Traditional Chinese medicine composition for treating heat toxin stasis type infantile adenoid hypertrophy and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating heat toxin stasis type infantile adenoid hypertrophy and application thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 6-12 parts of honeysuckle, 6-12 parts of red paeony root, 6-12 parts of burdock, 6-12 parts of spina gleditsiae, 6-12 parts of scutellaria baicalensis, 1-4 parts of coptis chinensis, 6-12 parts of kudzu vine root and 1-6 parts of liquorice. The composition can be prepared into dosage forms such as decoction, ointment, granules, tablets, capsules, oral liquid or pills, the invention further provides application of the composition in preparation of medicines for treating heat toxin stasis type infantile adenoid hypertrophy, and a perfect scheme of addition and subtraction along with symptoms is established aiming at core symptoms such as nasal obstruction, mouth breathing, sleep snoring, red and swollen pharynx and the like. The composition follows the monarch, minister, assistant and guide compatibility theory of traditional Chinese medicine, has the effects of clearing away heat and toxic materials, promoting blood circulation, removing stasis, relieving sore-throat and opening orifices, and has the advantages of multi-target treatment effect, exact curative effect, high safety and high popularization and application value proved by modern pharmacological research.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine composition, and particularly to a traditional Chinese medicine composition for treating pediatric adenoid hypertrophy of the heat-toxin stasis type and its application, belonging to the technical field of traditional Chinese medicine compositions and their applications. Background Art

[0002] Adenoid hypertrophy is a common upper respiratory tract disease in the pediatric field, with a relatively high incidence rate among children aged 3 - 10 years (epidemiological surveys show that it is approximately 30%). The main symptoms of this disease are nasal congestion and runny nose, mouth breathing, snoring during sleep, and pharyngeal swelling and redness. If not cured for a long time, it can lead to a series of complications such as adenoid facies, sleep hypoxia, and inattention in children, seriously affecting the growth and development and quality of life of children. The modern medical treatment of this disease mainly adopts two methods: local nasal spraying of glucocorticoids and surgical resection. However, long-term use of hormonal drugs may bring potential risks of restricted growth and development. As an invasive operation, adenoid resection not only has risks such as anesthesia accidents, bleeding and infection, but there is also a possibility of recurrence in some children after surgery. This makes the search for safe and effective alternative therapies an urgent problem to be solved clinically.

[0003] From the perspective of traditional Chinese medicine theory, the adenoids are located at the junction of the nasopharynx and belong to the category of "hang sang". It is a place where meridians circulate and converge, especially closely related to the meridians of the lung, stomach, liver, and gallbladder. The physiological characteristics of children often show that "the lung is often insufficient", "the spleen is often insufficient", and "yang is often excessive". External pathogenic factors of the six climatic exopathogens (especially wind-heat pathogenic toxin) are easily invaded from the mouth and nose, disturbing upward along the meridians, stagnating in the hang sang, resulting in qi and blood stasis, and phlegm turbidity coagulation, forming hypertrophy of the "throat nucleus" (adenoids). This pathological process mostly conforms to the core pathogenesis of "heat-toxin stasis". Clinically, common manifestations include pharyngeal swelling and redness, red and swollen throat nucleus, red or dark red tongue, thin yellow tongue coating, rapid pulse or purple stagnant fingerprint, etc., which are manifestations of heat-toxin accumulation and qi and blood stasis obstruction. This understanding has something in common with the pathological essence of lymphoid tissue hyperplasia caused by chronic inflammatory stimulation described in modern medicine.

[0004] Currently, traditional Chinese medicine (TCM) formulas for treating adenoid hypertrophy in children often focus on clearing heat and detoxifying, resolving phlegm and dissipating nodules, and promoting blood circulation and removing blood stasis. The "Jin Sang San Jie TCM Composition" (authorization announcement number: CN102363018B) recorded in the State Intellectual Property Office patent database consists of sixteen Chinese herbs including puffball, vinegar-processed turmeric, honeysuckle, roasted peach kernel, and scrophularia, possessing the effects of clearing heat and detoxifying, promoting blood circulation and removing blood stasis, and eliminating dampness and resolving phlegm. It is mainly used to treat vocal cord congestion, swelling, vocal cord nodules, and polyps. Another patent discloses a formula for treating colds and rhinitis (application publication number: CN110742995A), which, although containing heat-clearing and detoxifying herbs such as honeysuckle and forsythia, focuses on relieving exterior symptoms and opening the orifices. Its treatment of the core pathogenesis of adenoid hypertrophy is dispersed, and it contains potentially toxic ingredients such as realgar and cinnabar, making it unsuitable for long-term use in children. These existing technologies indicate that the field of traditional Chinese medicine has a certain understanding of throat lumps, but there is still a lack of targeted treatment for the specific condition of adenoid hypertrophy in children.

[0005] In clinical practice, many prescriptions for treating adenoid hypertrophy have certain limitations. For example, the patent "A Traditional Chinese Medicine Composition for Treating Dry Throat" (application publication number: CN104042748A) describes a composition for treating dry throat consisting of seven herbs, including Angelica sinensis, Coptis chinensis, and Rehmannia glutinosa. Although it has a clinical cure rate of 84%, its efficacy focuses on clearing the lungs, moistening dryness, nourishing yin, and clearing heat, and it is insufficient in resolving the phlegm stagnation and blood stasis pathogenesis commonly seen in adenoid hypertrophy. An article published in the *International Journal of Traditional Chinese Medicine*, titled "Xu Lingyun's Treatment of Adult Snoring with a Phlegm-Resolving and Blood-Activating Formula," states that Professor Xu Lingyun's research on treating adult snoring with a phlegm-resolving and blood-activating formula (calcined gold and maltite, Pinellia ternata, Trichosanthes kirilowii, Scutellaria baicalensis, etc.) shows that phlegm and blood stasis are important pathogenesis of snoring. However, the calcined gold and maltite in the formula is heavy and potent, and not suitable for long-term use in children with delicate constitutions. While these existing technologies offer insights into the treatment of adenoid hypertrophy from different perspectives, they still fall short in addressing the specific physical characteristics of children and the core pathogenesis of adenoid hypertrophy.

[0006] Further analysis of existing technologies reveals that, for example, the patent "A Traditional Chinese Medicine Preparation for Treating Snoring" (authorization announcement number: CN104398746B) discloses a traditional Chinese medicine preparation for treating snoring, composed of fourteen medicinal and edible ingredients such as angelica, platycodon, chrysanthemum, and mint. It primarily eliminates snoring by dispelling wind and dampness, reducing swelling, strengthening the spleen and stomach, supporting vital energy, and opening nasal passages, achieving a clinical efficacy rate of 91.5%. However, this formula focuses on regulating spleen and stomach function and supporting vital energy, and its ability to clear heat and resolve stagnation is relatively insufficient for addressing the core pathogenesis of adenoid hypertrophy—heat toxicity and blood stasis. Another patent, "A throat-soothing traditional Chinese medicine composition and its preparation method" (application publication number: CN108273031A), describes a throat-soothing traditional Chinese medicine composition composed of seven herbs, including Magnolia officinalis, Perilla frutescens, Poria cocos, and ginger. Its formulation focuses on promoting qi circulation, resolving dampness, relieving sore throat, and reducing swelling. However, for adenoid hypertrophy of the heat-toxin stagnation type, its effects of clearing heat and detoxifying, promoting blood circulation, and resolving stagnation are significantly insufficient.

[0007] In summary, existing TCM treatments for pediatric adenoid hypertrophy suffer from the following main problems: First, most prescriptions are not specifically designed for children's constitutions, and the safety of drug compatibility and dosage is not adequately considered; second, existing prescriptions often focus on a specific pathogenesis (such as simply clearing heat, resolving phlegm, or dispersing nodules), failing to comprehensively address multiple aspects of the core pathogenesis of heat-toxin stagnation; and third, some prescriptions contain drugs unsuitable for long-term use in children (such as mineral drugs like cinnabar and realgar, or potent medications), posing potential safety risks. Therefore, there is an urgent clinical need for a TCM prescription that better suits children's constitutions, targets the core pathogenesis of heat-toxin stagnation, has a scientifically sound and safe formulation, and fills the current technological gap in the treatment of pediatric adenoid hypertrophy. Summary of the Invention

[0008] The purpose of this invention is to provide a traditional Chinese medicine composition for treating pediatric adenoid hypertrophy of the heat-toxin stagnation type. This composition targets the core pathogenesis of "heat-toxin stagnation" in children and has the effects of clearing heat and detoxifying, promoting blood circulation and dispersing stagnation, and relieving sore throat and clearing nasal passages. Moreover, the formula is appropriate, the curative effect is definite, and the safety is high.

[0009] To achieve the above objectives, the present invention adopts the following technical solution:

[0010] A traditional Chinese medicine composition for treating adenoid hypertrophy in children with heat-toxin stagnation and blood stasis is made from the following raw materials in parts by weight: honeysuckle 6-12 parts by weight, red peony root 6-12 parts by weight, burdock fruit 6-12 parts by weight, soapberry thorn 6-12 parts by weight, scutellaria root 6-12 parts by weight, coptis root 1-4 parts by weight, kudzu root 6-12 parts by weight, and licorice root 1-6 parts by weight.

[0011] As a preferred embodiment of the present invention, the traditional Chinese medicine composition is made from raw materials comprising the following parts by weight: 9 parts by weight of honeysuckle, 9 parts by weight of red peony root, 9 parts by weight of burdock seed, 9 parts by weight of soapberry thorn, 9 parts by weight of scutellaria root, 2 parts by weight of coptis root, 9 parts by weight of kudzu root, and 3 parts by weight of licorice root.

[0012] Furthermore, the traditional Chinese medicine composition can be formulated into a dosage form acceptable to traditional Chinese medicine, including but not limited to decoctions, pastes, granules, tablets, capsules, oral liquids and / or pills.

[0013] On the other hand, the present invention provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for treating adenoid hypertrophy in children, wherein the traditional Chinese medicine syndrome of adenoid hypertrophy in children is heat-toxin stagnation type, and its typical symptoms include nasal congestion, mouth breathing, snoring during sleep, redness and swelling of the pharynx, or accompanied by tonsil enlargement, redness and swelling of the laryngeal tract, red or dark red tongue, thin yellow coating, rapid pulse or purplish finger veins.

[0014] To adapt to common concurrent symptoms in pediatric patients and achieve more precise individualized treatment, this invention also provides a scheme for adjusting the above-mentioned basic formula according to the specific symptoms, including:

[0015] When the patient also has symptoms of wind-evil binding the exterior, with obvious nasal congestion and runny nose, 1-6 parts by weight of peppermint and 1-6 parts by weight of magnolia flower can be added to the above raw materials. Preferably, the amount of peppermint added is 3 parts by weight and the amount of magnolia flower added is 3 parts by weight.

[0016] When the patient also presents with yin deficiency and significant dry mouth and throat, Coptis chinensis can be removed from the raw materials, but at the same time, Ophiopogon japonicus can be added in 1-6 parts by weight. Preferably, the amount of Ophiopogon japonicus added is 3 parts by weight.

[0017] When the patient also has excessive phlegm, obvious coughing, and heavy snoring, 1-6 parts by weight of Fritillaria thunbergii can be added to the raw materials. Preferably, the amount of Fritillaria thunbergii added is 3 parts by weight.

[0018] When the patient also has spleen and stomach weakness, poor appetite and loose stools, Coptis chinensis can be removed from the raw materials, but at the same time, 1-6 parts by weight of dried tangerine peel and 1-6 parts by weight of Poria cocos can be added. Preferably, the amount of dried tangerine peel added is 3 parts by weight and the amount of Poria cocos added is 3 parts by weight.

[0019] When the patient also presents with significant blood stasis and obstruction of collaterals, prolonged course of disease, and hard and tough glands, 1-6 parts by weight of Danshen and 1-6 parts by weight of Chuanxiong can be added to the above-mentioned raw materials. Preferably, the amount of Danshen added is 3 parts by weight and the amount of Chuanxiong added is 3 parts by weight. Compared with the prior art, the outstanding beneficial effects and significant progress of the present invention are as follows:

[0020] Firstly, based on the understanding that pediatric adenoid hypertrophy is caused by "heat toxin stagnation," this invention creatively integrates three methods—clearing heat and detoxifying, promoting blood circulation and resolving stagnation, and relieving sore throat and clearing nasal passages—to form a unique treatment system. The core formula is rigorously and scientifically formulated with the principal, assistant, and adjuvant herbs in the order of their properties. Specifically, honeysuckle and scutellaria are used synergistically as the principal herbs. Honeysuckle, being sweet, cold, and light, clears heat and detoxifies, making it a key herb for treating heat toxins in the upper burner. Scutellaria, being bitter and cold, clears heat and dries dampness, effectively clearing heat from the lungs and stomach. The synergistic effect of these two herbs enhances the ability to clear heat toxins from the upper burner, directly addressing the disease's progression. Burdock seed and soapberry thorn are selected as assistant herbs to enhance their effects. Burdock seed is bitter, pungent, and cold, dispersing wind-heat, detoxifying, and relieving sore throat; its slippery nature allows it to clear the nasal passages. Soapberry thorn is pungent, warm, and potent, specifically effective in reducing swelling and ulceration. The two herbs work together to help the principal herb expel pathogens and dissipate nodules; the adjuvant herb Coptis chinensis, being extremely bitter and cold, helps the principal herb purge fire and detoxify; Paeonia lactiflora, slightly cold, clears heat, cools the blood, disperses blood stasis, and relieves pain; Pueraria lobata, being light and dispersing, relieves muscle tension and reduces fever, and also guides the other herbs upwards, clearing the nasal passages; the three herbs work together, each fulfilling its function in strengthening heat clearing, promoting blood circulation and dissipating blood stasis, and guiding the herbs to the meridians, exerting a synergistic effect from different dimensions; the guiding herb Glycyrrhiza uralensis clears heat and detoxifies, harmonizes the other herbs, and alleviates urgency and harmonizes the middle jiao, enhancing the heat-clearing effect while preventing the bitter and cold herbs from damaging the spleen and stomach of children; this rigorous combination structure achieves the combined use of clearing and dissipating nodules, and the combined application of expelling pathogens and promoting blood circulation. Compared with the single treatment methods in existing techniques that either focus on clearing heat or resolving phlegm, this approach provides a more comprehensive and precise understanding of the pathogenesis, achieving innovation at the theoretical level of traditional Chinese medicine;

[0021] Secondly, modern pharmacological studies have confirmed that the formulation of this invention has multi-target and multi-pathway therapeutic advantages, manifested in the following aspects: In terms of anti-inflammatory and antiviral effects, components such as chlorogenic acid in honeysuckle, baicalin in scutellaria, and arctiin in burdock seed can effectively inhibit the production of inflammatory factors such as TNF-α and IL-6, and reduce the inflammatory response of adenoid tissue; in terms of immune regulation, components such as soapberry thorn and red peony root can regulate the function of T lymphocyte subsets and inhibit abnormal proliferation of lymphoid tissue, thus controlling adenoid hypertrophy from the immune perspective; and in terms of improving microcirculation, paeoniflorin in red peony root... It can improve microcirculation and inhibit platelet aggregation, while Gleditsia sinensis thorns can promote the absorption of pathological products, together relieving local blood stasis; in terms of anti-oxidation and mucosal protection, puerarin in kudzu root has antioxidant activity, and glycyrrhizic acid in licorice has mucosal protective function, which can reduce tissue edema and protect the respiratory mucosa; in summary, this invention constructs a scientific treatment network through the synergistic effect of multiple components and multiple targets, which not only has a definite curative effect, but also fully considers the physical characteristics of children, has high safety, fills the gap of existing technology in this field, and reflects the advanced nature of modern science;

[0022] Furthermore, the formulation and preparation of this invention are particularly suitable for the physiological characteristics of children aged 6-18 years during their growth and development: In the formulation design, the physical characteristics of children, such as "delicate internal organs and immature physical constitution", are fully considered, and the dosage of bitter and cold drugs such as Coptis chinensis is strictly controlled (1-4 parts by weight) to avoid excessive coldness that could damage the spleen and stomach; at the same time, licorice is added to harmonize the medicinal properties and protect the delicate digestive system of children; and scientific addition and subtraction schemes are designed according to the syndrome characteristics of children of different age groups: for example, Coptis chinensis is removed for those with spleen and stomach weakness, and Citrus reticulata and Poria cocos are added to strengthen the spleen and stomach; Ophiopogon japonicus is added for those with yin deficiency to nourish yin and moisten dryness. These adjustments all reflect the principle of individualized treatment.

[0023] In terms of formulation, granules offer significant clinical advantages: They are preparable granules manufactured by standardized companies, ensuring accurate drug content and stable quality, and avoiding efficacy differences caused by improper decoction methods in traditional preparations. For school-aged and adolescent children, granules are convenient to prepare and take, greatly improving medication adherence, making them particularly suitable for patients with chronic diseases requiring long-term treatment. Furthermore, granules allow for precise dosage control, enabling individualized dosing based on the child's age and weight within the prescribed range.

[0024] In conclusion, it can be seen that:

[0025] This invention is not a simple superposition or replacement of existing technologies, but rather a creative and scientific combination of drugs with synergistic effects, targeting the key pathogenesis of adenoid hypertrophy in children. Its significant progress is reflected in the following aspects: From the perspective of traditional Chinese medicine theory, it establishes a precise treatment plan that highly unifies pathogenesis, treatment principles, and prescriptions; from the perspective of modern science, its formulation contains multiple pharmacological effects such as anti-inflammatory, antiviral, immune regulation, and circulation improvement, forming a scientific treatment network, thereby more effectively treating adenoid hypertrophy in children from the root cause, while also taking into account the safety of medication for children, filling the gap in existing technologies in this field. Detailed Implementation

[0026] To make the technical solution, beneficial effects and significant progress of the present invention clearer, more comprehensive and specific, the technical solution provided by the present invention will be clearly and completely described below through specific embodiments and their effects. Obviously, the embodiments and their effects described below are only some embodiments and effects of the present invention, and not all of them.

[0027] Based on the embodiments and effects provided by this invention, all other embodiments and effects obtained by those skilled in the art without creative effort are within the scope of protection of this invention.

[0028] It should be noted that:

[0029] The terms "firstly," "secondly," etc., used in the claims, description, and embodiments and effect examples of this invention are merely for distinguishing different objects and not for describing a specific order. Furthermore, the term "comprising" and any variations thereof are intended to cover non-exclusive inclusion, for example, including not only a series of listed steps or units of processes, methods, systems, products, or devices, but also optionally steps or units not listed, or optionally other operational steps or units inherent to these processes, methods, products, or devices.

[0030] It should be understood that some basic operational terms commonly used in the art are used in the description of the embodiments of the present invention, such as "decoction" and "extraction". These terms should be interpreted broadly, that is, they can refer to routine operations performed using various conventional equipment and instruments in the art, or operations performed using the latest equipment, such as program-controlled operations and unmanned automatic operations. Unless otherwise explicitly limited, those skilled in the art should understand the specific meaning of the above terms in the present invention according to the specific circumstances and adopt specific operating methods to achieve their operational objectives.

[0031] It should also be noted that the following specific embodiments can be combined with each other, and the same or similar concepts or processes may not be repeated in subsequent implementations; in addition, all kinds of instruments, equipment, Chinese medicinal materials, reagents and standards involved in the following specific embodiments are commercially available unless otherwise specified.

[0032] The technical solution of the present invention will now be described in detail with reference to specific embodiments. Example 1

[0033] This embodiment provides a basic traditional Chinese medicine decoction for treating adenoid hypertrophy in children with heat-toxin stagnation (hereinafter referred to as Qingxian Liyan Formula).

[0034] First, take the following raw materials by weight: 9 parts honeysuckle, 9 parts red peony root, 9 parts burdock fruit, 9 parts soapberry thorn, 9 parts scutellaria root, 2 parts coptis root, 9 parts kudzu root, and 3 parts licorice root. Then, decoct the above raw materials twice with water. For the first decoction, add 10 times the amount of water and boil for 1 hour. For the second decoction, add 8 times the amount of water and boil for 0.5 hours. Combine the decoctions, filter, and concentrate to a relative density of 1.10-1.20 (60℃) to obtain the decoction.

[0035] This embodiment is the basic formula of the present invention, which is applicable to adenoid hypertrophy in children with heat-toxin stagnation type, typical symptoms of which include nasal congestion, mouth breathing, snoring during sleep, and redness and swelling of the pharynx.

[0036] This embodiment strictly follows the treatment principle of "clearing heat and detoxifying, promoting blood circulation and resolving stagnation, and benefiting the throat and opening the orifices". Honeysuckle and Scutellaria baicalensis are used together to enhance the effect of clearing heat and detoxifying the upper burner. Arctium lappa and Gleditsia sinensis thorn work together to dispel evil and resolve stagnation. Coptis chinensis, Paeonia lactiflora, and Pueraria lobata are added to strengthen the effects of clearing heat, dispersing blood stasis and guiding the medicine to the meridian. Licorice harmonizes the various medicines, forming a new type of Chinese medicine composition called "Qingqian Liyan Fang" that is specifically for treating adenoid hypertrophy in children with heat and blood stasis.

[0037] Modern pharmacology has confirmed that this formula has multi-target advantages, namely, honeysuckle, scutellaria, burdock seed and other ingredients can inhibit inflammatory factors (such as TNF-α, IL-6) and reduce inflammation of adenoid tissue; gleditsia sinensis thorn and red peony can regulate immune function and inhibit lymphoid tissue hyperplasia; while red peony can improve microcirculation and relieve blood stasis.

[0038] At the same time, the formulation strictly controls the dosage of bitter and cold herbs such as Coptis chinensis (1-4 parts by weight), thereby avoiding damage to the spleen and stomach of children and ensuring high safety.

[0039] In addition, decoctions, as a traditional dosage form of Chinese medicine, can give full play to their characteristics of rapid absorption and rapid efficacy, thereby quickly relieving acute symptoms in children (such as nasal congestion, sore throat, etc.), and can provide a flexible base for subsequent prescription adjustments based on symptoms, making it convenient for clinicians to adjust prescriptions and dosage ratios in a timely manner according to changes in the child's condition.

[0040] It can be seen that the traditional Chinese medicine composition provided in this embodiment, compared with the existing technology which tends to focus on a single treatment method, has a more comprehensive grasp of the pathogenesis, which not only reflects the innovation of traditional Chinese medicine theory, but also can effectively achieve better therapeutic effects. Example 2

[0041] This embodiment provides a basic traditional Chinese medicine composition granule for treating pediatric adenoid hypertrophy of the heat-toxin stagnation type.

[0042] First, take the following raw materials by weight: 6 parts honeysuckle, 12 parts red peony root, 6 parts burdock seed, 12 parts soapberry thorn, 6 parts scutellaria, 1 part coptis, 6 parts kudzu root, and 1 part licorice. Then, extract, concentrate, and dry the above raw materials with water, add an appropriate amount of excipients (such as dextrin), granulate, and package in a quantitative manner to form granules, each bag equivalent to 10g of raw herbs.

[0043] This embodiment demonstrates another dosage form of the traditional Chinese medicine composition provided by the present invention within the range of its raw material dosage, which is suitable for children with different degrees of disease severity.

[0044] It can be seen that:

[0045] This embodiment presents the drug in granule form, which has the advantage of strong clinical applicability. Furthermore, granules can be prepared in a standardized manner by manufacturers, which can better ensure the accuracy of drug content and the stability of quality, avoiding the differences in traditional decoction preparation.

[0046] In addition, for school-aged children, granules are easy to prepare, have a relatively easy-to-accept taste, and are convenient to take, which can improve medication compliance. At the same time, the dosage of granules can be precisely adjusted according to the child's age and weight within the dosage range (such as 6-12 parts by weight of honeysuckle, 1-4 parts by weight of coptis, etc.), thereby achieving individualized treatment and making it an ideal carrier for individualized drug administration.

[0047] Modern pharmacology supports that this formula constructs a therapeutic network through the synergistic effect of multiple components (such as puerarin for antioxidant effects and glycyrrhizic acid for mucosal protection), fundamentally controlling adenoid hypertrophy while also ensuring safety in children. Example 3

[0048] This embodiment provides a modified traditional Chinese medicine decoction for treating pediatric adenoid hypertrophy of the heat-toxin stagnation type combined with wind-evil binding the exterior.

[0049] First, based on the basic formula raw materials provided in Example 1, add 3 parts by weight of peppermint and 3 parts by weight of magnolia flower. Then, prepare the modified formula decoction according to the same preparation method as in Example 1. It is used for children with heat-toxin stagnation syndrome combined with wind-evil binding the exterior syndrome, and obvious symptoms of nasal congestion and runny nose.

[0050] This embodiment adds peppermint and magnolia flower to the basic formula provided in embodiment 1. Peppermint is pungent and cool, which can penetrate the exterior, while magnolia flower is pungent and warm, which can open the nasal passages. Together, they can further enhance the effects of dispelling wind and evil and opening the nasal passages. This reflects the flexibility of this invention in adding or subtracting ingredients according to the symptoms, and can achieve precise treatment for common concurrent symptoms in children.

[0051] This embodiment adopts the decoction form, aiming to take advantage of the rapid absorption and fast onset of the decoction so that the volatile active ingredients in peppermint (such as menthol) and the volatile oil in magnolia flower can be fully retained and quickly absorbed, thereby rapidly relieving acute symptoms of wind-evil binding the exterior such as nasal congestion and runny nose, thus achieving the emergency treatment effect of "decoction is to purge".

[0052] Modern pharmacology shows that menthol in peppermint has anti-inflammatory and analgesic effects, while volatile oil in magnolia flower can inhibit histamine release and reduce nasal mucosal edema. This adjustment not only strengthens the anti-inflammatory and antiviral effects of the original formula, but also improves nasal symptoms by guiding the medicine upward, demonstrating the advanced nature of multi-target treatment. Example 4

[0053] This embodiment provides a modified traditional Chinese medicine composition ointment for treating pediatric adenoid hypertrophy of the heat-toxin stagnation type with yin fluid deficiency.

[0054] First, based on the basic formula of raw materials provided in Example 1, remove Coptis chinensis and add 3 parts by weight of Ophiopogon japonicus. Then, decoct the raw materials with water, concentrate them into a clear paste, and add honey to make a paste.

[0055] This embodiment is applicable to the heat-toxin stagnation type with yin fluid deficiency, where the child has significant dry mouth and throat.

[0056] It can be seen that by removing the bitter and cold Coptis chinensis from this modified formula, the damage to Yin is avoided; while the addition of Ophiopogon japonicus to nourish Yin and moisten dryness can meet the physiological characteristics of children's "frequent Yin deficiency". By adjusting the formula, the Yin fluid of children is protected and the treatment is more targeted, which reflects the principle of individualized treatment of this invention.

[0057] This embodiment uses a paste dosage form, which has the following advantages: First, the paste has a thick texture and a stronger moisturizing effect, especially good at nourishing yin fluids, and can significantly relieve the symptoms of dry mouth and throat; Second, after adding flavoring agents such as honey, the taste is sweet and moist, making it easier for children to accept and suitable for children with chronic diseases who need long-term conditioning; Finally, the paste concentrates the essence of the medicine, and the amount taken each time is small, making it convenient to carry and store.

[0058] Modern pharmacological studies have shown that the polysaccharide components in Ophiopogon japonicus have immunomodulatory and antioxidant effects, which can relieve dry throat and protect respiratory mucosa. This modified formula maintains the original formula's effects of clearing heat and detoxifying, and dispersing nodules, while also taking into account nourishing yin and moisturizing dryness, thus improving the overall efficacy and safety. Example 5

[0059] This embodiment provides a modified traditional Chinese medicine oral liquid for treating pediatric adenoid hypertrophy with heat-toxin stagnation and phlegm accumulation.

[0060] First, based on the basic formula of raw materials provided in Example 1, add 3 parts by weight of Fritillaria thunbergii. Then, after water extraction, alcohol precipitation and filtration, the raw materials can be prepared into an oral liquid and bottled.

[0061] This embodiment is applicable to the heat-toxin stagnation type with phlegm accumulation, where the child has obvious coughing and snoring.

[0062] It can be seen that by adding Fritillaria thunbergii to clear heat, resolve phlegm, disperse nodules, and reduce swelling, this modified formula enhances the original formula's ability to resolve phlegm and turbidity.

[0063] The alkaloids in Fritillaria thunbergii have antitussive and expectorant effects, which can effectively reduce respiratory secretions and improve snoring. The application of Fritillaria thunbergii demonstrates the scalability of this invention in cases of complex pathogenesis, that is, this invention can achieve more comprehensive treatment through the synergistic effect of multiple drugs (such as Gleditsia sinensis thorns for swelling reduction and Fritillaria thunbergii for expectoration). Modern pharmacology has also confirmed that this approach can strengthen the expectoration process on the basis of anti-inflammatory and immune regulation, which meets the clinical needs of pediatric adenoid hypertrophy with phlegm turbidity syndrome.

[0064] Oral liquid formulations offer several distinct advantages: first, they allow for rapid absorption of the medication, enabling it to directly reach the affected area and quickly relieve phlegm and cough; second, they provide accurate dosage, facilitating divided doses, making them particularly suitable for young children whose swallowing function is not yet fully developed; and third, the addition of appropriate sweeteners can improve the taste, addressing the problem of bitter taste and children's refusal to take traditional Chinese medicine, thereby improving treatment adherence. Example 6

[0065] This embodiment provides a modified traditional Chinese medicine composition tablet for treating adenoid hypertrophy in children with heat-toxin stagnation and spleen-stomach weakness.

[0066] First, based on the basic formula of raw materials provided in Example 1, Coptis chinensis is removed, and 3 parts by weight of Citrus reticulata peel and 3 parts by weight of Poria cocos are added. Then, the raw materials are pulverized, granulated, and compressed to obtain tablets.

[0067] This embodiment is applicable to the heat-toxin stagnation type combined with spleen and stomach weakness, with poor appetite and loose stools in children.

[0068] It can be seen that this modified formula removes Coptis chinensis to prevent its bitter and cold properties from damaging the spleen, while adding Citrus reticulata peel and Poria cocos to strengthen the spleen and stomach, reflecting the importance this invention places on protecting the spleen and stomach of children.

[0069] Tangerine peel regulates qi and dries dampness, while poria strengthens the spleen and eliminates dampness. Together, they can enhance digestive function and avoid the side effects of drugs. Modern pharmacology shows that the volatile oil in tangerine peel and the polysaccharides in poria can regulate gastrointestinal motility and immunity, thereby improving the tolerance of children. This adjustment ensures long-term safety of treatment and is especially suitable for children with weak spleen and stomach, demonstrating the humanistic design of the formula.

[0070] The advantages of choosing tablet dosage form are: First, tablet manufacturing technology is mature, quality is stable, and it is easy to mass-produce and control quality; second, tablets are small in size, making them easy to take, carry, and store, which is especially convenient for school-aged children who need to attend school and maintain a regular lifestyle; third, coating technology can further mask the taste or protect the gastric mucosa, meeting the medication needs of children with weak spleen and stomach. Example 7

[0071] This embodiment provides a modified traditional Chinese medicine composition capsule for treating pediatric adenoid hypertrophy of the heat-toxin stagnation type with blood stasis obstructing the collaterals.

[0072] First, based on the basic formula of raw materials provided in Example 1, add 3 parts by weight of Danshen and 3 parts by weight of Chuanxiong. Then, after extracting the raw materials, fill them into capsule shells to make capsules.

[0073] This embodiment is applicable to the heat-toxin stagnation type combined with blood stasis obstructing the collaterals syndrome, where the child's disease course is prolonged and the glands are hard and tough.

[0074] It can be seen that this modified formula, by adding Danshen and Chuanxiong to enhance the effects of promoting blood circulation, removing blood stasis, clearing the channels, and dispersing nodules, can effectively treat children with blood stasis syndrome with a long course of disease.

[0075] The active ingredients in Danshen and Chuanxiong (such as tanshinone and ligustrazine) can improve microcirculation, inhibit fibrous tissue hyperplasia, and promote glandular softening and absorption. This modified formula reflects the dynamic adjustment capability of the present invention in the evolution of pathogenesis, and solves the problem of local qi and blood stagnation by strengthening the blood-activating dimension.

[0076] Modern pharmacology supports that this regimen, in addition to anti-inflammatory and immunomodulatory effects, adds a target for improving circulation, thus enhancing the treatment efficacy for refractory adenoid hypertrophy.

[0077] This embodiment uses a capsule dosage form, which has unique advantages: First, the capsule shell can effectively mask the unpleasant odor and bitter taste of the drug, greatly improving the child's medication experience; second, the capsule can protect drug components that are irritating to the stomach or easily destroyed by stomach acid, ensuring that active ingredients (such as tanshinone and ligustrazine) are smoothly absorbed in the intestine and improving bioavailability; third, the contents of the capsule can be powder or granules, which facilitates precise dosage control and is suitable for long-term, stable administration required for a prolonged course of disease; as an additional target for improving circulation on the basis of anti-inflammatory and immune-modulating effects, the capsule dosage form is a better form of administration.

[0078] It should be noted that:

[0079] The above embodiments only illustrate the implementation of some raw material dosage ranges (such as 6-12 parts by weight of honeysuckle, 1-4 parts by weight of coptis, 6-12 parts by weight of kudzu root, etc.) in the technical solution provided by the present invention. In fact, in practical applications, those skilled in the art can adjust the dosage range described in the present invention according to the specific condition of the child (such as the severity of symptoms, age, physical condition, etc.). For example, for those with severe heat toxicity, the dosage of honeysuckle or scutellaria can be appropriately increased to the upper limit; for those with sensitive spleen and stomach, the dosage of coptis can be reduced to the lower limit. This flexibility not only enables the present invention to treat children in a more targeted and personalized manner, but also proves in practice that such a treatment plan can achieve the same or similar excellent therapeutic effects as shown in the above embodiments.

[0080] As can be seen from the above embodiments, the traditional Chinese medicine composition for treating pediatric adenoid hypertrophy of the heat-toxin stagnation type provided by the present invention takes the principles of clearing heat and detoxifying, promoting blood circulation and dispersing stagnation, and relieving sore throat and opening the orifices as its treatment principles. Through the synergistic effect of multiple targets, it exerts anti-inflammatory, antiviral, immune-regulating and microcirculation-improving effects. Its formulation is appropriate and its efficacy is significant. The basic formula and the formula modified according to the symptoms can cover common pediatric syndromes. Moreover, the dosage forms are diverse, the administration is convenient, and the safety of children is taken into account. It achieves the unity of accurate understanding of the pathogenesis and individualized treatment. Compared with the existing technology, the efficacy is definite and the progress is significant.

[0081] To further help understand the technical solutions provided in the above embodiments and the achievable technical effects, the technical effects of the products provided in the above embodiments will be further described below through specific effect examples.

[0082] It should be noted that those skilled in the art should understand that the specific effect examples described below are only for illustrative purposes and do not constitute a limitation on the protection scope of the present invention. Effect Example 1

[0083] In this effect example, the technical solution provided by the present invention (Qingxian Liyan Formula) was evaluated through animal experiments.

[0084] 1.1) Experimental materials

[0085] 1.1.1) Experimental subjects and feeding

[0086] Forty male SPF (Specific Pathogen Free) - level SD (Sprague - Dawley) rats, 4 - 5 weeks old and weighing 120 - 140 g, were selected (provided by Zhejiang Vital River Laboratory Animal Technology Co., Ltd., [Experimental Animal Production License Number: SCXK(Zhe)2019 - 0001]). They were adaptively fed in a barrier environment for 1 week. The room had a 12 - hour light - dark cycle, the room temperature was maintained at 20 - 26°C, the relative humidity was 40% - 70%, and they had free access to food and water.

[0087] 1.1.2) Main experimental instruments

[0088] Multifunctional microplate reader (Bio Tek Company, USA, Synergy2 model), pathological slicer (Leica Instruments Co., Ltd., Shanghai, RM2016 model), and automatic blood cell analyzer (Celltac α, MEK - 6450 model, Japan).

[0089] 1.1.3) Main experimental reagents

[0090] Ovalbumin (OVA, Sigma, A5503-5G), aluminum hydroxide powder (Nanjing Chemical Reagent Co., Ltd., C015152032), budesonide suspension for inhalation (Chia Tai Tianqing Pharmaceutical Group Co., Ltd., National Drug Approval Number H20203063), teletamine hydrochloride and zolazepam hydrochloride for injection (Shutai 50, Victoza, France, 2020 Veterinary Drug Certificate No. 06), interleukin-4 (IL-4) ELISA kit (R&D Systems, R4000), immunoglobulin E (IgE) ELISA kit (Abcam, ab157736).

[0091] 1.2) Experimental Methods

[0092] 1.2.1) Grouping of experimental subjects

[0093] A rat adenoid hypertrophy model was established using the method reported in the literature (Zhang Yixing, Jiang Zhiyan, Liu Anqi, et al.: Discussion on the establishment of an experimental animal model of rat adenoid hypertrophy [J]. Chinese Journal of Comparative Medicine, 2023, 33(07): 9-16.).

[0094] Using a suspension of 1 mg OVA + 10 mg aluminum hydroxide powder + 1 mL normal saline (NS) as the basic sensitization solution, intraperitoneal injection was performed on days 1, 8, and 15. From days 16 to 22, 25 μL of OVA solution with a concentration of 10 mg / mL was dripped into each nostril once a day as a challenge.

[0095] The blank control group rats were given intraperitoneal injection and nasal instillation with the same dose of physiological saline at the same time.

[0096] Behavioral observation and scoring of rats were conducted within one hour after the final challenge and sensitization.

[0097] Each indicator uses a superimposed quantitative scoring method, where:

[0098] Itchy nose (scratching the mouth and nose 1-5 times is 1 point, 6-10 times is 2 points, and more than 11 times is 3 points);

[0099] Sneezing or coughing (1-3 sneezes = 1 point, 4-10 sneezes = 2 points, 11 or more sneezes = 3 points);

[0100] Clear nasal discharge or oral secretions (1 point for discharge flowing into the nostrils or only around the mouth, 2 points for discharge flowing beyond the nostrils or around the mouth, and 3 points for discharge running all over the face).

[0101] A total score of over 5 points indicates a successful model creation.

[0102] All 30 rats exhibited varying degrees of scratching of the mouth and nose, sneezing or coughing, clear nasal discharge or oral secretions, and all scored over 5 points, indicating that the model was successfully established.

[0103] Thirty rats that successfully developed the model were randomly divided into a model group, a positive control group (nebulized budesonide suspension), and a Qingxian Liyanfang intervention group (0.5g / kg), with 10 rats in each group; another 10 age-matched normal rats were used as a blank control group.

[0104] The intervention group received the drug twice daily via gavage, with a gavage volume of 1.0 mL per animal; the model group and the blank control group received an equal volume of physiological saline twice daily via gavage; the positive control group received budesonide suspension via nebulizer for 15 minutes daily at 3 PM. All animals had free access to water during the experiment, and the general condition of the rats was observed and recorded daily.

[0105] 1.2.2) General Observation

[0106] After administration, observe the general condition of the rats, including nasal itching, sneezing or coughing, clear nasal discharge or oral secretions.

[0107] 1.2.3) Sample Collection

[0108] Rats were anesthetized by intraperitoneal injection of 0.1 mL / 100g body weight after preparing Shutai 50 according to the instructions.

[0109] After euthanizing the rat by blood collection from the abdominal aorta, the nasal cavity was dissected along the midline suture of the nasal dorsum, and the nasal and pharyngeal mucosa was separated. The entire palate was dissected, and the nasopharyngeal lymphoid tissue was located and separated. The tissue was gently rinsed in pre-cooled phosphate-buffered saline (PBS) to remove blood. One part of the tissue was quickly fixed in 4% paraformaldehyde, and the other part was stored at -80°C for later use.

[0110] After fixation, the nasal and pharyngeal mucosa and lymphoid tissues were routinely embedded in paraffin, sectioned, stained with hematoxylin-eosin (HE), and the pathological morphological changes were observed under a 200x microscope.

[0111] 1.2.4) Detection of eosinophil (EOS) levels

[0112] After anesthetizing the rats, collect about 5 mL of blood from the abdominal aorta. Centrifuge at 3000 r / min at 4℃ to obtain serum, and store at -80℃. Take another 1 mL of whole blood and place it in an anticoagulant tube. Immediately perform a complete blood cell count using a fully automated hematology analyzer.

[0113] 1.2.5) Detection of IL-4 and IgE levels

[0114] Nasopharyngeal mucosal tissue was collected, rewarmed, homogenized, and centrifuged to obtain the supernatant. The levels of IL-4 and IgE in serum and tissue supernatant were detected using an enzyme-linked immunosorbent assay (ELISA). All procedures were strictly performed according to the kit instructions.

[0115] 1.3) Statistical methods

[0116] SPSS 26.0 statistical software was used for analysis. One-way ANOVA was used for comparisons between groups. < 0.05 indicates a statistically significant difference.

[0117] 1.4) Experimental Conclusions

[0118] 1.4.1) Effects of Qingxian Liyan Formula on the General Condition of Rats

[0119] The rats in the blank control group were in good mental condition and showed no signs of scratching their mouth and nose, coughing, sneezing, or clear nasal discharge or oral secretions.

[0120] The rats in the model group were in poor mental condition, frequently scratched their mouths and noses, and exhibited coughing, sneezing, and excessive nasal discharge or oral secretions.

[0121] The positive control group rats showed some recovery in mental state, but the reduction in scratching of the mouth and nose was not significant, coughing and sneezing were reduced, and clear nasal discharge or oral secretions were significantly reduced.

[0122] The rats in the Qingxian Liyan Fang intervention group gradually showed improved mental state, reduced scratching of mouth and nose, significantly reduced coughing and sneezing, and significantly reduced nasal discharge or oral secretions.

[0123] 1.4.2) Pathological changes in the nasal and pharyngeal mucosa and nasopharyngeal lymph nodes of rats

[0124] The blank control group showed normal nasal mucosal tissue structure, with dense and intact cilia on the mucosal surface. The lamina propria contained small mixed glands, plasma cells, and mast cells, and there was no edema or degeneration in the interstitium. In the model group, cilia were severely damaged, epithelial cells degenerated, some cytoplasm dissolved, and margins were indistinct. Small blood vessels within the mucosa were significantly dilated, interstitial edema was observed, and inflammatory cell infiltration was significant. In the positive control group, the number of cilia was slightly reduced, some epithelial cells detached, structural boundaries were blurred, interstitial edema was present, and eosinophils, neutrophils, and lymphocytes were infiltrated within the mucosa. In the intervention group, the number of cilia was slightly reduced, occasional epithelial cell detachment was observed, structural boundaries were relatively blurred, there was no interstitial edema, and a small number of eosinophils, neutrophils, and lymphocytes were infiltrated within the mucosa.

[0125] In the blank control group, the pharyngeal mucosa lamina propria remained intact, with a small number of plasma cells and lymphocytes infiltrating, but no obvious pathological damage was observed. In the model group, the pharynx was severely damaged, with extensive mucosal necrosis, significant submucosal edema, structural disorder, marked inflammatory cell infiltration, and hemorrhage in the glandular stroma. In the positive control group and the intervention group, only minor pharyngeal damage was observed, with a small number of plasma cells and lymphocytes infiltrating.

[0126] In the blank control group, the lymph node tissue structure was normal, and the lymphocytes were densely arranged. In the model group, the lymph nodes were larger and more numerous, with indistinct germinal centers and uneven lymphocyte distribution. In the positive control group and the intervention group, the lymph node volume was not significantly increased, the number of lymph nodes was slightly increased, and the lymphocytes were evenly distributed.

[0127] 1.4.3) Rat whole blood EOS% count level

[0128] Statistical analysis showed that the percentage of eosinophils (EOS%) in the model group, positive control group, and intervention group was all increased compared with the blank control group. < 0.05, with the model group showing the most significant upregulation compared to the blank control group ( < 0.01), there was no statistically significant difference between the positive control group and the intervention group. > 0.05), see Table 1 for details, where: ± s, n=10. Table 1

[0129]

[0130] 1.4.3) Serum and nasopharyngeal mucosal tissue IL-4 and IgE levels in rats

[0131] Compared with the blank control group, the serum and tissue levels of IL-4 and IgE in the model group rats were increased ( < 0.05); Compared with the model group, the serum and tissue levels of IL-4 and IgE in rats in the positive control group and the intervention group were decreased ( < 0.05), and the decrease was more significant in the intervention group; compared with the blank control group, the serum and tissue levels of IL-4 and IgE in the positive control group and the intervention group were still higher ( < 0.05), see Table 2 for details, where: ± s, n=10. Table 2

[0132] Example 2

[0133] This effect example evaluates the technical solution provided by the present invention through clinical trials.

[0134] 2.1) Source of cases

[0135] The cases observed in this efficacy study were all children aged 4-12 years who were diagnosed with adenoid hypertrophy at the Pediatric Outpatient Department of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, affiliated with Shanghai University of Traditional Chinese Medicine, between November 2023 and November 2024.

[0136] 2.2) Diagnostic criteria

[0137] 2.2.1) Western Medicine Diagnostic Criteria

[0138] Clinical manifestations:

[0139] (1) Systemic symptoms: poor nutrition and development, slow reaction, poor concentration, night terrors, teeth grinding, bedwetting, etc.;

[0140] (2) Sleep disorder related symptoms: snoring, mouth breathing, sleep apnea, nasal flaring, excessive sweating, bedwetting and abnormal body position during sleep;

[0141] (3) Nasal symptoms: nasal congestion, runny nose, obstructive nasal voice, rhinitis or sinusitis that is difficult to cure.

[0142] (4) Ear symptoms: ear pain, a feeling of fullness in the ear, and hearing loss, etc.;

[0143] (5) Symptoms of the pharynx, larynx and lower respiratory tract: sore throat, cough and phlegm.

[0144] Physical signs: Long-term mouth breathing can affect facial bone development, resulting in elongated maxilla, high arched palate, malocclusion, protruding upper incisors, thick lips, and lack of facial expression, forming "adenoid facies"; pharyngeal congestion, purulent secretions adhering to the posterior pharyngeal wall, high and narrow hard palate, often accompanied by palatine tonsil hypertrophy; indirect nasopharyngoscopy reveals red, lumpy bulges in the nasopharynx; a mass of soft, non-bleeding lymphoid tissue can be palpated on the posterior wall of the nasopharynx.

[0145] Imaging examinations: Adenoid hypertrophy can be diagnosed if the ratio of adenoid thickness (A) to nasopharyngeal width (N) is greater than 0.60, as determined by lateral nasopharyngeal X-ray or MRI (Magnetic Resonance Imaging): ① Mild hypertrophy: 0.61≤A / N value≤0.70; ② Moderate hypertrophy: 0.71≤A / N value≤0.80; ③ Severe hypertrophy: A / N value≥0.81.

[0146] 2.2.2) Traditional Chinese Medicine Diagnostic Criteria

[0147] Referring to the "Expert Consensus on the Diagnosis and Treatment of Sleep-Disordered Breathing Caused by Adenoid Hypertrophy in Children" (2014 Edition) and the TCM diagnostic criteria for phlegm-stasis type adenoid hypertrophy in children in "Traditional Chinese Medicine Otorhinolaryngology", and combined with clinical experience, the following criteria are proposed:

[0148] Main symptoms: nasal congestion, thick yellow nasal discharge, loud snoring during sleep, mouth breathing, or accompanied by sore throat, red and swollen tonsils, etc.

[0149] Secondary symptoms: persistent nasal congestion, copious yellow and turbid nasal discharge; dry and painful throat, difficulty swallowing; obvious redness and swelling of the tonsils, or redness and swelling of the adenoids; snoring during sleep, mouth breathing, which may be accompanied by fever, or low-grade fever in the afternoon; thirst with a preference for cold drinks; constipation, and dark yellow urine.

[0150] Tongue and pulse: The tongue is red or crimson, the sublingual veins are tortuous, the coating is yellow and greasy or yellow and dry, and the pulse is rapid or slippery and rapid.

[0151] Syndrome diagnosis: If two or more primary symptoms are present, combined with secondary symptoms and tongue and pulse manifestations, the syndrome is diagnosed as heat-toxin stagnation syndrome.

[0152] 2.2.3) Inclusion criteria

[0153] (1) Meets the diagnostic criteria for adenoid hypertrophy in both traditional Chinese and Western medicine (A / N value > 0.6);

[0154] (2) No glucocorticoids were used for treatment within 3 months prior to enrollment;

[0155] (3) Age 4-12 years old, gender not limited;

[0156] (4) The guardian understands and agrees to participate in this study and signs the informed consent form.

[0157] 2.2.4) Exclusion Criteria

[0158] (1) Those with congenital maxillofacial deformities or abnormal nasal anatomical structures;

[0159] (2) Individuals with serious primary diseases such as cardiovascular and cerebrovascular diseases, hereditary metabolic diseases, and liver diseases;

[0160] (3) Those who participated in other clinical studies within one month prior to enrollment;

[0161] (4) Individuals known to be allergic to any of the components of the research drug.

[0162] 2.2.5) Exclusion Criteria

[0163] (1) Those who were mistakenly included but did not meet the inclusion criteria;

[0164] (2) Those who fail to take medication as prescribed, making it impossible to determine the efficacy, or whose incomplete data affects the determination of efficacy or safety;

[0165] Before statistical analysis of the data, the statisticians and principal researchers jointly discuss and decide whether to exclude cases.

[0166] 2.2.6) Shedding criteria;

[0167] (1) An adverse event occurs; (2) The treatment is ineffective; (3) The trial protocol is violated (including poor compliance); (4) The patient is lost to follow-up (including the patient withdraws on their own); (5) The patient withdraws the informed consent form.

[0168] All patients who signed informed consent forms and passed the screening process to enter the trial, regardless of when or for what reason they withdrew, are considered dropouts if they did not complete the entire clinical trial. Patients who discontinued medication on their own after three days or more when their symptoms disappeared are not considered dropouts.

[0169] Management of Dropout Cases: Researchers must fill in the reason for dropout in the Case Report Form (CRF) and complete the final visit assessment as much as possible, recording the last medication time. For dropouts due to adverse reactions, if follow-up determines that it is related to the investigational drug, this must be recorded in the CRF and the sponsor notified.

[0170] 2.3) Test Results

[0171] A prospective, randomized controlled study was conducted, selecting 72 children aged 4-12 years with adenoid hypertrophy admitted between November 2023 and November 2024, and randomly dividing them into a treatment group and a control group, with 36 cases in each group.

[0172] The control group received budesonide nebulization therapy, while the treatment group received "Qingxian Liyan Fang" (a traditional Chinese medicine formula for clearing the glands and relieving sore throat) in addition to nebulization therapy.

[0173] After 3 months of treatment, the total effective rates in the treatment group and the control group were 80.56% and 63.89%, respectively. The improvement in the A / N ratio in the treatment group was significantly better than that in the control group after treatment.

[0174] The clinical efficacy comparison trial results of the two groups of children [x (s%)] are listed in Table 3 below. Table 3

[0175]

[0176] In the table: Overall effective rate = (Number of cured cases + Number of cases with significant improvement) / Total number of cases × 100%

[0177] Comparison of A / N values ​​between the two groups of children before and after treatment ( ± s) are listed in Table 4 below. Table 4

[0178]

[0179] Table 4 shows that the A / N values ​​of both groups of children before and after treatment conformed to a normal distribution and had homogeneity of variance; paired t-tests were used for intragroup comparisons, and the results showed that the A / N values ​​of both groups improved significantly after treatment. < 0.05); Independent samples t-test was used for intergroup comparisons, and the improvement in A / N value in the treatment group was significantly better than that in the control group ( < 0.05).

[0180] It needs to be emphasized that:

[0181] Although the above-mentioned effect examples only applied the basic Chinese herbal decoction for treating adenoid hypertrophy of children with heat-toxin stagnation provided in Example 1, namely Qingxian Liyan Fang, to conduct animal and clinical trials, in fact, clinical evidence shows that all Chinese herbal composition preparations of the dosage forms claimed in this invention, prepared using all the technical solutions provided by this invention, can achieve the same or similar therapeutic effects as Qingxian Liyan Fang provided in Example 1, and each modified formula and the corresponding children with the same symptoms can also achieve the corresponding therapeutic effects;

[0182] Furthermore, although only children aged 4-12 years were selected for clinical efficacy data statistics and analysis in the efficacy examples, clinical evidence shows that all the traditional Chinese medicine composition preparations and their modified formulations of the dosage forms claimed in this invention, prepared using all the technical solutions provided by this invention, can achieve the same or similar therapeutic effects as in efficacy example 2 for children aged 3-10 years, especially children aged 6-18 years with heat-toxin stagnation type adenoid hypertrophy. This specification is only for the sake of concise description and has not made too many elaborations. It only uses the above efficacy examples as representative examples for description. Therefore, it can be understood that the above efficacy examples cannot be regarded as limiting cases of this invention.

[0183] In conclusion, it can be seen that:

[0184] Through the above specific embodiments, this invention provides a complete technical solution from core formulation, syndrome differentiation and modification to preparation of different dosage forms and clinical application. These embodiments fully demonstrate that this invention not only provides a standardized Chinese medicine compound, but more importantly, it constructs a flexible and precise prescription system. Its significant technical progress lies in integrating the holistic concept of traditional Chinese medicine and the essence of syndrome differentiation and treatment into the modern drug development process. That is, through standardized preparation processes and diverse dosage form designs, it achieves multi-level and individualized treatment for children with adenoid hypertrophy of the heat-toxin stagnation type, ultimately achieving outstanding beneficial effects of treating both the symptoms and the root cause, reducing toxicity and increasing efficacy, demonstrating significant clinical value and broad application prospects.

[0185] In the description process of the above instruction manual:

[0186] The terms “this embodiment,” “this embodiment of the invention,” “this case,” “this comparative example,” “as shown,” “further,” etc., are used to indicate that the specific features, structures, materials, or characteristics described in the embodiment or case or comparative example are included in at least one embodiment or case or comparative example of the present invention.

[0187] In this specification, the illustrative expressions of the above terms are not necessarily specific to any particular embodiment or effect example. Moreover, the specific features, structures, materials, or characteristics described may be combined or combined in any suitable manner in one or more embodiments or effect examples. Furthermore, without causing contradiction, those skilled in the art may combine or combine the different embodiments or cases, comparative examples, and features in the different embodiments or cases, comparative examples, as described in this specification.

[0188] Finally, it should be noted that:

[0189] The above embodiments and effect examples are only used to illustrate the technical solutions and effects of the present invention, and are not intended to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments and effect examples, those skilled in the art should understand that they can still modify or supplement the technical solutions or effects described in the foregoing embodiments and effect examples, or make equivalent substitutions for some or all of the technical features. However, these modifications or substitutions cannot cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions described in the embodiments of the present invention. Non-essential improvements, adjustments or substitutions made by those skilled in the art based on the content of this specification are all within the scope of protection claimed by the present invention.

Claims

1. A traditional Chinese medicine composition for treating pediatric adenoid hypertrophy of the heat-toxin and blood stasis type, characterized in that, Made from the following active pharmaceutical ingredient in parts by weight: Honeysuckle 6-12 parts by weight, red peony root 6-12 parts by weight, burdock fruit 6-12 parts by weight, soapberry thorn 6-12 parts by weight, scutellaria root 6-12 parts by weight, coptis root 1-4 parts by weight, kudzu root 6-12 parts by weight, licorice root 1-6 parts by weight.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, Made from the following active pharmaceutical ingredient in parts by weight: Honeysuckle 9 parts by weight, red peony root 9 parts by weight, burdock fruit 9 parts by weight, soapberry thorn 9 parts by weight, scutellaria baicalensis 9 parts by weight, coptis chinensis 2 parts by weight, kudzu root 9 parts by weight, and licorice root 3 parts by weight.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The traditional Chinese medicine composition is formulated into a dosage form that is acceptable in traditional Chinese medicine.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, The dosage forms that are acceptable in traditional Chinese medicine include decoctions, pastes, granules, tablets, capsules, oral liquids and / or pills.

5. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that: The traditional Chinese medicine composition is used to prepare a drug for treating adenoid hypertrophy in children. The traditional Chinese medicine syndrome of adenoid hypertrophy in children is heat-toxin stagnation type, and its symptoms include nasal congestion, mouth breathing, snoring during sleep, redness and swelling of the pharynx, or accompanied by tonsil enlargement, red and swollen tonsils, red or dark red tongue, thin yellow coating, rapid pulse or purplish finger veins.

6. The traditional Chinese medicine composition according to claim 5, characterized in that: When the patient also experiences wind-evil binding the exterior, with significant nasal congestion and runny nose, add 1-6 parts by weight of peppermint and 1-6 parts by weight of magnolia flower to the above-mentioned raw materials.

7. The traditional Chinese medicine composition according to claim 5, characterized in that, The amount of peppermint added is 3 parts by weight, and the amount of magnolia buds added is 3 parts by weight.

8. The traditional Chinese medicine composition according to claim 5, characterized in that: When the patient also presents with yin deficiency and significant dry mouth and throat, remove Coptis chinensis from the above-mentioned raw materials, but at the same time increase Ophiopogon japonicus by 1-6 parts by weight.

9. The traditional Chinese medicine composition according to claim 5, characterized in that, The amount of Ophiopogon japonicus added is 3 parts by weight.

10. The traditional Chinese medicine composition according to claim 5, characterized in that: When the patient also presents with excessive phlegm, significant coughing, and heavy snoring, add 1-6 parts by weight of Fritillaria thunbergii to the above-mentioned raw materials.

11. The traditional Chinese medicine composition according to claim 10, characterized in that, The amount of Fritillaria thunbergii added is 3 parts by weight.

12. The traditional Chinese medicine composition according to claim 5, characterized in that: When the patient also has spleen and stomach weakness, poor appetite and loose stools, remove Coptis chinensis from the above-mentioned raw materials, but at the same time increase 1-6 parts by weight of Citrus reticulata peel and 1-6 parts by weight of Poria cocos.

13. The traditional Chinese medicine composition according to claim 12, characterized in that, The amount of dried tangerine peel added is 3 parts by weight, and the amount of poria cocos added is 3 parts by weight.

14. The traditional Chinese medicine composition according to claim 5, characterized in that: When the patient also presents with significant blood stasis and obstruction of collaterals, prolonged course of disease, and hard and tough glands, add 1-6 parts by weight of Danshen and 1-6 parts by weight of Chuanxiong to the above-mentioned raw materials.

15. The traditional Chinese medicine composition according to claim 14, characterized in that, The amount of Danshen added is 3 parts by weight, and the amount of Chuanxiong added is 3 parts by weight.

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