A traditional Chinese medicine preparation for treating adenoid hypertrophy and adenoid hyperplasia

Abstract

The application discloses a traditional Chinese medicine preparation for treating adenoid hypertrophy and adenoid hyperplasia, and relates to the technical field of traditional Chinese medicine preparations. The traditional Chinese medicine preparation is prepared by using multiple drugs, and has the effects of dredging collaterals, resolving phlegm, eliminating food stagnation and the like. According to long-term clinical use, the traditional Chinese medicine preparation has remarkable treatment effects on symptoms such as night snoring, suffocation, mouth breathing, bad breath, dry throat, hot nasal breath, dry stool, sweating, frequent turning over in bed and the like in diseases such as adenoid hypertrophy and chronic tonsillitis, and is especially suitable for long-term treatment. The traditional Chinese medicine composition is used for treating adenoid hypertrophy and adenoid hyperplasia by the principle of dredging collaterals, resolving phlegm, eliminating food stagnation and the like, and is safe and effective.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparations, specifically to a traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia. Background Technology

[0002] Adenoids have a clear developmental pattern. Physiologically, the peak of hypertrophy usually occurs around age 6, and they gradually shrink after age 8. However, due to the continuous improvement of living standards in today's society, parental anxiety about nutrition, and forced feeding, children with adenoid hypertrophy often experience dietary indiscretions and excessive nutrition. This leads to impaired digestion and absorption of nutrients, resulting in the accumulation of dampness and phlegm, and pathological hyperplasia of the adenoids. Symptoms include snoring, mouth breathing, even shortness of breath, sleep disturbances, and nasal congestion. Prolonged mouth breathing can lead to "adenoid facies," significantly impacting children's growth, development, and learning, causing growth retardation, learning difficulties, and poor concentration. It may also affect multiple systems. Therefore, adenoid hypertrophy is receiving increasing attention from clinicians and parents, who hope for early diagnosis and treatment.

[0003] Childhood adenoid hypertrophy is related to dysfunction of the lungs, spleen, and liver, and has a long course. The lungs are particularly vulnerable in children, making them susceptible to external pathogens, leading to abnormal fluid distribution and the formation of phlegm. Spleen deficiency results in impaired digestion and absorption. In today's society, parental anxiety about nutrition and improper care often lead to irregular eating habits, excessive nutrition, and overconsumption of spicy, hot, fried, raw, cold, and fatty foods, placing a heavy burden on the spleen and stomach. This excessive internal heat makes the body more susceptible to external pathogens, further disrupting fluid distribution and causing phlegm formation. Furthermore, impaired spleen and stomach function prevents the proper transport of essential nutrients, easily leading to dampness and phlegm accumulation. Phlegm stagnates in the meridians, causing blockage and worsening the condition. Finally, children often have excess liver qi, which thrives on free flow and dislikes stagnation. Children's fluctuating emotions easily lead to liver qi stagnation, which, if prolonged, can transform into fire. "Qi is the commander of blood, and blood is the mother of qi." Qi stagnation leads to blood stasis, obstructing the meridians and making the disease chronic and difficult to cure. Traditional Chinese medicine (TCM) offers diverse prescriptions and treatment methods for adenoid hypertrophy, encompassing both holistic regulation of the body's constitution and localized attacks on the enlarged lesions, theoretically possessing unique advantages. However, current clinical efficacy remains unstable, with varying feedback, indicating a lack of standardized formulas with proven efficacy that can be widely adopted. Therefore, it is necessary to provide a TCM formula with proven efficacy for the effective treatment of adenoid hypertrophy and hyperplasia. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia, in order to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention specifically adopts the following technical solution: A traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia, wherein the raw materials of the preparation are composed of the following parts by weight: 6-12 parts of cinnamon twig, 6-14 parts of atractylodes macrocephala, 6-14 parts of pseudobulb of Cremastra appendiculata, 6-14 parts of fritillaria thunbergii, 6-14 parts of kelp, 6-14 parts of seaweed, 18-30 parts of raw oyster shell, 10-14 parts of bamboo shavings, 20-40 parts of Imperata cylindrica root, 6-14 parts of wine-processed scutellaria baicalensis, 20-40 parts of raw gypsum, and 2-10 parts of wine-processed rhubarb.

[0006] Furthermore, the raw materials of the traditional Chinese medicine preparation are composed of the following parts by weight: 7 parts of cinnamon twig, 8 parts of atractylodes macrocephala, 8 parts of pseudobulb of Pseudobulbus Cremastrae, 8 parts of fritillaria thunbergii, 8 parts of kelp, 8 parts of seaweed, 20 parts of raw oyster shell, 10 parts of bamboo shavings, 25 parts of Imperata cylindrica root, 8 parts of wine-processed scutellaria baicalensis, 25 parts of raw gypsum, and 2 parts of wine-processed rhubarb.

[0007] Furthermore, the raw materials of the traditional Chinese medicine preparation are composed of the following parts by weight: 9 parts of cinnamon twig, 10 parts of atractylodes macrocephala, 10 parts of pseudobulb of Pseudobulbus Cremastrae, 10 parts of fritillaria thunbergii, 10 parts of kelp, 10 parts of seaweed, 24 parts of raw oyster shell, 12 parts of bamboo shavings, 30 parts of Imperata cylindrica root, 10 parts of wine-processed scutellaria baicalensis, 30 parts of raw gypsum, and 5 parts of wine-processed rhubarb.

[0008] Furthermore, the raw materials of the traditional Chinese medicine preparation are composed of the following parts by weight: 11 parts of cinnamon twig, 12 parts of atractylodes macrocephala, 12 parts of pseudobulb of Pseudobulbus Cremastrae, 12 parts of fritillaria thunbergii, 12 parts of kelp, 12 parts of seaweed, 28 parts of raw oyster shell, 14 parts of bamboo shavings, 35 parts of Imperata cylindrica root, 12 parts of wine-processed scutellaria baicalensis, 35 parts of raw gypsum, and 8 parts of wine-processed rhubarb.

[0009] Furthermore, the traditional Chinese medicine preparations include pills, granules, capsules, decoctions, pastes, powders, and mixtures.

[0010] Furthermore, the preparation method of the compound includes the following steps: extracting and concentrating the raw material with water, adding excipients, mixing evenly, and dispensing to obtain the compound.

[0011] Furthermore, the raw material is extracted with water 2 to 3 times, with 8 to 12 times the amount of water added each time, and the decoction time is 0.5 to 1 hour each time. The decoctions are combined and concentrated, excipients are added, mixed evenly, and packaged after quality inspection.

[0012] Furthermore, the mass ratio of the active pharmaceutical ingredient to the excipient is 600-700:100-110.

[0013] Furthermore, the excipients include benzoic acid, ethylparaben, and sucrose.

[0014] Furthermore, the mass ratio of benzoic acid, ethylparaben, and sucrose is 1~3:0.1~1:100, preferably 2:0.5:100.

[0015] Furthermore, the decoction was concentrated to a relative density of 1.01–1.17.

[0016] The beneficial effects of this invention are as follows: This invention uses cinnamon twig as the principal ingredient to warm and unblock blood vessels and disperse stagnation. It is combined with atractylodes macrocephala to invigorate the spleen and replenish qi, dry dampness and resolve phlegm to aid digestion and eliminate stagnation. Furthermore, it uses pseudobulbus Cremastrae, bamboo shavings, seaweed, kelp, fritillaria thunbergii, and raw oyster shell to resolve phlegm, disperse nodules, soften hardness and reduce swelling. Combined with wine-processed scutellaria baicalensis, imperata cylindrica root, raw gypsum, and wine-processed rhubarb to clear damp-heat in the upper burner and stagnation in the internal organs, promote digestion and eliminate stagnation, and promote metabolism. All the herbs work together to unblock the meridians, resolve phlegm, eliminate stagnation and eliminate accumulation. Through long-term clinical verification, this formula has shown significant efficacy in treating symptoms such as snoring, shortness of breath, mouth breathing, halitosis, dry throat, burning sensation in the nose, constipation, excessive sweating and restlessness at night caused by adenoid hypertrophy and chronic tonsillitis. It is especially suitable for long-term treatment. The preparation has been approved by the Sichuan Provincial Drug Administration (Sichuan Drug Preparation Permit No. Z20220391000) and is used as an in-hospital preparation at the Chengdu Wuhou Kou Pediatric Traditional Chinese Medicine Clinic for the treatment of adenoid hypertrophy and hyperplasia in children. Attached Figure Description

[0017] Figure 1 Process flow diagram Figure 2 Colorimetric diagram of Imperata cylindrica root Detailed Implementation To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. It should be understood that the specific embodiments described herein are only for explaining the invention and are not intended to limit the invention; that is, the described embodiments are merely some embodiments of the invention, and not all embodiments.

[0018] Therefore, the following detailed description of the embodiments of the present invention is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0019] It should be noted that relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes the element.

[0020] The features and performance of the present invention will be further described in detail below with reference to embodiments.

[0021] This invention provides a traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia. The raw materials of the preparation are composed of the following parts by weight: 6-12 parts of cinnamon twig, 6-14 parts of atractylodes macrocephala, 6-14 parts of pseudobulb of Cremastra appendiculata, 6-14 parts of fritillaria thunbergii, 6-14 parts of kelp, 6-14 parts of seaweed, 18-30 parts of raw oyster shell, 10-14 parts of bamboo shavings, 20-40 parts of Imperata cylindrica root, 6-14 parts of wine-processed scutellaria baicalensis, 20-40 parts of raw gypsum, and 2-10 parts of wine-processed rhubarb.

[0022] Cinnamon twig, according to the 2020 edition of the Chinese Pharmacopoeia: Properties and Channels Entered: pungent, sweet, warm. Enters the Heart, Lung, and Bladder channels; Functions and Indications: Induces sweating and relieves muscle tension, warms and unblocks the channels, assists Yang and transforms Qi, calms and descends Qi. Atractylodes macrocephala, according to the 2020 edition of the Chinese Pharmacopoeia: Properties and Channels Entered: Bitter, sweet, warm. Enters the Spleen and Stomach channels; Functions and Indications: Strengthens the Spleen and replenishes Qi, dries dampness and promotes diuresis, stops sweating, and calms the fetus; According to the 2020 edition of the Chinese Pharmacopoeia, the properties and channels of *Cremastra appendiculata* are: sweet, slightly pungent, and cool. It enters the liver and spleen channels; its functions and indications are: clearing heat and detoxifying, resolving phlegm and dissipating nodules. According to the 2020 edition of the Chinese Pharmacopoeia, the properties and channels of Fritillaria thunbergii tablets are: bitter and cold. It enters the lung and heart channels; its functions and indications are: clearing heat, resolving phlegm, relieving cough, detoxifying, dissipating nodules, and reducing swelling. According to the 2020 edition of the Chinese Pharmacopoeia, kelp is salty and cold in nature, and enters the liver, stomach, and kidney meridians. Its functions and indications include resolving phlegm, softening hard masses, dissipating nodules, promoting diuresis, and reducing swelling. According to the 2020 edition of the Chinese Pharmacopoeia, seaweed is characterized by the following properties and channels: bitter, salty, and cold. It enters the liver, stomach, and kidney channels. Its functions and indications include: resolving phlegm, softening hard masses, dissipating nodules, promoting diuresis, and reducing swelling. Raw oyster, according to the 2020 edition of the Chinese Pharmacopoeia: Properties and Channels Entered: Salty, slightly cold. Enters the Liver, Gallbladder, and Kidney channels; Functions and Indications: Calms the mind and spirit, nourishes Yin and subdues Yang, softens hardness and dissipates nodules; Bamboo shavings, according to the 2020 edition of the Chinese Pharmacopoeia: Properties and Channels Entered: Sweet, slightly cold. Enters the Lung, Stomach, Heart, and Gallbladder channels; Functions and Indications: Clears heat and resolves phlegm, relieves irritability, and stops vomiting; According to the 2020 edition of the Chinese Pharmacopoeia, Imperata cylindrica root is sweet and cold in nature, and enters the lung, stomach, and bladder meridians. Its functions and indications include cooling the blood and stopping bleeding, clearing heat and promoting diuresis. According to the 2020 edition of the Chinese Pharmacopoeia, the properties and channels of Scutellaria baicalensis prepared with wine are: bitter and cold. It enters the lung, gallbladder, spleen, large intestine, and small intestine channels; its functions and indications are: clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. Gypsum, according to the 2020 edition of the Chinese Pharmacopoeia: Properties and Channels Entered: Sweet, pungent, very cold. Enters the Lung and Stomach channels; Functions and Indications: Clears heat and drains fire, relieves irritability and quenches thirst; Rhubarb processed with wine, according to the 2020 edition of the Chinese Pharmacopoeia: Properties and Channels Entered: Bitter, cold. Enters the Spleen, Stomach, Large Intestine, Liver, and Pericardium channels; Functions and Indications: Purgative, clears heat and fire, cools blood and detoxifies, removes blood stasis and unblocks menstruation, promotes diuresis and relieves jaundice.

[0023] The combined effects of these herbs work synergistically to clear the meridians, resolve phlegm, and eliminate stagnation. Long-term clinical use has shown that Xiaoxian Compound is remarkably effective in treating symptoms such as snoring, shortness of breath, mouth breathing, halitosis, dry throat, burning sensation in the nose, constipation, excessive sweating, and frequent tossing and turning at night associated with adenoid hypertrophy and chronic tonsillitis. It is particularly suitable for the long-term treatment of these conditions.

[0024] Example 1 The following is a traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia, comprising the following components by weight: 7 parts cinnamon twig, 8 parts atractylodes macrocephala, 8 parts pseudobulb of Pseudobulbus Cremastrae, 8 parts fritillaria thunbergii, 8 parts kelp, 8 parts seaweed, 20 parts raw oyster shell, 10 parts bamboo shavings, 25 parts imperata root, 8 parts wine-processed scutellaria baicalensis, 25 parts raw gypsum, and 2 parts wine-processed rhubarb.

[0025] In this embodiment, preferably, the traditional Chinese medicine composition described above and pharmaceutically acceptable excipients, including but not limited to sucrose, benzoic acid, ethylparaben, etc.

[0026] In this embodiment, preferably, the preparation includes pills, granules, capsules, decoctions, ointments, powders, and mixtures.

[0027] When the preparation is a compound, the preparation method includes the following steps: extract with water 2 to 3 times, each time adding 8 to 12 times the amount of water (8 to 12 ml of water per gram of raw material), decoct for 0.5 to 1 hour each time, combine the decoctions and concentrate to a suitable volume, a concentrated liquid with a relative density of 1.01 to 1.17, add sucrose and other excipients, mix evenly, and after quality inspection, dispense into the final product.

[0028] Example 2 The following is a traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia, comprising the following components by weight: 9 parts cinnamon twig, 10 parts atractylodes macrocephala, 10 parts pseudobulb of Pseudobulbus Cremastrae, 10 parts fritillaria thunbergii flakes, 10 parts kelp, 10 parts seaweed, 24 parts raw oyster shell, 12 parts bamboo shavings, 30 parts imperata root, 10 parts wine-processed scutellaria baicalensis, 30 parts raw gypsum, and 5 parts wine-processed rhubarb.

[0029] In this embodiment, preferably, the traditional Chinese medicine composition described above and pharmaceutically acceptable excipients, including but not limited to sucrose, benzoic acid, ethylparaben, etc.

[0030] In this embodiment, preferably, the preparation includes pills, granules, capsules, decoctions, ointments, powders, and mixtures.

[0031] When the preparation is a compound, the preparation method includes the following steps: extract with water 2 to 3 times, each time adding 8 to 12 times the amount of water (8 to 12 ml of water per gram of raw material), decoct for 0.5 to 1 hour each time, combine the decoctions and concentrate to a suitable volume, a concentrated liquid with a relative density of 1.01 to 1.17, add sucrose and other excipients, mix evenly, and after quality inspection, dispense into the final product.

[0032] Example 3 The following is a traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia, comprising the following components by weight: 11 parts cinnamon twig, 12 parts atractylodes macrocephala, 12 parts pseudobulb of Pseudobulbus Cremastrae, 12 parts fritillaria thunbergii, 12 parts kelp, 12 parts seaweed, 28 parts raw oyster shell, 14 parts bamboo shavings, 35 parts imperata root, 12 parts wine-processed scutellaria baicalensis, 35 parts raw gypsum, and 8 parts wine-processed rhubarb.

[0033] In this embodiment, preferably, the traditional Chinese medicine composition described above and pharmaceutically acceptable excipients, including but not limited to sucrose, benzoic acid, ethylparaben, etc.

[0034] In this embodiment, preferably, the preparation includes pills, granules, capsules, decoctions, ointments, powders, and mixtures.

[0035] When the preparation is a compound, the preparation method includes the following steps: extract with water 2 to 3 times, each time adding 8 to 12 times the amount of water (8 to 12 ml of water per gram of raw material), decoct for 0.5 to 1 hour each time, combine the decoctions and concentrate to a suitable volume, a concentrated liquid with a relative density of 1.01 to 1.17, add sucrose and other excipients, mix evenly, and after quality inspection, dispense into the final product.

[0036] Example 4 Formula: 36g cinnamon twig, 40g atractylodes macrocephala, 40g pseudobulb of Pseudobulbus Cremastrae, 40g fritillaria thunbergii flakes, 40g kelp, 40g seaweed, 96g raw oyster shell, 48g bamboo shavings, 120g imperata root, 40g wine-processed scutellaria baicalensis, 120g raw gypsum, 20g wine-processed rhubarb; Preparation method: Weigh the above-mentioned medicinal materials according to the ratio, soak all the medicinal materials in water for 30 minutes; decoct twice, the first time for 1 hour and the second time for 1 hour, combine the decoctions, concentrate, filter, concentrate the filtrate under reduced pressure to 1000ml, add 2g of benzoic acid, 0.5g of ethylparaben, and 100g of sucrose, mix well, and package to obtain the final product.

[0037] Example 5 Formula: 28g cinnamon twig, 32g atractylodes macrocephala, 32g pseudobulb of Pseudobulbus Cremastrae, 32g fritillaria thunbergii flakes, 32g kelp, 32g seaweed, 80g raw oyster shell, 40g bamboo shavings, 100g imperata root, 32g wine-processed scutellaria baicalensis, 100g raw gypsum, 8g wine-processed rhubarb; Preparation method: Weigh the above-mentioned medicinal materials according to the ratio, soak all the medicinal materials in water for 30 minutes; decoct twice, the first time for 1 hour and the second time for 1 hour, combine the decoctions, concentrate, filter, concentrate the filtrate under reduced pressure to 1000ml, add 2g of benzoic acid, 0.5g of ethylparaben, and 100g of sucrose, mix well, and package to obtain the final product.

[0038] Example 6 Formula: Cinnamon twig 44g, Atractylodes macrocephala 48g, Cremastra appendiculata 48g, Fritillaria thunbergii flakes 48g, Laminaria japonica 48g, Sargassum fusiforme 48g, Raw oyster shell 112g, Bamboo shavings 56g, Imperata cylindrica root 140g, Scutellaria baicalensis (processed with wine) 48g, Gypsum fibrosum 140g, Rheum palmatum (processed with wine) 32g; Preparation method: Weigh the above-mentioned medicinal materials according to the ratio, soak all the medicinal materials in water for 30 minutes; decoct twice, the first time for 1 hour and the second time for 1 hour, combine the decoctions, concentrate, filter, concentrate the filtrate under reduced pressure to 1000ml, add 2g of benzoic acid, 0.5g of ethylparaben, and 100g of sucrose, mix well, and package to obtain the final product.

[0039] The following experimental examples further illustrate the beneficial effects of the present invention: Experimental Example 1: Study on the preparation process of the anti-glandular compound of the present invention 1. Preparation method: Soak all medicinal materials in water for 30 minutes. Decoction twice, the first time for 1 hour and the second time for 1 hour. Combine the decoctions, concentrate, filter, and concentrate the filtrate under reduced pressure to 1000ml. Add 2g of benzoic acid, 0.5g of ethylparaben, and 100g of sucrose, mix well, and dispense into containers.

[0040] The herbal formula is as follows: 36g cinnamon twig, 40g atractylodes macrocephala, 40g pseudobulb of Pseudobulbus Cremastrae, 40g fritillaria thunbergii flakes, 40g kelp, 40g seaweed, 96g raw oyster shell, 48g bamboo shavings, 120g Imperata cylindrica root, 40g wine-processed scutellaria baicalensis, 120g raw gypsum, and 20g wine-processed rhubarb.

[0041] 2. Process flow diagram See Figure 1 3. Preparation process research 3.1 Water Addition Amount The experimental results showed that the dry extract yield was most suitable when the water content was 8 times the amount of medicine. Therefore, the water content was set at 8 times the amount of medicine.

[0042] 3.2 Simmering time The experimental results showed that the decoction time was 1 hour, which resulted in the highest overall dry extract rate. Therefore, the decoction time was determined to be 1 hour.

[0043] 3.3 Number of times to boil The experimental results showed that the overall dry extract rate was highest when the medicine was decocted twice, so the number of decoctions was determined to be twice.

[0044] 3.4 Conclusions on Water Extraction Process Experimental results show that the optimal dry extract yield is achieved by adding 8 times the amount of water (8 ml of water per gram of raw material), boiling twice for 1 hour each time, as part of the water extraction process.

[0045] 4. Pilot-scale experiment Table 5. Pilot-scale test data of three batches of Xiaogan Mixture All other test items met the requirements according to quality and hygiene standards.

[0046] 5. Conclusion Through three batches of pilot production of "Xiaoqian Heji" and the analysis of the test results of the pilot products, it has been proven that the "Xiaoqian Heji" produced by this process is stable, the quality is controllable, and it is fully capable of adapting to future mass production.

[0047] Experimental Example 2: Quality Study of the Anti-Glandular Compound of the Present Invention 1. Sample Source Pilot-scale sample: Anti-glandular compound; Batch numbers: 210704, 210705, and 210706, prepared in pilot-scale of Experimental Example 1. 2. Appearance: Light brown to brownish-red liquid with a slightly bitter taste. 3. Identification Based on the relevant identification requirements of the Pharmacopoeia (General Chapter 0502), a thin-layer chromatography (TLC) identification method for Imperata cylindrica root was formulated in the quality standard of Xiaoxian Heji. The specific TLC identification method for Imperata cylindrica root is as follows: Take 20 ml of this product, add 20 ml of ether and shake to extract twice, each time. Combine the ether extracts, evaporate to dryness, and dissolve the residue in 1 ml of ether to prepare the test solution. Separately, take 1 g of Imperata cylindrica root reference material, add 20 ml of ether, sonicate for 10 minutes, filter, evaporate the filtrate to dryness, and dissolve the residue in 1 ml of ether to prepare the reference material solution. Perform thin-layer chromatography (General Rule 0502), apply 10 µl of each of the above two solutions separately to the same silica gel G thin-layer plate, develop with dichloromethane as the developing solvent, remove, air dry, spray with 10% sulfuric acid ethanol solution, and heat at 105℃ until the spots are clearly visible. In the chromatogram of the test sample, spots of the same color appear at the corresponding positions as in the chromatogram of the reference material. Figure 2 ) The results showed that the method was reliable, accurate, and reproducible. Therefore, its identification method was included in the thin-layer chromatography identification of Imperata cylindrica root in the draft quality standard of Xiaoxianheji.

[0048] Experimental Example 3: Stability Study of the Anti-Glandular Compound of the Present Invention 1 Accelerated testing 1.1 Test Samples Pilot-scale samples: Anti-glandular compound prepared in pilot-scale experiment Example 1, batch numbers: 210704, 210705, 210706 1.2 Items and Methods of Investigation Based on the "Guiding Principles for Stability Research of Traditional Chinese Medicine Natural Drugs" in document "Guo Shi Yao Jian Zhu

[2006] No. 678" and the "Technical Requirements for Quality and Stability Research of Traditional Chinese Medicine Preparations in Sichuan Medical Institutions" in document "Chuan Shi Yao Jian Zhu (2009) No. 1", the accelerated testing items and standards for this preparation are proposed as follows: Properties (clarity): During storage, there shall be no mold, rancidity, foreign matter, discoloration, gas production or other deterioration. A small amount of easily dispersed sediment is permissible.

[0049] Identification: When using thin-layer chromatography, Imperata cylindrica root should show color change; Relative density: should not be less than 1.03 (General Rule 0601).

[0050] pH value: should be 3.0 to 5.0 (General rule 0631).

[0051] Microbiological testing: Unless otherwise specified, the microbial limit tests for non-sterile products shall comply with the following standards: microbial count method (General Rule 1105) and control microorganism test method (General Rule 1106), and the microbial limit standards for non-sterile drugs (General Rule 1107).

[0052] Three batches of samples with complete packaging were taken and placed in the hospital's internal packaging at a temperature of 40℃ and a relative humidity of 20% for 6 months. Samples were taken at the end of the 0th, 1st, 2nd, 3rd and 6th months respectively, and tested according to the key stability test items.

[0053] The results of the investigation are shown in the table: Table 6. Stability test results of Xiaoxian Mixture (0 months) Table 7. Results of the stability test of Xiaogan Compound (1 month) Table 8. Stability test results of Xiaogan Compound (2 months) Table 9. Results of the stability test of Xiaogan Compound (3 months) Table 10. Results of the stability test of Xiaogan Compound (6 months) 2. Conclusions and Results The anti-inflammatory compound packaged in plastic bottles was placed at room temperature and at a temperature of 40±2℃ and a relative humidity of 20%±5% for six months (equivalent to one year at room temperature). The results showed that the quality of the product remained stable during the placement process, and the packaging material had no effect on the quality.

[0054] Case Study 4: Clinical Efficacy Study 1. Materials and Methods 1.1 General Information A random sample of children with related conditions treated by Dr. Kou Enpei from January 1, 2019 to December 31, 2021 were collected. All of them were diagnosed with adenoid hypertrophy and chronic tonsillitis, with symptoms of phlegm stagnation and food retention. They met the relevant diagnostic criteria of traditional Chinese medicine pediatrics for the above-mentioned conditions. They also had symptoms such as snoring, apnea, mouth breathing, hearing loss, poor concentration, delayed growth and development, nasal speech, halitosis, dry throat, burning sensation in the nose, constipation, excessive sweating, and frequent turning over at night.

[0055] Selection criteria: Adenoid hypertrophy: a. The child may snore, hold their breath, breathe through their mouth, and have a nasal voice. They may also experience hearing loss, poor concentration, and delayed growth and development. They may also have bad breath, dry throat, burning nasal breath, constipation, excessive sweating, and frequent turning over at night. They may also have a history of recurrent upper respiratory tract infections and recurrent tonsillitis. Some children may have food stagnation or a history of picky eating. b. Take the anti-prostate compound continuously for 5-7 days; c. Those with follow-up visit records or return visit records that clearly show the treatment effect.

[0056] Chronic tonsillitis: A. The child presents with throat discomfort, dry throat, and enlarged tonsils, accompanied by snoring, shortness of breath, mouth breathing, and a noticeably nasal voice. Hearing loss and poor concentration may also occur. Halitosis, burning nasal breath, constipation, excessive sweating, and frequent turning over at night are also common symptoms. The child may have a history of recurrent tonsillitis, a history of external infection, or a history of dietary indiscretion. Symptoms may worsen after fatigue or exposure to cold. b. Take the anti-prostate compound continuously for 7-28 days; c. Those with follow-up visit records or return visit records that clearly show the treatment effect.

[0057] After this screening and statistical analysis, a total of 174 children were identified, including 109 with adenoid hypertrophy and 65 with chronic tonsillitis.

[0058] 1.2 Treatment methods The anti-glandular compound prepared in the pilot-scale experiment of Example 1 was used. The appropriate dosage and frequency of administration were selected according to the child's age. The treatment course was 7-28 days, with the medication taken three times daily. No other medications were given to any child during the treatment period.

[0059] 1.3 Efficacy Evaluation Indicators According to the diagnostic and efficacy standards for relevant diseases in the "Standards for Diagnosis and Efficacy of Pediatric Diseases in Traditional Chinese Medicine", the following indicators were used to evaluate the efficacy: airway symptoms such as snoring, apnea, and mouth breathing during sleep; accompanying symptoms such as hearing, attention, growth and development, and nasal voice; and systemic symptoms such as halitosis and dry throat. The statistical standards are as follows: Statistical criteria: The statistics are based on random sampling, and the treatment effect is divided into three levels: cured, improved, and not cured.

[0060] Cure criteria: Symptoms such as snoring, breath-holding, and mouth breathing at night have completely disappeared; nasal speech has been eliminated; hearing has returned to normal; attention can be focused; growth and development tend to be normal; symptoms such as halitosis, dry throat, burning nasal breath, constipation, excessive sweating, and frequent turning over at night have completely disappeared; and clinical symptoms have been completely relieved. Improvement criteria: Significant relief of symptoms such as snoring, breath-holding, and mouth breathing during sleep; reduced nasal tone in speech; improved hearing; improved concentration; no further delay in growth and development; significant reduction of symptoms such as halitosis, dry throat, burning sensation in the nose, constipation, excessive sweating, and frequent turning over at night; and significant improvement in clinical symptoms. Criteria for non-healing: No improvement or even worsening of airway symptoms such as snoring, breath-holding, and mouth breathing during sleep, as well as accompanying symptoms such as hearing loss and difficulty concentrating, and systemic symptoms such as halitosis and dry throat; 2 Results After treatment with anti-inflammatory compound, among the 174 children in this study: Of the 109 children with adenoid hypertrophy, 14 were cured (12.84%), 84 improved (77.06%), and 11 did not improve (10.09%). The overall effective rate of treatment was 89.90%.

[0061] Of the 65 children with chronic tonsillitis, 6 were cured (cure rate 9.23%), 51 improved (improvement rate 78.46%), and 8 did not improve (12.30%). The overall effective treatment rate was 87.69%.

[0062] 3 Discussion Pediatric adenoid hypertrophy is related to dysfunction of the lung, spleen and liver, and has a long course of disease: the lung is a delicate viscus, and this characteristic is particularly prominent in children, making it difficult for children to resist the invasion of external pathogens, which results in abnormal distribution of body fluid, and the body fluid accumulates to form phlegm. Insufficiency of the spleen leads to abnormal transportation and transformation. In the current social environment, parents have nutritional anxiety and improper care, so children often eat irregularly with excessive nutrition. Excessive consumption of pungent-hot fried food, raw-cold, greasy and sweet food places a heavy burden on the spleen and stomach, leading to excess yang heat in the body, which makes children frequently attacked by external pathogens, resulting in abnormal distribution of body fluid that accumulates to form phlegm. Moreover, abnormal transportation and transformation of the spleen and stomach prevents the normal transportation of nutritional essence, which easily leads to accumulation of dampness that forms phlegm. Phlegm turbidity stagnates in the meridians, causing blockage of the meridians and aggravating the condition. Finally, children also have the characteristic of "frequently excess liver qi". The liver prefers free flow and avers to depression. Children's emotions are changeable, which easily leads to liver depression and qi stagnation. Long-term depression transforms into fire. "Qi is the commander of blood, and blood is the mother of qi". Qi stagnation leads to blood coagulation, and qi and blood stasis block the meridians, making the disease difficult to cure after a long course. Therefore, this disease is a combination of deficiency and excess. The treatment should address both the symptoms and root causes, balance yin and yang. For the excess symptoms, it is advisable to dredge collaterals, resolve phlegm and eliminate stagnation; for the root deficiency, it is advisable to consolidate and protect the spleen and stomach, adjust the dietary structure, and reduce the continuous generation of pathological products. In the prescription of Xiaoxian Mixture (Adenoid-Eliminating Mixture), Guizhi (Ramulus Cinnamomi) is pungent, sweet and warm, which can activate yang and resolve stagnation, and acts as the monarch drug; Baizhu (Rhizoma Atractylodis Macrocephalae) can invigorate the spleen, replenish qi, dry dampness and promote diuresis, and acts as the minister drug; it is assisted with Shancigu (Pseudobulbus Cremastrae Appendiculatae) which can clear heat and detoxify, resolve phlegm and dissipate binds, Zhuru (Caulis Bambusae in Taenia) which can purge phlegm and resolve depression, Haizao (Sargassum) and Kunbu (Thallus Laminariae) which can soften hardness and dissipate binds, resolve phlegm and promote diuresis, and Beimu (Bulbus Fritillariae) which can resolve phlegm, reduce swelling, resolve depression and dissipate binds; Muli (Concha Ostreae) can nourish yin, subdue yang, soften hardness and eliminate scrofula, wine-processed Huangqin (Radix Scutellariae) can purge damp-heat in the upper energizer and treat phlegm-heat; Baimaogen (Rhizoma Imperatae) can dispel stagnant heat in viscera, Shigao (Gypsum Fibrosum) can purge stomach fire, phlegm fire and food retention, and small-dose of wine-processed Dahuang (Radix et Rhizoma Rhei) can promote digestion, remove food stagnation and remove the stale to promote the generation of new. Combined with long-term clinical results, Xiaoxian Mixture has significant therapeutic effect on symptoms caused by adenoid hypertrophy and chronic tonsillitis, such as snoring during sleep at night, breath holding, mouth breathing, halitosis, dry throat, burning nasal breath, dry stool, hyperhidrosis and frequent turning over during sleep at night.

[0063] Test Example 5 Typical Cases Case 1: Zhang, female, aged 7 years and 1 month, visited the clinic on October 29, 2023 due to "mouth breathing for 1 year". The symptoms were mouth breathing, salivation, poor appetite, formed stool, and little turning over during sleep at night. The diagnosis was "pediatric miscellaneous disease: upper energizer accumulated heat syndrome, adenoid hypertrophy, chronic rhinitis". The traditional Chinese medicine preparation described in the present application (the preparation prepared in Example 2) was prescribed for the patient. After 2 weeks of administration, the mouth breathing was reduced by 80%, the appetite became normal, and there was no abnormal turning over during sleep at night.

[0064] Case 2: Yuan, male, aged 12 years and 1 month, visited the clinic on November 30, 2023 due to "diagnosed adenoid hypertrophy for more than 1 month". The symptoms were mouth breathing, loud snoring in bilateral sleeping positions, normal appetite, formed stool, occasional cough in the morning and daytime with phlegm, pale red tongue with white and greasy coating. The traditional Chinese medicine diagnosis was "pediatric miscellaneous disease: upper energizer accumulated heat syndrome". The traditional Chinese medicine preparation described in the present application (the preparation prepared in Example 2) was prescribed for the patient. After 1 month of administration, mouth breathing was reduced, snoring was reduced and the sound became lighter, halitosis disappeared, emotional irritability was reduced, attention was improved a little, cough almost disappeared, and the tongue was pale red with thin white coating.

[0065] Case 3: Lin, male, 11 years and 4 months old, was diagnosed with allergic rhinitis at age 6. On September 13, 2022, he visited the hospital due to "snoring for 1 year." Symptoms included: significant snoring when lying flat, frequent nose picking, rubbing, and sneezing; significant nasal congestion after exposure to cold; ear discomfort; occasional blurred vision; difficulty concentrating in class; nose twitching; occasional blinking; throat clearing; shoulder shrugging; and halitosis. He frequently tossed and turned at night, kicking off the covers. His tongue was pale red with a slightly greasy white coating. His tonsils were grade 2+, and his nasal mucosa was red and swollen. The TCM diagnosis was Upper Jiao Heat Accumulation Syndrome, and the Western medicine diagnosis was: chronic tonsillitis, adenoid hypertrophy, chronic rhinitis, and chronic catarrhal otitis media. He was prescribed the TCM preparation described in this application (the preparation obtained in Example 2). After 2 weeks of use, his snoring decreased by 60%; after 4 weeks, occasional snoring occurred when lying flat at night (snoring completely stopped when lying on his side).

[0066] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia, characterized in that, The raw materials for the traditional Chinese medicine preparation are specified in the following weight proportions. Composition: Cinnamon twig 6-12 parts, Atractylodes macrocephala 6-14 parts, Cremastra appendiculata 6-14 parts, Fritillaria thunbergii 6-14 parts, Laminaria japonica 6-14 parts, Sargassum fusiforme 6-14 parts, Raw oyster shell 18-30 parts, Bambusa textilis 10-14 parts, Imperata cylindrica root 20-40 parts, Scutellaria baicalensis (processed with wine) 6-14 parts, Gypsum fibrosum 20-40 parts, Rheum palmatum (processed with wine) 2-10 parts.

2. The traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia according to claim 1, characterized in that, The raw materials for the traditional Chinese medicine preparation are specified in the following weight proportions. Composition: 7 parts cinnamon twig, 8 parts atractylodes macrocephala, 8 parts pseudobulb of Pseudobulbus Cremastrae, 8 parts fritillaria thunbergii, 8 parts kelp, 8 parts seaweed, 20 parts raw oyster shell, 10 parts bamboo shavings, 25 parts imperata root, 8 parts wine-processed scutellaria baicalensis, 25 parts raw gypsum, and 2 parts wine-processed rhubarb.

3. A traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia according to claim 1, characterized in that, The raw materials for the traditional Chinese medicine preparation are specified in the following weight proportions. Composition: 9 parts cinnamon twig, 10 parts atractylodes macrocephala, 10 parts pseudobulb, 10 parts fritillaria thunbergii, 10 parts kelp, 10 parts seaweed, 24 parts raw oyster, 12 parts bamboo shavings, 30 parts imperata root, 10 parts wine-processed scutellaria baicalensis, 30 parts raw gypsum, and 5 parts wine-processed rhubarb.

4. A traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia according to claim 1, characterized in that, The raw materials for the traditional Chinese medicine preparation are specified in the following weight proportions. Composition: 11 parts cinnamon twig, 12 parts atractylodes macrocephala, 12 parts pseudobulb of Pseudobulbus Cremastrae, 12 parts fritillaria thunbergii, 12 parts kelp, 12 parts seaweed, 28 parts raw oyster shell, 14 parts bamboo shavings, 35 parts imperata root, 12 parts wine-processed scutellaria baicalensis, 35 parts raw gypsum, and 8 parts wine-processed rhubarb.

5. A traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia according to claim 1, characterized in that, The traditional Chinese medicine preparations include pills, granules, capsules, decoctions, pastes, powders, and mixtures.

6. A traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia according to claim 5, characterized in that, The preparation method of the compound includes the following steps: extracting and concentrating the raw material with water, adding excipients, mixing evenly, and dispensing to obtain the compound.

7. A traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia according to claim 6, characterized in that, The raw material is extracted with water 2 to 3 times, with 8 to 12 times the amount of water added each time, and the decoction time is 0.5 to 1 hour each time. The decoctions are combined and concentrated, excipients are added, and the mixture is mixed evenly. After quality inspection, it is packaged to obtain the final product.

8. A traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia according to claim 6 or 7, characterized in that, The mass ratio of the active pharmaceutical ingredient to the excipient is 600-700:100-110.

9. A traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia according to claim 8, characterized in that, The excipients include benzoic acid, ethylparaben, and sucrose; The mass ratio of benzoic acid, ethylparaben, and sucrose is 1~3:0.1~1:100, preferably 2:0.5:

100.

10. A traditional Chinese medicine preparation for the treatment of adenoid hypertrophy and adenoid hyperplasia according to claim 7, characterized in that, The decoction was concentrated to a relative density of 1.01–1.17.

Images