A traditional Chinese medicine composition for treating chronic gastritis with cold and heat symptoms, a preparation method thereof, and a traditional Chinese medicine preparation

Abstract

The present application relates to the field of traditional Chinese medicine, and provides a traditional Chinese medicine composition for treating chronic gastritis with cold and heat symptoms, which is prepared from the following traditional Chinese medicines in parts by weight: 20-45 parts of lily, 10-25 parts of Jiang Banxia, 10-25 parts of atractylodes, 10-25 parts of white peony root, 8-20 parts of codonopsis, 8-20 parts of Anemarrhena, 8-20 parts of areca nut, 8-20 parts of magnolia bark, 8-20 parts of jujube, 6-15 parts of scutellaria, 6-15 parts of dried ginger, 6-15 parts of licorice, 6-15 parts of fried licorice, 3-12 parts of sandalwood, and 1.5-6 parts of coptis. The present application is based on the theory of traditional Chinese medicine, and can regulate the whole body through multiple targets such as clearing heat and dampness, harmonizing stomach and descending adverse qi, promoting qi circulation and eliminating mass, and nourishing yin and strengthening the body resistance. The present application can promote blood circulation and qi circulation, unblock qi, and improve the overall health of patients with chronic gastritis. Moreover, the present application has few side effects and is suitable for long-term use.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating chronic gastritis of the mixed cold and heat type, its preparation method, and a traditional Chinese medicine preparation thereof. Background Technology

[0002] Chronic gastritis, a common inflammation of the gastric mucosa, is caused by a variety of factors. These causes include long-term bacterial infections, such as Helicobacter pylori infection, acid reflux and bile reflux, improper diet, excessive alcohol consumption, and unhealthy lifestyle habits such as smoking. Patients often experience persistent or intermittent upper abdominal pain, bloating, loss of appetite, and other digestive problems. Recently, the application of traditional Chinese medicine preparations in the treatment of chronic gastritis has been increasing, and their therapeutic efficacy and safety have attracted widespread attention in the industry.

[0003] Existing treatments for chronic gastritis include drug therapy, such as antacids (e.g., omeprazole, lansoprazole), to reduce gastric acid secretion and relieve symptoms; aluminum phosphate and bismuth compounds, which aim to maintain gastric mucosal health and promote ulcer healing; and antibiotics, used to eradicate Helicobacter pylori infection. While these treatments for chronic gastritis are effective, they suffer from the following significant drawbacks, which are precisely the technical challenges that the traditional Chinese medicine compound formula in this application aims to address: 1. Prominent side effects ① Long-term use of PPIs (omeprazole, lansoprazole, etc.) can cause hypomagnesemia, osteoporosis, hip and wrist fractures, intestinal flora imbalance, Clostridium difficile infection, and an increased risk of gastric cancer. ② Continuous use of bismuth preparations (bismuth potassium citrate, colloidal bismuth pectin) for more than 8 weeks can lead to bismuth encephalopathy, nephrotoxicity, black tongue and black stools, resulting in poor compliance; ③ Triple / quadruple antibiotic therapy (clarithromycin + amoxicillin + metronidazole, etc.) has led to diarrhea, pseudomembranous colitis, abnormal liver function, skin rash, and an increasing rate of drug resistance (clarithromycin resistance >30%). The *Helicobacter pylori* eradication rate has decreased to <80%. ④ Long-term use of antacids (aluminum magnesium carbonate, aluminum phosphate) in large doses can cause constipation, hypophosphatemia, and aluminum accumulation poisoning. Patients with renal insufficiency should use them with caution.

[0004] 2. High recurrence rate The recurrence rate of chronic gastritis and erosion is 50-70% within 6 months after stopping PPIs; symptoms often rebound rapidly after Hp eradication failure or reinfection, requiring repeated medication.

[0005] 3. It has a single function and is difficult to target multiple targets simultaneously. Western medicine targets the three links of "acid-bacteria-mucosa" separately, but lacks a holistic intervention that simultaneously takes into account "inflammatory microenvironment-mucosal blood flow-gastrointestinal motility-immune regulation", thus having limited effectiveness for complications such as bile reflux, functional dyspepsia, and anxiety.

[0006] 4. Insufficient reversal effect on dysplasia or intestinal metaplasia. Current Western medicines cannot effectively block the "Correa chain" of chronic gastritis → atrophy → intestinal metaplasia → dysplasia → gastric cancer. They can only perform regular endoscopic follow-up, which places a heavy psychological burden on patients.

[0007] 5. Restrictions on special groups In children, pregnant women, breastfeeding mothers, patients with hepatic or renal insufficiency, and elderly patients taking multiple medications, most PPIs, bismuth preparations, and antibiotics are listed as requiring caution or are contraindicated due to their narrow therapeutic window.

[0008] 6. Drug resistance and superinfection Broad-spectrum antibiotics disrupt the gut microbiota, leading to fungal infections, vitamin deficiencies, and metabolic disorders; the number of multidrug-resistant strains of *Helicobacter pylori* (Hp) such as levofloxacin and clarithromycin is increasing, and the failure rate of first-line treatments continues to rise.

[0009] In summary, while the existing chemical drug "acid suppression-film protection-bacterial" model can quickly relieve symptoms, it has significant side effects, a high recurrence rate, prominent drug resistance, and cannot reverse precancerous lesions. Summary of the Invention

[0010] To address the aforementioned problems, this invention aims to provide a traditional Chinese medicine composition and its preparation method for treating chronic gastritis with mixed cold and heat patterns. Based on traditional Chinese medicine theory, it achieves overall regulation through multiple targets—clearing heat and dampness, harmonizing the stomach and suppressing nausea, promoting qi circulation and eliminating stagnation, and nourishing yin and strengthening the body's resistance—to invigorate blood circulation, promote qi flow, and improve the overall health of patients with chronic gastritis. Compared with Western medicine, traditional Chinese medicine has fewer side effects and is suitable for long-term use.

[0011] To achieve the above objectives, the technical solution adopted by the present invention is as follows: In the first aspect, this application discloses a traditional Chinese medicine composition for treating chronic gastritis of the mixed cold and heat type. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 20-45 parts of lily bulb, 10-25 parts of ginger-processed pinellia, 10-25 parts of atractylodes lancea, 10-25 parts of white peony root, 8-20 parts of codonopsis pilosula, 8-20 parts of anemarrhena asphodeloides, 8-20 parts of areca nut, 8-20 parts of lindera strychnifolia, 8-20 parts of jujube, 6-15 parts of scutellaria baicalensis, 6-15 parts of dried ginger, 6-15 parts of licorice root, 6-15 parts of prepared licorice root, 3-12 parts of sandalwood, and 1.5-6 parts of coptis chinensis.

[0012] Furthermore, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: Lily bulb 30 parts, ginger-processed Pinellia ternata 15 parts, Atractylodes lancea 15 parts, white peony root 15 parts, Codonopsis pilosula 12 parts, Anemarrhena asphodeloides 12 parts, Areca catechu 12 parts, Lindera strychnifolia 12 parts, jujube 12 parts, Scutellaria baicalensis 9 parts, dried ginger 9 parts, licorice root 9 parts, prepared licorice root 9 parts, sandalwood 9 parts, Coptis chinensis 3 parts.

[0013] Secondly, this application discloses a method for preparing the above-mentioned traditional Chinese medicine composition, including the following steps: S1: Weigh out the following ingredients in the order of the above-mentioned Chinese herbal composition: lily bulb, ginger-processed pinellia, atractylodes lancea, white peony root, codonopsis pilosula, anemarrhena asphodeloides, areca nut, lindera strychnifolia, jujube, scutellaria baicalensis, dried ginger, licorice root, prepared licorice root, sandalwood, and coptis chinensis, and set aside. S2: Crush the Coptis chinensis, sandalwood, dried ginger, and ginger-processed Pinellia ternata weighed in S1, and then mix them with half the amount of Paeonia lactiflora and Atractylodes lancea weighed in S1 to obtain mixture 1. Add water to mixture 1 and decoct it. After decoction, filter it to obtain medicinal juice 1 and medicinal residue 1. S3: Add the remaining half of the white peony root and atractylodes rhizome, along with the lily bulb, scutellaria root, codonopsis root, anemarrhena rhizome, areca nut, lindera root, jujube, licorice root, and prepared licorice root weighed in S1 to the dregs 1 to obtain mixture 2. Add water to mixture 2 twice and decoct and filter it twice. Combine the two filtrates to obtain medicinal juice 2. S4: Combine medicinal juice 1 and medicinal juice 2 to obtain total medicinal juice. Concentrate and filter the total medicinal juice to obtain an extract, thus obtaining a traditional Chinese medicine composition.

[0014] Furthermore, in S2, the amount of water added is 6-10 times that of mixture 1, and the decoction conditions are: decoction temperature 75℃-90℃, decoction time 20-40min, and after adding water to mixture 1, it is soaked for 20-40min before decoction.

[0015] Furthermore, in S3, mixture 2 is added to water twice and boiled and filtered twice, including: Add water to mixture 2 for the first time. The amount of water added for the first time is 6-10 times that of mixture 2. After boiling, keep it for 30-60 minutes, filter, and obtain the first filtrate and the first filter residue. Add water to the first filter residue, the amount of water being 4-6 times that of the first filter residue. Boil for 20-40 minutes, then filter to obtain the second filtrate.

[0016] Furthermore, the extract is obtained by concentrating the total medicinal juice of S4 to a relative density of 1.05-1.15, centrifuging, refrigerating and standing at 0-4℃ for 12-24 hours, filtering, and then further concentrating the filtered medicinal juice to a relative density of 1.20-1.30.

[0017] Thirdly, this application discloses a traditional Chinese medicine preparation, which includes the above-mentioned traditional Chinese medicine composition and acceptable excipients.

[0018] Furthermore, the dosage form of the traditional Chinese medicine preparation is selected from at least one of tablets, granules, capsules, pills, drop pills, powders, syrups, and mixtures.

[0019] In the above-mentioned Chinese herbal medicine composition, ginger and pinellia are the principal herbs. They are pungent and warm, which can open up blockages, harmonize the stomach and relieve nausea, eliminate bloating and stop vomiting, and directly attack the bloating caused by the mutual binding of cold and heat. Scutellaria baicalensis, Coptis chinensis, and dried ginger are the assistant herbs. Among them, Scutellaria baicalensis is bitter and cold, clears stomach heat, dries dampness and reduces inflammation, and forms a "pungent-opening and bitter-descending" effect with Pinellia ternata; Coptis chinensis is bitter and cold, strengthens the stomach and intestines, clears stagnant heat, and inhibits Hp. Small amounts can prevent the bitter and cold herbs from damaging Yang; Dried ginger is pungent and hot, warms the middle and dispels cold, and invigorates spleen Yang. When combined with Scutellaria baicalensis and Coptis chinensis, which are both cold and hot, Yang is restored and the stagnation is relieved. Atractylodes lancea, areca nut, Lindera strychnifolia, sandalwood, lily bulb, Anemarrhena asphodeloides, white peony root, and jujube are all adjuvant herbs. Among them, Atractylodes lancea is bitter and warm, drying dampness and strengthening the spleen, raising clear yang, and assisting dried ginger in invigorating the spleen; Areca catechu is bitter and pungent, descending and draining, promoting qi circulation and relieving stagnation, resolving accumulation and bloating, and regulating qi mechanism; Lindera strychnifolia is pungent and warm, promoting qi circulation and dispelling cold, regulating the three jiaos, and relieving epigastric pain, forming the "four grinding" principle with Areca catechu; Sandalwood is pungent and warm, aromatic, clearing qi stagnation in the chest and diaphragm, invigorating the spleen and stomach, and assisting in ascending and descending; Lilium brownii is sweet and slightly cold, nourishing yin and moistening the lungs and stomach, clearing deficiency heat, protecting stomach yin, and preventing pungent dryness from damaging yin; Anemarrhena asphodeloides is bitter and cold, clearing stomach heat, generating fluids and moistening dryness, and counteracting the dryness of dried ginger and Areca catechu; Paeonia lactiflora is sour and sweet, transforming yin, softening the liver and relieving spasms, harmonizing ying and relieving pain, and when combined with Glycyrrhiza uralensis, it becomes Paeonia lactiflora and Glycyrrhiza uralensis decoction; Codonopsis pilosula is sweet and neutral, tonifying the middle and replenishing qi, invigorating the spleen and stomach, and preventing bitter diarrhea from damaging the body's vital energy; Jujube is sweet and warm, tonifying the spleen and harmonizing ying, moderating the strong properties of other medicines, and assisting Glycyrrhiza uralensis in replenishing the middle qi; Licorice (raw + roasted) is used as an adjuvant. Licorice clears heat and detoxifies, while roasted licorice invigorates qi, harmonizes the middle jiao, regulates the effects of other herbs, and relieves spasms and pain.

[0020] In the above-mentioned traditional Chinese medicine composition, the synergistic mechanism of each component is as follows: 1. It has a pungent and bitter nature, and can balance cold and heat. Pinellia ternata and dried ginger, with their pungent and warm properties, open up stagnation and relieve congestion; Scutellaria baicalensis and Coptis chinensis, with their bitter and cold properties, descend and purge. When used together, these four herbs, one ascending and one descending, one cold and one hot, open up stagnation and congestion in the middle jiao, dispel damp-heat, and eliminate cold pathogens, restoring the spleen's ascending and stomach's descending function. Modern research shows that Pinellia ternata, Scutellaria baicalensis, and Coptis chinensis synergistically can inhibit Helicobacter pylori (Hp), reduce inflammatory factors such as IL-8 and TNF-α, and improve gastric mucosal congestion and erosion.

[0021] 2. Promotes the flow of Qi and eliminates dampness, regulating the Qi mechanism. Atractylodes lancea dries dampness and strengthens the spleen, while areca nut, Lindera root, and sandalwood promote qi circulation and relieve stagnation. Together, these four herbs eliminate the symptoms of "dampness obstructing qi stagnation." Atractylodes lancea combined with dried ginger is pungent and warm, drying dampness without generating heat; Lindera root and sandalwood are pungent and aromatic, promoting gastric emptying and reducing bile reflux; areca nut and its active ingredient arecoline can significantly enhance the amplitude of gastric body-antrum contractions and the main power of gastric electrical activity by stimulating cholinergic M receptors, upregulating motilin (MTL) levels, and activating the central vagal-vagal reflex pathway, thereby promoting gastric emptying and regulating the interdigestive migratory complex (MMC) cycle.

[0022] 3. Nourishes Yin and balances blood, prevents dryness and protects Yin Lily bulb and anemarrhena rhizome are sweet, cold, and moistening, while white peony root and licorice root are sour and sweet, nourishing yin. This not only counteracts the bitterness of the pungent and dry herbs but also addresses the "stomach yin deficiency" constitution of CAG (Central Aged Gastroenteritis). Lily bulb polysaccharides and anemarrhena rhizome saponins can promote mucus secretion, increase prostaglandin E2 levels, and strengthen the gastric mucosal barrier; peony and licorice root decoction can inhibit gastric acid, reduce pepsin activity, and relieve pain.

[0023] 4. Tonify Qi and strengthen the body's resistance, prevent depletion and damage to the body's vital energy. Codonopsis pilosula, jujube, and prepared licorice root invigorate qi and harmonize the middle jiao, ensuring that "opening and draining without harming the body's vital energy." Codonopsis pilosula polysaccharides can regulate the Th1 / Th2 balance, promote gastrin secretion, and accelerate gastric mucosal repair; jujube cyclic adenosine monophosphate (cAMP) can enhance the cell's resistance to damage.

[0024] 5. Use both hot and cold herbs, and balance strength and gentleness. The formula is warm without being drying (lily bulb and anemarrhena rhizome counteract its dryness), clearing without being cooling (dried ginger and lindera root counteract its coldness), promoting qi circulation without depleting qi (codonopsis root and jujube support the body's vital energy), and nourishing yin without stagnation of pathogenic factors (atractylodes rhizome and areca nut resolve dampness). Together, they achieve the effect of "harmonizing yin and yang".

[0025] Compared with the prior art, the beneficial effects of the present invention are: The traditional Chinese medicine composition of this application restores the ascending and descending functions of the spleen and stomach through "pungent opening and bitter descending", eliminates pathogenic factors through "promoting qi and resolving dampness", protects stomach yin through "nourishing yin and harmonizing blood", and assists the source of transformation through "tonifying qi and supporting the body's resistance". The entire formula closely adheres to the core of the complex interplay of cold and heat and the mutual manifestation of deficiency and excess, embodying the essence of "harmonizing the body".

[0026] Coptis chinensis, Scutellaria baicalensis, and Glycyrrhiza uralensis contain berberine, baicalin, and glycyrrhizic acid, which inhibit Hp growth, block the NF-κB pathway, and reduce IL-8 and TNF-α. Lily polysaccharides, Anemarrhena asphodeloides saponins, and Codonopsis pilosula polysaccharides promote mucus / PGE2 secretion, upregulate occludin and claudin-1, and enhance the skin barrier. Paeonia lactiflora and Glycyrrhiza uralensis decoction inhibits gastric acid and pepsin. Coptis chinensis and Zingiber officinale bidirectionally regulate gastric acid (small doses of Coptis chinensis inhibit acid, while Zingiber officinale promotes acid, resulting in an overall return to normal). Areca catechu, Lindera strychnifolia, and Santalum album promote gastric emptying and enhance MMC. Pinellia ternata and Scutellaria baicalensis relieve nausea and vomiting and reduce reflux. Scutellaria baicalensis, Lilium brownii, Paeonia lactiflora, and Glycyrrhiza uralensis contain flavonoids, polysaccharides, and paeoniflorin, which scavenge ROS and increase SOD and GSH-Px activity. Scutellaria baicalensis, Coptis chinensis, Lilium brownii, and Glycyrrhiza uralensis can downregulate COX-2 and Bcl-2, upregulate Bax, inhibit abnormal cell proliferation, induce apoptosis, and delay precancerous lesions. Attached Figure Description

[0027] Figure 1 These are HE-stained histopathological images of gastric mucosa after treatment with different drugs according to the present invention. From left to right, they are: NC group, MD group, and TYHYG group.

[0028] Figure 2The images show the protein expression levels (AC) of caspase-1, IL-1β, and NLRP3 in the gastric mucosa and the expression level of NLRP3 mRNA in the gastric mucosa after intervention with serum containing the traditional Chinese medicine composition of the present invention in a CAG rat model. A and B are gray bars and bar graphs of IL-1β, NLRP3, and caspase-1 protein expression levels detected by Western blot (WB) in the NC, MD, and TYHYG groups, respectively; C is a bar graph of NLRP3 mRNA expression levels detected by qRT-PCR in the NC, MD, and TYHYG groups.

[0029] Figure 3 These are gastroscopy images before and after treatment in Case 1, where the traditional Chinese medicine composition of Example 1 of this invention was used for treatment. A is the gastroscopy image before treatment in the control group; B is the gastroscopy image after treatment in the control group; C is the gastroscopy image before treatment in Case 1 of the observation group; and D is the gastroscopy image after treatment in Case 1 of the observation group.

[0030] Figure 4 The images show the pathological morphology of the gastric mucosa before and after treatment in Case 1, where the traditional Chinese medicine composition of Example 1 was used for treatment according to the present invention. A is the pathological image of the control group before treatment; B is the pathological image of the control group after treatment; C is the pathological image of Case 1 in the observation group before treatment; and D is the pathological image of Case 1 in the observation group after treatment.

[0031] Figure 5 These are gastroscopic images before and after treatment in Case 2, where the traditional Chinese medicine composition of Example 1 was used for treatment according to the present invention. The left image shows the image before treatment, and the right image shows the image after treatment.

[0032] Figure 6 These are gastroscopic images before and after treatment in a typical case of treatment using the traditional Chinese medicine composition of Example 2 of this invention. The left image shows the image before treatment, and the right image shows the image after treatment.

[0033] Figure 7 This is a flowchart illustrating the research process for the clinical studies of this invention. Detailed Implementation

[0034] To enable those skilled in the art to better understand the technical solutions of the present invention, the technical solutions of the present invention will be further described below in conjunction with the accompanying drawings and embodiments.

[0035] Example 1 This application provides a traditional Chinese medicine composition for treating chronic gastritis of mixed cold and heat type, which is prepared from the following traditional Chinese medicines in parts by weight: 30 parts of lily bulb, 15 parts of ginger-processed pinellia, 15 parts of atractylodes lancea, 15 parts of white peony root, 12 parts of codonopsis pilosula, 12 parts of anemarrhena asphodeloides, 12 parts of areca nut, 12 parts of lindera strychnifolia, 12 parts of jujube, 9 parts of scutellaria baicalensis, 9 parts of dried ginger, 9 parts of licorice root, 9 parts of prepared licorice root, 9 parts of sandalwood, and 3 parts of coptis chinensis.

[0036] The preparation method of the traditional Chinese medicine composition in this embodiment includes the following steps: S1: Weigh out 30 parts of cleaned lily bulbs, 15 parts of ginger-processed pinellia, 15 parts of atractylodes lancea, 15 parts of white peony root, 12 parts of codonopsis pilosula, 12 parts of anemarrhena asphodeloides, 12 parts of areca nut, 12 parts of lindera strychnifolia, 12 parts of jujube, 9 parts of scutellaria baicalensis, 9 parts of dried ginger, 9 parts of licorice root, 9 parts of prepared licorice root, 9 parts of sandalwood, and 3 parts of coptis chinensis, and set aside. S2: Crush the Coptis chinensis, sandalwood, dried ginger, and ginger-processed Pinellia ternata weighed in S1, and then mix them with half the amount of Paeonia lactiflora and Atractylodes lancea weighed in S1 to obtain mixture 1. Add water to mixture 1 and decoct it. After decoction, filter it to obtain medicinal juice 1 and medicinal residue 1. S3: Add the remaining half of the white peony root and atractylodes rhizome, along with the lily bulb, scutellaria root, codonopsis root, anemarrhena rhizome, areca nut, lindera root, jujube, licorice root, and prepared licorice root weighed in S1 to the dregs 1 to obtain mixture 2. Add water to mixture 2 twice and decoct and filter it twice. Combine the two filtrates to obtain medicinal juice 2. S4: Combine medicinal juice 1 and medicinal juice 2 to obtain total medicinal juice. Concentrate and filter the total medicinal juice to obtain an extract, thus obtaining a traditional Chinese medicine composition.

[0037] Example 2 This application provides a traditional Chinese medicine composition for treating chronic gastritis of mixed cold and heat type, which is prepared from the following traditional Chinese medicines in parts by weight: 20 parts of lily bulb, 10 parts of ginger-processed pinellia, 10 parts of atractylodes lancea, 10 parts of white peony root, 8 parts of codonopsis pilosula, 8 parts of anemarrhena asphodeloides, 8 parts of areca nut, 8 parts of lindera strychnifolia, 8 parts of jujube, 6 parts of scutellaria baicalensis, 6 parts of dried ginger, 6 parts of licorice root, 6 parts of prepared licorice root, 3 parts of sandalwood, and 1.5 parts of coptis chinensis.

[0038] The preparation method of the traditional Chinese medicine composition in this embodiment includes the following steps: S1: Weigh out 20 parts of cleaned lily bulbs, 10 parts of ginger-processed pinellia, 10 parts of atractylodes lancea, 10 parts of white peony root, 8 parts of codonopsis pilosula, 8 parts of anemarrhena asphodeloides, 8 parts of areca nut, 8 parts of lindera strychnifolia, 8 parts of jujube, 6 parts of scutellaria baicalensis, 6 parts of dried ginger, 6 parts of licorice root, 6 parts of prepared licorice root, 3 parts of sandalwood, and 1.5 parts of coptis chinensis. S2: Crush the Coptis chinensis, sandalwood, dried ginger, and ginger-processed Pinellia ternata weighed in S1, and then mix them with half the amount of Paeonia lactiflora and Atractylodes lancea weighed in S1 to obtain mixture 1. Add water to mixture 1 and decoct it. After decoction, filter it to obtain medicinal juice 1 and medicinal residue 1. S3: Add the remaining half of the white peony root and atractylodes rhizome, along with the lily bulb, scutellaria root, codonopsis root, anemarrhena rhizome, areca nut, lindera root, jujube, licorice root, and prepared licorice root weighed in S1 to the dregs 1 to obtain mixture 2. Add water to mixture 2 twice and decoct and filter it twice. Combine the two filtrates to obtain medicinal juice 2. S4: Combine medicinal juice 1 and medicinal juice 2 to obtain total medicinal juice. Concentrate and filter the total medicinal juice to obtain an extract, thus obtaining a traditional Chinese medicine composition.

[0039] Example 3 This application provides a traditional Chinese medicine composition for treating chronic gastritis of mixed cold and heat type, which is prepared from the following traditional Chinese medicines in parts by weight: 45 parts of lily bulb, 25 parts of ginger-processed pinellia, 25 parts of atractylodes lancea, 25 parts of white peony root, 20 parts of codonopsis pilosula, 20 parts of anemarrhena asphodeloides, 20 parts of areca nut, 20 parts of lindera strychnifolia, 20 parts of jujube, 15 parts of scutellaria baicalensis, 15 parts of dried ginger, 15 parts of licorice root, 15 parts of prepared licorice root, 12 parts of sandalwood, and 6 parts of coptis chinensis.

[0040] The preparation method of the traditional Chinese medicine composition in this embodiment includes the following steps: S1: Weigh out the following ingredients by weight: 45 parts of cleaned lily bulbs, 25 parts of ginger-processed pinellia, 25 parts of atractylodes lancea, 25 parts of white peony root, 20 parts of codonopsis pilosula, 20 parts of anemarrhena asphodeloides, 20 parts of areca nut, 20 parts of lindera strychnifolia, 20 parts of jujube, 15 parts of scutellaria baicalensis, 15 parts of dried ginger, 15 parts of licorice root, 15 parts of prepared licorice root, 12 parts of sandalwood, and 6 parts of coptis chinensis. S2: Crush the Coptis chinensis, sandalwood, dried ginger, and ginger-processed Pinellia ternata weighed in S1, and then mix them with half the amount of Paeonia lactiflora and Atractylodes lancea weighed in S1 to obtain mixture 1. Add water to mixture 1 and decoct it. After decoction, filter it to obtain medicinal juice 1 and medicinal residue 1. S3: Add the remaining half of the white peony root and atractylodes rhizome, along with the lily bulb, scutellaria root, codonopsis root, anemarrhena rhizome, areca nut, lindera root, jujube, licorice root, and prepared licorice root weighed in S1 to the dregs 1 to obtain mixture 2. Add water to mixture 2 twice and decoct and filter it twice. Combine the two filtrates to obtain medicinal juice 2. S4: Combine medicinal juice 1 and medicinal juice 2 to obtain total medicinal juice. Concentrate and filter the total medicinal juice to obtain an extract, thus obtaining a traditional Chinese medicine composition.

[0041] The efficacy of the traditional Chinese medicine compositions provided in Examples 1-3 of this invention is basically the same. Therefore, Example 1 will be used as an example to conduct relevant clinical research below.

[0042] 1. Clinical Data A total of 148 patients meeting the diagnostic criteria for chronic gastritis with mixed cold and heat syndrome were screened at the outpatient and inpatient departments of the gastroenterology departments of the Affiliated Ruikang Hospital of Guangxi University of Chinese Medicine, Hengzhou Traditional Chinese Medicine Hospital, and Nandan County Traditional Chinese Medicine Hospital. These patients were selected between June 2023 and June 2024, with an equal number of males and females (74 cases). The age range of the subjects was 18 to 80 years, with a median age of 53.5 years. The duration of disease ranged from 2 months to 10 years, with a mean disease duration of 35.2 months. The subjects were randomly assigned to a control group and an observation group using a block randomization method. There were no significant differences in basic characteristics such as gender, age, and disease duration between the two groups. p The baseline characteristics of the two groups were >0.05 (Table 1), therefore they were comparable. This study protocol was approved by the Ethics Committee of Ruikang Hospital, Guangxi University of Chinese Medicine (No. KY2022-052).

[0043] Table 1 General Information

[0044] 1.1 Selection Criteria 1.1.1 Western Medicine Inclusion Criteria Western medicine diagnostic criteria: 148 patients diagnosed with chronic gastritis were selected. The diagnosis of all cases was based on the "Expert Consensus Opinion on the Diagnosis and Treatment of Chronic Gastritis with Traditional Chinese Medicine (2017)" issued by the China Association of Traditional Chinese Medicine.

[0045] (1) Symptoms: discomfort in the upper abdominal area (manifested as irregular burning, dull pain or bloating), bloating in the stomach, accompanied by nausea and acid reflux.

[0046] (2) Endoscopic diagnosis: The gastric mucosa shows a red and white color (predominantly red), accompanied by punctate, striped or patchy red areas, and an uneven mucosal surface, which is usually characteristic of non-atrophic gastritis. The gastric mucosa is predominantly white, accompanied by granular and nodular variations, while the mucosal folds tend to be flat or completely disappear.

[0047] 1.1.2 Selection Criteria for Traditional Chinese Medicine The inclusion criteria for the TCM chronic gastritis syndrome with mixed cold and heat patterns were formulated with reference to the "Guidelines for Clinical Diagnosis and Treatment of Traditional Chinese Medicine".

[0048] (1) Main symptoms: stomach pain.

[0049] (2) Secondary symptoms: abdominal distension, dry mouth and bitter taste, poor appetite, loose stools.

[0050] (3) Tongue and pulse characteristics: The tongue coating is white and greasy or yellow and thick, and the pulse is wiry and slippery.

[0051] 1.2 Inclusion Criteria (1) The patient was diagnosed with chronic gastritis and pathological examination and underwent gastroscopy, which meets the requirements of the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines"; (2) The patient is between 18 and 80 years old; (3) The patient has complete clinical data; (4) The patient voluntarily participates in the study and signs an informed consent form.

[0052] 1.3 Exclusion Criteria (1) The patient has communication difficulties due to hearing or speech impairment, lack of consciousness or mental illness; (2) The patient withdraws from treatment, dies, the treatment plan is changed, or the patient loses follow-up; (3) The patient's clinical data is incomplete; (4) The patient has severe organic disease, accompanied by severe gastric ulcers and gastric mucosal damage; (5) The patient has atypical hyperplasia or is suspected of gastric mucosal cancer; (6) The patient has recently been treated with glucocorticoids; (7) Those with a history of gastrointestinal surgery; (8) Individuals allergic to the drug being studied; (9) Patients with insufficient gastric acid secretion may have chronic gastritis; (10) Pregnant or lactating women.

[0053] 1.4 Ethical Approval The project has obtained formal approval from the Ethics Committee of Ruikang Hospital of Guangxi University of Chinese Medicine (approval number: KY2022-052), and all participants have signed informed consent forms.

[0054] 2. Treatment methods 2.1 Control Group The patient was given rabeprazole (approved by Jichuan Pharmaceutical Group Co., Ltd., National Drug Approval Number H20061220), once daily, one tablet (20mg) each time, for 8 consecutive weeks. Concurrently, a placebo (mainly composed of food-grade dextrin; the paste's viscosity, color, taste, and odor were consistent with the herbal composition in Example 1; both pastes were prepared by the Traditional Chinese Medicine Pharmacy of the Affiliated Ruikang Hospital of Guangxi University of Traditional Chinese Medicine according to the 2020 edition of the Chinese Pharmacopoeia), 10ml / time, three times daily, taken warm half an hour after breakfast, lunch, and dinner, for 8 consecutive weeks. This was combined with dietary adjustments, regular health education on chronic gastritis, and appropriate exercise, among other comprehensive treatment measures.

[0055] 2.2 Observation Group In addition to the treatment given to the control group, patients received a traditional Chinese medicine paste (hereinafter referred to as "Yang-regulating and Yin-harmonizing paste") prepared according to the herbal composition of Example 1. The paste consisted of 30 parts lily bulb, 15 parts ginger-processed pinellia, 15 parts atractylodes lancea, 15 parts white peony root, 12 parts codonopsis pilosula, 12 parts anemarrhena asphodeloides, 12 parts areca nut, 12 parts lindera strychnifolia, 12 parts jujube, 9 parts scutellaria baicalensis, 9 parts dried ginger, 9 parts licorice root, 9 parts prepared licorice root, 9 parts sandalwood, and 3 parts coptis chinensis. The paste was prepared by decocting the herbs. The dosage was 10 ml per dose, three times daily, taken warm half an hour after breakfast, lunch, and dinner, for eight consecutive weeks.

[0056] 3. Observation Indicators 3.1 Main clinical efficacy evaluation indicators 3.1.1 Overall Score of Target Symptoms and Effectiveness of Improvement Response Target symptoms include epigastric pain, epigastric distension, belching, and acid reflux. Based on the "Expert Consensus on the Diagnosis and Treatment of Chronic Gastritis with Traditional Chinese Medicine (2017)" and the "Technical Guidelines for Clinical Efficacy Evaluation of New Traditional Chinese Medicine Drugs for Chronic Gastritis (Trial Implementation)," a comprehensive scoring scale was used, combining the frequency and severity of symptoms for scoring. Frequency score: 0: no symptoms; 1: occasional (less than once a week); 2: sometimes (1-2 times a week); 3: frequent (3-4 times a week); 4: persistent (multiple times a day). Severity score: 0: no symptoms; 1: mild (almost no discomfort); 2: mild (mild discomfort, but does not affect normal activities); 3: moderate (significant discomfort, affecting normal activities); 4: severe (severely affects normal activities and quality of life). The overall score is obtained by adding the frequency score and the severity score. Regarding improving response efficiency, a response was defined as a decrease of at least 50% in weekly symptom scores compared to baseline, and an effectiveness was defined as a response lasting more than 50% of the total observation period. The response efficiency was calculated as follows: Improve response efficiency = = ×100%.

[0057] 3.1.2 Traditional Chinese Medicine Syndrome Scoring Referring to the "Guidelines for Clinical Research of New Traditional Chinese Medicine Drugs," the symptoms of patients with chronic gastritis before treatment were quantitatively assessed, and changes in symptoms after treatment were observed. A comparison of TCM symptom scores before and after treatment was performed: TCM syndromes were divided into three levels—mild, moderate, and severe—using a 2, 4, and 6-point scoring system, with higher scores indicating more severe TCM syndromes. TCM syndromes included symptoms such as epigastric fullness, epigastric pain, epigastric discomfort, poor appetite, postprandial abdominal distension, early satiety, excessive hunger, hiccups, nausea and vomiting, belching, and acid reflux.

[0058] 3.2 Secondary clinical efficacy evaluation indicators 3.2.1 Quality of Life Scale for Patients with Chronic Gastritis (QLICD-CG) Questionnaires were distributed face-to-face to patients with dyslexia one day before treatment and the day after treatment ended. Researchers read the questionnaires aloud to each patient, who then answered independently based on their individual circumstances. The answers were recorded. The questionnaire covered four main areas: physical function, psychological function, social function, and specific symptoms of chronic gastritis, totaling 42 questions. Each question had a five-point rating scale, ranging from 1 to 5, with higher scores indicating lower quality of life.

[0059] 3.2.2 Endoscopic gastric mucosal manifestation scoring Gastroscopy was performed within one week before and after treatment. The "Trial Opinions on Endoscopic Classification and Grading Standards and Treatment of Chronic Gastritis" were used as a reference. The severity of gastric mucosal erythema, vascular visibility, bleeding points, edema, erosion, and bile reflux was assessed using a scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The higher the score, the more severe the condition.

[0060] 3.2.3 Gastric mucosal histopathological scoring Gastroscopy was performed before and after treatment, and biopsies were taken from the same location in the gastric antrum and body. The pathological grading criteria for chronic gastritis (New Sydney system) were used to semi-quantitatively score chronic inflammation, active inflammation, glandular atrophy, and intestinal metaplasia (0-3 points).

[0061] 3.3 Criteria for Evaluating Therapeutic Effect The efficacy assessment was based on the "Guidelines for the Diagnosis and Treatment of Digestive Diseases in Traditional Chinese Medicine" and combined with the patient's TCM syndrome score. The specific formula for calculating the efficacy index (%) is: (Pre-treatment score - Post-treatment score) / Pre-treatment score × 100%. The efficacy assessment criteria are as follows: Clinical symptoms are basically absent, with an efficacy index between 95% and 100%; Significantly effective: Clinical symptoms are significantly improved, with an efficacy index between 70% and 95%; Effective: Clinical symptoms show relatively significant improvement, with an efficacy index between 30% and 70%; Ineffective: If the above criteria are not met, it is considered ineffective. The total effective rate (%) = (Cure + Significantly Effective + Effective) / Total number of cases × 100%.

[0062] 3.4 Safety Indicators Before and after treatment, patients' vital signs, including blood pressure, temperature, and heart rate, must be recorded in detail, and electrocardiograms, blood tests, urine tests, liver function tests, and kidney function tests must be performed. Simultaneously, any side effects such as nausea, vomiting, abdominal pain, and diarrhea that may occur should be closely monitored and recorded. Furthermore, long-term follow-up is necessary to assess the durability of treatment effects, monitor for relapses, new symptoms, or complications, and ensure timely intervention and management of any necessary issues.

[0063] 3.5 Record the relapse rate. Follow up for 1 year after the end of treatment, record the number of people who relapsed, and calculate the relapse rate.

[0064] 3.7 Quality Control Measures All researchers participating in the trial received the necessary training to ensure they possessed the professional knowledge and skills required to perform the procedures before conducting the clinical trial. They were also required to sign an investigator's declaration guaranteeing that they would conduct the trial with integrity and responsibility. To ensure the rights of the subjects were protected during the clinical trial, the project leader appointed experienced monitors to oversee the trial. After the trial concluded, the monitors carefully reviewed the data in the trial records and reports to ensure the accuracy, completeness, and error-free nature of the data.

[0065] 4. Statistical Analysis Statistical analysis was performed using SPSS 26.0 software. The Shapiro-Wilk test was used to verify the normality of the data. When the data were normally distributed, continuous data were analyzed using... The independent samples t-test was used for comparisons between two groups, and the paired t-test was used for comparisons before and after treatment within the same group; categorical data were expressed using the χ² test. 2 For the test, count data are expressed as the percentage of cases, using the χ² method. 2 test. p＜ A value of 0.05 is considered statistically significant.

[0066] 5. Results 5.1 Research Process ( Figure 7 ) and the actual number of cases included in the statistical analysis During treatment, 4 patients in the control group and 3 patients in the observation group dropped out due to poor compliance and loss of contact. The actual number of cases included in the treatment efficacy statistical analysis was 70 in the control group and 71 in the observation group. One year after treatment, 11 patients in the control group and 8 patients in the observation group lost contact. A total of 59 patients in the control group and 63 patients in the observation group were included in the recurrence rate statistical analysis.

[0067] 5.2 Comparison of overall average scores for target symptoms and effective response rate for improvement (Table 2) There was no significant difference in the overall target symptom scores between the two groups before treatment (baseline). However, after treatment, both groups showed a significant reduction in overall target symptom scores, with the observation group having a significantly higher overall target symptom score than the control group. p＜ (0.001), the effective rate of improvement in response in the observation group was 96.3%, which was significantly higher than that in the control group (85.2%).

[0068] Table 2 Comparison of overall target symptom scores and effective response rate to improvement (x±s)

[0069] Note: Comparison with before and after treatment in this group. *** p＜ 0.001; compared with the control group after treatment, △△△ p＜0.001 5.3 Comparison of TCM syndrome scores among patients Before treatment, there was no significant difference in TCM syndrome scores between the two groups. After treatment, the TCM syndrome scores of both groups decreased. However, the TCM syndrome score of the observation group was significantly lower than that of the control group. P < 0.001).

[0070] Table 3 Comparison of TCM syndrome scores before and after treatment (x±s)

[0071] Note: Comparison with before and after treatment in this group. *** p＜ 0.001; compared with the control group after treatment, △△△ p＜ 0.001 5.4 Comparison of gastric mucosal histopathological scores ( Figure 4 (Table 4) After HE staining of gastric mucosal tissue in both groups before and after treatment, the control group was observed under a microscope: before treatment ( Figure 4 A): Numerous lymphocytes and plasma cells are infiltrated in the lamina propria of the gastric mucosa, with significant interstitial congestion and edema. Some glands show disordered morphology, and intestinal metaplasia (goblet cells) is observed, which is typical of chronic gastritis in its active phase; after treatment ( Figure 4 B): Inflammatory cell infiltration decreased, and interstitial congestion and edema were slightly relieved, but the improvement in glandular structural disorder and intestinal metaplasia was not significant, suggesting that conventional treatment has limited repair effects on inflammation and tissue damage. Observation group: Before treatment ( Figure 4 C): More pronounced gastric mucosal inflammation, dense infiltration of inflammatory cells in the lamina propria, significant interstitial congestion and edema, severely disordered glandular morphology, and more extensive intestinal metaplasia; epithelial cell atypia was observed in some areas, indicating that the inflammation was in a severely active phase; after treatment ( Figure 4 D): Inflammatory cell infiltration was significantly reduced, interstitial congestion and edema basically subsided, the gastric mucosal gland structure became more regular, intestinal metaplasia basically disappeared, and cell morphology was close to normal, showing that the treatment had a significant repairing effect on inflammation and tissue damage. Compared with before treatment, the pathological scores of both groups of patients decreased significantly. p <0.001); and all pathological scores in the observation group were lower than those in the control group ( p <0.001).

[0072]

[0073] 5.5 Comparison of Quality of Life Scores After treatment, both groups of patients showed a decline in quality of life scores across four areas: physical function, psychological function, social function, and specific symptoms of chronic gastritis. The observation group showed a more significant decrease in scores compared to the control group, and this difference was highly statistically significant. P <0.001), as shown in Table 5.

[0074] Table 5 Comparison of quality of life scores before and after treatment in the two groups

[0075] Note: Comparison with before and after treatment in this group. *** p＜ 0.001; compared with the control group after treatment, △△△ p＜ 0.001 5.5 Comparison of gastric mucosal manifestations under gastroscopy Before treatment, there was no significant difference in the endoscopic findings of the gastric mucosa between the two groups. After treatment, endoscopically, the scores for erythema, vascular visibility, bleeding points, edema, erosion, and bile reflux of the gastric mucosa were significantly lower in both groups, with the observation group showing significantly lower scores than the control group. p <0.001). The scores are shown in Table 4, and the gastroscopy images are shown below. Figure 3 As shown, the control group: before treatment ( Figure 3 A): The gastric mucosa is rough, diffusely congested and red, with a darker color, small erosions, and a lot of mucus adhering to the surface. This is a typical endoscopic finding of chronic gastritis (active phase); after treatment ( Figure 3 B): The gastric mucosa became rougher and smoother, and the mucosal congestion was reduced, but it was still light red. No erosions were observed, indicating that the inflammation had been mildly relieved but not completely resolved. 2. Observation group: Before treatment ( Figure 3 C): The gastric mucosa is relatively rough, with obvious congestion and redness, multiple erosions, and multiple edematous bulges. Scattered mucus is visible on the surface, indicating that the inflammation is in an active phase; after treatment ( Figure 3 D): The mucosa becomes smooth, the color returns to normal light pink, the congestion and edema subside, the mucosal texture is clear and regular, no erosion foci are seen, and only a small amount of clear mucus is seen, indicating that the inflammation has been controlled and the endoscopic manifestations of clinical cure have been achieved.

[0076] Table 6 Comparison of scores before and after treatment in the two groups

[0077] Note: Comparison with before and after treatment in this group. *** p＜ 0.001; compared with the control group after treatment, △△△ p＜ 0.001 5.6 Comparison of clinical treatment effects between the two groups Comparison of clinical efficacy between the two groups after treatment (Table 7): The total effective rate in the observation group was 95.77%, while that in the control group was 81.42%. The total effective rate in the observation group was significantly higher than that in the control group (χ²). 2 =7.237, p＜ 0.01).

[0078] Table 7 Comparison of clinical efficacy between the two groups of patients [n(%)]

[0079] Note: Compared with the control group, ** p＜ 0.01 5.7 Comparison of safety indicators between the two groups of patients (Table 8) In both groups, no abnormalities were found in electrocardiograms, complete blood counts, urinalysis, liver function tests, and kidney function tests before and after treatment. However, during treatment, both groups experienced some adverse reactions: headache, nausea, diarrhea, abdominal distension, and constipation. The incidence rate in the observation group was significantly lower than that in the control group (χ²). 2 =7.237, p＜ 0.05).

[0080] Table 8 Comparison of adverse reactions between the two groups of patients [n(%)]

[0081] Note: Compared with the control group, * p＜ 0.05 5.8 Comparison of recurrence rates between the two groups (Table 9) One year after the completion of treatment, the follow-up data analysis showed that the recurrence rate in the observation group was significantly lower than that in the control group (χ2=4.962, p<0.05). Table 9 Comparison of relapse rates one year after treatment in the two groups (%)

[0082] Note: Compared with the control group, * p＜ 0.05 Basic animal research 1. Experimental Design The experimental design included three groups: a blank control group (hereinafter referred to as NC), a model group (hereinafter referred to as MD), and the intervention group of the traditional Chinese medicine composition of this application (hereinafter referred to as TYHYG). Gastric mucosal tissue was collected from rats in each group the day after drug intervention. Histopathological examination of the gastric mucosal tissue was performed using hematoxylin and eosin (HE) staining. The concentrations of serum inflammatory markers (IL-1β, IL-18, TNF-α, and LPS) were quantified using ELISA and LPS detection kits. The expression level of NLRP3 inflammasome mRNA was assessed using qRT-PCR, while Western blotting was used to determine the protein expression levels of caspase-1, IL-1β, and NLRP3.

[0083] 1.4 Construction of animal models After a one-week initial acclimatization feeding period, 40 SPF-grade Wistar rats were randomly divided into two groups according to sex: the NC group (n=10) and the model group (n=30). Starting from week 14 of modeling, two rats from the model group were randomly selected every two weeks for gastric histopathological evaluation, and lesion progression was monitored by H&E staining. At week 24, gastric mucosal specimens were collected for HE staining. The results showed that the CAG rat model was successfully established. Rats in the model group with a glandular atrophy or chronic inflammatory infiltration score ≥2 (moderate to severe) were considered successful models. During the model construction process, pathological evaluations consumed 10 rats, leaving 20 rats as the final model. Based on this criterion, the successfully modeled rats were divided into the MD group (n=10) and the TYHYG group (n=10). All subsequent interventions and analyses were performed on the MD group, the TYHYG group, and the NC rats.

[0084] Each rat in the MD group was given 100 mL of MNNG solution for free drinking each day, and the remaining volume was recorded to monitor intake. This treatment was continued for 24 weeks to establish a CAG rat model. The MNNG solution was prepared by dissolving MNNG in drinking water, and the concentration of the MNNG solution was 150 μg / mL. To control the daily MNNG intake, the rats were housed individually and provided with graduated drinking bottles.

[0085] Grouping and Dosing The NC group (n=10) each normal rat was given tap water to drink daily and physiological saline was administered by gavage for 8 weeks.

[0086] The MD group (n=10) each model rat was given MNNG solution for free drinking every day and physiological saline was given by gavage for 8 weeks.

[0087] The TYHYG group (n=10) each model rat was given MNNG solution for free drinking every day, and TYHYG was administered by gavage for 8 weeks.

[0088] 2. Experimental Results 2.1 TYHY reduces gastric mucosal inflammatory infiltration. Significant differences in gastric mucosal pathology were observed among the groups using HE staining. Results are shown below. Figure 1 See Table 1. Figure 1 In the NC group, gastric mucosal cells were neatly arranged, glands were of normal number, and there was no inflammatory infiltration. In contrast, the MD group showed significant inflammatory cell infiltration, neutrophil infiltration, and atrophy and reduction of glands in the lamina propria. Figure 1 The pathological changes of the gastric mucosa in the TYHYG group were significantly improved, with reduced inflammatory infiltration and significant relief of glandular atrophy.

[0089] 2.2 TYHYG reduced the levels of serum inflammatory cytokines IL-1β, IL-18, TNF-α, and LPS. The experimental results (Table 10) showed that, compared with the NC group, the levels of inflammatory cytokines in MD rats were significantly increased. p＜ 0.01). After administration of TYHYG, the levels of inflammatory factors in MD rats were significantly lower than those in untreated rats. p <0.01).

[0090] Table 10 Comparison of gastric mucosal inflammatory factor levels among experimental groups

[0091] Note: MD is different from NC. ** p＜ 0.01; Compared with the MD group, the TYHYG group... ## p＜ 0.01, #p < 0.05.

[0092] 2.3 TYHYG can reduce the protein expression of caspase-1, IL-1β and NLRP3 in the gastric mucosa of CAG rats, as well as the mRNA expression level of NLRP3.

[0093] like Figure 2 As shown, the protein expression of IL-1β, NLRP3, and caspase-1, as well as the mRNA expression of NLRP3, were analyzed by Western blotting and qRT-PCR. The results showed that compared with the NC group rats, the protein expression of IL-1β, NLRP3, and caspase-1 in the MD group rats was significantly lower. Figure 2 The levels of A and B in the figure and NLRP3 mRNA (Figure C) were significantly increased. p＜ 0.01). Treatment with TYHYG significantly reduced the expression of these proteins compared to untreated MD rats. Figure 2 (A, B) and NLRP3 mRNA ( Figure 2 C) expression level (p ＜ 0.01).

[0094] The following is a typical case for Example 1. Case 1 Name: Mr. Ma, male, 52 years old, visited the Department of Gastroenterology, Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine, on March 14, 2022. Chief Complaint: Recurrent upper abdominal dull pain for over 2 years. Present Illness: The patient reported experiencing intermittent, dull pain in the upper middle abdomen without any obvious cause over two years ago. The pain was unrelated to eating and did not radiate elsewhere. He reported no acid reflux, belching, chest tightness, palpitations, dizziness, headache, fatigue, lower back pain, nausea, vomiting, abdominal distension, diarrhea, cough, or sputum. The patient was in good spirits, had a good appetite, slept well, and had normal bowel movements. His weight had not changed significantly recently. Past Medical History: No history of hepatitis, malaria, tuberculosis, hypertension, coronary heart disease, diabetes, cerebrovascular disease, or mental illness. Vaccination history was unclear. No history of surgery, trauma, or blood transfusion. He denied any allergies. Traditional Chinese Medicine Diagnosis: Red tongue with a white, greasy coating; wiry and slippery pulse. Physical examination: Temperature 37.1℃, respiratory rate 20 breaths / min, pulse 84 beats / min, blood pressure 129 / 76 mmHg, height 166cm, weight 71.1KG, alert and oriented, normal facial appearance, negative results on cardiopulmonary and abdominal examinations. Auxiliary examinations: Electronic gastroscopy showed chronic non-atrophic gastritis with erosion; gastric mucosal pathological examination showed chronic active inflammation, partial glandular intestinal metaplasia, and negative H. pylori. Diagnosis: Traditional Chinese medicine diagnosis was epigastric pain, phlegm and blood stasis, and mixed cold and heat syndrome; Western medicine diagnosis was chronic non-atrophic gastritis. Treatment recommendation: "Tiao Yang He Yin Gao" (a traditional Chinese medicine formula) from Example 1 was administered to strengthen the spleen, remove blood stasis, and balance cold and heat. A follow-up electronic gastroscopy on May 20, 2022, showed significant reduction in erythema symptoms of chronic non-atrophic gastritis, with no erosion or glandular intestinal metaplasia observed. The patient's clinical symptoms also significantly improved.

[0095] Electronic gastroscopy before and after treatment, as shown below Figure 3 As shown in C and D: C represents the gastric antrum before treatment: the gastric mucosa is relatively rough, with obvious congestion and redness, multiple erosions, and multiple edema bulges on the mucosa. Scattered mucus can be seen on the surface, and the inflammation is in the active phase; D represents the gastric antrum after treatment: the mucosa becomes smooth, the color returns to the normal light pink, the congestion and edema subside, the mucosal texture is clear and regular, no erosions are seen, and only a small amount of clear mucus is seen, indicating that the inflammation has been controlled and the endoscopic manifestations of clinical cure have been achieved.

[0096] The gastric mucosa pathological images before and after treatment are as follows: Figure 4As shown in Figures C and D: Before treatment (Figure C): Gastric mucosal inflammation was more pronounced, with dense infiltration of inflammatory cells in the lamina propria, significant interstitial congestion and edema, severely disordered glandular morphology, and a wider range of intestinal metaplasia. Epithelial cell atypia was observed in some areas, indicating that the inflammation was in a severely active phase. After treatment (Figure D): Inflammatory cell infiltration was significantly reduced, interstitial congestion and edema basically subsided, the structure of gastric mucosal glands became more regular, intestinal metaplasia basically disappeared, and cell morphology was close to normal, showing that the treatment had a significant repairing effect on inflammation and tissue damage.

[0097] Case 2 Name: Li, male, 65 years old. Presented at the Gastroenterology Outpatient Department of Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine on October 16, 2024. Chief complaint: Recurrent upper abdominal pain for over a year, with a recent worsening over the past 10 days. Present illness: The patient reported experiencing upper abdominal distending pain without any obvious cause one year ago, unrelated to eating, accompanied by acid reflux and belching. At that time, there was no nausea, vomiting, dizziness, headache, chills, or fever. Since the onset of the illness, the patient has been alert, in good spirits, with poor appetite and sleep, normal bowel movements, frequent and copious urination, and no significant weight change. Past medical history: History of hypertension, with a highest recorded blood pressure of 150+ / 109+ mmHg, currently untreated, and reports poor blood pressure control. History of chronic antral gastritis and rectal polyps, with endoscopic removal of rectal polyps at another hospital, details unknown. The patient denies a history of chronic diseases such as diabetes and coronary heart disease, and denies a history of infectious diseases such as hepatitis B and tuberculosis. There is a history of right ankle and right knee injuries, details unknown. The patient denies a history of surgery or blood transfusions. There is also a denial of food or drug allergies. Traditional Chinese Medicine diagnosis: dark tongue, white and greasy coating, wiry and slippery pulse. Physical examination: T: 36.5℃, P: 60 bpm, R: 20 bpm, BP: 142 / 96 mmHg. The patient is alert and in good spirits. Cardiopulmonary and abdominal examinations were negative. Auxiliary examinations: Electronic gastroscopy showed multiple polyps in the gastric body and chronic atrophic gastritis (C2) with erosion. Gastric mucosal pathology (antral erosion): moderate chronic superficial active inflammation of the mucosa. Special staining results: HP(+), VG(-). (Gastric body polyps) 2 tissue samples: one fundic gland polyp, one foveolar epithelial hyperplasia polyp. Special staining results: HP(-), VG(-). (Gastric angle mucosa) Moderate chronic superficial inflammation of the mucosa, mildly active, with reduced and atrophic intrinsic glands in some areas, and interstitial lymphoid tissue hyperplasia. Specific staining results: HP (+), VG (-). Diagnosis: Traditional Chinese medicine diagnosis: stomach pain, phlegm and blood stasis, mixed cold and heat syndrome; Western medicine diagnosis: chronic atrophic gastritis. Treatment recommendations: 1. Monitor blood pressure and adjust the dosage of antihypertensive drugs; 2. Administer the "Tiaoyang Heyin Gao" (a traditional Chinese medicine formula) from Example 1 to strengthen the spleen and regulate qi, balance cold and heat, regulate the ascending and descending of qi in the spleen and stomach, restore the normal digestive function of the spleen and stomach, and harmonize the pathogenic factors of cold and heat, thereby achieving the goal of treating the disease. On December 23, 2024, a follow-up electronic gastroscopy showed that the chronic atrophic gastritis (C1) had significantly reduced erythema symptoms, no erosion was observed, and the patient's clinical symptoms had also significantly improved.

[0098] Electronic gastroscopy before and after treatment Figure 5 As shown: Left image: Gastric antrum before treatment: The mucosa is rough, pale in color, with red and white interspersed, mainly white, showing a mottled appearance, and scattered erosions are seen on the four walls; Right image: Gastric antrum after treatment: The mucosa is smooth, light red in color, LCI is pink, and the microvessels on the surface of BLI+WE are slightly dilated and tortuous, arranged regularly, with no obvious defects or changes, and the microstructure is arranged regularly.

[0099] The following is a typical case for Example 2. Name: Lin, male, 57 years old. Presented at the Department of Gastroenterology, Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine, on May 7, 2023. Chief complaint: Recurrent upper abdominal pain for over 3 years, with a recurrence in the past 2 months. Present illness: The patient reported experiencing upper abdominal pain for over 3 years without any obvious cause. The pain was intermittent, distending, and unrelated to eating or emotions. It was accompanied by acid reflux and belching, but without heartburn, vomiting, melena, diarrhea, or tenesmus. The patient was alert, in fair spirits, with good appetite and sleep. Urination was normal, and bowel movements were 2-3 times per day, with loose stools occasionally containing mucus. Recent weight changes were not significant. Past medical history: History of chronic gastritis; denies history of chronic diseases such as hypertension, diabetes, and coronary heart disease; denies history of infectious diseases such as hepatitis and tuberculosis; denies history of major trauma, surgery, or blood transfusions. Denies any history of drug or food allergies; vaccination history is unknown. Traditional Chinese Medicine (TCM) Four Diagnostic Methods: Tongue is dark red with a greasy, yellowish-white coating; pulse is wiry. Physical Examination: Temperature 36.4℃, respiration 20 breaths / min, pulse 89 beats / min, blood pressure 127 / 84 mmHg; alert and in good spirits; no obvious abnormalities found in cardiopulmonary examination. Abdomen is soft and flat, without tenderness or rebound tenderness; liver and spleen are not palpable below the costal margin; gallbladder point is not tender; shifting dullness is negative; bowel sounds are normal, approximately 4 times / min. No edema in lower extremities. Auxiliary Examinations: Gastroscopy: Chronic non-atrophic gastritis with erosion. Gastroscopy Pathology: Moderate chronic superficial active inflammation of the mucosa. Special stain: HP (+). Diagnosis: TCM diagnosis is stomach pain, phlegm and blood stasis, and mixed cold and heat syndrome. The Western medicine diagnosis was chronic non-atrophic gastritis. Treatment recommendation: granules made from the traditional Chinese medicine composition described in Example 2 were administered to treat the patient using a method that strengthens the spleen, regulates qi, and balances cold and heat. A follow-up electronic gastroscopy on July 15, 2023, showed significant relief of the chronic non-atrophic gastritis symptoms, with no erosion observed, and the patient's clinical symptoms also significantly improved.

[0100] Electronic gastroscopy before and after treatment Figure 6 As shown: Before treatment, the gastric antrum was rough, with a pale reddish-white color, alternating between red and white, with white predominating, showing a mottled appearance. Multiple small patchy erosions were seen on the lesser curvature. After treatment, the gastric antrum was smooth, with a pale reddish color, clear and regularly arranged vascular patterns, and a regular arrangement of microstructures.

[0101] Clinical studies and literature reports show that Western medicine treatment for chronic gastritis has relatively many side effects, mainly affecting liver and kidney function, and is prone to relapse after symptom relief. However, the traditional Chinese medicine composition used in the embodiments of this application can effectively treat chronic gastritis with mixed cold and heat syndromes, with fewer and milder side effects, focusing on overall conditioning, and is suitable for long-term use.

[0102] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of this invention is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for treating chronic gastritis of mixed cold and heat type, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 20-45 parts of lily bulb, 10-25 parts of ginger-processed pinellia, 10-25 parts of atractylodes lancea, 10-25 parts of white peony root, 8-20 parts of codonopsis pilosula, 8-20 parts of anemarrhena asphodeloides, 8-20 parts of areca nut, 8-20 parts of lindera strychnifolia, 8-20 parts of jujube, 6-15 parts of scutellaria baicalensis, 6-15 parts of dried ginger, 6-15 parts of licorice root, 6-15 parts of prepared licorice root, 3-12 parts of sandalwood, and 1.5-6 parts of coptis chinensis.

2. The traditional Chinese medicine composition for treating chronic gastritis of mixed cold and heat type according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: Lily bulb 30 parts, ginger-processed Pinellia ternata 15 parts, Atractylodes lancea 15 parts, white peony root 15 parts, Codonopsis pilosula 12 parts, Anemarrhena asphodeloides 12 parts, Areca catechu 12 parts, Lindera strychnifolia 12 parts, jujube 12 parts, Scutellaria baicalensis 9 parts, dried ginger 9 parts, licorice root 9 parts, prepared licorice root 9 parts, sandalwood 9 parts, Coptis chinensis 3 parts.

3. A method for preparing a traditional Chinese medicine composition for treating chronic gastritis of mixed cold and heat type, characterized in that, Includes the following steps: S1: Weigh out the following ingredients in the following weight proportions according to the traditional Chinese medicine composition described in claim 1 or 2: lily bulb, ginger-processed pinellia, atractylodes lancea, white peony root, codonopsis pilosula, anemarrhena asphodeloides, areca nut, lindera strychnifolia, jujube, scutellaria baicalensis, dried ginger, licorice root, prepared licorice root, sandalwood, and coptis chinensis, and set aside. S2: Crush the Coptis chinensis, sandalwood, dried ginger, and ginger-processed Pinellia ternata weighed in S1, and then mix them with half the amount of Paeonia lactiflora and Atractylodes lancea weighed in S1 to obtain mixture 1. Add water to mixture 1 and decoct it. After decoction, filter it to obtain medicinal juice 1 and medicinal residue 1. S3: Add the remaining half of the white peony root and atractylodes rhizome, along with the lily bulb, scutellaria root, codonopsis root, anemarrhena rhizome, areca nut, lindera root, jujube, licorice root, and prepared licorice root weighed in S1 to the dregs 1 to obtain mixture 2. Add water to mixture 2 twice and decoct and filter it twice. Combine the two filtrates to obtain medicinal juice 2. S4: Combine medicinal juice 1 and medicinal juice 2 to obtain total medicinal juice. Concentrate and filter the total medicinal juice to obtain an extract, thus obtaining a traditional Chinese medicine composition.

4. The method for preparing the traditional Chinese medicine composition according to claim 3, characterized in that, In S2, the amount of water added is 6-10 times that of mixture 1. The decoction conditions are: decoction temperature 75℃-90℃, decoction time 20-40min, and after adding water to mixture 1, it is soaked for 20-40min before decoction.

5. The method for preparing the traditional Chinese medicine composition according to claim 3, characterized in that, In S3, mixture 2 is added to water twice and boiled and filtered twice, including: Add water to mixture 2 for the first time. The amount of water added for the first time is 6-10 times that of mixture 2. After boiling, keep it for 30-60 minutes, filter, and obtain the first filtrate and the first filter residue. Add water to the first filter residue, the amount of water being 4-6 times that of the first filter residue. Boil for 20-40 minutes, then filter to obtain the second filtrate.

6. The method for preparing the traditional Chinese medicine composition according to claim 3, characterized in that, The extract is obtained by concentrating the total medicinal juice of S4 to a relative density of 1.05-1.15, centrifuging, refrigerating and standing at 0-4℃ for 12-24 hours, filtering, and further concentrating the filtered medicinal juice to a relative density of 1.20-1.

30.

7. A traditional Chinese medicine preparation, characterized in that, The traditional Chinese medicine preparation includes the traditional Chinese medicine composition according to claim 1 or 2, and acceptable excipients.

8. The traditional Chinese medicine preparation as described in claim 7, characterized in that, The dosage form of the traditional Chinese medicine preparation is selected from at least one of tablets, granules, capsules, pills, drop pills, powders, syrups, and mixtures.

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