Traditional Chinese medicine composition and pharmaceutical preparation for treating chronic atrophic gastritis with dysplasia as well as preparation method and application of traditional Chinese medicine composition and pharmaceutical preparation

Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia, a pharmaceutical preparation and a preparation method and application thereof. The traditional Chinese medicine composition comprises the following components in parts by weight: 5-18 parts of ginseng, 5-18 parts of ligusticum wallichii, 4-15 parts of poria cocos, 5-18 parts of dendrobe, 9-27 parts of bighead atractylodes rhizome, 5-18 parts of hypericum perforatum, 5-18 parts of coptis chinensis, 5-18 parts of sculellaria barbata, 5-18 parts of immature bitter orange and 5-18 parts of curcuma zedoary. The traditional Chinese medicine composition provided by the invention can effectively block, slow down and reverse the chronic atrophic gastritis with dysplastic hyperplasia'inflammation-cancer transformation 'process, and is low in cost, small in side effect and high in patient compliance.

Description

Technical Field

[0001] The present application relates to the field of traditional Chinese medicine, and more specifically, to a traditional Chinese medicine composition, a pharmaceutical preparation, and a preparation method and application thereof for treating chronic atrophic gastritis with dysplasia. Background Art

[0002] Chronic atrophic gastritis (CAG) is a common digestive system disease characterized by atrophy of the gastric mucosal epithelium and glands, a decrease in glandular number, thinning of the gastric mucosa, and thickening of the basal mucosa. Key symptoms include upper abdominal distension and pain, belching, and acid reflux. While the etiology of CAG remains unclear, long-term studies suggest it may be associated with multiple factors, including Helicobacter pylori infection, bile reflux, immune dysfunction, aging, a high-salt diet, an overheated diet, a low-vitamin diet, and genetic factors. As the disease progresses, CAG patients may develop dysplasia. Dysplasia refers to the pathological, atypical proliferation of gastric epithelial cells under the influence of chronic inflammation. This process is a key stage in the transformation of CAG into cancer. In my country, the cancerization rate of CAG ranges from 1.2% to 7.1%. Accompanying dysplasia significantly increases the risk of cancer. How to effectively block, delay or even reverse the "inflammation-cancer transformation" process of CAG has become a major challenge faced by both Chinese and Western medicine in the field of modern medicine. Summary of the Invention

[0003] In order to solve the problems in the prior art of using traditional Chinese medicine to treat chronic atrophic gastritis with dysplasia, such as the large number of single drugs leading to high costs, increased adverse reactions, and poor patient compliance, the present invention aims to provide a traditional Chinese medicine composition, a pharmaceutical preparation, and a preparation method and application thereof, which have the advantages of streamlined formula, reasonable selection of raw materials, and comprehensive efficacy, and the effect of treating chronic atrophic gastritis with dysplasia is greatly improved.

[0004] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0005] The invention provides a traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia. The composition comprises the following components in proportion by weight: 5-18 parts of ginseng, 5-18 parts of chuanxiong, 4-15 parts of tuckahoe, 5-18 parts of dendrobium, 9-27 parts of atractylodes, 5-18 parts of hypericum perforatum, 5-18 parts of coptis chinensis, 5-18 parts of scutellaria barbata, 5-18 parts of immature bitter orange, and 5-18 parts of zedoaria.

[0006] Specifically, in some embodiments of the present invention, the traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia includes the following components in proportions by weight: 6-14 parts of ginseng, 6-14 parts of Chuanxiong, 5-11 parts of Poria, 6-14 parts of Dendrobium, 11-19 parts of Atractylodes, 6-14 parts of Hypericum perforatum, 6-14 parts of Coptis chinensis, 6-14 parts of Scutellaria barbata, 6-14 parts of Citrus aurantium, and 6-14 parts of Curcuma.

[0007] Specifically, in some embodiments of the present invention, the traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia comprises the following components in parts by weight:

[0008] 6 parts of ginseng, 8 parts of chuanxiong, 8 parts of poria, 10 parts of dendrobium, 6 parts of atractylodes, 6 parts of hypericum perforatum, 4 parts of coptis, 6 parts of barbata, 9 parts of immature bitter orange, 3 parts of zedoary; or

[0009] 10 parts of ginseng, 10 parts of Chuanxiong, 8 parts of Poria, 10 parts of Dendrobium, 10 parts of Atractylodes, 10 parts of Hypericum perforatum, 10 parts of Coptis chinensis, 10 parts of Scutellaria barbata, 10 parts of Citrus aurantium, 10 parts of Curcuma zedoaria; or

[0010] 12 parts of ginseng, 12 parts of Chuanxiong, 12 parts of Poria, 12 parts of Dendrobium, 17 parts of Atractylodes, 8 parts of Hypericum perforatum, 8 parts of Coptis chinensis, 8 parts of Scutellaria barbata, 8 parts of Citrus aurantium, 8 parts of Curcuma zedoaria; or

[0011] 8 parts of ginseng, 8 parts of chuanxiong, 12 parts of tuckahoe, 6 parts of dendrobium, 8 parts of atractylodes, 13 parts of hypericum perforatum, 12 parts of coptis chinensis, 8 parts of scutellaria barbata, 12 parts of immature bitter orange, and 12 parts of zedoary turmeric.

[0012] Specifically, in some embodiments of the present invention, in the traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia, the Atractylodes macrocephala is stir-fried Atractylodes macrocephala.

[0013] The present invention also provides a method for preparing a traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia, the method comprising:

[0014] The Chinese medicinal raw materials in the formula amount are weighed respectively, decocted in water for extraction, filtered, the filtrates are combined, concentrated under reduced pressure, dried, and auxiliary materials are added to obtain the product.

[0015] Specifically, in some embodiments of the present invention, the Chinese medicinal raw materials are soaked for 0.5-4 hours before extraction, the weight of water added for decoction is 5-10 times the weight of the Chinese medicinal raw materials, the number of extractions is 2-4 times, and the extraction time each time is 0.5-2 hours.

[0016] The present invention also provides a pharmaceutical preparation of the Chinese medicine composition for treating chronic atrophic gastritis with dysplasia and / or a preparation method of the Chinese medicine composition for treating chronic atrophic gastritis with dysplasia, wherein the pharmaceutical preparation comprises the Chinese medicine composition and excipients.

[0017] Specifically, in some embodiments of the present invention, the dosage forms of the pharmaceutical preparation include tablets, capsules, powders, granules, ointments, oral liquid preparations, suppositories, injections, inhalants, gels, microspheres, and aerosols.

[0018] The present invention also provides the above-mentioned traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia and / or the preparation method of the above-mentioned traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia, and the use of the obtained traditional Chinese medicine composition in preparing medicines and / or preparations for preventing and / or treating chronic atrophic gastritis.

[0019] The present invention also provides the above-mentioned traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia and / or the preparation method of the above-mentioned traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia, and the use of the obtained traditional Chinese medicine composition in preparing drugs and / or preparations for preventing and / or treating dysplasia.

[0020] In summary, this application has the following beneficial effects:

[0021] 1. Compared with the prior art, patent CN115518142A includes 20 single drugs. The large number of single drugs leads to high costs, increased adverse reactions, poor patient compliance and other problems. The present invention creatively combines 10 single drugs in a reasonable combination, so that the components can act synergistically, optimize and reduce the number and types of single drugs. Through in-depth exploration and research, ginseng, Chuanxiong, Poria, and Hypericum perforatum are added, and pinellia, scutellaria, dried ginger, turmeric, atractylodes, astragalus, Hedyotis diffusa, salvia miltiorrhiza, Pseudostellaria pseudoginseng, barley sprout, malt, Magnolia officinalis, ginger and jujube are removed. The dosage ratio is limited, and significant technological progress has been achieved. The said technological progress specifically relates to reducing costs, improving efficacy, reducing side effects, and improving patient compliance.

[0022] 2. The present invention creatively uses stir-fried Atractylodes macrocephala instead of raw Atractylodes macrocephala, resulting in better results. The inventors have found in clinical practice that stir-fried Atractylodes macrocephala has a stronger effect of replenishing qi and strengthening the spleen in treating spleen and stomach diseases, and that stir-fried Atractylodes macrocephala is more effective in treating chronic atrophic gastritis with dysplasia.

[0023] 3. Based on clinical practice, the present invention has found the optimal weight ratio relationship, so that the entire prescription is reasonably compatible with the monarch, minister, adjuvant and envoy, and exerts the best therapeutic effect;

[0024] 4. The present invention creatively combines 10 single drugs in a reasonable combination, so that the components act synergistically. The Chinese medicine composition has the effects of strengthening the spleen and eliminating dampness, promoting qi and blood circulation, clearing away heat and removing phlegm, and removing blood stasis and detoxifying. The Chinese medicine composition of the present application has significant clinical effects in preventing and treating chronic atrophic gastritis with dysplasia, especially for patients with epigastric distension and pain, belching, acid reflux, noisy stomach, poor appetite, fatigue, irritability, red tongue with yellow or white greasy coating or ecchymosis, and deep and stringy pulse caused by spleen deficiency and dampness, qi stagnation and blood stasis, mixed cold and heat, and toxic blood stasis. The composition can effectively block, slow down, and reverse the "inflammation-cancer transformation" process of chronic atrophic gastritis with dysplasia. DETAILED DESCRIPTION

[0025] The invention discloses a traditional Chinese medicine composition, a preparation method and application thereof.

[0026] It should be understood that the expression "one or more of" includes individually each of the items recited after the expression and various combinations of two or more of the recited items, unless otherwise apparent from the context and usage. The expression "and / or" in conjunction with three or more recited items should be understood to have the same meaning, unless otherwise apparent from the context.

[0027] The terms "comprising", "having" or "containing", including their grammatical synonyms, should generally be understood as open and non-restrictive, e.g., not excluding other unrecited elements or steps, unless otherwise specifically stated or understood from the context.

[0028] It should be understood that the order of steps or the order in which certain actions are performed are not important as long as the present invention remains operable. Additionally, two or more steps or actions may be performed simultaneously.

[0029] The use of any and all examples or exemplary language, such as "such as" or "including," herein is intended merely to better illustrate the invention and does not limit the scope of the invention unless otherwise claimed. No language in this specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

[0030] In addition, the numerical ranges and parameters used to define the present invention are approximate values. The relevant numerical values in the specific examples have been presented as accurately as possible. However, any numerical value inherently inevitably contains standard deviations due to individual testing methods. Therefore, unless otherwise expressly stated, all ranges, amounts, values, and percentages used in this disclosure should be understood to be modified by the word "about." As used herein, "about" generally means that the actual value is within plus or minus 10%, 5%, 1%, or 0.5% of a specified value or range.

[0031] The Chinese medicinal raw materials used in the present invention are all conventional raw materials in the art, and their corresponding plant sources and medicinal parts are all known and common. The reagents used in the present invention can all be purchased from the market.

[0032] The invention provides a traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia. The composition comprises the following components in proportion by weight: 5-18 parts of ginseng, 5-18 parts of chuanxiong, 4-15 parts of tuckahoe, 5-18 parts of dendrobium, 9-27 parts of atractylodes, 5-18 parts of hypericum perforatum, 5-18 parts of coptis chinensis, 5-18 parts of scutellaria barbata, 5-18 parts of immature bitter orange, and 5-18 parts of zedoaria.

[0033] The traditional Chinese medicine composition provided by the present invention comprises 5-18 parts by weight of ginseng, preferably 6-17 parts by weight, and more preferably 7-16 parts by weight.

[0034] The traditional Chinese medicine composition provided by the present invention comprises 5-18 parts by weight of Chuanxiong, preferably 6-17 parts by weight, and more preferably 7-16 parts by weight.

[0035] The traditional Chinese medicine composition provided by the present invention comprises 4-15 parts by weight of Poria cocos, preferably 5-14 parts by weight, and more preferably 6-13 parts by weight.

[0036] The traditional Chinese medicine composition provided by the present invention comprises 5-18 parts by weight of dendrobium, preferably 6-17 parts by weight, and more preferably 7-16 parts by weight.

[0037] The traditional Chinese medicine composition provided by the present invention comprises 9-27 parts by weight of Atractylodes macrocephala, preferably 10-26 parts by weight, and more preferably 11-25 parts by weight.

[0038] The traditional Chinese medicine composition provided by the present invention comprises 5-18 parts by weight of Hypericum perforatum, preferably 6-17 parts by weight, and more preferably 7-16 parts by weight.

[0039] The traditional Chinese medicine composition provided by the present invention comprises 5-18 parts by weight of coptis chinensis, preferably 6-17 parts by weight, and more preferably 7-16 parts by weight.

[0040] The traditional Chinese medicine composition provided by the present invention comprises 5-18 parts by weight of Scutellaria barbata, preferably 6-17 parts by weight, and more preferably 7-16 parts by weight.

[0041] The traditional Chinese medicine composition provided by the present invention comprises 5-18 parts by weight of Citrus aurantium immaturum, preferably 6-17 parts by weight, and more preferably 7-16 parts by weight.

[0042] The traditional Chinese medicine composition provided by the present invention comprises 5-18 parts by weight of Curcuma zedoaria, preferably 6-17 parts by weight, and more preferably 7-16 parts by weight.

[0043] In one preferred embodiment of the present invention, the above-mentioned traditional Chinese medicine composition includes the following components in proportions by weight: 6-17 parts of ginseng, 6-17 parts of Chuanxiong, 5-14 parts of Poria, 6-17 parts of Dendrobium, 10-26 parts of Atractylodes, 6-17 parts of Hypericum perforatum, 6-17 parts of Coptis chinensis, 6-17 parts of Scutellaria barbata, 6-17 parts of Citrus aurantium, and 6-17 parts of Curcuma.

[0044] In one preferred embodiment of the present invention, the above-mentioned traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia includes the following components in proportions by weight: 7-16 parts of ginseng, 7-16 parts of Chuanxiong, 6-13 parts of Poria, 7-16 parts of Dendrobium, 11-25 parts of Atractylodes, 7-16 parts of Hypericum perforatum, 7-16 parts of Coptis chinensis, 7-16 parts of Scutellaria barbata, 7-16 parts of Citrus aurantium, and 7-16 parts of Curcuma.

[0045] In one preferred embodiment of the present invention, the above-mentioned traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia includes the following components in proportions by weight: 6-14 parts of ginseng, 6-14 parts of Chuanxiong, 5-11 parts of Poria, 6-14 parts of Dendrobium, 11-19 parts of Atractylodes, 6-14 parts of Hypericum perforatum, 6-14 parts of Coptis chinensis, 6-14 parts of Scutellaria barbata, 6-14 parts of Citrus aurantium, and 6-14 parts of Curcuma.

[0046] In some preferred embodiments of the present invention, the above-mentioned traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia includes the following components in proportions by weight: 8-12 parts of ginseng, 8-12 parts of Chuanxiong, 6-10 parts of Poria, 8-12 parts of Dendrobium, 13-17 parts of Atractylodes, 8-12 parts of Hypericum perforatum, 8-12 parts of Coptis chinensis, 8-12 parts of Scutellaria barbata, 8-12 parts of Citrus aurantium, and 8-12 parts of Curcuma.

[0047] In some preferred embodiments of the present invention, in the above-mentioned traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia, the Atractylodes macrocephala is stir-fried Atractylodes macrocephala, the Fructus Aurantii Immaturus is stir-fried Fructus Aurantii Immaturus, and the Curcuma zedoaria is vinegar-cured Curcuma zedoaria. Where necessary, if the processing specifications are not specified in the prescription, the raw product shall be used.

[0048] The processed products selected in the present invention are all obtained through a large amount of clinical practice and / or pharmacodynamic experiments. They are the most effective among various processed products of similar Chinese medicinal raw materials and can exert the best therapeutic effect in treating CAG with dysplasia.

[0049] The traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia has the effects of strengthening the spleen and eliminating dampness, promoting qi and blood circulation, clearing away heat and removing phlegm, and removing blood stasis and detoxifying. It is used for epigastric distension and pain, belching, acid reflux, noisy stomach, poor appetite, fatigue, irritability, red tongue with yellow fur or ecchymosis, and deep, stringy pulse caused by spleen deficiency and qi stagnation, insufficient stomach yin, mixed cold and heat, and toxic blood stasis; and for chronic atrophic gastritis with dysplasia presenting with the above symptoms.

[0050] The inventors of this application have conducted extensive research based on the theory of traditional Chinese medicine formulation, modern pharmacology and clinical practice, thereby obtaining the traditional Chinese medicine composition for the treatment of CAG with dysplasia described in this application, which has the optimal raw material composition and weight ratio.

[0051] Another object of the present invention is to provide a method for preparing the Chinese medicine preparation, which can effectively enrich the active ingredients in the Chinese medicine raw materials and has the characteristics of simple process, low cost, non-toxicity, and convenient industrial production.

[0052] In order to achieve the above object, the technical solution of the present invention is as follows:

[0053] A method for preparing a traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia comprises the following steps: weighing medicinal materials according to weight ratio, extracting, filtering, combining filtrates, concentrating, and adding auxiliary materials to obtain the composition.

[0054] In some preferred embodiments of the present invention, the preparation method comprises: weighing medicinal materials according to weight ratio, decocting in water for extraction, filtering, combining the filtrates, concentrating under reduced pressure to obtain a thick paste, drying the thick paste to obtain a dry paste, and adding auxiliary materials to obtain the dry paste.

[0055] In some preferred embodiments of the present invention, the preparation method comprises: weighing medicinal materials according to a weight ratio, decocting with water for extraction, filtering, combining the filtrates, concentrating under reduced pressure to obtain a thick paste, drying the thick paste to obtain a dry paste, adding excipients, and preparing it as a Chinese medicine preparation; the weight of water added to the water decoction is 5-10 times the weight of the Chinese medicine raw material, extracting 2-4 times, each time for 0.5-2 hours, and soaking the medicinal materials for 0.5-4 hours before extraction; the concentration temperature is controlled at no more than 80°C, and the drying temperature is controlled at no more than 70°C.

[0056] In some preferred embodiments of the present invention, the preparation method comprises: decocting with water with a weight of 6 times the weight of the Chinese medicinal raw material, extracting twice, each time for 1 hour, and soaking the medicinal materials for half an hour before extraction; the concentration temperature is controlled at no more than 70°C, and the drying temperature is controlled at no more than 60°C.

[0057] Another object of the present invention is to provide a pharmaceutical preparation for treating chronic atrophic gastritis with dysplasia based on the above-mentioned traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia, which can be conveniently used in clinical practice, ensure the safety of the medicine, be quality-controlled, and fully exert its therapeutic effect.

[0058] In order to achieve the above object, the technical solution of the present invention is as follows:

[0059] The present invention provides a pharmaceutical preparation of the traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia and / or a preparation method of the traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia, wherein the pharmaceutical preparation comprises the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0060] The pharmaceutically acceptable excipients may include any adjuvant, carrier, excipient, glidant, sweetener, diluent, preservative, dye / colorant, flavor enhancer, flavoring agent, disintegrant, lubricant, binder, surfactant, wetting agent, dispersant, suspending agent, stabilizer, isotonic agent, solvent or emulsifier, etc.

[0061] In some preferred embodiments of the present invention, the Chinese medicine preparation can be formulated into a solid, semisolid, liquid or gaseous form, such as tablets, capsules, powders, granules, ointments, oral liquid preparations, suppositories, injections, inhalants, gels, microspheres and aerosols. Typical routes of administration of such drugs or health care compositions include oral, topical, transdermal, inhalation, parenteral, sublingual, buccal, rectal, vaginal or intranasal.

[0062] In some preferred embodiments of the present invention, the Chinese medicine preparation is an oral preparation, preferably an oral solid, semisolid or liquid preparation, such as tablets, capsules, powders, granules, oral liquid preparations, and gels.

[0063] For the above-mentioned oral preparations, one or more of the following substances may be present: binders, such as carboxymethyl cellulose, ethyl cellulose, cyclodextrin, microcrystalline cellulose, tragacanth gum or gelatin; excipients, such as starch, lactose or dextrin; disintegrants, such as alginic acid, sodium alginate, corn starch, etc.; lubricants, such as magnesium stearate; glidants, such as colloidal silicon dioxide; sweeteners, such as sucrose or saccharin; flavorings, such as mint, methyl salicylate or orange flavoring; and coloring agents, etc.

[0064] In some cases, the Chinese medicine preparation may also be an injection to achieve faster therapeutic effects, or it may be suitable for patients who are not convenient to take the medicine orally.

[0065] In some preferred embodiments of the present invention, the Chinese medicine preparation is a granule, which has the characteristics of a long shelf life, high patient acceptance, ease of use, and rapid therapeutic effect. In particular, when the Chinese medicine preparation is a granule, under the same dosage, due to the characteristics of requiring less excipients and being more effective in the stomach, it can produce a better therapeutic effect than other conventional oral solid preparations such as tablets, pills, and capsules. In addition, the Chinese medicine granule preparation has a longer shelf life and lower excipient usage than oral liquid preparations. In other words, it is optimal for the Chinese medicine preparation of the present invention to be selected as a granule.

[0066] In some preferred embodiments of the present invention, the excipient of the granules is one or more of lactose, dextrin or soluble starch.

[0067] In some preferred embodiments of the present invention, the excipient is lactose. Preferably, the drug-excipient ratio of the traditional Chinese medicine component to the excipient is 1:1-4:1, preferably 3:1.

[0068] Another object of the present invention is to provide the use of the traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia in the preparation of a medicament. The traditional Chinese medicine composition can effectively exert its therapeutic effect and has a good therapeutic effect on various types of chronic atrophic gastritis with dysplasia.

[0069] In order to achieve the above object, the technical solution of the present invention is as follows:

[0070] The present invention provides the above-mentioned traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia and / or the preparation method of the above-mentioned traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia, and the use of the traditional Chinese medicine composition in treating chronic atrophic gastritis with dysplasia.

[0071] The Chinese medicine composition for treating chronic atrophic gastritis with dysplasia can also be used to prepare medicines for treating epigastric distension and pain, belching, acid reflux, noisy stomach, poor appetite, fatigue, irritability, red tongue with yellow or white greasy coating or ecchymosis, and deep and stringy pulse caused by spleen deficiency and dampness, qi stagnation and blood stasis, mixed cold and heat, and toxic blood stasis.

[0072] The above components and proportions provided by the present invention have been clearly described and will not be repeated here.

[0073] To further illustrate the present invention, a Chinese medicine composition for treating chronic atrophic gastritis with dysplasia, a preparation method thereof and applications thereof provided by the present invention are described in detail below with reference to examples.

[0074] Examples 1-9

[0075] The formulas of the Chinese medicine compositions of Examples 1-9 are shown in Table 1.

[0076] Table 1: Formulas of Chinese medicine compositions of Examples 1-9

[0077]

[0078]

[0079] The preparation method of the Chinese medicine composition of Examples 1-9 includes: weighing each medicinal material according to the formula amount of Examples 1-9, decocting and extracting with water, the mass of water added during decoction is 6 times the total mass of each medicinal material, extracting twice, each time for 1 hour, and soaking the medicinal materials for 0.5 hours before extraction; filtering after each extraction, combining the filtrates, and concentrating under reduced pressure at a temperature not exceeding 70°C to obtain a thick paste, drying the thick paste at a temperature not exceeding 60°C to obtain a dry paste, crushing the dry paste, adding lactose at a drug-excipient ratio of 3:1 based on the amount of dry paste, and preparing granules using a dry granulation method.

[0080] Examples 11-19

[0081] The formulas of the Chinese medicine compositions of Examples 11-19 are the same as those of Examples 1-9.

[0082] The preparation method of the Chinese medicine composition of Examples 11-19 includes: weighing each medicinal material according to the formula amount of Examples 1-9, decocting and extracting with water, the mass of water added during decoction is 5 times the total mass of each medicinal material, extracting 4 times, each time for 0.5 hour, and soaking the medicinal materials for 4.5 hours before extraction; filtering after each extraction, combining the filtrates, and concentrating under reduced pressure at a temperature not exceeding 80°C to obtain a thick paste, spray drying the thick paste at a temperature not exceeding 70°C to obtain a dry paste powder, adding lactose at a drug-excipient ratio of 4:1 based on the amount of dry paste, using 75% ethanol as a wetting agent, preparing granules, and filling them into capsules to prepare capsules.

[0083] Examples 21-29

[0084] The formulas of the Chinese medicine compositions of Examples 21-29 are the same as those of Examples 1-9.

[0085] The preparation method of the Chinese medicine composition of Examples 21-29 includes: weighing each medicinal material according to the formula amount of Examples 1-9, decocting and extracting with water, the mass of water added during decoction is 10 times the total mass of each medicinal material, extracting 3 times, each time for 2 hours, and soaking the medicinal materials for 1.5 hours before extraction; filtering after each extraction, combining the filtrates, and concentrating under reduced pressure at a temperature not exceeding 75°C to obtain a thick paste, drying the thick paste at a temperature not exceeding 70°C to obtain a dry paste, crushing the dry paste, adding soluble starch at a drug-excipient ratio of 1:1 based on the amount of the dry paste, using 95% ethanol as a wetting agent, preparing granules, and then adding magnesium stearate and microcrystalline cellulose, pressing into tablets, and preparing tablets.

[0086] Examples 31-39

[0087] The formulas of the Chinese medicine compositions of Examples 31-39 are the same as those of Examples 1-9.

[0088] The preparation method of the Chinese medicine composition of Examples 31-39 includes: weighing each medicinal material according to the formula amount of Examples 1-9, extracting with ethanol reflux, decocting under 10 times the solvent, extracting twice, each time for 1 hour, and soaking the medicinal materials for 0.5 hour before extraction; filtering after each extraction, combining the filtrates, and concentrating under reduced pressure at a temperature not exceeding 80°C to obtain a thick paste, drying the thick paste at a temperature not exceeding 60°C to obtain a dry paste, crushing the dry paste, and adding dextrin at a drug-excipient ratio of 2:1 based on the amount of the dry paste to prepare granules.

[0089] Examples 41-49

[0090] The formulas of the Chinese medicine compositions of Examples 41-49 are the same as those of Examples 1-9.

[0091] The preparation method of the Chinese medicine composition of Examples 41-49 includes: weighing each medicinal material according to the formula amount of Examples 1-9, extracting with ethanol reflux, decoction conditions are 10 times the solvent, extracting twice, each time for 1 hour, and soaking the medicinal materials for 0.5 hours before extraction; filtering after each extraction, combining the filtrates, and concentrating under reduced pressure at a temperature not exceeding 80°C to obtain a thick paste, drying the thick paste at a temperature not exceeding 65°C to obtain a dry paste, crushing the dry paste, and preparing it into orally disintegrating tablets.

[0092] Examples 51-59

[0093] The formulas of the Chinese medicine compositions of Examples 51-59 are the same as those of Examples 1-9.

[0094] The preparation method of the Chinese medicine composition of Examples 51-59 includes: weighing each medicinal material according to the formula amount of Examples 1-9, refluxing extraction with 50% ethanol, decocting under 8 times the solvent, extracting 3 times, each time for 1.5 hours, and soaking the medicinal materials for 0.5 hours before extraction; filtering after each extraction, combining the filtrates, and concentrating under reduced pressure at no more than 80°C to obtain a fluid extract, adding a flavoring agent, and preparing it as an oral liquid preparation.

[0095] Comparative Example 1

[0096] The different processed products of Example 1, wherein the Atractylodes macrocephala is raw Atractylodes macrocephala and the Pinellia ternata is processed Pinellia ternata, and the contents of other ingredients and the preparation method are the same as those of Example 1.

[0097] Comparative Example 2

[0098] Formula of Chinese medicine composition: 12g of Pinellia, 10g of Codonopsis, 9g of Coptis, 9g of Scutellaria, 9g of Dried Ginger, 6g of Roasted Licorice, 4 jujubes, 15g of Curcuma, 15g of Salvia miltiorrhiza, 20g of Astragalus, and 12g of Atractylodes.

[0099] Comparative Example 3

[0100] Formula of the Chinese medicine composition: 10g of Pinellia ternata, 10g of Scutellaria baicalensis, 8g of Coptis chinensis, 10g of dried ginger, 10g of Curcuma aromatica, 10g of stir-fried Atractylodes lancea, 10g of stir-fried Atractylodes macrocephala, 15g of Astragalus membranaceus, 20g of Hedyotis diffusa, 20g of Scutellaria barbata, 10g of Salvia miltiorrhiza, 10g of Dendrobium candidum, 10g of Pseudostellaria pseudoginseng, 6g of stir-fried barley sprout, 6g of stir-fried malt, 10g of Citrus aurantium immaturum, 10g of Magnolia officinalis, 10g of Curcuma zedoaria, 3g of ginger, and 6g of jujube.

[0101] Comparative Example 4

[0102] Formula of the Chinese medicine composition: 5g of ginseng, 10g of Chuanxiong, 7g of Poria, 12g of Dendrobium, 5g of Atractylodes, 7g of Hypericum perforatum, 5g of Coptis chinensis, 8g of Scutellaria barbata, 11g of Citrus aurantium, and 4g of Curcuma.

[0103] Comparative Example 5

[0104] Formula of the Chinese medicine composition: ginseng 7g, Chuanxiong 9g, Poria 10g, Dendrobium 13g, Atractylodes 5g, Hypericum perforatum 4g, Coptis chinensis 3g, Scutellaria barbata 7g, Citrus aurantium 10g, and Curcuma 3g.

[0105] Verification example: API composition and ratio screening experiment

[0106] 1. Animals

[0107] SPF rats, half male and half female, weighing 200-220g, aged 6-8 weeks, were randomly divided into a control group and a modeling group. During the experimental period, the laboratory temperature was maintained at 22.5±0.5°C, within the range of 20-25°C, and the humidity was maintained at 54.7±3.1%, within the range of 40%-70%, meeting national standards. The control group rats were housed as usual and provided with adequate feed. The model group rats received free access to a 120μg / ml aqueous solution of MNNG (1-methyl-3-nitro-1-nitrosoguanidine) daily for 26 weeks. They were also gavaged with a 20mg / ml sodium salicylate solution twice weekly and fasted for 16-18 hours twice weekly. At week 26 of modeling, three control and modeling rats of both sexes were randomly killed and examined for gastric histopathological changes to confirm successful modeling.

[0108] 2. Drugs and grouping

[0109] Set up the following animal groups:

[0110] Group 1: Example 1;

[0111] Group 2: Example 2;

[0112] Group 3: Example 3;

[0113] Group 4: Comparative Example 1;

[0114] Group 5: Comparative Example 2;

[0115] Group 6: Comparative Example 3;

[0116] Group 7: Comparative Example 4;

[0117] Group 8: Comparative Example 5.

[0118] The raw materials of each group mentioned above were prepared into granules according to the method of Example 6, and then formulated into suspensions with distilled water.

[0119] 3. Administer medication

[0120] At week 27, the model rats were randomly divided into 10 groups according to body weight: blank group, model group, group 1, group 2, group 3, group 4, group 5, group 6, group 7, and group 8.

[0121] The normal control group and the model group were gavaged with drinking water every day, and the other groups were gavaged with 10 ml / kg of the corresponding drugs. The results were observed after 8 weeks of administration.

[0122] 4. Results

[0123] 4.1 Effects of each group on gastric juice volume, acidity and pepsin activity in CAG rat model

[0124] In CAG with dysplasia, gastric mucosal atrophy leads to a decrease in gastric glands and a decrease in gastric acid secretion, manifested as decreased gastric fluid volume, decreased acidity, and decreased pepsin secretion. Therefore, changes in gastric fluid volume, acidity, and pepsin activity can serve as key indicators of disease progression and efficacy. The results showed that compared with the blank group, the gastric fluid volume in the model group was significantly reduced (P < 0.01). Compared with the model group, the gastric fluid volume in treatment groups 1, 2, 3, and 4 was significantly increased (P < 0.05), while no significant changes were observed in the other treatment groups. Compared with the blank group, the gastric fluid acidity in the model group was significantly decreased (P < 0.01). Compared with the model group, the gastric fluid acidity in treatment groups 1 and 2 was significantly increased (P < 0.05). There were no statistically significant differences in gastric fluid acidity among the other groups. Compared with the blank group, the pepsin activity in the model group was significantly decreased (P < 0.01); compared with the model group, the pepsin activity in the implementation groups 1, 2, 3, and 4 was significantly increased, with statistically significant differences (P < 0.05). The results are shown in Table 2.

[0125] Table 2 Effects of gastric juice volume, acidity and pepsin activity in each group of CAG rat models

[0126] Group n Gastric juice volume (ml) Gastric acidity (mmol / L) Pepsin activity (U / ml) Blank group 8 4.63±0.98 105.33±24.26 42.60±6.82 Model Group 8 1.56±0.31** 41.89±10.73** 18.67±4.36** 1 group 8 <![CDATA[3.82±0.64 △ ]]> <![CDATA[78.89±19.56 △ ]]> <![CDATA[41.31±5.43 △ ]]> 2 groups 8 <![CDATA[3.91±1.39 △ ]]> <![CDATA[77.52±24.36 △ ]]> <![CDATA[42.73±5.28 △ ]]> 3 groups 8 <![CDATA[3.75±0.48 △ ]]> 50.77±6.09 <![CDATA[42.48±5.82 △ ]]> 4 groups 8 <![CDATA[3.82±0.97 △ ]]> 49.46±14.38 <![CDATA[44.55±10.46 △ ]]> 5 groups 8 2.72±1.35 59.85±16.22 33.07±13.30 6 groups 8 1.87±1.15 53.22±14.59 30.09±12.58 7 groups 8 2.39±1.18 61.16±13.39 36.58±18.02 8 groups 8 2.88±1.28 64.49±16.39 32.97±16.73

[0127] Note: **P<0.01 compared with the blank group; △P<0.05 compared with the model group

[0128] 4.2 Changes in the thickness of the muscularis mucosa (L1), mucosal thickness (L2), and L2 / L1 ratio of rats in each group

[0129] In the rat CAG dysplasia model, typical pathological changes include thickening of the muscularis mucosa (L1) and thinning of the mucosal layer (L2). Therefore, changes in L1 and L2 can be used to reflect the degree of gastric mucosal atrophy and the improvement of the mucosa after treatment. The experimental results showed that, with the exception of groups 5, 6, 7, and 8, treatment groups 1, 2, 3, and 4 all showed varying degrees of improvement in gastric atrophy lesions, with mucosal thickness increasing to varying degrees, with statistically significant differences (P < 0.05). Compared with the model group, the muscularis mucosa thickness in groups 1, 2, 3, and 4 increased to varying degrees, showing a significant increase (P < 0.05). The results are shown in Table 3.

[0130] Table 3 Mucosal muscularis mucosa thickness (L1) and mucosal thickness (L2) of rats in each group

[0131] Group n Muscularis mucosa thickness (L1) Mucosal thickness (L2) Blank group 8 55.00±7.25 525.50±51.38 Model Group 8 88.88±16.34** 357.13±22.34** 1 group 8 <![CDATA[70.13±6.34 △ ]]> <![CDATA[470.13±42.09 △ ]]> 2 groups 8 <![CDATA[66.88±7.38 △ ]]> <![CDATA[474.63±24.97 △ ]]> 3 groups 8 <![CDATA[67.38±5.78 △ ]]> <![CDATA[463.75±46.25 △ ]]> 4 groups 8 <![CDATA[68.13±6.16 △ ]]> <![CDATA[486.13±37.91 △ ]]> 5 groups 8 78.50±8.50 440.63±61.78 6 groups 8 80.13±11.13 437.75±57.25 7 groups 8 75.13±8.31 443.00±55.75 8 groups 8 76.25±5.94 446.00±59.50

[0132] Note: Compared with the normal group, **P<0.01; compared with the model group, △P<0.05.

[0133] 4.3 Changes in the number of glands in each group of rats

[0134] A decrease in the number of gastric mucosal glands is a core pathological feature of CAG with dysplasia. In a rat model of CAG with dysplasia, the number of gastric mucosal glands in moderate to severe dysplasia was negatively correlated with the degree of dysplasia. Therefore, the number of gastric mucosal glands is an important indicator for assessing the severity of CAG with dysplasia and the efficacy of treatment. Experimental results showed that compared with the blank group, the number of glands in the model group was significantly lower (P < 0.01). The number of glands in treatment groups 1, 2, 3, 4, and 5 was significantly higher than that in the model group (P < 0.05). The results are shown in Table 4.

[0135] Table 4 Number of gastric mucosal glands in rats in each group

[0136] Group n Number of glands Blank group 8 26.13±1.63 Model Group 8 15.00±1.50** 1 group 8 <![CDATA[22.13±1.94 △ ]]> 2 groups 8 <![CDATA[20.25±2.94 △ ]]> 3 groups 8 <![CDATA[20.88±2.91 △ ]]> 4 groups 8 <![CDATA[21.75±2.75 △ ]]> 5 groups 8 <![CDATA[20.50±2.25 △ ]]> 6 groups 8 16.75±1.31 7 groups 8 17.38±2.53 8 groups 8 19.13±2.13

[0137] Note: Compared with the normal group, **P<0.01; compared with the model group, △P<0.05.

[0138] 4.4 Changes in gastric epithelial dysplasia scores in rats of each group

[0139] In the rat CAG model with dysplasia, the gastric epithelial dysplasia score is an important criterion for assessing disease severity and quantifying treatment. This score categorizes lesions based on histopathological features: Grade 1 (mild): multifocal atypical glands characterized by elongated, altered morphology, and back-to-back arrangement; Grade 2 (mild): confluent dysplasia characterized by glandular expansion, branching, folding, cell stacking, and spherical cells; Grade 3 (moderate): gastric intraepithelial neoplasia characterized by loss of normal architecture and columnar arrangement and atypically enlarged, hyperchromatic cells; and Grade 4 (severe): invasive adenocarcinoma characterized by invasion of cancer cells into the submucosa, vascular and lymphatic vessels, and / or deeper layers. The severity of dysplasia is categorized into 5 grades: none, mild, mild, moderate, and severe, with scores of 0, 1, 2, 3, and 4, respectively. This score closely correlates with disease progression and therapeutic efficacy.

[0140] The experimental results showed that compared with the blank group, the gastric mucosal epithelial dysplasia score in the model group was significantly higher than that in the blank group, with a statistically significant difference (P < 0.01). The gastric mucosal epithelial dysplasia score in implementation groups 1, 2, 3, and 4 was significantly lower than that in the model group, with a statistically significant difference (P < 0.05). The results are shown in Table 5.

[0141] Table 5 Gastric mucosal epithelial dysplasia scores of rats in each group

[0142] Group n score Blank group 8 0.00±0.00 Model Group 8 3.50±0.63** 1 group 8 <![CDATA[2.13±0.44 △ ]]> 2 groups 8 <![CDATA[2.00±0.25 △ ]]> 3 groups 8 <![CDATA[2.88±0.44 △ ]]> 4 groups 8 <![CDATA[2.25±0.38 △ ]]> 5 groups 8 3.00±0.50 6 groups 8 3.00±0.75 7 groups 8 2.75±0.75 8 groups 8 3.13±0.88

[0143] Note: Compared with the normal group, **P<0.01; compared with the model group, △P<0.05.

[0144] This specific embodiment is only an explanation of the present application, and it is not a limitation of the present application. After reading this specification, those skilled in the art can make non-creative modifications to the present embodiment as needed, but as long as it is within the scope of the claims of the present application, it is protected by the patent law.

Claims

1. A Chinese medicine composition for treating chronic atrophic gastritis with dysplasia, characterized in that: The invention comprises the following components in proportion by weight: 5-18 parts of ginseng, 5-18 parts of chuanxiong, 4-15 parts of tuckahoe, 5-18 parts of dendrobium, 9-27 parts of atractylodes, 5-18 parts of hypericum perforatum, 5-18 parts of coptis chinensis, 5-18 parts of barbata scabra, 5-18 parts of immature bitter orange, and 5-18 parts of zedoaria.

2. The Chinese medicine composition for treating chronic atrophic gastritis with dysplasia according to claim 1, characterized in that: The invention comprises the following components in proportion by weight: 6-14 parts of ginseng, 6-14 parts of chuanxiong, 5-11 parts of tuckahoe, 6-14 parts of dendrobium, 11-19 parts of atractylodes, 6-14 parts of hypericum perforatum, 6-14 parts of coptis chinensis, 6-14 parts of barbata scabra, 6-14 parts of immature bitter orange, and 6-14 parts of zedoaria.

3. The Chinese medicine composition for treating chronic atrophic gastritis with dysplasia according to claim 1, characterized in that: The composition comprises the following components in parts by weight: 6 parts of ginseng, 8 parts of chuanxiong, 8 parts of poria, 10 parts of dendrobium, 6 parts of atractylodes, 6 parts of hypericum perforatum, 4 parts of coptis, 6 parts of barbata, 9 parts of immature bitter orange, 3 parts of zedoary; or 10 parts of ginseng, 10 parts of Chuanxiong, 8 parts of Poria, 10 parts of Dendrobium, 10 parts of Atractylodes, 10 parts of Hypericum perforatum, 10 parts of Coptis chinensis, 10 parts of Scutellaria barbata, 10 parts of Citrus aurantium, 10 parts of Curcuma zedoaria; or 12 parts of ginseng, 12 parts of Chuanxiong, 12 parts of Poria, 12 parts of Dendrobium, 17 parts of Atractylodes, 8 parts of Hypericum perforatum, 8 parts of Coptis chinensis, 8 parts of Scutellaria barbata, 8 parts of Citrus aurantium, 8 parts of Curcuma zedoaria; or 8 parts of ginseng, 8 parts of chuanxiong, 12 parts of tuckahoe, 6 parts of dendrobium, 8 parts of atractylodes, 13 parts of hypericum perforatum, 12 parts of coptis chinensis, 8 parts of scutellaria barbata, 12 parts of immature bitter orange, and 12 parts of zedoary turmeric.

4. The Chinese medicine composition for treating chronic atrophic gastritis with dysplasia according to any one of claims 1 to 3, characterized in that: The Atractylodes macrocephala is stir-fried Atractylodes macrocephala.

5. A method for preparing the traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia according to any one of claims 1 to 4, characterized in that: The method includes: The Chinese medicinal raw materials in the formula amount are weighed respectively, decocted in water for extraction, filtered, the filtrates are combined, concentrated under reduced pressure, dried, and auxiliary materials are added to obtain the product.

6. The method for preparing the Chinese medicine composition for treating chronic atrophic gastritis with dysplasia according to claim 5, characterized in that: The Chinese medicinal raw materials are soaked and then extracted. The weight of water added in the decoction is 5-10 times the weight of the Chinese medicinal raw materials. The extraction times are 2-4 times.

7. A pharmaceutical preparation of the Chinese medicine composition obtained according to the method for preparing the Chinese medicine composition for treating chronic atrophic gastritis with dysplasia according to any one of claims 1 to 4 and / or the Chinese medicine composition for treating chronic atrophic gastritis with dysplasia according to any one of claims 5 to 6, characterized in that: The pharmaceutical preparation comprises the traditional Chinese medicine composition and excipients.

8. The pharmaceutical preparation of the Chinese medicine composition for treating chronic atrophic gastritis with dysplasia according to claim 7, characterized in that: The dosage forms of the pharmaceutical preparation include tablets, capsules, powders, granules, ointments, oral liquid preparations, suppositories, injections, inhalants, gels, microspheres, and aerosols.

9. Use of the traditional Chinese medicine composition obtained by the method for preparing the traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia according to any one of claims 1 to 4 and / or the traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia according to any one of claims 5 to 6 in the preparation of a medicament and / or preparation for preventing and / or treating chronic atrophic gastritis.

10. Use of the traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia according to any one of claims 1 to 4 and / or the traditional Chinese medicine composition for treating chronic atrophic gastritis with dysplasia according to any one of claims 5 to 6 in preparing a medicament and / or preparation for preventing and / or treating dysplasia.

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