Traditional Chinese medicine composition with effect of preventing and treating infantile adenoid hypertrophy as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition with an effect of preventing and treating children adenoid hypertrophy and a preparation method thereof. The composition is prepared from 10g of thunberg fritillary bulb, 10g of kelp, 10g of wild buckwheat rhizome, 10g of bistort rhizome, 10g of lychee seed, 8g of selfheal, 6g of ligusticum wallichii, 6g of magnolia flower and 12g of raw coix seed. The traditional Chinese medicine composition is prepared by screening the medicinal materials through a large number of clinical tests and adopting a syndrome differentiation and treatment method rule according to the pathogenesis characteristics of the child adenoid hypertrophy, and the whole formula has the functions of reducing phlegm and resolving masses, promoting blood circulation to remove meridian obstruction and activating spleen and inducing resuscitation and has a good treatment effect on the child adenoid hypertrophy. Clinical verifications prove that the traditional Chinese medicine is remarkable in curative effect, free of toxic and side effects and good in safety.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition capable of preventing and treating adenoid hypertrophy in children, and a preparation method and application thereof. Background Art

[0002] Adenoidal hypertrophy (AH) is the most common cause of upper airway obstruction in children and adolescents, with a high prevalence. Adenoid hypertrophy is a natural response to increased immune activity in early life, but if excessive hyperplasia leads to severe upper airway obstruction, it may cause mouth breathing, nasal lesions such as sleep apnea, craniofacial growth changes and cognitive impairment, which will seriously affect children's growth and development, physical and mental health and quality of life.

[0003] The main clinical treatment methods are surgery, traditional Chinese medicine, and Western medicine. The main treatment for moderate to severe adenoids hypertrophy is surgical resection, but this operation requires a high level of professionalism from doctors, and there are residual tissues after surgery. The short-term effect is good, but the long-term effect is unstable, the recurrence rate is high, and scraping the lesions can cause damage to the surrounding normal tissues. In addition, the children feel very uncomfortable after surgery, and the acceptance of children and parents is not high. At the same time, the cost of surgery and complications are also factors that need to be considered. Children and parents prefer conservative treatment. At present, Western medicine treatment is mainly anti-inflammatory, anti-infective, and antihistamine, which cannot be eradicated and is only symptomatic treatment. The long-term effect is not ideal, and the side effects of long-term use are large.

[0004] Traditional Chinese medicine treatment is holistic and has significant effects on children's adenoids hypertrophy, low recurrence rate, good safety, and unique advantages. Chinese patent medicine treatment can treat both the symptoms and the root cause, is safe and effective, and has low treatment costs. Currently, the commonly used Chinese patent medicines in clinical practice, such as Rhinitis Tablets, Biyuanshu Oral Liquid, Yupingfeng Granules, Huangqi Granules, and Tongqiao Rhinitis Tablets, are mostly aimed at rhinitis symptoms. There is no effective Chinese medicine preparation specifically for the treatment of children's adenoids hypertrophy on the market.

[0005] Therefore, developing a Chinese patent medicine for treating adenoids hypertrophy in children is of great significance for pediatric clinical practice. The present invention is based on the pathogenesis characteristics of adenoids hypertrophy in children and is summarized in combination with many years of clinical experience, which can better fill the gap of related drugs on the current market. Summary of the invention

[0006] The purpose of the present invention is to provide a Chinese medicine composition that can effectively improve the symptoms of mouth breathing, snoring, nasal congestion, etc. in children with adenoids hypertrophy, and can safely and effectively treat the disease of adenoids hypertrophy in children, according to the pathogenesis characteristics of adenoids hypertrophy in children. Another purpose of the present invention is to provide a preparation method of the Chinese medicine composition.

[0007] Adenoids are mainly composed of T and B lymphocytes. The mechanism of their hyperplasia is still not fully understood. The most common theory is that it is closely related to inflammatory response. Adenoids hypertrophy is a common and frequently occurring disease in pediatrics. The main clinical manifestations are mouth breathing, nasal congestion, snoring and obstructive sleep apnea. The incidence rate is high and the impact on children is also great. Adenoids hypertrophy, in traditional Chinese medicine, belongs to the category of "nasal congestion", "snoring" and "phlegm nodules".

[0008] Western medicine mainly uses surgical resection or symptomatic treatment with Western medicine for adenoid hypertrophy, which has certain limitations. Traditional Chinese medicine treatment starts from the overall perspective, treats based on syndrome differentiation, and treats the root cause of the disease. It can shrink adenoids, alleviate symptoms, and improve children's sleep. It has good results and is highly safe.

[0009] Adenoids hypertrophy belongs to the category of "nasal congestion", "snoring" and "phlegm nodules" in traditional Chinese medicine. It has the characteristics of "long-term, stubborn and complicated" diseases and can be treated under the guidance of the theory of "network disease" in traditional Chinese medicine. "Lingshu Jizhu·Volume 8" says: "The forehead is the orifice above the palate, and the air and saliva of the mouth and nose are connected from here." The location of the adenoids was called "the forehead" in ancient times. "Huangdi Neijing" contains: "The liver foot Jueyin meridian... follows the back of the throat, goes up to the forehead, and connects to the eye system", proposing that the forehead is where the liver meridian passes. "Medical True Transmission·Position" says "The place where the nose and mouth communicate in the nose is the forehead... It is the part where the liver and lungs meet." This is the place where the nose and mouth communicate, and it is also related to the Yangming meridian. The nose is located in the position of spleen and earth, and is connected to the spleen through meridians, and the formation of phlegm nodules is inseparable from the spleen. Therefore, although adenoids hypertrophy occurs in the nasopharynx, it is closely related to the lungs, spleen, liver and other internal organs, and the collaterals are spread throughout, which serves to connect the internal organs. The technical solution of the present invention is based on the profound understanding of the pathogenesis of adenoids hypertrophy in children by traditional Chinese medicine. It is believed that the delicate internal organs of children, the incomplete physical and qi, the susceptibility to external evil, the evil stagnation in the collaterals are the fundamental causes of the disease, and the phlegm accumulation, blood stasis and the obstruction of the collaterals are the key to the pathogenesis. Because the lung is a delicate organ, it is weak to clear and purify after being affected by evil, and the evil qi is easy to invade through the nasal cavity; the spleen is often insufficient, and after being affected by evil, the transportation and transformation are abnormal, dampness and turbidity are endogenous, and phlegm and dampness are stagnant; the collaterals are affected by evil, and the evil stagnates the liver collaterals, and the qi and blood are not smooth. Stasis and blood stasis block the collaterals for a long time, which eventually leads to adenoids hyperplasia. Children are deficient in vital energy and their lung and spleen functions are not yet sound. They are easily invaded by external factors such as the six evils and improper diet. If they are not removed for a long time, phlegm and dampness will be generated internally, blocking the qi mechanism, blood circulation, and collateral stasis, gradually forming a phenomenon of phlegm and blood stasis, which will lead to hypertrophy and hyperplasia of the adenoids. Based on this pathogenesis, the innovative treatment principle of "resolving phlegm and dispersing nodules, activating blood circulation and unblocking collaterals, and regulating the spleen and opening the orifices" is proposed, and a traditional Chinese medicine formula for the treatment of adenoids hypertrophy in children is self-prepared. This formula aims to treat both the symptoms and the root causes by resolving phlegm and dispersing nodules, unblocking collaterals, activating blood circulation and removing blood stasis, strengthening the spleen and stomach, opening the orifices and stopping snoring, so as to effectively improve the symptoms of adenoids hypertrophy and prevent its recurrence.

[0010] The specific technical solutions of the present invention are as follows:

[0011] A Chinese medicine composition having the effect of treating adenoids hypertrophy in children, which is made of the following raw materials:

[0012] Fritillaria thunbergii, kelp, golden buckwheat, polygonum multiflorum, litchi kernel, selfheal, ligusticum chuanxiong, magnolia, raw coix seed.

[0013] As a preferred embodiment, a Chinese medicine composition having the efficacy of treating adenoids hypertrophy in children is prepared from the following raw materials in parts by weight:

[0014] 6-14 parts of Fritillaria thunbergii, 6-14 parts of Kelp, 6-14 parts of Fagopyrum serrata, 6-14 parts of Polygonum multiflorum, 6-14 parts of Litchi seed, 4-12 parts of Prunella vulgaris, 3-9 parts of Ligusticum chuanxiong, 3-9 parts of Magnolia officinalis, and 9-15 parts of raw Coix seeds.

[0015] As a preferred embodiment, the above-mentioned Chinese medicine composition having the efficacy of treating adenoids hypertrophy in children is prepared from the following raw materials in parts by weight:

[0016] 8-12 parts of Fritillaria thunbergii, 8-12 parts of kelp, 8-12 parts of golden buckwheat, 8-12 parts of polygonum multiflorum, 8-12 parts of litchi seeds, 6-10 parts of selfheal, 4-8 parts of chuanxiong, 4-8 parts of magnolia, and 10-14 parts of raw coix seeds.

[0017] As a preferred embodiment, the above-mentioned Chinese medicine composition having the efficacy of treating adenoids hypertrophy in children is prepared from the following raw materials in parts by weight:

[0018] 10 parts of Fritillaria thunbergii, 10 parts of Kelp, 10 parts of Fagopyrum scabra, 10 parts of Polygonum multiflorum, 10 parts of Semen litchi, 8 parts of Spica Prunellae, 6 parts of Rhizoma Chuanxiong, 6 parts of Flos Magnoliae, and 12 parts of Semen Coicis.

[0019] The TCM syndrome differentiation formula of the Chinese medicine composition of the present invention is explained as follows:

[0020] The prescription of this Chinese medicine compound is composed of Fritillaria thunbergii, kelp, golden buckwheat, polygonum multiflorum, litchi seed, selfheal, chuanxiong, magnolia and raw coix seed.

[0021] In the formula, Fritillaria thunbergii is bitter and cold, and enters the lung and heart meridians. It can clear away heat, resolve phlegm, relieve cough, detoxify, disperse nodules and eliminate carbuncles; Kelp is salty and cold, and enters the liver, stomach, and kidney meridians. The salty taste is the best for softening hard lumps and can dissolve the tangible evil accumulated in the body. It can eliminate phlegm, promote diuresis, reduce swelling, soften hard lumps and disperse nodules. The two are both the main medicines.

[0022] Golden buckwheat is slightly pungent and astringent, cool in nature, and enters the lung meridian. It can clear away heat and detoxify, relieve sore throat and swelling, and promote blood circulation and remove blood stasis. Bistoria is bitter, astringent, slightly cold, and enters the lung, liver, and large intestine meridians. It can clear away heat and detoxify and reduce swelling. Prunella vulgaris is pungent, cold in nature, and enters the liver and gallbladder meridians.

[0023] Function: clearing the liver and purging fire, dispersing stagnation and reducing swelling; treating phlegm must treat qi. Litchi kernel is sweet and slightly bitter, warm in nature, and enters the liver and kidney meridians. Function: dispersing qi stagnation, reducing swelling and dispersing stagnation. Quan Shen, Prunella Vulgaris, and litchi kernel all go through the liver meridians and reach the forehead to help the main medicine dispersing stagnation and reducing swelling. The above four herbs are used together with cold and warm properties to eliminate phlegm and are collectively the minister medicines.

[0024] Phlegm and dampness condense, obstructing the flow of qi and blood. Long-term illness enters the collaterals, and long-term illness will cause stasis. Chuanxiong is pungent and warm, and enters the liver, gallbladder, and pericardium meridians. It is a "blood qi medicine". Chuanxiong is used to promote qi, activate blood circulation, and dredge the collaterals, and guide all the medicines to ascend to the head and face. Xinyi is pungent and warm, and enters the lung and stomach meridians. It has the function of dispelling wind and cold, dispersing evil qi, and is an important medicine for clearing the nasal passages. The spleen is responsible for transportation and transformation. If the spleen and stomach transportation and transformation are not functioning properly, water and dampness will accumulate, which is easy to produce phlegm and dampness. Raw coix seed can strengthen the spleen and stomach, promote water and eliminate dampness. Adhering to the academic thought of "the spleen is not healthy but the movement is important", it is used to strengthen and transport, strengthen without stagnation, and is suitable for the spleen. It can move the spleen and transform dampness to eliminate the source of phlegm. The above three flavors are used as adjuvants.

[0025] These medicines are used together to resolve phlegm and dampness, relieve depression, treat both Qi and blood, and balance cold and heat. Together they have the effects of resolving phlegm and dispersing stagnation, activating blood circulation and unblocking meridians, and invigorating the spleen and opening the orifices.

[0026] The preparation method of the Chinese medicine composition provided by the present invention comprises the following steps:

[0027] (1) taking Fritillaria thunbergii, kelp, golden buckwheat, bistort, selfheal, litchi seed, ligusticum chuanxiong, magnolia and raw coix seed, soaking them in water, then heating and extracting, filtering, combining the filtrate, and concentrating to obtain a concentrate;

[0028] (2) Add an appropriate amount of ethanol to the concentrated solution of step (1), stir evenly, let stand, filter, take the supernatant, recover the ethanol until there is no alcohol taste, concentrate, and use it to prepare various preparations.

[0029] As a preferred embodiment, in the method for preparing the above-mentioned Chinese medicine composition, in step (1), first add 8 to 16 times the weight of water as the raw material drug, soak for 20 to 30 minutes, then heat and boil for extraction for 1 to 2 hours, filter to obtain a filtrate, add 6 to 12 times the amount of water to the residue, heat and boil for extraction for 1 to 1.5 hours, filter, combine the filtrates of the two extractions, and concentrate to a ratio of medicinal material: liquid medicine of 2:1.

[0030] As a preferred embodiment, in the method for preparing the Chinese medicine composition described above, ethanol is added in step (2) to make the alcohol content in the concentrated solution reach 70% to 80%, and the concentrated solution is allowed to stand for 24 to 48 hours to be concentrated to a relative density of 1.1 to 1.3.

[0031] As a preferred embodiment, in the method for preparing the above-mentioned Chinese medicine composition, pharmaceutically acceptable excipients are added to the concentrated solution of step (2) to prepare an oral liquid, capsule, tablet, granule, mixture, powder, pill oral preparation or external spray (including throat spray, etc.).

[0032] Beneficial effects: The Chinese medicine composition with the efficacy of treating adenoids hypertrophy in children provided by the present invention has the following advantages: According to the pathogenesis of adenoids hypertrophy in children, the present invention optimizes the best Chinese medicine compound through a large number of experiments. Clinical observations show that the Chinese medicine composition of the present invention has the functions of resolving phlegm and dispersing nodules, promoting blood circulation and unblocking meridians, and promoting spleen and opening the orifices. It is particularly suitable for the syndrome of phlegm and blood stasis, and can significantly improve the symptoms of open mouth breathing, snoring, nasal congestion and the like in children with adenoids hypertrophy, achieving good therapeutic effects and high safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 This is Ren's lateral cervical spine radiograph. Figure 1 (A) represents a lateral radiograph of the cervical spine of Ren Mou before being treated with the Chinese medicine composition of the present invention; (B) represents a lateral radiograph of the cervical spine of Ren Mou after being treated with the Chinese medicine composition of the present invention.

[0034] Figure 2 This is Xiao's lateral cervical spine radiograph. Figure 2 (A) shows the lateral view of the cervical spine of Xiao before the treatment with the Chinese medicine composition of the present invention; (B) shows the lateral view of the cervical spine of Xiao after the treatment with the Chinese medicine composition of the present invention. DETAILED DESCRIPTION

[0035] The present invention can be better understood according to the following examples. However, it is easy for those skilled in the art to understand that the specific material ratios, process conditions and results described in the examples are only used to illustrate the present invention, and should not and will not limit the present invention described in detail in the claims.

[0036] Example 1

[0037] 1. A drug for treating adenoid hypertrophy in children, which is made from the following raw materials in the following weight ratios:

[0038] Fritillaria thunbergii 10g, kelp 10g, golden buckwheat 10g, polygonum multiflorum 10g, litchi seed 10g, selfheal 8g, chuanxiong 6g, magnolia 6g, raw coix seed 12g.

[0039] 2. A method for preparing a Chinese medicine oral liquid for treating adenoids hypertrophy in children, comprising the following steps:

[0040] (1) Take 10g of Fritillaria thunbergii, 10g of Kelp, 10g of Fagopyrum sibiricum, 10g of Polygonum multiflorum, 10g of Litchi seed, 8g of Prunella vulgaris, 6g of Ligusticum chuanxiong, 6g of Magnolia officinalis, and 12g of Raw Coix seeds, place them in an extraction tank, add 8 times the weight of the medicinal materials of drinking water, soak for 30 minutes, heat and boil for 1 hour, filter, take the filtrate, add 8 times the amount of water of the original medicinal materials to the residue, boil and extract for 1.5 hours, filter, combine the two filtrates, and concentrate to 2:1 (medicinal materials: medicinal solution);

[0041] (2) Take the concentrated drug solution prepared in step (1), add ethanol having a volume concentration of 95% to the concentrated drug solution to make the ethanol content reach 80%, let it stand for 24 hours, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.2, add distilled water to a specified volume, add an appropriate amount of flavoring agent, mix well, let it stand for 12 to 24 hours, filter, can, and sterilize to prepare an oral solution.

[0042] Example 2: Preparation of a Chinese medicine capsule for treating adenoids hypertrophy in children, comprising the following steps:

[0043] (1) Take 14g of Fritillaria thunbergii, 14g of Kelp, 14g of Fagopyrum sibiricum, 14g of Polygonum multiflorum, 14g of Litchi seed, 12g of Prunella vulgaris, 9g of Ligusticum chuanxiong, 9g of Magnolia officinalis, and 15g of Raw Coix seeds, place them in an extraction tank, add 8 times the weight of the medicinal materials in drinking water, soak for 30 minutes, then decoct and extract for 1 hour, filter, take the filtrate, add 8 times the amount of water of the original medicinal materials to the residue, decoct and extract for 1.5 hours, filter, combine the secondary filtrates, and concentrate to 2:1 (medicinal materials: medicinal solution);

[0044] (2) Add 95% ethanol by volume to the drug solution in step (1) until the alcohol content reaches 75%, let it stand for 48 hours, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.3, add dextrin, mix well, vacuum dry, crush, granulate, dry, granulate, and encapsulate to prepare capsules.

[0045] Example 3: Preparation of a Chinese medicine tablet for treating adenoids hypertrophy in children, comprising the following steps:

[0046] (1) Take 6 g of Fritillaria thunbergii, 6 g of Kelp, 6 g of Fagopyrum sibiricum, 6 g of Polygonum multiflorum, 6 g of Litchi seed, 4 g of Prunella vulgaris, 3 g of Ligusticum chuanxiong, 3 g of Magnolia officinalis, and 9 g of Raw Coix seeds, place them in an extraction tank, add 10 times the weight of the medicinal materials in drinking water, soak for 30 minutes, then heat and boil for 2 hours, filter, add 10 times the amount of water of the original medicinal materials to the residue, boil and extract for 1.5 hours, filter, combine the filtrate, and concentrate to 2:1 (medicinal materials: medicinal solution);

[0047] (2) Add 95% ethanol by volume to the drug solution in step (1) until the alcohol content reaches 78%, let it stand for 48 hours, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.3, add dextrin, mix well, vacuum dry, crush, granulate, dry, granulate, compress, and coat to make tablets.

[0048] Example 4: Preparation of a Chinese medicine granule for treating adenoids hypertrophy in children, comprising the following steps:

[0049] (1) Take 10g of Fritillaria thunbergii, 10g of Kelp, 10g of Fagopyrum sibiricum, 10g of Polygonum multiflorum, 8g of Prunella vulgaris, 10g of Litchi seed, 6g of Chuanxiong, 6g of Magnolia officinalis, and 12g of Raw Coix seeds, add 10 times the weight of the medicinal materials in drinking water and soak for 30 minutes, then heat and boil to extract for 1.5 hours, filter, add 8 times the amount of water of the original medicinal materials to the residue and extract for 1.5 hours, filter, combine the two filtrates, and concentrate to 2:1 (medicinal materials: medicinal solution);

[0050] (2) Add 95% ethanol by volume to the drug solution in step (1) until the alcohol content reaches 70%, let it stand for 48 hours, filter, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.1-1.2, granulate in one step, shape the particles, and package them to prepare granules.

[0051] Example 5: A preparation of a Chinese medicine soft capsule for treating adenoids hypertrophy in children, comprising the following steps:

[0052] (1) Take 10g of Fritillaria thunbergii, 10g of Kelp, 10g of Fagopyrum sibiricum, 10g of Polygonum multiflorum, 8g of Prunella vulgaris, 10g of Litchi seed, 6g of Ligusticum chuanxiong, 6g of Magnolia officinalis, and 12g of Raw Coix seeds, place them in an extraction tank, add 10 times the weight of the medicinal materials in drinking water and soak for 30 minutes, then heat and extract for 2 hours, filter, add 10 times the weight of water to the medicinal residue and extract for 1.5 hours, filter, combine the filtrate, and concentrate to 2:1 (medicinal materials: medicinal solution);

[0053] (2) Add 95% ethanol by volume to the drug solution in step (1) until the alcohol content reaches 75%, let it stand for 24 hours, filter, take the supernatant and recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.1, dry, add an appropriate amount of glycerol, mix well, drip or press into soft capsules, and package to prepare soft capsules.

[0054] Example 6: Preparation of a Chinese medicine external throat spray for treating adenoids hypertrophy in children, comprising the following steps:

[0055] (1) Take 10g of Fritillaria thunbergii, 10g of Kelp, 10g of Fagopyrum sibiricum, 10g of Polygonum multiflorum, 8g of Prunella vulgaris, 10g of Litchi seed, 6g of Ligusticum chuanxiong, 6g of Magnolia officinalis, and 12g of Raw Coix seeds, place them in an extraction tank, add 10 times the weight of the medicinal materials of drinking water, soak for 30 minutes, decoct and heat to extract for 2 hours, filter, add 10 times the amount of water to the residue, extract for 1.5 hours, filter, combine the filtrate, and concentrate to 2:1 (medicinal materials: medicinal solution);

[0056] (2) Take the liquid medicine from step (1), add ethanol with a volume concentration of 95% to the concentrated solution to make the ethanol content reach 80%, let it stand for 24 hours, take the supernatant to recover the ethanol until there is no alcohol taste, continue to concentrate to a relative density of 1.2, add distilled water to a specified volume, mix well, let it stand for 12 to 24 hours, filter, can, and sterilize to prepare a throat spray.

[0057] Example 7: Clinical trial of Chinese medicine composition in treating adenoids hypertrophy and phlegm and blood stasis syndrome in children

[0058] (1) Case selection: All cases were from children who visited the pediatric outpatient clinic of Jiangsu Provincial Hospital of Traditional Chinese Medicine between February 2021 and February 2024 and were diagnosed with adenoids hypertrophy in children. A total of 105 cases were selected, including 66 males and 39 females with an average age of 5.72±2.27 years.

[0059] (2) Therapeutic drugs and dosage: Decoction is performed according to step (1) of the preparation method of Example 1. For children aged 1 to 5 years, 100 mL per day; for children aged 6 to 10 years, 120 mL per day; for children aged 11 to 14 years, 150 mL per day. Take orally twice a day, morning and evening.

[0060] (3) Evaluation and judgment of therapeutic efficacy

[0061] Main symptom efficacy score:

[0062]

[0063] Secondary efficacy score:

[0064]

[0065]

[0066] The efficacy index was used to evaluate the efficacy. The efficacy index = (total score before treatment - total score after treatment) / total score before treatment × 100%. If the symptoms were significantly alleviated after taking the medicine, the efficacy index > 70%, which was considered remarkable; if the clinical symptoms improved after taking the medicine, 30% ≤ efficacy index < 70%, which was considered effective; if the symptoms did not improve after taking the medicine, the efficacy index < 30%, which was considered ineffective.

[0067] (4) Observation of treatment effect:

[0068] Clinical observation was conducted on the improvement of symptoms before and after treatment of children with adenoids hypertrophy treated with the Chinese medicine composition provided by the present invention. The experimental results showed that after 2 weeks of treatment, 45 cases were effective, 10 cases were markedly effective, 50 cases were ineffective, and the total effective rate was 52.38%; after 4 weeks of treatment, 63 cases were effective, 12 cases were markedly effective, 30 cases were ineffective, and the total effective rate was 71.43%, indicating that the Chinese medicine composition of the present invention can significantly improve the symptoms of children with adenoids hypertrophy; it has a more obvious improvement on snoring symptoms, and after 4 weeks of treatment, the improvement rate reached 80.46%, and the specific results are shown in Tables 1 to 5. In addition, no children had obvious adverse reactions during the treatment, and no adverse reactions of the test drugs were observed.

[0069] Clinical observation results show that the traditional Chinese medicine provided by the present invention is safe and effective in treating adenoids hypertrophy in children.

[0070] Table 1 Statistics on the effectiveness of the Xiaogan Tongqiao prescription

[0071]

[0072] Table 2 Comparison of total scores

[0073] Median (interquartile range) Test statistic Significance Before treatment 12(9，15) 2 weeks of treatment <![CDATA[8(5,11) ### ]]> 112.699 0.000 4 weeks of treatment <![CDATA[6(4,9) ### *]]>

[0074] Paired comparison results, compared with before treatment, ### p<0.001; *p<0.05 compared with 2 weeks after treatment.

[0075] Table 3 Comparison of main symptom scores

[0076]

[0077] Paired comparison results, compared with before treatment, ### p<0.001.

[0078] Table 4 Comparison of symptom scores

[0079] Before treatment 2 weeks of treatment 4 weeks of treatment Test statistic Significance Nasal congestion 2(2，2) <![CDATA[1(0,2) ### ]]> <![CDATA[1(0,1) ### ]]> 70.635 0.000 Itchy nose 2(2，2) <![CDATA[1(0,2) ## ]]> <![CDATA[1(0,1) ### ]]> 33.493 0.000 Runny nose 2(2，2) <![CDATA[1(0,2) ### ]]> <![CDATA[1(0,1) ### ]]> 55.779 0.000 sneeze 2(2，2) <![CDATA[1(1,2) ## ]]> <![CDATA[1(0,1) ### ]]> 41.484 0.000 cough 2(1，2) <![CDATA[0(0,1) ### ]]> <![CDATA[0(0,1) ### ]]> 34.422 0.000 Phlegm in the throat 2(2，2) 1(0，2) <![CDATA[1(0,2) ## ]]> 16.791 0.000 Tongue coating 1(1，1) <![CDATA[1(0,1) ## ]]> <![CDATA[1(0,1) ## ]]> 28.541 0.014 Total score of secondary symptoms 5(3，8) <![CDATA[3(1,5) ### ]]> <![CDATA[2(1,5) ### ]]> 38.577 0.000

[0080] Paired comparison results, compared with before treatment, # p<0.05, ## p<0.01, ### p<0.001.

[0081] Table 5 Improvement of all symptoms before and after treatment

[0082]

[0083]

[0084] Case 1

[0085] Ren ×, male, 8 years old

[0086] First visit on March 31, 2024

[0087] Chief complaint: Mouth breathing and snoring at night for 4 years.

[0088] Current medical history: The child has been breathing with his mouth open at night, snoring, and nasal congestion for nearly 4 years. Recently, the symptoms are obvious, with immediate nasal congestion, clear runny nose, nasal itching, sneezing, itchy eyes, pharyngeal discomfort, no epistaxis, and no cough. Usually, he has a normal appetite and is picky about food. He breathes with his mouth open at night, snores, grinds his teeth, has dry stools, and has difficulty defecating, 1 to 2 days / time. The tongue is dark red, with a greasy white coating.

[0089] Medical and family history: Father has a history of rhinitis. Past history of rhinitis and infantile eczema. Allergens: soybeans, shepherd's purse.

[0090] Auxiliary examination: Adenoid lateral film on March 31, 2024 showed: adenoids hypertrophy, see Figure 1 (A), adenoid thickness / nasopharyngeal width (A / N) = 0.81.

[0091] Prescription: 10g of Fritillaria thunbergii, 10g of Kelp, 10g of Fagopyrum sibiricum, 10g of Polygonum multiflorum, 10g of Litchi seed, 8g of Prunella Vulgaris, 6g of Ligusticum chuanxiong, 6g of Magnolia officinalis, 12g of raw Coix seed, 14 doses, 1 dose per day.

[0092] Diagnosis: Western medicine: adenoids hypertrophy. Traditional Chinese medicine: snoring (phlegm and blood stasis syndrome)

[0093] Second visit on April 18, 2024: After taking the medicine, the child's mouth breathing improved compared with before, nasal congestion and runny nose improved, but he still snored. Recently, he had phlegm in his throat when he woke up in the morning, which he could not cough out, and he occasionally had itchy eyes and skin, but no rash. His appetite was normal, he did not sleep well at night, liked to lie prone, did not grind his teeth, and his stool texture became normal, 1 to 2 days / time. The tongue was dark red and the fur was white.

[0094] Prescription: If the child's skin occasionally itches, add 10g of Dictamni peel to the previous prescription, 10 doses, 1 dose per day.

[0095] Third visit on April 27, 2024: After taking the medicine, the child's mouth breathing improved, and nasal congestion and runny nose did not occur. In recent days, he was infected with external pathogens again, snoring loudly at night, coughing, and phlegm in the throat, which was yellow and large in quantity. He had a bad sleep at night and liked to lie prone. The itchy eyes disappeared, but the skin still itched from time to time. His appetite was normal, and the stool texture was normal, 1 to 2 days / time. The tongue was dark red and the fur was white.

[0096] Prescription: For children with cough and sputum, add 10g of white mulberry bark, 5g of pinellia ternata, and 5g of arisaema, 14 doses, 1 dose per day.

[0097] Fourth visit on May 16, 2024: The child's snoring has been significantly reduced after taking the medicine, but he still snores from time to time. He does not breathe with his mouth open, have a stuffy nose, or runny nose at night. He occasionally coughs and has little sputum. He does not sleep well at night, likes to lie prone, does not grind his teeth, has no epistaxis, and does not cough. He has poor appetite, but normal bowel movements, 1 time a day. Physical examination: Tonsils are not enlarged. The tongue is dark red, with a thin white coating.

[0098] Prescription: The child has no obvious cough. Take 10g of white mulberry bark, 5g of pinellia ternata, and 5g of arisaema consanguineum for 14 doses, 1 dose per day.

[0099] Fifth visit on May 30, 2024: After taking the medicine, the child's snoring improved significantly, there was no mouth breathing, and the cough disappeared. In the past two days, the allergic symptoms occasionally recurred, intermittent nasal congestion, runny nose, obvious in the morning, itchy nose and rubbing nose, itchy eyes, itchy skin, scattered rash, poor sleep at night, no teeth grinding. Appetite improved, bowel movements normal. Dark red tongue, thin white fur

[0100] Prescription: Symptoms have improved significantly. Continue with the previous 7 doses, but change to one dose every 2 days.

[0101] Sixth visit on June 15, 2024: After taking the medicine, the child's symptoms improved, the rash disappeared, and he did not breathe with his mouth open. Due to the alternating hot and cold environments, he occasionally snored and had a stuffy nose, but his appetite, sleep, and bowel movements were normal. The tongue was pale red with a thin white coating.

[0102] Prescription: The child's symptoms are normal, 7 doses, change to one dose every 3 days.

[0103] Seventh visit on July 6, 2024: After taking the medicine, the child did not breathe with his mouth open or snore, had no nasal congestion or runny nose, and had normal appetite, sleep, and bowel movements. The tongue was pale red with a thin white coating. Adenoids lateral film was repeated and showed mild hypertrophy of the adenoids. Figure 1 (B), adenoid thickness / nasopharyngeal width (A / N) = 0.62.

[0104] The child's symptoms improved and his adenoids shrank significantly, so the medication was stopped.

[0105] Case 2

[0106] Xiao ×, female, 7 years old

[0107] First visit on April 13, 2024

[0108] Chief complaint: Long-term breathing with slightly open mouth and snoring during sleep.

[0109] Current medical history: The child has long been sleeping with slightly open mouth breathing and snoring. 5 days ago, an external hospital examination found that the adenoids were enlarged. He is now accompanied by nasal itching, occasional coughing and sputum, runny nose, and nasal congestion. Usually, his complexion is yellowish, his body shape is normal, his diet is normal, he occasionally turns over when sleeping, and his bowel movements are normal, once a day. The tongue is red and the coating is yellow.

[0110] Medical history and family history: No history of asthma, but history of rhinitis and eczema.

[0111] Auxiliary examination: Adenoid lateral radiograph was performed in an external hospital on April 8, 2024: Adenoids were severely enlarged, as shown in Figure 2 (A), clogging is about 90% (A / N is about 0.9).

[0112] Diagnosis: Western medicine: adenoids hypertrophy. Traditional Chinese medicine: snoring (phlegm and blood stasis syndrome)

[0113] Prescription: Fritillaria thunbergii 10g, Kelp 10g, Golden Fagopyrum 10g, Polygonum multiflorum 10g, Lychee seed 10g, Prunella vulgaris 8g, Ligusticum chuanxiong 6g, Magnolia officinalis 6g, Raw Coix seeds 12g. 14 doses, 1 dose per day.

[0114] Second visit on May 18, 2024: After taking the medicine, the child's nighttime mouth opening and snoring improved compared to before, with occasional nasal congestion and a small amount of runny nose, basically no cough, no obvious nasal itching, no sneezing, less sweating than before, good appetite, occasional tossing when sleeping. Occasionally dry stool, once a day. Red tongue with thin yellow tongue coating.

[0115] Prescription: The patient's symptoms improved after taking the medicine, and he continued to take 14 doses of the previous prescription, 1 dose per day.

[0116] Third visit on June 1, 2024: The child's nighttime mouth opening and snoring have improved significantly, with occasional nasal congestion and a small amount of runny nose, no obvious nasal itching, no sneezing, and good appetite. The bowel movement is dry at first and then normal, once a day. The tongue is red, with a thin yellow coating.

[0117] Prescription: The child's symptoms improved significantly. Continue taking 14 doses of the previous medicine to consolidate the therapeutic effect, 1 dose per day.

[0118] Fourth visit on June 15, 2024: Symptoms improved after taking the medicine, all symptoms were normal, no teeth grinding, delirium, no nasal congestion, itchy eyes, cough, good appetite, improved bowel movements, one bowel movement per day. The tongue is dark red, with a thin yellow coating.

[0119] Auxiliary examination: Review the lateral adenoid film: the adenoids are slightly enlarged, such as Figure 2 As shown in (A), adenoid thickness / nasopharyngeal width (A / N) = 0.7. During a telephone follow-up on July 1, 2024, the child's symptoms were normal, so the medication was stopped.

[0120] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition having the effect of treating adenoids hypertrophy in children, characterized in that: It includes the following APIs: Fritillaria thunbergii, kelp, golden buckwheat, polygonum multiflorum, litchi kernel, selfheal, ligusticum chuanxiong, magnolia, raw coix seed.

2. The Chinese medicine composition for treating adenoids hypertrophy in children according to claim 1, characterized in that: It is made of the following raw materials by weight: 6-14 parts of Fritillaria thunbergii, 6-14 parts of Kelp, 6-14 parts of Fagopyrum serrata, 6-14 parts of Polygonum multiflorum, 6-14 parts of Litchi seed, 4-12 parts of Prunella vulgaris, 3-9 parts of Ligusticum chuanxiong, 3-9 parts of Magnolia officinalis, and 9-15 parts of raw Coix seeds.

3. The Chinese medicine composition for treating adenoids hypertrophy in children according to claim 2, characterized in that: It is made of the following raw materials by weight: 8-12 parts of Fritillaria thunbergii, 8-12 parts of kelp, 8-12 parts of golden buckwheat, 8-12 parts of polygonum multiflorum, 8-12 parts of litchi seeds, 6-10 parts of selfheal, 4-8 parts of chuanxiong, 4-8 parts of magnolia, and 10-14 parts of raw coix seeds.

4. The Chinese medicine composition for treating adenoids hypertrophy in children according to claim 2, characterized in that: It is made of the following raw materials in parts by weight: 10 parts of Fritillaria thunbergii, 10 parts of Kelp, 10 parts of Fagopyrum scabra, 10 parts of Polygonum multiflorum, 10 parts of Semen litchi, 8 parts of Spica Prunellae, 6 parts of Rhizoma Chuanxiong, 6 parts of Flos Magnoliae, and 12 parts of Semen Coicis.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The following steps are involved: (1) taking Fritillaria thunbergii, kelp, golden buckwheat, bistort, litchi seed, selfheal, ligusticum chuanxiong, magnolia bud and raw coix seed, adding a certain amount of extraction solvent, then heating for extraction, filtering, combining the filtrate, and concentrating to obtain a concentrated solution; (2) Add an appropriate amount of ethanol to the concentrated solution of step (1), stir evenly, let stand, filter, take the supernatant, recover the ethanol until there is no alcohol taste, concentrate, and use it to prepare various preparations.

6. The method for preparing the Chinese medicine composition according to claim 5, characterized in that: In step (1), first add 8 to 16 times the weight of the raw material of water, soak for 10 to 30 minutes, then heat and boil for extraction for 1 to 2 hours, filter to obtain a filtrate, add 6 to 12 times the weight of water to the residue, heat and boil for extraction for 1 to 1.5 hours, filter, combine the filtrates of the two extractions, and concentrate to a ratio of 2:1 between the raw material and the liquid.

7. The method for preparing the Chinese medicine composition according to claim 5, characterized in that: In step (2), ethanol is added to make the alcohol content in the concentrated solution reach 70% to 80%, and the concentrated solution is allowed to stand for 24 to 48 hours to be concentrated to a relative density of 1.1 to 1.

3.

8. The method for preparing the Chinese medicine composition according to claim 5, characterized in that: The concentrated solution of step (2) is added with pharmaceutically acceptable excipients to prepare an oral liquid, capsule, tablet, granule, mixture, powder, pill oral preparation or external spray.

9. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for preventing and treating adenoid hypertrophy in children.

10. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for preventing and treating adenoid hypertrophy due to phlegm and blood stasis in children.

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