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

Abstract

The invention relates to a traditional Chinese medicine composition for treating chronic atrophic gastritis and a preparation method and application thereof, and relates to the technical field of traditional Chinese medicine, and the traditional Chinese medicine composition for treating chronic atrophic gastritis comprises the following components in parts by weight: 30-45 parts of caulis perllae, 25-35 parts of rhizoma cyperi, 10-15 parts of pericarpium citri reticulatae, 10-15 parts of clinacanthus nutans, 8-12 parts of radix bupleuri, 5-10 parts of poria cocos, 5-10 parts of curcuma zedoary and 3-7 parts of rabdosia lingua. The caulis perllae and the rhizoma cyperi in a proper ratio are combined as monarch drugs, the pericarpium citri reticulatae, the clinacanthus nutans and the radix bupleuri are matched as ministerial drugs, the poria cocos, the curcuma zedoary and the rabdosia lingua are used as adjuvant drugs, all the drugs are combined, both symptoms and root causes are treated, the effect of treating the chronic atrophic gastritis is remarkable, and a new treatment means is provided for patients with the chronic atrophic gastritis.

Description

Technical Field

[0001] This application relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for treating chronic atrophic gastritis, its preparation method, and its application. Background Technology

[0002] Chronic atrophic gastritis (CAG) is a common digestive system disease characterized by atrophy and reduced number of gastric mucosal epithelium and glands, thinning of the gastric mucosa, thickening of the mucosal basal layer, and sometimes accompanied by pyloric gland metaplasia and intestinal metaplasia, or atypical hyperplasia. Symptoms often include upper abdominal pain, bloating, belching, loss of appetite or weight loss, and anemia. It is characterized by a long course, high recurrence rate, and difficulty in complete cure, severely impacting patients' quality of life. More importantly, chronic atrophic gastritis is recognized as a precancerous condition for gastric cancer, especially when accompanied by moderate to severe dysplasia and incomplete intestinal metaplasia, significantly increasing the risk of cancer and posing a serious threat to patients' health and lives.

[0003] Currently, modern medicine treats chronic atrophic gastritis primarily through symptomatic treatment, eradication of Helicobacter pylori infection, and regular gastroscopy follow-up monitoring. Symptomatic treatment often involves using acid-suppressing agents (such as proton pump inhibitors and H2 receptor antagonists) to relieve symptoms like upper abdominal pain and acid reflux; prokinetic drugs (such as domperidone and mosapride) to improve bloating and belching; and gastric mucosal protectants (such as sucralfate and bismuth potassium citrate) to promote gastric mucosal repair. However, most of these medications only provide temporary symptom relief and cannot fundamentally reverse the pathological changes such as gastric mucosal atrophy and intestinal metaplasia. Furthermore, long-term use may lead to adverse reactions; for example, acid-suppressing agents may cause osteoporosis and intestinal flora imbalance, while prokinetic drugs may cause serious side effects such as cardiac arrhythmias.

[0004] In contrast, Traditional Chinese Medicine (TCM) possesses unique advantages and potential in treating chronic atrophic gastritis. TCM believes that chronic atrophic gastritis is often caused by factors such as improper diet, emotional imbalance, spleen and stomach weakness, and invasion of external pathogens, leading to dysfunction of the spleen and stomach, stagnation of Qi, internal generation of blood stasis, and malnourishment of the stomach meridians, thus triggering a series of symptoms. TCM treatment emphasizes a holistic approach and syndrome differentiation, aiming to improve spleen and stomach function and promote the circulation of Qi and blood by adjusting the body's Yin-Yang balance, thereby achieving both symptomatic and root-cause treatment. However, existing TCM treatments for chronic atrophic gastritis suffer from unsatisfactory therapeutic effects, failing to meet clinical needs. Summary of the Invention

[0005] To address the aforementioned issues, this application provides a traditional Chinese medicine composition for treating chronic atrophic gastritis, its preparation method, and its application.

[0006] In a first aspect, this application provides a traditional Chinese medicine composition for treating chronic atrophic gastritis, wherein, by weight, the traditional Chinese medicine composition for treating chronic atrophic gastritis comprises the following components: Perilla stem 35-45 parts, Cyperus rhizome 25-35 parts, dried tangerine peel 10-15 parts, alligator beak flower 10-15 parts, Bupleurum root 8-12 parts, Poria cocos 5-10 parts, Curcuma zedoaria 5-10 parts, and narrow-based striped fragrant tea leaves 3-7 parts.

[0007] Furthermore, the weight ratio of the perilla stem to the cyperus rhizome is 1.4.

[0008] Furthermore, the traditional Chinese medicine composition for treating chronic atrophic gastritis comprises the following components in parts by weight: Perilla stem 42.7 parts, Cyperus rhizome 30.5 parts, dried tangerine peel 12 parts, alligator beak flower 12 parts, Bupleurum root 10 parts, Poria cocos 7.5 parts, Curcuma zedoaria 7.5 parts, and narrow-based striped fragrant tea leaves 5 parts.

[0009] Secondly, this application provides a method for preparing the traditional Chinese medicine composition for treating chronic atrophic gastritis as described in any one of the first aspects, the preparation method comprising the following steps: The following herbs were crushed and mixed to obtain a traditional Chinese medicine mixture: Perilla stem, Cyperus rhizome, dried tangerine peel, alligator beak flower, Bupleurum root, Poria cocos, Curcuma rhizome, and narrow-based striped tea leaves. The Chinese herbal mixture was added to water for a first vacuum reflux extraction, followed by filtration to obtain a first extract and herbal residue. The dregs were added to water for a second vacuum reflux extraction, followed by filtration to obtain a second extract. The first extract and the second extract were concentrated and dried to obtain the traditional Chinese medicine composition for treating chronic atrophic gastritis.

[0010] Furthermore, the working conditions parameters for the first depressurized reflux extraction include: temperature of 34~44℃, pressure of 4~8kPa, time of 1~2 hours, number of extractions of 1~3 times, and the weight of water added is 5~10 times the weight of the Chinese herbal medicine mixture.

[0011] Furthermore, the working conditions parameters for the second depressurized reflux extraction include: a temperature of 70~78℃, a pressure of 22~40kPa, a time of 1~2 hours, a number of extractions of 1~3 times, and the weight of water added being 5~10 times the weight of the herbal mixture.

[0012] Furthermore, the working conditions parameters for the first depressurized reflux extraction include: a temperature of 40°C, a pressure of 6 kPa, a time of 1 to 2 hours, a number of extractions of 1 to 3 times, and the weight of water added being 5 to 10 times the weight of the herbal mixture.

[0013] Furthermore, the working conditions for the second vacuum reflux extraction include: a temperature of 75°C, a pressure of 30 kPa, a time of 1 to 2 hours, a number of extractions of 1 to 3 times, and the weight of water added being 5 to 10 times the weight of the herbal mixture.

[0014] Thirdly, this application provides the use of the traditional Chinese medicine composition for treating chronic atrophic gastritis as described in any one of the first aspects, or the traditional Chinese medicine composition for treating chronic atrophic gastritis prepared by the preparation method described in any one of the second aspects, in the preparation of a drug for treating chronic atrophic gastritis.

[0015] Furthermore, the dosage form of the drug for treating chronic atrophic gastritis includes at least one of liquid formulations, solid capsules, solid tablets, and solid granules.

[0016] The technical solutions provided in this application have at least the following advantages compared with the prior art: This application provides a traditional Chinese medicine composition for treating chronic atrophic gastritis. The composition uses a suitable ratio of Perilla stem and Cyperus rhizome as the principal herbs, combined with Citrus reticulata peel, Eriocaulon buergerianum, and Bupleurum chinense as the assistant herbs, and Poria cocos, Curcuma zedoaria, and Citrus aurantium as adjuvant herbs. The combined effects of these herbs address both the symptoms and the root cause, resulting in a significant therapeutic effect on chronic atrophic gastritis and providing a new treatment option for patients with this condition. Specifically: 1. Principal drug The formula uses a suitable proportion of Perilla stem and Cyperus rhizome as the principal herbs. Perilla stem enters the stomach meridian, regulating qi, relieving stagnation, harmonizing the stomach, and alleviating pain. Cyperus rhizome enters the liver meridian, soothing the liver, relieving stagnation, regulating qi, and harmonizing the stomach. These two herbs dominate the entire formula, based on the theory that "when qi flows, blood flows; when qi is smooth, pain stops." This formula addresses the core contradiction of "qi stagnation" in chronic atrophic gastritis, laying the foundation for its overall therapeutic effect.

[0017] 2. Assistant Medicine Tangerine peel enters the spleen and stomach meridians, excelling at regulating qi, strengthening the spleen, drying dampness, and resolving phlegm. It assists the principal herb in enhancing its qi-regulating and stomach-harmonizing effects, while also addressing the concurrent symptoms of "spleen deficiency and dampness obstruction," embodying the principle that "the spleen is the pivot of qi." Alligator beak flower contains flavonoids and terpenoids, possessing anti-inflammatory and antioxidant properties, which can assist the principal herb in alleviating gastric mucosal inflammation and improving the pathological state of "internal damp-heat" or "heat-toxin accumulation." Bupleurum enters the liver and gallbladder meridians, serving as a "key herb for soothing the liver," and synergistically enhances its liver-soothing and mood-regulating effects with Cyperus rotundus. The assistant herbs support the principal herb from multiple dimensions—"qi stagnation, damp-heat, liver stagnation, and emotional state"—strengthening the core therapeutic effect while also addressing concurrent symptoms, forming a comprehensive treatment approach of "soothing the liver and stomach, regulating qi and resolving dampness, and treating both mind and body."

[0018] 3. Adjuvant and guiding herbs Poria cocos enters the spleen and kidney meridians, excelling at strengthening the spleen and eliminating dampness. It not only assists tangerine peel in enhancing the effect of "strengthening the spleen to restore qi," but also prevents the pungent, warm, and drying properties of the principal and assistant herbs from damaging yin. Curcuma zedoaria enters the liver and spleen meridians, excelling at breaking up blood stasis, promoting qi circulation, eliminating stagnation, and relieving pain. Targeting the pathological characteristics of "blood stasis in the gastric collaterals" in chronic atrophic gastritis, it forms a "treating both qi stagnation and blood stasis" combination with Perilla frutescens and Cyperus rotundus. Narrow-base variegated tea leaves contain diterpenoids and flavonoids, which can assist Alligator's Mouth Flower in enhancing its anti-inflammatory effect and target the precancerous lesion tendency of "gastric mucosal atrophy accompanied by dysplasia." The adjuvant herbs, through their comprehensive effects of strengthening the spleen and protecting yin, promoting blood circulation and unblocking collaterals, and anti-inflammatory and preventative effects, not only assist the principal and assistant herbs in enhancing efficacy but also harmonize the properties of the entire formula, taking into account the pathological characteristics of "excess in the symptoms and deficiency in the root." Attached Figure Description

[0019] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application.

[0020] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This is a schematic flowchart illustrating a method for preparing a traditional Chinese medicine composition for treating chronic atrophic gastritis, as provided in an embodiment of this application. Detailed Implementation

[0022] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0023] Unless otherwise specified, all raw materials, reagents, instruments and equipment used in this application can be purchased from the market or prepared by existing methods.

[0024] In a first aspect, this application provides a traditional Chinese medicine composition for treating chronic atrophic gastritis, wherein, by weight, the traditional Chinese medicine composition for treating chronic atrophic gastritis comprises the following components: Perilla stem 35-45 parts, Cyperus rhizome 25-35 parts, dried tangerine peel 10-15 parts, alligator beak flower 10-15 parts, Bupleurum root 8-12 parts, Poria cocos 5-10 parts, Curcuma zedoaria 5-10 parts, and narrow-based striped fragrant tea leaves 3-7 parts.

[0025] This application provides a traditional Chinese medicine composition for treating chronic atrophic gastritis. The composition uses a suitable ratio of Perilla stem and Cyperus rhizome as the principal herbs, combined with Citrus reticulata peel, Eriocaulon buergerianum flower, and Bupleurum chinense as the assistant herbs, and Poria cocos, Curcuma zedoaria, and Scutellaria baicalensis as the adjuvant herbs. The combined use of these herbs treats both the symptoms and the root cause, resulting in a significant therapeutic effect on chronic atrophic gastritis and providing a new treatment option for patients with chronic atrophic gastritis.

[0026] Perilla stem: Derived from the dried stem of *Perilla frutescens* (L.) Britt., a plant in the Lamiaceae family. Harvested in autumn after the fruit matures, the twigs, leaves, and fruit are removed, and then dried in the sun or sliced ​​while fresh and then dried. It has the effects of regulating qi, relieving depression, relieving pain, and calming the fetus; it is used to treat qi stagnation, food stagnation, chest tightness, abdominal pain, and fetal disharmony.

[0027] Cyperus rotundus L., a plant in the Cyperaceae family, is a dried rhizome. The plant has a fragrant aroma when crushed, especially the roots, which are particularly aromatic. Its oval tubers grow continuously attached to each other, hence the ancient saying "fruits grow on the roots," thus the name Cyperus rotundus. It is believed to have the effects of soothing the liver and relieving depression, regulating qi and relieving chest tightness, and regulating menstruation and relieving pain.

[0028] Dried tangerine peel: It comes from the dried, mature peel of Citrus reticulata Blanco and its cultivated varieties, and has the effects of regulating qi, strengthening the spleen, drying dampness and resolving phlegm.

[0029] Clinacanthus nutans (Burm. f.) Lindau, commonly known as alligator beak flower, is an herbaceous plant belonging to the genus Clinacanthus in the family Acanthaceae. It is a traditional Chinese medicine used for both food and medicine, entering the liver and kidney meridians. It possesses properties such as clearing heat and detoxifying, dispersing blood stasis and reducing swelling, reducing inflammation and alcohol intoxication, and preventing and fighting cancer.

[0030] Bupleurum: Derived from the dried root of Bupleurum chinense DC. or Bupleurum corzonerifolium Willd., both belonging to the Apiaceae family. Harvested in spring and autumn, the stems, leaves, and soil are removed, and then dried. It has the effects of harmonizing the exterior and interior, soothing the liver, and raising yang. It is used to treat colds with fever, alternating chills and fever, malaria, liver qi stagnation, chest and rib pain, rectal prolapse, uterine prolapse, and irregular menstruation.

[0031] Poria cocos: Derived from the dried sclerotium of the fungus Poria cocos (Schw.) Wolf. Wild Poria cocos is generally harvested from pine forests between July and March of the following year. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen and calming the mind.

[0032] Curcuma zedoaria: Derived from the dried rhizomes of Curcuma phaeocaulis Valeton, Curcuma kwangsiensis S. Lee et CF Liang, or Curcuma wenyujin YHChen et C. Ling (all belonging to the ginger family). After processing, it is used medicinally, possessing the effects of promoting blood circulation, removing blood stasis, regulating qi, relieving pain, and eliminating stagnation. It is commonly used to treat amenorrhea due to blood stasis, chest pain, abdominal masses, and abdominal distension due to food stagnation.

[0033] Narrow-base striped fragrant tea plant: a perennial, delicate herb belonging to the subfamily Ocimidae and genus Fragaria. The whole plant is used medicinally, possessing the effects of clearing heat and detoxifying, dispersing blood stasis and reducing swelling. It is used to treat acute jaundice hepatitis, acute cholecystitis, pharyngitis, gynecological diseases, and tumor-type leprosy.

[0034] In some specific embodiments, the weight parts of the perilla stem can be 35.0 parts, 35.5 parts, 36.0 parts, 36.5 parts, 37.0 parts, 37.5 parts, 38.0 parts, 38.5 parts, 39.0 parts, 39.5 parts, 40.0 parts, 40.5 parts, 41.0 parts, 41.5 parts, 42.0 parts, 42.5 parts, 43.0 parts, 43.5 parts, 44.0 parts, 44.5 parts, 45.0 parts, etc.

[0035] In some specific embodiments, the weight parts of Cyperus rotundus can be 25.0 parts, 25.5 parts, 26.0 parts, 26.5 parts, 27.0 parts, 27.5 parts, 28.0 parts, 28.5 parts, 29.0 parts, 29.5 parts, 30.0 parts, 30.5 parts, 31.0 parts, 31.5 parts, 32.0 parts, 32.5 parts, 33.0 parts, 33.5 parts, 34.0 parts, 34.5 parts, 35.0 parts, etc.

[0036] In some specific embodiments, the weight parts of dried tangerine peel may be 10.0 parts, 10.5 parts, 11.0 parts, 11.5 parts, 12.0 parts, 12.5 parts, 13.0 parts, 13.5 parts, 14.0 parts, 14.5 parts, 15.0 parts, etc.

[0037] In some specific embodiments, the weight parts of the alligator beak flower can be 10.0 parts, 10.5 parts, 11.0 parts, 11.5 parts, 12.0 parts, 12.5 parts, 13.0 parts, 13.5 parts, 14.0 parts, 14.5 parts, 15.0 parts, etc.

[0038] In some specific embodiments, the weight parts of Bupleurum chinense can be 8.0 parts, 8.5 parts, 9.0 parts, 9.5 parts, 10.0 parts, 10.5 parts, 11.0 parts, 11.5 parts, 12.0 parts, etc.

[0039] In some specific embodiments, the weight parts of Poria cocos can be 5.0 parts, 5.5 parts, 6.0 parts, 6.5 parts, 7.0 parts, 7.5 parts, 8.0 parts, 8.5 parts, 9.0 parts, 9.5 parts, 10.0 parts, etc.

[0040] In some specific embodiments, the weight parts of Curcuma zedoaria may be 5.0 parts, 5.5 parts, 6.0 parts, 6.5 parts, 7.0 parts, 7.5 parts, 8.0 parts, 8.5 parts, 9.0 parts, 9.5 parts, 10.0 parts, etc.

[0041] In some specific embodiments, the weight portions of the narrow-base patterned fragrant tea vegetable can be 3.0 parts, 3.5 parts, 4.0 parts, 4.5 parts, 5.0 parts, 5.5 parts, 6.0 parts, 6.5 parts, 7.0 parts, etc.

[0042] Preferably, the weight ratio of the perilla stem to the cyperus rhizome is 1.4.

[0043] Further research by the inventors of this application revealed that when the weight ratio of the Perilla stem and the Cyperus rhizome is controlled to be 1.4, the resulting traditional Chinese medicine composition has a better therapeutic effect on chronic atrophic gastritis.

[0044] More preferably, the traditional Chinese medicine composition for treating chronic atrophic gastritis comprises the following components in parts by weight: Perilla stem 42.7 parts, Cyperus rhizome 30.5 parts, dried tangerine peel 12 parts, alligator beak flower 12 parts, Bupleurum root 10 parts, Poria cocos 7.5 parts, Curcuma zedoaria 7.5 parts, and narrow-based striped fragrant tea leaves 5 parts.

[0045] It should be noted that, unless otherwise specified or indicated, all raw materials used in the traditional Chinese medicine composition for treating chronic atrophic gastritis provided in this application embodiment can be commercially available products.

[0046] Secondly, based on a general inventive concept, this application provides a method for preparing the traditional Chinese medicine composition for treating chronic atrophic gastritis as described in any one of the first aspects, such as... Figure 1 As shown, the preparation method includes the following steps: The following herbs were crushed and mixed to obtain a traditional Chinese medicine mixture: Perilla stem, Cyperus rhizome, dried tangerine peel, alligator beak flower, Bupleurum root, Poria cocos, Curcuma rhizome, and narrow-based striped tea leaves. The Chinese herbal mixture was added to water for a first vacuum reflux extraction, followed by filtration to obtain a first extract and herbal residue. The dregs were added to water for a second vacuum reflux extraction, followed by filtration to obtain a second extract. The first extract and the second extract were concentrated and dried to obtain the traditional Chinese medicine composition for treating chronic atrophic gastritis.

[0047] The method for preparing the traditional Chinese medicine composition for treating chronic atrophic gastritis provided in this application is simple to operate, requires no additional specific equipment, and is suitable for industrial production. Furthermore, this method for preparing the traditional Chinese medicine composition for treating chronic atrophic gastritis is based on the traditional Chinese medicine composition for treating chronic atrophic gastritis described in any one of the first aspects above, and therefore possesses at least all the beneficial effects brought about by the technical solutions of the above embodiments, which will not be elaborated upon here.

[0048] In some specific embodiments, the working conditions parameters of the first depressurized reflux extraction include: temperature of 34~44℃, pressure of 4~8kPa, time of 1~2 hours, number of extractions of 1~3 times, and the weight of water added is 5~10 times the weight of the Chinese herbal medicine mixture.

[0049] Further research by the inventors of this application revealed that when the first depressurization reflux extraction is controlled within the above-mentioned parameter range, the resulting traditional Chinese medicine composition has a better therapeutic effect on chronic atrophic gastritis.

[0050] In some specific embodiments, the working conditions parameters for the second depressurized reflux extraction include: a temperature of 70~78℃, a pressure of 22~40kPa, a time of 1~2 hours, a number of extractions of 1~3 times, and the weight of water added being 5~10 times the weight of the herbal mixture.

[0051] Further research by the inventors of this application revealed that when the second decompression reflux extraction was controlled within the aforementioned parameter range, the resulting traditional Chinese medicine composition exhibited better therapeutic effects on chronic atrophic gastritis.

[0052] Preferably, the working conditions for the first depressurized reflux extraction include: a temperature of 40°C, a pressure of 6 kPa, a time of 1 to 2 hours, a number of extractions of 1 to 3 times, and the weight of water added being 5 to 10 times the weight of the herbal mixture.

[0053] Preferably, the working conditions for the second vacuum reflux extraction include: a temperature of 75°C, a pressure of 30 kPa, a time of 1 to 2 hours, a number of extractions of 1 to 3 times, and the weight of water added being 5 to 10 times the weight of the herbal mixture.

[0054] It should be noted that, unless otherwise specified or specifically described, the operation steps and parameters involved in the preparation process of the traditional Chinese medicine composition for treating chronic atrophic gastritis provided in the embodiments of this application can be carried out in accordance with existing preparation processes or using existing equipment.

[0055] Thirdly, based on a general inventive concept, this application provides the use of the traditional Chinese medicine composition for treating chronic atrophic gastritis as described in any one of the first aspects, or the traditional Chinese medicine composition for treating chronic atrophic gastritis prepared by the preparation method described in any one of the second aspects, in the preparation of a drug for treating chronic atrophic gastritis.

[0056] In some specific embodiments, the dosage form of the drug for treating chronic atrophic gastritis includes at least one of liquid formulations, solid capsules, solid tablets, and solid granules.

[0057] The present application is further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the application. Experimental methods in the following embodiments that do not specify specific conditions are generally determined according to national standards. If there is no corresponding national standard, then general international standards, conventional conditions, or conditions recommended by the manufacturer are followed.

[0058] Example 1

[0059] This example provides a traditional Chinese medicine composition for treating chronic atrophic gastritis. By weight, the traditional Chinese medicine composition for treating chronic atrophic gastritis comprises the following components: Perilla stem 42.7 parts, Cyperus rhizome 30.5 parts, dried tangerine peel 12 parts, alligator beak flower 12 parts, Bupleurum root 10 parts, Poria cocos 7.5 parts, Curcuma zedoaria 7.5 parts, and narrow-based striped fragrant tea leaves 5 parts.

[0060] The preparation method of the above-mentioned traditional Chinese medicine composition includes the following steps: The following herbs were crushed and mixed to obtain a traditional Chinese medicine mixture: Perilla stem, Cyperus rhizome, dried tangerine peel, alligator beak flower, Bupleurum root, Poria cocos, Curcuma rhizome, and narrow-based striped tea leaves. The Chinese herbal mixture was added to water for a first vacuum reflux extraction, followed by filtration to obtain a first extract and herbal residue. The dregs were added to water for a second vacuum reflux extraction, followed by filtration to obtain a second extract. The first extract and the second extract were concentrated and dried to constant weight to obtain the traditional Chinese medicine composition for treating chronic atrophic gastritis. The working conditions for the first vacuum reflux extraction include: a temperature of 40°C, a pressure of 6 kPa, a time of 1.5 hours, two extractions, and water added at a weight of 8 times the weight of the herbal mixture. The working conditions for the second vacuum reflux extraction include: a temperature of 75°C, a pressure of 30 kPa, a time of 1.5 hours, two extractions, and water added at a weight of 5 times the weight of the herbal mixture.

[0061] Example 2

[0062] This example provides a traditional Chinese medicine composition for treating chronic atrophic gastritis. By weight, the traditional Chinese medicine composition for treating chronic atrophic gastritis comprises the following components: 45 parts of Perilla stem, 35 parts of Cyperus rhizome, 15 parts of dried tangerine peel, 15 parts of alligator beak flower, 12 parts of Bupleurum root, 10 parts of Poria cocos, 10 parts of Curcuma zedoaria, and 7 parts of narrow-based striped fragrant tea leaves.

[0063] The preparation method of the above-mentioned traditional Chinese medicine composition includes the following steps: The following herbs were crushed and mixed to obtain a traditional Chinese medicine mixture: Perilla stem, Cyperus rhizome, dried tangerine peel, alligator beak flower, Bupleurum root, Poria cocos, Curcuma rhizome, and narrow-based striped tea leaves. The Chinese herbal mixture was added to water for a first vacuum reflux extraction, followed by filtration to obtain a first extract and herbal residue. The dregs were added to water for a second vacuum reflux extraction, followed by filtration to obtain a second extract. The first extract and the second extract were concentrated and dried to constant weight to obtain the traditional Chinese medicine composition for treating chronic atrophic gastritis. The working conditions for the first vacuum reflux extraction include: a temperature of 34°C, a pressure of 4 kPa, a time of 2 hours, a number of extractions of 2, and the weight of water added being 5 times the weight of the herbal mixture. The working conditions for the second vacuum reflux extraction include: a temperature of 70°C, a pressure of 22 kPa, a time of 2 hours, a number of extractions of 2, and the weight of water added being 5 times the weight of the herbal mixture.

[0064] Example 3

[0065] This example provides a traditional Chinese medicine composition for treating chronic atrophic gastritis. By weight, the traditional Chinese medicine composition for treating chronic atrophic gastritis comprises the following components: 35 parts of Perilla stem, 25 parts of Cyperus rhizome, 10 parts of dried tangerine peel, 10 parts of alligator beak flower, 8 parts of Bupleurum root, 5 parts of Poria cocos, 5 parts of Curcuma zedoaria, and 3 parts of narrow-based variegated tea leaves.

[0066] The preparation method of the above-mentioned traditional Chinese medicine composition includes the following steps: The following herbs were crushed and mixed to obtain a traditional Chinese medicine mixture: Perilla stem, Cyperus rhizome, dried tangerine peel, alligator beak flower, Bupleurum root, Poria cocos, Curcuma rhizome, and narrow-based striped tea leaves. The Chinese herbal mixture was added to water for a first vacuum reflux extraction, followed by filtration to obtain a first extract and herbal residue. The dregs were added to water for a second vacuum reflux extraction, followed by filtration to obtain a second extract. The first extract and the second extract were concentrated and dried to constant weight to obtain the traditional Chinese medicine composition for treating chronic atrophic gastritis. The working conditions for the first vacuum reflux extraction include: a temperature of 44°C, a pressure of 8 kPa, a time of 1 hour, and 2 extractions, with the weight of water added being 10 times the weight of the herbal mixture; the working conditions for the second vacuum reflux extraction include: a temperature of 78°C, a pressure of 40 kPa, a time of 1 hour, and 2 extractions, with the weight of water added being 10 times the weight of the herbal mixture.

[0067] Comparative Example 1 This example provides a traditional Chinese medicine composition and its preparation method, which differs from Example 1 only in that the dosage relationship of the principal herb is changed, namely: (1) The weight of perilla stems was adjusted to 30.5 parts; (2) The weight of Cyperus rotundus was adjusted to 42.7 parts.

[0068] Comparative Example 2 This example provides a traditional Chinese medicine composition and its preparation method, which differs from Example 1 only in that the components of the assistant and adjuvant drugs are changed, namely: (1) The weight of the alligator beak flower was adjusted to 0 parts; (2) The weight of the narrow-base patterned tea vegetable was adjusted to 0 parts.

[0069] Comparative Example 3 This example provides a traditional Chinese medicine composition and its preparation method, which differs from Example 1 only in that the extraction temperature in the preparation method is changed, namely: (1) The temperature of the first vacuum reflux extraction was adjusted to 55℃; (2) The temperature of the second depressurization reflux extraction was adjusted to 85℃.

[0070] Test Example 1 In this example, an animal model of chronic atrophic gastritis was established according to the methods disclosed in the prior art, in order to examine the therapeutic effects of the traditional Chinese medicine compositions obtained in Examples 1-3 and Comparative Examples 1-3 on chronic atrophic gastritis.

[0071] The testing method is as follows: (1) Modeling: Healthy male Wistar rats were selected and given 50 μg / mL methyl-nitro-nitrosoguanidine for drinking. The solution was changed every 24 hours. No other drinking water was provided during this period. Ranitidine hydrochloride solution prepared with distilled water at a concentration of 3 mg / mL was administered by gavage at a dose of 0.03 g / (kg·rat) once a day. The rats were fed for 2 days and fasted for 1 day for a total of 24 weeks to establish a chronic atrophic gastritis model.

[0072] (2) Test grouping: 80 rats were divided into 8 groups of 10 each. One group was set as the normal control group, which was fed a normal diet (rats without modeling). The other group was set as the model control group. The rats were modeled using the above modeling method without any drugs. The remaining groups were modeled using the above modeling method. The rats were given the Chinese medicine compositions obtained in Examples 1-3 and Comparative Examples 1-3 by gavage. The gavage dose was 3g / (kg·rats) once a day until the modeling was completed.

[0073] (3) Data detection and statistics: The levels of lipid peroxides (LPO) and superoxide dismutase (SOD) in rat serum were detected using the thiobarbituric acid (TBA) colorimetric method and the modified NBT method (based on the NBT method, xanthine oxidase system was added, and the absorbance was measured at 560 nm after reaction in a 37℃ water bath). In addition, a 1 mm × 1 mm piece of gastric antrum mucosa was excised from a fresh rat gastric specimen, and the mucosal muscle thickness was measured in 5 randomly selected fields under a high-power microscope. The results are summarized in Table 1, and the data are expressed as mean ± standard deviation (x ± s).

[0074]

[0075] As shown in Table 1, compared with the normal control group, the LPO value of rats in the model control group increased and the SOD activity decreased after modeling, and the gastric mucosa underwent severe changes, indicating that the modeling was successful. In addition, compared with comparative examples 1-3, the rats given the traditional Chinese medicine composition provided in Examples 1-3 of this application showed a more significant decrease in LPO value, higher SOD activity, and significantly reduced mucosal muscle thickness, indicating that the traditional Chinese medicine composition provided in this application has a more significant therapeutic effect on chronic atrophic gastritis.

[0076] Test Example 2 In this example, the traditional Chinese medicine composition provided in Example 1 was prepared into traditional Chinese medicine granules (using wet granulation, with excipients of sucrose, dextrin and mannitol, meeting the requirements of the Chinese Pharmacopoeia for granules; packaged in bags, with a specification of 12g / bag) for clinical research.

[0077] 1. General information of the subjects Inclusion criteria for subjects: (1) meeting the Western medicine diagnosis of chronic gastritis in China (2017, Shanghai); (2) mucosal pathological histological changes found by endoscopic diagnosis, pathological diagnosis or special imaging methods, belonging to mild / moderate non-metaplastic atrophy or mild / moderate intestinal metaplasia; (3) age between 25 and 65 years old (including the boundary value), gender not limited; (4) meeting the liver-stomach disharmony syndrome (including liver-stomach qi stagnation syndrome and liver-stomach heat stagnation syndrome) in the traditional Chinese medicine syndrome differentiation of chronic atrophic gastritis (2017). (5) voluntarily participating in the trial and signing the informed consent form.

[0078] Exclusion criteria for subjects: (1) Patients with known malignant tumors or intraepithelial neoplasia (dysplasia) and more serious lesions; (2) Pregnant or planning to become pregnant; (pregnant, lactating women or patients of childbearing potential (male or female) who plan to conceive within 3 months from the first use of the drug until the end of the trial); (3) Patients who have previously undergone gastric-related surgery or suffered major trauma; (4) Patients with current Helicobacter pylori infection; (5) Patients with hyperthyroidism, severe chronic heart, liver, kidney dysfunction and immunodeficiency; (6) Patients with major mental illness who have difficulty controlling their actions and are unable to cooperate; (7) Patients who have taken other drugs that may affect the results of this trial within the past month, such as prokinetic drugs, antibiotics, probiotics, etc.; (8) Patients who are currently participating in other clinical trials; (9) Patients with allergic constitution or allergy to the ingredients of this product; (10) Other factors that may affect the results of this trial or those who are deemed unsuitable for the trial by the investigator.

[0079] A total of 62 subjects were enrolled in this trial, divided into a traditional Chinese medicine group (n=31) and a Western medicine group (n=31). Among the enrolled subjects, 27 were male (43.55%) and 35 were female (56.45%). In the traditional Chinese medicine group, 16 were male (51.61%) and 15 were female (48.39%), while in the Western medicine group, 11 were male (35.48%) and 20 were female (64.52%). There was no statistically significant difference in gender between the two groups (P=0.2003>0.05). The mean age of all enrolled subjects was 53.9 years. The average age of the subjects was 8 ± 9.18 years. The mean age of the subjects in the traditional Chinese medicine group was 55.94 ± 7.42 years, and the mean age of the subjects in the Western medicine group was 52.03 ± 10.41 years. There was no statistically significant difference in age between the two groups (P = 0.0944 > 0.05). The mean duration of participation for all enrolled subjects was 186.19 ± 23.84 days. The mean duration of participation for the subjects in the traditional Chinese medicine group was 178.29 ± 24.97 days, and the mean duration of participation for the subjects in the Western medicine group was 194.10 ± 20.08 days. There was a statistically significant difference in duration of participation between the two groups (P = 0.0079 < 0.05).

[0080] 2. Grouping and Drug Administration Traditional Chinese Medicine Group: The traditional Chinese medicine composition provided in Example 1 was prepared into granules, dissolved in boiling water, one sachet at a time, twice a day, morning and evening; Western Medicine Group: Teprenone capsules (Shiweishu) were taken, 3 capsules each time, three times a day after meals. Both the experimental and control groups received their medication on the day of enrollment and continued for 12 weeks. During the treatment period, both groups were advised to avoid spicy, cold, and greasy foods as much as possible, while respecting the subjects' dietary habits.

[0081] 3. Some test results are as follows: The rates of disappearance of upper abdominal (stomach) fullness after 12 weeks of medication, disappearance of belching after 12 weeks after the end of medication, and disappearance of all symptoms after 12 weeks after the end of medication were significantly better in the traditional Chinese medicine group than in the western medicine control group. Details are as follows: 3.1) The disappearance rate of the main symptom, upper abdominal (stomach) distension, was 78.57% in the traditional Chinese medicine group and 33.33% in the Western medicine group after 12 weeks of medication. The difference between the two groups was statistically significant (P=0.0199<0.05).

[0082] 3.2) The disappearance rate of the main symptom, belching, was 89.47% in the traditional Chinese medicine group and 60.00% in the Western medicine group 12 weeks after the end of medication. The difference between the two groups was statistically significant (P=0.0443<0.05).

[0083] 3.3) The disappearance rate of all main symptoms 12 weeks after the end of medication was 58.62% in the traditional Chinese medicine group and 29.03% in the Western medicine group. The difference between the two groups was statistically significant (P=0.0208<0.05).

[0084] The test results above show that the traditional Chinese medicine composition for treating chronic atrophic gastritis provided in this application has a better therapeutic effect compared with the Western medicine control group.

[0085] In summary, this application provides a traditional Chinese medicine composition for treating chronic atrophic gastritis, its preparation method, and its application. This application uses a suitable ratio of Perilla stem and Cyperus rhizome as the principal herbs, combined with Citrus reticulata peel, Eriocaulon buergerianum, and Bupleurum chinense as the assistant herbs, and Poria cocos, Curcuma zedoaria, and Scutellaria baicalensis as adjuvant herbs. The combined use of these herbs treats both the symptoms and the root cause, resulting in a significant therapeutic effect on chronic atrophic gastritis and providing a new treatment option for patients with chronic atrophic gastritis.

[0086] Various embodiments of this application may exist in the form of a range; it should be understood that the description in the form of a range is merely for convenience and brevity and should not be construed as a hard limitation on the scope of this application; therefore, it should be considered that the range description has specifically disclosed all possible sub-ranges and single numerical values ​​within that range. For example, it should be considered that the range description from 1 to 6 has specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and single numbers within the range, such as 1, 2, 3, 4, 5, and 6, regardless of the range. Furthermore, whenever a numerical range is referred to herein, it means including any referenced number (fraction or integer) within the referred range.

[0087] The above description is merely a specific embodiment of this application, enabling those skilled in the art to understand or implement this application. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of this application. Therefore, this application is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A traditional Chinese medicine composition for treating chronic atrophic gastritis, characterized in that, The traditional Chinese medicine composition for treating chronic atrophic gastritis comprises the following components in parts by weight: Perilla stem 35-45 parts, Cyperus rhizome 25-35 parts, dried tangerine peel 10-15 parts, alligator beak flower 10-15 parts, Bupleurum root 8-12 parts, Poria cocos 5-10 parts, Curcuma zedoaria 5-10 parts, and narrow-based striped fragrant tea leaves 3-7 parts.

2. The traditional Chinese medicine composition for treating chronic atrophic gastritis according to claim 1, characterized in that, The weight ratio of the perilla stem to the cyperus rhizome is 1.

4.

3. The traditional Chinese medicine composition for treating chronic atrophic gastritis according to claim 1, characterized in that, The traditional Chinese medicine composition for treating chronic atrophic gastritis comprises the following components in parts by weight: Perilla stem 42.7 parts, Cyperus rhizome 30.5 parts, dried tangerine peel 12 parts, alligator beak flower 12 parts, Bupleurum root 10 parts, Poria cocos 7.5 parts, Curcuma zedoaria 7.5 parts, and narrow-based striped fragrant tea leaves 5 parts.

4. A method for preparing a traditional Chinese medicine composition for treating chronic atrophic gastritis according to any one of claims 1 to 3, characterized in that, The preparation method includes the following steps: The following herbs were crushed and mixed to obtain a traditional Chinese medicine mixture: Perilla stem, Cyperus rhizome, dried tangerine peel, alligator beak flower, Bupleurum root, Poria cocos, Curcuma rhizome, and narrow-based striped tea leaves. The Chinese herbal mixture was added to water for a first vacuum reflux extraction, followed by filtration to obtain a first extract and herbal residue. The dregs were added to water for a second vacuum reflux extraction, followed by filtration to obtain a second extract. The first extract and the second extract were concentrated and dried to obtain the traditional Chinese medicine composition for treating chronic atrophic gastritis.

5. The preparation method according to claim 4, characterized in that, The working conditions for the first depressurized reflux extraction include: temperature of 34~44℃, pressure of 4~8kPa, time of 1~2 hours, number of extractions of 1~3, and the weight of water added is 5~10 times the weight of the herbal mixture.

6. The preparation method according to claim 4, characterized in that, The working conditions for the second depressurized reflux extraction include: a temperature of 70-78°C, a pressure of 22-40 kPa, a time of 1-2 hours, a number of extractions of 1-3 times, and water added at a weight of 5-10 times the weight of the herbal mixture.

7. The preparation method according to claim 4, characterized in that, The working conditions for the first depressurized reflux extraction include: a temperature of 40°C, a pressure of 6 kPa, a time of 1 to 2 hours, a number of extractions of 1 to 3 times, and the weight of water added being 5 to 10 times the weight of the herbal mixture.

8. The preparation method according to claim 4, characterized in that, The working conditions for the second depressurized reflux extraction include: a temperature of 75°C, a pressure of 30 kPa, a time of 1 to 2 hours, a number of extractions of 1 to 3 times, and the weight of water added being 5 to 10 times the weight of the herbal mixture.

9. The use of a traditional Chinese medicine composition for treating chronic atrophic gastritis according to any one of claims 1 to 3, or a traditional Chinese medicine composition for treating chronic atrophic gastritis prepared by any one of claims 4 to 8, in the preparation of a drug for treating chronic atrophic gastritis.

10. The application according to claim 9, characterized in that, The dosage form of the drug for treating chronic atrophic gastritis includes at least one of liquid formulations, solid capsules, solid tablets, and solid granules.

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