A traditional Chinese medicine composition for treating chronic atrophic gastritis, a preparation method and use thereof

Abstract

The application belongs to the technical field of traditional Chinese medicines, discloses a traditional Chinese medicine composition for treating chronic atrophic gastritis and a preparation method and application thereof, and the technical scheme points are as follows: the traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by weight: radix codonopsis 10-50 parts, fried atractylodes 5-20 parts, prepared pinellia 5-10 parts, coptis 2-8 parts, poria 8-40 parts, salvia miltiorrhiza 5-15 parts, dried ginger 3-6 parts, cyperus 5-15 parts, actinidia root 1-20 parts, and fried licorice 1-5 parts. The traditional Chinese medicine composition can improve the pathological morphology of the stomach tissue, improve the expression of PG I and the ratio of PG I / PG II, reduce the level of inflammatory factors, and improve the atrophy degree of the gastric mucosa, and is used for treating stomachache, fullness, poor appetite, stomach rumbling and other symptoms caused by spleen-stomach qi deficiency, qi stagnation and blood stasis, and mutual accumulation of dampness and toxicity.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, more specifically, it relates to a traditional Chinese medicine composition for treating chronic atrophic gastritis and a preparation method and application thereof. BACKGROUND

[0002] Chronic atrophic gastritis (CAG) is a common digestive system disease, which is caused by connective tissue (non-hyperplastic atrophy) or different non-natural epithelium (hyperplastic atrophy) replacing the appropriate gastric gland structure due to chronic inflammation. It usually has no symptoms or is accompanied by stomach pain, fullness, belching and other clinical manifestations. It is affected by factors such as patient's physical condition, eating habits, Helicobacter pylori (Hp) infection, and is a precancerous lesion (PLGC) of gastric cancer. It is the first step in the multi-step gastric cancer (GC) precancerous cascade reaction. The incidence and prevalence of CAG are high, and the global prevalence rate is as high as 25%. At present, there is a lack of epidemiological data of CAG. A large-scale cross-sectional survey result suggests that the prevalence and detection rate of CAG increase with age.

[0003] At present, the treatment of CAG in the clinic is mainly based on the principle of individualized treatment and targeting the cause. In addition to the quadruple therapy method, supplements such as folic acid also play an important role in the treatment of CAG. However, its treatment has certain limitations, and lacks high-quality evidence-based evidence support, and the clinical benefit is limited. In recent years, there are less than 10 clinical trials on PLGC, and some preclinical new drug research and development have made no progress in the past 5 years. Due to the limited previous treatment methods, lack of drug varieties, and the treatment of PLGC is difficult, new drugs that can improve or even reverse PLGC are urgently needed.

[0004] TCM has obvious advantages in the prevention and treatment of complex diseases, and Chinese medicine has the characteristics of multi-component, multi-pathway, multi-level, multi-target and small adverse reactions, which has great research and application value. There is no record of "atrophic gastritis" in TCM literature. According to its pathogenesis and clinical symptoms, it can be classified into the category of "stomach pain, distension, and rumbling" in TCM. The mild one may only have stomach discomfort, and the clinical symptoms are not prominent. The severe one may have stomach pain, acid reflux, distension, and rumbling. The main disease location is the spleen and stomach. The top three disease nature elements are qi deficiency, dampness and blood stasis. In terms of etiology and pathogenesis, Li Dongyuan's "Spleen and Stomach Theory" states that "internal injury of the spleen and stomach leads to various diseases", and "Zhuozhong Luntan" says "insufficient stomach qi leads to deficiency and inability to accept food and drink". The spleen and stomach are the basis of acquired constitution. Weakness and deficiency of stomach qi lead to reduced function of the spleen and stomach in transporting and transforming water and nutrient essence, which is considered by ancient physicians as the root cause of many diseases and the prerequisite for disease occurrence. Most ancient physicians believe that the main pathogenesis of this disease is weakness of the spleen and stomach. Most contemporary physicians believe that the etiology and pathogenesis of CAG follow the theory of "deficiency, stasis and toxicity". In terms of syndrome research, literature research suggests that the frequency of spleen and stomach dampness syndrome is higher in this specific pathological stage of CAG. Further exploration of the distribution of syndromes shows that liver and stomach heat syndrome and spleen and stomach dampness syndrome rank first and second. Analysis of the distribution of syndromes of national master physicians in the treatment of chronic atrophic gastritis over the years shows that spleen and stomach qi deficiency, liver and stomach disharmony, qi stagnation and blood stasis, and dampness accumulation are the core syndromes of CAG. The main pathogenesis is deficiency of spleen and stomach qi, and phlegm, stasis and toxicity are the secondary pathogenesis. Deficiency of healthy qi and invasion of pathogenic factors in the stomach for a long time, deficiency, phlegm, stagnation, stasis and toxicity interact, leading to stasis of stomach collaterals, accumulation of mass and development of cancer. The basic principle is to protect the spleen and stomach, and to tonify qi and invigorate the spleen throughout the treatment, supplemented by methods such as resolving dampness and detoxifying, promoting qi and activating blood.

[0005] The existing technology has the problems of single efficacy and difficulty in multi-target synergistic effect. Most existing Chinese medicine compounds focus on a single dimension of "spleen and stomach" (such as four gentlemen decoction with addition and subtraction), and lack of simultaneous intervention of "qi stagnation and blood stasis-dampness and toxicity complex pathogenesis", which leads to limited improvement of gastric mucosa microcirculation disorder and inflammatory infiltration, and cannot effectively improve the PG I / PG II ratio. Second, the synergistic effect of components is insufficient. The same kind of patent uses 15 or more kinds of medicinal materials, but the proportion of blood-activating and detoxifying components is insufficient, which affects the regulation efficiency of TNF-α, IL-6 and other inflammatory factors in gastric tissue. Third, the time effectiveness of the action is defective. The commercially available Chinese medicine (such as Molo Dan) needs to be taken continuously for 3 months to see the effect. Its slow-release system does not consider the influence of gastric acid environment. In vitro dissolution test shows that the release rate of effective components under pH 1.5 environment is 37.6% lower than that under pH 5.5. Fourth, the risk of metabolic interference. When the same kind of product uses curcumin and rabeprazole, LC-MS detection found that the key components decreased by 29.4% due to drug interaction.

[0006] Therefore, the application takes spleen and stomach qi deficiency, qi stagnation and blood stasis, and dampness and toxin mutual knotting as the main TCM pathogenesis of CAG. CAG has a long course, and the disease nature is deficiency in origin and excess in superficiality. In treatment, the therapeutic principle is to invigorate the spleen and stomach, regulate qi and remove stasis, and resolve dampness and detoxify. A medicine prepared from a multi-component and multi-target traditional Chinese medicine composition is proposed to intervene in CAG in multiple dimensions and inhibit the progression of PLGC, thereby providing further evidence for clinical application. SUMMARY

[0007] In order to solve the problem that there is a lack of traditional Chinese medicine prescriptions that can effectively treat CAG for clinical use at present, the application provides a novel traditional Chinese medicine composition for treating CAG as well as a preparation method and application thereof.

[0008] Specifically, the application is realized through the following technical solutions:

[0009] In a first aspect, the application provides a traditional Chinese medicine composition for treating chronic atrophic gastritis, which is prepared from the following raw medicinal materials in parts by weight: radix codonopsis 10-50 parts, fried atractylodes 5-20 parts, prepared pinellia 5-10 parts, goldthread 2-8 parts, poria 8-40 parts, salvia miltiorrhiza 5-15 parts, dried ginger 3-6 parts, cyperus 5-15 parts, actinidia root 1-20 parts, and fried licorice 1-5 parts.

[0010] In a preferred embodiment, the traditional Chinese medicine composition is prepared from the following raw medicinal materials in parts by weight: radix codonopsis 10-30 parts, fried atractylodes 10-20 parts, prepared pinellia 5-10 parts, goldthread 2-8 parts, poria 8-30 parts, salvia miltiorrhiza 10-15 parts, dried ginger 3-6 parts, cyperus 5-15 parts, actinidia root 10-20 parts, and fried licorice 1-5 parts.

[0011] In a more preferred embodiment, the traditional Chinese medicine composition is prepared from the following raw medicinal materials in parts by weight: radix codonopsis 10-20 parts, fried atractylodes 8-10 parts, prepared pinellia 6-9 parts, goldthread 4-6 parts, poria 8-12 parts, salvia miltiorrhiza 10-15 parts, dried ginger 5-6 parts, cyperus 8-12 parts, actinidia root 12-15 parts, and fried licorice 2-3 parts.

[0012] In a most preferred embodiment, the traditional Chinese medicine composition is prepared from the following raw medicinal materials in parts by weight: radix codonopsis 15 parts, fried atractylodes 10 parts, prepared pinellia 9 parts, goldthread 6 parts, poria 10 parts, salvia miltiorrhiza 15 parts, dried ginger 6 parts, cyperus 10 parts, actinidia root 10 parts, and fried licorice 3 parts.

[0013] In another most preferred embodiment, the traditional Chinese medicine composition is prepared from the following raw medicinal materials in parts by weight: radix codonopsis 10 parts, fried atractylodes 8 parts, prepared pinellia 6 parts, goldthread 4 parts, poria 10 parts, salvia miltiorrhiza 8 parts, dried ginger 5 parts, cyperus 8 parts, actinidia root 10 parts, and fried licorice 3 parts.

[0014] In another preferred embodiment, the traditional Chinese medicine composition has the effects of invigorating the spleen and stomach, regulating qi and activating blood, and resolving dampness and detoxifying.

[0015] In the second aspect, the medicine of the present application can be prepared by the conventional preparation method in the art, with or without the addition of pharmaceutically acceptable adjuvants. As long as the traditional Chinese medicine raw materials are radix codonopsis 10-50 parts, fried atractylodes 5-20 parts, fried pinellia 5-10 parts, goldthread 2-8 parts, poria 8-40 parts, salvia miltiorrhiza 5-15 parts, dried ginger 3-6 parts, cyperus 5-15 parts, actinidia root 1-20 parts, and fried licorice 1-5 parts, regardless of the various changes in the preparation method, they all fall within the scope of the present application. The forms of the medicine include solid, semi-solid or liquid forms, etc.; specifically including but not limited to decoction pieces, decoction, powder, oral liquid, ointment, granules, tablets or capsules.

[0016] In another most preferred embodiment, the present application provides a preparation method of the traditional Chinese medicine composition described in the first aspect above, which comprises the following steps: weighing each raw material according to the weight parts described in the first aspect above, extracting, and concentrating.

[0017] Preferably, in the above preparation method, the traditional Chinese medicine composition of the present application can further comprise a pretreatment step.

[0018] Preferably, it comprises weighing each raw material, pretreatment, extraction, and concentration.

[0019] Preferably, the pretreatment step comprises soaking and / or crushing.

[0020] Preferably, in the above preparation method, the traditional Chinese medicine composition of the present application is prepared by the conventional method known in the art.

[0021] Preferably, the extraction method used in the present application includes but is not limited to decoction extraction, reflux extraction, ultrasonic extraction, supercritical extraction, etc.

[0022] Preferably, the treated raw materials can be extracted with water, organic solvents commonly used in the art, or mixtures thereof.

[0023] Preferably, the organic solvent is methanol, ethanol, propanol, butanol, ethyl acetate, petroleum ether, etc.

[0024] In a preferred embodiment, the decoction is performed twice, the first decoction is filtered after 1-3 hours to obtain a first filtrate, the filter residue is decocted with water for 1-3 hours, filtered to obtain a second filtrate, and the first filtrate and the second filtrate are combined.

[0025] In a more preferred embodiment, the water used in the first decoction and the second decoction is distilled water; and the concentration is reduced pressure concentration.

[0026] In addition, as an optional way, the decoction machine can be used to prepare the traditional Chinese medicine composition, and the preparation method comprises the following steps:

[0027] 1. Preparation work:

[0028] (1) Put the medicine to be processed into a special non-woven bag, tie the opening, and put it into a container. Soak in cold water for 30 minutes;

[0029] (2) Clean the decoction machine, open the waste liquid valve, put in clean water, close the waste liquid valve, close the medicine liquid valve, put the soaked medicine bag into the medicine pot, and add the soaking liquid and water;

[0030] (3) Water ratio: water amount = required medicine liquid amount + 20%.

[0031] Calculation formula: water amount = (medicine capacity per bag × number of times per day × total number of decocted medicine) × 1.2.

[0032] 2. Operation steps of medicine decoction:

[0033] (1) Put the traditional Chinese medicine and water into the decoction machine, cover the pot cover, tighten the handle, close the pressure relief valve, set the decoction time and temperature, press the heating button, and the machine will automatically heat. When the set temperature is reached, it will automatically switch to a slow fire. When the set time is reached, the heating is automatically stopped;

[0034] (2) After the medicine is decocted, first open the pressure relief valve and appropriately reduce the pressure (so that the pressure drops to about 1 kg), then open the medicine liquid valve, and the medicine liquid is injected into the packaging machine tank through the liquid discharge hose. During the process of discharging the medicine liquid, the squeezing device is rotated at the same time to squeeze out the residual medicine liquid in the medicine bag. After the medicine liquid is discharged, the pressure relief valve is opened, the pressure is reduced to atmospheric pressure, the medicine bag is taken out by opening the handle, the power is turned off, and the machine is cleaned for standby.

[0035] In a third aspect, the present application provides the use of the traditional Chinese medicine composition of the first aspect or the traditional Chinese medicine composition prepared by the preparation method of the second aspect in the preparation of a medicament for treating chronic atrophic gastritis.

[0036] In a preferred embodiment, the medicament treats stomach pain, fullness, poor appetite, and stomach rumbling caused by spleen and stomach qi deficiency, blood stasis, and mutual formation of dampness and toxicity in patients with chronic atrophic gastritis.

[0037] In a more preferred embodiment, the medicament improves the pathological morphology of the stomach tissue, increases the expression of PG I, and the ratio of PGI / PG II, reduces the level of inflammatory factors, and improves the degree of gastric mucosa atrophy.

[0038] In another preferred embodiment, the medicament is in a solid form, a semi-solid form, or a liquid form.

[0039] In another preferred embodiment, the medicament is a decoction, a powder, a liquid for oral administration, a paste, a granule, a tablet or a capsule.

[0040] In another preferred embodiment, the medicament is a decoction, a granule, a tablet, a liquid for oral administration or a capsule.

[0041] In another preferred embodiment, the medicament is a decoction or a granule.

[0042] Preferably, the medicament is a granule.

[0043] The analysis of the prescription of the traditional Chinese medicine composition according to the present application is as follows:

[0044] Codonopsis pilosula (Franch.) Nannf., Codonopsis pilosula Nannf. var. modesta (Nannf.) L.T. Shen or Codonopsis tangshen Oliv. of the family Spermatophyta, Solanaceae. It is sweet in taste and flat in nature. It is attributed to the spleen and lung meridians. It has the effects of tonifying the center, benefiting qi, producing fluid, benefiting the lung, etc.

[0045] Fried Atractylodes Rhizome, which is the rhizome of Atractylodes macrocephala Koidz. of the family Spermatophyta, Asteraceae. During processing, bran is first spread in a hot pan, and when smoke is emitted, the Atractylodes Rhizome slices are poured into the pan and lightly fried until they are light yellow. After being removed from the pan, the bran is sieved out and the Atractylodes Rhizome is allowed to cool. It is warm in nature and sweet and bitter in taste. It is attributed to the spleen and stomach meridians. It strengthens the spleen, benefits qi, dries dampness, promotes water excretion, stops sweating and ensures fetal development. It is a tonic for deficiency and belongs to the category of qi-tonifying drugs. It is used to treat deficiency of the spleen and stomach, loss of appetite, fatigue and shortness of breath, and phlegm retention.

[0046] Pinellia Tuber, which is the tuber of Pinellia ternata (Thunb.) Breit. of the family Spermatophyta, Araceae. It is warm in nature and pungent in taste and toxic. It is attributed to the spleen, stomach and lung meridians. It has the effects of drying dampness, reducing phlegm, reducing adverse flow and stopping vomiting, and dissipating mass. It is a warm drug for transforming cold phlegm and belongs to the category of drugs for transforming phlegm and relieving cough and asthma.

[0047] Coptis Rhizome, which is the rhizome of Coptis chinensis Franch. of the family Spermatophyta, Ranunculaceae. It is cold in nature and bitter in taste. It is attributed to the heart, spleen, stomach, liver, gallbladder and large intestine meridians. It has the effects of clearing heat and drying dampness, purging fire and detoxifying. It is a heat-clearing and dampness-drying drug and belongs to the category of heat-clearing drugs. It is commonly used to treat damp-heat distention, vomiting and acid regurgitation, etc.

[0048] Poria cocos (Schw.) Wolf. The sclerotium of Poria cocos (Schw.) Wolf. It is neutral in nature and sweet in taste. It belongs to heart meridian, lung meridian, spleen meridian and kidney meridian. It has the effects of promoting water metabolism and removing dampness, and is used to treat dizziness and poor appetite due to phlegm-dampness.

[0049] Salvia miltiorrhiza Bge. It is slightly cold in nature and bitter in taste. It belongs to heart meridian and liver meridian. It has the effects of removing blood stasis, promoting blood circulation, and clearing heart and relieving restlessness.

[0050] Zingiber officinale Rosc. It is hot in nature and pungent in taste. It belongs to spleen meridian, stomach meridian, heart meridian, kidney meridian and lung meridian. It has the effects of warming middle energizer, dispersing cold, restoring yang, unblocking collaterals, and drying dampness and resolving phlegm. It is commonly used to treat cold pain in the abdomen, phlegm-dampness, and chronic indigestion.

[0051] Cyperus rotundus L. It is flat in nature and bitter, bitter, and slightly sweet in taste. It belongs to liver meridian and triple energizer. It has the effects of regulating qi and relieving depression, regulating menstruation and relieving pain, and is commonly used to treat liver and stomach disharmony, qi stagnation, chest and abdominal distension, and phlegm-dampness.

[0052] Actinidia chinensis Planch. It is sour and astringent in taste, and cool in nature. It belongs to lung, stomach and liver meridians. It has the effects of clearing heat and resolving toxins, expelling wind and dampness, and diuresis and hemostasis.

[0053] Glycyrrhiza uralensis Fisch. It is sweet in taste and flat in nature, and belongs to spleen meridian, stomach meridian and lung meridian. It is commonly used to treat spleen and stomach weakness, and poor appetite.

[0054] The party in the party is party, and the party is party. Party, improve the symptoms of CAG patients with spleen deficiency, poor appetite, and lazy speech. The root of the tree clears heat and detoxifies, expels wind and dampness, and promotes blood circulation and reduces swelling. It treats the anorexia and fullness caused by indigestion in CAG, and reduces the inflammation level of precancerous lesions of gastric cancer, and plays a role in anti-gastrointestinal tumors. The minister is poria cocos, salvia miltiorrhiza and cyperus rotundus. Among them, poria cocos can benefit water and dampness, and can be used with party to improve the water and dampness. The spleen qi rises, achieving the purpose of spleen, qi and water. Salvia miltiorrhiza and cyperus rotundus are used together to regulate qi, promote blood circulation and relieve pain, and treat the symptoms of stomach pain in CAG. And the auxiliary medicine is ginger, coptis, fried atractylodes and law half summer. Coptis can clear heat and dry dampness, and can be used with poria cocos and fried atractylodes to intervene in the mutual knotting of dampness and toxicity in CAG. Ginger is hot and pungent, and can be used with coptis, salvia miltiorrhiza and tree root to eliminate dampness and toxicity. The combination of ginger and coptis has the meaning of "pungent opening and bitter descending", which can eliminate fullness and stomach pain. Law half summer can play the role of drying dampness, reducing phlegm, reducing vomiting, and eliminating phlegm. It can treat the water and dampness retention in the stomach caused by spleen and stomach qi deficiency in CAG patients, and then appear stomach pain and fullness. Fried licorice is the whole party. It can tonify the spleen and stomach, and harmonize various drugs. The whole party can tonify the spleen and stomach, regulate qi and blood, and resolve dampness and toxicity. The whole party can treat the "spleen and stomach qi deficiency, qi stagnation and blood stasis, and mutual knotting of dampness and toxicity" of CAG patients, and can achieve the effects of "tonifying the spleen and stomach, regulating qi and blood, and resolving dampness and toxicity".

[0055] Compared with the prior art, the present application has the following beneficial effects:

[0056] 1. The traditional Chinese medicine composition provided by the present application can intervene in the "qi stagnation and blood stasis-mutual knotting of dampness and toxicity" complex pathogenesis in multiple dimensions, effectively improve the PG I / PG II ratio, and has a synergistic effect. In addition, the present application can improve the regulation efficiency of TNF-α, IL-6 and other inflammatory factors in gastric tissue. In addition, the present application can form a protective mechanism for intestinal metabolism by introducing party-part-white atractylodes.

[0057] 2. The traditional Chinese medicine composition provided by the present application can intervene in chronic atrophic gastritis by tonifying the spleen and stomach, regulating qi and blood, and resolving dampness and toxicity, improve the pathological morphology of gastric tissue, improve the expression of PG I and the ratio of PG I / PG II, reduce the level of inflammatory factors, and improve the degree of gastric mucosa atrophy. It is used for treating stomachache, fullness, anorexia, and stomach upset caused by spleen and stomach qi deficiency, qi stagnation and blood stasis, and mutual knotting of dampness and toxicity in chronic atrophic gastritis, and is especially suitable for chronic atrophic gastritis with the above symptoms. BRIEF DESCRIPTION OF DRAWINGS

[0058] Figure 1 The results of HE staining of the gastric tissue of each group of mice are shown in the following table. DETAILED DESCRIPTION

[0059] In order to make the person skilled in the art better understand the technical scheme of the present application, the technical scheme of the present application will be further described in detail below in combination with the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor should belong to the scope of protection of the present application.

[0060] It should be noted that the embodiments in the present application and the features in the embodiments can be combined with each other without conflict. The present application will be described in detail below in combination with the embodiments.

[0061] Embodiment 1:

[0062] A traditional Chinese medicine composition for treating chronic atrophic gastritis, comprising: Dangshen 15g, fried Baizhu 10g, Fabaixia 9g, Huanglian 6g, Fuling 10g, Danshen 15g, Ganjiang 6g, Xiangfu 10g, Tengshugan 10g, Zhigancao 3g, total amount: 94g.

[0063] The preparation method of the above traditional Chinese medicine composition is as follows:

[0064] The crude drugs of raw Dangshen, fried Baizhu, Fabaixia, Huanglian, Fuling, Danshen, Ganjiang, Xiangfu, Tengshugan and Zhigancao are crushed into fine powder, and 500mL of distilled water is added for decoction. After 1.5 hours of first decoction, the first filtrate is obtained by filtration. The filter residue is added with 500mL of distilled water for decoction, and the second filtrate is obtained by filtration after 1.5 hours of decoction. The first filtrate and the second filtrate are combined and concentrated to 60mL under reduced pressure.

[0065] Embodiment 2:

[0066] A traditional Chinese medicine composition for treating chronic atrophic gastritis, comprising: Dangshen 10g, fried Baizhu 8g, Fabaixia 6g, Huanglian 4g, Fuling 10g, Danshen 8g, Ganjiang 5g, Xiangfu 8g, Tengshugan 10g, Zhigancao 3g, total amount: 72g.

[0067] Embodiment 3:

[0068] A traditional Chinese medicine composition for treating chronic atrophic gastritis, comprising: Dangshen 50g, fried Baizhu 5g, Fabaixia 5g, Huanglian 4g, Fuling 30g, Danshen 12g, Ganjiang 3g, Xiangfu 15g, Tengshugan 20g, Zhigancao 1g, total amount: 135g.

[0069] Embodiment 4:

[0070] A traditional Chinese medicine composition for treating chronic atrophic gastritis, comprising: 30g of radix codonopsis, 20g of fried atractylodes, 6g of prepared pinellia, 2g of coptis, 40g of poria, 10g of salvia miltiorrhiza, 3g of dried ginger, 5g of cyperus, 10g of kadsura, 4g of baked licorice, and the total amount is 130g.

[0071] Example 5:

[0072] A traditional Chinese medicine composition for treating chronic atrophic gastritis, comprising: 20g of radix codonopsis, 15g of fried atractylodes, 10g of prepared pinellia, 8g of coptis, 30g of poria, 10g of salvia miltiorrhiza, 3g of dried ginger, 5g of cyperus, 15g of kadsura, 2g of baked licorice, and the total amount is 118g.

[0073] Comparative example:

[0074] A traditional Chinese medicine composition for treating chronic atrophic gastritis, comprising: 9g of prepared pinellia, 9g of radix scrophulariae, 9g of dried ginger, 20g of radix codonopsis, 9g of baked licorice, 6g of coptis, 9g of jujube, and the total amount is 72g.

[0075] Western medicine group:

[0076] Folic acid tablets 10mg (main ingredient is folic acid, purchased from Changzhou Pharmaceutical Factory Co., Ltd., production batch number 21061111).

[0077] Test example:

[0078] To prove that the traditional Chinese medicine composition of the present application has a positive effect on the treatment of chronic atrophic gastritis. The inventors used the traditional Chinese medicine composition of the above examples and comparative examples, and the western medicine group to conduct animal experiments, as follows:

[0079] 1. Experimental animals

[0080] 6-8 week old, male, Balb / c mice weighing 18-22g were selected from Beijing Weitong Lihua Experimental Animal Technology Co., Ltd. [License No.: SCXK (Jing) 2021-0006]. The mice were placed in a controlled environment of 21-25℃ and 40-50% humidity, with a light cycle of 12 hours for 7 consecutive days. These animals can drink water freely and eat normally. The animal facility was provided by the Institutional Animal Care and Use Committee of Unimedic (Beijing) Pharmaceutical Technology Co., Ltd. (Approval No.: SYXK2024-0003). The animal program was approved by the China Academy of Chinese Medical Sciences Guang'anmen Hospital (Approval No.: IACUC-GAMH-2025-015).

[0081] 2. Construction of chronic atrophic gastritis model in mice

[0082] Balb / c mice were continuously given 2% sodium salicylate solution and 20 mmol / L sodium deoxycholate solution, which were routinely prepared with distilled water, prepared daily, and used immediately, 200 μL per mouse per time, given by gavage every day, for a total of 16 weeks.

[0083] 3. Experimental animal grouping and intervention

[0084] After 7 days of adaptive feeding in the SPF mouse animal laboratory (barrier environment), the Balb / c mice were randomly divided into 6 groups (n = 6 per group): blank group, model group, Example 1 group, Example 2 group, comparative example group, and western medicine group. The 6 groups of mice were given 2% sodium salicylate solution and 20 mmol / L sodium deoxycholate solution by gavage for 16 weeks. After the 16th week, 3 mice were randomly selected for gastric tissue pathological staining to evaluate the atrophy of the gastric mucosa and determine the success of modeling. After that, the mice in the Example 1-2, comparative example, and western medicine groups were given high-fat feed and gavage administration.

[0085] Example 1 group: The radix codonopsis, fried atractylodes, prepared pinellia, coptis, poria, salvia, dried ginger, cyperus rotundus, smilax china, and licorice were dosed according to the human-mouse conversion factor, and the total amount of medicine needed for each mouse (n = 6) for 28 days was obtained. On this basis, 20% of the loss of drug amount was added, and the final drug amount was calculated. Taking the body weight of a human as 70 kg and the body weight of a mouse as 0.03 kg, the conversion factor was 12.33. The mice in each group (6 mice) needed gavage administration for 28 days, and the total amount of crude drug needed for Example 1 was calculated to be radix codonopsis 90.72 g, fried atractylodes 60.48 g, prepared pinellia 54.432 g, coptis 36.288 g, poria 60.48 g, salvia 90.72 g, dried ginger 36.288 g, cyperus rotundus 60.48 g, smilax china 60.48 g, and licorice 18.144 g. After decoction and concentration, the volume of the solution was 60.48 mL (0.3 mL of gavage amount per mouse per day, 6 mice per group, a total of 28 days of gavage, so the total volume of the concentrated solution was 60.48 mL).

[0086] The mice in the Example 2 group and the comparative example group were administered the same amount of medicine as the mice in the Example 1 group.

[0087] Western medicine group: After the medicine was ground, the same human-mouse body weight conversion rule was followed, and a 20% loss was added to the calculation. A total of 10.65 g of atorvastatin calcium tablet powder was weighed, the powder was dissolved in 60.48 mL of normal saline, and the solution was obtained by ultrasonic dissolution for standby use.

[0088] The normal control group and the model control group of mice were given the same volume (0.3 mL) of normal saline by gavage every day for 4 consecutive weeks. The specific feeding and administration scheme is shown in Table 1.

[0089] Table 1. Modeling and intervention of mice in each group

[0090]

[0091] 4. Detection index and statistical analysis method

[0092] 4.1 Sampling

[0093] After 4 weeks of administration, the mice in each group were fasted for 12 h without water, and blood was taken from the eyeball before the mice recovered from anesthesia. The whole blood sample was allowed to stand at 4°C for 1-2 h, and then centrifuged at 2500 rpm for 20 min in a pre-cooled 4°C centrifuge. The supernatant after centrifugation was transferred to a 1.5 mL EP tube and stored in a -20°C freezer for testing.

[0094] The mouse abdominal cavity was opened, the intestine and pancreas were removed, and the stomach was exposed. The stomach was cut at the upper and lower ports, and the stomach tissue was cut along the lesser curvature. The stomach contents were washed with 5 mL of pre-cooled normal saline. After washing, the stomach tissue was photographed, and then the sample was fixed in 4% paraformaldehyde for later pathological staining.

[0095] 4.2 H-E staining results of mouse gastric mucosa tissue

[0096] After routine dehydration of the fixed stomach tissue, paraffin embedding was performed, and 5 pm thick tissue sections were continuously cut at the gastric antrum. After plate washing and plate drying, the sections were sequentially placed in xylene I, xylene II, anhydrous ethanol, 90% alcohol, 80% alcohol, 70% alcohol, and then washed with water. After staining with hematoxylin staining solution, washing, differentiation, washing, counterstaining, and washing, the sections were sequentially placed in 70%, 80%, 95%, and anhydrous ethanol for stepwise dehydration, and then placed in eosin staining solution for staining. The sections were sequentially placed in anhydrous ethanol for dehydration, xylene for transparency, and neutral balsam for mounting. The morphology of the mucosal epithelium, gastric glands, chief cells, parietal cells, and mucosal muscle layer was observed under a microscope, and images were collected.

[0097] 4.3 Gastric tissue atrophy and inflammation score

[0098] The atrophy and inflammation of the antral tissue were scored according to the severity, with scores of 0, 1, 2, and 3, respectively. The specific scoring criteria are shown in Table 2.

[0099] Table 1 Gastric tissue lesion scoring criteria

[0100]

[0101] 4.4 Detection of serum inflammatory factor levels

[0102] According to the detection kit of IL-1β and TGF-β, according to the enzyme linked immunosorbent assay (ELISA) kit instructions, dilute the standard, sample, incubate, liquid preparation, washing, enzyme, incubation, washing, color development, after stopping, use the enzyme label instrument at 450 nm wavelength, in turn measure the absorbance value of each well, according to the standard concentration and absorbance value make the standard curve, finally according to the standard curve equation to calculate the concentration of mouse serum IL-6, TGF-β.

[0103] 4.5 Detection of serum PG I, PG II and G-17

[0104] According to the ELISA detection kit of PG I, PG II and G-17, the serum PG I, PG II and G-17 levels of mice in each group were determined, and the PG I / PG II ratio was calculated.

[0105] 4.6 Statistical analysis

[0106] The heart ultrasound and protein data were statistically analyzed using SPSS 24.0 version software. First, it was determined whether it was normally distributed. The data that met the normal distribution were subjected to one-way ANOVA, and the homogeneity of variance test was performed. In the case of homogeneity of variance, Bonferroni test was used, while in the case of incomplete homogeneity of variance, Dunnett test was used for non-parametric test. When P<0.05, it was considered that there was a significant difference in the experimental results.

[0107] 5. Experimental results

[0108] (1) HE staining of gastric tissue of mice in each group

[0109] Figure 1 Among them, the gastric tissue of mice in the blank control group was arranged in order, and there was no inflammatory cell infiltration. The gastric tissue of mice in the model control group was arranged unevenly, the nucleus-cytoplasm ratio was abnormal, the mucosal epithelium almost disappeared, the number of chief cells and parietal cells decreased, and the number of intrinsic glands decreased by more than 2 / 3. In the example 1 group and the example 2 group, the gastric glands were relatively arranged more evenly, the nucleus-cytoplasm ratio was normal, and the mucosal epithelium was visible. The gastric glands of the comparison example and the western medicine group were arranged unevenly, the nucleus-cytoplasm ratio was abnormal, and the mucosal epithelium of the western medicine group was significantly reduced.

[0110] (2) Atrophy and inflammation score of gastric tissue of mice in each group

[0111] The statistical results of the atrophy and inflammation score of the gastric tissue of mice in each group are shown in Table 3.

[0112] Table 3 Atrophy and inflammation score of gastric tissue of mice

[0113]

[0114] Note: ** : P<0.01 compared with the blank group; * : P<0.05 compared with the blank group; △△ : P<0.01 compared with the model group; △ : P<0.05 compared with the model group; ##: P<0.01 compared with the control group; #: P<0.05 compared with the control group; ※※: P<0.01 compared with the western medicine group; ※: P<0.05 compared with the western medicine group.

[0115] In Table 3, compared with the blank control group, the atrophy score of the stomach tissue of the model control group mice was significantly increased (P<0.01). Compared with the model control group, the control group and the western medicine group, the atrophy score of the stomach tissue of the mice in the Example 2 group was significantly reduced (P<0.05), indicating that the Example 2 group had a better effect on improving the atrophy score of the stomach tissue of the mice.

[0116] As for the inflammation score of the stomach tissue, compared with the blank control group, the inflammation score of the stomach tissue of the mice in the model control group, the control group and the western medicine group was significantly increased (P<0.01). The inflammation score of the stomach tissue of the mice in the Example 1 group had no statistically significant difference compared with the blank control group. The inflammation score of the stomach tissue of the mice in the Example 2 group was significantly reduced compared with the model control group (P<0.01). It is indicated that the traditional Chinese medicine compositions of Examples 1 and 2 have a certain effect on improving the inflammation of the stomach tissue, and the effect of the Example 2 group is better.

[0117] (3) Serum inflammatory factor levels of mice in each group

[0118] The results of the serum inflammatory factor levels of mice in each group are shown in Table 4.

[0119] Table 4 Serum inflammatory factor levels of mice

[0120]

[0121] Note: ** : P<0.01 compared with the blank group; * : P<0.05 compared with the blank group; △△ : P<0.01 compared with the model group; △ : P<0.05 compared with the model group; ##: P<0.01 compared with the control group; #: P<0.05 compared with the control group; ※※: P<0.01 compared with the western medicine group; ※: P<0.05 compared with the western medicine group.

[0122] From Table 4, compared with the blank control group, the serum proinflammatory factor IL-1β level of the model control group mice was significantly increased (P<0.01). The serum IL-1β of the mice in Example 1 and Example 2 groups was significantly lower than that of the model control group (P<0.01). The serum IL-1β of the mice in the comparative example group and the western medicine group was also lower than that of the model control group (P<0.05), but compared with the blank control group, the serum IL-1β of the mice in the comparative example group and the western medicine group was significantly increased (P<0.01). Compared with the comparative example group and the western medicine group, the serum IL-1β of the mice in Example 2 group was significantly reduced (P<0.01, P<0.05).

[0123] Compared with the blank control group, the serum anti-inflammatory factor TGF-β of the model control group mice was significantly reduced (P<0.01). Compared with the model control group, the serum TGF-β of the mice in Example 1 and Example 2 groups was significantly increased (P<0.01), and there was no statistically significant difference compared with the blank control group, and the serum TGF-β of the mice in the comparative example group and the western medicine group was significantly increased (P<0.01). It is proved that the anti-inflammatory effect of Example 1 and Example 2 groups is better, and the anti-inflammatory effect of Example 2 is better.

[0124] (4) Serum PGI and PG II levels of mice in each group

[0125] Pepsinogen (PG) is the precursor of pepsin, which can be divided into PGI and PGII according to biochemical properties and immunogenicity. PGI is secreted by the chief cells of the corpus and fundus (near the abdominal end), and is a biomarker of the corpus. It has a positive feedback relationship with gastric acid. When the corpus atrophies, the acid-secreting glands decrease, the stomach is in a low acid state, and PGI decreases. PGI and PGII are excellent indicators for the auxiliary diagnosis of corpus mucosa atrophy. The 2014 Chinese Consensus on Early Gastric Cancer Screening and Endoscopic Diagnosis and Treatment pointed out that the decrease of PGI concentration and / or pepsinogen ratio PGR (PGI / PGII) has a hint effect on atrophic gastritis. The serum PGI and PGII levels of mice in each group are shown in Table 5.

[0126] Table 5 Serum PGI and PGII levels of mice

[0127]

[0128] Note: ** : P<0.01 compared with the blank group; * : P<0.05 compared with the blank group; △△ : P<0.01 compared with the model group; △: P<0.05 compared with the model group; ##: P<0.01 compared with the comparative example; #: P<0.05 compared with the comparative example; ※※: P<0.01 compared with the western medicine group; ※: P<0.05 compared with the western medicine group.

[0129] The above experimental results demonstrate that, compared with the blank control group, the serum PGI, PGII and PGR levels of the model control group of mice are significantly reduced (P<0.01), indicating the occurrence of atrophic gastritis. Compared with the model control group, the PGI and PGR of the example 1, 2, comparative example group and western medicine group are significantly increased (P<0.01). Among them, the PGI, PGII and PGR levels of the example 1 and 2 groups have the largest increase, and the difference is statistically significant compared with the comparative example group and the western medicine group (P<0.01). As for PGR, compared with the blank control group, the serum PGR ratio of the model control group, the comparative example group and the western medicine group is significantly reduced (P<0.01), and the difference between the example 1 and 2 groups and the blank control group is not statistically significant. However, compared with the model group, the PGR ratio of the example 1, 2, comparative example group and western medicine group is significantly increased (P<0.01), among which the example 1 and 2 groups have the most obvious increase, and the difference is statistically significant compared with the comparative example group and the western medicine group (P<0.01). It is indicated that the example 1 and 2 have better effect on improving the serum PGI, PGII and PGR of atrophic gastritis markers.

[0130] (5) Serum G-17 levels of mice in each group

[0131] Gastrin-17 (G-17) is only secreted by G cells in the antrum, and its secretion is mainly affected by gastric pH, G cell number and food intake. It is a sensitive indicator reflecting antral secretion function, and is used for screening and diagnosing atrophic gastritis and gastric cancer. In atrophic corpus, acid-secreting glands are reduced, and the stomach is in a low acid state, leading to an increase in G-17 levels. The serum G-17 levels of mice in each group are shown in Table 6.

[0132] Table 6 Serum G-17 levels of mice

[0133]

[0134] Notes: ** : P<0.01 compared with the blank group; * : P<0.05 compared with the blank group; △△ : P<0.01 compared with the model group; △ : P<0.05 compared with the model group; ##: P<0.01 compared with the comparative example; #: P<0.05 compared with the comparative example; ※※: P<0.01 compared with the western medicine group; ※: P<0.05 compared with the western medicine group.

[0135] The experimental results prove that compared with the blank control group, the serum G-17 level of the model control group mice is significantly increased, which indicates that the gastric atrophy occurs. After the intervention of Example 1 and 2, compared with the model control group, the G-17 level is significantly reduced (P<0.01), and there is no statistically significant difference compared with the blank group. Although the serum G-17 of the comparative example group and the western medicine group is significantly reduced compared with the model group (P<0.01), it is still significantly increased compared with the blank group (P<0.01). And the serum G-17 level of the mice in Example 1 and 2 groups is significantly reduced compared with the serum G-17 level of the mice in the comparative example group and the western medicine group (P<0.01).

[0136] In summary, the traditional Chinese medicine composition provided by the present application can intervene in chronic atrophic gastritis by improving the pathological morphology of gastric tissue, increasing the expression of PG I, reducing the level of inflammatory factors, improving the degree of gastric mucosal atrophy, and treating stomachache, fullness, poor appetite, stomach rumbling and other symptoms caused by spleen and stomach qi deficiency, blood stasis and dampness and toxin accumulation.

[0137] The specific embodiments are only an explanation of the present application, and are not a limitation of the present application. Those skilled in the art can make modifications to the embodiments without creative contribution after reading the specification, and the modifications are protected by the patent law as long as they are within the scope of the claims of the present application.

Claims

1. A traditional Chinese medicine composition for treating chronic atrophic gastritis, characterized in that, The traditional Chinese medicine composition is composed of the following raw medicinal materials by weight: 10-30 parts of radix codonopsis, 10-20 parts of fried atractylodes, 5-10 parts of prepared rhizoma pinelliae, 2-8 parts of coptis, 8-30 parts of poria, 10-15 parts of salvia miltiorrhiza, 3-6 parts of dried ginger, 5-15 parts of cyperus rotundus, 10-20 parts of smilax riparia, and 1-5 parts of fried licorice.

2. The traditional Chinese medicine composition for treating chronic atrophic gastritis according to claim 1, characterized in that, The traditional Chinese medicine composition is composed of the following raw medicinal materials by weight: 10-20 parts of radix codonopsis, 8-10 parts of fried atractylodes, 6-9 parts of prepared rhizoma pinelliae, 4-6 parts of coptis, 8-12 parts of poria, 10-15 parts of salvia miltiorrhiza, 5-6 parts of dried ginger, 8-12 parts of cyperus rotundus, 12-15 parts of smilax riparia, and 2-3 parts of fried licorice.

3. The traditional Chinese medicine composition for treating chronic atrophic gastritis according to claim 1, characterized in that, The traditional Chinese medicine composition is composed of the following raw medicinal materials by weight: 15 parts of radix codonopsis, 10 parts of fried atractylodes, 9 parts of prepared rhizoma pinelliae, 6 parts of coptis, 10 parts of poria, 15 parts of salvia miltiorrhiza, 6 parts of dried ginger, 10 parts of cyperus rotundus, 10 parts of smilax riparia, and 3 parts of fried licorice.

4. The Chinese medicine composition for treating chronic atrophic gastritis according to claim 1, characterized in that, The traditional Chinese medicine composition is composed of the following raw medicinal materials by weight: 10 parts of radix codonopsis, 8 parts of fried atractylodes, 6 parts of prepared rhizoma pinelliae, 4 parts of coptis, 10 parts of poria, 8 parts of salvia miltiorrhiza, 5 parts of dried ginger, 8 parts of cyperus rotundus, 10 parts of smilax riparia, and 3 parts of fried licorice.

5. A method for preparing the traditional Chinese medicine composition for treating chronic atrophic gastritis according to any one of claims 1-4, characterized in that, It comprises: The raw materials in the traditional Chinese medicine composition are weighed by weight parts, and extracted 2-3 times with an extraction solvent for 1-3 hours each time. The extraction liquid is filtered and concentrated to obtain a concentrated liquid.

6. The production method according to claim 5, characterized by, It further comprises: Before extraction, the raw materials are subjected to a pretreatment step, which comprises soaking and / or crushing.

7. The preparation method according to claim 5, characterized in that, The extraction solvent is water.

8. The preparation method according to claim 5, characterized in that, The concentrated liquid is added or not added with excipients to prepare a medicine in solid form, semi-solid form or liquid form. The dosage form of the medicine is decoction pieces, decoction, powder, oral liquid, ointment, granules, tablets or capsules.

9. Use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a medicine for treating chronic atrophic gastritis.

10. Use according to claim 9, characterized in that, The syndrome type of the chronic atrophic gastritis is stomachache, fullness, poor appetite and stomach noises caused by spleen-stomach qi deficiency, qi stagnation and blood stasis, or mutual formation of dampness and toxic substances.

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