reduce the potential impact on children's growth and development.

[0017] The Chinese medicine composition adopts a double decoction method, the first decoction extracts the effective ingredients in the medicinal materials, and the second decoction further releases the remaining effective ingredients, ensuring the maximum utilization of medicinal resources and improving the concentration and efficacy of the medicinal solution. The decoction is concentrated to an appropriate volume, which is convenient for storage and carrying, and also convenient for controlling the dosage, ensuring the accuracy and stability of each dose. Through high-pressure steam sterilization, bacteria, viruses and other microorganisms in the medicinal solution are completely killed, ensuring the sterility of the product. DETAILED DESCRIPTION

[0018] The specific implementation modes of the present invention are described below so that those skilled in the art can understand the present invention. However, it should be clear that the present invention is not limited to the scope of the specific implementation modes. For those of ordinary skill in the art, as long as various changes are within the spirit and scope of the present invention as defined and determined by the attached claims, these changes are obvious, and all inventions and creations utilizing the concept of the present invention are protected.

[0019] The present embodiment provides a traditional Chinese medicine composition for treating acute and chronic bronchitis in children. The composition is processed from the following raw materials: 3 parts of ephedra, 3 parts of apricot kernel, 15 parts of honeysuckle, 15 parts of desmodium, 5 parts of gastrodia, 5 parts of fritillaria, 5 parts of tangerine peel, 5 parts of Uncaria rhynchophylla, 10 parts of Poria, and 6 parts of liquorice.

[0020] The above-mentioned Chinese medicine composition for treating acute and chronic bronchitis in children is prepared according to the following steps:

[0021] S1, decoction: take 30g of ephedra, 30g of almond, 150g of honeysuckle, 150g of Lysimachia chinensis, 50g of Gastrodia elata, 50g of Fritillaria cirrhosa, 50g of dried tangerine peel, 50g of Uncaria rhynchophylla, 100g of Poria cocos and 60g of Licorice, put the medicinal materials into a container and add water, the mass ratio of the medicinal materials to water is 1:8, and the water in this embodiment is 5760ml, and soak the medicinal materials for 30 minutes.

[0022] After soaking, place the container on the fire and heat it to boiling. Keep boiling for 30 minutes, stirring in time to prevent the herbs from sticking to the bottom. After decoction is completed, separate the decoction from the dregs through a filter and collect the decoction. Add 5760 ml of pure water to the dregs again and repeat the decoction process. After 30 minutes of decoction, separate the second decoction from the dregs and collect the decoction.

[0023] The decoctions obtained from the two decoctions are combined, placed in a clean container, and allowed to stand for a period of time to allow the suspended impurities to naturally settle. The combined decoction is filtered using a filtering device to remove the suspended impurities and fine particles to obtain a medicinal juice.

[0024] S2, concentration: concentrate the medicinal juice to 2500 ml to obtain a medicinal solution.

[0025] S3, Repackaging: Repack the liquid medicine into clean and dry glass bottles according to the dosage of 250 ml per bottle and seal them.

[0026] S4, Sterilization: Place the packaged liquid medicine into a high-pressure steam sterilizer for sterilization for 30 minutes.

[0027] Clinical trial of the combination for treating phlegm-heat cough in children:

[0028] 1. Case selection criteria

[0029] (1) Diagnostic criteria for TCM syndromes: With reference to Practical TCM Pediatrics and TCM Diagnosis and Treatment Guidelines for Acute Tracheobronchitis (2021 edition), the criteria for pediatric cough with phlegm and heat are formulated: ① Main symptoms: cough, expectoration, yellow or yellow and white sputum, sticky texture, and difficult to cough up. ② Concomitant symptoms: irritability, dry mouth, thirst, hot hands and feet, restless sleep, constipation and yellow urine. ③ Tongue and pulse: red tongue, yellow or greasy tongue coating, rapid or slippery pulse, purple and stagnant fingerprints. If all the main symptoms and any two of the secondary symptoms are present, the diagnosis can be made by referring to the tongue and pulse.

[0030] (2) Western medicine diagnostic criteria: Refer to the diagnostic criteria for acute tracheobronchitis in Zhu Futang's Practical Pediatrics for diagnosis. ① Medical history: Multiple or secondary to upper respiratory tract infection. ② Symptoms: Cough and sputum are the main manifestations, often accompanied by varying degrees of fever and digestive tract symptoms such as poor appetite, vomiting, abdominal pain, and diarrhea. ③ Physical signs: Auscultation of the lungs can reveal coarse breath sounds in both lungs, with scattered and irregular dry and wet rales. ④ Physical and chemical examinations: The number of white blood cells in patients with viral infection is normal or low, and the number of white blood cells and neutrophils in patients with bacterial infection is increased. Chest X-ray shows thickened and disordered lung texture.

[0031] 2. Clinical data:

[0032] All cases that met the above criteria were obtained through compliant channels, and the selected cases were divided into an observation group and a control group using a random number table method. There were 72 cases in the observation group, including 42 males and 30 females, aged 2 to 14 years old, with an average age of (6.56±1.24) years, and a course of 2-10 days, with an average of (5.5±2.4) days. There were 68 cases in the control group, including 36 males and 32 females, aged 2 to 14 years old, with an average age of (6.39±1.41) years old, and a course of 2-10 days, with an average of (5.8±2.2) days. There was no significant difference in the age, gender, course of disease, symptoms and other general data between the two groups (P>0.05), and they were comparable.

[0033] 3. Exclusion and elimination criteria

[0034] Exclusion criteria: those who do not meet the inclusion criteria; those with cough caused by other respiratory diseases (upper respiratory tract infection, asthma, pneumonia, etc.); those with other systemic diseases such as circulation, nerves, digestion, and blood; those who are allergic to the drugs used in this study; and those who are participating in other clinical studies.

[0035] Exclusion criteria: those who did not follow the treatment plan of this study or used other drugs on their own; those who had severe allergic reactions or serious adverse reactions; those who had poor compliance and discontinued treatment on their own or were lost to follow-up.

[0036] 4. Treatment methods

[0037] Control group: Western medicine treatment, ambroxol hydrochloride oral solution (Sichuan Otsuka Pharmaceutical Co., Ltd., production batch number: National Medicine Standard H20073944) 2-5 years old 2.5 ml each time, 3 times a day; 6-14 years old 5 ml each time, 3 times a day, orally after meals. Blood routine test showed that there was bacterial infection, cefaclor dry suspension (Eli Lilly Suzhou Pharmaceutical Co., Ltd., production batch number: National Medicine Standard H10983028) was given at 40 mg / kg per day, twice a day. If the body temperature exceeds 38.5℃, temporary oral antipyretics are taken.

[0038] Observation group: Oral administration of Ma Xing Shuang Jin Yin, prescribed by the hospital, consists of the following ingredients: 3 g ephedra, 3 g apricot kernel, 15 g honeysuckle, 15 g desmodium, 5 g gastrodia, 5 g fritillaria, 5 g tangerine peel, 5 g Uncaria rhynchophylla, 10 g poria, and 6 g liquorice.

[0039] All drugs are processed and bottled by our hospital's preparation room in proportion, 250ml per bottle. 2-5 years old 25ml each time, 6-9 years old 35ml each time, 10-14 years old 50ml each time, twice a day, warm and take after meals.

[0040] The treatment course for both groups of children was 10 days. After the treatment, the clinical efficacy and related physical and chemical indicators were observed, and the efficacy statistics were performed.

[0041] The children in both groups had good compliance during the treatment and no case dropped out.

[0042] 5. Observation indicators

[0043] Efficacy determination criteria: formulated based on the efficacy determination criteria for cough in the "Efficacy Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes". (1) Cured: TCM symptoms completely disappear or basically disappear, and the efficacy index ≥ 95%; (2) Markedly effective: TCM symptoms are significantly relieved, 70% ≤ efficacy index < 95%; (3) Effective: TCM symptoms are slightly relieved, 30% ≤ efficacy index < 70%; (4) Ineffective: TCM symptoms are not relieved or even worsen, and the efficacy index is < 30%. Among them, the efficacy index = (the sum of the symptom scores before treatment - the sum of the symptom scores after treatment) / the sum of the symptom scores before treatment. *100%

[0044] Comparison of TCM syndrome scores before and after treatment: A quantitative table of TCM syndrome scores for children with phlegm-heat cough was developed according to the "Guidelines for Clinical Research of New Chinese Medicines (Trial)", in which the main syndrome was calculated according to the severity of the symptoms: severe (6 points), moderate (4 points), mild (1 point), and none (0 points). Concomitant syndromes were calculated according to the severity of the symptoms: severe (3 points), moderate (2 points), mild (1 point), and none (0 points). The average syndrome scores of the two groups were compared before and after treatment.

[0045] Comparison of the average time for fever reduction, cough and sputum disappearance in children before and after treatment: The average time for fever reduction, cough and sputum disappearance in the two groups after treatment were calculated and compared.

[0046] Comparison of serum inflammatory factor levels: Enzyme-linked immunosorbent assay was used to measure serum tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and interleukin-6 (IL-6) before and after treatment.

[0047] Comparison of adverse reactions: observe whether the two groups of children experience vomiting, rash, diarrhea, abdominal pain and other adverse reactions during treatment.

[0048] Statistical analysis: SPSS25.0 statistical software was used to analyze various data. The data were expressed as x±s. The chi-square test was used to compare the count data, and the t-test was used to compare the measurement data. P < 0.05 was considered statistically significant.

[0049] 6. Results

[0050] The comparison of the total clinical efficacy of the observation group and the control group after treatment is shown in Table 1. * P<0.05. The statistical results showed that the total clinical effective rate of the observation group was significantly higher than that of the control group, indicating that the Chinese medicine composition has a good therapeutic effect in the treatment of acute and chronic bronchitis in children.

[0051] Table 1:

[0052] Group n get well Significant effect efficient invalid Total effective rate (%) Observation Group 72 7 24 36 5 <![CDATA[93.1 * ]]> Control group 68 3 6 44 15 77.9

[0053] The comparison of TCM syndrome scores between the observation group and the control group before and after treatment is shown in Table 2. △ P>0.05, * P<0.05. The statistical results showed that the Chinese medicine combination could significantly improve the TCM symptoms of the children.

[0054] Table 2:

[0055] Group n Before treatment After treatment Observation Group 72 <![CDATA[17.96±4.24 △ ]]> <![CDATA[5.31±2.39 * ]]> Control group 68 17.83±4.68 12.46±3.34

[0056] The comparison of the average disappearance time of fever, cough and sputum in the observation group and the control group after treatment is shown in Table 3. * P<0.05. The statistical results showed that the Chinese medicine combination could relieve the symptoms of the children more quickly.

[0057] Table 3:

[0058] Group n fever cough Expectoration Observation Group 72 <![CDATA[3.45±1.12 * ]]> <![CDATA[6.54±2.87 * ]]> <![CDATA[4.25±2.12 * ]]> Control group 68 6.73±2.29 10.78±3.79 6.44±2.32

[0059] The comparison of serum inflammatory factor levels between the observation group and the control group before and after treatment is shown in Table 4. * P<0.05, △ P<0.05. Table 4 shows that the Chinese medicine composition can reduce the level of serum inflammatory factors in children, thereby alleviating the inflammatory response.

[0060] Table 4:

[0061]

[0062] During the trial, no severe allergic reactions or serious adverse reactions occurred in the two groups of children. After taking the Chinese medicine combination, the children in the observation group did not experience adverse reactions such as vomiting, rash, diarrhea, and abdominal pain.

[0063] The results of this example show that the Chinese medicine composition has significant efficacy and good safety in treating acute and chronic bronchitis in children. Compared with conventional Western medicine treatment, Chinese medicine treatment shows obvious advantages in relieving Chinese medicine symptoms, accelerating symptom disappearance, and reducing inflammatory factor levels.

Claims

1. A Chinese medicine composition for treating acute and chronic bronchitis in children, characterized in that: The composition is prepared by processing the following raw materials: 3 parts of ephedra, 3 parts of apricot kernel, 15 parts of honeysuckle, 15 parts of desmodium, 5 parts of gastrodia, 5 parts of fritillaria, 5 parts of tangerine peel, 5 parts of Uncaria rhynchophylla, 10 parts of tuckahoe and 6 parts of liquorice.

2. The Chinese medicine composition for treating acute and chronic bronchitis in children according to claim 1, characterized in that: The composition is prepared according to the following steps: S1, decoction: weigh the above medicinal materials according to the prescription ratio, put the medicinal materials into a container and soak them in water, decoct the soaked medicinal materials twice, combine the two decoctions, let them stand and filter them to obtain medicinal juice; S2, concentration: concentrating the medicinal juice to obtain a medicinal solution; S3, packaging: Pack the liquid medicine into clean and dry glass bottles and seal them; S4, Sterilization: Place the packaged liquid medicine into a high-pressure steam sterilizer for sterilization for 30 minutes.

3. The Chinese medicine composition for treating acute and chronic bronchitis in children according to claim 2, characterized in that: The S1 is specifically as follows: take 30g of ephedra, 30g of almond, 150g of honeysuckle, 150g of desmodium, 50g of gastrodia, 50g of fritillaria, 50g of tangerine peel, 50g of Uncaria rhynchophylla, 100g of Poria and 60g of liquorice, put the medicinal materials into a container and add 5760ml of water, soak them for 30 minutes, decoct the soaked medicinal materials with water for 30 minutes, separate the decoction from the residue; add 5760ml of water to the residue, decoct it for 30 minutes, obtain a second separated decoction and the residue, combine the two decoctions, let them stand and filter them, and obtain a medicinal juice.

4. The Chinese medicine composition for treating acute and chronic bronchitis in children according to claim 3, characterized in that: The S2 specifically comprises: concentrating the medicinal juice to 2500 ml to obtain a medicinal solution.

5. The Chinese medicine composition for treating acute and chronic bronchitis in children according to claim 4, characterized in that: The S3 is specifically as follows: packaging the liquid medicine into clean and dry glass bottles according to a dosage of 250 ml per bottle, and sealing the bottles.

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