Traditional Chinese medicine composition and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition and application thereof, raw material medicines of the traditional Chinese medicine composition comprise first raw material medicines, and the first raw material medicines comprise 10-40 parts by weight of mangnolia officinalis, 10-60 parts by weight of astragalus membranaceus, 10-40 parts by weight of bighead atractylodes rhizome, 10-40 parts by weight of curcuma zedoary, 5-40 parts by weight of rhizoma bletillae and 5-40 parts by weight of rhizoma zingiberis; the raw material medicine of the traditional Chinese medicine composition further comprises a second raw material medicine, and the second raw material medicine is pseudo-ginseng; the weight ratio of the first raw material medicine to the second raw material medicine is (15-17): (1-12). The traditional Chinese medicine composition can effectively relieve digestive tract discomfort symptoms caused by chronic atrophic gastritis, can effectively improve the pathological state of gastrointestinal tract tissues, reverses the pathological states of stomach tissue atrophy, intestinal metaplasia and / or dysplasia and the like, relieves gastrointestinal tract disease symptoms such as poor appetite, abdominal distension, fullness, belching, sour regurgitation and heartburn in the past, and improves the curative effect of chronic atrophic gastritis. And the traditional Chinese medicine composition is simple in taking method, low in dosage and high in clinical value.

Description

[0001] Priority Information

[0002] The present application claims priority to the Chinese patent application No. 2024110877333, filed on August 8, 2024, and entitled "A Traditional Chinese Medicine Composition and Applications Thereof", the contents of which are incorporated herein by reference in its entirety. TECHNICAL FIELD

[0003] The present application relates to the field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition and applications thereof. BACKGROUND

[0004] Chronic atrophic gastritis (CAG) is an inflammatory disease characterized by a decrease in the number of gastric mucosal epithelial cells and structural degeneration and atrophy of the gastric glands. It is a precancerous condition that is closely related to the development of gastric cancer. It is a long-term and recurrent condition that is difficult to cure. Chronic atrophic gastritis is an important stage in the progression of chronic gastritis to gastric cancer according to the Correa model. It is the result of the combined effects of Helicobacter pylori (Hp) infection, environmental and genetic factors. It is often associated with intestinal metaplasia, and a small number of cases have dysplasia. It undergoes long-term evolution, and a small number of cases can develop into gastric cancer.

[0005] Chronic atrophic gastritis is a common clinical disease with high incidence and canceration tendency, but there is no effective treatment in modern medicine. The treatment of chronic gastritis by western medicine mainly eliminates the factors causing chronic gastritis, such as Hp infection, bile reflux, gastroesophageal reflux and other reasons, and gives different treatment schemes for different types and conditions. Related studies have shown that: (1) Hp infection is a common factor of chronic gastritis, and Hp must be eradicated. Studies have shown that more than 50% of humans are infected with Hp, and the classic antibacterial treatment method includes first-line “triple therapy” and second-line “quadruple therapy”, that is, PPI + bismuth agent + (amoxicillin / metronidazole / clarithromycin) two antibiotics, due to the increase of the body's resistance to antibiotics, quadruple therapy has become the preferred method for eradicating Hp at present. (2) Acid suppression therapy, gastric acid is one of the stimulating factors, and inhibiting the secretion of gastric acid is the main measure for the treatment of chronic gastritis, and the drugs for inhibiting the secretion of gastric acid mainly include proton pump inhibitors and H2 receptor blockers, but due to their greater side effects, they need to be used normatively. (3) Protect the gastric mucosa, including mucus protectants, gastric mucosa repair agents and local analgesics, gastric mucosa repair agents can promote the proliferation and secretion of mucosal cells and improve their resistance to gastric acid, such as aluminum phosphate gel combined with omeprazole sodium bicarbonate capsules, which can well reduce the level of inflammation and protect the gastric mucosa. (4) Due to the repeated occurrence of chronic gastritis, patients will gradually develop unhealthy minds such as anxiety and depression, which will have an undeniable impact on the diagnosis and prognosis of chronic gastritis. For patients with anxiety, depression and other symptoms, psychological treatment or deep breathing, exercise, distraction and other methods can be sought, such as oral amitriptyline and paroxetine, etc. (5) Surgical treatment, for patients with refractory ulcers with inflammation, ulcer bleeding and perforation, duodenal bulb stenosis and other patients, appropriate surgical treatment can be taken, and postoperative rest and nutritional support should be paid attention to to prevent complications. In short, the treatment of chronic gastritis by western medicine has the disadvantages of large side effects, easy recurrence and many adverse reactions. Clinical results show that traditional Chinese medicine can relieve the symptoms of chronic gastritis such as indigestion, and may even help improve the pathological condition of the gastric mucosa.

[0006] In addition, a number of studies have found that intestinal metaplasia can be reversed to some extent through long-term follow-up. Studies have shown that the overall histological improvement cumulative risk of intestinal metaplasia reversal fluctuates between 19.4% and 29.7% at 1, 3 and 5 years of follow-up. In summary, it is still necessary to seek new treatment methods.

[0007] "intestinal metaplasia" is referred to as "intestinal metaplasia", which refers to the appearance of cells similar to intestinal mucosa in the gastric mucosa epithelium when chronic superficial gastritis develops into chronic atrophic gastritis, so that the secretion function of normal gastric mucosa is changed into absorption function. Studies have shown that the gastric mucosa of patients with chronic atrophic gastritis continuously absorbs harmful substances or cannot remove harmful substances in time, especially carcinogens, which are long-term accumulated in the gastric mucosa, and finally lead to canceration. There is no specific treatment for intestinal metaplasia, and general symptomatic treatment methods such as eradication of Helicobacter pylori (when infected), COX-2 inhibitor treatment, antioxidant or vitamin supplementation are used, but it is difficult to achieve "reversal" of intestinal metaplasia.

[0008] Therefore, the development of traditional Chinese medicine for treating chronic atrophic gastritis symptoms and / or reversing gastric tissue atrophy, intestinal metaplasia and / or dysplasia is of great significance for the clinical treatment of chronic atrophic gastritis. SUMMARY

[0009] The present application aims to at least solve one of the technical problems in the prior art. To this end, the present application provides a traditional Chinese medicine composition which can effectively relieve the symptoms of digestive tract discomfort caused by chronic atrophic gastritis, effectively improve the pathological state of the gastrointestinal tract, reverse the pathological state of gastric tissue atrophy, intestinal metaplasia and / or dysplasia, and relieve the symptoms of anorexia, abdominal distension, fullness, belching, acid reflux and other gastrointestinal diseases, and relieve anxiety, weakness and other sub-health symptoms. The method of taking is simple, the amount of taking is low, and the clinical value is high.

[0010] It should be stated that the present application is based on the following work of the inventor:

[0011] CAG belongs to the category of "fullness", "stomach pain" and "acid vomiting" in traditional Chinese medicine, and is often related to the invasion of external pathogens, improper diet, emotional disorders, overwork, weak constitution, drug stimulation, etc. The "Consensus on Diagnosis and Treatment of Chronic Atrophic Gastritis in Combination of Traditional Chinese and Western Medicine (2017)" divides it into liver and stomach qi stagnation, liver and stomach heat, spleen and stomach weakness (spleen and stomach cold), spleen and stomach dampness, stomach yin deficiency, and stomach collateral blood stasis. More than 20 years of clinical research shows that CAG has many causes, a prolonged course, and a complex pathogenesis of virtual and real, cold and heat, and the composite syndrome is obviously more than the single syndrome. At present, the Chinese patent medicine for treating CAG is mainly aimed at virtual and real lesions, and there is no patent medicine for the production of cold and heat and virtual and real syndromes, which cannot provide effective treatment drugs for such patients.

[0012] The inventors combine rich clinical diagnosis and treatment experience, and propose the Chinese medicinal composition for complex syndromes of cold, heat, deficiency and excess. Long-term clinical treatment results show that the Chinese medicinal composition can obviously reverse CAG accompanied by intestinal epithelial metaplasia and dysplasia and / or dysplasia, thereby slowing down and inhibiting the malignant progression of CAG to gastric cancer.

[0013] Therefore, in the first aspect of the present application, the present application proposes a Chinese medicinal composition. According to an embodiment of the present application, the raw materials of the Chinese medicinal composition include a first raw material, which includes: 10-40 parts by weight of Houpu, 15-60 parts by weight of Huangqi, 10-40 parts by weight of Baishu, 10-40 parts by weight of E'zhu, 10-40 parts by weight of Baiji, and 10-40 parts by weight of Ganjiang; the raw materials of the Chinese medicinal composition further include a second raw material, which is Sanqi; and the weight ratio of the first raw material to the second raw material is (15-17):(1-12). The Chinese medicinal composition of the present application can effectively treat chronic atrophic gastritis, relieve digestive tract discomfort symptoms caused by chronic atrophic gastritis, improve the pathological state of the gastrointestinal tract, reverse pathological states such as atrophy of the stomach tissue, intestinal metaplasia and / or dysplasia, relieve symptoms such as poor appetite, abdominal distension, fullness, belching, acid reflux, heartburn and other gastrointestinal diseases, relieve symptoms such as anxiety, weakness and other sub-health symptoms, has a simple taking method, a low taking amount, and a high clinical value.

[0014] According to an embodiment of the present application, the raw materials of the Chinese medicinal composition include a first raw material, which includes: 10-40 parts by weight of Houpu, 15-60 parts by weight of Huangqi, 10-40 parts by weight of Baishu, 10-40 parts by weight of E'zhu, 10-40 parts by weight of Baiji, and 10-40 parts by weight of Ganjiang; the raw materials of the Chinese medicinal composition further include a second raw material, which is Sanqi; and the weight ratio of the first raw material to the second raw material is (16-18):(1-12). The Chinese medicinal composition of the present application has a significant effect in treating gastrointestinal diseases clinically, can effectively improve the pathological state of the gastrointestinal tract (such as improving the atrophy of the stomach tissue, reversing pathological states such as intestinal metaplasia and / or dysplasia), has a simple taking method, a low taking amount, and a high clinical application value.

[0015] According to an embodiment of the present application, the raw material of the traditional Chinese medicine composition comprises a first raw material, and the first raw material comprises: 10-40 parts by weight of Magnolia officinalis, 10-60 parts by weight of Astragalus membranaceus, 10-40 parts by weight of Atractylodes macrocephala, 10-40 parts by weight of Curcuma zedoaria, 5-40 parts by weight of Bletilla striata, and 5-40 parts by weight of Zingiber officinale. The raw material of the traditional Chinese medicine composition further comprises a second raw material, and the second raw material is Panax notoginseng. The weight ratio of the first raw material and the second raw material is (15-17):(1-12). The traditional Chinese medicine composition of the present application can effectively treat chronic atrophic gastritis, relieve the digestive tract discomfort symptoms caused by chronic atrophic gastritis, improve the pathological state of the gastrointestinal tract, reverse the pathological state of atrophy, intestinal metaplasia and / or dysplasia of the stomach tissue, relieve the symptoms of anorexia, abdominal distension, bloating, belching, acid reflux, heartburn and other gastrointestinal diseases, relieve anxiety, and other sub-health symptoms. The method of taking is simple, the dosage is low, and the clinical value is high.

[0016] Exemplarily, the weight ratio of the first raw material and the second raw material is (15-17):1, (15-17):2, (15-17):3, (15-17):4, (15-17):5, (15-17):6, (15-17):7, (15-17):8, (15-17):9, (15-17):10, (15-17):11, or (15-17):12.

[0017] According to an embodiment of the present application, the first raw material comprises: 15-25 parts by weight of Magnolia officinalis, 25-35 parts by weight of Astragalus membranaceus, 10-20 parts by weight of Atractylodes macrocephala, 10-20 parts by weight of Curcuma zedoaria, 5-15 parts by weight of Bletilla striata, and 5-15 parts by weight of Zingiber officinale. The inventors have summarized the above-mentioned preferable components through a large number of clinical experiences. Thus, the traditional Chinese medicine composition according to the embodiment of the present application can further improve the treatment effect of chronic atrophic gastritis.

[0018] According to an embodiment of the present application, the first raw material comprises: 15-25 parts by weight of Magnolia officinalis, 10-35 parts by weight of Astragalus membranaceus, 10-20 parts by weight of Atractylodes macrocephala, 10-20 parts by weight of Curcuma zedoaria, 5-20 parts by weight of Bletilla striata, and 5-15 parts by weight of Zingiber officinale. The inventors have summarized the above-mentioned preferable components through a large number of clinical experiences. Thus, the traditional Chinese medicine composition according to the embodiment of the present application can further improve the treatment effect of chronic atrophic gastritis.

[0019] According to an embodiment of the present application, the first raw material comprises: 20 parts by weight of Magnolia officinalis, 30 parts by weight of Astragalus membranaceus, 15 parts by weight of Atractylodes macrocephala, 15 parts by weight of Curcuma zedoaria, 10 parts by weight of Bletilla striata, and 10 parts by weight of Zingiber officinale. The inventors have determined the above-mentioned preferable components through a large number of clinical experiences. Thus, the traditional Chinese medicine composition according to the embodiment of the present application can effectively treat chronic atrophic gastritis, significantly reverse chronic atrophic gastritis accompanied by intestinal metaplasia and dysplasia, and slow down and inhibit the malignant progression of chronic atrophic gastritis to gastric cancer.

[0020] According to the embodiment of the present application, the first raw medicine comprises: 15 parts by weight of Magnolia officinalis, 10 parts by weight of Astragalus, 15 parts by weight of Atractylodes, 15 parts by weight of Curcuma, 10 parts by weight of Bletilla, and 10 parts by weight of Zingiber. The inventor determines this preferred formula through a large number of clinical experiences, which can effectively treat chronic atrophic gastritis, significantly reverse intestinal metaplasia and dysplasia caused by chronic atrophic gastritis, and slow down and inhibit the malignant process of transformation of chronic atrophic gastritis to gastric cancer.

[0021] According to the embodiment of the present application, the first raw medicine comprises: 15 parts by weight of Magnolia officinalis, 10 parts by weight of Astragalus, 15 parts by weight of Atractylodes, 15 parts by weight of Curcuma, 10 parts by weight of Bletilla, and 10 parts by weight of Zingiber. The inventor determines this preferred formula through a large number of clinical experiences, which can effectively treat chronic atrophic gastritis, significantly reverse intestinal metaplasia and dysplasia caused by chronic atrophic gastritis, and slow down and inhibit the malignant process of transformation of chronic atrophic gastritis to gastric cancer.

[0022] According to the embodiment of the present application, the weight ratio of the first raw medicine and the second raw medicine is (16-18):(4-8), preferably (16-18):(5-6). Thus, the traditional Chinese medicine composition of the present application can further improve the treatment effect of chronic atrophic gastritis.

[0023] According to the embodiment of the present application, the weight ratio of the first raw medicine and the second raw medicine is (15-17):(1-8), preferably (15-17):(2-6). Thus, the traditional Chinese medicine composition of the present application can further improve the treatment effect of chronic atrophic gastritis.

[0024] Exemplarily, the weight ratio of the first raw medicine and the second raw medicine is 15:2, 15:3, 15:4, 15:5, 15:6, 16:1, 16:2, 16:3, 16:4, 16:5, 16:6, 17:1, 17:2, 17:3, 17:4, 17:5, 17:6.

[0025] According to an embodiment of the present invention, the first raw material further includes at least one of the following: 15-25 parts by weight of Citrus aurantium, 15-60 parts by weight of Ostrea gigas, and 10-40 parts by weight of Dendrobium nobile. Citrus aurantium, being bitter, pungent, and slightly cold, promotes qi circulation and relieves stagnation. Combined with Magnolia officinalis, which also promotes qi circulation and relieves fullness, it effectively improves the main symptoms of fullness and distending pain caused by qi stagnation, making it a commonly used herbal pair for relieving fullness and distending pain. In clinical practice, "CAG" often presents with acid reflux; calcined Ostrea gigas combined with Dendrobium nobile enhances its acid-neutralizing and analgesic effects. Dendrobium nobile nourishes yin and the stomach; considering that stagnant heat can damage yin and that pungent, warm, bitter, and drying substances can damage body fluids, this herbal pair aims to prevent future problems. Therefore, following the principle of adjusting the prescription according to the symptoms, the raw materials of the Chinese medicine composition are increased or decreased accordingly based on the specific changes in the patient's condition, in order to achieve the best therapeutic effect.

[0026] In some specific embodiments of the present invention, the first active pharmaceutical ingredient further includes: 15-20 parts by weight of Citrus aurantium, 30 parts by weight of Ostrea gigas, and 10-15 parts by weight of Dendrobium nobile. The inventors determined this preferred formula based on extensive clinical experience. Therefore, the therapeutic effect of the traditional Chinese medicine composition of the present invention on chronic atrophic gastritis is further improved.

[0027] In some specific embodiments of the present invention, the first active pharmaceutical ingredient further includes: 20 parts by weight of Citrus aurantium, 30 parts by weight of Ostrea gigas, and 15 parts by weight of Dendrobium nobile. The inventors determined this preferred formula based on extensive clinical experience. Therefore, the therapeutic effect of the traditional Chinese medicine composition of the present invention on chronic atrophic gastritis is further improved.

[0028] According to the embodiment of the present application, the first raw medicine further comprises at least one of the following: 10-20 parts by weight of dandelion, 10-20 parts by weight of poria, 5-15 parts by weight of raw licorice, 10-20 parts by weight of polygonatum, 15-25 parts by weight of radix codonopsis and / or radix salviae miltiorrhizae, 5-20 parts by weight of pinellia, 10-20 parts by weight of hedgehog skin, and 10-20 parts by weight of large abdominal skin. According to the embodiment of the present application, the first raw medicine further comprises at least one of the following: 15 parts by weight of dandelion, 15 parts by weight of poria, 10 parts by weight of raw licorice, 15 parts by weight of polygonatum, 20 parts by weight of radix codonopsis, 15 parts by weight of radix salviae miltiorrhizae, 15 parts by weight of pinellia, 15 parts by weight of hedgehog skin, and 15 parts by weight of large abdominal skin. Among them, dandelion is bitter and cold, and can clear heat and resolve stagnation. It is also a medicine for purging stomach fire, but its gas is very flat, so it can not only purge fire, but also not harm the earth. It can be taken for a long time without harm. For the fire of Yangming, it can be taken in large doses. When the fire subsides, the stomach gas will be generated (Newly Compiled Herbal). Radix codonopsis is sweet and warm, and can tonify the spleen and stomach. When combined with radix astragali and atractylodes, the effect of tonifying qi and invigorating the spleen is enhanced. Poria is slightly permeable and can drain dampness. When combined with citri fructus, magnolia officinalis, and zedoary, it can help the movement of qi, blood, and body fluid. This is for qi stagnation, blood stasis, and fluid retention. Polygonatum nourishes spleen yin and spleen qi, and cooperates with dendrobium to nourish yin and stomach, and assists atractylodes and zedoary to tonify the spleen and invigorate the center. Radix salviae miltiorrhizae activates blood and removes stasis, and has a mild effect that can remove stasis and promote blood circulation without damaging the normal body. Hedgehog skin moves qi and removes stasis, and is good at stopping stomach pain. When combined with zedoary and sanqi, the effect of activating blood and relieving pain is enhanced. Pinellia is bitter and warm, and can dry dampness, lower qi, and reverse. When combined with bletilla striata, and calcined mussels, it can harmonize the stomach and regulate acid, and take into account the acid reflux caused by stomach qi rising. Large abdominal skin moves qi and removes water, and when combined with magnolia officinalis, citri fructus, poria, and atractylodes, it can enhance the effect of moving qi and removing dampness. Raw licorice benefits qi and harmonizes the center to regulate all medicines. Therefore, according to the law of adding and subtracting according to the syndrome, according to the above pathogenesis, the raw materials of the traditional Chinese medicine composition are increased or decreased accordingly according to the specific condition of the patient, so as to achieve satisfactory therapeutic effect.

[0029] According to the embodiment of the present application, the first raw medicine further comprises: 10-20 parts by weight of dandelion, 10-20 parts by weight of poria, 5-15 parts by weight of raw licorice, 10-20 parts by weight of polygonatum, and 15-25 parts by weight of radix codonopsis. Therefore, the traditional Chinese medicine composition according to the embodiment of the present application has the effect of strengthening qi and tonifying the center by poria, raw licorice, polygonatum, and radix codonopsis, and can better improve the symptoms of not wanting to eat and drink, lassitude, and loose stools caused by spleen and stomach deficiency. It also has the effect of clearing heat by adding dandelion, and can treat the symptoms of bitter taste and slight thirst caused by internal heat.

[0030] According to the embodiment of the present application, the first raw medicine further comprises: 15 parts by weight of dandelion, 15 parts by weight of poria, 10 parts by weight of raw licorice, and 15 parts by weight of polygonatum. The inventor has determined this better formula through a large number of clinical experiences. This formula can further improve the therapeutic effect of chronic atrophic gastritis, and slow down and inhibit the malignant progression of chronic atrophic gastritis to gastric cancer.

[0031] According to the embodiment of the present application, the first raw medicinal material further comprises: 10-20 parts by weight of hedgehog skin and 10-20 parts by weight of big belly skin. Thus, the hedgehog skin and the big belly skin can promote the flow of qi and relieve pain, remove blood stasis and promote water flow, and can treat diseases of qi stagnation, blood stasis and dampness blockage, so as to improve the symptoms of discomfort, fullness and pain in the upper abdomen.

[0032] The first raw medicinal material further comprises 15 parts by weight of hedgehog skin and 15 parts by weight of big belly skin. Thus, it can be better applied to those with obvious abdominal distension.

[0033] According to the embodiment of the present application, the first raw medicinal material further comprises 10-20 parts by weight of dandelion, 10-20 parts by weight of poria and 10-20 parts by weight of polygonatum.

[0034] According to the embodiment of the present application, the first raw medicinal material further comprises 15 parts by weight of dandelion, 15 parts by weight of poria and 15 parts by weight of polygonatum. The inventors have determined this preferred formula through a large number of clinical experiences.

[0035] According to the embodiment of the present application, the first raw medicinal material further comprises 10-20 parts by weight of dandelion, 10-20 parts by weight of poria, 15-25 parts by weight of salvia miltiorrhiza and 5-15 parts by weight of pinellia. Thus, the traditional Chinese medicine composition according to the embodiment of the present application can promote blood circulation to remove dampness, treat blood stasis and dampness blockage, and treat diseases of stomach qi reversal, so as to relieve the symptoms of abdominal distension and pain, acid reflux and the like.

[0036] According to the embodiment of the present application, the first raw medicinal material further comprises 15 parts by weight of dandelion, 15 parts by weight of poria, 15 parts by weight of salvia miltiorrhiza and 15 parts by weight of pinellia. The inventors have determined this preferred formula through a large number of clinical experiences.

[0037] According to the embodiment of the present application, the weight ratio of the first raw medicinal material to the second raw medicinal material is (15-17):(2-6).

[0038] According to an embodiment of the present application, the first raw medicinal material further comprises at least one of the following: hedgehog skin 10-20 parts by weight, large belly skin 10-20 parts by weight, ground beetle 10-15 parts by weight, corydalis 15-30 parts by weight, dried orange peel 15-30 parts by weight, inula flower 10-20 parts by weight, ocher 15-20 parts by weight, fresh ginger 15-20 parts by weight, ophiopogon 10-20 parts by weight, lily 15-30 parts by weight, bupleurum 15-20 parts by weight, white peony root 15-30 parts by weight, coptis 5-10 parts by weight, evodia 5-10 parts by weight, wormwood 10-15 parts by weight, scutellaria 10-15 parts by weight, Jianqu 15-20 parts by weight, malt 20-30 parts by weight, atractylodes 10-20 parts by weight, mace 10-15 parts by weight. Further, according to the changes of the prescription following the addition and subtraction of the syndrome, the raw material composition of the traditional Chinese medicine composition of the embodiment of the present application is increased or decreased accordingly according to the specific condition of the patient, so as to achieve the best therapeutic effect.

[0039] According to an embodiment of the present application, the first raw medicinal material further comprises at least one of the following: ground beetle 10-15 parts by weight, corydalis 15-30 parts by weight, dried orange peel 15-30 parts by weight, inula flower 10-20 parts by weight, ocher 15-20 parts by weight, fresh ginger 15-20 parts by weight, ophiopogon 10-20 parts by weight, lily 15-30 parts by weight, bupleurum 15-20 parts by weight, white peony root 15-30 parts by weight, coptis 5-15 parts by weight, evodia 5-10 parts by weight, wormwood 10-20 parts by weight, scutellaria 10-15 parts by weight, Jianqu 15-20 parts by weight, malt 20-30 parts by weight, atractylodes 10-20 parts by weight, mace 10-15 parts by weight, fried mustard 5-15 parts by weight, raw radix astragali 10-20 parts by weight, peach kernel 10-20 parts by weight. Further, according to the changes of the prescription following the addition and subtraction of the syndrome, the raw material composition of the traditional Chinese medicine composition of the embodiment of the present application is increased or decreased accordingly according to the specific condition of the patient, so as to achieve the best therapeutic effect.

[0040] According to an embodiment of the present application, the first raw medicinal material further comprises: ground beetle 10-15 parts by weight, corydalis 15-30 parts by weight. Thus, it can be better applied to those with obvious abdominal pain.

[0041] According to an embodiment of the present application, the first raw medicinal material further comprises: pinellia 10-20 parts by weight, dried orange peel 15-30 parts by weight, inula flower 10-20 parts by weight, ocher 15-20 parts by weight, fresh ginger 15-20 parts by weight. Thus, it can be better applied to those with excessive belching.

[0042] According to an embodiment of the present application, the first raw medicinal material further comprises: ophiopogon 10-20 parts by weight, lily 15-30 parts by weight. Thus, it can be better applied to those with dry mouth.

[0043] According to the embodiment of the present application, the first raw medicine further comprises: Radix Bupleuri 15-20 parts by weight, Radix Paeoniae Alba 15-30 parts by weight. Thus, it can be better applied to patients with rib pain or poor emotion.

[0044] According to the embodiment of the present application, the first raw medicine further comprises: Coptis 5-15 parts by weight, Evodia 5-10 parts by weight. Thus, it can be better applied to patients with pantothenic acid.

[0045] According to the embodiment of the present application, the first raw medicine further comprises: Capillaris 10-15 parts by weight, Radix Scrophulariae 10-15 parts by weight. Thus, it can be better applied to patients with bitter mouth.

[0046] According to the embodiment of the present application, the first raw medicine further comprises: Jianqu 15-20 parts by weight, Malt 20-30 parts by weight. Thus, it can be better applied to patients with poor appetite.

[0047] According to the embodiment of the present application, the first raw medicine further comprises: Atractylodes 10-20 parts by weight, Amomum 10-15 parts by weight. Thus, it can be better applied to patients with greasy tongue coating.

[0048] According to the embodiment of the present application, the first raw medicine further comprises: Fried Radix Heterophyllae 5-15 parts by weight, Radix Bupleuri 15-20 parts by weight, Jianqu 15-20 parts by weight, Radix Rehmanniae 10-20 parts by weight, Semen Persicae 10-20 parts by weight. Thus, Fried Radix Heterophyllae can dispel phlegm and dampness, Radix Bupleuri can regulate qi and soothe liver, which can enhance the effects of Fructus Aurantii, Cortex Magnoliae Officinalis and Rhizoma Pinelliae in regulating qi, dispelling phlegm and removing dampness, and treat patients with thick and greasy tongue coating and heavy phlegm and dampness; Jianqu can benefit stomach and promote digestion, which can treat patients with poor appetite due to dysfunction of spleen; Radix Rehmanniae can clear heat and cool blood, which can enhance the effect of Herba Euphorbiae in clearing heat, and treat patients with red tongue and heavy heat in stomach.

[0049] According to the embodiment of the present application, the first raw medicine further comprises: Malt 20-30 parts by weight, Coptis 5-15 parts by weight, Amomum 10-15 parts by weight, Capillaris 10-20 parts by weight. Thus, Malt can benefit stomach and promote digestion, which can treat patients with poor appetite due to dysfunction of spleen; Coptis can clear stomach and detoxify, which can enhance the effect of Herba Euphorbiae in clearing heat and detoxifying, and treat patients with dry mouth, red tongue and yellowish tongue coating due to heavy heat in stomach; Amomum can dispel dampness with fragrance, and Capillaris can clear heat and drain dampness, which can treat patients with bitter mouth, yellow urine and yellowish and greasy tongue coating due to heavy damp-heat.

[0050] According to the embodiment of the present application, the first raw medicine comprises: 20 parts by weight of Fructus Aurantii, 20 parts by weight of Magnoliae Officinalis Cortex, 10 parts by weight of Zingiberis Rhizoma, 30 parts by weight of Radix Paeoniae Alba, 15 parts by weight of Atractylodis Macrocephalae Rhizoma, 15 parts by weight of Herba Taraxaci, 15 parts by weight of Bletillae Rhizoma, 10 parts by weight of Bletillae Rhizoma, 30 parts by weight of Ostreae Concha, 15 parts by weight of Poria, 10 parts by weight of Radix Glycyrrhizae, 15 parts by weight of Echinops Echinatus, 15 parts by weight of Pericarpium Arecae, 15 parts by weight of Rhizoma Polygonati, 10 parts by weight of Dipsaci Radix, and 20 parts by weight of Radix Codonopsis. Thus, the formula of the present application can effectively treat chronic atrophic gastritis, not only can effectively improve the pathological state of gastrointestinal tissue, relieve gastric tissue atrophy, but also can reverse intestinal metaplasia, even improve or reverse dysplasia, and has important clinical application value.

[0051] According to the embodiment of the present application, the first raw medicine comprises: 20 parts by weight of Fructus Aurantii, 20 parts by weight of Magnoliae Officinalis Cortex, 10 parts by weight of Zingiberis Rhizoma, 30 parts by weight of Radix Paeoniae Alba, 15 parts by weight of Atractylodis Macrocephalae Rhizoma, 15 parts by weight of Herba Taraxaci, 15 parts by weight of Bletillae Rhizoma, 10 parts by weight of Bletillae Rhizoma, 30 parts by weight of Ostreae Concha, 15 parts by weight of Poria, 9-10 parts by weight of Radix Glycyrrhizae, 15 parts by weight of Echinops Echinatus, 15 parts by weight of Pericarpium Arecae, 15-20 parts by weight of Rhizoma Polygonati, 10-15 parts by weight of Dipsaci Radix, and 20 parts by weight of Radix Codonopsis. Thus, the formula of the present application can effectively treat chronic atrophic gastritis, not only can effectively improve the pathological state of gastrointestinal tissue, relieve gastric tissue atrophy, but also can reverse intestinal metaplasia, even improve or reverse dysplasia, and has important clinical application value.

[0052] According to the embodiment of the present application, the first raw medicine comprises: 20 parts by weight of Fructus Aurantii, 20 parts by weight of Magnoliae Officinalis Cortex, 10 parts by weight of Zingiberis Rhizoma, 30 parts by weight of Radix Paeoniae Alba, 15 parts by weight of Atractylodis Macrocephalae Rhizoma, 15 parts by weight of Herba Taraxaci, 15 parts by weight of Bletillae Rhizoma, 10 parts by weight of Bletillae Rhizoma, 30 parts by weight of Ostreae Concha, 15 parts by weight of Poria, 15 parts by weight of Rhizoma Polygonati, and 10 parts by weight of Dipsaci Radix.

[0053] According to the embodiment of the present application, the first raw medicine comprises: 20 parts by weight of Fructus Aurantii, 20 parts by weight of Magnoliae Officinalis Cortex, 10 parts by weight of Zingiberis Rhizoma, 30 parts by weight of Radix Paeoniae Alba, 15 parts by weight of Atractylodis Macrocephalae Rhizoma, 15 parts by weight of Herba Taraxaci, 15 parts by weight of Bletillae Rhizoma, 10 parts by weight of Bletillae Rhizoma, 30 parts by weight of Ostreae Concha, 15 parts by weight of Poria, 15 parts by weight of Rhizoma Polygonati, 15 parts by weight of Dipsaci Radix, 15 parts by weight of Salviae Miltiorrhizae Radix et Rhizoma, and 15 parts by weight of Rhizoma Pinelliae.

[0054] According to an embodiment of the present application, the first raw medicinal materials include: Fructus Aurantii 15 parts by weight, Magnoliae Officinalis 15 parts by weight, Zingiberis 10 parts by weight, Radix Scrophulariae 10 parts by weight, Radix Codonopsis 20 parts by weight, Rhizoma Atractylodis Macrocephalae 15 parts by weight, Bletilla 10 parts by weight, Ostreae 30 parts by weight, Poria 15 parts by weight, Radix Glycyrrhizae 5 parts by weight, Dendrobium 15 parts by weight, Rhizoma Pinelliae 10 parts by weight, Erinacei 15 parts by weight, Salviae Miltiorrhizae 15 parts by weight, Fried Radish Seed 10 parts by weight, Bupleurum 15 parts by weight, Jianqu 15 parts by weight, Radix Rehmanniae 15 parts by weight, Semen Persicae 15 parts by weight.

[0055] According to an embodiment of the present application, the first raw medicinal materials include: Fructus Aurantii 10 parts by weight, Magnoliae Officinalis 15 parts by weight, Zingiberis 5 parts by weight, Radix Astragali 20 parts by weight, Curcumae 15 parts by weight, Herba Taraxaci 20 parts by weight, Bletilla 20 parts by weight, Poria 20 parts by weight, Radix Glycyrrhizae 5 parts by weight, Rhizoma Atractylodis Macrocephalae 15 parts by weight, Dendrobium 30 parts by weight, Rhizoma Pinelliae 15 parts by weight, Fructus Hordei Germinatus 30 parts by weight, Rhizoma Coptidis 12 parts by weight, Salviae Miltiorrhizae 20 parts by weight, Erinacei 10 parts by weight, Amomi Rotundus 15 parts by weight, Herba Artemisiae Scopariae 20 parts by weight.

[0056] The inventors have determined the above-mentioned preferred formula through a large number of clinical experiences. The Chinese medicine composition obtained thereby is clinically used for treating chronic atrophic gastritis, and can effectively improve the atrophic symptoms of the stomach tissue, reverse the pathological states such as intestinal metaplasia and / or heterotypic hyperplasia, and significantly improve the other gastrointestinal discomfort symptoms of the patient, and also has a universal improvement effect on the sub-health symptoms such as the thinness of the patient.

[0057] In a specific embodiment of the present application, the second raw medicinal material is Radix Notoginseng 42.2 parts by weight.

[0058] According to an embodiment of the present application, the Magnoliae Officinalis is Jianghuopo.

[0059] According to an embodiment of the present application, the Fructus Aurantii is Chaozhiqiao.

[0060] According to an embodiment of the present application, the Rhizoma Atractylodis Macrocephalae is Chao Baishu or Sheng Baishu.

[0061] In some embodiments, the Sheng Baishu is suitable for persons with formed stools or constipation.

[0062] In some embodiments, the Chao Baishu is suitable for persons with unformed stools.

[0063] According to an embodiment of the present application, the Rhizoma Pinelliae is Jiang Banxia or Fa Banxia.

[0064] In some embodiments, the Rhizoma Pinelliae is Fa Banxia.

[0065] In some embodiments, the Radix Notoginseng is Sheng Sanqi powder or Shu Sanqi powder.

[0066] In the present text, the term "Banxia" refers to the Chinese medicinal material Bai Zhi, which has various processing forms such as "Sheng Banxia", "Qing Banxia", "Jiang Banxia", and "Fa Banxia". Among them, "Jiang Banxia" is obtained by processing with ginger and white alum together. Jiang Banxia is good at stopping vomiting, and also has the effects of reducing phlegm and strengthening the spleen to dry dampness. "Fa Banxia" is obtained by processing with licorice water. This processing method can reduce the toxicity of Banxia and enhance its efficacy, so that it is more suitable for clinical use.

[0067] According to an embodiment of the present application, the oyster is calcined oyster.

[0068] According to an embodiment of the present application, the hedgehog skin is scalded hedgehog skin.

[0069] According to an embodiment of the present application, the dendrobium is dried dendrobium.

[0070] According to an embodiment of the present application, the yellow thistle is processed yellow thistle.

[0071] According to an embodiment of the present application, the radix astragali is raw radix astragali or wine radix astragali.

[0072] According to an embodiment of the present application, the coptis is wine coptis.

[0073] According to an embodiment of the present application, the malt is roasted malt.

[0074] According to an embodiment of the present application, the radix bupleuri is radix bupleuri.

[0075] According to an embodiment of the present application, the traditional Chinese medicine composition is a decoction, a powder, a capsule, a tablet, or a pill.

[0076] According to an embodiment of the present application, further comprising a pharmaceutically acceptable excipient.

[0077] According to an embodiment of the present application, the excipient comprises one or more pharmaceutically acceptable excipients, diluents, stabilizers, or carriers.

[0078] According to an embodiment of the present application, the traditional Chinese medicine composition is a powder.

[0079] According to the clinical practice experience, compared with decoctions, capsules, tablets, and pills, the powder of the traditional Chinese medicine composition of the present application has a larger drug loading amount, and after oral administration by patients, it can directly enter the stomach and be applied to the lesion site, and a better effect can be achieved. At the same time, according to clinical feedback, a small number of patients taking capsules and the like easily have symptoms of stomach discomfort, but do not have such symptoms after taking the powder. Therefore, the powder can further improve the therapeutic effect, safety, and patient dependence of the traditional Chinese medicine composition of the present application.

[0080] In a second aspect, the present application provides use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for preventing and / or treating gastrointestinal diseases, and / or the medicament for relieving sub-health symptoms.

[0081] According to an embodiment of the present application, the gastrointestinal diseases include chronic atrophic gastritis.

[0082] According to an embodiment of the present application, the chronic atrophic gastritis is chronic atrophic gastritis combined with intestinal epithelial biochemistry and / or dysplasia.

[0083] According to an embodiment of the present application, the gastrointestinal diseases have at least one of the following symptoms: poor appetite, abdominal distension, bloating, belching, and acid reflux.

[0084] According to an embodiment of the present application, the sub-health symptoms include at least one of anxiety and emaciation.

[0085] It can be understood by those skilled in the art that the features and advantages described above for the traditional Chinese medicine composition also apply to the use, which will not be repeated here.

[0086] Additional aspects and advantages of the present application will be in part apparent and in part pointed out below in the description of embodiments of the present application. BRIEF DESCRIPTION OF DRAWINGS

[0087] The above and / or additional aspects and advantages of the present application will become apparent and be readily appreciated from the following description of embodiments, taken in conjunction with the accompanying drawings, in which:

[0088] Figure 1 Fig. 1 is a gastroscope examination result chart of a patient in Example 1 of the present application on March 7, 2022;

[0089] Figure 2 Fig. 2 is a gastroscope examination result chart of the patient in Example 1 of the present application on February 24, 2023;

[0090] Figure 3 Fig. 3 is a gastric tissue biopsy result chart of the patient in Example 1 of the present application on March 7, 2022;

[0091] Figure 4 Fig. 4 is a gastric tissue biopsy result chart of the patient in Example 1 of the present application on February 24, 2023;

[0092] Figure 5 Fig. 5 is a gastroscope examination result chart of a patient in Example 2 of the present application on March 23, 2021;

[0093] Figure 6 Fig. 6 is a gastric tissue biopsy result chart of the patient in Example 2 of the present application on March 23, 2021;

[0094] Figure 7 Figure for gastric tissue biopsy result of the patient of Example 2 of the present application on December 7, 2022;

[0095] Figure 8 Figure for gastroscopy result of the patient of Example 3 of the present application on August 30, 2017;

[0096] Figure 9 Figure for gastric tissue biopsy result of the patient of Example 3 of the present application on August 30, 2017;

[0097] Figure 10 Figure for gastroscopy result of the patient of Example 3 of the present application on April 17, 2019;

[0098] Figure 11 Figure for gastric tissue biopsy result of the patient of Example 3 of the present application on April 17, 2019. DETAILED DESCRIPTION

[0099] Embodiments of the present application are described in detail herein. The embodiments described herein are merely exemplary and are not to be construed as limiting the present application.

[0100] It should be noted that the terms "first", "second" are used only for descriptive purposes and should not be construed as indicating or implying relative importance or a quantity of the indicated technical features. Thus, features with "first", "second" can explicitly or implicitly include one or more of the features. Further, in the description of the present application, unless otherwise stated, the meaning of "a plurality" is two or more.

[0101] The endpoints of the ranges and any values disclosed herein are not limited to the precise values stated. The endpoints of the ranges and the values are provided as approximate descriptions of the ranges and values. The endpoints of the ranges of values, the endpoints of the ranges of values and single values between the endpoints of the ranges of values, and single values between the endpoints of the ranges of values can be combined with one or more other endpoints of the ranges and / or single values to form new ranges of values and / or new single values not expressly mentioned herein. These new ranges and / or single values are considered to be within the scope of the present application.

[0102] In the present text, the terms "comprising" or "including" are open-ended terms that is, they include the indicated content but not excluding other aspects.

[0103] In the present text, the terms "optionally", "optional" or "optional" generally mean that the event or circumstance subsequently described can or can not occur, and the description includes instances where the event or circumstance occurs and instances where it does not.

[0104] Terms and definitions

[0105] In the present text, the term "enterization" is equivalent to "enteric biochemistry", "intestinal metaplasia".

[0106] In the present text, the term "pharmaceutical composition" generally refers to a unit dosage form and can be prepared by any one of the methods well known in the pharmaceutical art. All methods involve the step of bringing the active ingredient into association with a carrier that constitutes one or more accessory ingredients. In the present application, the traditional Chinese medicine composition is a specific form of pharmaceutical composition and can be prepared by any one of the methods well known in the traditional Chinese medicine pharmaceutical art.

[0107] In the present text, the term "pharmaceutically acceptable excipient" can include any solvent, solid excipient, diluent or other liquid excipient, and the like, suitable for the particular intended unit dosage form. Except insofar as any conventional excipient is incompatible with the traditional Chinese medicine composition of the application, such as by producing any adverse biological effect or otherwise interacting in a deleterious manner with any other component(s) of the pharmaceutically acceptable composition, its use is contemplated to be within the scope of this application.

[0108] In the present text, the term "administration" refers to the act of introducing a predetermined amount of a substance into a patient by some suitable means. The traditional Chinese medicine composition of the present application can be administered by any common route, so long as it can reach the intended tissue. Various modes of administration are contemplated, including oral, peritoneal, intravenous, intramuscular, subcutaneous, and the like, but the present application is not limited to these exemplified modes of administration. Preferably, the composition of the present application is administered orally.

[0109] In the present text, the term "treatment" refers to obtaining a desired pharmacological and / or physiologic effect. The effect can be prophylactic in terms of completely or partially preventing a disease or symptom thereof and / or can be therapeutic in terms of a partial or complete cure of a disease and / or adverse effect attributable to the disease. "Treatment" as used herein covers the treatment of a disease in a mammal, particularly in a human, and includes: (a) preventing the disease or condition from occurring in an individual which can be predisposed to the disease but has not yet developed the disease; (b) inhibiting the disease, i.e., arresting its development; or (c) relieving the disease, i.e., causing the partial or complete regression of the disease. "Treatment" as used herein covers any use of a drug or bispecific antibody to treat, cure, relieve, alleviate, improve, lessen, or inhibit a disease in an individual, including but not limited to administering a drug comprising a traditional Chinese medicine composition described herein to an individual in need thereof.

[0110] In this document, the term "cold and heat syndrome" is a cold and heat syndrome in traditional Chinese medicine, which refers to two basic pathological states caused by the imbalance of yin and yang inside the human body. Cold belongs to yin, which manifests as a decrease in body energy, such as aversion to cold, fear of cold, cold pain, preference for warm, tasteless and no thirst, cold limbs, and other symptoms. Heat belongs to yang, which manifests as excessive body energy, such as fever, aversion to heat and preference for cool, thirst and desire for cold drinks, flushed face, restlessness, and other symptoms. The term "cold and heat complex syndrome" refers to the same patient having both cold and heat symptoms at the same time, which is a complex pathological phenomenon of cold and heat appearing simultaneously. When treating cold and heat syndromes in traditional Chinese medicine, appropriate treatment methods will be adopted according to the specific circumstances, such as "heat for cold" and "cold for heat".

[0111] In this document, the term "deficiency and excess syndrome" is a deficiency and excess syndrome in traditional Chinese medicine, which refers to two different pathological changes of yin and yang, qi and blood, and the functional state of viscera inside the human body. The term "excess syndrome" refers to excessive evil qi in the body, which manifests as accumulation of pathological products, qi stagnation and blood stasis, etc. The term "deficiency syndrome" refers to deficiency of vital qi in the body, which manifests as weakened function of viscera, loss of qi and blood, etc. The treatment principle is usually "reducing excess with purgation and tonifying deficiency", that is, excess syndrome should be treated with purgation to remove evil qi, and deficiency syndrome should be treated with tonification to strengthen vital qi.

[0112] In this document, the term "cold, heat, deficiency and excess complex syndrome" is equivalent to "cold, heat, deficiency and excess complex syndrome", which refers to the complex pathological state of cold, heat, deficiency and excess appearing simultaneously in the same patient. This situation is relatively complex in traditional Chinese medicine syndrome differentiation and needs careful diagnosis and treatment. In traditional Chinese medicine, the combination of traditional Chinese medicine compositions usually follows the basic structure of "monarch, minister, assistant and guide".

[0113] In this document, the term "monarch drug" refers to the drug that plays a major therapeutic role in the prescription and is the core of the whole prescription, which plays a leading role in the main symptoms or pathogenesis. The dosage of monarch drug is usually large, which is the most important component in the prescription.

[0114] In this document, the term "minister drug" refers to the drug that assists the monarch drug to enhance the therapeutic effect or treat secondary symptoms. The minister drug can enhance the effect of the monarch drug or treat the secondary aspects of the symptoms.

[0115] In this document, the term "assistant drug" refers to the drug that assists the monarch and minister drugs to reduce their side effects or treats other aspects of the symptoms. The assistant drug can have multiple effects, such as adjusting drug properties, reducing side effects, enhancing certain therapeutic effects, etc.

[0116] In this document, the term "guide drug" refers to the drug that guides other drugs directly to the lesion or adjusts the properties of each drug to make the whole prescription consistent. The guide drug is sometimes used to handle adverse reactions caused by the main and auxiliary drugs. The combination of these four drugs reflects the holistic concept of traditional Chinese medicine treatment and the principle of syndrome differentiation and treatment. Through reasonable combination, the therapeutic effect can be enhanced, the side effects can be reduced, and the purpose of treating diseases can be achieved.

[0117] In the present text, the term "processed Chinese medicinal material" refers to specific processing of Chinese medicinal materials to adjust their medicinal properties, enhance their therapeutic effects, reduce their side effects, or facilitate their storage and use. Chinese medicinal raw materials can be reasonably selected based on various factors such as dialectical treatment, medicinal property adjustment, efficacy enhancement, side effect reduction, convenience of use, and clinical application experience. In the present text, unless otherwise specified, no specific processed product of a specific Chinese medicinal material is particularly limited.

[0118] In the present text, the term "licorice" refers to the Chinese medicinal material licorice, which has various processing forms such as "raw licorice" and "roasted licorice". Among them, "raw licorice" refers to licorice that has not been processed, retaining the original properties of licorice, which is believed in traditional Chinese medicine to have the effects of clearing heat and resolving toxicity, moistening the lungs and relieving cough, and regulating medicinal properties. Unless otherwise specified, the licorice in the Chinese medicinal composition of the present invention is selected from raw licorice.

[0119] In the present text, the term "notoginseng" refers to the Chinese medicinal material notoginseng, which has various processing forms such as "raw notoginseng powder" and "cooked notoginseng powder". Among them, "raw notoginseng powder" refers to notoginseng that has not been processed, retaining the original properties of notoginseng, which is believed in traditional Chinese medicine to have stronger blood-activating and stasis-removing effects. Cooked notoginseng powder refers to notoginseng that has been decocted with oil, dried, and then ground into powder with a traditional Chinese medicine powder grinder, which has stronger tonifying effects. Unless otherwise specified, the notoginseng in the Chinese medicinal composition of the present invention is selected from raw notoginseng powder.

[0120] In the present text, the term "magnolia bark" refers to the Chinese medicinal material magnolia bark, which has various processing forms such as "net processing", "ginger magnolia bark", "ginger decoction", "ginger juice immersion", "ginger juice steaming", "ginger and perilla juice mixing", and "vinegar frying". Modern research suggests that ginger-baked magnolia bark can eliminate its irritation to the throat and enhance its warm and stomach-regulating functions. Among them, the processing technology of "ginger magnolia bark" includes: mixing magnolia bark silk or slices with ginger juice, soaking until the ginger juice is absorbed, and then frying dry with a low heat; or using ginger slices to decoct a soup, bundling the magnolia bark without rough skin into bundles, and cooking in the ginger soup until cooked through, then taking out, slicing, and drying.

[0121] In the present text, the term "white atractylodes" refers to the Chinese medicinal material white atractylodes, which has various processing forms such as "raw white atractylodes", "fried white atractylodes", "wheat bran-fried white atractylodes", and "soil-fried white atractylodes". Among them, "raw white atractylodes" refers to white atractylodes that has not been processed, which is drier and better at draining dampness and water than fried white atractylodes; "fried white atractylodes" is a form of white atractylodes after processing, which is generally believed to include: sprinkling bran or hearth soil into a hot pan, when smoke appears, pour in white atractylodes slices and fry until light yellow, then take out, sieve off the bran, and cool down. The processing methods of fried white atractylodes are different, and their effects are also different. "Soil-fried white atractylodes" is processed with hearth soil, which can enhance the effects of tonifying the spleen and stopping diarrhea; "wheat bran-fried white atractylodes" is processed with wheat bran, which can moderate the warm and dry nature of white atractylodes and enhance the effects of tonifying the spleen and reducing distension.

[0122] In the present document, the term "oyster" refers to the Chinese herbal medicine oyster, which is equivalent to "oyster shell". "Calcined oyster" is the product of the Chinese herbal medicine oyster after calcination, which has the effects of astringing, tonifying, soothing liver and yang, relieving acid and pain, softening and resolving mass, etc.

[0123] In the present document, the term "hedgehog skin" refers to the Chinese herbal medicine hedgehog skin, which is derived from the dried skin of the hedgehog Erinaceus europaeus L., short-spined hedgehog Hemichianus dauricus Sundevall. or large-eared hedgehog Hemichianus auritus Gmelin. There are many processing methods for hedgehog skin. The processing process of "scalded hedgehog skin" usually includes cleaning the hedgehog skin and then scalding it with boiling water to achieve the purpose of cleaning and softening. Sometimes other auxiliary materials are added to enhance the efficacy or change the nature of the medicine. Unless otherwise specified, the processing process of "scalded hedgehog skin" in the present document includes cleaning the hedgehog skin and then scalding it with boiling water to achieve the purpose of cleaning and softening.

[0124] The present application provides a traditional Chinese medicine composition for preventing and / or treating gastrointestinal diseases and its use. The function and indications of the composition will be described in detail below.

[0125] Function and indications

[0126] The traditional Chinese medicine composition of the present application has the functions of invigorating the spleen, warming the middle, promoting blood circulation and relieving pain, and is suitable for chronic atrophic gastritis with gastric mucosa and intestinal epithelial metaplasia, and other diseases, such as atypical hyperplasia, with the syndrome of deficiency of the spleen and stomach, stagnation of qi and blood stasis, and internal heat. Symptoms include fullness in the epigastrium, or abdominal distention, fear of cold food, increased cold and fullness, loss of appetite, fatigue, loose stools, pale or pale tongue, white and greasy or slightly yellowish and greasy fur, and a stringy or slow pulse. Or the physical examination results are positive but the clinical symptoms are not obvious.

[0127] There is no "CAG" disease name in traditional Chinese medicine. According to clinical practice, the main signs of upper abdominal discomfort, fullness, pain, acid reflux, etc. are attributed to the disease categories of "fullness syndrome", "stomach pain" and "acid regurgitation". External pathogens invade directly into the spleen and stomach; or improper diet, especially overeating cold food, damages the spleen and stomach; or emotional distress, liver stagnation and spleen, or improper rest, or old age and physical decline, leading to reduced function of the spleen and stomach. The middle jiao is cold and deficient, the spleen fails to transport, the stomach loses its function, and the blood and qi are not sufficient, resulting in fear of cold food, loss of appetite, fatigue, and loose stools. The spleen and stomach are the pivot of qi movement, and the spleen is deficient in ascending and descending, causing qi stagnation, blood stasis and dampness, resulting in fullness in the epigastrium and abdominal distention. The disease is cold and deficient, so cold and fullness, distention and pain are aggravated, and the tongue is pale or pale, the fur is white and greasy, and the pulse is stringy. The earth is deficient and the wood is dominant, the stomach qi is reversed, and the acid reflux occurs. The blood and qi stagnate and the heat is generated, resulting in bitter mouth and slight thirst, and slightly yellowish and greasy fur.

[0128] The disease treated by the present prescription (the traditional Chinese medicine composition of the present application) has complex causes, mechanisms and symptoms, which include deficiency of spleen and stomach, internal heat, stagnation of qi and blood, and retention of fluid. It belongs to the syndrome of cold-heat complex and deficiency-excess complex. Although the disease is caused by deficiency of spleen and stomach, it is accompanied by stagnation of qi and blood throughout the whole process. Therefore, the treatment should focus on invigorating the spleen, warming the middle, promoting qi and activating blood, and eliminating mass and relieving pain.

[0129] Explanation of the prescription

[0130] The disease is caused by deficiency of spleen and stomach, and accompanied by excess of heat. The cold-heat deficiency-excess complex should be treated by eliminating heat and tonifying deficiency.

[0131] Radix Astragali has a sweet and warm flavor, and is a main herb for tonifying qi. It is especially good at tonifying qi and invigorating the spleen, and is used for the treatment of qi deficiency of the spleen and stomach. Therefore, it is used in a large amount as the monarch drug.

[0132] Radix Notoginseng has a sweet and slightly bitter flavor and a warm nature, and is good at activating blood and relieving pain. Magnolia Bark has a bitter and pungent flavor and a warm nature, and is a common herb for promoting qi and eliminating distension. It is also good at resolving dampness and turbidity. The two herbs are combined to treat the pathological changes of stagnation of qi and blood and retention of fluid, and the main symptoms of mass and distension and pain. Therefore, they are both the ministerial drugs.

[0133] Rhizoma Zingiberis has a pungent and hot flavor, and is good at warming the spleen and stomach. Rhizoma Atractylodis Macrocephalae has a sweet and warm flavor, and is good at tonifying the spleen and stomach, and also at drying dampness. The two herbs are combined to eliminate the cause of deficiency of the middle and deficiency of the spleen, and to resolve dampness and turbidity. Radix Zingiberis is combined with Magnolia Bark to enhance the effect of resolving dampness and turbidity. Radix Zingiberis is good at activating blood and relieving pain, and is combined with Radix Notoginseng and Magnolia Bark to enhance the effect of activating blood and relieving pain. They are both the auxiliary drugs.

[0134] Bletilla has a bitter and astringent flavor and a cold nature, and is good at clearing heat and resolving stagnation, and also at relieving pain. It is also an auxiliary drug.

[0135] In summary, the present prescription is used to treat the disease of deficiency of the spleen and stomach, stagnation of qi and blood, and retention of fluid, and the main symptoms of mass and distension and pain. It is also used to treat the disease of chronic atrophic gastritis with gastric metaplasia and dysplasia, which belongs to the syndrome of deficiency of the spleen and stomach, stagnation of qi and blood, and retention of fluid. The prescription is a good one for treating the disease from both the root and the branch.

[0136] In summary, the present prescription is used to treat the disease of deficiency of the spleen and stomach, stagnation of qi and blood, and retention of fluid, and the main symptoms of mass and distension and pain. It is also used to treat the disease of chronic atrophic gastritis with gastric metaplasia and dysplasia, which belongs to the syndrome of deficiency of the spleen and stomach, stagnation of qi and blood, and retention of fluid. The prescription is a good one for treating the disease from both the root and the branch.

[0137] For the main symptoms of distending pain, Jujube can be added. Jujube is bitter and acrid, slightly cold, and is used for removing stagnation and resolving distension. It is combined with Magnolia officinalis to remove distension and fullness, which is a commonly used drug pair for removing distension and fullness. Poria is used to remove dampness, and is combined with Jujube, Magnolia officinalis, and Curcuma zedoaria to facilitate the movement of qi, blood, and body fluid, which is used for qi stagnation, blood stasis, and body fluid stagnation. To assist in removing blood stasis, Danshen can be added. Danshen is bitter and slightly cold, and is combined with Sanqi and Curcuma zedoaria to achieve better blood circulation and pain relief. The combination of the five drugs can better improve the main symptoms of distending pain caused by qi stagnation and blood stasis.

[0138] Qi stagnation and blood stasis can easily generate heat, so Taraxacum mongolicum can be added. Taraxacum mongolicum is bitter and cold, and can clear heat, and when combined with white and Danshen, the heat-clearing effect is enhanced. Half summer is bitter and warm, and can dry dampness, and can also lower qi and reverse, and when combined with white and calcined oyster, it can regulate the stomach and reduce acid, and can also treat acid reflux. The clinical symptoms of acid reflux are often seen in "CAG", so oyster can be added. The combination of oyster and white can enhance the effect of reducing acid and relieving pain.

[0139] To prevent gradual and prevent the emergence, Dendrobium can be added. Dendrobium nourishes yin and stomach, and takes into account the yin damage caused by heat, and the body fluid damage caused by pungent and warm drugs.

[0140] Comparison of related Chinese patent medicines for appropriate syndromes

[0141] CAG is complex and has multiple syndromes. Currently, there is no Chinese patent medicine for treating related syndromes. For example, Molo Dan is combined with drugs for tonifying yin, promoting blood circulation, clearing heat, and removing dampness, and is suitable for people with stomach yin deficiency, qi stagnation and blood stasis, and internal accumulation of damp heat. Weifuchun is combined with red ginseng, Xiangcha, and Jujube, and has the functions of invigorating the spleen and tonifying qi, promoting blood circulation, and is suitable for people with spleen and stomach qi deficiency and qi stagnation and blood stasis. However, there is no Chinese patent medicine for patients with spleen and stomach deficiency, qi stagnation and blood stasis, and internal accumulation of damp heat.

[0142] The present application (see the formula explanation part) takes into account cold, heat, deficiency, and excess, and can be used for multiple syndromes, and is more widely applicable.

[0143] More suitable dosage forms

[0144] According to clinical experience, the loading capacity of the powder of the present application is larger than that of capsules, tablets, and pills. After oral administration, the powder can directly enter the stomach and be applied to the affected area, and can achieve good efficacy. At the same time, according to clinical feedback, a small number of patients taking capsules, pills, and compressed tablets may experience stomach discomfort, but taking the powder can alleviate this symptom.

[0145] The scheme of the present application will be explained in combination with examples. Those skilled in the art will understand that the following examples are only used to illustrate the present application, and should not be regarded as limiting the scope of the present application. If the specific technology or condition is not specified in the examples, it is carried out according to the technology or condition described in the literature in the art or according to the product instruction. If the reagent or instrument is not specified by the manufacturer, it is a conventional product that can be purchased on the market.

[0146] Example 1: Treatment of a typical case of chronic atrophic gastritis with the traditional Chinese medicine composition of the present application

[0147] Patient: male, 47 years old.

[0148] Auxiliary examination: On March 7, 2022, the patient underwent gastroscopy and biopsy of one polyp each from the lesser curvature of the antrum, the angle of the stomach, and the lesser curvature of the antrum at West China Hospital of Sichuan University.

[0149] Gastroscopy results showed that Figure 1 ): chronic atrophic gastritis (C2 type) with pox rash; antral polypoid protrusion.

[0150] Biopsy results showed that Figure 3 ): (1) lesser curvature of the antrum: mild chronic inflammation of the mucosa, intestinalization (+++), and atrophy (+++). (2) angle of the stomach: mild to moderate chronic inflammation of the mucosa, intestinalization (++), atrophy (++), and local lymphocyte aggregation. (3) lesser curvature of the antrum: mild chronic inflammation of the mucosa, focal intestinalization (+), and individual glandular dilation with slight hyperplasia of the non-glandular epithelium.

[0151] Traditional Chinese medicine diagnosis and treatment methods and results: When the patient was treated in March 2022, he had poor appetite, abdominal distension and pain, weight loss, anxiety, pale tongue, and a thin, greasy coating. The patient was treated with the traditional Chinese medicine composition.

[0152] Prescription: Fructus Aurantii Immaturus roasted with bran 20 parts by weight, Rhizoma Zingiberis Recens and Magnolia officinalis 20 parts by weight, Rhizoma Zingiberis Recens 10 parts by weight, Radix Paeoniae Alba 30 parts by weight, Radix Codonopsis 20 parts by weight, Rhizoma Atractylodis Macrocephalae 15 parts by weight, Curcuma zedoaria 15 parts by weight, Herba Taraxaci 15 parts by weight, Bletilla striata 10 parts by weight, Calculus Bovis 30 parts by weight, Poria cocos 15 parts by weight, Radix Glycyrrhizae 9 parts by weight, Dendrobium nobile 15 parts by weight, Rhizoma Polygonati 20 parts by weight, Erigeron canadensis 15 parts by weight, Pericarpium Aesculi 15 parts by weight.

[0153] Method of administration: After being ground or finely pulverized, the traditional Chinese medicine composition is prepared into a powder. The patient takes 9g of the powder twice a day, with 3g of Radix Notoginseng added. The powder is taken with warm water before or after meals. Food and water should not be consumed within 1 hour after taking the medicine. A course of treatment lasts 3 months, and the patient takes two consecutive courses of treatment.

[0154] Follow-up results:

[0155] On February 24, 2023, the patient underwent gastroscopy and tissue biopsy at West China Hospital of Sichuan University. Gastroscopy results showed that Figure 2 ): chronic atrophic gastritis (C2 type) with pox rash; antral polypoid protrusion. Biopsy results showed that Figure 4 ): (1) antral polyp in the lesser curvature: mild chronic inflammation of the mucosa with polypoid hyperplasia, intestinalization (+), and atrophy (+). (2) angle of the stomach: mild to moderate chronic inflammation of the mucosa, intestinalization (+), atrophy (+), and local lymphoid tissue hyperplasia. (3) anterior wall of the antrum: mild to moderate chronic inflammation of the mucosa, intestinalization (+), and atrophy (+).

[0156] TCM diagnosis: The symptoms of poor appetite, abdominal distension, anxiety, etc. were relieved, and the body weight increased by 4 kg.

[0157] The above results show that the traditional Chinese medicine composition of Example 1 can effectively improve the atrophy symptoms of gastric tissue and reverse the pathological state of intestinal metaplasia when used for treating chronic atrophic gastritis; the symptoms of poor appetite, abdominal distension, etc. are significantly improved, and the symptoms of anxiety, emaciation, etc. are relieved.

[0158] Example 2: A typical case of chronic atrophic gastritis treated by the traditional Chinese medicine composition of the present application

[0159] Patient: male, 62 years old.

[0160] Auxiliary examination: On March 23, 2021, the patient underwent gastroscopy and tissue biopsy in a Sichuan Province hospital of traditional Chinese and Western medicine integration.

[0161] The gastroscopy results show that: Figure 5 (1) Gastric fundus: a submucosal nodule about 0.5*0.4 cm in size is seen. (2) Gastric body: submucosal blood vessel network is vaguely seen in the lower segment, with red and white interlaced mucosa, mainly white, and scattered erythema and congestion of the mucosa. (3) Gastric angle: there is a mucosal mottling change with an arc, mainly white, with peristalsis, and one biopsy is taken. (4) Gastric antrum: red and white interlaced mucosa, mainly white, with mucosal congestion.

[0162] The biopsy results show that: Figure 6 Severe chronic atrophic gastritis in the gastric angle, with moderate intestinal metaplasia.

[0163] TCM diagnosis and treatment: On March 2021, the patient had poor appetite, abdominal distension and pain, emaciation, anxiety, pale tongue, and a thin and greasy coating, and was treated with the traditional Chinese medicine composition.

[0164] Prescription: 15 parts by weight of Poria cocos, 15 parts by weight of ginger, 10 parts by weight of dried ginger, 10 parts by weight of wine Huangqi, 20 parts by weight of Dangshen, 15 parts by weight of Shengbaishu, 15 parts by weight of E Zhu, 10 parts by weight of Baiji, 30 parts by weight of calcined Mu Li, 15 parts by weight of Fuling, 5 parts by weight of Shenggancao, 15 parts by weight of dried Dendrobium, 10 parts by weight of Faba, 15 parts by weight of Erzhi Pi, 15 parts by weight of Danshen, 10 parts by weight of Chaojiezi, 15 parts by weight of Beiqiehu, 15 parts by weight of Jianqu, 15 parts by weight of Shengdiju, and 15 parts by weight of Taoren.

[0165] Method of taking: After being crushed or finely ground into a powder, 3g of Sanqi powder is added, and the mixture is taken 2 times a day, 9g each time. It should be taken with warm water before or after meals, and food and drink should not be taken within 1 hour after taking the medicine. One course of treatment is 3 months, and two courses should be taken in succession.

[0166] Follow-up results:

[0167] On December 7, 2022, the patient underwent an upper gastrointestinal endoscopy and tissue biopsy at Sichuan Cancer Hospital. The results of the stomach examination showed that: Figure 7 (1) Gastric fundus: mucus lake clear, smooth mucosa, no varices. (2) Gastric body: smooth. Gastric angle: arc-shaped, smooth mucosa, red and white interlaced mucosa, no varices. (3) Gastric antrum: good peristalsis, red and white interlaced mucosa, mainly white, mottled, scattered patchy red.

[0168] Western diagnosis: chronic atrophic gastritis (C1 type).

[0169] Chinese diagnosis: previous poor appetite, abdominal distension, anxiety and other symptoms improved, weight increased by 2 kg.

[0170] The above results show that the traditional Chinese medicine composition of Example 2 can be used to treat chronic atrophic gastritis, effectively improve the atrophic symptoms of the gastric tissue, and reverse the pathological state of intestinal metaplasia; the symptoms of gastrointestinal discomfort such as poor appetite and abdominal distension are significantly improved, and the symptoms of sub-health such as anxiety and weakness are relieved.

[0171] Example 3: A typical case of treating chronic atrophic gastritis with the traditional Chinese medicine composition of the present application

[0172] Patient: male, 57 years old.

[0173] Auxiliary examination: On August 30, 2017, the patient underwent a gastroscopy and tissue biopsy at Chengdu Second People's Hospital.

[0174] The results of the gastroscopy showed that: Figure 8 (1) Gastric body: mucosal rhexis is regular, small-bend mucosa is thin, submucosal blood vessel texture is visible, and the thin mucosa extends from the small-bend to the anterior wall and posterior wall. (2) Gastric angle: normal shape, smooth, with an arc. Mucosa is swollen, with multiple white patchy flat elevations. (3) Gastric antrum: mucosa is swollen, with local mucosal thinning, multiple patchy gray flat elevations, and a white elevation about 0.3 cm in diameter near the large-bend of the gastric body.

[0175] The biopsy results showed that: Figure 9 (1) Gastric body small-bend: biopsy specimen, moderate chronic inflammation of the mucosa with bleeding, intestinal metaplasia (+++), and atrophy of the gland (++). (2) Gastric angle: biopsy specimen, moderate chronic inflammation of the mucosa, intestinal metaplasia (+++), atrophy of the gland (+), and significant expansion of individual glands. (3) Gastric antrum small-bend: biopsy specimen, severe chronic inflammation of the mucosa, intestinal metaplasia (++), atrophy of the gland (+), and mild atypical hyperplasia of the intestinal metaplasia epithelium. (4) Gastric antrum large-bend: biopsy specimen, severe chronic inflammation of the mucosa.

[0176] TCM diagnosis and results: In September 2017, the patient had poor appetite, abdominal distension and abdominal pain, weight loss, anxiety, pale tongue, and a thin and greasy coating. The patient was treated with a traditional Chinese medicine composition.

[0177] Prescription: Fructus Aurantii Immaturus 10 parts by weight, Rhizoma Anisidi 15 parts by weight, Rhizoma Zingiberis Recens 5 parts by weight, Radix Astragali 20 parts by weight, Curcuma 15 parts by weight, Herba Taraxaci 20 parts by weight, Bletilla 20 parts by weight, Radix Glycyrrhizae 5 parts by weight, Fructus Aurantii Immaturus 15 parts by weight, Dendrobium 30 parts by weight, Rhizoma Pinelliae 15 parts by weight, Fructus Hordei Germinatus 30 parts by weight, Rhizoma Coptidis 12 parts by weight, Radix Salviae Miltiorrhizae 20 parts by weight, Erzhi skin 10 parts by weight, Amomum 15 parts by weight, Artemisia capillaris 20 parts by weight.

[0178] Method of administration: After being ground or finely ground into a powder, 9g of the powder is taken twice a day. Three grams of panax notoginseng powder is added when taking the medicine. The medicine is taken with warm water before or after meals. Food and water should not be consumed within one hour after taking the medicine. One treatment course is three months, and two treatment courses are taken in succession.

[0179] Follow-up results:

[0180] On April 17, 2019, the patient underwent a gastroscopy and tissue biopsy at the Second People's Hospital of Chengdu. The gastroscopy results showed that the gastric mucosa was swollen, and the mucus lake was slightly turbid. The gastric body mucosa was swollen, and the gastric angle and antral mucosa were congestive and edematous, with mottling changes. The biopsy results showed that the mucosa was moderately chronic inflammation with erosion, lymphoid hyperplasia, intestinal metaplasia (++), and atrophy (++). Figure 10 Figure 11

[0181] TCM diagnosis: The patient's previous symptoms of poor appetite, abdominal distension, and anxiety were relieved, and the patient's weight increased by 3 kg.

[0182] The above results show that the traditional Chinese medicine composition of Example 3 can be used to treat chronic atrophic gastritis, effectively improve the atrophy symptoms of the gastric tissue, reverse the intestinal metaplasia pathological state, and improve or reverse dysplasia. The patient's previous symptoms of poor appetite, abdominal distension, and other gastrointestinal discomfort were significantly improved, and the patient's anxiety and emaciation were relieved.

[0183] Example 4: Basic prescription, clinical commonly used prescription, method of administration, and clinical effectiveness of the present application for treating chronic atrophic gastritis

[0184] Basic prescription: Magnolia officinalis 10-40 parts by weight, Astragalus 15-60 parts by weight, Atractylodes 10-40 parts by weight, Curcuma 10-40 parts by weight, Bletilla 10-40 parts by weight, Rhizoma Zingiberis Recens 10-40 parts by weight, and Panax. The ratio of the amount of Panax to the total weight of the other raw materials is controlled to be (1-12):(15-17), which can achieve the effect of treating chronic atrophic gastritis and improving the pathological state of the gastrointestinal tissue.

[0185] ​​Common prescription A: Houpu 15-25 parts by weight, Huangqi 25-35 parts by weight, Baishu 10-20 parts by weight, E'zhu 10-20 parts by weight, Baiji 5-20 parts by weight, Ganjiang 5-15 parts by weight, Zhike 10-25 parts by weight, Muli 15-60 parts by weight, Shandou 10-40 parts by weight, Sanqi, wherein the ratio of the amount of Sanqi to the sum of the amounts of other raw medicinal materials is controlled to be (1-12):(15-17), which can achieve the curative effect of treating chronic atrophic gastritis and improving the histopathological state of the gastrointestinal tract.

[0186] Common prescription B: On the basis of common prescription A, increase: Pugongying 10-20 parts by weight, Fuling 10-20 parts by weight, Shenggancao 5-15 parts by weight, Huangjing 10-20 parts by weight, Dangshen 15-25 parts by weight.

[0187] Common prescription C: On the basis of common prescription A, increase: Pugongying 10-20 parts by weight, Fuling 10-20 parts by weight, Shenggancao 5-15 parts by weight, Huangjing 10-20 parts by weight, Dangshen 15-25 parts by weight, Shihupi 10-20 parts by weight, Dafupi 10-20 parts by weight

[0188] Common prescription D: On the basis of common prescription A, increase: Pugongying 10-20 parts by weight, Fuling 10-20 parts by weight, Huangjing 10-20 parts by weight.

[0189] Common prescription E: On the basis of common prescription A, increase: Pugongying 10-20 parts by weight, Fuling 10-20 parts by weight, Danshen 15-25 parts by weight, Banxia 5-15 parts by weight.

[0190] Under the premise of following the law of prescription addition and subtraction according to the syndrome, based on syndrome differentiation, main disease and main prescription, disease mechanism change, symptom change, system difference, season and climate, drug characteristics, dosage adjustment, drug interaction, treatment stage, etc., the raw material composition of the above-mentioned traditional Chinese medicine composition can be increased or decreased according to the specific condition of different patients, so as to achieve the best therapeutic effect.

[0191] Method of taking: After being crushed or finely ground, make into a powder, take 8-9g each time, 2-3 times a day, and add 1-3g of Sanqi powder when taking. Take with warm water before or after meals, and do not eat or drink within 1 hour after taking the medicine. 3 months is a course of treatment, and take two courses continuously.

[0192] The inventor summarizes the above basic formula based on thousands of cases of chronic atrophic gastritis in the past ten years, and optimizes the formula based on a large number of patient clinical feedback and efficacy observation data, and finally obtains the above commonly used formula. Clinical application shows that compared with the conventional gastric tissue atrophy, the total effective rate of the basic formula of the present application is about 50%, which can significantly improve the pathological state of the gastrointestinal tract, effectively alleviate gastric atrophy, reverse intestinal metaplasia, and improve or reverse dysplasia.

[0193] The basic formula clinical effectiveness investigation scheme is as follows: according to the reported data of about 25% improvement of intestinal epithelial metaplasia, assuming that the improvement target of the test group is 45%, lower=0.8, one-sided a=0.025, effective test is carried out, and the effective sample size is calculated. The test group and the control group are randomly allocated cases in a ratio of 1:1. The effectiveness and safety of the basic formula of the present application in treating chronic atrophic gastritis with intestinal metaplasia are preliminarily evaluated by using placebo as control.

[0194] End point index: (1) After 24 weeks of treatment and follow-up, the effective rate of intestinal epithelial metaplasia score and gastric mucosa atrophy score by pathological visual analog scale. (2) After 24 weeks of treatment and follow-up, the total score effective rate by pathological visual analog scale and the change of total score compared with baseline. The operator divides the region (position) based on the judgment of atrophy and intestinal metaplasia under the microscope, and if it is judged that there is atrophy or intestinal metaplasia, gastric mucosa positioning mark and biopsy should be carried out in each subzone where the lesion is relatively heavy and evenly distributed. During gastroscopy, biopsy should be performed on the heavier lesions at the previous positioning mark. In principle, in addition to the target lesion, it is not recommended to perform biopsy in the region (position) other than the previous positioning mark. If there is biopsy in addition to the positioning mark in the same region (position), the heavier one is used for evaluation. Evaluation uses "visual analog scale", total score calculation: total score = sum of actual region score / actual region theoretical score range*100. If additional target lesions are generated outside the previous region during re-evaluation, the sum of actual region score (numerator) is calculated according to the actual calculation, and the actual region theoretical score range (denominator) is calculated according to the first calculation, which is not expanded at different times. Those with a decrease in total score of more than 30% are defined as effective; if it is confirmed that new intraepithelial neoplasia (dysplasia) occurs after treatment, it is directly defined as ineffective.

[0195] (3) After 24 weeks of treatment and follow-up, the change of inflammation, bile reflux, and gastric mucosa lesions compared with baseline.

[0196] (4) The total volume fraction improvement response effective rate of clinical symptoms (upper abdominal pain, upper abdominal distension, early satiety, acid regurgitation, and heartburn) after 4 weeks, 6 weeks, and 8 weeks of treatment.

[0197] Effective: the number of response weeks is greater than 50% of the number of weeks of the entire observation period;

[0198] Integral improvement response: the average integral of symptoms per week is at least 50% lower than baseline.

[0199] (5) The change value of the score of the single clinical symptom (upper abdominal pain, upper abdominal distension, early satiety, belching, acid reflux, heartburn) after 4 weeks, 6 weeks, and 8 weeks of medication and the effective rate of integral improvement response

[0200] Effective: the number of response weeks is greater than 50% of the number of weeks of the entire observation period; Integral improvement response: the average integral of symptoms per week is at least 30% lower than baseline (6) The change of the score of the gastrointestinal disease PRO scale after 8 weeks and 24 weeks of medication compared with baseline.

[0201] (7) The proportion of patients with positive H. pylori test results after 24 weeks of medication and at follow-up.

[0202] According to the current clinical data collected by the inventors, the results show that the basic prescription of the present application has a total clinical effective rate of about 50%, can significantly improve the pathological state of the gastrointestinal tract, effectively relieve gastric atrophy, reverse intestinal metaplasia, and improve or reverse dysplasia.

[0203] To improve efficacy, facilitate drug administration, and improve patient dependence, the above-mentioned traditional Chinese medicine composition is prepared into a powder for administration. Long-term clinical diagnosis and treatment results show that, compared with decoctions, capsules, tablets, and pills, the powder dosage form can be directly administered into the stomach after oral administration, applied to the lesion site, can significantly promote the penetration of the effective components of the drug into the gastric mucosa and sufficient absorption, thereby effectively improving the treatment effect on the local lesion. Compared with capsules, the powder dosage form does not have symptoms of stomach discomfort, has better safety and patient dependence.

[0204] Example 5: Clinical efficacy investigation of the traditional Chinese medicine composition of the present application

[0205] The inventors have statistically analyzed the clinical treatment effectiveness of the following two commonly used prescriptions in clinical practice on 50 patients diagnosed by gastroscopy and biopsy as chronic atrophic gastritis with intestinal metaplasia during 2018-2024.

[0206] Prescription 1: Fructus Aurantii 20g, Magnolia officinalis 20g, Zingiber officinale 10g, Astragalus membranaceus 30g, Atractylodes macrocephala 15g, Curcuma zedoaria 15g, Taraxacum mongolicum 15g, Bletilla striata 10g, Mactra 30g, Poria cocos 15g, Glycerine 10g, Scabrous hedgehog skin 15g, Large abdominal skin 15g, Polygonatum 15g, Dendrobium 10g, Radix Codonopsis 20g, and Sanchi 15g.

[0207] Prescription 2: Fructus Aurantii 20g, Magnoliae Officinalis 20g, Zingiberis 10g, Radix Astragali 30g, Atractylodis Macrocephalae 15g, Curcumae 15g, Herba Taraxaci 15g, Bletillae 10g, Conchi 30g, Poria 15g, Salviae Miltiorrhizae 15g, Rhizoma Pinelliae 15g, and Sanchi 1 appropriate amount.

[0208] Method of taking: The above traditional Chinese medicinal materials are provided by the Chinese medicine pharmacy of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, are crushed into powder, 8g is taken at a time, 2.5-3g of Sanchi powder is added, and then is taken by washing, 2 times a day, 1 course of treatment is 3 months, and 1-2 courses of treatment are observed.

[0209] Alternatively, the above traditional Chinese medicinal materials are provided by the Chinese medicine pharmacy of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, are crushed into powder, 8g is taken at a time, 1-3g of Sanchi powder is added, and then is taken by washing, 3 times a day, 1 course of treatment is 3 months, and 1-2 courses of treatment are observed.

[0210] Enrollment criteria and test grouping: 50 patients diagnosed as chronic atrophic gastritis with intestinal metaplasia by gastroscope and biopsy results. Among them, 23 patients are observed for 1 course of treatment by using prescription 1 due to limited hedgehog skin supply; the remaining 27 patients are observed for 2 courses of treatment by using prescription 2.

[0211] Efficacy evaluation criteria:

[0212] According to the gastroscope and pathological results before and after, if the pathological results of the patient before and after are not aggravated, the atrophy, intestinal metaplasia or dysplasia is defined as effective, the atrophy, intestinal metaplasia or dysplasia is defined as effective, and the intestinal metaplasia or dysplasia is defined as ineffective.

[0213] Total effective rate = (effective + effective) number of cases / total number of cases x 100%.

[0214] Table 1: Comparison of clinical effects of two groups of patients with chronic atrophic gastritis with intestinal metaplasia (washing 2 times a day)

[0215]

[0216] Table 2: Comparison of clinical effects of two groups of patients with chronic atrophic gastritis with intestinal metaplasia (washing 3 times a day)

[0217] Experimental group Example Effective Effective Ineffective Total effective rate % Prescription 1 23 17 6 0 100％ Prescription 2 27 20 7 0 100％

[0218] The above results further prove that the traditional Chinese medicine composition of the present application can effectively improve the pathological state of the gastrointestinal tract, improve the symptoms of chronic atrophic gastritis, reverse the pathological state of atrophy, intestinal metaplasia or dysplasia, and has high clinical application value for chronic atrophic gastritis.

[0219] The inventor further found that the above-mentioned prescription has a high effective rate for treating chronic atrophic gastritis, can obviously reverse intestinal epithelial metaplasia and dysplasia of chronic atrophic gastritis, and can slow down and inhibit the malignant process of chronic atrophic gastritis to gastric cancer; at the same time, the prescription has a significant improvement effect on other gastrointestinal discomfort symptoms (such as fullness, belching, acid reflux, heartburn, etc.), and has a universal improvement effect on weak constitution symptoms.

[0220] Therefore, the prescription of the present application has a significant treatment effect on gastrointestinal diseases, especially chronic atrophic gastritis, and has a high clinical value.

[0221] Although the embodiments of the present application have been shown and described above, it should be understood that the above-mentioned embodiments are exemplary and should not be construed as limiting the present application, and those skilled in the art can make changes, modifications, replacements and variations to the above-mentioned embodiments within the scope of the present application.

Claims

1. A traditional Chinese medicine composition, characterized in that, The raw material of the traditional Chinese medicine composition comprises a first raw material, The first raw material comprises 10-40 parts by weight of Magnolia officinalis, 10-60 parts by weight of Astragalus membranaceus, 10-40 parts by weight of Atractylodes macrocephala, 10-40 parts by weight of Curcuma zedoaria, 5-40 parts by weight of Bletilla striata, and 5-40 parts by weight of Zingiber officinale; The raw material of the traditional Chinese medicine composition further comprises a second raw material, and the second raw material is Panax notoginseng; The weight ratio of the first raw material and the second raw material is (15-17):(1-12).

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The first raw material comprises: 15-25 parts by weight of Magnolia officinalis, 10-35 parts by weight of Astragalus membranaceus, 10-20 parts by weight of Atractylodes macrocephala, 10-20 parts by weight of Curcuma zedoaria, 5-20 parts by weight of Bletilla striata, and 5-15 parts by weight of Zingiber officinale; Further, the first raw material comprises 20 parts by weight of Magnolia officinalis, 30 parts by weight of Astragalus membranaceus, 15 parts by weight of Atractylodes macrocephala, 15 parts by weight of Curcuma zedoaria, 10 parts by weight of Bletilla striata, and 10 parts by weight of Zingiber officinale; Further, the first raw material comprises 15 parts by weight of Magnolia officinalis, 10 parts by weight of Astragalus membranaceus, 15 parts by weight of Atractylodes macrocephala, 15 parts by weight of Curcuma zedoaria, 10 parts by weight of Bletilla striata, and 10 parts by weight of Zingiber officinale; Further, the first raw material comprises 15 parts by weight of Magnolia officinalis, 20 parts by weight of Astragalus membranaceus, 15 parts by weight of Atractylodes macrocephala, 15 parts by weight of Curcuma zedoaria, 20 parts by weight of Bletilla striata, and 5 parts by weight of Zingiber officinale; Optionally, the weight ratio of the first raw material and the second raw material is (15-17):(1-8); Further, the weight ratio of the first raw material and the second raw material is (15-17):(2-6).

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The first raw material further comprises at least one of the following: 10-25 parts by weight of Citrus aurantium, 15-60 parts by weight of Mactra, and 10-40 parts by weight of Dendrobium; Further, the first raw material further comprises 15-20 parts by weight of Citrus aurantium, 30 parts by weight of Mactra, and 10-15 parts by weight of Dendrobium.

4. The traditional Chinese medicine composition according to claim 2 or 3, characterized in that, The first raw material further comprises at least one of the following: 10-20 parts by weight of Taraxacum mongolicum, 10-20 parts by weight of Poria cocos, 5-15 parts by weight of raw licorice, 10-20 parts by weight of Polygonatum, 15-25 parts by weight of Codonopsis pilosula and / or Salvia miltiorrhiza, 5-20 parts by weight of Pinellia ternata, 10-20 parts by weight of hedgehog skin, and 10-20 parts by weight of large abdominal skin; Further, the first raw material further comprises at least one of the following: 15 parts by weight of Taraxacum mongolicum, 15 parts by weight of Poria cocos, 10 parts by weight of raw licorice, 15 parts by weight of Polygonatum, 20 parts by weight of Codonopsis pilosula, 15 parts by weight of Salvia miltiorrhiza, 15 parts by weight of Pinellia ternata, 15 parts by weight of hedgehog skin, and 15 parts by weight of large abdominal skin; Further, the first raw material further comprises 10-20 parts by weight of Taraxacum mongolicum, 10-20 parts by weight of Poria cocos, 5-15 parts by weight of raw licorice, 10-20 parts by weight of Polygonatum, and 15-25 parts by weight of Codonopsis pilosula; Further, the first raw material further comprises 15 parts by weight of Taraxacum mongolicum, 15 parts by weight of Poria cocos, 10 parts by weight of raw licorice, 15 parts by weight of Polygonatum, and 20 parts by weight of Codonopsis pilosula; Optionally, the first raw material further comprises 10-20 parts by weight of hedgehog skin and 10-20 parts by weight of large abdominal skin; Further, the first raw medicinal material further comprises: hedgehog skin 15 parts by weight, large belly skin 15 parts by weight.

5. The traditional Chinese medicine composition according to claim 4, characterized in that, The first raw medicinal material further comprises: dandelion 10-20 parts by weight, poria cocos 10-20 parts by weight, polygonatum 10-20 parts by weight; Further, the first raw medicinal material further comprises: dandelion 15 parts by weight, poria cocos 15 parts by weight, polygonatum 15 parts by weight; Optionally, the first raw medicinal material further comprises: dandelion 10-20 parts by weight, poria cocos 10-20 parts by weight, salvia miltiorrhiza 15-25 parts by weight, pinellia 5-15 parts by weight; Further, the first raw medicinal material further comprises: dandelion 15 parts by weight, poria cocos 15 parts by weight, salvia miltiorrhiza 15 parts by weight, pinellia 15 parts by weight.

6. The traditional Chinese medicine composition according to any one of claims 4-5, characterized in that, The first raw medicinal material further comprises at least one of the following: nine spice worms 10-15 parts by weight, corydalis 15-30 parts by weight, dried tangerine or orange peel 15-30 parts by weight, inula 10-20 parts by weight, ocher 15-20 parts by weight, ginger 15-20 parts by weight, ophiopogon 10-20 parts by weight, lily 15-30 parts by weight, bupleurum 15-20 parts by weight, white peony root 15-30 parts by weight, coptis 5-15 parts by weight, evodia 5-10 parts by weight, gambir 10-20 parts by weight, scutellaria 10-15 parts by weight, Jianqu 15-20 parts by weight, malt 20-30 parts by weight, atractylodes 10-20 parts by weight, cardamom 10-15 parts by weight, fried mustard seed 5-15 parts by weight, raw sanguisorba 10-20 parts by weight, peach kernel 10-20 parts by weight; Optionally, the first raw medicinal material further comprises: nine spice worms 10-15 parts by weight, corydalis 15-30 parts by weight; Optionally, the first raw medicinal material further comprises: pinellia 10-20 parts by weight, dried tangerine or orange peel 15-30 parts by weight, inula 10-20 parts by weight, ocher 15-20 parts by weight, ginger 15-20 parts by weight; Optionally, the first raw medicinal material further comprises: ophiopogon 10-20 parts by weight, lily 15-30 parts by weight; Optionally, the first raw medicinal material further comprises: bupleurum 15-20 parts by weight, white peony root 15-30 parts by weight; Optionally, the first raw medicinal material further comprises: coptis 5-15 parts by weight, evodia 5-10 parts by weight; Optionally, the first raw medicinal material further comprises: gambir 10-15 parts by weight, scutellaria 10-15 parts by weight; Optionally, the first raw medicinal material further comprises: Jianqu 15-20 parts by weight, malt 20-30 parts by weight; Optionally, the first raw medicinal material further comprises: atractylodes 10-20 parts by weight, cardamom 10-15 parts by weight; Optionally, the first raw medicinal material further comprises: fried mustard seed 5-15 parts by weight, bupleurum 15-20 parts by weight, Jianqu 15-20 parts by weight, raw sanguisorba 10-20 parts by weight, peach kernel 10-20 parts by weight; Optionally, the first raw medicinal material further comprises: malt 20-30 parts by weight, coptis 5-15 parts by weight, cardamom 10-15 parts by weight, gambir 10-20 parts by weight.

7. The traditional Chinese medicine composition according to any one of claims 4-6, characterized in that, The first raw medicinal materials include Fructus Aurantii 20 parts by weight, Magnoliae Officinalis Cortex 20 parts by weight, Zingiberis Rhizoma 10 parts by weight, Radix Paeoniae Alba 30 parts by weight, Rhizoma Atractylodis Macrocephalae 15 parts by weight, Curcumae Rhizoma 15 parts by weight, Herba Taraxaci 15 parts by weight, Bletillae Rhizoma 10 parts by weight, Concha Arcae 30 parts by weight, Poria 15 parts by weight, Radix Glycyrrhizae 9-10 parts by weight, Echinops 15 parts by weight, Pericarpium Citri Reticulatae Viridis 15 parts by weight, Rhizoma Polygonati 10-15 parts by weight, Radix Codonopsis 20 parts by weight; or, The first raw medicinal materials include Fructus Aurantii 20 parts by weight, Magnoliae Officinalis Cortex 20 parts by weight, Zingiberis Rhizoma 10 parts by weight, Radix Paeoniae Alba 30 parts by weight, Rhizoma Atractylodis Macrocephalae 15 parts by weight, Curcumae Rhizoma 15 parts by weight, Herba Taraxaci 15 parts by weight, Bletillae Rhizoma 10 parts by weight, Concha Arcae 30 parts by weight, Poria 15 parts by weight, Rhizoma Polygonati 10 parts by weight; or, The first raw medicinal materials include Fructus Aurantii 20 parts by weight, Magnoliae Officinalis Cortex 20 parts by weight, Zingiberis Rhizoma 10 parts by weight, Radix Paeoniae Alba 30 parts by weight, Rhizoma Atractylodis Macrocephalae 15 parts by weight, Curcumae Rhizoma 15 parts by weight, Herba Taraxaci 15 parts by weight, Bletillae Rhizoma 10 parts by weight, Concha Arcae 30 parts by weight, Poria 15 parts by weight, Bletillae Rhizoma 15 parts by weight, Salviae Miltiorrhizae Radix 15 parts by weight, Rhizoma Pinelliae 15 parts by weight; or, The first raw medicinal materials include Fructus Aurantii 15 parts by weight, Magnoliae Officinalis Cortex 15 parts by weight, Zingiberis Rhizoma 10 parts by weight, Radix Paeoniae Alba 10 parts by weight, Radix Codonopsis 20 parts by weight, Rhizoma Atractylodis Macrocephalae 15 parts by weight, Bletillae Rhizoma 10 parts by weight, Concha Arcae 30 parts by weight, Poria 15 parts by weight, Radix Glycyrrhizae 5 parts by weight, Bletillae Rhizoma 15 parts by weight, Rhizoma Pinelliae 10 parts by weight, Echinops 15 parts by weight, Salviae Miltiorrhizae Radix 15 parts by weight, Semen Armeniacae Amarum 10 parts by weight, Radix Bupleuri 15 parts by weight, Jianqu 15 parts by weight, Radix Alismae 15 parts by weight, Semen Persicae 15 parts by weight; or, The first raw medicinal materials include Fructus Aurantii 10 parts by weight, Magnoliae Officinalis Cortex 15 parts by weight, Zingiberis Rhizoma 5 parts by weight, Radix Paeoniae Alba 20 parts by weight, Curcumae Rhizoma 15 parts by weight, Herba Taraxaci 20 parts by weight, Bletillae Rhizoma 20 parts by weight, Poria 20 parts by weight, Radix Glycyrrhizae 5 parts by weight, Rhizoma Atractylodis Macrocephalae 15 parts by weight, Bletillae Rhizoma 30 parts by weight, Rhizoma Pinelliae 15 parts by weight, Fructus Hordei Germinatus 30 parts by weight, Rhizoma Coptidis 12 parts by weight, Salviae Miltiorrhizae Radix 20 parts by weight, Echinops 10 parts by weight, Amomi Fructus 15 parts by weight, Herba Artemisiae Scopariae 20 parts by weight.

8. The traditional Chinese medicine composition according to any one of claims 1-7, characterized in that, The Magnoliae Officinalis Cortex is Jianghuopu; Optionally, the Fructus Aurantii is Chaozhiqie; Optionally, the Rhizoma Atractylodis Macrocephalae is Chaohuangzhu or Shenghuangzhu; Optionally, the Rhizoma Pinelliae is Jiangbanxia or Fahuangxia; Optionally, the Concha Arcae is Nuanmuoli; Optionally, the Echinops is Nian Echinops; Optionally, the Bletillae Rhizoma is Gan Bletillae Rhizoma; Optionally, the Rhizoma Polygonati is Zhi Rhizoma Polygonati; Optionally, the Radix Paeoniae Alba is Shenghuangqi or Jiuhuangqi; Optionally, the Rhizoma Coptidis is Jiuhuanglian; Optionally, the Fructus Hordei Germinatus is Chao Fruetus Hordei Germinatus; Optionally, the Radix Bupleuri is Beibupleuri.

9. The traditional Chinese medicine composition according to any one of claims 1-8, characterized in that, The traditional Chinese medicine composition is a decoction, a powder, a capsule, a tablet or a pill; Optionally, further comprising a pharmaceutically acceptable excipient; Optionally, the excipient comprises: one or more pharmaceutically acceptable excipients, diluents, stabilizers or carriers; Optionally, the traditional Chinese medicine composition is a powder.

10. Use of the traditional Chinese medicine composition according to any one of claims 1-9 in the preparation of a medicament for preventing and / or treating a gastrointestinal disease, and / or a medicament for relieving a sub-health symptom; Optionally, the gastrointestinal disease comprises chronic atrophic gastritis; Optionally, the chronic atrophic gastritis is chronic atrophic gastritis with intestinal metaplasia and / or dysplasia; Optionally, the gastrointestinal disease has at least one of the following symptoms: poor appetite, abdominal distension, bloating, belching, acid regurgitation and heartburn; Optionally, the sub-health symptom comprises at least one of anxiety and emaciation.

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