Traditional Chinese medicine for treating infantile adenoid hypertrophy and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine for treating infantile adenoid hypertrophy and a preparation method thereof. The traditional Chinese medicine is prepared from nine medicinal materials including pericarpium citri reticulatae, thunberg fritillary bulb, selfheal, oroxylum indicum, platycodon grandiflorum, radix scrophulariae, semen coicis, biond magnolia flower and radix saposhnikoviae, clinical research shows that the medicine can remarkably improve symptoms such as nasal obstruction, snoring and mouth breathing of sick children and has the effect of reducing adenoid hypertrophy, the total effective rate can reach 90.15%, and safety is good. The traditional Chinese medicine overcomes the defects that existing western medicines have many side effects after being used for a long time and the operation is likely to relapse, embodies the characteristic of treating both symptoms and root causes of the traditional Chinese medicine, and has good clinical application prospects.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating adenoid hypertrophy in children and a preparation method and application thereof. BACKGROUND

[0002] Adenoid hypertrophy (AH) in children is a common disease in children, and a common cause is inflammation of the nasopharynx and its adjacent organs and tissues, which causes the adenoid in the junction of the top wall and the back wall of the nasopharynx to grow and become hypertrophic. The disease is often accompanied by chronic tonsillitis and tonsillar hypertrophy, and the main clinical symptoms include nasal congestion, snoring, mouth breathing, runny nose, cough, and accompanying symptoms include expectoration, clearing the throat, sore throat, and the like, which are aggravated at night. The current treatment drugs mainly include anti-infective drugs, nasal glucocorticoids, and the like, and usually, the doctor will use drugs for treating rhinitis to relieve the relevant symptoms according to the symptoms and causes.

[0003] The treatment of children's adenoid hypertrophy by traditional Chinese medicine is mainly from the whole, and the evil is expelled while the healthy is assisted, which can improve the symptoms of the children and also regulate their constitution, improve the immune function, and prevent recurrence. Therefore, the development of traditional Chinese medicine treatment drugs has very important clinical significance for the treatment of the disease and the improvement of the life quality of the children.

[0004] There is no disease name of adenoid hypertrophy in ancient Chinese medical books, and according to the clinical manifestations and pathological characteristics, it can be classified into the categories of “nose congestion”, “snoring”, “pharyngeal swelling”, and “phlegm nucleus”. Traditional Chinese medicine believes that the causes of adenoid hypertrophy in children have two aspects of external and internal causes, and the external cause is mainly caused by external evil or food accumulation, and the internal cause is mainly due to the weakness of the children, and the deficiency of the lung and spleen. The lung of children is tender and easy to be invaded by external evil, and the evil from the skin, mouth and nose invades the lung system, causes the lung to lose the function of descending, the waterway to be not smooth, the normal distribution of body fluid to be not normal, the body fluid to be condensed into phlegm, the phlegm to be accumulated in the nasopharynx, the lung orifice to be not smooth, and the adenoid to be hypertrophic, resulting in symptoms such as nasal congestion, snoring, mouth breathing and the like. The spleen of children is often insufficient, and the children do not know how to regulate the diet, and often have a partial taste for fatty and thick flavors, and if the food accumulation damages the spleen and stomach, the function of the spleen and stomach is disordered, the distribution of body fluid is obstructed, the body fluid is condensed into phlegm, and the phlegm is accumulated in the throat, resulting in the disease. It can be seen that the AH of children is located in the pharyngeal swelling, and is closely related to the lung and spleen, and the phlegm is an important pathological product, and the phlegm is accumulated in the pharyngeal swelling for a long time, which is the pathological basis of the adenoid hypertrophy and repeated nasal congestion and runny nose.

[0005] The traditional Chinese medicine prescription of the present application is an experienced prescription formed by Dr. Chen Yonghui, the affiliated children's hospital of Capital Institute of Pediatrics, on the basis of a large amount of clinical practice, which is composed of 9 medicinal materials such as Pericarpium Citri Reticulatae, Fritillaria Thunbergii Miq., Prunella Vulgaris L., Ostericum Magnolioides and Platycodon Grandiflorum, has the effects of resolving phlegm, dispelling accumulation, benefiting the throat and dredging the orifice, and is mainly used for treating adenoid hypertrophy in children. At present, the traditional Chinese medicine is being systematically researched by the Jianmin Pharmaceutical Group Co., Ltd. as a new drug of traditional Chinese medicine, and the formula and process have not been published. SUMMARY

[0006] The purpose of the present application is to provide a new treatment of pediatric adenoid hypertrophy of traditional Chinese medicine.

[0007] 1. Dialectical treatment AH in children belongs to the syndrome of deficiency in origin and excess in superficiality, and the core pathogenesis has the following aspects: Lung and spleen disorder, causing phlegm turbidity: children's "spleen is often insufficient", improper diet can easily cause the spleen to lose its transportation function, accumulate dampness and produce phlegm; "lungs are often insufficient", leading to external evil invading easily, lung losing its descending function, and fluid retention as phlegm. Phlegm turbidity is the pathological basis.

[0008] Phlegm and qi mutual knotting, stagnation and heat transformation: phlegm turbidity rises and falls with qi, stagnates in the junction of nose and pharynx (adenoid), and is mutually blocked with qi stagnation, forming phlegm nucleus (hypertrophic tissue), and heat is transformed due to long-term stagnation in the local area.

[0009] Obstruction of the passageway: phlegm nucleus blocks the nasal cavity, causing nasal congestion and snoring; stagnates in the throat, causing discomfort in the throat, cough.

[0010] Therefore, the treatment principle should be mainly "regulating qi, resolving phlegm and removing obstruction", and "clearing heat, moistening the throat and unblocking the passageway" at the same time.

[0011] 2. Prescription In the prescription, pericarpium citri reticulatae, which is pungent, bitter and warm, belongs to the spleen and lung meridians, and its core function is to "regulate qi, invigorate the spleen and dry dampness and resolve phlegm". The pathogenesis of pediatric adenoid hypertrophy begins with the dysfunction of the spleen and lung, poor qi movement, accumulation of dampness and phlegm. Pericarpium citri reticulatae can regulate qi to make the lung and spleen qi movement smooth, and can invigorate the spleen and dry dampness to reduce the generation of phlegm, which embodies the fundamental principle of "treating phlegm by regulating qi, and phlegm will be eliminated when qi is smooth". Fritillaria thunbergii miq., which is bitter and cold, belongs to the lung and heart meridians, and is the auxiliary monarch drug, with the functions of "clearing heat and resolving phlegm, and removing obstruction". Its "removing obstruction" function complements the "regulating qi" function of pericarpium citri reticulatae, and together resolves the core pathogenesis of "qi and phlegm obstruction". Its "removing obstruction" function directly acts on the lesion. The two drugs, one warm and one cold, one regulating qi and one removing obstruction, together are the monarch drug.

[0012] Herba prunellae, which is pungent, bitter and cold, belongs to the liver and gallbladder meridians, and has the functions of clearing liver fire and removing obstruction. Its "removing obstruction" function directly assists fritillaria thunbergii miq. to strengthen the effect, and its clearing liver fire effect can target the heat transformed by long-term phlegm and qi obstruction, or the physical characteristics of children's liver often having excess and easily assisting fire. Radix scrophulariae, which is sweet, bitter, salty and cold, belongs to the lung, stomach and kidney meridians, and has the functions of nourishing yin, clearing heat, resolving phlegm and removing obstruction. Its "removing obstruction" function is synergistic with herba prunellae and fritillaria thunbergii miq.. Phlegm and heat accumulation can easily damage yin fluid, radix scrophulariae can nourish yin and clear heat to prevent the dryness of phlegm and phlegm-removing drugs from damaging yin, and can also target the possible dry throat. Radix et rhizoma scrophulariae, which is bitter and sweet and cool, belongs to the lung, liver and stomach meridians, and has the functions of clearing lung and relieving throat. It targets the symptoms of discomfort in the throat, foreign body sensation and cough caused by phlegm and qi obstruction in the throat, and its cool nature can clear heat and its light quality can unblock the passageway, which is the key drug for improving the local symptoms of the throat. The three drugs, which are the auxiliary monarch drugs, remove obstruction, clear heat and relieve the throat, together are the ministerial drugs.

[0013] Yiyiren, Gan cool, spleen, stomach, lung, function of spleen, exudation, heat, pus, one, help, Chenpi, spleen, dampness, from the source to strengthen the power of phlegm, "Spleen for the source of phlegm"; two, auxiliary, its "pus" effect helps to dissipate local congestion, for the local congestion, as a minister. Jiegeng, bitter and acrid, spleen, function of lung, phlegm, throat, pus, one, load the drug up, the force of the drug up to the nose and throat disease; two, help, Chenpi, spleen, qi, phlegm, help, Zhebeimu, phlegm, throat, help, Muhu die, as a minister. Xinyi, Xingwen, spleen, stomach, lung, can be with aromatic Xindan power to promote the nasal passages, solve the airway obstruction of the emergency symptoms, as a minister. Fangfeng, Xinggan, slightly warm, spleen, liver, spleen, function of wind, table, dampness, help, Xinyi, and protect the table, prevent the induction or exacerbation of the disease, as a minister.

[0014] 3. Overall formula feature analysis: (1) "treatment of gas" first: Chenpi is the monarch, highlighting the "qi movement" in the development of AH key role. That only gas smooth, phlegm can be transported, stagnation can be scattered.

[0015] (2) monarch and minister, clear main and secondary: monarch (Chenpi, Zhebeimu) to solve the core pathogenesis (phlegm and qi resistance to form a knot); minister (Xiaakucaocao, Xuanshen, Muhudi) in "dissipate, clear heat, throat" three specific directions to strengthen the power of monarch, clear division of labor.

[0016] (3) dissipation of the power of concentration: Zhebeimu, Xiaakucaocao, Xuanshen three drugs with "dissipate" effect of the drug belongs to monarch and minister, forming a strong force to dissipate the adenoid hypertrophy of the pathological products.

[0017] (4) throat, nose, orderly: throat medicine Muhudi as a minister, emphasizing the importance of the throat symptoms; Xinyi, a throat medicine, focuses on solving the prominent symptom of nasal congestion. Clear levels, clear target.

[0018] (5) the function of the minister is comprehensive: Yiyiren spleen, solid foundation, Jiegeng, guided by the phlegm, Xinyi, throat, prevent changes, together with the monarch and minister, consolidate the effect, and pay attention to the whole.

[0019] Based on this, the application provides a kind of drug composition for treating pediatric adenoid hypertrophy, it is by following weight fraction raw materials composition: 20-80 of Chenpi, 30-120 of Zhebeimu, 30-120 of Xiaakucaocao, 20-80 of Muhudi, 20-80 of Jiegeng, 30-120 of Xuanshen, 50-150 of Yiyiren, 20-80 of Xinyi, 10-50 of Fangfeng.

[0020] Preferably, the weight parts of the raw materials are: 30-60 parts of dried orange peel, 50-100 parts of Zhejiang fritillary bulb, 50-100 parts of Prunella vulgaris, 30-60 parts of Lonicera japonica, 30-60 parts of Platycodon grandiflorum, 50-100 parts of Scrophularia ningpoensis, 80-120 parts of Coix lachryma-jobi, 30-60 parts of Magnolia biondii, and 20-40 parts of Saposhnikovia divaricata.

[0021] Further preferably, the weight parts of the raw materials are: 50 parts of dried orange peel, 80 parts of Zhebei fritillary bulb, 80 parts of Prunella vulgaris, 50 parts of Lonicera japonica, 50 parts of Platycodon grandiflorum, 80 parts of Scrophularia ningpoensis, 100 parts of Coix lachryma-jobi, 50 parts of Magnolia biondii, and 30 parts of Saposhnikovia divaricata.

[0022] The application also provides use of the pharmaceutical composition in preparation of a medicine for treating hypertrophy of adenoids in children.

[0023] The application further provides a preparation method of the medicine, comprising the following steps: (1) taking dried orange peel, Magnolia biondii, and Saposhnikovia divaricata, and extracting volatile oil by water vapor distillation for standby use; (2) mixing the residue after extraction of volatile oil in step (1) with the remaining medicinal materials, then adding water for decoction, filtering, concentrating the filtrate into extract, and then adding pharmaceutically acceptable adjuvants (such as flavoring agents and excipients) and volatile oil to prepare a medicine preparation suitable for clinical use.

[0024] Preferably, the number of times of adding water for decoction is 2-3 times, and the time for each decoction is 1-3 hours.

[0025] The medicine can be prepared into any one of the following dosage forms suitable for clinical use by using the above method, including granules, decoction, powder, tablets, capsules, pills, mixture, syrup, etc.

[0026] The preferred dosage form of the application is granules, which has the advantages of good compliance, fast digestion and absorption, and few side effects, and is especially suitable for children.

[0027] The application has the following beneficial effects: Hypertrophy of adenoids is one of the common clinical diseases in children, which seriously affects the sleep and life quality of children. Surgery is the main method for treating hypertrophy of adenoids in children in western medicine, which can significantly improve the clinical symptoms of children, but has the possibility of recurrence. Drug treatment mainly uses leukotriene receptor antagonists and nasal glucocorticoids, but long-term use has many adverse reactions. The application treats hypertrophy of adenoids in children from the whole, expelling evil and tonifying the body, which can improve the symptoms of children and also regulate their constitution, and has achieved good results. DETAILED DESCRIPTION

[0028] The application will be further described in detail below in connection with specific examples.

[0029] Example 1 Prescription: Pericarpium Citri Reticulatae 50g, Fritillariae Thunbergii Miq. 80g, Prunella vulgaris L. 80g, Buddleja officinalis Maxim. 50g, Platycodonis 50g, Scrophulariae 80g, Fried Seeds of Cyperus rotundus 100g, Magnoliae 50g, Saposhnikovia divaricata 30g.

[0030] Preparation: The above medicinal materials are weighed, and the volatile oil is extracted from Pericarpium Citri Reticulatae, Magnoliae and Saposhnikovia divaricata by water vapor distillation method, then the residue and the remaining medicinal materials in the prescription are decocted with water for 2 times, the water amount is 8 times of the weight of the medicinal materials each time, and the decoction time is 1.5 hours each time. After the decoction is completed, filtration is performed, the filtrates are combined, and the extract is concentrated to the relative density of 1.20. Appropriate amounts of sucrose and dextrin are taken, the extract is sprayed, and granulation is performed. Then, the volatile oil is added and uniformly mixed to prepare granules.

[0031] Method of taking: The granules are taken with boiling water, and one bag (equivalent to 9.5g of traditional Chinese medicinal materials) is taken by children aged 5-8 years old, 3 times a day.

[0032] Function and indication: Regulating qi and resolving phlegm, benefiting throat and dredging orifices. It is used for children with adenoid hypertrophy, and the syndrome is caused by the obstruction of phlegm and qi, the accumulation of heat, the obstruction in nasopharynx, obvious nasal obstruction, snoring, foreign body sensation in throat, accompanied by sticky phlegm, dry throat, greasy tongue fur and slippery pulse.

[0033] Example 2 Prescription: Pericarpium Citri Reticulatae 60g, Fritillariae Thunbergii Miq. 50g, Prunella vulgaris L. 50g, Buddleja officinalis Maxim. 30g, Platycodonis 30g, Scrophulariae 50g, Fried Seeds of Cyperus rotundus 80g, Magnoliae 30g, Saposhnikovia divaricata 20g.

[0034] Preparation: The above medicinal materials are weighed, and the volatile oil is extracted from Pericarpium Citri Reticulatae, Magnoliae and Saposhnikovia divaricata by water vapor distillation method, then the residue and the remaining medicinal materials in the prescription are decocted with water for 3 times, the water amount is 5 times of the weight of the medicinal materials each time, and the decoction time is 1 hour each time. After the decoction is completed, filtration is performed, the filtrates are combined, and the extract is concentrated to the relative density of 1.20. Appropriate amounts of sucrose and dextrin are taken, the extract is sprayed, and granulation is performed. Then, the volatile oil is added and uniformly mixed to prepare granules.

[0035] Example 3 Prescription: Pericarpium Citri Reticulatae 80g, Fritillariae Thunbergii Miq. 100g, Prunella vulgaris L. 100g, Buddleja officinalis Maxim. 60g, Platycodonis 60g, Scrophulariae 100g, Fried Seeds of Cyperus rotundus 120g, Magnoliae 60g, Saposhnikovia divaricata 50g.

[0036] Preparation: The above medicinal materials are weighed, and the volatile oil is extracted from Pericarpium Citri Reticulatae, Magnoliae and Saposhnikovia divaricata by water vapor distillation method, then the residue and the remaining medicinal materials in the prescription are decocted with water for 2 times, the water amount is 10 times of the weight of the medicinal materials each time, and the decoction time is 2 hours each time. After the decoction is completed, filtration is performed, the filtrates are combined, and the extract is concentrated to the relative density of 1.20. Appropriate amounts of sucrose and dextrin are taken, the extract is sprayed, and granulation is performed. Then, the volatile oil is added and uniformly mixed to prepare granules.

[0037] Example 4: Clinical observation of the treatment of adenoid hypertrophy in children 1. Method 1.1 General information: 132 cases of outpatients who met the AH diagnostic and syndrome criteria from April 2023 to August 2024 at the Children's Hospital Affiliated to the Capital Institute of Pediatrics were selected as observation objects, including 75 males and 57 females; age 3-12 years, average age (4.27±2.62) years; disease duration 6 months-2 years, average disease duration (0.79±0.48) years.

[0038] 1.2 Diagnostic criteria: Referring to "Clinical Diagnosis and Treatment of Pediatric ENT Diseases" [1] and "Chinese Medicine Diagnosis and Treatment Expert Consensus on Sleep-Disordered Breathing Caused by Adenoid Hypertrophy in Children" [2] Developed: ① Children with nasal congestion, open-mouth breathing, snoring, sleeplessness, and inattention; ② Nasal endoscopy: adenoid obstruction of the posterior naris Ⅲ degree or more (more than 50%) and clinical symptoms; ③ Imaging examination: nasopharyngeal lateral X-ray and nasopharyngeal CT examination showed adenoid hypertrophy, and the adenoid-nasopharyngeal cavity ratio A / N value was >0.60. Two main symptoms and one auxiliary examination were diagnosed.

[0039] 1.3 TCM syndrome differentiation criteria: Referring to "Snoring TCM Diagnosis and Treatment Expert Consensus" developed by the Chinese Medicine Association [3] and combined with clinical practice. Phlegm retention syndrome, symptoms of snoring during sleep, intermittent, or respiratory arrest, open-mouth breathing, nasal congestion, throat discomfort, throat clearing, repeated colds, sleeplessness, irregular bowel movements, pale tongue, greasy or white tongue fur, and slippery pulse.

[0040] 1.4 Inclusion criteria: ① Meet the diagnostic criteria and TCM syndrome differentiation criteria; ② Age 3-12 years.

[0041] 1.5 Exclusion criteria: ① Other causes of nasopharyngeal obstruction or respiratory tract stenosis, such as congenital craniofacial deformity, nasal polyps, severe nasal septum deviation, or obesity, tracheal disease, neuromuscular dysfunction, etc.; ② Associated with severe diseases of other systems, such as cardiovascular system, liver and kidney system, nervous system, blood system, endocrine system; ③ May have allergic reactions to drugs used in the study; ④ Combined with other drug use.

[0042] 1.6 Treatment method: Children's Jiebeizhisun Decoction composed of 9 kinds of drugs, including Xinyi, Chenpi, Fangfeng, Jiegeng, Xiaakuca, Zhebeimu, Yiyiren, Muhuhetie, and Xuanmi, was used, water decoction, 70ml for 3-6 years old, 100ml for 7-14 years old, twice a day, morning and evening. 4 weeks as a course of treatment, generally 1-2 courses.

[0043] 1.7 Observation indicators 1.7.1 Main symptom score: The main symptoms (nasal congestion, snoring, mouth breathing) were scored according to the severity, with 0 points (normal), 2 points (mild), 4 points (moderate), and 6 points (severe). The total symptom score of the children before and after treatment was recorded and compared.

[0044] 1.7.2 Adenoid grading score: The adenoid hypertrophy grading quantification table referred to the "Expert Consensus on Traditional Chinese Medicine Diagnosis and Treatment of Children's Adenoid Hypertrophy Induced Sleep Disordered Breathing" [2] was developed. The adenoid-nasopharyngeal ratio (A / N ratio) was used to judge the degree of adenoid hypertrophy. According to the nasopharyngeal imaging results, if A / N > 0.8, it was considered as severe hypertrophy, scored 6 points; 0.7 < A / N ≤ 0.8, moderate hypertrophy, scored 4 points; 0.6 < A / N ≤ 0.7, mild hypertrophy, scored 2 points; A / N ≤ 0.6, no hypertrophy, scored 0 points. The grading score of adenoid size in children before and after treatment was recorded and compared.

[0045] 1.8 Efficacy evaluation criteria 1.8.1 Overall efficacy evaluation criteria: Referring to "Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine (Trial)" [4] The efficacy was evaluated as follows: ① Clinical recovery: The clinical symptoms and signs basically disappeared after taking the medicine, and the total score decreased by ≥95%; ② Marked effect: The clinical symptoms and signs were significantly improved after taking the medicine, and the total score decreased by ≥70%-94%; ③ Effectiveness: The clinical symptoms and signs were improved after taking the medicine, and the total score decreased by ≥30%-69%; ④ Ineffective: The clinical symptoms were not significantly improved, or even aggravated, after taking the medicine, and the total score decreased by <30%. The total effective rate (%) = (clinical recovery + marked effect + effectiveness) number of cases / total number of cases x 100%.

[0046] 1.8.2 Adenoid grading score efficacy evaluation criteria: ① Recovery: The adenoid grading score decreased by 2 or more grades; ② Marked effect: The adenoid grading score decreased by 1 grade; ③ Effectiveness: The A / N value decreased, but the adenoid grading score decreased by less than 1 grade; ④ Ineffective, A / N did not decrease or increased. The total effective rate = (recovery + marked effect + effectiveness) number of cases / total number of cases x 100%.

[0047] 2. Results 2.1 Overall efficacy: After 1 course of treatment, 18 cases were clinically cured, 43 cases had marked effect, 58 cases had effectiveness, 13 cases had no effect, and the total effective rate was 90.15%.

[0048] 2.2 Comparison of main symptoms scores of children before and after treatment: The main symptoms (nasal congestion, snoring, mouth breathing) scores of children before treatment were 3.12±0.76, 3.75±0.87, and 3.17±0.57, respectively, and after treatment were 1.47±0.52, 1.35±0.85, and 1.43±0.71, respectively, which were significantly decreased after treatment.

[0049] 2.3 Therapeutic effect of adenoid division: Among the 132 children, 34 underwent image review of adenoid after the treatment, of which 5 were cured, 8 were markedly effective, 12 were effective, and 9 were ineffective, with a total effective rate of 73.53%.

[0050] References [1] Liu D. Clinical Pediatric Otorhinolaryngological Disease Diagnosis and Treatment [M]. Beijing: Science and Technology Literature Publishing House, 2017: 111-114.

[0051] [2] World Federation of Chinese Medicine Societies Sleep Medicine Technology Standard Review Committee, Children's Sleep Apnea Working Committee. Expert consensus on TCM diagnosis and treatment of children's adenoid hypertrophy-induced sleep apnea [J]. World Journal of Sleep Medicine, 2014, 1(6): 316-320.

[0052] [3] Chen ZB, Lan L. Expert consensus on TCM diagnosis and treatment of snoring [J]. Chinese Journal of Chinese Medicine Information, 2019, 26(1): 1-5.

[0053] [4] State Food and Drug Administration. Guidelines for Clinical Research on New Drugs of Traditional Chinese Medicine (Trial) [M]. Beijing: China Medical Science and Technology Publishing House, 2002: 364.

Claims

1. A pharmaceutical composition for treating adenoid hypertrophy in children, characterized in that, The raw materials are composed of the following components in parts by weight: Pericarpium Citri Reticulatae 20-80 parts, Fritillariae Thunbergii Miq. 30-120 parts, Prunella Vulgaris L. 30-120 parts, Buddleja Davidii 20-80 parts, Platycodon Grandiflorum 20-80 parts, Scrophularia Ningpoensis 30-120 parts, Coix Lacryma-Jobi 50-150 parts, Magnolia Biondii 20-80 parts, Saposhnikovia Divaricata 10-50 parts.

2. The pharmaceutical composition of claim 1, wherein, The raw materials are composed of the following components in parts by weight: Pericarpium Citri Reticulatae 30-60 parts, Fritillariae Thunbergii Miq. 50-100 parts, Prunella Vulgaris L. 50-100 parts, Buddleja Davidii 30-60 parts, Platycodon Grandiflorum 30-60 parts, Scrophularia Ningpoensis 50-100 parts, Coix Lacryma-Jobi 80-120 parts, Magnolia Biondii 30-60 parts, Saposhnikovia Divaricata 20-40 parts.

3. The pharmaceutical composition of claim 1, wherein The raw materials are composed of the following components in parts by weight: Pericarpium Citri Reticulatae 50 parts, Fritillariae Thunbergii Miq. 80 parts, Prunella Vulgaris L. 80 parts, Buddleja Davidii 50 parts, Platycodon Grandiflorum 50 parts, Scrophularia Ningpoensis 80 parts, Coix Lacryma-Jobi 100 parts, Magnolia Biondii 50 parts, Saposhnikovia Divaricata 30 parts.

4. The use of the pharmaceutical composition of any one of claims 1-3 in the preparation of a medicament for treating hypertrophy of adenoids in children.

5. Process for the preparation of a pharmaceutical composition according to any one of claims 1 to 3, characterized in that, The method comprises the following steps: (1) Pericarpium Citri Reticulatae, Magnolia Biondii and Saposhnikovia Divaricata are extracted by water vapor distillation to obtain volatile oil; (2) The residue after extraction of volatile oil in step (1) is mixed with the remaining medicinal materials, and then water is added for decoction, the filtrate is concentrated into extract, and then auxiliary materials and volatile oil are added to prepare a pharmaceutical preparation suitable for clinical use.

6. The production method according to claim 5, characterized by: The decoction with water is performed 2-3 times, and each time the decoction is performed for 1-3 hours.

7. The production method according to claim 5, wherein: The pharmaceutical preparation is an oral preparation, including granules, powder, tablets, capsules, pills, mixture, syrup.