Traditional Chinese medicine composition for inhibiting helicobacter pylori as well as preparation method and application thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for inhibiting helicobacter pylori and a preparation method and application thereof. Comprising the following raw materials: honeysuckle, dandelion, dendrobium officinale, chrysanthemum, clove and hericium erinaceus. The preparation method comprises the following steps: taking honeysuckle, dandelion, dendrobium officinale, chrysanthemum, clove and hericium erinaceus, extracting, concentrating and drying. The honeysuckle, the dandelion and the chrysanthemum in the whole formula have the effects of clearing damp-heat and removing toxins; dendrobium officinale and hericium erinaceus protect the stomach, complement each other in compatibility, dispel turbid toxins, strengthen healthy qi and jointly prevent and treat Hp, the whole formula combines cold and warm, honeysuckle and dandelion are cold in nature, clove is warm in nature, and it is avoided that the stomach is injured by bitter cold; the antibacterial effect of the honeysuckle and the clove is synchronous with the repairing effect of the dendrobium officinale and the hericium erinaceus, so that the traditional Chinese medicine composition has a remarkable effect of resisting helicobacter pylori.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for inhibiting Helicobacter pylori, its preparation method, and its application. Background Technology

[0002] Helicobacter pylori (Hp) is a Gram-negative, spiral-shaped, microaerophilic bacterium that primarily resides on the gastric mucosa of its host. It proliferates parasitically and is highly contagious in humans. Hp is transmitted through multiple routes, including zoonotic transmission, close contact, and oral-oral transmission, and familial clustering is also observed. Infection with Hp is closely related to the development and progression of diseases such as gastric cancer, chronic active gastritis, and peptic ulcers. In 1994, Hp was officially classified as a Group 1 carcinogen by the International Agency for Research on Cancer. Therefore, the search for new anti-Hp products that are less likely to induce drug resistance is urgently needed.

[0003] Currently, triple or quadruple therapy is mainly used in clinical practice both domestically and internationally. However, due to the overuse of antibiotics, bacteria have developed drug resistance, and adverse reactions such as nausea, vomiting, and rashes also occur. There is an urgent need for new treatment methods to address drug resistance and side effects. Traditional Chinese medicinal herbs, which are also used in food and medicine, have rich medicinal and nutritional value. In recent years, these herbs have demonstrated good safety in the prevention and treatment of *Helicobacter pylori* (Hp) and show broad application prospects.

[0004] Therefore, in-depth research is needed on specific Chinese herbal medicines or prescriptions used in the prevention and treatment of *Helicobacter pylori* (Hp) and their mechanisms of action. This can provide a theoretical basis and new options for the clinical application of Hp treatment using Chinese herbal medicines that are also considered food. The rational use of these Chinese herbal medicines can not only exert antibacterial effects but also avoid antibiotic resistance. Herbs such as astragalus, licorice, ginger, poria, polygonatum, jujube, and honey have shown significant clinical efficacy. However, current research on the development of products using these Chinese herbal medicines for the prevention and treatment of Hp infection is relatively limited. Therefore, future research should focus on developing products using these Chinese herbal medicines for the prevention and treatment of Hp to assist in its treatment.

[0005] For a long time, domestic and international treatments for *Helicobacter pylori* (Hp) have mainly focused on antibiotic therapy, with limited research on traditional Chinese medicine (TCM) that are both food and medicine. my country possesses abundant and diverse resources of TCM that are both food and medicine, and these TCMs have long been widely recognized. They could not only provide new treatment options for Hp but also open up new avenues for the utilization of TCM. Therefore, developing safe, non-drug-resistant, and more effective Hp-related products is a pressing technical problem that needs to be solved in this field and has significant social implications. Summary of the Invention

[0006] To address the shortcomings of existing technologies, this invention provides a traditional Chinese medicine composition for inhibiting Helicobacter pylori, its preparation method, and its application.

[0007] The objective of this invention is achieved through the following technical solution: A traditional Chinese medicine composition for inhibiting Helicobacter pylori includes the following ingredients: honeysuckle, dandelion, dendrobium officinale, chrysanthemum, clove, and hericium erinaceus.

[0008] honeysuckle( Lonicera japonica (Thunb.) refers to the dried flower buds or newly opened flowers of *Lonicera japonica*, a plant in the Caprifoliaceae family. It is harvested in early summer before the flowers open and then dried. Honeysuckle is a perennial, semi-evergreen, twining vine with young branches densely covered in soft hairs. Its flowers are twin, axillary, with a bilipped corolla, initially white, gradually turning yellow, hence the name "honeysuckle" (or "gold and silver flower"). The flower tube is slender and fragrant. Harvesting time is May to June in northern regions (the first flush is of the best quality); in southern regions, April to May, with some areas allowing for 2-3 harvests. The optimal harvesting period is during the bud stage (before the flowers open, they are bluish-white or pale green). It is mainly distributed in China, Japan, South Korea, and some North American countries. Major producing areas in China include Henan, Shandong, Hebei, Shaanxi, Hubei, Guizhou, and Sichuan. Honeysuckle has a sweet and cold nature; it enters the lung, heart, and stomach meridians, and has the effects of clearing heat and detoxifying, and dispersing wind-heat. Honeysuckle has antibacterial and antiviral properties. Its components, such as chlorogenic acid and luteolin, have significant inhibitory effects on Helicobacter pylori, Staphylococcus aureus, and influenza virus. It can also exert anti-inflammatory and immunomodulatory effects by inhibiting the NF-κB pathway to reduce inflammatory factors such as IL6 and TNF-α.

[0009] Dandelion is a plant belonging to the Asteraceae family. Taraxacum mongolicum Hand. -Mazz., Alkali Dandelion Taraxacum borealisinense The dried whole herb of *Taraxacum mongolicum* or several species of the same genus is harvested from spring to autumn when the flowers are just beginning to bloom. Impurities are removed, the herbs are washed, and then sun-dried. The optimal harvesting period for the whole herb is spring (April-May) when the flowers are just beginning to open. It is mainly distributed in the North Temperate Zone and is common in China, Europe, and North America. Major producing areas in China include Hebei, Shanxi, Inner Mongolia, Heilongjiang, Jilin, and Gansu provinces. Dandelion has a bitter and sweet taste and is cold in nature; it enters the liver and stomach meridians and has the effects of clearing heat and detoxifying, reducing swelling and dissipating nodules, and promoting diuresis. Modern pharmacological studies have shown that dandelion has antibacterial and anti-inflammatory effects. Its components, such as taraxacin and chlorogenic acid, have inhibitory effects on *Helicobacter pylori* and *Staphylococcus aureus*, and can reduce gastric mucosal inflammation by inhibiting COX-2 enzymes. In addition, its polysaccharide components can enhance the phagocytic ability of macrophages.

[0010] Dendrobium officinale is a plant belonging to the Orchidaceae family. Dendrobium officinale The dried stems of *Dendrobium officinale* et Migo. Harvested from November to March of the following year, impurities are removed, some fibrous roots are trimmed, and the stems are twisted into a spiral or spring shape while heated before drying; alternatively, they are cut into sections and dried or dried at low temperature. The former is commonly known as "Tiepi Fengdou" (earring-shaped Dendrobium); the latter is commonly known as "Tiepi Shihu" (iron-skin Dendrobium). *Dendrobium officinale* is a perennial epiphytic herb with clustered, cylindrical stems, distinct nodes, 15-50 cm long and 2-4 mm in diameter, with a bluish-gray or grayish-green surface (hence the name "iron-skin"). Its optimal harvesting period is autumn (September to November), when the stems are plump and have the highest polysaccharide content. It is mainly distributed in Zhejiang, Yunnan, Anhui, and Guangxi provinces of China. Its wild resources are a national second-class protected plant, and it is now mostly cultivated in a semi-wild manner. *Dendrobium officinale* has a sweet and slightly cold taste; it enters the stomach and kidney meridians. It has the effects of nourishing the stomach and promoting body fluids, nourishing yin and clearing heat. Modern clinical studies have shown that various components in Dendrobium officinale can promote mucosal repair by promoting the proliferation of gastric epithelial cells.

[0011] Chrysanthemum is a plant of the Asteraceae family. Chrysanthemum morifolium The dried capitulum of *Ramat.*. Harvested in batches during peak bloom from September to November, dried in the shade, baked, or steamed and then sun-dried. The medicinal material is classified into "Boju," "Chuju," "Gongju," "Hangju," and "Huaiju" according to its origin and processing method. The chrysanthemum is a terminal capitulum, 2.5-5 cm in diameter, with white or yellow ray florets (depending on the variety). The optimal harvesting period is from September to November when the flowers are in full bloom, ideally picked on a sunny morning after the dew has dried. It is mainly distributed in Anhui (Boju, Gongju), Zhejiang (Hangju), and Henan (Huaiju) in China. Chrysanthemum has a sweet and bitter taste, and is slightly cold in nature; it enters the lung and liver meridians, and has the effects of dispelling wind and clearing heat, calming the liver and improving eyesight, and clearing heat and detoxifying. It is commonly used to treat wind-heat colds, headaches and dizziness, red and swollen eyes, blurred vision, and carbuncles and boils.

[0012] Clove is a plant of the Myrtaceae family called clove. Eugenia caryophyllata Clove buds are dried flower buds. They are harvested when the buds turn from green to red and then dried. Clove buds are nail-shaped and turn reddish-brown after drying. The optimal harvest time is when the buds turn from green to red (harvesting can be done year-round in tropical regions). It is mainly distributed in Indonesia (the main producing area), Madagascar, and Sri Lanka. Cloves are pungent and warm in nature; they enter the spleen, stomach, and kidney meridians, and have the effects of warming the middle jiao (spleen and stomach), relieving nausea and vomiting, and tonifying the kidneys and strengthening yang. Modern pharmacological studies have shown that eugenol, the main component of cloves, has a significant inhibitory effect on Helicobacter pylori, with a MIC of 15.6 μg / mL.

[0013] Hericium erinaceus is a plant of the Hericaceae family (Hericium erinaceus family). Hericium erinaceusThe dried fruiting body of *Hericium erinaceus* (Bull. ex Fr.) Pers. Harvested when nearly mature and sun-dried. *Hericium erinaceus* is hemispherical or capitate, 3.5–8 cm or larger in diameter, with a short, thick stipe at the base. The surface is brownish-yellow or light brown, densely covered with numerous fleshy, soft spines. The spines are 0.3–2 cm long and 0.3–0.5 cm thick, light and soft, with a milky-white cross-section. It has a fragrant aroma and a mild taste. It is mainly distributed in Heilongjiang, Jilin, and Yunnan (wild) and Fujian and Zhejiang (cultivated) in China. *Hericium erinaceus* is sweet and neutral in nature; it enters the spleen and stomach meridians, and has the effects of strengthening the spleen and stomach, invigorating qi, and calming the mind. Modern pharmacological studies have shown that β-glucan in *Hericium erinaceus* can promote mucoprotein secretion, thereby protecting the gastric mucosa.

[0014] Preferably, the raw materials include the following parts by weight: 6-15 parts honeysuckle, 5-15 parts dandelion, 4-12 parts dendrobium officinale, 3-10 parts chrysanthemum, 1-3 parts clove and 5-30 parts monkey head mushroom.

[0015] Preferably, the raw materials include the following parts by weight: 10-15 parts honeysuckle, 5-10 parts dandelion, 4-10 parts dendrobium officinale, 3-8 parts chrysanthemum, 1-3 parts clove and 5-20 parts monkey head mushroom.

[0016] Preferably, the raw materials include the following parts by weight: 6 parts honeysuckle, 10 parts dandelion, 6 parts dendrobium officinale, 10 parts chrysanthemum, 1 part clove, and 30 parts monkey head mushroom.

[0017] Preferably, the raw materials include the following parts by weight: 15 parts honeysuckle, 10 parts dandelion, 12 parts dendrobium officinale, 5 parts chrysanthemum, 3 parts clove, and 10 parts monkey head mushroom.

[0018] Preferably, the raw materials include the following parts by weight: 10 parts honeysuckle, 10 parts dandelion, 9 parts dendrobium officinale, 8 parts chrysanthemum, 2 parts clove, and 20 parts monkey head mushroom.

[0019] Preferably, the raw materials include the following parts by weight: 12 parts honeysuckle, 8 parts dandelion, 8 parts dendrobium officinale, 5 parts chrysanthemum, 2 parts clove, and 5 parts monkey head mushroom.

[0020] Preferably, the ingredients include the following parts by weight: 15g honeysuckle, 5g dandelion, 4g dendrobium officinale, 3g chrysanthemum, 3g clove, and 5g monkey head mushroom.

[0021] Preferably, the honeysuckle is the honeysuckle harvested during the second white bud stage.

[0022] The second objective of this invention is to provide a method for preparing the aforementioned traditional Chinese medicine composition for inhibiting Helicobacter pylori, comprising the following steps: The extract is obtained by extracting and concentrating honeysuckle, dandelion, dendrobium officinale, chrysanthemum, clove, and monkey head mushroom, followed by drying. It is then granulated with excipients using a wet granulation process.

[0023] Preferably, the method includes the following steps: (1) Take honeysuckle, dandelion, chrysanthemum and clove, add water and steam distill to obtain volatile oil, water extract and residue; (2) Concentrate the aqueous extract and precipitate it with alcohol to obtain supernatant 1; (3) Mix the dregs with the remaining medicinal materials, add water and decoct to obtain a decoction, concentrate and precipitate with alcohol to obtain supernatant 2; (4) Combine supernatant 1 and supernatant 2, add volatile oil, and you will get the product.

[0024] Preferably, the amount of water added in step (1) is 8-15 times the total mass of honeysuckle, dandelion, chrysanthemum and clove, and the steam distillation time is 1-5 hours.

[0025] Preferably, the alcohol precipitation conditions in steps (2) and (3) are: adding ethanol to make the alcohol content of the drug solution reach 65-75% and letting it stand for 22-26 hours.

[0026] Preferably, the amount of water added in step (3) is 8-15 times the total mass of the other medicinal materials, and the number of times the decoction is performed is 1-3 times, with each decoction lasting 20-60 minutes.

[0027] Preferably, after adding volatile oil in step (4), the auxiliary materials are added and wet granulation is carried out to obtain the product.

[0028] Preferably, the excipients in step (4) are soluble starch and mannitol in a mass ratio of 1:3-5. With this excipient, the wet granulation yield is high, the granules have better water solubility and better stability.

[0029] Preferably, in step (4), after combining supernatant 1 and supernatant 2, spray drying is performed, with or without the addition of food or pharmaceutical-acceptable excipients, and volatile oil is added to obtain the final product.

[0030] Another object of the present invention is to provide a pharmaceutical preparation comprising the aforementioned traditional Chinese medicine composition for inhibiting Helicobacter pylori or the traditional Chinese medicine composition for inhibiting Helicobacter pylori prepared by the aforementioned preparation method.

[0031] Another objective of this invention is to provide the application of the aforementioned traditional Chinese medicine composition for inhibiting Helicobacter pylori in health products or medicines for clearing damp-heat and / or inhibiting Helicobacter pylori and / or protecting the gastric mucosa, characterized in that the syndrome of Helicobacter pylori is spleen and stomach damp-heat syndrome.

[0032] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. The clinical symptoms of *Helicobacter pylori* (Hp) infection are complex, and its etiology and pathogenesis are also relatively intricate. However, in general, it can be summarized as external pathogenic invasion, damp-heat accumulation, impaired qi transformation in the middle jiao (middle burner), blood stasis, emotional imbalance, improper diet, and spleen and stomach weakness. Most scholars believe that spleen and stomach weakness is the pathological basis of Hp infection, and as the disease progresses, a series of "excess" pathological changes occur. Therefore, based on the TCM theoretical system, protecting the body's vital energy and eliminating pathogenic factors are the treatment principles for Hp infection. Treatment should be based on the differentiation of excess and deficiency, purging for excess and tonifying for deficiency. For excess, damp-heat is the main factor, and the focus is on clearing heat and removing dampness; for deficiency, spleen deficiency is the main factor, and the focus is on strengthening the spleen and stomach, and tonifying the middle jiao and replenishing qi. Currently, there is no unified standard for the TCM syndrome classification of Hp infection, because neither TCM nor Western medicine can definitively classify Hp infection as a specific disease. However, modern medicine considers "chronic superficial gastritis - atrophic gastritis - intestinal metaplasia - atypical hyperplasia - gastric cancer" to be the recognized progression of Hp infection. Traditional Chinese medicine classifies diseases based on their onset and clinical manifestations, categorizing them into syndromes such as spleen and stomach deficiency, liver and stomach disharmony, spleen and stomach damp-heat, and liver and stomach stagnation heat. Clinically, compound medications are often prescribed based on the symptoms and syndromes following Hp infection. For example, the liver and stomach disharmony type is treated with a formula to soothe the liver, relieve stagnation, regulate qi, and alleviate pain, using a formula like Shugan Liqi Huoxue Tang (Liver-Soothing, Qi-Regulating, and Blood-Activating Decoction); the spleen and stomach deficiency type is treated with a formula to strengthen the spleen and stomach, and replenish qi, using a formula like Buzhong Yiqi Tang (Replenishing the Middle and Benefiting Qi Decoction); the spleen and stomach damp-heat type is treated with a formula like Qilian Wendan Tang (Astragalus and Coptis Decoction for Warming the Gallbladder); and the liver and stomach stagnation heat type is treated with a formula like Qinggan Lianyang Tang (Liver-Clearing and Ulcer-Astringing Decoction for Clearing the Liver, Regulating Qi, and Clearing Stomach Heat). Traditional Chinese medicine also frequently uses external therapies such as acupuncture as adjunctive treatment. Clinical studies have found that acupuncture combined with Wenwei Tang (Warm Stomach Decoction), Yiqi Huoxue Jiedu Fang (Qi-Boosting, Blood-Activating, and Detoxifying Decoction), and modified Banxia Xiexin Tang (Pinellia Decoction for Draining the Heart) for treating Hp-related gastric diseases improves clinical efficacy and Hp eradication rates compared to using compound medications or Western medicine alone. Honeysuckle, with its heat-clearing and detoxifying properties, is sweet and cold in nature without harming the stomach, serving as the principal ingredient. Dandelion, Dendrobium officinale, and chrysanthemum assist the principal ingredient in enhancing its heat-clearing and damp-heat-removing effects, acting as assistant ingredients. Clove dispels cold, relieves pain, warms the middle jiao, and relieves nausea; Hericium erinaceus aids digestion, and both can alleviate symptoms such as acid reflux and stomach pain caused by Hp infection, acting as adjuvant ingredients. The entire formula, with honeysuckle, dandelion, and chrysanthemum clearing heat and removing toxins, and Dendrobium officinale and Hericium erinaceus protecting the stomach, complements each other, removing turbid toxins while supporting the body's vital energy, jointly preventing and treating Hp. Furthermore, the entire formula uses both cold and warm properties; honeysuckle and dandelion are cold in nature, while clove is warm, avoiding the bitter and cold properties that could harm the stomach. It combines attack and tonification, with honeysuckle and clove inhibiting bacteria while Dendrobium officinale and Hericium erinaceus repairing simultaneously, exhibiting significant anti-Helicobacter pylori effects.

[0033] 2. This invention uses two dosage forms: granules and compressed candies, which are easy to carry and convenient for patients to choose from. In particular, the solid beverage made from the extract has a high content of effective ingredients. Detailed Implementation

[0034] The technical solution of the present invention will be further described below with reference to specific embodiments.

[0035] Example 1 A traditional Chinese medicine composition for inhibiting Helicobacter pylori, comprising the following ingredients: 6g honeysuckle, 10g dandelion, 6g dendrobium officinale, 10g chrysanthemum, 1g clove, and 30g hericium erinaceus.

[0036] The preparation method is as follows: (1) Take honeysuckle, dandelion, chrysanthemum and clove, add 12 times the amount of water, and steam distill for 3.5 hours to extract volatile oil, water extract and residue; (2) Concentrate the aqueous extract under reduced pressure, add 95% ethanol to make the alcohol content of the drug solution reach 70%, let stand for 24 hours, precipitate with alcohol, and obtain supernatant 1 for later use. (3) Mix the dregs with the remaining medicinal materials, add water in a volume of 12 times the total weight of the medicinal materials, decoct twice, each time for 40 minutes, filter, obtain the decoction, concentrate, add 95% ethanol to make the alcohol content of the decoction reach 70%, let stand for 24 hours, precipitate alcohol, and obtain the supernatant 2. (4) Combine supernatant 1 and supernatant 2, add the volatile oil obtained in step (1), concentrate, dry, add excipients (the mass ratio of soluble starch to mannitol is 1:4, and the total amount of excipients added in the single prescription is 20.84g), and granulate by wet method, 10g per bag.

[0037] Example 2 A traditional Chinese medicine composition for inhibiting Helicobacter pylori, comprising the following raw materials by weight: 15 parts honeysuckle, 10 parts dandelion, 12 parts dendrobium officinale, 5 parts chrysanthemum, 3 parts clove, and 10 parts hericium erinaceus.

[0038] The preparation method is as follows: (1) Take honeysuckle, dandelion, chrysanthemum and clove, add 10 times the amount of water, and steam distill for 5 hours to extract volatile oil, water extract and residue; (2) Concentrate the aqueous extract under reduced pressure, add 95% ethanol to make the alcohol content of the drug solution reach 65%, let it stand for 26 hours, precipitate with alcohol, and obtain supernatant 1 for later use. (3) Mix the dregs with the remaining medicinal materials, add water in a volume of 15 times the total weight of the medicinal materials, decoct for 50 minutes, filter, obtain the decoction, concentrate, add 95% ethanol to make the alcohol content of the decoction reach 65%, let stand for 26 hours, precipitate alcohol, and obtain the supernatant 2. (4) Combine supernatant 1 and supernatant 2, add the volatile oil obtained in step (1), extract and concentrate, and dry to obtain the final product.

[0039] Example 3 A traditional Chinese medicine composition for inhibiting Helicobacter pylori, comprising the following raw materials by weight: 10 parts honeysuckle, 10 parts dandelion, 9 parts dendrobium officinale, 8 parts chrysanthemum, 2 parts clove, and 20 parts hericium erinaceus.

[0040] The preparation method is as follows: (1) Take honeysuckle, dandelion, chrysanthemum and clove, add 15 times the amount of water, steam distill for 2 hours to extract volatile oil, water extract and residue; (2) Concentrate the aqueous extract under reduced pressure, add 95% ethanol to make the alcohol content of the drug solution reach 75%, let it stand for 22 hours, precipitate with alcohol, and obtain supernatant 1 for later use. (3) Mix the dregs with the remaining medicinal materials, add water in a volume of 8 times the total weight of the medicinal materials, decoct 3 times, each time for 20 minutes, filter, obtain water decoction, concentrate, add 95% ethanol to make the alcohol content of the decoction reach 75%, let stand for 22 hours, precipitate alcohol, and obtain supernatant 2. (4) Combine supernatant 1 and supernatant 2, add the volatile oil obtained in step (1), extract and concentrate, and dry to obtain the final product.

[0041] Example 4 A traditional Chinese medicine composition for inhibiting Helicobacter pylori, comprising the following raw materials by weight: 12 parts honeysuckle, 8 parts dandelion, 8 parts dendrobium officinale, 5 parts chrysanthemum, 2 parts clove, and 8 parts hericium erinaceus.

[0042] The preparation method is as follows: (1) Take honeysuckle, dandelion, chrysanthemum and clove, add 10 times the amount of water, and steam distill for 5 hours to extract volatile oil, water extract and residue; (2) Concentrate the aqueous extract under reduced pressure, add 95% ethanol to make the alcohol content of the drug solution reach 70%, let stand for 24 hours, precipitate with alcohol, and obtain supernatant 1 for later use. (3) Mix the dregs with the remaining medicinal materials, add water in a volume of 12 times the total weight of the medicinal materials, decoct twice, each time for 40 minutes, filter, obtain the decoction, concentrate, add 95% ethanol to make the alcohol content of the decoction reach 70%, let stand for 24 hours, precipitate alcohol, and obtain the supernatant 2. (4) Combine supernatant 1 and supernatant 2, add the volatile oil obtained in step (1), and prepare an oral liquid.

[0043] Example 5 A traditional Chinese medicine composition for inhibiting Helicobacter pylori, comprising the following ingredients: 15g honeysuckle, 5g dandelion, 4g dendrobium officinale, 3g chrysanthemum, 3g clove, and 5g monkey head mushroom.

[0044] The preparation method is as follows: (1) Take honeysuckle, dandelion, chrysanthemum and clove, add 12 times the amount of water, and steam distill for 3.5 hours to extract volatile oil, water extract and residue; (2) Concentrate the aqueous extract under reduced pressure, add 95% ethanol to make the alcohol content of the drug solution reach 70%, let stand for 24 hours, precipitate with alcohol, and obtain supernatant 1 for later use. (3) Mix the dregs with the remaining medicinal materials, add water in a volume of 12 times the total weight of the medicinal materials, decoct twice, each time for 40 minutes, filter, obtain the decoction, concentrate, add 95% ethanol to make the alcohol content of the decoction reach 70%, let stand for 24 hours, precipitate alcohol, and obtain the supernatant 2. (4) Combine supernatant 1 and supernatant 2, spray dry, add excipients (soluble starch: mannitol mass ratio = 1:4, the total amount of excipients added in single prescription amount is 20.84g), add volatile oil obtained in step (1), and prepare solid beverage.

[0045] All the honeysuckle flowers mentioned above were harvested during the second white bud stage.

[0046] Comparative Example 1 The difference between this comparative example and Example 5 is that chrysanthemum is replaced with peppermint and Dendrobium officinale is replaced with licorice; otherwise, they are the same as in Example 5. Specifically, take 15g of honeysuckle, 5g of dandelion, 4g of licorice, 3g of peppermint, 3g of clove, and 5g of Hericium erinaceus.

[0047] The preparation method is as follows: (1) Take honeysuckle, dandelion, peppermint and clove, add 12 times the amount of water, and steam distill for 3.5 hours to extract volatile oil, water extract and residue; (2) Concentrate the aqueous extract under reduced pressure, add 95% ethanol to make the alcohol content of the drug solution reach 70%, let stand for 24 hours, precipitate with alcohol, and obtain supernatant 1 for later use. (3) Mix the dregs with the remaining medicinal materials, add water in a volume of 12 times the total weight of the medicinal materials, decoct twice, each time for 40 minutes, filter, obtain the decoction, concentrate, add 95% ethanol to make the alcohol content of the decoction reach 70%, let stand for 24 hours, precipitate alcohol, and obtain the supernatant 2. (4) Combine supernatant 1 and supernatant 2, spray dry, add excipients (soluble starch: mannitol mass ratio = 1:4, the total amount of excipients added in single prescription amount is 20.84g), add volatile oil obtained in step (1), and prepare solid beverage.

[0048] Comparative Example 2 The difference between this comparative example and Example 5 is that honeysuckle is replaced with coptis, and monkey head mushroom is replaced with immature bitter orange; otherwise, they are the same as in Example 5.

[0049] The specific ingredients are: 15g of Coptis chinensis, 5g of dandelion, 4g of Dendrobium officinale, 3g of chrysanthemum, 3g of clove, and 5g of Citrus aurantium.

[0050] The preparation method is as follows: (1) Take Coptis chinensis, dandelion, chrysanthemum, clove and immature bitter orange, add 12 times the amount of water, and steam distill for 3.5 hours to extract volatile oil, water extract and residue; (2) Concentrate the aqueous extract under reduced pressure, add 95% ethanol to make the alcohol content of the drug solution reach 70%, let stand for 24 hours, precipitate with alcohol, and obtain supernatant 1 for later use. (3) Mix the dregs with the remaining medicinal materials, add water in a volume of 12 times the total weight of the medicinal materials, decoct twice, each time for 40 minutes, filter, obtain the decoction, concentrate, add 95% ethanol to make the alcohol content of the decoction reach 70%, let stand for 24 hours, precipitate alcohol, and obtain the supernatant 2. (4) Combine supernatant 1 and supernatant 2, spray dry, add excipients (soluble starch: mannitol mass ratio = 1:4, the total amount of excipients added in single prescription amount is 20.84g), add volatile oil obtained in step (1), and prepare solid beverage.

[0051] Comparative Example 3: The only difference between this comparative example and Example 5 is the preparation method.

[0052] The specific preparation method is as follows: (1) Take honeysuckle, dandelion, chrysanthemum and clove, add 12 times the amount of water, and steam distill for 3.5 hours to extract volatile oil, water extract and residue; (2) Concentrate the water extract under reduced pressure, add 95% ethanol to make the alcohol content of the drug solution reach 50%, let stand for 24 hours, precipitate with alcohol, and obtain supernatant 1 for later use. (3) Mix the dregs with the remaining medicinal materials, add water in a volume of 12 times the total weight of the medicinal materials, decoct twice, each time for 40 minutes, filter, obtain the decoction, concentrate, add 95% ethanol to make the alcohol content of the decoction reach 80%, let stand for 24 hours, precipitate alcohol, and obtain the supernatant 2. (4) Combine supernatant 1 and supernatant 2, spray dry, add excipients (soluble starch: mannitol mass ratio = 1:4, the total amount of excipients added in single prescription amount is 20.84g), add volatile oil obtained in step (1), and prepare solid beverage.

[0053] Example 1: The in vitro antibacterial effect of the traditional Chinese medicine composition for inhibiting Helicobacter pylori of the present invention on Helicobacter pylori. 1.1 Objective: To investigate the in vitro antibacterial effect of the traditional Chinese medicine composition for inhibiting Helicobacter pylori of the present invention on Helicobacter pylori. 1.2 Drugs: Drugs prepared in Examples 1-5 and Comparative Examples 1-3.

[0054] 1.3 Grouping: The control group was divided into blank control group, positive control group, example groups 1-5, and comparative examples 1-3.

[0055] 1.4 Experimental Methods: The antibacterial activity was determined using the disc diffusion method. 50 μL of each of the prepared sample solution, clarithromycin positive control, and blank control were pipetted onto 8 mm blank drug susceptibility filter paper discs for absorption. The drug susceptibility filter paper discs were then labeled and evenly affixed to discs coated with Helicobacter pylori indicator bacteria (logarithmic growth phase, bacterial concentration 1×10⁻⁶). 8 The samples were placed on petri dishes containing cfu / ml and inverted in a tri-gas incubator (5% O2, 10% CO2, 85% N2) for 48 hours. The results were observed and the size of the inhibition zone was measured. Each sample was repeated three times. The results are shown in Table 1.

[0056]

[0057] Example 2: The therapeutic effect of the traditional Chinese medicine composition for inhibiting Helicobacter pylori of the present invention on mice infected with Helicobacter pylori. 2.1 Objective: To investigate the effects of the drug of the present invention on the gastric mucosa of mice infected with Helicobacter pylori and on improving inflammation.

[0058] 2.2 Drugs: Drugs prepared in Examples 1-5 and Comparative Examples 1-3.

[0059] 2.3 Animal grouping: Healthy male C57BL / 6 mice, clean grade, weighing 20±5g; fed with standard diet and tap water in an animal laboratory at a constant temperature of 25℃ and a constant humidity of 55±5% for one week.

[0060] 2.4 Preparation and administration of a mouse model of Helicobacter pylori infection: Seventy-two male C57BL / 6 mice were randomly divided into a normal group (n=9) and a model group (n=63). The normal group was administered 0.2 ml / mouse of Brucella broth by gavage; the model group was administered 0.2 ml / mouse of Hp bacterial suspension by gavage. Both groups were administered the suspension every other day for a total of 5 times. During the modeling process, the general physiological status of each group of mice (survival rate, weight, food intake, water intake, spontaneous activity, defecation, etc.) was observed. Fourteen days after modeling, 3 mice from each of the normal and model groups were randomly sacrificed, and their stomachs were removed and divided in half. One part of the stomach was used for rapid urease testing, and the other part was used for Warthin-Starry silver staining. If the rapid urease test was positive and short spiral black or dark brown material was visible in the Warthin-Starry silver-stained section, it indicated that Hp had successfully colonized the mouse stomach.

[0061] After successful modeling, 60 HAG model mice were randomly divided into 10 groups using a random number table: model group (6 mice), positive (quadruple drug) group (6 mice), Examples 1-5 groups (30 mice), comparative examples 1-3 groups (18 mice), and the original normal group (6 mice), for a total of 11 groups. After successful modeling, bacteria were colonized for 2 weeks, and then oral administration of drugs was started. The normal and model groups were given 0.2 ml of physiological saline per mouse once a day. Examples 1-5 and comparative examples 1-3 were given 0.2 ml of the drug solution per mouse, with a dosage equivalent to 2.05 g of crude drug per kg / day, once a day. The positive group was given a standard quadruple therapy: clarithromycin 2.05 g / kg / day, omeprazole 8.2 mg / kg / day, amoxicillin 205 mg / kg / day, and colloidal bismuth pectin 123 mg / kg / day, administered as a quadruple therapy mixture of 0.2 ml per mouse once a day. This was repeated for 2 weeks. Samples were collected 30 minutes after the last gavage. Blood was collected from the eyeballs, centrifuged at 3500 rpm for 5 minutes, and the supernatant serum was collected and stored at -80°C for later use. After blood collection, the mice were euthanized by cervical dislocation, and their stomachs were cut along the greater curvature. The stomach tissue was washed with ice-cold saline, and the gastric mucosa was visually inspected for damage. A portion of the gastric tissue was fixed and embedded for immunohistochemical analysis; another portion was used for a rapid urease test; and the remaining portion was used to extract total protein for Western blotting. All experimental data were statistically processed using SPSS 27 software, and values ​​are expressed as ± standard deviation. T-tests were used for comparisons between groups. The experimental results are shown in Tables 2 and 3.

[0062] Table 2 Comparison of TLRs / NF-κB pathway expression levels in gastric mucosa of mice in different groups

[0063] Note: The letter 'a' indicates that the model group has a significant difference compared with the normal group (p < 0.05), and A indicates that the difference is extremely significant (p < 0.01). The letter b indicates a significant difference compared to the model group (p < 0.05), and B indicates a highly significant difference (p < 0.01). The letter 'c' indicates a significant difference compared to the positive group (p < 0.05), and 'C' indicates a highly significant difference (p < 0.01). The letter d indicates a significant difference compared to the group in Example 5 (p < 0.05), and D indicates a highly significant difference (p < 0.01).

[0064] Table 3 Comparison of inflammatory mediator expression levels in gastric mucosa of mice in different groups

[0065] Note: The letter 'a' indicates that the model group has a significant difference compared with the normal group (p < 0.05), and A indicates that the difference is extremely significant (p < 0.01). The letter b indicates a significant difference compared to the model group (p < 0.05), and B indicates a highly significant difference (p < 0.01). The letter 'c' indicates a significant difference compared to the positive group (p < 0.05), and 'C' indicates a highly significant difference (p < 0.01). The letter d indicates a significant difference compared to the group in Example 5 (p < 0.05), and D indicates a highly significant difference (p < 0.01).

[0066] The TLR2 experimental results in Table 2 show that compared with the normal group, all indicators in the model group mice were significantly different, and the differences between the two groups were statistically significant (P < 0.001), indicating successful modeling. Compared with the positive group, Examples 1-5 and Comparative Examples 1-3 showed no significant differences, indicating good efficacy. Comparative Examples 1-3 showed significant differences compared with Example 5, indicating that the treatment effect of Example 5 was superior to that of Comparative Examples 1-3.

[0067] Taking the TNF-α experimental results in Table 3 as an example, the analysis shows that: compared with the positive group, the groups of Examples 1-5 and the groups of Comparative Examples 1-3 did not show significant differences, indicating that they have a significant effect in reducing TNF-α inflammation; compared with the group of Example 5, the groups of Comparative Examples 1-3 all showed significant differences, indicating that the treatment effect of Example 5 was better than that of Comparative Examples 1-3.

[0068] Example 3: Experimental study on the function of the traditional Chinese medicine composition for inhibiting Helicobacter pylori in this invention 3.1 Objective: To investigate the functional effects of the drug of the present invention on people infected with Helicobacter pylori.

[0069] 3.2 Drug: The drug prepared in Example 5.

[0070] 3.3 Grouping: A total of 82 patients with Helicobacter pylori who visited the school outpatient clinic were selected, including 47 males and 35 females; aged 18 to 80 years; with a disease duration of 1 to 6 years. The patients were compared before and after drug administration.

[0071] Inclusion criteria: Patients meeting the Western medicine diagnostic criteria for chronic gastritis (CAG) with *Helicobacter pylori* infection and the traditional Chinese medicine diagnostic criteria for spleen and stomach damp-heat syndrome; aged 18-80 years; patients and their families were aware of and accepted the treatment methods used in this study and signed informed consent forms. ① The diagnostic criteria for CAG were based on the "Chinese Guidelines for the Diagnosis and Treatment of Chronic Gastritis (2022, Shanghai)," and confirmed by gastric biopsy. *Helicobacter pylori* infection was diagnosed based on... 13A positive urea breath test is required. ② Referencing the "Spleen and Stomach Damp-Heat Syndrome" in the "Expert Consensus on the Diagnosis and Treatment of Chronic Atrophic Gastritis with Integrated Traditional Chinese and Western Medicine (2025)," the following TCM diagnostic criteria for CAG (Chronic Atrophic Gastritis) spleen and stomach damp-heat syndrome are proposed. Main symptoms: epigastric fullness or pain. Secondary symptoms: ① bitter taste and halitosis; ② nausea or vomiting; ③ burning sensation in the epigastric region; ④ sticky or loose stools. Tongue and pulse: red tongue with a thick, yellow, or greasy coating; slippery and rapid pulse.

[0072] Exclusion criteria: (1) Patients with acute / chronic infectious diseases; (2) Patients with a history of gastric cancer or upper gastrointestinal surgery; (3) Patients with severe organic lesions; (4) Patients with mental illness / cognitive impairment; (5) Patients with allergic constitution.

[0073] Treatment process: During the treatment, patients need to discontinue other related medications and maintain regular diet and rest. The granules prepared in Example 5 of this invention are used, one sachet (10 grams per sachet) three times daily for 14 days. Traditional Chinese medicine syndrome scores, motilin, gastrin, and related inflammatory factors are measured before and after treatment.

[0074] The TCM syndrome score is calculated as follows: Before treatment and 2 weeks after treatment, all symptoms are divided into 4 levels: none, mild, moderate and severe. The main symptoms are scored as 0, 2, 4 and 6 points, the secondary symptoms are scored as 0, 1, 2 and 3 points, and abnormal tongue and pulse are scored as 1 point. If they are normal, no points are added. The total score is 0 to 25 points.

[0075] The criteria for evaluating therapeutic efficacy are as follows: Cure: After treatment, clinical symptoms disappeared. One month after stopping medication, a follow-up visit showed no recurrence of symptoms. A gastroscopy revealed that the gastric mucosa had returned to normal, and the Hp test was negative.

[0076] Effective: Clinical symptoms were alleviated, and follow-up gastroscopy showed a reduction in the extent of gastric mucosal lesions. Hp may turn negative or show only a weak positive result.

[0077] Ineffective: Clinical symptoms show slight improvement or no change, gastroscopy shows no significant changes in the diseased gastric mucosa, and Hp test is positive.

[0078] The effectiveness of Hp was calculated. The results are shown in Tables 4 and 5.

[0079] Table 4 Comparison of relevant levels before and after treatment

[0080] Compared with pre-treatment levels, *p<0.05, **p<0.01.

[0081] Table 5. *H. pylori* eradication rate

[0082] Results: After treatment, the TCM syndrome score decreased; the levels of motilin and gastrin increased. This was likely due to the components in the prescription promoting gastrointestinal motility and regulating gastrointestinal hormone levels, thereby delaying gastric mucosal cell apoptosis. Furthermore, the levels of TNF-α and IL-6 inflammatory factors also significantly decreased. In addition, the prescription showed a high *Helicobacter pylori* eradication rate.

[0083] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for inhibiting Helicobacter pylori, characterized in that, The ingredients include: honeysuckle, dandelion, dendrobium officinale, chrysanthemum, cloves, and monkey head mushroom.

2. The traditional Chinese medicine composition for inhibiting Helicobacter pylori according to claim 1, characterized in that, The ingredients include the following parts by weight: honeysuckle 6-15 parts, dandelion 5-15 parts, dendrobium officinale 4-12 parts, chrysanthemum 3-10 parts, clove 1-3 parts, and monkey head mushroom 5-30 parts.

3. The traditional Chinese medicine composition for inhibiting Helicobacter pylori according to claim 1, characterized in that, The ingredients include the following parts by weight: honeysuckle 10-15 parts, dandelion 5-10 parts, dendrobium officinale 4-10 parts, chrysanthemum 3-8 parts, clove 1-3 parts, and monkey head mushroom 5-20 parts.

4. The traditional Chinese medicine composition for inhibiting Helicobacter pylori according to claim 1, characterized in that, The ingredients include the following parts by weight: 6 parts honeysuckle, 10 parts dandelion, 6 parts dendrobium officinale, 10 parts chrysanthemum, 1 part clove, and 30 parts monkey head mushroom; And / or, 15 parts honeysuckle, 10 parts dandelion, 12 parts dendrobium officinale, 5 parts chrysanthemum, 3 parts clove, and 10 parts monkey head mushroom; And / or, 10 parts honeysuckle, 10 parts dandelion, 9 parts dendrobium officinale, 8 parts chrysanthemum, 2 parts clove, and 20 parts monkey head mushroom; And / or, 12 parts honeysuckle, 8 parts dandelion, 8 parts dendrobium officinale, 5 parts chrysanthemum, 2 parts clove, and 5 parts monkey head mushroom; And / or, honeysuckle 15g, dandelion 5g, dendrobium officinale 4g, chrysanthemum 3g, clove 3g, monkey head mushroom 5g; And / or, honeysuckle refers to honeysuckle harvested during the second white bud stage.

5. A method for preparing a traditional Chinese medicine composition for inhibiting Helicobacter pylori according to any one of claims 1-4, characterized in that, Includes the following steps: Take honeysuckle, dandelion, dendrobium officinale, chrysanthemum, clove, and monkey head mushroom, extract and concentrate the extract, and then dry it to obtain the final product.

6. The preparation method according to claim 5, characterized in that, Includes the following steps: (1) Take honeysuckle, dandelion, chrysanthemum and clove, add water and steam distill to obtain volatile oil, water extract and residue; (2) Concentrate the aqueous extract and precipitate it with alcohol to obtain supernatant 1; (3) Mix the dregs with the remaining medicinal materials, add water and decoct to obtain a decoction, concentrate and precipitate with alcohol to obtain supernatant 2; (4) Combine supernatant 1 and supernatant 2, add volatile oil, and you will get the product.

7. The preparation method according to claim 6, characterized in that, In step (1), the amount of water added is 8-15 times the total mass of honeysuckle, dandelion, chrysanthemum and clove, and the steam distillation time is 1-5 hours. And / or, the alcohol precipitation conditions in steps (2) and (3) are: add ethanol to make the alcohol content of the drug solution reach 65-75%, and let it stand for 22-26 hours; And / or, the amount of water added in step (3) is 8-15 times the total mass of the other medicinal materials, the number of times of decoction is 1-3, and the time of each decoction is 20-60 minutes; And / or, after adding volatile oil in step (4), add excipients and perform wet granulation to obtain the product.

8. The preparation method according to claim 6, characterized in that, Step (4) After combining supernatant 1 and supernatant 2, spray dry them, add or not add food or pharmaceutical acceptable excipients, add volatile oil, and you will get the product.

9. A pharmaceutical preparation, characterized in that, The traditional Chinese medicine composition for inhibiting Helicobacter pylori as described in any one of claims 1-4 or the traditional Chinese medicine composition for inhibiting Helicobacter pylori prepared by the preparation method described in any one of claims 5-8.

10. The use of the traditional Chinese medicine composition for inhibiting Helicobacter pylori according to any one of claims 1-4 in health products or medicines for clearing damp-heat and / or inhibiting Helicobacter pylori and / or assisting in protecting the gastric mucosa, characterized in that, The syndrome type of Helicobacter pylori mentioned is spleen and stomach damp-heat syndrome.

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