Traditional Chinese medicine composition for treating chronic gastritis with syndrome of liver stagnation and spleen deficiency and preparation method of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions and preparations, in particular to a traditional Chinese medicine composition for treating liver depression and spleen deficiency type chronic gastritis and a preparation method thereof. The traditional Chinese medicine composition is prepared from codonopsis pilosula, rhizoma atractylodis macrocephalae stir-fried with bran, radix bupleuri, stir-fried radix paeoniae alba, pericarpium citri reticulatae, fructus aurantii stir-fried with bran, ginger processed pinellia, radix salviae miltiorrhizae, medicated leaven, stir-fried endothelium corneum gigeriae galli and fingered citron according to The traditional Chinese medicine composition is based on the theory of inhibiting wood and supporting soil in traditional Chinese medicine, and all the components have a synergistic effect and have the effects of soothing the liver, relieving depression, strengthening the spleen and harmonizing the stomach. Animal experiments prove that the traditional Chinese medicine composition provided by the invention can significantly improve the gastric emptying rate and the small intestine propulsion rate of a chronic gastritis model, and can down-regulate the gene expression of gastric mucosa intestinal metaplasia related markers CDX2 and MUC2.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compositions and preparations, specifically to a traditional Chinese medicine composition for treating chronic gastritis with liver stagnation and spleen deficiency syndrome, and its preparation method. Background Technology

[0002] The *Huangdi Neijing* states that "the spleen and stomach are the officials in charge of granaries, from which the five flavors originate," clearly indicating that the spleen and stomach are the foundation of postnatal health, responsible for the transformation and transportation of food and water. The *Suwen* (Plain Questions) chapter "On Preserving Life and Completing the Form" states that "earth is aided by wood," revealing that the spleen's transformative function depends on the liver's function of regulating and dispersing. In the Five Elements theory, the liver belongs to wood, and the spleen and stomach belong to earth. Wood controlling earth is a normal physiological process, meaning the liver (wood) regulates the spleen (earth) to aid transformation and transportation. If wood is stagnant and controls earth, or if wood is excessive and overacts on earth, the spleen and stomach's ascending and descending functions will be disrupted, leading to symptoms of chronic gastritis such as "abdominal distension and heartburn." This is the pathological basis for the *Jinkui Yaolue*'s statement, "When seeing liver disease, know that the liver transmits to the spleen; therefore, first strengthen the spleen."

[0003] Chronic gastritis (CG) refers to various chronic inflammatory lesions of the gastric mucosa caused by different etiologies. It is one of the most common diseases found during gastroscopy. Based on endoscopic and pathological diagnosis, CG is divided into non-atrophic (superficial) gastritis (CSG) and atrophic gastritis (CAG), falling under the categories of "stomach fullness" and "stomach pain" in Traditional Chinese Medicine (TCM). Modern research indicates that CG patients often exhibit liver qi stagnation and spleen deficiency syndromes, manifesting as epigastric distension, abdominal pain, belching, acid reflux, loss of appetite, and depression. The mechanism is related to liver qi stagnation leading to gastrointestinal motility disorders, abnormal gastric acid secretion, and mucosal barrier damage. As emphasized in *Wenbing Tiaobian* (Treatise on Warm Diseases), "Treating the middle jiao is like balancing a scale; without balance, there is no peace." Regulating the middle jiao requires considering both the liver and spleen to restore the dynamic balance of "wood and earth in harmony."

[0004] Current traditional Chinese medicine treatments for chronic gastritis (CG) often focus solely on strengthening the spleen or soothing the liver, neglecting the generative and regulatory relationship between the liver and spleen. For example, some formulas only use spleen-strengthening and qi-tonifying herbs (such as Sijunzi Tang), which can enhance spleen and stomach function but do not address the liver's function of regulating qi; or they only use liver-soothing and stagnation-relieving herbs (such as Chaihu Shugan San), which can alleviate liver stagnation but easily depletes spleen qi. Such approaches fail to achieve precise regulation of "suppressing wood and supporting earth," leading to unstable efficacy or easy relapse.

[0005] This invention is based on the Five Elements theory of mutual generation and restraint ("Wood controls Earth"), proposing a treatment principle of "maintaining balance." It regulates excessive liver qi by "suppressing Wood" to prevent excessive Wood from controlling Earth; and enhances the spleen's digestive function by "supporting Earth," enabling Earth to nourish Wood. Targeting the core pathogenesis of chronic gastritis (CG)—liver stagnation and spleen deficiency—this invention restores the physiological balance of the liver and spleen through the "suppressing Wood and supporting Earth" method, developing a traditional Chinese medicine composition for treating chronic gastritis, providing an innovative approach that addresses both the symptoms and the root cause in clinical practice. Summary of the Invention

[0006] The purpose of this invention is to screen and obtain a traditional Chinese medicine composition that can restore the physiological balance of the liver and spleen through the "suppressing wood and supporting earth" method, targeting the core pathogenesis of chronic gastritis (CG)—liver stagnation and spleen deficiency. To achieve the above objective, this invention provides the following technical solution.

[0007] On one hand, the present invention provides a traditional Chinese medicine composition, which, by mass parts, comprises 12-16 parts of Codonopsis pilosula, 12-18 parts of stir-fried Atractylodes macrocephala, 7-10 parts of Bupleurum chinense, 8-12 parts of stir-fried Paeonia lactiflora, 8-12 parts of Citrus reticulata peel, 10-15 parts of stir-fried Citrus aurantium, 5-8 parts of ginger-processed Pinellia ternata, 6-10 parts of Salvia miltiorrhiza, 10-15 parts of Massa fermentata, 10-15 parts of stir-fried chicken gizzard lining, and 9-12 parts of Citrus medica.

[0008] Furthermore, the traditional Chinese medicine composition, by mass parts, consists of 15 parts of Codonopsis pilosula, 15 parts of stir-fried Atractylodes macrocephala, 8 parts of Bupleurum chinense, 10 parts of stir-fried Paeonia lactiflora, 10 parts of Citrus reticulata peel, 12 parts of stir-fried Citrus aurantium, 6 parts of ginger-processed Pinellia ternata, 8 parts of Salvia miltiorrhiza, 12 parts of Shenqu (medicated leaven), 12 parts of stir-fried chicken gizzard lining, and 10 parts of Citrus medica.

[0009] Secondly, the present invention also provides the application of the traditional Chinese medicine composition described herein in the preparation of a medicament for treating chronic gastritis due to liver stagnation and spleen deficiency.

[0010] Furthermore, the drug is used in the application to improve gastrointestinal motility.

[0011] Furthermore, the drug in the application is used to reduce CDX2 and / or MUC2 gene expression.

[0012] Thirdly, a pharmaceutical preparation is also provided, the pharmaceutical preparation containing the traditional Chinese medicine composition described in this invention and pharmaceutically acceptable excipients.

[0013] Furthermore, the pharmaceutical preparation is in the form of pills.

[0014] Fourthly, a method for preparing the pill form of the pharmaceutical preparation is also provided, the method comprising the following steps: S1. Pre-treat the following ingredients in the traditional Chinese medicine composition: stir-fried Atractylodes macrocephala, stir-fried Citrus aurantium, stir-fried Paeonia lactiflora, stir-fried chicken gizzard lining, and ginger-processed Pinellia ternata. S2. Mix, pulverize, and sieve the pretreated raw materials from S1 and the remaining raw materials in the traditional Chinese medicine composition to obtain medicinal powder; S3. The powdered medicine is mixed with excipients to form the pills.

[0015] Furthermore, in the preparation method, in step S2, the raw material is pulverized to 400-500 mesh.

[0016] Furthermore, in the preparation method, in step S3, the excipient is honey, and the mass ratio of the medicinal powder to honey is 3:1.

[0017] Compared with the prior art, the technical solution provided by the present invention has at least the following beneficial effects or advantages: (1) This invention follows the TCM treatment principles of "wood overcoming earth" and "suppressing wood and supporting earth" in its formulation. The formula uses Bupleurum, stir-fried white peony root, Buddha's hand, and tangerine peel to soothe the liver, relieve depression, and harmonize the stomach, addressing the cause of "liver stagnation"; Codonopsis and stir-fried Atractylodes macrocephala to strengthen the spleen and replenish qi, addressing the root cause of "spleen deficiency"; stir-fried Citrus aurantium and ginger-processed Pinellia ternata to regulate qi, relieve chest congestion, and eliminate stagnation; and Shenqu and stir-fried chicken gizzard to aid digestion, promote digestion, and strengthen the spleen and stomach, thus regulating the ascending and descending of qi in the spleen and stomach. The entire formula soothes the liver without harming the spleen, strengthens the spleen without causing stagnation, and is supplemented with Salvia miltiorrhiza to invigorate blood and unblock collaterals to prevent prolonged illness from affecting the collaterals. It effectively restores the physiological balance of "wood and earth in harmony," overcoming the shortcomings of existing technologies where soothing the liver and strengthening the spleen are difficult to coordinate and only one aspect is treated.

[0018] (2) Animal experiments showed that after treatment with the traditional Chinese medicine composition of the present invention, the gastric emptying rate and small intestinal propulsion rate of rats with chronic gastritis due to liver stagnation and spleen deficiency were significantly improved. The improvement effect was not only significantly better than that of the model group, but also reached or even exceeded the level of the positive control drug - mosapride. This confirms from the perspective of modern pharmacology the outstanding effect of the composition of the present invention in promoting gastrointestinal motility and improving digestive function.

[0019] (3) The traditional Chinese medicine composition of the present invention has unexpected potential to "treat the root cause". Experimental results show that the traditional Chinese medicine composition of the present invention significantly downregulates key markers of intestinal metaplasia in gastric mucosal tissue. CDX2 and MUC2 The gene expression level was measured. This effect was significantly better than that of simply adding or subtracting medicinal materials in each ratio, and better than the positive control drug. This indicates that the present invention not only relieves symptoms such as bloating and loss of appetite, but may also intervene at the molecular level and delay the pathological process of chronic gastritis developing into intestinal metaplasia.

[0020] (4) Through extensive experimental screening, the core formula of this invention, consisting of eleven medicinal herbs, was determined. Parallel experiments were conducted to demonstrate that adding or removing components of this invention, such as adding digestive herbs like hawthorn and malt, or reducing liver-soothing and qi-regulating herbs, resulted in a decrease in efficacy. This indicates that there is a close and irreplaceable synergistic effect among the specific components described in this invention. Attached Figure Description

[0021] Figure 1 This is a flowchart illustrating the preparation process of Tiaozhong Jianwei Pills.

[0022] Figure 2 In rats with chronic gastritis model of liver stagnation and spleen deficiency syndrome after treatment with different drugs CDX2 Gene expression patterns.

[0023] Figure 3 In rats with chronic gastritis model of liver stagnation and spleen deficiency syndrome after treatment with different drugs MUC2Gene expression patterns. Detailed Implementation

[0024] The technical solution of the present invention will be described below with reference to the embodiments. However, the present invention is not limited to the following embodiments.

[0025] To enable those skilled in the art to better understand and implement the technical solutions of the present invention, the present invention will be further described below in conjunction with specific embodiments and accompanying drawings. However, the embodiments described are not intended to limit the present invention.

[0026] Unless otherwise specified, the experimental and detection methods described in the following embodiments are conventional methods; unless otherwise specified, the reagents and materials are commercially available.

[0027] Example 1 This embodiment provides a traditional Chinese medicine composition for treating chronic gastritis.

[0028] The traditional Chinese medicine composition for chronic gastritis in this embodiment includes, by weight parts: 12 parts Codonopsis pilosula, 12 parts stir-fried Atractylodes macrocephala, 7 parts Bupleurum chinense, 8 parts stir-fried Paeonia lactiflora, 8 parts Citrus reticulata peel, 10 parts stir-fried Citrus aurantium, 5 parts ginger-processed Pinellia ternata, 6 parts Salvia miltiorrhiza, 10 parts Shenqu (medicated leaven), 10 parts stir-fried chicken gizzard lining, and 9 parts Citrus medica.

[0029] Example 2 This embodiment provides a traditional Chinese medicine composition for treating chronic gastritis.

[0030] The traditional Chinese medicine composition for chronic gastritis in this embodiment includes, by weight parts: 15 parts Codonopsis pilosula, 15 parts stir-fried Atractylodes macrocephala, 8 parts Bupleurum chinense, 10 parts stir-fried Paeonia lactiflora, 10 parts Citrus reticulata peel, 12 parts stir-fried Citrus aurantium, 6 parts ginger-processed Pinellia ternata, 8 parts Salvia miltiorrhiza, 12 parts Shenqu (medicated leaven), 12 parts stir-fried chicken gizzard lining, and 10 parts Citrus medica.

[0031] Example 3 This embodiment provides a traditional Chinese medicine composition for treating chronic gastritis.

[0032] The traditional Chinese medicine composition for chronic gastritis in this embodiment includes, by weight parts: 16 parts of Codonopsis pilosula, 18 parts of stir-fried Atractylodes macrocephala, 10 parts of Bupleurum chinense, 12 parts of stir-fried Paeonia lactiflora, 12 parts of Citrus reticulata peel, 15 parts of stir-fried Citrus aurantium, 8 parts of ginger-processed Pinellia ternata, 10 parts of Salvia miltiorrhiza, 15 parts of Shenqu (medicated leaven), 15 parts of stir-fried chicken gizzard lining, and 12 parts of Citrus medica.

[0033] Example 4 This embodiment provides a traditional Chinese medicine composition for treating chronic gastritis.

[0034] The traditional Chinese medicine composition for chronic gastritis in this embodiment includes, by weight parts: 10 parts Codonopsis pilosula, 10 parts stir-fried Atractylodes macrocephala, 6 parts Bupleurum chinense, 7 parts stir-fried Paeonia lactiflora, 7 parts Citrus reticulata peel, 8 parts stir-fried Citrus aurantium, 4 parts ginger-processed Pinellia ternata, 5 parts Salvia miltiorrhiza, 9 parts Shenqu (medicated leaven), 9 parts stir-fried chicken gizzard lining, and 8 parts Citrus medica.

[0035] Example 5 This embodiment provides a traditional Chinese medicine composition for treating chronic gastritis.

[0036] The traditional Chinese medicine composition for chronic gastritis in this embodiment includes, by weight parts: 17 parts Codonopsis pilosula, 19 parts stir-fried Atractylodes macrocephala, 11 parts Bupleurum chinense, 13 parts stir-fried Paeonia lactiflora, 13 parts Citrus reticulata peel, 17 parts stir-fried Citrus aurantium, 9 parts Pinellia ternata, 11 parts Salvia miltiorrhiza, 16 parts Shenqu (medicated leaven), 16 parts stir-fried chicken gizzard lining, and 13 parts Citrus medica.

[0037] Example 6 This embodiment describes the preparation of Tiaozhong Jianwei Pills, which contain a traditional Chinese medicine composition for treating chronic gastritis.

[0038] The traditional Chinese medicine compositions for treating chronic gastritis described in Examples 1-5 were used to prepare Tiaozhong Jianwei Pills according to the following steps: The process flow for preparing Tiaozhong Jianwei Pills is as follows. Figure 1 As shown.

[0039] Step 1: Raw Material Preparation According to the components of the traditional Chinese medicine composition for treating chronic gastritis in Examples 1-5, each raw material was weighed, and some raw materials were pretreated. Stir-fried Atractylodes macrocephala / Citrus aurantium: Stir-fried with wheat bran until slightly yellow to enhance spleen-strengthening and stomach-regulating effects. Stir-fried Paeonia lactiflora / Chicken gizzard lining: Stir-fried over low heat until slightly charred to reduce coldness and enhance digestive function. Ginger-processed Pinellia ternata: Soaked in ginger juice and then dried to reduce irritation and enhance antiemetic effect.

[0040] Step 2: Crushing and Sieving After the raw materials pretreated in step one are dried at a low temperature of 60℃, they are pulverized into a fine powder of 400-500 mesh using an ultra-micro pulverizer to ensure that the cell walls are fully broken. The powder is then prepared by mixing the components thoroughly using a V-type mixer for 30 minutes.

[0041] Step 3: Making pills The powder obtained in step three is mixed with honey at a mass ratio of 3:1 and then added to a pill-making machine to form pills, each weighing 10 grams. The pills prepared according to the composition ratio of Example 1 are labeled as 1# Tiaozhong Jianwei Pills; the pills prepared according to the composition ratio of Example 2 are labeled as 2# Tiaozhong Jianwei Pills; the pills prepared according to the composition ratio of Example 3 are labeled as 3# Tiaozhong Jianwei Pills; the pills prepared according to the composition ratio of Example 4 are labeled as 4# Tiaozhong Jianwei Pills; and the pills prepared according to the composition ratio of Example 5 are labeled as 5# Tiaozhong Jianwei Pills.

[0042] Comparative Example 1 This comparative example is a contrast agent for Tiaozhong Jianwei Pill prepared using the preparation method of Example 6.

[0043] The difference between the traditional Chinese medicine composition for treating chronic gastritis in this comparative example and that in Example 2 is the addition of 10 parts hawthorn, 8 parts malt, 2 parts Cyperus rotundus, 3 parts Curcuma longa, and 5 parts rose petals to the traditional Chinese medicine composition for treating chronic gastritis in Example 2. The components of the traditional Chinese medicine composition for treating chronic gastritis in this comparative example, by mass parts, include: 15 parts Codonopsis pilosula, 15 parts stir-fried Atractylodes macrocephala, 8 parts Bupleurum chinense, 10 parts stir-fried Paeonia lactiflora, 10 parts Citrus reticulata peel, 12 parts stir-fried Citrus aurantium, 6 parts Pinellia ternata, 8 parts Salvia miltiorrhiza, 12 parts Massa fermentata, 12 parts stir-fried chicken gizzard lining, 10 parts Citrus medica, 10 parts hawthorn, 8 parts malt, 2 parts Cyperus rotundus, 3 parts Curcuma longa, and 5 parts rose petals. The Tiaozhong Jianwei Pill prepared according to the preparation method of Example 6 is labeled as 1# Tiaozhong Jianwei Pill Comparative Agent.

[0044] Comparative Example 2 This comparative example is a contrast agent for Tiaozhong Jianwei Pill prepared using the preparation method of Example 6.

[0045] The difference between the traditional Chinese medicine composition for treating chronic gastritis in this comparative example and that in Example 2 is the addition of 8 parts hawthorn, 8 parts yam, 3 parts safflower, 3 parts poria cocos, and 5 parts rose in the traditional Chinese medicine composition for treating chronic gastritis in Example 2. The components of the traditional Chinese medicine composition for treating chronic gastritis in this comparative example, by mass parts, include: 15 parts codonopsis pilosula, 15 parts stir-fried atractylodes macrocephala, 8 parts bupleurum chinense, 10 parts stir-fried white peony root, 10 parts tangerine peel, 12 parts stir-fried immature bitter orange peel, 6 parts ginger-processed pinellia ternata, 8 parts salvia miltiorrhiza, 12 parts medicated leaven, 12 parts stir-fried chicken gizzard lining, 10 parts citronella chinensis, 8 parts hawthorn, 8 parts yam, 3 parts safflower, 3 parts poria cocos, and 5 parts rose. The prepared Tiaozhong Jianwei Pill, prepared according to the preparation method of Example 6, is labeled as Comparative Agent 2# Tiaozhong Jianwei Pill.

[0046] Comparative Example 3 This comparative example is a contrast agent for Tiaozhong Jianwei Pill prepared using the preparation method of Example 6.

[0047] The difference between the traditional Chinese medicine composition for treating chronic gastritis in this comparative example and that in Example 2 is the reduction of several herbs in the traditional Chinese medicine composition for treating chronic gastritis in Example 2. The components of the traditional Chinese medicine composition for treating chronic gastritis in this comparative example, by mass parts, include: 15 parts Codonopsis pilosula, 15 parts stir-fried Atractylodes macrocephala, 10 parts stir-fried Paeonia lactiflora, 10 parts Citrus reticulata peel, 6 parts Pinellia ternata, 8 parts Salvia miltiorrhiza, 12 parts stir-fried chicken gizzard lining, and 10 parts Citrus medica. The Tiaozhong Jianwei Pill prepared according to the preparation method of Example 6 is labeled as Comparative Agent 3# Tiaozhong Jianwei Pill.

[0048] Comparative Example 4 This comparative example is a contrast agent for Tiaozhong Jianwei Pill prepared using the preparation method of Example 6.

[0049] The difference between the traditional Chinese medicine composition for treating chronic gastritis in this comparative example and that in Example 2 is the reduction of several herbs in the traditional Chinese medicine composition for treating chronic gastritis in Example 2. The components of the traditional Chinese medicine composition for treating chronic gastritis in this comparative example, by mass parts, include: 8 parts Bupleurum chinense, 10 parts Citrus reticulata peel, 12 parts stir-fried Citrus aurantium, 6 parts Pinellia ternata, 12 parts Shenqu (medicated leaven), and 10 parts Citrus medica. The Tiaozhong Jianwei Pill prepared according to the preparation method of Example 6 is labeled as Comparative Agent 4# Tiaozhong Jianwei Pill.

[0050] Example 7 This embodiment is a test experiment to evaluate the therapeutic effect of regulating the middle jiao and strengthening the stomach on an animal model of chronic gastritis caused by liver stagnation and spleen deficiency.

[0051] (1) Establishing an experimental model Ninety-six male SD rats of SPF grade, aged 8 weeks and weighing (200±20) g, were acclimatized for 1 week and then randomly divided into blank group, model group, test group 1#-5#, control group 1#-4#, and positive control group, with 8 SD rats in each group.

[0052] The control group was not included in the model. The other 11 groups used a combined stress method—dietary instability, excessive fatigue, chronic restraint stress, and tail-clamping stimulation—to establish an animal model of chronic gastritis due to liver stagnation and spleen deficiency. Specifically, the model involved 3 hours of restraint stress daily from 8:00 AM to 11:00 AM, followed by 10 minutes of forced swimming (water temperature 22±1℃) at 2:00 PM. Alternating between fasting / full feeding and 30 minutes of tail-clamping stimulation were performed every other day for 21 days. Modeling was then completed.

[0053] (2) Test the gastric emptying rate and small intestinal propulsion rate of SD rats in different treatment groups. After the model was established, the blank group and the model group were given 10 mL / (kg·d) of physiological saline by gavage daily; the test groups 1#-5# were given 2 g / (kg·d) of Tiaozhong Jianwei Pills (1#-5#), which were crushed and mixed with water into a paste by gavage; the control groups 1#-4# were given 2 g / (kg·d) of Tiaozhong Jianwei Pills contrast agent (1#-4#), which were also crushed and mixed with water into a paste by gavage; the positive control group was given 1.35×10 -3 Mosapride suspension (g / kg) was administered to all groups once daily by gavage for 14 days.

[0054] After the final gavage, all experimental animals were fasted for 24 hours but allowed free access to water. Each rat was then orally administered 4 mL of a semi-solid nutrient suspension containing activated charcoal (preparation method: 2 g activated charcoal, 8 g sucrose, 8 g starch, 16 g milk powder, diluted with distilled water to 300 mL). Thirty minutes after gavage, the rats were anesthetized by intraperitoneal injection of 3% sodium pentobarbital solution (5 mL / kg). After abdominal incision, the esophageal cardia and duodenal pylorus were ligated sequentially, and the stomach tissue was completely removed and weighed wet. The stomach was cut along the greater curvature, rinsed with physiological saline to remove any remaining contents, and the net weight of the stomach tissue was measured. The duodenal to ileocecal segment was separated, flattened on filter paper, and the total length of the intestinal segment (L) and the maximum propulsion distance of the charcoal suspension in the intestine (L0) were recorded using measuring tools. The gastric emptying rate and small intestinal propulsion rate were calculated using the following formula: Gastric emptying rate (%) = 1 - [(total stomach weight - net stomach weight) / volume of black semi-solid paste administered] × 100% Small intestinal propulsion rate (%) = L0 / L × 100%.

[0055] The results of gastric emptying rate and small intestinal propulsion rate of SD rats under different treatments are shown in Table 1.

[0056] Table 1. Statistical results of gastric emptying rate and small intestinal propulsion rate in SD rats under different treatments.

[0057] Table 1 shows that the gastric emptying rate of the model group was significantly reduced to 30.25% compared with the blank control group, indicating that the combined stress method successfully established a chronic gastritis model of liver stagnation and spleen deficiency. The gastric emptying rate of experimental groups 1#-3# was 45.32%-50.25%, which is close to or equivalent to the treatment effect of the positive control, indicating that the Tiaozhong Jianwei Pills in experimental groups 1#-3# have a significant therapeutic effect. The effects of control groups 1# and 2# (with added medicinal materials) were slightly better than the model group (about 40%), but significantly lower than those of experimental group 2#; the effects of control groups 3# and 4# (with reduced medicinal materials) were the worst (about 35%-37%), indicating that the absence of components significantly reduced the efficacy. This shows that the specific components and specific proportions of the Tiaozhong Jianwei Pills in experimental groups 1#-3# provided by this invention work synergistically, making the efficacy of Tiaozhong Jianwei Pills in groups 1#-3# close to or equivalent to the positive control. The trend of small intestinal propulsion rate in each treatment group was the same as that of gastric emptying rate. It is particularly noteworthy that the small intestinal propulsion rate of experimental group 2# was better than that of the positive control, indicating that the Tiaozhong Jianwei Pill used in experimental group 2# had a better overall effect than the positive control.

[0058] (3) RT-PCR detection of SD rats in different treatment groups CDX2 and MUC2 Gene expression Homeobox transcription factor 2 (CDX2) is significantly upregulated in gastric mucosal intestinal metaplasia, driving intestinal epithelial differentiation. Bile acids activate CDX2 through two pathways: FXR / SHP / NF-κB and miR-92a / FOXD1 / NF-κB, promoting intestinal metaplasia. Mucin 2 (MUC2) is highly expressed in goblet cells in the intestinal metaplasia region, serving as a characteristic marker of intestinal metaplasia and a key indicator for its pathological diagnosis; its expression level reflects the degree of intestinal metaplasia. [The text then abruptly shifts to a different topic:] ...by detecting... CDX2 and MUC2 The expression levels were used to assess the effects of different treatments on the progression of intestinal metaplasia in rats.

[0059] Total RNA was extracted from rat gastric antrum mucosa (avoiding blood vessels), and cDNA was obtained by reverse transcription using a reverse transcription kit. Real-time PCR was performed using a Real-time PCR kit, with β-actin as an internal reference gene, and assays were performed according to standard Real-time PCR methods. CDX2 and MUC2 mRNA levels ( CDX2 and MUC2 All primers used were standard primers, and each reaction was repeated three times. The 2-ΔΔCT method was used to quantify relative mRNA expression levels. Results are shown below. Figure 2 and Figure 3 As shown.

[0060] Depend on Figure 2 It can be seen that, compared with the model group and the positive control group, the experimental groups 1#-3#, CDX2 The expression level was significantly reduced in experimental groups 4# and 5#. CDX2 The expression levels of these substances also decreased to varying degrees, but the decrease was much lower than that in the experimental groups 1#-3#, while the decrease was greater than that in the control group 1#-4#.

[0061] Depend on Figure 3 It can be seen that, compared with the model group and the positive control group, the experimental groups 1#-3#, MUC2 The expression level was significantly reduced in experimental groups 4# and 5#. MUC2 The expression levels of these substances also decreased to varying degrees, but the decrease was slightly less than that in experimental groups 1#-3#, and greater than that in control groups 1#-4#. (Control group 1#-4#) MUC2 The expression levels were almost identical in the model group and the positive control group, indicating that increasing or decreasing any component in the specific traditional Chinese medicine composition provided in this invention affects the efficacy of the traditional Chinese medicine composition. MUC2 The inhibitory effect on expression.

[0062] In summary, the traditional Chinese medicine composition for treating chronic gastritis provided by this invention effectively treats chronic gastritis while downregulating the expression of genes related to intestinal metaplasia, thus providing a clinically significant treatment option for chronic gastritis.

[0063] As described above, the basic principles, main features, and advantages of the present invention have been well described. The above embodiments and specifications are merely descriptions of preferred embodiments of the present invention, and the present invention is not limited to the above embodiments. Various changes and improvements made to the technical solutions of the present invention by those skilled in the art without departing from the spirit and scope of the present invention should fall within the protection scope defined by the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, By weight, it consists of 12-16 parts of Codonopsis pilosula, 12-18 parts of Atractylodes macrocephala stir-fried with wheat bran, 7-10 parts of Bupleurum chinense, 8-12 parts of Paeonia lactiflora stir-fried with wheat bran, 8-12 parts of Citrus reticulata peel, 10-15 parts of Citrus aurantium stir-fried with wheat bran, 5-8 parts of Pinellia ternata stir-fried with ginger, 6-10 parts of Salvia miltiorrhiza, 10-15 parts of Massa fermentata, 10-15 parts of chicken gizzard lining stir-fried with wheat bran, and 9-12 parts of Citrus medica.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, By weight, it consists of 15 parts Codonopsis pilosula, 15 parts stir-fried Atractylodes macrocephala, 8 parts Bupleurum chinense, 10 parts stir-fried Paeonia lactiflora, 10 parts Citrus reticulata peel, 12 parts stir-fried Citrus aurantium, 6 parts ginger-processed Pinellia ternata, 8 parts Salvia miltiorrhiza, 12 parts Shenqu (medicated leaven), 12 parts stir-fried chicken gizzard lining, and 10 parts Citrus medica.

3. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating chronic gastritis with liver stagnation and spleen deficiency syndrome.

4. Use according to claim 3, characterized in that, The drug is used to improve gastrointestinal motility.

5. Use according to claim 3, characterized in that, The drug is used to reduce the expression of CDX2 and / or MUC2 genes.

6. A pharmaceutical preparation, characterized by, The pharmaceutical preparation contains the traditional Chinese medicine composition as described in claim 1 or 2 and pharmaceutically acceptable excipients.

7. The pharmaceutical preparation according to claim 6, characterized in that, The pharmaceutical preparation is in the form of pills.

8. A process for the preparation of a pellet according to claim 7, characterised in that, Includes the following steps: S1. Pre-treat the following ingredients in the traditional Chinese medicine composition: stir-fried Atractylodes macrocephala, stir-fried Citrus aurantium, stir-fried Paeonia lactiflora, stir-fried chicken gizzard lining, and ginger-processed Pinellia ternata. S2. Mix, pulverize, and sieve the pretreated raw materials from S1 and the remaining raw materials in the traditional Chinese medicine composition to obtain medicinal powder; S3. The powdered medicine is mixed with excipients to form the pills.

9. The production method according to claim 8, characterized by, In step S2, the raw materials are crushed to 400-500 mesh.

10. The preparation method according to claim 8, characterized in that, In step S3, the excipient is honey, and the mass ratio of the medicinal powder to honey is 3:1.

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