Traditional Chinese medicine composition for treating infantile adenoid hypertrophy as well as preparation method, application and pharmaceutical preparation thereof

Abstract

The invention relates to a traditional Chinese medicine composition for treating infantile adenoid hypertrophy, a preparation method and application thereof, and a pharmaceutical preparation, and belongs to the technical field of traditional Chinese medicines. The technical problems to be solved are that an existing traditional Chinese medicine composition for treating the infantile adenoid hypertrophy is still poor in effect, complex in component and high in cost. According to the technical scheme, the traditional Chinese medicine composition for treating infantile adenoid hypertrophy is prepared from the following components: platycodon grandiflorum, houttuynia cordata, perilla stem, spina gleditsiae, radix scrophulariae, liquorice, pericarpium citri reticulatae and astragalus membranaceus.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating pediatric adenoid hypertrophy, its preparation method and application, and pharmaceutical preparations. Background Technology

[0002] Adenoids, also known as pharyngeal tonsils or adenoids, are important peripheral immune organs in childhood and are the largest lymphoid tissue in the nasopharynx. Under the stimulation of repeated infections, allergies, and other pathological factors, inflammation and pathological hyperplasia of the adenoids in children can occur, adenoid hypertrophy (AH). Clinically, the main symptoms are nasal congestion, mouth breathing, snoring, and sleep apnea. Prolonged illness can lead to "adenoid facies" and is prone to complications such as secretory otitis media, sinusitis, and even serious conditions like obstructive sleep apnea-hypopnea syndrome (OSAHS), affecting the child's physical and mental health. Statistics show that its incidence rate can reach 34%.

[0003] In terms of treatment, Western medicine mainly divides it into surgical treatment and conservative medical treatment. Surgical treatment carries risks such as reducing the child's immune function or incomplete eradication leading to recurrence, including complications like bleeding, infection, and voice changes. Furthermore, surgery weakens the body's immune system, making patients more susceptible to bacterial and viral infections, potentially leading to adenoid hypertrophy recurrence. Conservative medical treatment currently lacks specific drugs. Compared to Western medicine, Traditional Chinese Medicine (TCM) has the advantage of fundamentally improving immunity and reducing recurrence, with significant effects, fewer adverse reactions, and high safety; however, there are currently no commercially available TCM preparations.

[0004] Relevant patent documents retrieved:

[0005] Chinese Invention Patent Publication No. CN116870122A discloses a traditional Chinese medicine composition for treating pediatric adenoid hypertrophy and its application. The composition, by weight, comprises 4.5-13.5 parts of *Trollius chinensis*, 7.5-22.5 parts of *Bauhinia purpurea* bark, 7.5-22.5 parts of *Magnolia biondii*, 6-18 parts of *Smilax glabra*, 4.5-13.5 parts of *Gleditsia sinensis* thorns, 5-15 parts of oyster shell, 4.5-13.5 parts of fish brain stone, 4.5-13.5 parts of *Curcuma zedoaria*, 6-18 parts of *Prunella vulgaris*, and 1.5-4.5 parts of *Stevia repens*. This traditional Chinese medicine composition precisely addresses the pathogenesis of pediatric adenoid hypertrophy, and the entire formula works synergistically to clear heat and detoxify, clear nasal passages, and resolve blood stasis and nodules. Experiments have shown that the Chinese herbal composition not only inhibits the occurrence and development of adenoid hypertrophy in children through anti-inflammation, but also significantly improves the TCM symptoms of children with adenoid hypertrophy, with efficacy significantly better than conventional treatment.

[0006] Relevant non-patent literature retrieved: The journal title is *Chinese Journal of Integrated Traditional and Western Medicine in Otorhinolaryngology*, and the article title is "Exploring the Mechanism and Treatment of Adenoid Hypertrophy from the Theory of Wind-Evil and Pure Yang in Children," volume number 33 (06), published on December 18, 2025. This article discloses that: "Pure Yang in children" does not refer to the absence of Yin, but rather to a relatively unbalanced constitution where, based on a balance of Yin and Yang, the child's body has a slightly higher proportion of Yang and a slightly lower proportion of Yin. When affected by external wind-evil, this leads to the formation of pure Yang heat and phlegm accumulation. Treatment with methods to dispel wind-evil, clear heat and resolve stagnation, and regulate the spleen and stomach can alleviate the symptoms of pure Yang heat and phlegm accumulation. Pure Yang heat is the root cause of adenoid hypertrophy, while external wind-evil leading to spleen dysfunction is the manifestation of adenoid hypertrophy.

[0007] However, the traditional Chinese medicine composition disclosed in the above-mentioned invention patent is still not very effective in treating pediatric adenoid hypertrophy, and its components are complex and costly. Summary of the Invention

[0008] The purpose of this invention is to provide: A traditional Chinese medicine composition for treating pediatric adenoid hypertrophy, its preparation method, and its application, to address the technical problems of existing traditional Chinese medicine compositions for treating pediatric adenoid hypertrophy being unsatisfactory in effect, having complex components, and being costly, or a combination thereof.

[0009] Specifically, the herbal composition of this invention consists of eight medicinal materials: Platycodon grandiflorus, Gleditsia sinensis thorns, Citrus reticulata peel, Perilla frutescens stem, Scrophularia ningpoensis, Houttuynia cordata, Astragalus membranaceus, and Glycyrrhiza uralensis. The theoretical framework of this formula is based on the ascending and descending of Qi, regulating Qi and blood. Platycodon grandiflorus disperses lung Qi, clearing blockages and promoting lung Qi circulation; Gleditsia sinensis thorns promote the elimination of toxins, disperse nodules, and reduce swelling; these are the principal herbs. Citrus reticulata peel and Perilla frutescens stem descend turbid Yin and stop stomach upset; Scrophularia ningpoensis clears lung metal and generates water; Houttuynia cordata clears heat and detoxifies; these are the assistant herbs. Astragalus membranaceus strengthens the defensive Qi, promotes the elimination of toxins and generates tissue, assists the principal herbs in opening and clearing lung blockages, descending rebellious lung Qi, clearing the nasal and pharyngeal orifices, and penetrating the interior and exterior; this is the guiding herb. Glycyrrhiza uralensis tonifies the lungs and spleen, protects the middle Jiao, and harmonizes the other herbs. The combined effects of these herbs resolve phlegm, clear heat, cool the blood, and disperse nodules.

[0010] Terminology Explanation: Unless otherwise defined, all technical terms in this invention have the same meanings as commonly understood by one of ordinary skill in the art to which the subject matter of the claims pertains. Unless otherwise stated, all patents, patent inventions, and disclosures referenced in this invention are incorporated herein by reference in their entirety. If multiple definitions exist for terms in this invention, the definitions in this chapter shall prevail.

[0011] It should be understood that the above brief description and the following detailed description are exemplary and for illustrative purposes only, and do not limit the subject matter of the invention in any way. In this invention, the singular is used in conjunction with the plural unless otherwise specifically stated. It should also be noted that, unless otherwise stated, the use of “or” or “or” means “and / or”. Furthermore, the use of the term “comprising” and other forms such as “including,” “containing,” and “contains” are not limiting.

[0012] The definitions of standard chemical terms can be found in the reference "Pharmacopoeia of the People's Republic of China (2020 Edition), China Medical Science and Technology Press, May 2020, 1st Edition".

[0013] Unless otherwise stated, conventional methods within the scope of the art, such as pathological testing and immunological marker testing, shall be used.

[0014] Unless specifically defined, the use of various commercially available products in this invention employs standard techniques. For example, it may be carried out using the manufacturer's instructions for use with the reagent kit, or in accordance with methods known in the art or the description of this invention. The techniques and methods described herein can generally be implemented according to conventional methods well known in the art, based on the descriptions in the various summary and more specific documents cited and discussed in this specification.

[0015] The terms “optional / arbitrary” or “optionally / arbitrarily” mean that the event or situation described below may or may not occur, including both the occurrence and non-occurrence of the event or situation.

[0016] As used in this invention, the term "treatment" means: to achieve a desired pharmacological and / or physiological effect. An effect may be preventative, but not necessarily preventative, in relation to the prevention or partial prevention of a disease, symptom, or condition (such as dermatitis). An effect may be therapeutic in relation to the partial or complete cure of a disease, condition, symptom, or adverse reaction attributable to that disease, condition, or condition. Specifically, the term "treatment" can include any treatment of a subject (especially a person) for a relevant symptom or disease, and may include any one or more of the following: (a) prevention of the disease in subjects who may be susceptible to the disease but have not yet been diagnosed with it; (b) suppression of the disease, i.e., prevention of its development; and (c) relief of the disease, i.e., reduction or improvement of the disease and / or its symptoms or condition. The term "treatment" can refer to therapeutic treatment alone, preventative treatment alone, or both therapeutic and preventative treatment. A person requiring treatment (a subject requiring treatment) can include a person who already has a symptom and / or a person who needs to prevent a symptom.

[0017] In a first aspect, the present invention provides: A traditional Chinese medicine composition for treating adenoid hypertrophy in children includes the following components: Platycodon grandiflorus, Houttuynia cordata, Perilla frutescens stem, Gleditsia sinensis thorn, Scrophularia ningpoensis, Glycyrrhiza uralensis, Citrus reticulata peel, and Astragalus membranaceus.

[0018] Includes: group allocation ratio.

[0019] The ingredients, by weight, include the following components: Platycodon grandiflorus 2-10 parts, Houttuynia cordata 4-12 parts, Perilla frutescens stem 2-10 parts, Gleditsia sinensis thorn 2-10 parts, Scrophularia ningpoensis 4-12 parts, Glycyrrhiza uralensis 2-10 parts, Citrus reticulata peel 4-12 parts, and Astragalus membranaceus 4-12 parts.

[0020] Preferably, by weight, it comprises the following components: 4-10 parts of Platycodon grandiflorus, 6-12 parts of Houttuynia cordata, 4-10 parts of Perilla frutescens stem, 4-10 parts of Gleditsia sinensis thorn, 6-12 parts of Scrophularia ningpoensis, 4-10 parts of Glycyrrhiza uralensis, 6-12 parts of Citrus reticulata peel, and 6-12 parts of Astragalus membranaceus.

[0021] This invention relates to a traditional Chinese medicine composition for treating adenoid hypertrophy in children, made from eight medicinal materials: Platycodon grandiflorus, Houttuynia cordata, Perilla frutescens stem, Gleditsia sinensis thorn, Scrophularia ningpoensis, Glycyrrhiza uralensis, Citrus reticulata peel, and Astragalus membranaceus. Platycodon grandiflorus, as the principal ingredient, promotes the flow of lung qi, clearing blockages and facilitating the proper distribution of qi, blood, and body fluids, thus alleviating various symptoms. Houttuynia cordata clears heat and detoxifies, drains pus, and reduces swelling; Citrus reticulata peel enters the qi level, clears lung qi, lowers stomach qi, and resolves phlegm and counterflow. Both assist the principal ingredient in clearing heat from the qi and blood levels. With the removal of phlegm and heat, phlegm nodules dissipate, and with the dissipation of phlegm nodules, lung qi is restored. These two ingredients serve as assistant ingredients. Perilla stem is primarily used to treat spleen and stomach qi stagnation, chest tightness, and vomiting. It can also promote lung function, stop coughing, and resolve phlegm, allowing stagnant qi to flow smoothly. Among all qi-regulating herbs, this is the purest and most effective. Gleditsia sinensis thorns promote detoxification, disperse nodules, and reduce swelling. Astragalus membranaceus strengthens the body's defensive qi, promotes detoxification, and promotes tissue regeneration. These three herbs serve as adjuvant herbs, assisting the principal herb in opening up blocked lung qi, descending rebellious lung qi, clearing the nasal and pharyngeal orifices, and penetrating both the exterior and interior. Scrophularia ningpoensis enters the yin aspect, clearing and reducing superficial heat; Glycyrrhiza uralensis tonifies the lungs and spleen, protects the middle jiao, and harmonizes the other herbs. These two herbs serve as guiding herbs. When used together, these herbs clear heat, resolve phlegm, disperse nodules, eliminate symptoms, tonify the lungs, strengthen the body's defensive qi, and improve overall health. This eliminates internal phlegm, heat, and dampness, strengthens the lungs and defensive qi, clears the child's internal organs, eliminates phlegm nodules, and stops snoring.

[0022] Based on further solutions to the technical problems of the present invention, or simultaneous solutions to multiple technical problems, the preferred solution in the technical solution provided in the first aspect of the present invention includes: The first preferred embodiment, by weight, comprises the following components: 2-10 parts Platycodon grandiflorus, 4-12 parts Houttuynia cordata, 2-10 parts Perilla frutescens stem, 2-10 parts Gleditsia sinensis thorn, 4-12 parts Scrophularia ningpoensis, 2-10 parts Glycyrrhiza uralensis, 4-12 parts Citrus reticulata peel, and 4-12 parts Astragalus membranaceus. This technical solution addresses the technical problem that "the efficacy of existing traditional Chinese medicine compositions for treating pediatric adenoid hypertrophy is still unsatisfactory," and further solves the technical problem that "existing traditional Chinese medicine compositions for treating pediatric adenoid hypertrophy have complex components and high costs."

[0023] The second preferred option, by weight, comprises the following components: Platycodon grandiflorus 4-10 parts, Houttuynia cordata 6-12 parts, Perilla frutescens stem 4-10 parts, Gleditsia sinensis thorn 4-10 parts, Scrophularia ningpoensis 6-12 parts, Glycyrrhiza uralensis 4-10 parts, Citrus reticulata peel 6-12 parts, and Astragalus membranaceus 6-12 parts. This technical solution addresses the technical problem that "the efficacy of existing traditional Chinese medicine compositions for treating pediatric adenoid hypertrophy is still unsatisfactory," and further solves the technical problem that "existing traditional Chinese medicine compositions for treating pediatric adenoid hypertrophy have complex components and high costs."

[0024] Secondly, the present invention provides: The preparation method of the above-mentioned traditional Chinese medicine composition includes the following steps: mixing the medicinal materials and decocting them with water, combining the filtrates, and concentrating them to obtain the final product.

[0025] Includes: water quality; boiling conditions; concentration, etc.

[0026] The mass of the water is 6-12 times the total mass of the medicinal materials.

[0027] Preferably, the mass of the water is 6-8 times the total mass of the medicinal materials.

[0028] More preferably, the mass of the water is 6, 7, or 8 times the total mass of the medicinal materials.

[0029] The decoction is performed 2-4 times, and the decoction time is 1-3 hours.

[0030] Preferably, the decoction is performed 2-3 times, and the decoction time is 1.5-2 hours.

[0031] The concentration yields an extract with a relative density of 1.15-1.25 g / mL at 60°C.

[0032] Based on further solutions to the technical problems of the present invention, or simultaneous solutions to multiple technical problems, the preferred solution in the technical solution provided in the second aspect of the present invention includes: The first preferred embodiment: the mass of the water is 6-12 times the total mass of the medicinal materials; the number of decoctions is 2-4 times, and the decoction time is 1-3 hours. This technical solution solves the technical problem that "the effect of existing traditional Chinese medicine compositions for treating pediatric adenoid hypertrophy is still unsatisfactory," and further solves the technical problem that "existing traditional Chinese medicine compositions for treating pediatric adenoid hypertrophy have complex components and high costs."

[0033] The second preferred embodiment: the concentration yields an extract with a relative density of 1.15-1.25 g / mL at 60℃. This technical solution addresses the technical problem that "the efficacy of existing traditional Chinese medicine compositions for treating pediatric adenoid hypertrophy is still unsatisfactory," and further solves the technical problem that "existing traditional Chinese medicine compositions for treating pediatric adenoid hypertrophy have complex components and high costs."

[0034] Thirdly, the present invention provides: A pharmaceutical preparation comprising the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0035] Includes: excipients; dosage form of the formulation; pH of the formulation, etc.

[0036] The excipients include one or more of the following: preservatives, humectants, suspending agents, flavoring agents, diluents, flavoring agents, and solubilizers.

[0037] The flavoring agents include one or more of the following: grapefruit flavoring, passion fruit flavoring, blueberry flavoring, mango flavoring, milk flavoring, peach flavoring, orange flavoring, sweet orange flavoring, pineapple flavoring, grape flavoring, apple flavoring, banana flavoring, strawberry flavoring, and chocolate flavoring.

[0038] The flavoring agent is preferably one or more of apple flavoring, sweet orange flavoring, strawberry flavoring, and chocolate flavoring.

[0039] The dosage form of the preparation is: tablet, capsule, granule, liquid preparation or ointment.

[0040] The pH of the preparation is 5.0-6.1.

[0041] Based on further solutions to the technical problems of the present invention, or simultaneous solutions to multiple technical problems, the preferred solution in the technical solution provided in the third aspect of the present invention includes: The first preferred embodiment: the excipients include one or more of preservatives, humectants, suspending agents, flavoring agents, diluents, flavoring agents, and solubilizers; the flavoring agents include one or more of grapefruit flavoring, passion fruit flavoring, blueberry flavoring, mango flavoring, milk flavoring, peach flavoring, orange flavoring, sweet orange flavoring, pineapple flavoring, grape flavoring, apple flavoring, banana flavoring, strawberry flavoring, and chocolate flavoring. This technical solution addresses the technical problem that "the efficacy of existing traditional Chinese medicine compositions for treating pediatric adenoid hypertrophy is still unsatisfactory," and further solves the technical problem that "existing traditional Chinese medicine compositions for treating pediatric adenoid hypertrophy have complex components and high costs."

[0042] The second preferred embodiment: the dosage form of the preparation is tablets, capsules, granules, liquid preparations, or ointments; the pH of the preparation is 5.0-6.1. This technical solution addresses the technical problem that "the efficacy of existing traditional Chinese medicine compositions for treating pediatric adenoid hypertrophy is still unsatisfactory," and further solves the technical problem that "existing traditional Chinese medicine compositions for treating pediatric adenoid hypertrophy have complex components and high costs."

[0043] Fourthly, the present invention provides: The application of the above-mentioned traditional Chinese medicine composition or pharmaceutical preparation in the preparation of drugs for treating adenoid hypertrophy.

[0044] Examples 1-12 of this invention at least support the protection scope of "a traditional Chinese medicine composition for treating adenoid hypertrophy in children, comprising the following components: Platycodon grandiflorus, Houttuynia cordata, Perilla frutescens stem, Gleditsia sinensis thorn, Scrophularia ningpoensis, Glycyrrhiza uralensis, Citrus reticulata peel and Astragalus membranaceus".

[0045] The phrase "a traditional Chinese medicine composition for treating adenoid hypertrophy in children, comprising the following components: Platycodon grandiflorus, Houttuynia cordata, Perilla frutescens stem, Gleditsia sinensis thorns, Scrophularia ningpoensis, Glycyrrhiza uralensis, Citrus reticulata peel, and Astragalus membranaceus" is derived from the foregoing explanation and / or Examples 1-12 under the term "traditional Chinese medicine composition." Therefore, those skilled in the art can reasonably infer that the phrase "a traditional Chinese medicine composition for treating adenoid hypertrophy in children, comprising the following components: Platycodon grandiflorus, Houttuynia cordata, Perilla frutescens stem, Gleditsia sinensis thorns, Scrophularia ningpoensis, Glycyrrhiza uralensis, Citrus reticulata peel, and Astragalus membranaceus" is a subordinate concept to "a traditional Chinese medicine composition for treating adenoid hypertrophy in children, comprising the following components: Platycodon grandiflorus, Houttuynia cordata, Perilla frutescens stem, Gleditsia sinensis thorns, Scrophularia ningpoensis, Glycyrrhiza uralensis, Citrus reticulata peel, and Astragalus membranaceus," and the phrase "a traditional Chinese medicine composition for treating adenoid hypertrophy in children, comprising the following components: Platycodon grandiflorus, Houttuynia cordata, Perilla frutescens stem, Gleditsia sinensis thorns, Scrophularia ningpoensis, Glycyrrhiza uralensis, Citrus reticulata peel, and Astragalus membranaceus," are all related to the concept of traditional Chinese medicine composition for treating adenoid hypertrophy in children. The following technical means, which are essentially equivalent to "a traditional Chinese medicine composition for treating adenoid hypertrophy in children, comprising the following components: Platycodon grandiflorus, Houttuynia cordata, Perilla frutescens stem, Gleditsia sinensis thorns, Scrophularia ningpoensis, Glycyrrhiza uralensis, Citrus reticulata peel and Astragalus membranaceus", and which, based on existing technical levels and within conventional technical means and common knowledge, can replace "a traditional Chinese medicine composition for treating adenoid hypertrophy in children, comprising the following components: Platycodon grandiflorus, Houttuynia cordata, Perilla frutescens stem, Gleditsia sinensis thorns, Scrophularia ningpoensis, Glycyrrhiza uralensis, Citrus reticulata peel and Astragalus membranaceus", should all fall within the protection scope of "a traditional Chinese medicine composition for treating adenoid hypertrophy in children, comprising the following components: Platycodon grandiflorus, Houttuynia cordata, Perilla frutescens stem, Gleditsia sinensis thorns, Scrophularia ningpoensis, Glycyrrhiza uralensis, Citrus reticulata peel and Astragalus membranaceus".

[0046] In this invention, Examples 1-12 at least support the protection scope of "including the following components by weight: 2-10 parts of Platycodon grandiflorus, 4-12 parts of Houttuynia cordata, 2-10 parts of Perilla frutescens stem, 2-10 parts of Gleditsia sinensis thorn, 4-12 parts of Scrophularia ningpoensis, 2-10 parts of Glycyrrhiza uralensis, 4-12 parts of Citrus reticulata peel, and 4-12 parts of Astragalus membranaceus".

[0047] "By weight, it includes the following components: Platycodon grandiflorus 2-10 parts, Houttuynia cordata 4-12 parts, Perilla frutescens stem 2-10 parts, Gleditsia sinensis thorn 2-10 parts, Scrophularia ningpoensis 4-12 parts, Glycyrrhiza uralensis 2-10 parts, Citrus reticulata peel 4-12 parts, Astragalus membranaceus 4-12 parts," which is summarized as "Traditional Chinese Medicine Composition" by the foregoing explanation and / or Examples 1-12 in this document. Therefore, those skilled in the art can reasonably presume that the following components, by weight, are included: 2-10 parts Platycodon grandiflorus, 4-12 parts Houttuynia cordata, 2-10 parts Perilla frutescens, 2-10 parts Gleditsia sinensis, 4-12 parts Scrophularia ningpoensis, 2-10 parts Glycyrrhiza uralensis, 4-12 parts Citrus reticulata, and 4-12 parts Astragalus membranaceus. The subordinate concept of "by weight, including the following components: 2-10 parts Platycodon grandiflorus, 4-12 parts Houttuynia cordata, 2-10 parts Perilla frutescens, 2-10 parts Gleditsia sinensis, 4-12 parts Scrophularia ningpoensis, 2-10 parts Glycyrrhiza uralensis, 4-12 parts Citrus reticulata, and 4-12 parts Astragalus membranaceus" and "by weight, including the following components: 2-10 parts Platycodon grandiflorus, 4-12 parts Houttuynia cordata, 2-10 parts Perilla frutescens, 2-10 parts Gleditsia sinensis, 4-12 parts Scrophularia ningpoensis, 2-10 parts Glycyrrhiza uralensis, 4-12 parts Citrus reticulata, and 4-12 parts Astragalus membranaceus" is also recognized. The technical means that are basically equivalent to "12 parts by weight, 2-10 parts by weight, 4-12 parts by weight, licorice, tangerine peel, and 4-12 parts by weight", and the technical means that can replace "by weight, including the following components: 2-10 parts by weight, houttuynia cordata, 2-10 parts by weight, 2-10 parts by weight, 2-10 parts by weight, 2-10 parts by weight, 4-12 parts by weight, scrophularia ningpoensis, licorice, tangerine peel, and 4-12 parts by weight" based on the existing technical level and conventional technical means and common knowledge, should all fall within the protection scope of "by weight, including the following components: 2-10 parts by weight, houttuynia cordata, 2-12 parts by weight, 2-10 parts by weight, 2-10 parts by weight, 2-10 parts by weight, 2-10 parts by weight, scrophularia ningpoensis, licorice, 2-10 parts by weight, 4-12 ...

[0048] In this invention, Examples 1-12 at least support the protection scope of "including the following components by weight: 4-10 parts of Platycodon grandiflorus, 6-12 parts of Houttuynia cordata, 4-10 parts of Perilla frutescens stem, 4-10 parts of Gleditsia sinensis thorn, 6-12 parts of Scrophularia ningpoensis, 4-10 parts of Glycyrrhiza uralensis, 6-12 parts of Citrus reticulata peel, and 6-12 parts of Astragalus membranaceus".

[0049] "By weight, it includes the following components: Platycodon grandiflorus 4-10 parts, Houttuynia cordata 6-12 parts, Perilla frutescens stem 4-10 parts, Gleditsia sinensis thorn 4-10 parts, Scrophularia ningpoensis 6-12 parts, Glycyrrhiza uralensis 4-10 parts, Citrus reticulata peel 6-12 parts, Astragalus membranaceus 6-12 parts," which is summarized as "Traditional Chinese Medicine Composition" by the foregoing explanation and / or Examples 1-12 in this document. Therefore, those skilled in the art can reasonably presume that the following components, by weight, are included: Platycodon grandiflorus 4-10 parts, Houttuynia cordata 6-12 parts, Perilla frutescens 4-10 parts, Gleditsia sinensis 4-10 parts, Scrophularia ningpoensis 6-12 parts, Glycyrrhiza uralensis 4-10 parts, Citrus reticulata 6-12 parts, Astragalus membranaceus 6-12 parts, and the sub-concept of "by weight, including the following components: Platycodon grandiflorus 4-10 parts, Houttuynia cordata 6-12 parts, Perilla frutescens 4-10 parts, Gleditsia sinensis 4-10 parts, Scrophularia ningpoensis 6-12 parts, Glycyrrhiza uralensis 4-10 parts, Citrus reticulata 6-12 parts, Astragalus membranaceus 6-12 parts" and "by weight, including the following components: Platycodon grandiflorus 4-10 parts, Houttuynia cordata 6-12 parts, Perilla frutescens 4-10 parts, Gleditsia sinensis 4-10 parts, Scrophularia ningpoensis 6-12 parts, Glycyrrhiza uralensis 4-10 parts, Citrus reticulata 6-12 parts, Astragalus membranaceus 6-12 parts" are all included. The technical means that are basically equivalent to "4-12 parts by weight of Platycodon grandiflorus, 4-10 parts by weight of Houttuynia cordata, 4-12 parts by weight of Perilla frutescens, 4-10 parts by weight of Gleditsia sinensis, 6-12 parts by weight of Scrophularia ningpoensis, 4-10 parts by weight of licorice, 6-12 parts by weight of tangerine peel, and 6-12 parts by weight of Astragalus membranaceus" and can replace the technical means that "by weight of licorice, Houttuynia cordata, 4-10 parts by weight of Perilla frutescens, 4-10 parts by weight of Gleditsia sinensis, 6-12 parts by weight of Scrophularia ningpoensis, 4-10 parts by weight of licorice, 6-12 parts by weight of tangerine peel, and 6-12 parts by weight of Astragalus membranaceus" based on the existing technical level and conventional technical means and common common sense should all fall within the protection scope of "4-10 parts by weight of Platycodon grandiflorus, 6-12 parts by weight of Houttuynia cordata, 4-12 parts by weight of Perilla frutescens, 4-10 parts by weight of Gleditsia sinensis, 6-12 parts by weight of Scrophularia ningpoensis, 4-10 parts by weight of licorice, 6-12 parts by weight of tangerine peel, and 6-12 parts by weight of Astragalus membranaceus".

[0050] In this invention, Examples 1-12 at least support the protection scope of "the preparation method of the traditional Chinese medicine composition includes the following steps: mixing the medicinal materials and decocting them with water, combining the filtrates, concentrating them, and thus obtaining the product".

[0051] "The preparation method of the traditional Chinese medicine composition includes the following steps: mixing the medicinal materials and decocting them with water, combining the filtrates, concentrating them, and thus obtaining the composition," which is summarized from the foregoing explanation and / or Examples 1-12 in the "Preparation Method of Traditional Chinese Medicine Composition". Therefore, based on reasonable presumption, those skilled in the art can determine that the subordinate concepts of "the method of preparing the traditional Chinese medicine composition includes the following steps: mixing the medicinal materials, decocting with water, combining the filtrates, concentrating, and obtaining the final product" and "the method of preparing the traditional Chinese medicine composition includes the following steps: mixing the medicinal materials, decocting with water, combining the filtrates, concentrating, and obtaining the final product", as well as the technical means that are essentially equivalent to "the method of preparing the traditional Chinese medicine composition includes the following steps: mixing the medicinal materials, decocting with water, combining the filtrates, concentrating, and obtaining the final product", and the technical means that can replace "the method of preparing the traditional Chinese medicine composition includes the following steps: mixing the medicinal materials, decocting with water, combining the filtrates, concentrating, and obtaining the final product" within the scope of protection of "the method of preparing the traditional Chinese medicine composition includes the following steps: mixing the medicinal materials, decocting with water, combining the filtrates, concentrating, and obtaining the final product" based on existing technical levels and conventional technical means and common knowledge, should all fall within the protection scope of "the method of preparing the traditional Chinese medicine composition includes the following steps: mixing the medicinal materials, decocting with water, combining the filtrates, concentrating, and obtaining the final product".

[0052] In this invention, Examples 1-12 at least support the protection scope of "the mass of the water is 6-12 times the total mass of the medicinal materials; the number of decoctions is 2-4 times, and the decoction time is 1-3 hours".

[0053] "The mass of the water is 6-12 times the total mass of the medicinal materials; the number of decoctions is 2-4 times, and the decoction time is 1-3 hours," is summarized from the foregoing explanation and / or Examples 1-12 in the "Preparation Method of Traditional Chinese Medicine Composition". Therefore, based on reasonable presumption, those skilled in the art can determine that the following subordinate concepts, namely "the mass of the water is 6-12 times the total mass of the medicinal materials; the number of decoctions is 2-4 times, and the decoction time is 1-3 hours," "the mass of the water is 6-12 times the total mass of the medicinal materials; the number of decoctions is 2-4 times, and the decoction time is 1-3 hours," as well as the technical means that are essentially equivalent to "the mass of the water is 6-12 times the total mass of the medicinal materials; the number of decoctions is 2-4 times, and the decoction time is 1-3 hours," and the technical means that can replace "the mass of the water is 6-12 times the total mass of the medicinal materials; the number of decoctions is 2-4 times, and the decoction time is 1-3 hours" based on existing technical levels and conventional technical means and common knowledge, should all fall within the protection scope of "the mass of the water is 6-12 times the total mass of the medicinal materials; the number of decoctions is 2-4 times, and the decoction time is 1-3 hours."

[0054] Examples 1-12 of this invention at least support the protection scope of "the concentration yields an extract with a relative density of 1.15-1.25 g / mL at 60°C".

[0055] The phrase "the concentrated extract with a relative density of 1.15-1.25 g / mL at 60°C" is derived from the foregoing explanation and / or Examples 1-12 summarized in the "Preparation Method of Traditional Chinese Medicine Composition". Therefore, those skilled in the art can reasonably infer that the following subordinate concepts of "the concentrated extract with a relative density of 1.15-1.25 g / mL at 60°C", the essentially equivalent technical means of "the concentrated extract with a relative density of 1.15-1.25 g / mL at 60°C", and the technical means that can replace "the concentrated extract with a relative density of 1.15-1.25 g / mL at 60°C" based on existing technology and conventional technical means and common knowledge should all fall within the protection scope of "the concentrated extract with a relative density of 1.15-1.25 g / mL at 60°C".

[0056] Examples 5-12 of this invention at least support the protection scope of "a pharmaceutical preparation comprising the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients".

[0057] The phrase "a pharmaceutical preparation comprising the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients" is derived from the foregoing explanation and / or Examples 5-12 summarized under the term "pharmaceutical preparation." Therefore, those skilled in the art, through reasonable presumption, can determine that "a pharmaceutical preparation comprising the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients," the subordinate concept of "a pharmaceutical preparation comprising the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients," the essentially equivalent technical means of "a pharmaceutical preparation comprising the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients," and the technical means that can replace "a pharmaceutical preparation comprising the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients" within the scope of protection of "a pharmaceutical preparation comprising the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients" based on existing technical levels and conventional technical means and common knowledge, should all fall within the protection scope of "a pharmaceutical preparation comprising the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients."

[0058] In this invention, Examples 5-12 at least support the protection scope of "the excipients include one or more of preservatives, wetting agents, suspending agents, flavoring agents, diluents, flavoring agents and solubilizers; the dosage form of the preparation is tablets, capsules, granules, liquid preparations or ointments; the pH of the preparation is 5.0-6.1".

[0059] "The excipients include one or more of preservatives, humectants, suspending agents, flavoring agents, diluents, flavoring agents, and solubilizers; the dosage form of the preparation is tablets, capsules, granules, liquid preparations, or ointments; the pH of the preparation is 5.0-6.1," as summarized in the foregoing explanation and / or Examples 5-12 under the category of "pharmaceutical preparations." Therefore, those skilled in the art can reasonably presume that the following sub-concepts can be recognized: "The excipients include one or more of preservatives, wetting agents, suspending agents, flavoring agents, diluents, flavoring agents, and solubilizers; the dosage form of the preparation is tablets, capsules, granules, liquid preparations, or ointments; the pH of the preparation is 5.0-6.1"; and "The excipients include one or more of preservatives, wetting agents, suspending agents, flavoring agents, diluents, flavoring agents, and solubilizers; the dosage form of the preparation is tablets, capsules, granules, liquid preparations, or ointments; the pH of the preparation is 5.0-6.1". The following technical means are essentially equivalent to those described in the phrase "the excipients include one or more of preservatives, wetting agents, suspending agents, flavoring agents, diluents, flavoring agents, and solubilizers; the dosage form of the preparation is tablets, capsules, granules, liquid preparations, or ointments; the pH of the preparation is 5.0-6.1" and are alternatives to those described in the phrase "the excipients include one or more of preservatives, wetting agents, suspending agents, flavoring agents, diluents, flavoring agents, and solubilizers; the dosage form of the preparation is tablets, capsules, granules, liquid preparations, or ointments; the pH of the preparation is 5.0-6.1" within the scope of protection:

[0060] In this invention, Examples 5-12 at least support the protection scope of "the flavoring agent includes one or more of the following: grapefruit flavoring, passion fruit flavoring, blueberry flavoring, mango flavoring, milk flavoring, peach flavoring, orange flavoring, sweet orange flavoring, pineapple flavoring, grape flavoring, apple flavoring, banana flavoring, strawberry flavoring, and chocolate flavoring".

[0061] "The flavoring agents include one or more of grapefruit flavoring, passion fruit flavoring, blueberry flavoring, mango flavoring, milk flavoring, peach flavoring, orange flavoring, sweet orange flavoring, pineapple flavoring, grape flavoring, apple flavoring, banana flavoring, strawberry flavoring, and chocolate flavoring," as summarized in the foregoing explanation and / or Examples 5-12 of this document under the term "pharmaceutical preparations." Therefore, those skilled in the art can reasonably presume that the following subordinate concepts are used to define "the flavoring agent includes one or more of grapefruit flavoring, passion fruit flavoring, blueberry flavoring, mango flavoring, milk flavoring, peach flavoring, orange flavoring, sweet orange flavoring, pineapple flavoring, grape flavoring, apple flavoring, banana flavoring, strawberry flavoring, and chocolate flavoring": "the flavoring agent includes one or more of grapefruit flavoring, passion fruit flavoring, blueberry flavoring, mango flavoring, milk flavoring, peach flavoring, orange flavoring, sweet orange flavoring, pineapple flavoring, grape flavoring, apple flavoring, banana flavoring, strawberry flavoring, and chocolate flavoring". The following technical means are essentially equivalent to "one or more of grape flavoring, apple flavoring, banana flavoring, strawberry flavoring, and chocolate flavoring" and, based on existing technology and within conventional technical means and common knowledge, can replace "one or more of grape flavoring, passion fruit flavoring, blueberry flavoring, mango flavoring, milk flavoring, peach flavoring, orange flavoring, sweet orange flavoring, pineapple flavoring, grape flavoring, apple flavoring, banana flavoring, strawberry flavoring, and chocolate flavoring" and should all fall within the protection scope of "one or more of grape flavoring, passion fruit flavoring, blueberry flavoring, mango flavoring, milk flavoring, peach flavoring, orange flavoring, sweet orange flavoring, pineapple flavoring, grape flavoring, apple flavoring, banana flavoring, strawberry flavoring, and chocolate flavoring".

[0062] Examples 1-12 of this invention at least support the protection scope of "the application of the traditional Chinese medicine composition or the pharmaceutical preparation in the preparation of a drug for treating adenoid hypertrophy".

[0063] The phrase "the application of the traditional Chinese medicine composition or the pharmaceutical preparation in the preparation of a drug for treating adenoid hypertrophy" is derived from the foregoing explanation and / or the summarization of Examples 5-12. Therefore, those skilled in the art can reasonably presume that the following subordinate concepts of "the application of the traditional Chinese medicine composition or the pharmaceutical preparation in the preparation of a drug for treating adenoid hypertrophy," the essentially equivalent technical means of "the application of the traditional Chinese medicine composition or the pharmaceutical preparation in the preparation of a drug for treating adenoid hypertrophy," and the technical means that can replace "the application of the traditional Chinese medicine composition or the pharmaceutical preparation in the preparation of a drug for treating adenoid hypertrophy" based on existing technology and conventional technical means and common knowledge should all fall within the protection scope of "the application of the traditional Chinese medicine composition or the pharmaceutical preparation in the preparation of a drug for treating adenoid hypertrophy."

[0064] The beneficial effects of this invention are as follows: The traditional Chinese medicine composition of the present invention can effectively improve the symptoms and signs of adenoid hypertrophy in children, with a low relapse rate after discontinuation of the drug and few adverse reactions.

[0065] Furthermore, based on the present invention: Based on the comparison of Examples 1-12 and Comparative Examples 1-3, the present invention employs a technical means: a traditional Chinese medicine composition comprising the following components: Platycodon grandiflorus, Houttuynia cordata, Perilla frutescens stem, Gleditsia sinensis thorns, Scrophularia ningpoensis, Glycyrrhiza uralensis, Citrus reticulata peel, and Astragalus membranaceus, achieving new technical effects: this traditional Chinese medicine composition can effectively improve the symptoms and signs of adenoid hypertrophy in children. The combined technical effect is superior to the sum of the effects of each individual technical means. Detailed Implementation

[0066] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and such changes should also fall within the scope of protection claimed by the present invention.

[0067] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all instruments, devices, equipment, reagents, products, etc., used in the embodiments of the present invention are obtained through conventional commercial means.

[0068] In this invention, the Platycodon grandiflorum can be the conventional Platycodon grandiflorum in the art, preferably produced in Anhui Province, and is the dried root of Platycodon grandiflorum (Jacq.) A.DC., a plant of the Campanulaceae family.

[0069] Houttuynia cordata can refer to the conventional Houttuynia cordata in this field, preferably from Hubei Province, and is the fresh whole herb or dried aerial parts of Houttuynia cordata Thunb., a plant of the Saururaceae family.

[0070] The perilla stem can be the conventional perilla stem in this field, preferably from Hubei Province, and is the dried stem of the plant Perilla frutescens (L.) Britt. of the Lamiaceae family.

[0071] The thorns of the soapberry can be the conventional soapberry thorns in this field, preferably those from Henan Province, which are the dried thorns of the legume plant Gleditsia sinensis Lam.

[0072] The Scrophularia can refer to the conventional Scrophularia in this field, preferably from Zhejiang Province, and is the dried root of Scrophularia ningpoensis Hemsl., a plant of the Scrophulariaceae family.

[0073] The licorice can be the conventional licorice in this field, preferably from Inner Mongolia, and is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., all belonging to the legume family.

[0074] The dried tangerine peel can be the conventional dried tangerine peel in this field, preferably produced in Hunan Province, and is the dried mature peel of Citrus reticulata Blanco and its cultivated varieties, belonging to the Rutaceae family.

[0075] Astragalus can refer to the conventional Astragalus in this field, preferably from Inner Mongolia, and is the dried root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. of the Fabaceae family.

[0076] Example 1 A traditional Chinese medicine composition for treating adenoid hypertrophy in children, comprising the following components by weight: 6 parts Platycodon grandiflorus, 9 parts Houttuynia cordata, 6 parts Perilla frutescens stem, 6 parts Gleditsia sinensis thorn, 9 parts Scrophularia ningpoensis, 6 parts Glycyrrhiza uralensis, 9 parts Citrus reticulata peel, and 9 parts Astragalus membranaceus.

[0077] The preparation method of this traditional Chinese medicine composition is as follows: First, add water equal to 6 times the total mass of the medicinal materials, decoct twice, the first time for 2 hours and the second time for 1.5 hours, filter, and combine the filtrates. Then, concentrate the combined filtrate under reduced pressure to a relative density of 1.15-1.25 g / mL (60℃), stop the concentration to obtain an extract, and finally dry it to obtain a dry extract powder for later use.

[0078] Example 2 A traditional Chinese medicine composition for treating adenoid hypertrophy in children, comprising the following components by weight: 10 parts Platycodon grandiflorus, 4 parts Houttuynia cordata, 2 parts Perilla frutescens stem, 2 parts Gleditsia sinensis thorn, 12 parts Scrophularia ningpoensis, 10 parts Glycyrrhiza uralensis, 8 parts Citrus reticulata peel, and 12 parts Astragalus membranaceus.

[0079] The preparation method of this traditional Chinese medicine composition is the same as in Example 1.

[0080] Example 3 A traditional Chinese medicine composition for treating adenoid hypertrophy in children, comprising the following components by weight: 2 parts Platycodon grandiflorus, 12 parts Houttuynia cordata, 10 parts Perilla frutescens stem, 10 parts Gleditsia sinensis thorn, 8 parts Scrophularia ningpoensis, 10 parts Glycyrrhiza uralensis, 4 parts Citrus reticulata peel, and 4 parts Astragalus membranaceus.

[0081] The preparation method of this traditional Chinese medicine composition is the same as in Example 1.

[0082] Example 4 A traditional Chinese medicine composition for treating adenoid hypertrophy in children, comprising the following components by weight: 7 parts Platycodon grandiflorus, 10 parts Houttuynia cordata, 8 parts Perilla frutescens stem, 7 parts Gleditsia sinensis thorn, 10 parts Scrophularia ningpoensis, 2 parts Glycyrrhiza uralensis, 12 parts Citrus reticulata peel, and 4 parts Astragalus membranaceus.

[0083] The preparation method of this traditional Chinese medicine composition is the same as in Example 1.

[0084] Example 5 A pharmaceutical preparation for treating adenoid hypertrophy in children, prepared as follows: Take 3 parts by weight of Platycodon grandiflorus, 9 parts of Gleditsia sinensis thorns, 5 parts of Citrus reticulata peel, 3 parts of Perilla frutescens stem, 11 parts of Houttuynia cordata, 11 parts of Scrophularia ningpoensis, 9 parts of Glycyrrhiza uralensis, and 5 parts of Astragalus membranaceus. Add 6 times the total weight of the medicinal materials to water, decoct twice, the first time for 2 hours and the second time for 1.5 hours. Filter and combine the filtrates. Concentrate the combined filtrate under reduced pressure to a relative density of 1.15-1.25 g / mL (60℃), stop concentration, and obtain an extract. Centrifuge the extract (8000-15000 r / min), add water (mass-volume ratio of extract to water is 7 g:3 mL), centrifuge (11000-15000 r / min), filter, adjust the pH to 5.6, filter again, and obtain the final product.

[0085] Example 6 A pharmaceutical preparation for treating adenoid hypertrophy in children, prepared as follows: Take 10 parts by weight of Platycodon grandiflorus, 8 parts of Gleditsia sinensis thorns, 6 parts of Citrus reticulata peel, 4 parts of Perilla frutescens stem, 10 parts of Houttuynia cordata, 7 parts of Scrophularia ningpoensis, 7 parts of Glycyrrhiza uralensis, and 6 parts of Astragalus membranaceus. Add 6 times the total weight of the medicinal materials to water, decoct 3 times, the first time for 2 hours, and the second and third times for 1.5 hours each. Filter and combine the filtrates. Concentrate the combined filtrate under reduced pressure to a relative density of 1.15-1.25 g / mL (60℃), stop concentration, and obtain an extract. Centrifuge the extract (8000-15000 r / min), add water (mass-volume ratio of extract to water is 7 g:3 mL), centrifuge (11000-15000 r / min), add strawberry flavoring, filter, adjust pH to 5.6, filter again, and obtain the final product.

[0086] Example 7 A pharmaceutical preparation for treating adenoid hypertrophy in children, prepared as follows: Take 5 parts by weight of Platycodon grandiflorus, 5 parts of Gleditsia sinensis thorns, 7 parts of Citrus reticulata peel, 8 parts of Perilla frutescens stem, 10 parts of Houttuynia cordata, 9 parts of Scrophularia ningpoensis, 5 parts of Glycyrrhiza uralensis, and 7 parts of Astragalus membranaceus. Add 8 times the total weight of the medicinal materials to water, decoct 3 times, 2 hours each time, filter, and combine the filtrates. Concentrate the combined filtrate under reduced pressure to a relative density of 1.15-1.25 g / mL (60℃), stop concentration, and obtain an extract. Centrifuge the extract (8000-15000 r / min), add water (mass-volume ratio of extract to water is 7 g:3 mL), centrifuge (11000-15000 r / min), add chocolate flavoring, filter, adjust pH to 5.6, filter again, and obtain the final product.

[0087] Example 8 A pharmaceutical preparation for treating adenoid hypertrophy in children, prepared as follows: Take 8 parts by weight of Platycodon grandiflorus, 4 parts of Gleditsia sinensis thorns, 10 parts of Citrus reticulata peel, 7 parts of Perilla frutescens stem, 6 parts of Houttuynia cordata, 5 parts of Scrophularia ningpoensis, 8 parts of Glycyrrhiza uralensis, and 12 parts of Astragalus membranaceus. Add 8 times the total weight of the Chinese medicinal materials to water, decoct 3 times, 1.5 h each time, filter, and combine the filtrates. Concentrate the combined filtrate under reduced pressure to a relative density of 1.15-1.25 g / mL (40℃), stop concentration, and obtain an extract. Add water to the extract to a relative density of 1.01-1.11 g / mL (20℃), centrifuge (1000-18000 r / min), concentrate under reduced pressure to a relative density of 1.11-1.21 g / mL (40℃), stop concentration, centrifuge (1000-18000 r / min), boil and concentrate until the weight loss is 20-30%, add green apple flavoring and sweet orange flavoring, filter, adjust pH to 6.0, filter again, and obtain the final product.

[0088] Example 9 A pharmaceutical preparation for treating adenoid hypertrophy in children, prepared as follows: Take 9 parts by weight of Platycodon grandiflorus, 3 parts of Gleditsia sinensis thorns, 11 parts of Citrus reticulata peel, 9 parts of Perilla frutescens stem, 5 parts of Houttuynia cordata, 4 parts of Scrophularia ningpoensis, 3 parts of Glycyrrhiza uralensis, and 10 parts of Astragalus membranaceus. Add 8 times the total weight of the medicinal materials to water, decoct 3 times, 2 hours each time, filter, and combine the filtrates. Concentrate the combined filtrate under reduced pressure to a relative density of 1.15-1.25 g / mL (40℃), stop the concentration, and obtain the extract. Centrifuge the extract (8000-15000 r / min), concentrate the centrifuged liquid to an appropriate volume, centrifuge (11000-15000 r / min), filter, adjust the pH to 5.9, filter again, and obtain the final product.

[0089] Example 10 A pharmaceutical preparation for treating adenoid hypertrophy in children, prepared as follows: Take 5 parts by weight of Platycodon grandiflorus, 7 parts of Gleditsia sinensis thorns, 8 parts of Citrus reticulata peel, 8 parts of Perilla frutescens stem, 10 parts of Houttuynia cordata, 8 parts of Scrophularia ningpoensis, 3 parts of Glycyrrhiza uralensis, and 11 parts of Astragalus membranaceus. Add 8 times the total weight of the medicinal materials to water, decoct 3 times, 1.5 hours each time, filter, and combine the filtrates. Concentrate the combined filtrate under reduced pressure to a relative density of 1.15-1.25 g / mL (40℃), stop concentration, and obtain the extract. Add water to the extract to a relative density of 1.01-1.11 g / mL (20℃), centrifuge (1000-18000 r / min), concentrate under reduced pressure to a relative density of 1.11-1.21 g / mL (40℃), stop concentration, centrifuge (1000-18000 r / min), filter, adjust the pH to 5.7, filter again, and obtain the final product.

[0090] Example 11 A pharmaceutical preparation for treating adenoid hypertrophy in children, prepared as follows: Take 4 parts by weight of Platycodon grandiflorus, 10 parts of Gleditsia sinensis thorns, 11 parts of Citrus reticulata peel, 5 parts of Perilla frutescens stem, 7 parts of Houttuynia cordata, 6 parts of Scrophularia ningpoensis, 4 parts of Glycyrrhiza uralensis, and 8 parts of Astragalus membranaceus. Add 8 times the total weight of the medicinal materials to water, decoct 3 times, 1.5 hours each time, filter, and combine the filtrates. Concentrate the combined filtrate under reduced pressure to a relative density of 1.15-1.25 g / mL (40℃), stop concentration, and obtain the extract. Add water to the extract to a relative density of 1.01-1.11 g / mL (20℃), centrifuge (1000-18000 r / min), concentrate under reduced pressure to a relative density of 1.11-1.21 g / mL (40℃), stop concentration, centrifuge (1000-18000 r / min), boil and concentrate until the weight loss is 20%-30%, add sweet orange flavoring, filter, adjust pH to 6.0, filter again, and obtain the final product.

[0091] Example 12 A pharmaceutical preparation for treating adenoid hypertrophy in children, prepared as follows: Take 5 parts by weight of Platycodon grandiflorus, 7 parts of Gleditsia sinensis thorns, 8 parts of Citrus reticulata peel, 8 parts of Perilla frutescens stem, 10 parts of Houttuynia cordata, 8 parts of Scrophularia ningpoensis, 11 parts of Glycyrrhiza uralensis, and 3 parts of Astragalus membranaceus. Add 8 times the total weight of the medicinal materials to water, decoct 3 times, 2 hours each time, filter, and combine the filtrates. Concentrate the combined filtrate under reduced pressure to a relative density of 1.15-1.25 g / mL (40℃), stop concentration, and obtain an extract. Add water to the extract to a relative density of 1.01-1.11 g / mL (20℃), centrifuge (1000-18000 r / min), concentrate under reduced pressure to a relative density of 1.11-1.21 g / mL (40℃), stop concentration, centrifuge (1000-18000 r / min), concentrate under reduced pressure to a relative density of 1.11-1.21 g / mL (40℃), add sweet orange flavoring, filter, adjust pH to 5.6, filter again, and obtain the final product.

[0092] Comparative Example 1 Compared with Example 1, the only difference is that the Gleditsia sinensis thorns, one of the principal ingredients, were removed.

[0093] Comparative Example 2 Compared with Example 1, the only difference is that Houttuynia cordata, one of the auxiliary herbs, was removed.

[0094] Comparative Example 3 Compared with Example 1, the only difference is that Astragalus membranaceus, one of the adjuvant herbs, was removed.

[0095] Comparative Example 4 Compared with Example 1, the only difference is that Scrophularia ningpoensis, one of the principal herbs, is replaced with Rehmannia glutinosa. In this formula, Scrophularia ningpoensis enters the Yin aspect and clears away floating heat, while Rehmannia glutinosa is sweet and cold, nourishes Yin, clears heat and cools the blood, and has similar effects.

[0096] Detection example An experiment was conducted to investigate the effects of ovalbumin sensitization (intraperitoneal injection + nasal drops) combined with ammonia throat spray on the establishment of a rat adenoid hypertrophy model. 1. Animal modeling, grouping, and drug administration On day 1 (the first day of modeling), the weight of the rats was measured, and 8 rats were randomly selected as the normal control group according to the random number generation method. The remaining rats were used for the adenoid hypertrophy model.

[0097] Basic sensitization was performed by intraperitoneal injection of 1 mL / animal ovalbumin-aluminum hydroxide suspension on days 1, 3, 5, 7, 9, 11, and 13, for a total of 7 times. A magnetic stirrer was used to continuously mix the suspension during injection to ensure the homogeneity of the injection solution.

[0098] From D14 to D21, rats were placed in a head-down position, and 50 μL of 5% OVA (ovalbumin) solution was dripped into each nostril using a micropipette as a challenge, once daily for 7 consecutive days.

[0099] From D22 to D29, rats were kept in a head-down position, and 50 μL of 1% OVA solution was dripped into each nostril using a micropipette to maintain the position once a day for 7 consecutive days.

[0100] From D1 to D29, 5% ammonia water was sprayed into the pharyngeal cavity of rats twice a day (once for D29), with each spray consisting of 2 puffs (approximately 200 μL) and an interval of approximately 6 hours between stimulations, for a total of 29 days.

[0101] The normal control group animals underwent the same procedure with an equal volume of 0.9% sodium chloride injection.

[0102] On day 14, after provocation with 5% OVA solution, the animals' allergic symptoms were scored (scoring criteria are shown in Table 1). A total score of over 5 points indicated successful model establishment. This method was used to construct an adenoid hypertrophy model.

[0103] Table 1. Scoring of allergy symptoms.

[0104] Rats that successfully developed the model were ranked from highest to lowest score, and animals with lower scores were culled and euthanized after the experiment. The selected model rats were randomly divided into four groups using the standard Latin square grouping method: normal control group, model control group, positive control group, Examples 1-4 groups, and Comparative Examples 1-3 groups, with 8 rats in each group. The positive control group was administered a children's throat-clearing and fever-reducing oral liquid by gavage, while Examples 1-4 groups and Comparative Examples 1-3 groups were administered the corresponding traditional Chinese medicine compositions by gavage. After grouping, the allergic symptom scores of each group were not statistically significant at the 5.0% significance level. Specific drug administration information is shown in Table 2 below. Table 2 Dosage Design Table

[0105] Starting from day 15, each group of animals began receiving the corresponding drug formulation and dosage via gavage, twice daily for 15 consecutive days. A magnetic stirrer was used to continuously mix the drug formulation during administration to ensure homogeneity. The normal control group and the model control group were administered the same volume of pure water via gavage as the drug-treated groups. The dosage was calculated based on the most recent animal weight. During the administration period, the procedure was performed in the following sequence: administration-ammonia spray-provocation-administration-ammonia spray.

[0106] 2. Indicator Inspection (1) General condition observation: During modeling and drug administration, animals should be observed at least once a day, including but not limited to behavioral activity, mental state, fecal characteristics, and mortality.

[0107] (2) Observation of allergy symptoms: D28. After challenging the animals with the corresponding OVA solution, according to the scoring criteria in Table 1, start timing each time OVA solution is applied, observe the animal behavior within 30 minutes after the challenge, score the allergic symptoms, and calculate the total score of each animal's symptoms.

[0108] (3) Immunological indicators: D28, all animals are kept on a fast but allowed water overnight.

[0109] On day 29, after administration and stimulation, the animals were anesthetized with a combination of salbutamol 50 and xylazine hydrochloride (50 mg / mL salbutamol and 50 mg / mL xylazine hydrochloride mixed in a volume ratio of 10:1), the abdominal cavity was opened, and blood was collected through the abdominal aorta for euthanasia.

[0110] The oropharynx of rats was opened, and a portion of pharyngeal tissue was collected. The tissue was temporarily stored on dry ice during collection and then stored at -20℃ after collection. Before testing, the tissue was weighed, and pre-chilled PBS was added at a ratio of 1 g: 9 mL. After homogenization, the supernatant was collected by centrifugation. The IL-6 level in the tissue was detected using ELISA.

[0111] (4) Pathological examination: The mandible was removed, and the rat head (including nasal mucosa and remaining pharyngeal tissue) was harvested and fixed with 10% neutral formalin solution. After thorough fixation, decalcification was performed, followed by tissue sampling, dehydration, embedding, sagittal sectioning, and hematoxylin-eosin (HE) staining for histopathological examination. The nasal mucosa and pharyngeal tissue were scored according to the severity of damage, and the total score for each animal was calculated. The scoring criteria are shown in Tables 3 and 4.

[0112] Table 3 Nasal Mucosal Pathology Scoring Criteria

[0113] Table 4 Pharyngeal Histopathological Scoring Criteria

[0114] 3. Results (1) General state observation Before administration, except for the normal control group which showed no obvious abnormalities, all animals in each group exhibited symptoms such as nasal and oral secretions, heavy breathing or rales, scratching of the mouth and nose, sneezing, or coughing. These symptoms became more pronounced after provocation. After two consecutive weeks of administration, the positive control group and the example group showed improvement in the symptoms of scratching of the mouth and nose, sneezing, or coughing.

[0115] (2) Observation of allergy symptoms The allergy symptom scores of animals in the model control group were significantly higher than those in the normal control group (P<0.01). After two weeks of continuous administration (D28), the allergy symptom scores of animals in the positive control group and the example group were significantly lower than those in the model control group (P<0.05 or P<0.01). In the comparative group, some animals showed improvement in allergy symptoms, but the overall improvement was not as significant as in the example groups, especially compared to the best-performing example group (Example 1) (P<0.05 or P<0.01). These results indicate that the example groups improved allergy symptoms, and the improvement effect of the example group was better than that of the comparative group. Specific results are shown in Table 5.

[0116] Table 5. Allergy Symptom Scores [M (P25, P75)]

[0117] Note: ## P<0.01, indicating a statistically significant difference compared to the normal control group; P<0.05, P<0.01, statistical difference between the model control group and the control group; ^P<0.05, ^^P<0.01, statistical difference between the model control group and the control group.

[0118] (3) Immunological indicators The IL-6 level in the pharyngeal tissue of the model control group was significantly higher than that of the normal control group, with a statistically significant difference (P<0.05). Compared with the model control group, the IL-6 level in the pharyngeal tissue of the positive control group, each group of the example, and each group of the comparative example decreased; among them, the decreasing trend in each group of the example was statistically significant (P<0.05 or P<0.01); the decrease in IL-6 level in the pharyngeal tissue of each group of the comparative example was less than that in the example group, with a statistically significant difference (P<0.05 or P<0.01). This indicates that the formulation of the example has an inhibitory effect on the increase of pro-inflammatory cytokine IL-6 level in animal pharyngeal tissue, and the inhibitory effect is better than that of the comparative example. Specific results are shown in Table 6.

[0119] Table 6 Immunological indicators ( x±s)

[0120] Note: # P<0.05, indicating a statistically significant difference compared to the normal control group; P<0.05, P<0.01, statistical difference between the model control group and the control group; ^P<0.05, ^^P<0.01, statistical difference between the model control group and the control group.

[0121] (4) Histopathology HE staining of nasal mucosa and pharyngeal tissue revealed the following under a microscope: In the normal control group, the nasal mucosa and pharyngeal tissue structure were normal, without edema or inflammatory cell infiltration; in the model control group, most animals showed mild edema of the nasal mucosa, edema of the pharyngeal lamina propria, and mild subepithelial inflammatory cell infiltration, even mucosal necrosis and sloughing. Compared with the model control group, the number of animals showing lesions in the nasal mucosa and pharyngeal tissue was reduced to varying degrees in the positive control group, each group of the example, and each group of the comparative example.

[0122] Histopathological scoring results showed that, compared with the normal control group, the model control group animals had significant damage to the nasal mucosa and pharyngeal tissues (P<0.01). Compared with the model control group, the positive control group and the example group animals showed significant improvement in nasal mucosa and pharyngeal tissue lesions (P<0.05 or P<0.01). The comparative group animals showed some improvement, but there was no significant difference except for the 4 comparative groups. The comparative groups showed significant differences compared with the example group 1 (P<0.05 or P<0.01). The above changes indicate that the example formula has an ameliorative effect on nasal mucosa and pharyngeal tissue lesions, and the ameliorative effect of the example formula is better than that of the comparative group. Specific results are shown in Table 7.

[0123] Table 7. Histopathological Scores [M (P25, P75)]

[0124] Note: ## P<0.01, indicating a statistically significant difference compared to the normal control group. P<0.05, P<0.01, statistical difference between the model control group and the control group; ^P<0.05, ^^P<0.01, statistical difference between the model control group and the control group.

[0125] In summary, this experiment used an ovalbumin-induced combined ammonia-stimulated method to create a combined allergic rhinitis and chronic pharyngitis SD rat animal model, simulating the allergic symptoms, inflammatory response, and pathological changes of adenoid hypertrophy. Under the conditions of this experiment, the traditional Chinese medicine composition showed an ameliorative effect on these symptoms.

[0126] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for treating adenoid hypertrophy in children, characterized in that, It includes the following components: Platycodon grandiflorus, Houttuynia cordata, Perilla frutescens stem, Gleditsia sinensis thorn, Scrophularia ningpoensis, Glycyrrhiza uralensis, Citrus reticulata peel, and Astragalus membranaceus.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, By weight, it includes the following components: Platycodon grandiflorus 2-10 parts, Houttuynia cordata 4-12 parts, Perilla frutescens stem 2-10 parts, Gleditsia sinensis thorn 2-10 parts, Scrophularia ningpoensis 4-12 parts, Glycyrrhiza uralensis 2-10 parts, Citrus reticulata peel 4-12 parts, Astragalus membranaceus 4-12 parts.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, By weight, it includes the following components: Platycodon grandiflorus 4-10 parts, Houttuynia cordata 6-12 parts, Perilla frutescens stem 4-10 parts, Gleditsia sinensis thorn 4-10 parts, Scrophularia ningpoensis 6-12 parts, Glycyrrhiza uralensis 4-10 parts, Citrus reticulata peel 6-12 parts, Astragalus membranaceus 6-12 parts.

4. A method for preparing a traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The process includes the following steps: mix all the medicinal materials, decoct them in water, combine the filtrates, and concentrate them to obtain the final product.

5. The preparation method according to claim 4, characterized in that, The mass of the water is 6-12 times the total mass of the medicinal materials; the number of decoctions is 2-4 times, and the decoction time is 1-3 hours.

6. The preparation method according to claim 4, characterized in that, The concentration yielded an extract with a relative density of 1.15-1.25 g / mL at 60°C.

7. A pharmaceutical preparation, characterized in that, It includes the traditional Chinese medicine composition according to any one of claims 1-3 and pharmaceutically acceptable excipients.

8. The pharmaceutical preparation according to claim 7, characterized in that, The excipients include one or more of the following: preservatives, humectants, suspending agents, flavoring agents, diluents, flavoring agents, and solubilizers; the dosage form of the preparation is tablets, capsules, granules, liquid preparations, or ointments; the pH of the preparation is 5.0-6.

1.

9. The pharmaceutical preparation according to claim 8, characterized in that, The flavoring agents include one or more of the following: grapefruit flavoring, passion fruit flavoring, blueberry flavoring, mango flavoring, milk flavoring, peach flavoring, orange flavoring, sweet orange flavoring, pineapple flavoring, grape flavoring, apple flavoring, banana flavoring, strawberry flavoring, and chocolate flavoring.

10. The use of a traditional Chinese medicine composition as described in any one of claims 1-3 or a pharmaceutical preparation as described in any one of claims 7-9 in the preparation of a medicament for treating adenoid hypertrophy.

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