A traditional Chinese medicine composition capable of improving gastric mucosa microenvironment and blocking gastric mucosa inflammation cancer transformation

CN122768367APending Publication Date: 2026-09-18XIYUAN HOSPITAL OF CHINA ACAD OF CHINESE MEDICAL SCI
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Patent Information

Application Number
CN202611120626.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-07-27
Publication Date
2026-09-18

AI Technical Summary

Technical Problem

其中西药多采用胃黏膜保护剂、抑酸药、促动力药、益生菌制剂等,仅可对症改善反酸、胀满、胃痛等临床症状,短期缓解黏膜表层炎症,可在一定程度上调节肠道菌群、减轻胆汁反流刺激,但无法逆转胃黏膜腺体萎缩、肠上皮化生及异型增生等器质性病理改变,难以阻断炎癌转化的核心进程,长期用药存在依赖性、肠道功能紊乱、肝肾代谢负担等问题,对远期癌变风险控制效果有限

Benefits of technology

本发明本组合物以四君子汤健脾固本、四逆散疏肝调脾为双重核心骨架,摒弃单一补气、清热、活血的片面组方思路,创新性融合清肠调菌、活血消癥、养阴护膜三大靶向组分,实现寒温制衡、补泻兼顾。全方药材均采用规范炮制品种,药性平和温润,无峻猛破血、大寒大热、有毒药材,既规避了补益类方剂壅滞气机、滋生内热的弊端,又解决了清热活血方剂耗伤脾胃正气、损伤胃阴的缺陷,彻底适配慢性萎缩性胃炎癌前病变3-6个月的长期持续干预需求,长期用药无脏腑损伤、无耐药性,安全性远优于常规对症治疗方。

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Abstract

This invention discloses a traditional Chinese medicine composition that can improve the gastric mucosal microenvironment and block the transformation of gastric mucosal inflammation into cancer. The composition comprises the following raw materials by weight: 10-20g of roasted Astragalus membranaceus, 10-15g of stir-fried Atractylodes macrocephala, 10-15g of Poria cocos, 1-3g of Coptis chinensis, 10-20g of Actinidia chinensis root, 10-15g of Portulaca oleracea, 6-10g of Salvia miltiorrhiza, 6-9g of vinegar-processed Curcuma zedoaria, 6-9g of vinegar-processed Bupleurum chinense, 9-12g of stir-fried Paeonia lactiflora, 6-9g of stir-fried Citrus aurantium, 6-10g of Dendrobium nobile, and 3-6g of roasted Glycyrrhiza uralensis. The advantages of this invention compared to existing technologies are: This composition uses the Si Jun Zi Tang (Four Gentlemen Decoction) for strengthening the spleen and consolidating the foundation, and the Si Ni San (Four Rebellions Powder) for soothing the liver and regulating the spleen as its dual core framework. It abandons the one-sided approach of simply tonifying qi, clearing heat, and promoting blood circulation, and innovatively integrates three targeted components: intestinal cleansing and bacterial regulation, blood circulation and mass elimination, and yin nourishment and mucosal protection, achieving a balance between cold and heat, and a combination of tonification and purgation.
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Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, specifically a traditional Chinese medicine composition that can improve the gastric mucosal microenvironment and block the transformation of gastric mucosal inflammation into cancer. Background Technology

[0002] Chronic atrophic gastritis (CAG) with intestinal metaplasia and low-grade intraepithelial neoplasia is a common precancerous lesion of gastric cancer. Its core pathological features are atrophy of the gastric mucosal glands, chronic and persistent inflammation of the mucosa, and abnormal proliferation of tissue structure, following the inflammatory-cancer transformation pattern of "chronic inflammation-atrophy-intestinal metaplasia-dysplasia-gastric cancer". This disease has a long course, is highly insidious, and has a high recurrence rate. It is often accompanied by complications such as intestinal flora imbalance, bile reflux, and brain-gut axis dysfunction, making it a difficult and chronic disease of the digestive system.

[0003] Currently, clinical intervention programs are mainly divided into two categories: Western medicine intervention and traditional Chinese medicine intervention. Western medicine mainly uses gastric mucosal protectants, acid-suppressing drugs, prokinetic drugs, and probiotic preparations, which can only symptomatically improve clinical symptoms such as acid reflux, bloating, and stomach pain, and relieve inflammation of the mucosal surface in the short term. It can regulate the intestinal flora and reduce bile reflux stimulation to a certain extent, but it cannot reverse organic pathological changes such as atrophy of gastric mucosal glands, intestinal metaplasia, and dysplasia. It is difficult to block the core process of inflammation-cancer transformation. Long-term use of these drugs has problems such as dependence, intestinal dysfunction, and metabolic burden on the liver and kidneys, and its effect on controlling the long-term risk of cancer is limited.

[0004] Traditional Chinese medicine is currently the mainstream approach for intervening in precancerous lesions of the stomach. Existing clinical prescriptions often focus solely on tonifying the spleen and replenishing qi, clearing heat and removing dampness, or promoting blood circulation and removing blood stasis. Among these, simple tonifying prescriptions focus on strengthening the body's foundation, but their ability to expel pathogens is insufficient, failing to effectively clear latent heat and stagnant nodules in the gastric mucosa, and making it difficult to reverse dysplasia. Simple heat-clearing and blood-activating prescriptions focus on expelling pathogens and reducing inflammation, but their potent medicinal properties deplete the spleen and stomach's vital energy, and long-term intervention can easily damage stomach yin and aggravate spleen and stomach deficiency. Conventional liver-soothing and stomach-harmonizing prescriptions can only regulate qi stagnation and cannot simultaneously address the multi-pathway regulation of intestinal flora, bile acid metabolism, and gastric mucosal barrier repair. Summary of the Invention

[0005] The technical problem to be solved by this invention is to overcome the above-mentioned technical defects.

[0006] To address the above problems, the technical solution of this invention is: a traditional Chinese medicine composition that can improve the gastric mucosal microenvironment and block the transformation of gastric mucosal inflammation into cancer, comprising the following raw materials by weight: The formula includes 10-20g of roasted Astragalus membranaceus, 10-15g of stir-fried Atractylodes macrocephala, 10-15g of Poria cocos, 1-3g of Coptis chinensis, 10-20g of Actinidia chinensis root, 10-15g of Portulaca oleracea, 6-10g of Salvia miltiorrhiza, 6-9g of vinegar-processed Curcuma zedoaria, 6-9g of vinegar-processed Bupleurum chinense, 9-12g of stir-fried Paeonia lactiflora, 6-9g of stir-fried Citrus aurantium, 6-10g of Dendrobium nobile, and 3-6g of roasted Glycyrrhiza uralensis.

[0007] Furthermore, the Chinese medicine composition uses Sijunzi Decoction and Si Ni San as the core formula framework, and adds three types of targeted pharmacological components: intestinal cleansing and bacterial regulation, blood circulation and mass elimination, and yin nourishment and membrane protection. It follows the principle of balancing cold and heat and taking into account both tonification and purgation. The medicine is mild and suitable for long-term continuous intervention for 3-6 months. The mechanism of action of the Chinese medicine composition fully covers five major regulatory pathways: gut microbiota, gastric mucosal microenvironment, gut-brain axis, bile acids, and inflammation-cancer transformation. It is specifically designed to intervene in precancerous lesions of chronic atrophic gastritis with intestinal metaplasia and low-grade intraepithelial neoplasia, and is also suitable for intervention in complication scenarios of chronic atrophic gastritis complicated with bile reflux and gut microbiota dysbiosis. The traditional Chinese medicine composition improves chronic gastric mucosal inflammation, blocks the process of inflammation-cancer transformation, and reduces the risk of progression of precancerous lesions in chronic atrophic gastritis by regulating the intestinal flora-bile acid metabolism pathway.

[0008] Furthermore, in the core formula framework, the Sijunzi Decoction component consists of roasted Astragalus membranaceus, stir-fried Atractylodes macrocephala, Poria cocos, and roasted Glycyrrhiza uralensis, which have the effects of strengthening the spleen and replenishing qi, consolidating the foundation and protecting the stomach; the Si Ni San component consists of vinegar-processed Bupleurum chinense, stir-fried Paeonia lactiflora, stir-fried Citrus aurantium, and roasted Glycyrrhiza uralensis, which have the effects of soothing the liver and regulating qi, harmonizing the liver and spleen, and achieving a balanced combination of tonification and detoxification in the formula.

[0009] Furthermore, the composition has a balanced combination of cold and warm properties, and takes into account both tonifying and purging effects. It contains no drastic medicinal ingredients, making it suitable for the long-term intervention needs of chronic atrophic gastritis and precancerous lesions. The continuous intervention cycle is 3-6 months, which can sustainably improve the pathological state of the gastric mucosa without short-term drug resistance or organ damage side effects.

[0010] The advantages of this invention compared to existing technologies are: This invention utilizes the Si Jun Zi Tang formula to strengthen the spleen and consolidate the foundation, and the Si Ni San formula to soothe the liver and regulate the spleen as its dual core framework. It abandons the one-sided approach of simply tonifying qi, clearing heat, and promoting blood circulation, and innovatively integrates three targeted components: intestinal cleansing and bacterial regulation, blood circulation and mass elimination, and yin nourishment and membrane protection, achieving a balance between cold and heat, and tonification and purgation. All medicinal materials used in the formula are standardized processed varieties, with mild and gentle properties, free from harsh blood-breaking, extremely cold or hot, or toxic herbs. This avoids the drawbacks of tonifying formulas that stagnate qi and generate internal heat, while also addressing the shortcomings of heat-clearing and blood-activating formulas that deplete the spleen and stomach's vital energy and damage stomach yin. It is perfectly suited for the long-term, continuous intervention needs of 3-6 months for precancerous lesions of chronic atrophic gastritis. Long-term use does not cause organ damage or drug resistance, and its safety is far superior to conventional symptomatic treatment formulas. Attached Figure Description

[0011] Figure 1 This is a process diagram of a traditional Chinese medicine composition of the present invention that can improve the gastric mucosal microenvironment and block the transformation of gastric mucosal inflammation into cancer. Detailed Implementation

[0012] The specific implementation of the present invention will be further illustrated below with reference to the embodiments.

[0013] It should be noted that the terms “front,” “back,” “left,” “right,” “up,” and “down” used in the following description refer to the directions shown in the attached diagram, while the terms “inside” and “outside” refer to the directions toward or away from the geometric center of a specific component, respectively.

[0014] The technical solutions in the embodiments of the present invention will be clearly and completely described.

[0015] like Figure 1 As shown, a traditional Chinese medicine composition can improve the gastric mucosal microenvironment and block the transformation of gastric mucosal inflammation into cancer. Example 1, suitable for low-dose formulations, is suitable for patients with mild precancerous lesions and weak constitution. 10g of roasted Astragalus membranaceus, 12g of stir-fried Atractylodes macrocephala, 10g of Poria cocos, 1g of Coptis chinensis, 10g of Actinidia chinensis root, 10g of Portulaca oleracea, 6g of Salvia miltiorrhiza, 6g of vinegar-processed Curcuma zedoaria, 6g of vinegar-processed Bupleurum chinense, 9g of stir-fried Paeonia lactiflora, 6g of stir-fried Citrus aurantium, 6g of Dendrobium nobile, and 3g of roasted Glycyrrhiza uralensis. Example 2 is suitable for medium-dose formulations, the conventional optimal intervention formulation, and is suitable for patients with moderate atrophy, intestinal metaplasia, and dysbiosis. Prepared Astragalus membranaceus 15g, stir-fried Atractylodes macrocephala 12g, Poria cocos 12g, Coptis chinensis 2g, Actinidia chinensis root 15g, Portulaca oleracea 12g, Salvia miltiorrhiza 8g, vinegar-processed Curcuma zedoaria 7g, vinegar-processed Bupleurum chinense 7g, stir-fried Paeonia lactiflora 10g, stir-fried Citrus aurantium 7g, Dendrobium nobile 8g, prepared Glycyrrhiza uralensis 4g; Example 3, applicable dosage formulation, suitable for patients with severe intestinal metaplasia, low-grade intraepithelial neoplasia combined with bile reflux; Prepared Astragalus membranaceus 20g, stir-fried Atractylodes macrocephala 12g, Poria cocos 15g, Coptis chinensis 3g, Actinidia chinensis root 20g, Portulaca oleracea 15g, Salvia miltiorrhiza 10g, vinegar-processed Curcuma zedoaria 9g, vinegar-processed Bupleurum chinense 9g, stir-fried Paeonia lactiflora 12g, stir-fried Citrus aurantium 9g, Dendrobium nobile 10g, prepared Glycyrrhiza uralensis 6g; All three formulas above use a uniform water-decocting preparation process, with the following steps: Step 1: Remove impurities from all raw materials, rinse quickly with clean water to remove surface dust, and soak in room temperature water for 30 minutes to fully moisten the herbs and extract the active ingredients; Step 2: Place the soaked herbs and soaking water into a clay pot, add water until it covers the herbs by 2-3cm, bring to a boil over high heat, then simmer over low heat for 25 minutes. Filter out the first decoction, add an appropriate amount of water again, simmer over low heat for 20 minutes, and filter out the second decoction. Step 3: Mix the two decoctions thoroughly, let them stand and cool, then filter out the dregs to obtain a pure Chinese herbal decoction. The total volume of the decoction for each single decoction should be controlled at 300-400ml. Step 4: Take 1 dose daily, twice a day, 150-200ml each time, for a continuous intervention period of 3-6 months. If developed into granules, the desired dosage is 3 times a day, one sachet each time.

[0016] This formula uses the classic Sijunzi Decoction and Si Ni San as its dual cores, achieving a balance of tonification and purgation, and harmonizing the liver and spleen. The Sijunzi Decoction consists of roasted Astragalus membranaceus, stir-fried Atractylodes macrocephala, Poria cocos, and roasted Glycyrrhiza uralensis. It avoids the drawbacks of raw herbs being too tonifying, and uses processed herbs to invigorate the spleen and replenish qi, warm the middle jiao and consolidate the foundation, and protect the stomach and dry dampness. It fundamentally improves the basic pathological state of spleen and stomach qi deficiency and abnormal gastric mucosal digestion, providing qi and blood support for gastric mucosal repair. The root of the formula is Actinidia chinensis root, which clears heat and detoxifies, invigorates blood and disperses stagnation, and can resolve stasis and toxins in the stomach, inhibit abnormal proliferation of gastric mucosal epithelium, and reverse precancerous lesions of the stomach.

[0017] The Si Ni San formula consists of vinegar-processed Bupleurum chinense, stir-fried Paeonia lactiflora, stir-fried Citrus aurantium, and prepared Glycyrrhiza uralensis. Vinegar-processed Bupleurum chinense soothes the liver and relieves depression, and regulates the Qi mechanism of the brain-intestinal axis. Stir-fried Paeonia lactiflora nourishes blood, softens the liver, and relieves pain. Stir-fried Citrus aurantium promotes Qi circulation, relieves bloating, and harmonizes the Qi mechanism of the spleen and stomach. Combined with prepared Glycyrrhiza uralensis, the formula harmonizes the effects of the other herbs, so as to soothe the liver, regulate Qi, and harmonize the liver and spleen. It resolves gastric mucosal congestion and reflux discomfort caused by liver Qi invading the stomach and Qi stagnation, and achieves a balanced formula that tonifies without stagnation and drains without harming the body's vital energy.

[0018] Intestinal cleansing and gut-regulating ingredients: Coptis chinensis, Actinidia chinensis root, and Portulaca oleracea. Coptis chinensis is bitter and cold, clearing away latent heat in the stomach and intestines, eradicating hidden fire in the gastric mucosa; Actinidia chinensis root clears heat and detoxifies, invigorates blood and dissipates nodules, dissolves stagnant toxins in the stomach and intestines, and inhibits abnormal epithelial proliferation to reverse precancerous lesions of the stomach; Portulaca oleracea clears heat and protects the intestines, regulates intestinal flora homeostasis, reduces enterogenic chronic inflammation, and blocks the continuous damage of inflammatory factors to the gastric mucosa through the gut-gastric axis.

[0019] The blood-activating and mass-eliminating components are: Danshen (Salvia miltiorrhiza) and vinegar-processed Curcuma zedoaria. Danshen activates blood circulation, cools the blood, unblocks the meridians, and protects the gastric mucosa, improving local microcirculation and relieving mucosal congestion and hypoxia. Vinegar-processed Curcuma zedoaria breaks up blood stasis, eliminates masses, promotes qi circulation, and disperses nodules. Its medicinal properties are moderated by vinegar processing, avoiding the adverse effects of severe blood-breaking. It can gradually dissipate gastric mucosal dysplasia, intestinal metaplasia, and stagnant nodules, blocking the progression of inflammatory blockage to precancerous lesions.

[0020] Yin-nourishing and membrane-protecting component: Dendrobium. Dendrobium nourishes yin and generates fluids, nourishes stomach yin, repairs damaged gastric mucosal barrier, alleviates gastric mucosal atrophy and fluid deficiency caused by long-term inflammation, compensates for the drying properties of qi-tonifying and blood-activating herbs, achieves a balance of cold and heat, and protects the normal physiological structure of gastric mucosa.

[0021] The present invention and its embodiments have been described above. This description is not restrictive. The accompanying drawings are only one embodiment of the present invention. In short, if a person skilled in the art is inspired by this description and designs a similar structure and embodiment without departing from the spirit of the present invention, such design should fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition that can improve the gastric mucosal microenvironment and block the transformation of gastric mucosal inflammation into cancer, characterized in that: Composed of the following active pharmaceutical ingredient by weight: The formula includes 10-20g of roasted Astragalus membranaceus, 10-15g of stir-fried Atractylodes macrocephala, 10-15g of Poria cocos, 1-3g of Coptis chinensis, 10-20g of Actinidia chinensis root, 10-15g of Portulaca oleracea, 6-10g of Salvia miltiorrhiza, 6-9g of vinegar-processed Curcuma zedoaria, 6-9g of vinegar-processed Bupleurum chinense, 9-12g of stir-fried Paeonia lactiflora, 6-9g of stir-fried Citrus aurantium, 6-10g of Dendrobium nobile, and 3-6g of roasted Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition according to claim 1, which can improve the gastric mucosal microenvironment and block the transformation of gastric mucosal inflammation into cancer, is characterized in that: The Chinese medicine composition is based on Sijunzi Decoction and Si Ni San as the core formula, and is combined with three types of targeted pharmacological components: intestinal cleansing and bacterial regulation, blood circulation and mass elimination, and yin nourishment and membrane protection. It follows the principle of balancing cold and heat and taking into account both tonification and purgation. The medicine is mild and suitable for long-term continuous intervention for 3-6 months. The mechanism of action of the Chinese medicine composition fully covers five major regulatory pathways: gut microbiota, gastric mucosal microenvironment, gut-brain axis, bile acids, and inflammation-cancer transformation. It is specifically designed to intervene in precancerous lesions of chronic atrophic gastritis with intestinal metaplasia and low-grade intraepithelial neoplasia, and is also suitable for intervention in complication scenarios of chronic atrophic gastritis complicated with bile reflux and gut microbiota dysbiosis. The traditional Chinese medicine composition improves chronic gastric mucosal inflammation, blocks the process of inflammation-cancer transformation, and reduces the risk of progression of precancerous lesions in chronic atrophic gastritis by regulating the intestinal flora-bile acid metabolism pathway.

3. The traditional Chinese medicine composition according to claim 1, which can improve the gastric mucosal microenvironment and block the transformation of gastric mucosal inflammation into cancer, is characterized in that: In the core formula framework, the Sijunzi Decoction component consists of roasted Astragalus membranaceus, stir-fried Atractylodes macrocephala, Poria cocos, and roasted Glycyrrhiza uralensis, which have the effects of strengthening the spleen and replenishing qi, consolidating the foundation and protecting the stomach. The Si Ni San component consists of vinegar-processed Bupleurum chinense, stir-fried Paeonia lactiflora, stir-fried Citrus aurantium, and roasted Glycyrrhiza uralensis, which have the effects of soothing the liver and regulating qi, harmonizing the liver and spleen, and achieving a balanced combination of tonification and detoxification in the formula. Actinidia chinensis root clears heat and detoxifies, invigorates blood and dissipates nodules, can resolve stasis and toxins in the stomach, inhibit abnormal proliferation of gastric mucosal epithelium, and reverse precancerous lesions of the stomach.

4. The traditional Chinese medicine composition according to claim 1, which can improve the gastric mucosal microenvironment and block the transformation of gastric mucosal inflammation into cancer, is characterized in that: The composition is balanced by its combination of cold and warm properties, and takes into account both tonifying and purging effects. It contains no drastic medicinal ingredients and is suitable for the long-term intervention needs of chronic atrophic gastritis and precancerous lesions. The continuous intervention cycle is 3-6 months, which can sustainably improve the pathological state of the gastric mucosa without short-term drug resistance or organ damage.