A composition for treating chronic gastritis and a method for preparing the same

Abstract

The application discloses a composition for treating chronic gastritis, which is prepared from the following raw medicinal materials in parts by weight: raw land 20-26 parts, ophiopogon 18-22 parts, radix paeonia 12-16 parts, gardenia 15-25 parts, rhizome of phragmites communis 20-24 parts, dendrobium 8-12 parts, salvia miltiorrhiza 16-24 parts, corydalis 12-16 parts, angelica 20-24 parts, chuanxiong 18-22 parts, bupleurum 18-22 parts, medlar 16-24 parts, pinellia 14-18 parts, tangerine peel 20-24 parts, white atractylodes 16-24 parts, poria 20-28 parts, yam 20-28 parts, wheat germ 16-24 parts, coix seed 20-24 parts, polygonatum 20-24 parts, gizzard 18-22 parts, citron 12-18 parts, and costus 10-18 parts. The composition is in line with the theories of traditional Chinese medicine and modern medical research, has the effects of nourishing yin and benefiting stomach, clearing liver and purging fire, and clearing stomach and discharging heat, and has good effects on treating chronic gastritis of the stomach yin deficiency type and is safe and free of side effects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a composition for treating chronic gastritis and its preparation method, which has the effect of invigorating qi and strengthening the spleen. Background Technology

[0002] Chronic gastritis is a very common digestive system disease with a high incidence rate in the population. Most people may experience symptoms of digestive system dysfunction such as stomach pain and bloating to varying degrees or for varying lengths of time in their lives. Chronic gastritis is a chronic inflammation of the gastric mucosa caused by various factors. It occurs in the gastric mucosal layer and is manifested as inflammatory cell infiltration of the gastric mucosa. Under gastroscopy, it can be seen as congestion, edema, erosion, and bleeding of mucosal cells. Chronic gastritis is very common in clinical practice. Studies have shown that about 80% to 90% of all people who undergo gastroscopy will be diagnosed with chronic gastritis. There are more male patients than female patients, and the incidence of chronic gastritis increases with age. Causes of chronic gastritis (1) Helicobacter pylori infection: Helicobacter pylori infection is the most important cause of chronic gastritis. About half of chronic gastritis is caused by Helicobacter pylori infection. (2) Poor dietary habits: Long-term consumption of strong tea, strong alcohol, and coffee, eating spicy and coarse foods, eating too quickly, liking to eat too hot food, and being too hungry or too full are all bad dietary habits that can easily lead to chronic gastritis. Taking nonsteroidal anti-inflammatory drugs, glucocorticoids, and some drugs for treating cardiovascular and cerebrovascular diseases may also cause chronic gastritis. (3) Mental and psychological factors: People engaged in highly competitive occupations with high mental stress have a significantly higher incidence of chronic gastritis than the general population. Tension, anxiety, irritability, sadness, etc. can all cause autonomic nervous system dysfunction, leading to chronic gastritis or inducing the symptoms of chronic gastritis. (4) Climate and environmental factors: When the climate changes and seasons change, if the human body cannot adapt in a short period of time, in addition to the possibility of catching a cold or other diseases, chronic gastritis may also be triggered. For people who have already suffered from chronic gastritis, seasonal changes and cooler weather may cause a relapse of chronic gastritis.

[0003] In addition, genetic factors and other diseases can also promote the development of chronic gastritis. The main cause of chronic atrophic gastritis is stagnation of stomach qi. The stomach functions smoothly when its qi is flowing downwards; if this flow is obstructed, the stomach loses its smooth downward movement, leading to pain. The entire pathological process is complex, but can be summarized in the following aspects.

[0004] 1. Stomach Qi stagnation leads to damp-heat: When stomach Qi stagnates, its function of descending and transforming is disrupted, and it cannot properly digest and transport food downwards. As food fails to be properly transformed, water becomes dampness and food becomes stagnant, and this stagnation can generate damp-heat.

[0005] 2. Prolonged stagnation of Qi can transform into heat or cold. Anger can lead to stagnation of Liver Qi. If Liver Qi stagnation persists, it often transforms into heat, initially consuming body fluids and eventually depleting vital Qi and damaging Stomach Yin. Conversely, worry and anxiety can cause Spleen Qi stagnation, often transforming into cold. Initially, Stomach Yang is injured, and over time, it depletes vital Qi and damages Middle Yang, resulting in various symptoms. Spleen deficiency and impaired Middle Yang function lead to water retention, which in turn produces dampness and phlegm, obstructing the Stomach and Intestines.

[0006] 3. Qi stagnation and blood stasis, prolonged illness affecting the collaterals: Stomach pain, if prolonged, can affect the blood, leading to blood stasis on top of qi stagnation. Hence the ancient saying, "Prolonged pain affects the collaterals." If stomach pain is persistent and unresolved, phlegm and blood stasis may accumulate, obstructing the stomach and worsening the symptoms. In such cases, be alert to the possibility of cancer. Summary of the Invention

[0007] This invention aims to provide a composition for treating chronic gastritis, its preparation method, and its uses. The traditional Chinese medicine composition uses a combination of medicinal materials that are well-matched and conform to the research theories of traditional Chinese medicine and modern medicine. The traditional Chinese medicine compound extract composition of this invention has the effects of nourishing yin and benefiting the stomach, clearing liver fire, and clearing stomach heat. It is effective in treating chronic gastritis of the stomach yin deficiency type and is safe with no toxic side effects.

[0008] To achieve the above objectives, the present invention adopts the following technical solution:

[0009] A composition for treating chronic gastritis, made from the following raw materials in parts by weight: 20-26 parts Rehmannia glutinosa, 18-22 parts Ophiopogon japonicus, 12-16 parts Paeonia suffruticosa, 15-25 parts Gardenia jasminoides, 20-24 parts Phragmites communis, 8-12 parts Dendrobium nobile, 16-24 parts Salvia miltiorrhiza, 12-16 parts Corydalis yanhusuo, 20-24 parts Angelica sinensis, 18-22 parts Ligusticum chuanxiong, 18-22 parts Bupleurum chinense, 16-24 parts Lycium barbarum, 14-18 parts Pinellia ternata, 20-24 parts Citrus reticulata, 16-24 parts Atractylodes macrocephala, 20-28 parts Poria cocos, 20-28 parts Dioscorea opposita, 16-24 parts Hordeum vulgare, 20-24 parts Coix lacryma-jobi, 20-24 parts Polygonatum sibiricum, 18-22 parts Gallus gallus domesticus gizzard lining, 12-18 parts Citrus aurantium, and 10-18 parts Aucklandia lappa.

[0010] The aforementioned traditional Chinese medicine composition is made from the following raw materials in parts by weight: 23 parts Rehmannia glutinosa, 20 parts Ophiopogon japonicus, 14 parts Paeonia suffruticosa, 20 parts Gardenia jasminoides, 22 parts Phragmites communis, 10 parts Dendrobium nobile, 20 parts Salvia miltiorrhiza, 14 parts Corydalis yanhusuo, 22 parts Angelica sinensis, 20 parts Ligusticum chuanxiong, 20 parts Bupleurum chinense, 20 parts Lycium barbarum, 16 parts Pinellia ternata, 22 parts Citrus reticulata peel, 20 parts Atractylodes macrocephala, 24 parts Poria cocos, 24 parts Dioscorea opposita, 20 parts Hordeum vulgare malt, 22 parts Coix lacryma-jobi, 22 parts Polygonatum sibiricum, 20 parts Gallus gallus domesticus gizzard lining, 15 parts Citrus aurantium, and 14 parts Aucklandia lappa.

[0011] The aforementioned traditional Chinese medicine composition contains ginger-processed Pinellia ternata.

[0012] The traditional Chinese medicine composition is prepared by the following method:

[0013] (1) Take peony bark, salvia miltiorrhiza, corydalis rhizome, angelica root, chuanxiong rhizome, bupleurum root, pinellia tuber, tangerine peel, poria cocos, immature bitter orange peel, and costus root, and grind them into coarse powder;

[0014] (2) Load the powder into the supercritical CO2 extraction device. After the cooling device, the extraction vessel and the separation vessel heating device are working normally, turn on the compressor pump to pressurize to the required fixed separation pressure of 22MPa, adjust the CO2 flow rate to 10kg / h, the extraction temperature to 50℃, the extraction time to 4h, and circulate the extraction twice to obtain an oily liquid.

[0015] (3) Take the residue after supercritical CO2 extraction and the remaining medicinal materials, add water and decoct twice. Add 10 times the amount of water for the first extraction and extract for 1.5 hours. Add 8 times the amount of water for the second extraction and extract for 1 hour. Combine the extracts, filter, concentrate the filtrate to a clear extract with a relative density of 1.10-1.15, dry under reduced pressure to obtain a dry extract, pulverize, pass through a 100-mesh sieve to obtain extract powder for later use.

[0016] (4) Take the oily liquid obtained in step (2) and the extract powder obtained in step (3), add excipients, and prepare one of the following: tablets, hard capsules, granules, soft capsules or pills.

[0017] The traditional Chinese medicine composition is prepared by the following method:

[0018] (1) Take peony bark, salvia miltiorrhiza, corydalis rhizome, angelica root, chuanxiong rhizome, bupleurum root, pinellia tuber, tangerine peel, poria cocos, immature bitter orange peel, and costus root, and grind them into coarse powder;

[0019] (2) Load the powder into the supercritical CO2 extraction device. After the cooling device, the extraction vessel and the separation vessel heating device are working normally, turn on the compressor pump to pressurize to the required fixed separation pressure of 22MPa, adjust the CO2 flow rate to 10kg / h, the extraction temperature to 50℃, the extraction time to 4h, and circulate the extraction twice to obtain an oily liquid.

[0020] (3) Take the residue after supercritical CO2 extraction and the remaining medicinal materials, add water and decoct twice. Add 10 times the amount of water for the first extraction and extract for 1.5 hours. Add 8 times the amount of water for the second extraction and extract for 1 hour. Combine the extracts, filter, and concentrate the filtrate to a clear extract with a relative density of 1.10-1.15 for later use.

[0021] (4) Take the oily liquid obtained in step (2) and the clear paste obtained in step (3), add excipients, and prepare one of the oral liquid or compound preparations.

[0022] The application of the aforementioned traditional Chinese medicine composition in the preparation of drugs for treating chronic gastritis.

[0023] The application of the aforementioned traditional Chinese medicine composition in the preparation of drugs for treating chronic gastritis, where the syndrome of chronic gastritis is stomach yin deficiency.

[0024] The application of the aforementioned traditional Chinese medicine composition in the preparation of drugs for treating chronic gastritis, specifically chronic atrophic gastritis.

[0025] The above-mentioned Pinellia ternata is ginger-processed Pinellia ternata. The processing method for ginger-processed Pinellia ternata is as follows: Take clean Pinellia ternata, separate them by size, and soak them in water until the inside is no longer dry; separately, take sliced ​​ginger and decoct it in water, add alum and cook together with the Pinellia ternata until thoroughly cooked, remove, air dry until semi-dry, slice thinly, and dry completely. For every 100kg of Pinellia ternata, use 25kg of ginger and 12.5kg of alum. This product is in the form of flakes, irregular granules, or near-spherical shapes. The surface is brown to brownish-brown. It is hard and brittle, with a light yellowish-brown cross-section, often with a horny luster. It has a slightly fragrant odor, a bland taste with a slightly numbing sensation on the tongue, and is slightly sticky when chewed.

[0026] Beneficial effects:

[0027] 1. The *Suwen* (Plain Questions) chapter on Bi syndrome states, "When one eats twice as much, the stomach and intestines are damaged." Zhu Danxi, in *Zheng Yin Mai Zhi* (Causes and Treatments of Diseases), points out that stomach pain can be caused by excessive labor, irregular eating habits, insufficient Qi, and invasion of cold pathogens. However, prolonged illness easily leads to "stagnation and the generation of heat, or pre-existing heat, where deficiency and heat combine and stagnate in the stomach, causing pain; or food stagnation and phlegm; or Qi and food stagnation that cannot be dispersed, causing pain in the stomach." Therefore, prolonged stomach pain, whether due to the use of warming and drying medicines, or liver Yin deficiency and liver Yang hyperactivity, which scorches stomach Yin and depletes kidney water, often manifests as stomach Yin deficiency. Symptoms include dull stomach pain, dry mouth and throat, poor appetite, constipation, red tongue with little coating, and a thready and rapid or thready and wiry pulse, indicating chronic gastritis. Gastroscopy often reveals chronic atrophic gastritis. Due to stomach yin deficiency, this invention uses Rehmannia glutinosa and Ophiopogon japonicus to nourish yin and benefit the stomach. For liver yin deficiency or liver yang hyperactivity that scorches stomach yin, Paeonia suffruticosa and Gardenia jasminoides are used to clear liver fire. For liver fire invading the stomach, Phragmites communis and Dendrobium nobile are used to clear stomach heat. Rehmannia glutinosa, Ophiopogon japonicus, Paeonia suffruticosa, Gardenia jasminoides, Phragmites communis, and Dendrobium nobile are the principal herbs. Moreover, since chronic and recurrent stomach pain inevitably involves phlegm and blood stasis, Salvia miltiorrhiza, Corydalis yanhusuo, Angelica sinensis, and Ligusticum chuanxiong are used to invigorate blood and remove blood stasis. Among them, Angelica sinensis and Ligusticum chuanxiong also have the effect of soothing the liver and relieving urgency, inhibiting liver yang hyperactivity. Bupleurum chinense is used to soothe the liver, Lycium barbarum is used to nourish the liver and kidneys, and Pinellia ternata and Citrus reticulata are used to regulate qi, strengthen the spleen, dry dampness and resolve phlegm. Salvia miltiorrhiza, Corydalis yanhusuo, Angelica sinensis, Ligusticum chuanxiong, Bupleurum chinense, Lycium barbarum, Pinellia ternata, and Citrus reticulata are the assistant herbs. Among the above herbs, Rehmannia glutinosa and Angelica sinensis can also treat constipation due to fluid deficiency, targeting dry stools. When wood is stagnant, earth weakens. Atractylodes macrocephala and Poria cocos support earth and suppress wood. Dioscorea opposita, malt, coix seed, polygonatum sibiricum, and chicken gizzard membrane promote diuresis, eliminate dampness, strengthen the spleen, and calm the mind, serving as adjuvant herbs. Citrus aurantium and costus root promote qi circulation and relieve pain, serving as guiding herbs. The entire formula takes nourishing yin and benefiting the stomach, clearing liver fire, and clearing stomach heat as its main treatment principles, while also regulating qi and blood. It helps the deficient to flow smoothly and helps the stagnant to be released. It includes Rehmannia glutinosa, Ophiopogon japonicus, Paeonia suffruticosa, Gardenia jasminoides, Phragmites communis, Dendrobium nobile, Salvia miltiorrhiza, Corydalis yanhusuo, Angelica sinensis, Ligusticum chuanxiong, Bupleurum chinense, Lycium barbarum, Pinellia ternata, Citrus reticulata, Atractylodes macrocephala, Poria cocos, Dioscorea opposita, malt, coix seed, polygonatum sibiricum, chicken gizzard membrane, Citrus aurantium, and costus root, and is used to treat chronic gastritis of the stomach yin deficiency type.

[0028] 2. Compared with the blank group, the pepsin activity of rats in the model group was significantly reduced (P<0.01); compared with the model group, the high, medium and low dose groups of Example 1 of the present invention and the positive control group could all increase the pepsin activity of rats, and the high dose group of Example 1 of the present invention and the positive control group had significant effects (P<0.05), indicating that the present invention can increase the pepsin activity of rats and has the effect of treating chronic gastritis.

[0029] 3. In this study, a total of 100 patients were collected in the clinical experimental group. 45 patients were cured, 28 patients showed significant improvement, 15 patients showed improvement, and 8 patients showed no improvement. The total effective rate was 92%. It can be seen that the traditional Chinese medicine composition of the present invention has a good clinical therapeutic effect on chronic gastritis of the stomach yin deficiency type. Detailed Implementation

[0030] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the description of this invention, those skilled in the art can make various alterations or modifications to the invention, but these equivalent forms also fall within the scope defined by the appended claims.

[0031] Example 1: Take 23g of Rehmannia glutinosa, 20g of Ophiopogon japonicus, 14g of Paeonia suffruticosa, 20g of Gardenia jasminoides, 22g of Phragmites communis, 10g of Dendrobium nobile, 20g of Salvia miltiorrhiza, 14g of Corydalis yanhusuo, 22g of Angelica sinensis, 20g of Ligusticum chuanxiong, 20g of Bupleurum chinense, 20g of Lycium barbarum, 16g of Pinellia ternata, 22g of Citrus reticulata peel, 20g of Atractylodes macrocephala, 24g of Poria cocos, 24g of Dioscorea opposita, 20g of Hordeum vulgare malt, 22g of Coix lacryma-jobi, 22g of Polygonatum sibiricum, 20g of Gallus gallus domesticus gizzard lining, 15g of Citrus aurantium, and 14g of Aucklandia lappa. The preparation method is as follows:

[0032] (1) Take peony bark, salvia miltiorrhiza, corydalis rhizome, angelica root, chuanxiong rhizome, bupleurum root, pinellia tuber, tangerine peel, poria cocos, immature bitter orange peel, and costus root, and grind them into coarse powder;

[0033] (2) Load the powder into the supercritical CO2 extraction device. After the cooling device, the extraction vessel and the separation vessel heating device are working normally, turn on the compressor pump to pressurize to the required fixed separation pressure of 22MPa, adjust the CO2 flow rate to 10kg / h, the extraction temperature to 50℃, the extraction time to 4h, and circulate the extraction twice to obtain an oily liquid.

[0034] (3) Take the residue after supercritical CO2 extraction and the remaining medicinal materials, add water and decoct twice. Add 10 times the amount of water for the first extraction and extract for 1.5 hours. Add 8 times the amount of water for the second extraction and extract for 1 hour. Combine the extracts, filter, concentrate the filtrate to a clear extract with a relative density of 1.10, dry under reduced pressure to obtain a dry extract, pulverize, pass through a 100-mesh sieve to obtain extract powder for later use.

[0035] (4) Take the oily liquid obtained in step (2) and the extract powder obtained in step (3), add excipients, and prepare granules.

[0036] Example 2: Take 20g of Rehmannia glutinosa, 22g of Ophiopogon japonicus, 12g of Paeonia suffruticosa, 25g of Gardenia jasminoides, 20g of Phragmites communis, 12g of Dendrobium nobile, 16g of Salvia miltiorrhiza, 16g of Corydalis yanhusuo, 20g of Angelica sinensis, 22g of Ligusticum chuanxiong, 18g of Bupleurum chinense, 24g of Lycium barbarum, 14g of Pinellia ternata, 24g of Citrus reticulata peel, 16g of Atractylodes macrocephala, 28g of Poria cocos, 20g of Dioscorea opposita, 24g of Hordeum vulgare malt, 20g of Coix lacryma-jobi, 24g of Polygonatum sibiricum, 18g of Gallus gallus domesticus gizzard lining, 18g of Citrus aurantium, and 10g of Aucklandia lappa. The preparation method is as follows:

[0037] (1) Take peony bark, salvia miltiorrhiza, corydalis rhizome, angelica root, chuanxiong rhizome, bupleurum root, pinellia tuber, tangerine peel, poria cocos, immature bitter orange peel, and costus root, and grind them into coarse powder;

[0038] (2) Load the powder into the supercritical CO2 extraction device. After the cooling device, the extraction vessel and the separation vessel heating device are working normally, turn on the compressor pump to pressurize to the required fixed separation pressure of 22MPa, adjust the CO2 flow rate to 10kg / h, the extraction temperature to 50℃, the extraction time to 4h, and circulate the extraction twice to obtain an oily liquid.

[0039] (3) Take the residue after supercritical CO2 extraction and the remaining medicinal materials, add water and decoct twice. Add 10 times the amount of water for the first extraction and extract for 1.5 hours. Add 8 times the amount of water for the second extraction and extract for 1 hour. Combine the extracts, filter, concentrate the filtrate to a clear extract with a relative density of 1.15, dry under reduced pressure to obtain a dry extract, pulverize, pass through a 100-mesh sieve to obtain extract powder for later use.

[0040] (4) Take the oily liquid obtained in step (2) and the extract powder obtained in step (3), add excipients, and prepare tablets.

[0041] Example 3: Take 26g of Rehmannia glutinosa, 18g of Ophiopogon japonicus, 16g of Paeonia suffruticosa, 15g of Gardenia jasminoides, 24g of Phragmites communis, 8g of Dendrobium nobile, 24g of Salvia miltiorrhiza, 12g of Corydalis yanhusuo, 24g of Angelica sinensis, 18g of Ligusticum chuanxiong, 22g of Bupleurum chinense, 16g of Lycium barbarum, 118g of Pinellia ternata, 20g of Citrus reticulata peel, 24g of Atractylodes macrocephala, 20g of Poria cocos, 28g of Dioscorea opposita, 16g of Hordeum vulgare malt, 24g of Coix lacryma-jobi, 20g of Polygonatum sibiricum, 22g of Gallus gallus domesticus gizzard lining, 12g of Citrus aurantium, and 18g of Aucklandia lappa. The preparation method is as follows:

[0042] (1) Take peony bark, salvia miltiorrhiza, corydalis rhizome, angelica root, chuanxiong rhizome, bupleurum root, pinellia tuber, tangerine peel, poria cocos, immature bitter orange peel, and costus root, and grind them into coarse powder;

[0043] (2) Load the powder into the supercritical CO2 extraction device. After the cooling device, the extraction vessel and the separation vessel heating device are working normally, turn on the compressor pump to pressurize to the required fixed separation pressure of 22MPa, adjust the CO2 flow rate to 10kg / h, the extraction temperature to 50℃, the extraction time to 4h, and circulate the extraction twice to obtain an oily liquid.

[0044] (3) Take the residue after supercritical CO2 extraction and the remaining medicinal materials, add water and decoct twice. Add 10 times the amount of water for the first extraction and extract for 1.5 hours. Add 8 times the amount of water for the second extraction and extract for 1 hour. Combine the extracts, filter, concentrate the filtrate to a clear extract with a relative density of 1.12, dry under reduced pressure to obtain a dry extract, pulverize, pass through a 100-mesh sieve to obtain extract powder for later use.

[0045] (4) Take the oily liquid obtained in step (2) and the extract powder obtained in step (3), add excipients, and prepare hard capsules.

[0046] Example 4: Take 23g of Rehmannia glutinosa, 20g of Ophiopogon japonicus, 14g of Paeonia suffruticosa, 20g of Gardenia jasminoides, 22g of Phragmites communis, 10g of Dendrobium nobile, 20g of Salvia miltiorrhiza, 14g of Corydalis yanhusuo, 22g of Angelica sinensis, 20g of Ligusticum chuanxiong, 20g of Bupleurum chinense, 20g of Lycium barbarum, 16g of Pinellia ternata, 22g of Citrus reticulata peel, 20g of Atractylodes macrocephala, 24g of Poria cocos, 24g of Dioscorea opposita, 20g of Hordeum vulgare malt, 22g of Coix lacryma-jobi, 22g of Polygonatum sibiricum, 20g of Gallus gallus domesticus gizzard lining, 15g of Citrus aurantium, and 14g of Aucklandia lappa. The preparation method is as follows:

[0047] (1) Take peony bark, salvia miltiorrhiza, corydalis rhizome, angelica root, chuanxiong rhizome, bupleurum root, pinellia tuber, tangerine peel, poria cocos, immature bitter orange peel, and costus root, and grind them into coarse powder;

[0048] (2) Load the powder into the supercritical CO2 extraction device. After the cooling device, the extraction vessel and the separation vessel heating device are working normally, turn on the compressor pump to pressurize to the required fixed separation pressure of 22MPa, adjust the CO2 flow rate to 10kg / h, the extraction temperature to 50℃, the extraction time to 4h, and circulate the extraction twice to obtain an oily liquid.

[0049] (3) Take the residue after supercritical CO2 extraction and the remaining medicinal materials, add water and decoct twice. Add 10 times the amount of water for the first extraction and extract for 1.5 hours. Add 8 times the amount of water for the second extraction and extract for 1 hour. Combine the extracts, filter, and concentrate the filtrate to a clear extract with a relative density of 1.15 for later use.

[0050] (4) Take the oily liquid obtained in step (2) and the clear paste obtained in step (3), add excipients, and prepare an oral liquid.

[0051] Example 5: Take 23g of Rehmannia glutinosa, 20g of Ophiopogon japonicus, 14g of Paeonia suffruticosa, 20g of Gardenia jasminoides, 22g of Phragmites communis, 10g of Dendrobium nobile, 20g of Salvia miltiorrhiza, 14g of Corydalis yanhusuo, 22g of Angelica sinensis, 20g of Ligusticum chuanxiong, 20g of Bupleurum chinense, 20g of Lycium barbarum, 16g of Pinellia ternata, 22g of Citrus reticulata peel, 20g of Atractylodes macrocephala, 24g of Poria cocos, 24g of Dioscorea opposita, 20g of Hordeum vulgare malt, 22g of Coix lacryma-jobi, 22g of Polygonatum sibiricum, 20g of Gallus gallus domesticus gizzard lining, 15g of Citrus aurantium, and 14g of Aucklandia lappa. The preparation method is as follows:

[0052] (1) Take peony bark, salvia miltiorrhiza, corydalis rhizome, angelica root, chuanxiong rhizome, bupleurum root, pinellia tuber, tangerine peel, poria cocos, immature bitter orange peel, and costus root, and grind them into coarse powder;

[0053] (2) Load the powder into the supercritical CO2 extraction device. After the cooling device, the extraction vessel and the separation vessel heating device are working normally, turn on the compressor pump to pressurize to the required fixed separation pressure of 22MPa, adjust the CO2 flow rate to 10kg / h, the extraction temperature to 50℃, the extraction time to 4h, and circulate the extraction twice to obtain an oily liquid.

[0054] (3) Take the residue after supercritical CO2 extraction and the remaining medicinal materials, add water and decoct twice. Add 10 times the amount of water for the first extraction and extract for 1.5 hours. Add 8 times the amount of water for the second extraction and extract for 1 hour. Combine the extracts, filter, and concentrate the filtrate to a clear extract with a relative density of 1.10 for later use.

[0055] (4) Take the oily liquid obtained in step (2) and the clear paste obtained in step (3), add excipients, and prepare a mixture.

[0056] Example 6: Pharmacodynamic Study of the Invention

[0057] Grouping: Except for 8 rats in the blank group that were normally fed and not subjected to modeling, the remaining 40 rats were modeled according to the method described in the literature. The modeling group received a combination of chronic injury factors: ① 60% ethanol, administered by gavage every 3 days on an empty stomach (with feed removed the previous night), 8 mL / kg each time; ② 20 mmol / L sodium deoxycholate, administered by gavage once daily, 8 mL / kg each time; ③ 0.1% ammonia solution was prepared daily as the rats' drinking water for free access, and the daily intake was recorded; ④ 0.05% indomethacin, administered by gavage once daily, 8 mL / kg each time; ⑤ An irregular feeding method was used: 2 days of adequate feeding, followed by 1 day of fasting. Modeling was continued for 40 weeks. At 30 weeks of modeling using the comprehensive method, rats were randomly selected every week, and gastric mucosal tissue was taken for pathological examination to determine the pathological changes of gastric mucosal atrophy. Treatment began after the pathological formation of gastric mucosal atrophy in the CAG model rats. CAG rats were numbered according to their body weight and randomly divided into a model group, a positive control group, and high, medium, and low dose groups according to Example 1 of this invention, with 8 rats in each group.

[0058] Administration: In Example 1 of this invention, the high, medium, and low dose groups were administered 24, 12, and 6 g of medicinal material / kg of Example 1 of this invention via gavage daily (equivalent to 12, 6, and 3 times the dose for a 60 kg adult, respectively); the positive control group was administered 0.30 g / kg of vitamin B complex via gavage daily (equivalent to 6 times the dose for a 60 kg adult). The equivalent dose was calculated according to the human-animal coefficient. Administration continued for 120 days. The daily administration volume was 10 mL / kg. The blank group and model group were administered an equal volume of distilled water via gavage.

[0059] Specimen Collection and Testing: After anesthesia and euthanasia, gastric mucosal tissue was rapidly dissected under low temperature conditions, rinsed with ice-cold physiological saline, blotted dry with filter paper, weighed, and quickly minced with ophthalmic scissors. The tissue was then placed in a homogenizer and homogenized with 9 times its weight of physiological saline. The homogenate was centrifuged at 3500 rpm for 10 min, and the supernatant was collected and stored at 4°C for testing of gastric tissue protease activity. The results are shown in Table 1.

[0060] Table 1 Comparison of pepsin activity in rats of different groups

[0061] Group Pepsin (U / mL) Blank group 142.45±17.42 Model group <![CDATA[103.78±14.98 ** ]]> High-dose group <![CDATA[132.28±21.65 △ ]]> medium dose group 126.46±19.27 low-dose group 119.89±23.16 Positive control group <![CDATA[127.91±18.45 △ ]]>

[0062] Note: Compared with the blank group, ** P < 0.01; compared with the model group, △ P < 0.05

[0063] Compared with the blank group, the pepsin activity of rats in the model group was significantly reduced (P<0.01); compared with the model group, the high, medium and low dose groups of Example 1 of the present invention and the positive control group could all increase the pepsin activity of rats, and the high dose group of Example 1 of the present invention and the positive control group had significant effects (P<0.05) and showed a dose-related relationship, indicating that the present invention can increase the pepsin activity of rats and has the effect of treating chronic gastritis.

[0064] Example 7: Clinical application of the traditional Chinese medicine composition of the present invention

[0065] 7.1 We collected 100 patients who met the inclusion criteria.

[0066] Traditional Chinese Medicine Diagnostic Criteria: Meets the diagnostic criteria for chronic gastritis (stomach pain), referring to the "Consensus Opinion on the Diagnosis and Treatment of Chronic Atrophic Gastritis in Traditional Chinese Medicine" (Spleen and Stomach Diseases Branch of China Association of Traditional Chinese Medicine) and the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs" (2002). It meets the criteria for chronic gastritis with stomach yin deficiency syndrome, with symptoms such as dull stomach pain, dry mouth and throat, poor appetite, dry stools, red tongue with little coating, thready and rapid or thready and wiry pulse, and varying degrees and types of stomach pain, abdominal distension, belching, nausea, loss of appetite, and acid reflux.

[0067] Western medicine diagnostic criteria: Refer to the "Chinese Consensus Opinion on Chronic Gastritis" (Second National Consensus Conference on Chronic Gastritis of the Chinese Medical Association Gastroenterology Branch, 2006, Shanghai). Common symptoms of chronic gastritis include upper abdominal pain, abdominal distension, early satiety, decreased appetite, reduced food intake, or heartburn and acid reflux. Symptoms lack specificity, and diagnosis depends on endoscopic examination and pathology. (1) Endoscopic diagnosis: The submucosal mucosa is red and white, with white predominating. The mucosal folds are flattened or even disappear, mucosal blood vessels are exposed, and the mucosa is granular or nodular. If accompanied by bile reflux, erosion, or intramucosal hemorrhage, it is described as atrophic gastritis or superficial gastritis with bile reflux, erosion, or intramucosal hemorrhage. (2) Pathological diagnosis: 2-5 biopsy tissues can be taken as needed. The pathology should classify HP, chronic inflammation, active inflammation, atrophy, intestinal metaplasia, and dysplasia. Chronic gastritis can be diagnosed as atrophic gastritis based on the presence of atrophy of the intrinsic glands on biopsy. The number and extent of atrophic lesions in the biopsy specimen need not be considered. Clinicians can make a judgment on the extent and degree of the lesion by combining pathological results and endoscopic findings.

[0068] 7.2 Efficacy Evaluation Criteria: The efficacy evaluation was based on the Consensus Opinion on the Diagnosis and Treatment of Chronic Gastritis in Traditional Chinese Medicine issued by the Spleen and Stomach Diseases Branch of the China Association of Traditional Chinese Medicine (2009).

[0069] Evaluation criteria: Evaluation criteria for the efficacy of main symptoms, recording and evaluation of main symptoms (stomach pain and bloating). The percentage of improvement of main symptoms is calculated as follows: (Total score before treatment - Total score after treatment) / Total score before treatment * 100%. (1) Cured: Symptoms disappear. (2) Significantly effective: Percentage of improvement of symptoms ≥ 80%. (3) Effective: 50% ≤ Percentage of improvement of symptoms < 80%. (4) Ineffective: Percentage of improvement of symptoms < 50%.

[0070] 7.3 Treatment Plan: The patient shall take the herbal composition (prepared as granules) of Example 1 of this invention, twice daily (morning and evening), with the following daily dosage: Rehmannia glutinosa 23g, Ophiopogon japonicus 20g, Paeonia suffruticosa 14g, Gardenia jasminoides 20g, Phragmites communis 22g, Dendrobium nobile 10g, Salvia miltiorrhiza 20g, Corydalis yanhusuo 14g, Angelica sinensis 22g, Ligusticum chuanxiong 20g, Bupleurum chinense 20g, Lycium barbarum 20g, Pinellia ternata 16g, Citrus reticulata 22g, Atractylodes macrocephala 20g, Poria cocos 24g, Dioscorea opposita 24g, Hordeum vulgare 20g, Coix lacryma-jobi 22g, Polygonatum sibiricum 22g, Gallus gallus domesticus gizzard lining 20g, Citrus aurantium 15g, Aucklandia lappa 14g. One course of treatment is 30 days, and two consecutive courses are recommended. During the treatment period, patients must follow the doctor's instructions to change their lifestyle, such as: quitting smoking, reducing alcohol consumption, avoiding spicy and stimulating foods, avoiding lying down immediately after meals and eating before bed, ensuring sufficient sleep, and maintaining a reasonable diet.

[0071] 7.4 Results: In this study, a total of 100 patients were collected in the clinical experimental group. 45 patients were cured, 28 patients showed significant improvement, 15 patients showed improvement, and 8 patients showed no improvement. The total effective rate was 92%. It can be seen that the traditional Chinese medicine composition of the present invention has a good clinical therapeutic effect on chronic gastritis of the stomach yin deficiency type.

[0072] Typical case: Mr. Li, male, 63 years old, gradually developed dull stomach pain, dry mouth and throat, poor appetite, constipation, red tongue with little coating, and a thready and rapid or thready and wiry pulse over the past two months. He also experienced varying degrees of abdominal distension, belching, nausea, loss of appetite, and acid reflux. Western medicine diagnosis revealed a red and white mucosa, predominantly white, with flattened mucosal folds, exposed mucosal blood vessels, and a granular appearance. He was diagnosed with chronic gastritis of the stomach yin deficiency type. He was instructed to take the herbal composition of Example 1 of this invention, orally, twice a day, once in the morning and once in the evening, with a daily dosage of (23g Rehmannia glutinosa, 20g Ophiopogon japonicus, and 14g Paeonia suffruticosa). The following herbs were used in a treatment regimen for 30 days: Gardenia 20g, Reed Rhizome 22g, Dendrobium 10g, Salvia Miltiorrhiza 20g, Corydalis Rhizome 14g, Angelica Sinensis 22g, Ligusticum chuanxiong 20g, Bupleurum 20g, Lycium barbarum 20g, Pinellia ternata 16g, Tangerine Peel 22g, Atractylodes macrocephala 20g, Poria cocos 24g, Dioscorea opposita 24g, Malt 20g, Coix Seed 22g, Polygonatum sibiricum 22g, Chicken Gizzard Membrane 20g, Citrus aurantium 15g, and Aucklandia lappa 14g. After continuous use, the symptoms and signs were significantly alleviated. The patient's belching, nausea, loss of appetite, and acid reflux were significantly improved. Microscopic examination showed a significant reduction in mucosal congestion and edema.

[0073] Typical Case: Ms. Wang, 48 years old. The patient reported years of persistent epigastric pain, nausea, loss of appetite, acid reflux, dry mouth and throat, reduced food intake, constipation, red tongue with little coating, and a thready, rapid or thready-wiry pulse. Various medications had failed to alleviate the symptoms. Western medicine diagnosis revealed submucosal congestion and edema, and exposed mucosal blood vessels. She was diagnosed with chronic gastritis of the stomach yin deficiency type. She was instructed to take the herbal composition from Example 1 of this invention, orally, twice daily, once in the morning and once in the evening, with a daily dosage of (23g Rehmannia glutinosa, 20g Ophiopogon japonicus, and dandelion). The following formula was used continuously for two months: 14g of Citrus reticulata peel, 20g of Gardenia jasminoides, 22g of Phragmites communis rhizome, 10g of Dendrobium nobile, 20g of Salvia miltiorrhiza, 14g of Corydalis yanhusuo, 22g of Angelica sinensis, 20g of Ligusticum chuanxiong rhizome, 20g of Bupleurum chinense root, 20g of Lycium barbarum fruit, 16g of Pinellia ternata, 22g of Citrus reticulata peel, 20g of Atractylodes macrocephala rhizome, 24g of Poria cocos, 24g of Dioscorea opposita rhizome, 20g of Hordeum vulgare malt, 22g of Coix lacryma-jobi seed, 22g of Polygonatum sibiricum rhizome, 20g of Gallus gallus domesticus gizzard lining, 15g of Citrus aurantium fruit, and 14g of Aucklandia lappa root. After this treatment, the symptoms and signs were significantly reduced, and microscopic examination revealed a significant reduction in mucosal congestion.

[0074] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A composition for treating chronic gastritis, characterized in that, It is made from the following raw materials in parts by weight: 20-26 parts Rehmannia glutinosa, 18-22 parts Ophiopogon japonicus, 12-16 parts Paeonia suffruticosa, 15-25 parts Gardenia jasminoides, 20-24 parts Phragmites communis, 8-12 parts Dendrobium nobile, 16-24 parts Salvia miltiorrhiza, 12-16 parts Corydalis yanhusuo, 20-24 parts Angelica sinensis, 18-22 parts Ligusticum chuanxiong, 18-22 parts Bupleurum chinense, 16-24 parts Lycium barbarum, 14-18 parts Pinellia ternata, 20-24 parts Citrus reticulata, 16-24 parts Atractylodes macrocephala, 20-28 parts Poria cocos, 20-28 parts Dioscorea opposita, 16-24 parts Hordeum vulgare, 20-24 parts Coix lacryma-jobi, 20-24 parts Polygonatum sibiricum, 18-22 parts Gallus gallus domesticus gizzard lining, 12-18 parts Citrus aurantium, and 10-18 parts Aucklandia lappa.

2. The composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 23 parts Rehmannia glutinosa, 20 parts Ophiopogon japonicus, 14 parts Paeonia suffruticosa, 20 parts Gardenia jasminoides, 22 parts Phragmites communis, 10 parts Dendrobium nobile, 20 parts Salvia miltiorrhiza, 14 parts Corydalis yanhusuo, 22 parts Angelica sinensis, 20 parts Ligusticum chuanxiong, 20 parts Bupleurum chinense, 20 parts Lycium barbarum, 16 parts Pinellia ternata, 22 parts Citrus reticulata peel, 20 parts Atractylodes macrocephala, 24 parts Poria cocos, 24 parts Dioscorea opposita, 20 parts Hordeum vulgare, 22 parts Coix lacryma-jobi, 22 parts Polygonatum sibiricum, 20 parts Gallus gallus domesticus gizzard lining, 15 parts Citrus aurantium, and 14 parts Aucklandia lappa.

3. The composition according to claim 1, characterized in that, Pinellia ternata is ginger-processed Pinellia ternata.

4. The composition according to claim 1, characterized in that, The preparation method is as follows: (1) Take peony bark, salvia miltiorrhiza, corydalis rhizome, angelica root, chuanxiong rhizome, bupleurum root, pinellia tuber, tangerine peel, poria cocos, immature bitter orange peel, and costus root, and grind them into coarse powder; (2) Load the powder into the supercritical CO2 extraction device. After the cooling device, the extraction vessel and the separation vessel heating device are working normally, turn on the compressor pump to pressurize to the required fixed separation pressure of 22MPa, adjust the CO2 flow rate to 10kg / h, the extraction temperature to 50℃, the extraction time to 4h, and circulate the extraction twice to obtain an oily liquid. (3) Take the residue after supercritical CO2 extraction and the remaining medicinal materials, add water and decoct twice. Add 10 times the amount of water for the first extraction and extract for 1.5 hours. Add 8 times the amount of water for the second extraction and extract for 1 hour. Combine the extracts, filter, concentrate the filtrate to a clear extract with a relative density of 1.10-1.15, dry under reduced pressure to obtain dry extract, pulverize, pass through a 100-mesh sieve to obtain extract powder for later use. (4) Take the oily liquid obtained in step (2) and the extract powder obtained in step (3), add excipients, and prepare one of the following: tablets, hard capsules, granules, soft capsules or pills.

5. The composition according to claim 1, characterized in that, The preparation method is as follows: (1) Take peony bark, salvia miltiorrhiza, corydalis rhizome, angelica root, chuanxiong rhizome, bupleurum root, pinellia tuber, tangerine peel, poria cocos, immature bitter orange peel, and costus root, and grind them into coarse powder; (2) Load the powder into the supercritical CO2 extraction device. After the cooling device, the extraction vessel and the separation vessel heating device are working normally, turn on the compressor pump to pressurize to the required fixed separation pressure of 22MPa, adjust the CO2 flow rate to 10kg / h, the extraction temperature to 50℃, the extraction time to 4h, and circulate the extraction twice to obtain an oily liquid. (3) Take the residue after supercritical CO2 extraction and the remaining medicinal materials, add water and decoct twice. Add 10 times the amount of water for the first extraction and extract for 1.5 hours. Add 8 times the amount of water for the second extraction and extract for 1 hour. Combine the extracts, filter, and concentrate the filtrate to a clear extract with a relative density of 1.10-1.15 for later use. (4) Take the oily liquid obtained in step (2) and the clear paste obtained in step (3), add excipients, and prepare an oral liquid.

6. Use of the composition according to claim 1 in the preparation of a medicament for treating chronic gastritis.

7. The use of the composition according to claim 6 in the preparation of a medicament for treating chronic gastritis, wherein the syndrome of chronic gastritis is stomach yin deficiency.

8. The use of the composition according to claim 6 in the preparation of a medicament for treating chronic gastritis, wherein the chronic gastritis is chronic atrophic gastritis.