Traditional Chinese medicine composition for treating chronic atrophic gastritis and preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating chronic atrophic gastritis and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition is prepared from the following components in parts by mass: 12 to 18 parts of herba dendrobii, 12 to 18 parts of cassia twig, 12 to 18 parts of radix pseudostellariae, 8 to 12 parts of radix ophiopogonis, 15 to 25 parts of radix salviae miltiorrhizae, 3 to 7 parts of aspongopus, 8 to 12 parts of rhizoma corydalis, 8 to 12 parts of fingered citron, 2 to 4 parts of rhizoma coptidis, 2 to 4 parts of fructus evodiae and 5 to 7 parts of liquorice root. Clinical experiments show that the traditional Chinese medicine composition prepared by the invention has a good treatment effect on patients suffering from spleen and stomach yin-yang deficiency and stomach collateral stasis type CAG, can improve the pathological reversion rate of gastric mucosa of the patients, has a total effective rate of 82.1%, and has a wide clinical application prospect.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for treating chronic atrophic gastritis, a preparation method thereof, and an application thereof. Background Art

[0002] Chronic Atrophic Gastritis (CAG) is a common disease in the digestive system, characterized by the atrophy of gastric mucosal glands and intestinal metaplasia, and belongs to the categories of "stomach stuffiness" and "epigastric pain" in traditional Chinese medicine. Traditional Chinese medicine believes that its pathogenesis is based on the weakness of the spleen and stomach, accompanied by such secondary syndromes as qi stagnation, blood stasis, and damp-heat, often manifested as a mixture of deficiency and excess, and imbalance between yin and yang. However, existing therapeutic drugs mostly have the defect of single tonifying deficiency or focusing on a certain pathological link, resulting in limited curative effects and easy recurrence.

[0003] For example, CN105749199A discloses a traditional Chinese medicine prescription for warming the middle-jiao and strengthening the spleen, mainly composed of aconite and codonopsis pilosula. Although it can improve spleen and stomach yang deficiency and cold, it lacks yin-nourishing components, and long-term use is likely to cause dryness-heat to damage yin, aggravating yin deficiency symptoms such as dry mouth and constipation.

[0004] CN104127758A discloses a traditional Chinese medicine composition that nourishes yin with dendrobium officinale and yam, and supplements digestion with hawthorn and malt, but lacks yang-warming drugs, and has poor curative effects on CAG of the spleen and stomach yang deficiency type.

[0005] CN104056172A discloses a traditional Chinese medicine composition containing warm-middle-jiao and cold-dispersing components such as cinnamon and evodia rutaecarpa, but compatibility with heat-clearing and blood-activating drugs such as coptis chinensis and salvia miltiorrhiza may exacerbate the yin and yang deficiency of patients with intermingled cold and heat.

[0006] Therefore, based on the defects of existing drugs, it is necessary to provide a new traditional Chinese medicine composition with the comprehensive curative effect of "warming yang without damaging yin, nourishing yin without hindering the spleen" to provide a new strategy for the treatment of CAG. Summary of the Invention

[0007] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating chronic atrophic gastritis, a preparation method thereof, and an application thereof, with the therapeutic principles of "benefiting the stomach and warming the middle-jiao, tonifying both yin and yang, and activating blood circulation and dredging collaterals", so as to provide a new drug for the treatment of chronic atrophic gastritis.

[0008] In order to achieve the above-mentioned invention purpose, the present invention provides the following technical solutions:

[0009] The present invention provides a traditional Chinese medicine composition for treating chronic atrophic gastritis, comprising the following components in parts by mass: 12-18 parts of dendrobium officinale, 12-18 parts of cassia twig, 12-18 parts of pseudostellaria heterophylla, 8-12 parts of ophiopogon japonicus, 15-25 parts of salvia miltiorrhiza, 3-7 parts of asopongopus japonicus, 8-12 parts of Corydalis yanhusuo, 8-12 parts of fingered citron, 2-4 parts of coptis chinensis, 2-4 parts of evodia rutaecarpa, and 5-7 parts of liquorice.

[0010] The invention provides a method for preparing the Chinese medicine composition, which comprises mixing the Chinese medicine components in the formula amount with water, decocting the mixture, separating the solid from the liquid, and collecting the liquid part to obtain the Chinese medicine composition.

[0011] Preferably, the mass volume ratio of the traditional Chinese medicine component and water when mixed is 0.8-1.2 g:5-15 ml.

[0012] Preferably, the decocting time is 20 to 40 minutes.

[0013] The present invention provides an application of the Chinese medicine composition or the Chinese medicine composition obtained by the method in preparing a medicine for treating chronic atrophic gastritis.

[0014] Preferably, the chronic atrophic gastritis is chronic atrophic gastritis of the spleen and stomach yin and yang deficiency and stomach collateral stasis type.

[0015] The present invention provides a medicine for treating chronic atrophic gastritis, wherein the medicine comprises the traditional Chinese medicine composition or the traditional Chinese medicine composition obtained by the method.

[0016] Preferably, the medicine further comprises pharmaceutical excipients.

[0017] Among the components added by the present invention: Dendrobium officinale is sweet, slightly cold, enters the stomach and kidney meridians, benefits the stomach and produces body fluid, nourishes yin and clears heat, is a yin-nourishing product, replenishes stomach yin to nourish the stomach body, and "Supplement to Compendium of Materia Medica" says that it "clears the stomach and eliminates deficiency heat, produces body fluid, and has relieved fatigue."

[0018] Cinnamon twig is pungent, sweet and warm in nature. It enters the heart, lung and bladder meridians, warms and circulates Yang Qi, and can help stomach Yang to move the spleen. "Jingyue Complete Works" says, "Those who are good at replenishing Yang must seek Yang in Yin, so that Yang can be helped by Yin and its vitality is endless; those who are good at replenishing Yin must seek Yin in Yang, so that Yin can be raised by Yang and its source is inexhaustible."

[0019] Pseudostellariae Radix, with a neutral nature, sweet and slightly bitter taste, can invigorate qi and strengthen the spleen, produce fluid and moisten the lungs. Radix Ophiopogonis, with a sweet and slightly bitter nature, slightly cold, can nourish yin and produce fluid, moisten the lungs and clear the heart. Radix Salviae Miltiorrhizae, can invigorate blood circulation and remove blood stasis. Rhizoma Corydalis, can regulate qi and relieve pain, warm the kidney and boost yang. Rhizoma Corydalis, can invigorate blood circulation, promote qi and relieve pain. Rhizoma Cibotii, can soothe the liver and regulate qi, harmonize the stomach and relieve pain.

[0020] Coptis chinensis is cold in nature, clears away heat and dampness, and relieves fire and detoxifies. Compendium of Materia Medica records that Coptis chinensis "treats stagnation of heat in the middle, irritability and nausea". Evodia rutaecarpa "warms the middle and lowers qi, relieves pain".

[0021] Licorice is sweet and neutral in nature. It enters the heart, lung, spleen, and stomach meridians. It can tonify the spleen and replenish qi, clear away heat and detoxify, and harmonize various medicines.

[0022] The present invention provides a traditional Chinese medicine composition for treating chronic atrophic gastritis according to the therapeutic principles of "nourishing the stomach and warming the middle energizer, tonifying both yin and yang, promoting blood circulation and dredging collaterals". The traditional Chinese medicine composition uses dendrobium and cassia twig as the monarch drugs; the yang of cassia twig and the yin of dendrobium interact with each other, reflecting the mutual rooting of yin and yang, achieving the wonderful effect of mutual generation and transformation of yin and yang, and jointly targeting the imbalance of yin and yang in the stomach to restore the normal physiological function of the stomach. Use pseudostellaria root, ophiopogon root, salvia miltiorrhiza, ascaridole, Corydalis yanhusuo, and fingered citron as ministerial drugs; pseudostellaria root and ophiopogon root assist dendrobium in nourishing yin and nourishing the stomach, supplementing stomach yin, and strengthening the power of nourishing yin; salvia miltiorrhiza, ascaridole, Corydalis yanhusuo, and fingered citron assist cassia twig in warming and dredging yang qi, promoting qi and blood circulation, and assisting the transportation of stomach yang; the combination of drugs for nourishing yin and warming yang, promoting qi and activating blood circulation in the ministerial drugs not only helps the monarch drugs to enhance the power of nourishing yin and warming yang, but also realizes the simultaneous regulation of qi and blood on the basis of the mutual rooting of yin and yang. Use coptis chinensis and evodia rutaecarpa as assistant drugs; coptis chinensis prevents the warm drugs such as cassia twig from helping heat and injuring yin, and at the same time clears the stagnant heat in the stomach; evodia rutaecarpa helps cassia twig to warm the stomach yang, and can also restrict the excessive bitterness and cold of coptis chinensis to prevent yang injury. Use licorice as the guiding drug, and the sweetness of licorice can reconcile the biases of yin and yang of various drugs, making the whole prescription nourish yin without being greasy and warm yang without being dry, enabling the drugs to play a synergistic role, reflecting the overall concept of balanced regulation of yin and yang.

[0023] Through clinical experiments, it is found that the traditional Chinese medicine composition prepared by the present invention has a good therapeutic effect on patients with CAG of spleen and stomach yin-yang deficiency complicated with gastric collaterals stasis obstruction type, can improve the pathological reversal rate of the patient's gastric mucosa, and the total effective rate reaches 82.1%, having broad clinical application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only the embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained according to the provided drawings.

[0025] Figure 1 It is the KEGG enrichment pathway diagram in the experimental example. DETAILED DESCRIPTION OF THE INVENTION

[0026] The present invention provides a traditional Chinese medicine composition for treating chronic atrophic gastritis, including the following components in parts by mass: 12-18 parts of dendrobium, 12-18 parts of cassia twig, 12-18 parts of pseudostellaria root, 8-12 parts of ophiopogon root, 15-25 parts of salvia miltiorrhiza, 3-7 parts of ascaridole, 8-12 parts of Corydalis yanhusuo, 8-12 parts of fingered citron, 2-4 parts of coptis chinensis, 2-4 parts of evodia rutaecarpa, and 5-7 parts of licorice.

[0027] In the present invention, the traditional Chinese medicine composition preferably comprises the following components in parts by mass: 14-16 parts of dendrobium officinale, 14-16 parts of cassia twig, 14-16 parts of pseudostellaria heterophylla, 9-11 parts of ophiopogon japonicus, 18-22 parts of salvia miltiorrhiza, 4-6 parts of aspongopus, 9-11 parts of Corydalis yanhusuo, 9-11 parts of fingered citron, 2.5-3.5 parts of coptis chinensis, 2.5-3.5 parts of evodia rutaecarpa, and 5.5-6.5 parts of licorice root. More preferably, it comprises the following components in parts by mass: 15 parts of dendrobium officinale, 15 parts of cassia twig, 15 parts of pseudostellaria heterophylla, 10 parts of ophiopogon japonicus, 20 parts of salvia miltiorrhiza, 5 parts of aspongopus, 10 parts of Corydalis yanhusuo, 10 parts of fingered citron, 3 parts of coptis chinensis, 3 parts of evodia rutaecarpa, and 6 parts of licorice root.

[0028] The present invention provides a preparation method of the traditional Chinese medicine composition, which comprises mixing the traditional Chinese medicine components in a formula amount with water, decocting, separating the solid from the liquid, and collecting the liquid part to obtain the traditional Chinese medicine composition.

[0029] In the present invention, the mass-volume ratio of the traditional Chinese medicine components to water during mixing is 0.8-1.2 g: 5-15 ml, preferably 0.9-1.1 g: 8-12 ml, and more preferably 1 g: 10 ml.

[0030] In the present invention, the decocting time is 20-40 min, preferably 25-35 min, and more preferably 30 min.

[0031] The present invention provides an application of the traditional Chinese medicine composition or the traditional Chinese medicine composition obtained by the method in the preparation of a drug for treating chronic atrophic gastritis.

[0032] In the present invention, the chronic atrophic gastritis is chronic atrophic gastritis of the type of deficiency of both spleen and stomach yin and yang with stasis of gastric collaterals.

[0033] The present invention provides a drug for treating chronic atrophic gastritis, which comprises the traditional Chinese medicine composition or the traditional Chinese medicine composition obtained by the method.

[0034] In the present invention, the drug further comprises pharmaceutical excipients.

[0035] The technical solutions provided by the present invention will be described in detail below with reference to the examples, but they should not be construed as limiting the protection scope of the present invention.

[0036] Example 1

[0037] A traditional Chinese medicine composition for treating chronic atrophic gastritis is composed of the following components in parts by mass: 12 parts of dendrobium officinale, 12 parts of cassia twig, 12 parts of pseudostellaria heterophylla, 8 parts of ophiopogon japonicus, 15 parts of salvia miltiorrhiza, 3 parts of aspongopus, 8 parts of Corydalis yanhusuo, 8 parts of fingered citron, 2 parts of coptis chinensis, 2 parts of evodia rutaecarpa, and 5 parts of licorice root.

[0038] The preparation method of the Chinese medicine composition is as follows: the Chinese medicine components in the formula amount are mixed with water in a mass volume ratio of 1g:5ml, and then boiled for 20 minutes, solid-liquid separation is performed, and the liquid part is collected to obtain the Chinese medicine composition.

[0039] Example 2

[0040] A traditional Chinese medicine composition for treating chronic atrophic gastritis, comprising the following components in parts by mass: 18 parts of dendrobium, 18 parts of cinnamon twig, 18 parts of pseudostellaria, 12 parts of ophiopogon, 25 parts of salvia miltiorrhiza, 7 parts of schizonepeta tenuifolia, 12 parts of yanhusuo, 12 parts of citron, 4 parts of coptis root, 4 parts of evodia rutaecarpa, and 7 parts of liquorice.

[0041] The preparation method of the traditional Chinese medicine composition is as follows: the traditional Chinese medicine components in the formula amount are mixed with water in a mass volume ratio of 1g:15ml, and then boiled for 40 minutes, solid-liquid separation is performed, and the liquid part is collected to obtain the traditional Chinese medicine composition.

[0042] Example 3

[0043] A traditional Chinese medicine composition for treating chronic atrophic gastritis, comprising the following components in parts by mass: 15 parts of dendrobium, 15 parts of cinnamon twig, 15 parts of pseudostellaria, 10 parts of ophiopogon, 20 parts of salvia miltiorrhiza, 5 parts of schizonepeta tenuifolia, 10 parts of corydalis, 10 parts of citron, 3 parts of coptis root, 3 parts of evodia rutaecarpa, and 6 parts of liquorice.

[0044] The preparation method of the traditional Chinese medicine composition is as follows: the traditional Chinese medicine components in the formula amount are mixed with water in a mass volume ratio of 1g:10ml, and then boiled for 30 minutes, solid-liquid separation is performed, and the liquid part is collected to obtain the traditional Chinese medicine composition.

[0045] Experimental Examples Clinical and Experimental Studies on Chinese Medicine Compositions

[0046] 1. Clinical Research

[0047] 1. Case selection

[0048] Chronic atrophic gastritis (CAG) cases that met the inclusion criteria and were treated in the Affiliated Hospital of Shaanxi University of Chinese Medicine from March 2023 to March 2024 were collected. The patient's four diagnostic information was collected using the research case observation form developed in the early stage. According to the unified syndrome differentiation standard, only patients with consistent syndrome differentiation by two or more experienced Chinese medicine physicians could be included in the case group.

[0049] The GAG ​​patients who meet the inclusion criteria are CAG patients with spleen and stomach yin and yang deficiency and stomach collateral stasis type, with symptoms including: fullness or dull pain in the epigastric region, preference for pressing or warmth in the stomach, or burning pain in the epigastric region, dry mouth, loss of appetite, persistent stomach pain, fatigue, weakness, weight loss, pale or dark tongue or with petechiae and ecchymoses, and deep, thready, weak and astringent pulse.

[0050] 2. Clinical treatment

[0051] Twenty-four patients who met the criteria after screening were divided into two groups of 12 each. Twelve CAG patients in the treatment group orally took the Yin-Yang tonifying Weiyu Prescription (i.e., the traditional Chinese medicine composition prepared in Example 3), twice a day, 180 ml each time, taken separately in the morning and evening, with an interval of 1 hour from meals. Twelve CAG patients in the control group orally took folic acid tablets, three times a day, 5 mg each time. Three months was taken as a course of treatment, and a total of one course of treatment was observed. After the end of the course of treatment, symptom scoring, endoscopic efficacy evaluation and analysis of pathological changes were carried out.

[0052] Clinical experimental research shows that: the pathological reversal rate of gastric mucosa in the treatment group (improvement of OLGA / OLGIM stage ≥ 1 level) was 48.7%, significantly higher than that in the control group (28.2%) (P < 0.05); the total effective rate of traditional Chinese medicine syndromes (82.1% in the treatment group vs. 59.6% in the control group) was significantly different, and the difference in its efficacy compared with the control group was statistically significant (P < 0.05). Compared with before treatment, the traditional Chinese medicine composition prepared in Example 3 (Yin-Yang tonifying Weiyu Prescription) can not only significantly relieve symptoms but also improve the pathological state of gastric mucosa atrophy and intestinal metaplasia in clinical application.

[0053] Table 1 shows the comparison results of the pathological histology grading of gastric mucosa in the treatment group and the control group before and after treatment. It can be seen that the improvement of gastric mucosa inflammation, inflammatory activity and gland atrophy in the treatment group after treatment was significantly better than that in the control group.

[0054] Table 1 Comparison of pathological histology scores of gastric mucosa in two groups of patients before and after treatment ( points)

[0055]

[0056] Note: Compared with before treatment in this group, △P < 0.05; compared with after treatment in the control group, *P < 0.05

[0057] II. Experimental Research

[0058] Based on targeted metabolomics analysis, the inventor used an ultra-high performance liquid chromatography-triple quadrupole mass spectrometer (UHPLC-QTRAP MS) to detect the differential metabolites in feces of healthy people and CAG patients before and after treatment, and finally obtained the significantly differential metabolites that were adjusted back to the normal level in CAG patients after treatment with the Yin-Yang tonifying Weiyu Prescription (the traditional Chinese medicine composition prepared in Example 3).

[0059] The results of metabolomics research found that the Yang-Yin tonifying Weiyu formula could significantly improve the clinical manifestations of patients with CAG of spleen and stomach Yang-Yin deficiency complicated with gastric collateral stasis, and regulate the levels of key metabolites in CAG patients to return to normal levels. Specifically, it showed a decrease in the contents of 2,3-diaminopropionic acid, sarcosine, and malonic acid, and an increase in the contents of ursodeoxycholic acid, nicotinic acid, cholalic acid, β-muricholic acid, hyodeoxycholic acid, isolithocholic acid, and lithocholic acid. The enrichment analysis of metabolic pathways showed that the treatment intervention mainly affected five metabolic pathways, namely, nicotinic acid and nicotinamide metabolism, glycine / serine / threonine metabolism, arginine / proline metabolism, primary bile acid biosynthesis, and fatty acid biosynthesis ( Figure 1 ). As a precursor for NAD+ biosynthesis, nicotinic acid (vitamin B3) promotes the degradation of HIF-1α protein by activating the SIRT1 deacetylase, thereby reversing the glycolysis-dependent state of cells; glycine inhibits the assembly of NLRP3 inflammasomes, blocks the caspase-1 activation pathway, and reduces the cleavage and maturation of pyroptosis execution proteins; arginine metabolites maintain the normal differentiation phenotype of intestinal epithelial cells by regulating the HIF-1α-dependent epithelial-mesenchymal transition process; the activation of the bile acid receptor FXR can double-inhibit the transcriptional activity of HIF-1α and the expression of NLRP3, synergistically reducing epithelial cell pyroptosis; the inhibition of fatty acid synthase improves mitochondrial function and antagonizes HIF-1α-mediated metabolic disorders.

[0060] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating chronic atrophic gastritis, characterized in that, It comprises the following components in parts by mass: 12-18 parts of Dendrobium officinale, 12-18 parts of Ramulus Cinnamomi, 12-18 parts of Pseudostellaria heterophylla, 8-12 parts of Ophiopogon japonicus, 15-25 parts of Salvia miltiorrhiza, 3-7 parts of Aspongopus chinensis Dallas, 8-12 parts of Corydalis yanhusuo W. T. Wang, 8-12 parts of Citrus medica L. var. sarcodactylis Swingle, 2-4 parts of Rhizoma Coptidis, 2-4 parts of Evodia rutaecarpa (Juss.) Benth., and 5-7 parts of Glycyrrhiza uralensis Fisch.

2. The preparation method of the traditional Chinese medicine composition according to claim 1, characterized in that, Mix the traditional Chinese medicine components in the formula amount with water and decoct, then perform solid-liquid separation, and collect the liquid part to obtain the traditional Chinese medicine composition.

3. The method according to claim 2, characterized in that The mass-volume ratio of the traditional Chinese medicine components to water during mixing is 0.8-1.2 g: 5-15 ml.

4. The method according to claim 2, characterized in that, The decocting time is 20-40 min.

5. Use of the traditional Chinese medicine composition according to claim 1 or the traditional Chinese medicine composition obtained by the method according to any one of claims 2-4 in the preparation of a drug for treating chronic atrophic gastritis.

6. The application according to claim 5, characterized in that, The chronic atrophic gastritis is of the type of chronic atrophic gastritis with deficiency of both spleen and stomach yin and yang and stasis of gastric collaterals.

7. A drug for treating chronic atrophic gastritis, characterized in that, The drug comprises the traditional Chinese medicine composition according to claim 1 or the traditional Chinese medicine composition obtained by the method according to any one of claims 2-4.

8. The medicament according to claim 7, wherein The drug further comprises pharmaceutical excipients.

Images