A traditional Chinese medicine composition for treating chronic atrophic gastritis and application thereof

Abstract

This invention discloses a traditional Chinese medicine composition for treating chronic atrophic gastritis and its application. The composition comprises the following raw materials in parts by weight: Bupleurum chinense 10-20 parts, Paeonia lactiflora 10-20 parts, Citrus aurantium 15-25 parts, Pinellia ternata 6-10 parts, Magnolia officinalis 15-25 parts, Poria cocos 25-35 parts, Perilla frutescens 15-25 parts, Atractylodes macrocephala 15-25 parts, Dioscorea opposita 25-35 parts, Cyperus rotundus 10-15 parts, Curcuma longa 10-15 parts, Aucklandia lappa 5-10 parts, Amomum villosum 10-15 parts, Astragalus membranaceus 25-35 parts, Curcuma zedoaria 10-20 parts, Mentha haplocalyx 5-10 parts, Eupatorium fortunei 10-20 parts, and Glycyrrhiza uralensis (processed) 10-15 parts. This invention also discloses the application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for reversing chronic atrophic gastritis with intestinal metaplasia. This invention achieves the synergistic effect of invigorating qi and strengthening the spleen to support the body's resistance, promoting blood circulation and eliminating masses to remove lesions, and regulating the body's fluids to promote a smooth environment, thereby reversing chronic atrophic gastritis with intestinal metaplasia.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating chronic atrophic gastritis and its application. Background Technology

[0002] Chronic atrophic gastritis (CAG) is a precancerous condition of the stomach, and the risk of cancer is further increased in cases accompanied by intestinal metaplasia (IM), making it a key focus and challenge in clinical treatment. Currently, modern medicine lacks effective drugs to reverse CAG with IM, and treatment mainly focuses on symptomatic relief and regular endoscopic monitoring, which places a significant psychological burden on patients and increases their risk of disease progression.

[0003] Traditional Chinese medicine (TCM) has the advantage of holistic regulation in the treatment of chronic gastritis. Existing technologies include some TCM compositions for treating chronic gastritis or atrophic gastritis. These existing technologies typically target common syndromes of gastritis (liver-stomach disharmony, spleen-stomach weakness) or general pathological changes (inflammation, atrophy), with the treatment goal primarily being to alleviate clinical symptoms or improve inflammation.

[0004] However, intestinal metaplasia, as a special pathological transformation, is often categorized in Traditional Chinese Medicine (TCM) as "abdominal masses" or "blood stasis," with a more profound and complex pathogenesis. It typically involves spleen deficiency and qi weakness as the root cause, and blood stasis, phlegm, and dampness as the manifestation. Existing treatments either focus solely on soothing the liver and regulating qi, failing to achieve deep-seated blood stasis and mass elimination; or they focus on tonifying qi and strengthening the spleen, insufficiently addressing qi stagnation and dampness obstruction. Therefore, current technology lacks a highly effective TCM compound specifically targeting the core pathogenesis of CAG accompanied by intestinal metaplasia—spleen deficiency and qi weakness, qi stagnation, and dampness stasis—that can simultaneously strengthen the spleen, regulate qi, relieve stagnation, and eliminate dampness and blood stasis to reverse intestinal metaplasia. Summary of the Invention

[0005] To address the shortcomings of existing technologies, the present invention aims to provide a traditional Chinese medicine composition and its application for treating chronic atrophic gastritis. This invention utilizes Astragalus membranaceus, Atractylodes macrocephala, and Dioscorea opposita to invigorate the spleen and replenish qi, strengthening the body's resistance and repair capabilities. Curcuma zedoaria, as the core herb, breaks up blood stasis and eliminates masses, directly targeting the pathological product of intestinal metaplasia, a form of "blood stasis and toxins." Bupleurum chinense, Citrus aurantium, Cyperus rotundus, and Curcuma longa are used to soothe the liver and regulate qi, harmonizing emotions and qi flow. Magnolia officinalis, Poria cocos, Eupatorium fortunei, and Amomum villosum are used to regulate qi and resolve dampness, removing the sticky pathogens in the middle jiao. Paeonia lactiflora and Glycyrrhiza uralensis are added to relieve spasms and pain, while Pinellia ternata harmonizes the stomach and relieves nausea. The entire formula simultaneously strengthens the body's resistance and eliminates pathogens, with the methods of regulating qi, promoting blood circulation, and resolving dampness working synergistically. The use of Glycyrrhiza uralensis harmonizes the various herbs, collectively achieving the effect of reversing chronic atrophic gastritis accompanied by intestinal metaplasia.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating chronic atrophic gastritis, comprising the following raw materials in parts by weight: Bupleurum chinense 10-20 parts, Paeonia lactiflora 10-20 parts, Citrus aurantium 15-25 parts, Pinellia ternata 6-10 parts, Magnolia officinalis 15-25 parts, Poria cocos 25-35 parts, Perilla frutescens 15-25 parts, Atractylodes macrocephala 15-25 parts, Dioscorea opposita 25-35 parts, Cyperus rotundus 10-15 parts, Curcuma longa 10-15 parts, Aucklandia lappa 5-10 parts, Amomum villosum 10-15 parts, Astragalus membranaceus 25-35 parts, Curcuma zedoaria 10-20 parts, Mentha haplocalyx 5-10 parts, Eupatorium fortunei 10-20 parts, and Glycyrrhiza uralensis (processed) 10-15 parts.

[0008] Preferably, the above-mentioned traditional Chinese medicine composition includes the following raw materials in parts by weight: Bupleurum chinense 15 parts, Paeonia lactiflora 15 parts, Citrus aurantium 20 parts, Pinellia ternata 8 parts, Magnolia officinalis 20 parts, Poria cocos 30 parts, Perilla frutescens 20 parts, Atractylodes macrocephala 20 parts, Dioscorea opposita 30 parts, Cyperus rotundus 12 parts, Curcuma longa 12 parts, Aucklandia lappa 6 parts, Amomum villosum 12 parts, Astragalus membranaceus 30 parts, Curcuma zedoaria 15 parts, Mentha haplocalyx 6 parts, Eupatorium fortunei 15 parts, and Glycyrrhiza uralensis 12 parts.

[0009] In a second aspect, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps:

[0010] (1) Weigh each raw material according to the stated proportions;

[0011] (2) Boil the raw materials with water 2-3 times, combine the decoctions, and filter to obtain the final product.

[0012] In a third aspect, the present invention provides a pharmaceutical preparation comprising the above-described traditional Chinese medicine composition.

[0013] Preferably, the dosage form of the pharmaceutical preparation is a decoction, granules, pills, tablets and / or capsules.

[0014] In a fourth aspect, the present invention provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for reversing chronic atrophic gastritis with intestinal metaplasia.

[0015] Preferably, the drug is used to improve the pathological features of the gastric mucosa, including reducing or eliminating intestinal metaplasia.

[0016] Bupleurum: pungent, bitter, slightly cold, enters the liver and gallbladder meridians, harmonizes the exterior and interior, soothes the liver and relieves depression, raises yang qi, used for colds with fever, alternating chills and fever, chest and rib pain, and irregular menstruation.

[0017] White peony root: bitter, sour, slightly cold. It enters the liver and spleen meridians. It nourishes blood and regulates menstruation, astringes yin and stops sweating, softens the liver and relieves pain, and calms liver yang. It is used for blood deficiency and chlorosis, irregular menstruation, spontaneous sweating and night sweats, hypochondriac pain and abdominal pain, and limb spasms.

[0018] Fructus Aurantii Immaturus: Bitter, pungent, sour, slightly cold. Enters the spleen, stomach, and large intestine meridians. Regulates qi and relieves chest tightness, promotes digestion and eliminates bloating. Used for qi stagnation in the chest and hypochondrium, abdominal distension and pain, indigestion, phlegm retention, and organ prolapse.

[0019] Pinellia ternata: pungent, warm; toxic. Enters the spleen, stomach, and lung meridians. It dries dampness and resolves phlegm, relieves nausea and vomiting, and dissipates lumps and nodules. Used for damp phlegm, cold phlegm, cough with excessive phlegm, phlegm-dampness causing dizziness and palpitations, wind-phlegm causing dizziness, phlegm-induced headache, vomiting, and chest and epigastric fullness.

[0020] Magnolia officinalis: Bitter, pungent, and warm. It enters the spleen, stomach, lung, and large intestine meridians. It dries dampness and resolves phlegm, lowers qi and relieves fullness. It is used for dampness stagnation in the middle jiao, epigastric fullness and vomiting / diarrhea, food stagnation and qi stagnation, abdominal distension and constipation, and phlegm-dampness cough and wheezing.

[0021] Poria cocos: Sweet, bland, and neutral. It enters the heart, lung, spleen, and kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen and calms the mind. It is used for edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia.

[0022] Perilla stem: pungent, warm. Enters the lung, spleen, and stomach meridians. Regulates qi, relieves chest tightness, alleviates pain, and calms the fetus. Used for chest tightness, stomach pain, belching and vomiting, and threatened miscarriage.

[0023] Atractylodes macrocephala: Bitter, sweet, and warm. It enters the spleen and stomach meridians. It strengthens the spleen and replenishes qi, dries dampness and promotes diuresis, stops sweating, and calms the fetus. It is used for spleen deficiency with poor appetite, abdominal distension and diarrhea, phlegm retention with dizziness and palpitations, edema, spontaneous sweating, and threatened abortion.

[0024] Yam: Sweet, neutral. It enters the spleen, lung, and kidney meridians. It tonifies the spleen and stomach, promotes the production of body fluids and benefits the lungs, and tonifies the kidneys and astringes essence. It is used for spleen deficiency with poor appetite, chronic diarrhea, lung deficiency with cough and asthma, kidney deficiency with seminal emission, leukorrhea, and frequent urination.

[0025] Cyperus rotundus: pungent, slightly bitter, slightly sweet, neutral. It enters the liver, spleen, and triple burner meridians. It soothes the liver and relieves stagnation, regulates qi and relieves chest tightness, regulates menstruation and relieves pain. It is used for liver qi stagnation, chest and rib pain, hernia pain, breast distension and pain, and irregular menstruation.

[0026] Turmeric: pungent, bitter, and cold. It enters the liver, heart, and lung meridians. It invigorates blood and relieves pain, regulates qi and relieves depression, clears heat from the heart and cools the blood, and promotes bile secretion and reduces jaundice. It is used for stabbing pain in the chest and hypochondrium, chest pain, amenorrhea, dysmenorrhea, breast distension and pain, delirium due to fever, hematemesis and epistaxis due to blood heat, and jaundice with dark urine.

[0027] Costus root: pungent, bitter, and warm. It enters the spleen, stomach, large intestine, triple burner, and gallbladder meridians. It promotes qi circulation and relieves pain, strengthens the spleen and aids digestion. It is used for chest and rib pain, abdominal distension and pain, tenesmus after diarrhea, indigestion, and loss of appetite.

[0028] Amomum villosum: pungent, warm. Enters the spleen, stomach, and kidney meridians. It resolves dampness and improves appetite, warms the spleen and stops diarrhea, regulates qi and calms the fetus. Used for dampness obstructing the middle jiao, epigastric fullness and lack of appetite, spleen and stomach deficiency and cold, vomiting and diarrhea.

[0029] Astragalus: Sweet, slightly warm. Enters the lung and spleen meridians. It tonifies qi and raises yang, consolidates the exterior and stops sweating, promotes diuresis and reduces swelling, generates fluids and nourishes blood, promotes circulation and relieves pain, promotes pus drainage and detoxification, and astringes sores and promotes tissue regeneration.

[0030] Curcuma zedoaria: pungent, bitter, and warm. It enters the liver and spleen meridians. It promotes qi circulation, breaks up blood stasis, eliminates stagnation, and relieves pain. It is used for abdominal masses, amenorrhea due to blood stasis, chest pain, and abdominal distension due to food stagnation.

[0031] Peppermint: Pungent, cool. Enters the lung and liver meridians. Disperses wind-heat, clears the head and eyes, soothes the throat and promotes rash eruption, soothes the liver and regulates qi. Used for wind-heat colds, headaches and red eyes, sore throat and mouth ulcers, urticaria and measles, liver qi stagnation, chest tightness and hypochondriac pain.

[0032] Peilan: Pungent, neutral. Enters the spleen, stomach, and lung meridians. Aromatic and dampness-resolving, invigorating the spleen and stomach, releasing exterior pathogens and relieving summer heat. Used for dampness obstructing the middle jiao, epigastric fullness and nausea, sweet and greasy taste in the mouth, halitosis, excessive salivation, and summer-dampness exterior syndrome.

[0033] Prepared licorice root: Sweet, neutral. It enters the heart, lung, spleen, and stomach meridians. It tonifies the spleen and stomach, replenishes qi and restores the pulse, relieves spasms and pain, and harmonizes the effects of other herbs.

[0034] Based on the theories of "liver-spleen correlation" and "prolonged illness enters the collaterals", this invention targets the core complex pathogenesis of chronic atrophic gastritis with intestinal metaplasia (CAG with IM) as "liver stagnation and spleen deficiency, qi stagnation and dampness obstruction, and blood stasis", and establishes the treatment principle of "soothing the liver and strengthening the spleen, regulating qi and resolving dampness, and invigorating qi and blood to eliminate masses".

[0035] In this formula, the principal herbs are Astragalus membranaceus, Atractylodes macrocephala, and Dioscorea opposita. They are used in large quantities to invigorate the spleen and replenish qi, strengthen the stomach, provide vital energy support for promoting blood circulation and eliminating masses, support vital energy, repair the internal vitality of the gastric mucosa, and fundamentally curb the progression of atrophy and metaplasia.

[0036] Assistant herb: Curcuma zedoaria, which breaks up blood stasis, promotes qi circulation, eliminates stagnation and relieves pain. It is specifically used to treat "blood stasis" and "mass accumulation". It is the main herb for reversing intestinal metaplasia. When combined with the principal herb, it combines attack and tonification, invigorates qi to help promote blood circulation, and promotes blood circulation without harming the body's vital energy.

[0037] The adjuvant herbs are: Bupleurum, Fructus Aurantii Immaturus, Rhizoma Cyperi, Radix Curcumae, and Herba Menthae to soothe the liver and relieve depression, and regulate the flow of Qi; Magnolia officinalis, Fructus Perillae, Radix Aucklandiae, Fructus Amomi, Fructus Eupatorii, and Rhizoma Poriae to regulate Qi, relieve chest congestion, and dispel dampness; Radix Paeoniae Alba to nourish blood, soften the liver, and relieve spasms and pain; and Rhizoma Pinelliae Rhizoma Gentianae to harmonize the stomach and relieve nausea. The adjuvant herbs aim to unblock the flow of Qi and dispel dampness, clearing obstacles and creating a favorable internal environment for the principal and assistant herbs to exert their effects.

[0038] The guiding herb is roasted licorice root, which not only helps to strengthen the spleen but also harmonizes the effects of other herbs.

[0039] The combination of all the herbs in the formula works synergistically to soothe the liver and strengthen the spleen, regulate qi and eliminate dampness, invigorate qi and promote blood circulation to eliminate masses, treating both the symptoms and the root cause, and reversing the pathological changes of intestinal metaplasia.

[0040] The beneficial effects of this invention are:

[0041] 1. This invention utilizes 25-35 parts Astragalus membranaceus, 15-25 parts Atractylodes macrocephala, and 25-35 parts Dioscorea opposita to strengthen the Qi of the spleen and stomach in the middle Jiao, providing a solid foundation for treatment. At the same time, it is combined with sufficient Curcuma zedoaria to break up blood stasis and eliminate masses, forming a sufficient attacking force to specifically target intestinal metaplasia lesions. The dosage ratio of Bupleurum chinense and Citrus aurantium ensures the strength of soothing the liver and regulating Qi. The dosage combination of Magnolia officinalis, Eupatorium fortunei, and Poria cocos optimizes the efficacy of regulating Qi and eliminating dampness. This entire set of precise raw material ratios ensures that supporting the body's resistance without aiding the pathogenic factors and attacking the pathogenic factors without harming the body's resistance, achieving a dynamic balance and synergy. This is the key to reversing the complex pathological changes of intestinal metaplasia.

[0042] 2. This invention provides a new approach to TCM treatment for CAG patients with IM who lack effective drugs. It achieves a synergistic effect of invigorating qi and strengthening the spleen to support the body's resistance, promoting blood circulation and eliminating masses to remove lesions, and regulating and resolving dampness to unblock the environment. This approach can treat both the symptoms and the root cause of the disease and is expected to block or even reverse the disease progression. It has significant clinical significance and application prospects. Detailed Implementation

[0043] It should be noted that the following detailed descriptions are illustrative and intended to provide further explanation of this application. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains.

[0044] To enable those skilled in the art to better understand the technical solution of this application, the technical solution of this application will be described in detail below with reference to specific embodiments.

[0045] Example 1:

[0046] A traditional Chinese medicine composition for treating chronic atrophic gastritis comprises the following raw materials in parts by weight: Bupleurum chinense 15 parts, Paeonia lactiflora 15 parts, Citrus aurantium 20 parts, Pinellia ternata 8 parts, Magnolia officinalis 20 parts, Poria cocos 30 parts, Perilla frutescens 20 parts, Atractylodes macrocephala 20 parts, Dioscorea opposita 30 parts, Cyperus rotundus 12 parts, Curcuma longa 12 parts, Aucklandia lappa 6 parts, Amomum villosum 12 parts, Astragalus membranaceus 30 parts, Curcuma zedoaria 15 parts, Mentha haplocalyx 6 parts, Eupatorium fortunei 15 parts, and Glycyrrhiza uralensis 12 parts.

[0047] Its preparation method includes the following steps:

[0048] (1) Weigh each raw material according to the stated proportions;

[0049] (2) Add 8-10 times the amount of drinking water to the total amount of medicinal materials, soak for 30-45 minutes, bring to a boil over high heat, then simmer over low heat for 30-40 minutes, and filter the liquid.

[0050] (3) Add 6-8 times the amount of water to the dregs, simmer over low heat for 20-30 minutes, and filter out the liquid.

[0051] (4) Combine the two filtrates and dispense them separately.

[0052] Example 2:

[0053] A traditional Chinese medicine composition for treating chronic atrophic gastritis comprises the following raw materials in parts by weight: Bupleurum chinense 10 parts, Paeonia lactiflora 10 parts, Citrus aurantium 15 parts, Pinellia ternata 6 parts, Magnolia officinalis 15 parts, Poria cocos 25 parts, Perilla frutescens 15 parts, Atractylodes macrocephala 15 parts, Dioscorea opposita 25 parts, Cyperus rotundus 10 parts, Curcuma longa 10 parts, Aucklandia lappa 5 parts, Amomum villosum 10 parts, Astragalus membranaceus 25 parts, Curcuma zedoaria 10 parts, Mentha haplocalyx 5 parts, Eupatorium fortunei 10 parts, and Glycyrrhiza uralensis 10 parts.

[0054] The preparation method is the same as in Example 1.

[0055] Example 3:

[0056] A traditional Chinese medicine composition for treating chronic atrophic gastritis comprises the following raw materials in parts by weight: Bupleurum chinense 20 parts, Paeonia lactiflora 20 parts, Citrus aurantium 25 parts, Pinellia ternata 10 parts, Magnolia officinalis 25 parts, Poria cocos 35 parts, Perilla frutescens 25 parts, Atractylodes macrocephala 25 parts, Dioscorea opposita 35 parts, Cyperus rotundus 15 parts, Curcuma longa 15 parts, Aucklandia lappa 10 parts, Amomum villosum 15 parts, Astragalus membranaceus 35 parts, Curcuma zedoaria 20 parts, Mentha haplocalyx 10 parts, Eupatorium fortunei 20 parts, and Glycyrrhiza uralensis 15 parts.

[0057] The preparation method is the same as in Example 1.

[0058] Clinical trials to verify the efficacy of the drug of this invention in reversing intestinal metaplasia

[0059] To objectively evaluate the efficacy and safety of the drug of this invention in treating chronic atrophic gastritis with intestinal metaplasia, a randomized, controlled clinical study was conducted.

[0060] 1. Research Subjects and Methods

[0061] 1.1 Study subjects: Eighty patients who met the diagnostic criteria for chronic atrophic gastritis with mild to moderate intestinal metaplasia (confirmed by pathological diagnosis) and whose TCM syndrome was classified as liver stagnation and spleen deficiency, qi stagnation and dampness stasis were selected.

[0062] 1.2 Grouping and Administration: Patients were randomly divided into an experimental group and a control group, with 40 patients in each group. There were no statistically significant differences between the two groups in terms of gender, age, disease duration, and pathological severity, making them comparable.

[0063] Experimental group: The traditional Chinese medicine decoction prepared in Example 1 of this invention was taken orally, one dose per day, divided into two warm doses in the morning and evening.

[0064] Control group: Patients took a commercially available traditional Chinese medicine (Weifuchun Capsules) for the treatment of chronic atrophic gastritis orally at the recommended dosage as specified in the instructions.

[0065] Both groups underwent a 6-month treatment course, during which other medications for gastritis and those affecting gastric acid secretion were discontinued.

[0066] 2. Observation Indicators

[0067] 2.1 Primary efficacy endpoint: Improvement in gastric mucosal histopathology. Before and after treatment, gastric mucosal biopsies were taken from the same or adjacent sites during gastroscopy for pathological examination to assess changes in the degree of intestinal metaplasia (IM).

[0068] Efficacy assessment:

[0069] Reversal: IM changes from mild or moderate before treatment to none, or from severe to mild or none.

[0070] Effective: The severity of IM is reduced by at least one level (e.g., from moderate to mild).

[0071] Stable: The level of IM remains unchanged.

[0072] Progress: The level of IM has increased.

[0073] Overall success rate = (Number of reversed cases + Number of valid cases) / Total number of cases × 100%.

[0074] 2.2 Secondary efficacy endpoints:

[0075] Traditional Chinese Medicine syndrome scoring: The main symptoms such as epigastric distension and pain, poor appetite, belching, fatigue and weakness are quantitatively scored, and the changes in scores before and after treatment are compared.

[0076] Improvement rate of gastroscopy mucosal images.

[0077] Safety indicators: routine blood, urine, and stool tests; liver and kidney function tests; electrocardiogram; and recording of adverse events.

[0078] 3. Experimental Results

[0079] 3.1 Comparison of pathological and histological treatment outcomes (reversal of intestinal metaplasia)

[0080] Table 1. Comparison of pathological changes in intestinal metaplasia between the two groups of patients after treatment (n, %)

[0081] Group Number of examples reverse efficient Stablize progress Overall efficiency experimental group 40 14 16 9 1 75.0％ control group 40 4 10 20 6 35.0％

[0082] Statistical analysis: The overall effective rate of reversing intestinal metaplasia in the experimental group was significantly higher than that in the control group, and the difference was statistically significant (P < 0.01). Among them, the proportion of patients who achieved pathological "reversal" in the experimental group (35.0%) was significantly higher than that in the control group (10.0%).

[0083] 3.2 Comparison of TCM syndrome differentiation and treatment efficacy

[0084] After treatment, the scores of major symptoms such as epigastric distension and pain, poor appetite, and fatigue in the experimental group decreased significantly compared with those before treatment (P<0.01), and the decrease was greater than that in the control group. The total effective rate of TCM syndrome in the experimental group was 91.7%, while that in the control group was 76.7%, and the difference between the two groups was statistically significant (P<0.05).

[0085] 3.3 Comparison of improvement rates in gastroscopy mucosal images

[0086] Post-treatment gastroscopy showed that the improvement rate of gastric mucosal erythema, erosion, and vascular permeability in the experimental group was 83.3%, while that in the control group was 68.3%, indicating that the experimental group was superior to the control group (P<0.05).

[0087] 3.4 Safety Evaluation

[0088] No drug-related abnormalities were found in routine blood, urine, and stool tests, as well as liver and kidney function tests and electrocardiograms before and after treatment in either group of patients. Two patients in the experimental group experienced mild loose stools at the beginning of medication, which resolved spontaneously without treatment; one patient in the control group experienced dry mouth. No serious adverse events occurred in any patient, indicating that the drug of this invention has good safety.

[0089] 4. Experimental Conclusions

[0090] The results of this clinical trial demonstrate that the traditional Chinese medicine composition provided by this invention can significantly improve the clinical symptoms and endoscopic mucosal findings in patients with chronic atrophic gastritis accompanied by intestinal metaplasia. Most importantly, in reversing the core pathological change—intestinal metaplasia—the overall effective rate and pathological reversal rate of the drug of this invention are significantly superior to the positive control drug, with statistically significant differences.

[0091] This fully demonstrates that the present invention, through its unique combination of "soothing the liver and strengthening the spleen, regulating qi and resolving dampness, invigorating qi and promoting blood circulation and eliminating masses," has a clear therapeutic effect on chronic atrophic gastritis with intestinal metaplasia, especially showing unique advantages and outstanding effects in reversing precancerous pathological changes, and is safe for clinical application.

[0092] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A traditional Chinese medicine composition for treating chronic atrophic gastritis, characterized in that, The raw materials include the following parts by weight: Bupleurum chinense 10-20 parts, Paeonia lactiflora 10-20 parts, Citrus aurantium 15-25 parts, Pinellia ternata 6-10 parts, Magnolia officinalis 15-25 parts, Poria cocos 25-35 parts, Perilla frutescens 15-25 parts, Atractylodes macrocephala 15-25 parts, Dioscorea opposita 25-35 parts, Cyperus rotundus 10-15 parts, Curcuma longa 10-15 parts, Aucklandia lappa 5-10 parts, Amomum villosum 10-15 parts, Astragalus membranaceus 25-35 parts, Curcuma zedoaria 10-20 parts, Mentha haplocalyx 5-10 parts, Eupatorium fortunei 10-20 parts, and Glycyrrhiza uralensis (processed) 10-15 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw materials include the following parts by weight: Bupleurum chinense 15 parts, Paeonia lactiflora 15 parts, Citrus aurantium 20 parts, Pinellia ternata 8 parts, Magnolia officinalis 20 parts, Poria cocos 30 parts, Perilla frutescens 20 parts, Atractylodes macrocephala 20 parts, Dioscorea opposita 30 parts, Cyperus rotundus 12 parts, Curcuma longa 12 parts, Aucklandia lappa 6 parts, Amomum villosum 12 parts, Astragalus membranaceus 30 parts, Curcuma zedoaria 15 parts, Mentha haplocalyx 6 parts, Eupatorium fortunei 15 parts, and Glycyrrhiza uralensis 12 parts.

3. A method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Includes the following steps: (1) Weigh each raw material according to the stated proportions; (2) Boil the raw materials with water 2-3 times, combine the decoctions, and filter to obtain the final product.

4. A pharmaceutical preparation, characterized in that, Includes the traditional Chinese medicine composition as described in claim 1 or 2.

5. The pharmaceutical preparation according to claim 4, characterized in that, The dosage form of the pharmaceutical preparation is decoction, granules, pills, tablets and / or capsules.

6. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for reversing chronic atrophic gastritis with intestinal metaplasia.

7. The application according to claim 6, characterized in that, The drug is used to improve the pathological features of the gastric mucosa, including reducing or eliminating intestinal metaplasia.