CN109394991B

CN109394991B - Traditional Chinese medicine compound preparation for treating spleen deficiency and liver depression qi stagnation type chronic atrophic gastritis

Info

Publication number: CN109394991B
Application number: CN201811609957.0A
Authority: CN
Inventors: 林平; 高远; 林雪阳; 黄铭涵; 李书楠
Original assignee: Fujian University of Traditional Chinese Medicine
Current assignee: Fujian University of Traditional Chinese Medicine
Priority date: 2018-12-27
Filing date: 2018-12-27
Publication date: 2021-04-20
Anticipated expiration: 2038-12-27
Also published as: CN109394991A

Abstract

The invention relates to a traditional Chinese medicine compound preparation for treating spleen deficiency and liver depression qi stagnation type chronic atrophic gastritis. The active ingredients of the traditional Chinese medicine compound preparation are prepared from the following raw materials in parts by weight: 10-20 parts of bran-fried bighead atractylodes rhizome, 3-9 parts of rice-scented mature, 6-15 parts of bupleurum chinense, 9-20 parts of radix paeoniae alba, 6-15 parts of fried perilla fruit, 25-35 parts of blighted wheat, 3-9 parts of flos mume, 6-15 parts of vinegar rhizoma corydalis and 9-15 parts of cortex magnoliae officinalis. The traditional Chinese medicine compound preparation takes spleen invigorating and qi tonifying medicines as monarch medicines, takes liver soothing and qi regulating medicines as ministerial medicines, is assisted by heart calming, liver calming and stomach harmonizing, spleen and stomach soothing and qi regulating, qi circulation promoting and pain relieving, and is assisted by monarch medicines and ministerial medicines to dredge qi activity and regulate five internal organs. The traditional Chinese medicine compound preparation is prepared according to a formula by a traditional method aiming at the core pathogenesis of spleen deficiency and liver depression and qi stagnation of chronic atrophic gastritis, and is used for strengthening spleen, soothing liver and regulating qi.

Description

Traditional Chinese medicine compound preparation for treating spleen deficiency and liver depression qi stagnation type chronic atrophic gastritis

Technical Field

The invention relates to a traditional Chinese medicine compound preparation and a preparation method thereof, in particular to a traditional Chinese medicine compound preparation for treating spleen deficiency and liver depression and qi stagnation type chronic atrophic gastritis.

Background

Chronic Atrophic Gastritis (CAG) refers to a Chronic gastric disease in which the gastric mucosal epithelium is repeatedly damaged to reduce the number of proper glands with or without fibrous replacement, Intestinal glandular Metaplasia and/or pseudopyloric Metaplasia, and is a type of Chronic gastritis, which is a common disease, a frequently encountered disease of the digestive system, with Intestinal Metaplasia (IM) and Dysplasia (DS) occurring on the basis of CAG, which are precancerous lesions of gastric cancer.

CAG belongs to the categories of epigastric pain, gastric fullness, abdominal distention and fullness, epigastric upset, hiccup and the like, and has the characteristics of hidden onset, lingering course of disease, difficult treatment and the like. At present, for the treatment of CAG, Western medicine mainly takes helicobacter pylori (Hp) resistance, stomach mucosa barrier protection, symptomatic treatment and the like as rules of treatment, but the clinical recurrence rate is high, the negative effect of the helicobacter pylori (Hp) resistance is common in clinic, and the chronic atrophic gastritis and the symptoms thereof are still the same. The traditional Chinese medicine has obvious advantages in the aspects of relieving symptoms, improving life quality and the like, and more patients are clinically required to be treated by the traditional Chinese medicine, so that the research on CAG diagnosis and treatment by the traditional Chinese medicine has certain clinical significance.

This condition also can lead to gastric cancer. Modern medicine for treating the disease is usually used for resisting helicobacter pylori, but not every patient with the disease has helicobacter pylori infection, and the treatment scheme for resisting the helicobacter pylori has poor curative effect and also has various side effects. Traditional Chinese medicine considers that the CAG needs to be strengthened in spleen, soothed liver and regulated qi, and a plurality of clinical practices prove that the traditional Chinese medicine has a plurality of advantages and definite curative effect in the aspects of treating CAG and precancerous lesion and the like.

The main symptoms of the chronic atrophic gastritis are epigastric pain or discomfort, fullness, dull pain, burning pain, early satiety, eructation, nausea and the like, and the most common pathogenesis of the chronic atrophic gastritis is the syndrome of spleen deficiency, liver depression and qi stagnation.

For years, a series of researches on the aspects of 'syndrome, pathogenesis, microscopic syndrome differentiation' and the like of chronic gastritis are carried out by a team. In 2013, the following findings are found: the chronic gastritis is basically the same in the traditional Chinese medicine diseases of stomachache and gastrectasia, the pathological changes are essentially deficiency-excess inclusion, the deficiency syndrome mainly refers to spleen qi deficiency and spleen yang deficiency, and the excess syndrome mainly refers to stomach qi failing to descend, liver qi stagnation and dampness evil blockage. Discovery in 2015: the syndrome distribution of damp-heat type chronic gastritis is usually manifested as qi stagnation, yang deficiency and qi deficiency, while the constitution distribution is mainly due to yang deficiency. In 2017, it was found that the constitution of chronic atrophic gastritis is mainly due to yang deficiency and qi deficiency, accompanied by qi depression, blood stasis, yin deficiency, phlegm dampness, damp-heat and other constitutions.

In microscopic differential study on chronic atrophic gastritis, 2015 finds that: the pathology of chronic atrophic gastritis indicates that the higher the degree of chronic inflammation, the higher the score of the stomach and qi stagnation. In 2016, the discovery: the morbid syndrome of chronic atrophic gastritis with intestinal metaplasia is mainly stomach, liver and spleen, the pathological nature is deficiency-excess inclusion, the excess syndrome is mainly qi stagnation, damp obstruction and heat, the deficiency syndrome is mainly yin deficiency, yang deficiency and qi deficiency, and the constitution is mainly yang deficiency, qi stagnation, fatigue, dampness, yin deficiency, blood stasis and dampness-heat. The discovery in 2017 is that: the occurrence and the progression of the precancerous lesions of the chronic atrophic gastritis are closely related to the syndrome of liver, yang deficiency and blood stasis, and the higher the grade of the syndrome of the precancerous lesions of the chronic atrophic gastritis is, the higher the risk of the precancerous lesions of the chronic atrophic gastritis is.

Based on the above studies, we proposed by the team: the core pathogenesis of the chronic atrophic gastritis is 'spleen deficiency and liver depression and qi stagnation', the core pathogenesis is kept in mind throughout the treatment, and the disease, the syndrome and the symptoms are treated by differentiation.

In 2016, the inventor has disclosed the prior art of the viscera-regulating qi-transporting decoction in volume 47, stage 3 of Fujian Chinese medicine, and the specific formula is as follows: 15g of rhizoma atractylodis macrocephalae (fried), 9g of radix bupleuri, 15g of radix paeoniae alba, 15g of poria cocos, 15g of malt (fried), 6g of rice-flavor tangerine peel, 9g of rhizoma corydalis (vinegar), 10g of perilla fruit (cloth bag), 30g of light wheat and 3g of liquorice. As our team has found the latest research on chronic atrophic gastritis: the pathology of chronic atrophic gastritis indicates that the higher the degree of chronic inflammation, the higher the score of the stomach and qi stagnation. The occurrence and the progression of the precancerous lesions of the chronic atrophic gastritis are closely related to the syndrome element 'liver', and the higher the grade of the syndrome element is, the higher the risk of the precancerous lesions of the chronic atrophic gastritis is. Therefore, we improve the 'soup for regulating viscera and transporting qi' by a team, and remove: poria, fructus Hordei Germinatus (parched), and Glycyrrhrizae radix. Adding: flos Pruni mume, and cortex Magnolia officinalis. Strengthen the efficacy of dispelling liver qi and regulating stomach qi. And is more specific to chronic atrophic gastritis with the syndrome of spleen deficiency and liver depression and qi stagnation.

Disclosure of Invention

The invention provides a traditional Chinese medicine compound preparation for treating spleen deficiency and liver depression type chronic atrophic gastritis and a preparation method thereof, aiming at solving the technical problems that in the prior art, an anti-helicobacter pylori treatment scheme has poor curative effect and various side effects, and helicobacter pylori is negative, but chronic atrophic gastritis still exists.

The active ingredients of the traditional Chinese medicine compound preparation are prepared from the following raw material medicines in parts by weight: 10-20 parts of bran-fried bighead atractylodes rhizome, 3-9 parts of rice-scented mature, 6-15 parts of bupleurum chinense, 9-20 parts of radix paeoniae alba, 6-15 parts of fried perilla fruit, 25-35 parts of blighted wheat, 3-9 parts of flos mume, 6-15 parts of vinegar rhizoma corydalis and 9-15 parts of cortex magnoliae officinalis.

In one embodiment, the active ingredients of the traditional Chinese medicine compound preparation are prepared from the following raw material medicines in parts by weight: 15 parts of bran-fried bighead atractylodes rhizome, 6 parts of rice-scented tangerine peel, 9 parts of bupleurum chinense, 15 parts of radix paeoniae alba, 10 parts of fried perilla fruit, 30 parts of light wheat, 6 parts of flos mume, 9 parts of vinegar rhizoma corydalis and 10 parts of cortex magnoliae officinalis.

The traditional Chinese medicine compound preparation can be prepared into the existing pharmaceutical preparation, and the pharmaceutical preparation can be decoction, dropping pills, powder, granules, medicinal liquor, tablets, capsules, sustained-release tablets, solid dispersion, mixture, oral liquid, micro-capsules and micro-pills, wherein the decoction, the granules, the tablets, the capsules and the pills are preferred, and the granules are more preferred.

The invention also provides a preparation method of the granules of the traditional Chinese medicine compound preparation, which comprises the following specific preparation steps:

(1) taking 15 parts of radix Paeoniae alba, 6 parts of Oryza sativa, 30 parts of fructus Tritici Levis and 6 parts of flos Pruni mume, adding 10 times of water, decocting by conventional method for 3 times, each for 1 hr, mixing extractive solutions, filtering, concentrating at below 60 deg.C to obtain extract with relative density of 1.10-1.20 at 60 deg.C;

(2) taking 15 parts of bran-fried bighead atractylodes rhizome, 9 parts of bupleurum chinense, 9 parts of vinegar-processed corydalis tuber and 10 parts of ginger-processed magnolia officinalis, adding 8 times of 75% ethanol, placing the mixture in a multifunctional extraction tank for reflux extraction for 3 times, extracting the mixture for 1 hour each time, combining the ethanol extracts, recovering the ethanol, concentrating the extract at the temperature of below 60 ℃ to obtain an extract, and keeping the relative density of the extract at the temperature of 60 ℃ to be 1.10-1.20 for later use;

(3) taking 10 parts of fried perilla seeds, adding 8 times of water, placing the fried perilla seeds in a multifunctional extraction tank for boiling, and performing reflux extraction for 6 hours to obtain volatile oil for later use;

(4) and (3) combining the extracts in the steps (1) and (2), drying to obtain a dry extract, crushing, adding the volatile oil in the step (3), adding a proper amount of lactose and dextrin, uniformly mixing, sieving by a 100-mesh sieve, carrying out dry compression granulation or wet granulation, drying at the temperature of below 60 ℃, and subpackaging to obtain the capsule.

The invention also provides a processing method of each medicine of the traditional Chinese medicine compound preparation, which comprises the following specific steps:

(1) stir-frying white atractylodes rhizome with bran: collecting Atractylodis rhizoma, removing impurities, moistening with water, slicing, and drying. And screening to remove the scraps. Heating the pot with middle fire, scattering wheat bran, adding Atractylodis rhizoma tablet when smoking, parching until Atractylodis rhizoma is yellow brown, taking out, sieving to remove wheat bran, and cooling. 10kg of wheat bran is used for every 100kg of the bighead atractylodes rhizome tablets. And (3) identification: 1. the powder was light yellow-brown. The calcium oxalate needle crystals are fine and have a length of 10-32 mu m, exist in parenchyma cells, and have a few needle crystals with a diameter of 4 mu m. The fibers are yellow, most of the fibers are bundled, are long fusiform, have the diameter of about 40 mu m, have very thick walls, are lignified and have obvious pores and ditches. The stone cells are yellowish, round-like, polygonal, rectangular or few spindle-shaped, and have the diameter of 37-64 mu m. The parenchyma cells contain inulin, and the surface of the parenchyma cells shows radial texture. The conduit molecules are short and small, and are reticulated conduit and rimmed pore conduit with the diameter of 48 μm. 2. Taking 0.5g of the product powder, adding 2ml of n-hexane, carrying out ultrasonic treatment for 15 minutes, filtering, and taking the filtrate as a test solution. Another 0.5g of bran-parched Atractylodis rhizoma as reference medicinal material is prepared into reference medicinal solution by the same method. Performing thin-layer chromatography (general rule 0502) test, sucking 10 μ l of the two newly prepared solutions, respectively dropping on the same silica gel G thin-layer plate, developing with petroleum ether (60-90 deg.C) -ethyl acetate (50: 1) as developing agent, taking out, air drying, spraying with 5% vanillin-sulfuric acid solution, and heating until the spots are clearly developed. In the chromatogram of the test solution, spots of the same color and peach-red main spot (atractylone) should appear at the corresponding positions of the chromatogram of the reference solution. Examination: the water content should not exceed 15.0% (general 0832 second method). The total ash content should not exceed 5.0% (rule 2302). Residual amount of sulfur dioxide: the sulfur dioxide residue content is measured by a sulfur dioxide residue measuring method (general rule 2331), and the sulfur dioxide residue content is not more than 400 mg/kg. The method comprises the following steps of taking 1g of the most coarse powder of the product, precisely weighing, placing the product in a conical flask with a plug, adding 200ml of 55% ethanol, adjusting the pH value to 2-3 by using dilute hydrochloric acid, continuously shaking for 1 hour, filtering, sucking 10ml of filtrate, placing the filtrate in a colorimetric tube, testing according to a solution color inspection method (general rule 0901 first method), and comparing the color with a yellow No. 9 standard colorimetric solution to obtain a color product. Extract: the content of the extract should not be less than 35.0% by hot dipping method under alcohol-soluble extract measuring method (general rule 2201) with 60% ethanol as solvent.

(2) Aging with rice fragrance: taking peel of Rutaceae plant fructus Citri Tangerinae as raw material, removing impurities, spraying water, moistening, shredding, and drying to obtain pericarpium Citri Tangerinae. Mixing licorice, water and dried orange peel in a weight ratio of 1: 20: 20; heating and concentrating Glycyrrhrizae radix and water, decocting until the total amount is about 1/3, and filtering to obtain filtrate. Adding appropriate amount of salt (20 kg of salt in 500kg of pericarpium Citri Tangerinae and 150kg of white sugar) into Glycyrrhrizae radix solution, dissolving, boiling, adding pericarpium Citri Tangerinae, stirring, allowing the pericarpium Citri Tangerinae to absorb the solution completely, standing overnight, if the absorption is not complete, sun drying to semi-dry, absorbing the solution again, and air drying to semi-dry. And (3) identification: 1. the powder of this product is yellowish white to yellowish brown. Mesocarp has numerous parenchyma, irregular cell shape, uneven and thickened wall, and some pearls. The surface of the epidermal cell of the pericarp is polygonal, square-like or rectangular, the vertical wall is slightly thick, the air holes are round-like, the diameter is 18-26 mu m, and the accessory defensive cell is unclear; the lateral aspect is thickened by the stratum corneum, the radial wall towards the outside. The calcium oxalate square crystals exist in mesocarp parenchyma cells in a flaky shape, are polyhedral, rhombic or biconical, have the diameter of 3-34 mu m and the length of 5-53 mu m, and one cell contains parallel bicrystals or 3-5 square crystals formed by two polyhedrons. Hesperidin crystals are mostly present in parenchyma cells, are yellow or colorless, present in round or amorphous lumps, and have visible radial stripes. The threaded conduit, the perforated conduit and the reticulated conduit and the cells are smaller. 2. Taking 0.3g of the product powder, adding 10ml of methanol, heating and refluxing for 20 minutes, filtering, taking 5ml of filtrate, and concentrating to 1ml to obtain a test solution. Adding methanol into hesperidin control to obtain saturated solution as control solution. Performing thin layer chromatography (general rule 0502) test, sucking 2 μ l of the above two solutions, respectively dropping on the same silica gel G thin layer plate prepared with 0.5% sodium hydroxide solution, spreading to about 3cm with ethyl acetate-methanol-water (100: 17: 13) as developing agent, taking out, air drying, spreading to about 8cm with upper layer solution of toluene-ethyl acetate-formic acid-water (20: 10:1:1) as developing agent, taking out, air drying, spraying with aluminum trichloride test solution, and inspecting under ultraviolet lamp (365 nm). The test chromatogram shows fluorescent spots of the same color at the positions corresponding to those of the control chromatogram. Examination: the water content should not exceed 13.0% (general method 0832, fourth method). Aflatoxins: measured according to the aflatoxin assay (general rule 2351). Weighing about 5g of the powder (sieved by a second sieve), precisely weighing, adding 3g of sodium chloride, measuring according to the preparation method of the test sample under the aflatoxin measurement method, and calculating to obtain the product. Every 1000G of the product contains no more than 5 mug of aflatoxin, and the total amount of aflatoxin G2, aflatoxin G1, aflatoxin B2 and aflatoxin B1 is no more than 10 mug. Content determination: measuring by high performance liquid chromatography (general rule 0512). Chromatographic conditions and system applicability test: octadecylsilane chemically bonded silica is used as a filling agent; methanol-acetic acid-water (35: 4: 61) is used as a mobile phase; the detection wavelength was 283 nm. The number of theoretical plates is not less than 2000 calculated according to hesperidin peak. Preparation of control solutions: taking appropriate amount of hesperidin control, precisely weighing, and adding methanol to obtain solution containing 0.4mg per 1 ml. Preparation of a test solution: taking about 1g of coarse powder of the product, precisely weighing, placing in a Soxhlet extractor, adding 80ml of petroleum ether (60-90 ℃), heating and refluxing for 2-3 hours, removing the petroleum ether, volatilizing the dregs of a decoction, adding 80ml of methanol, heating and refluxing until the extract is colorless, cooling, filtering, placing the filtrate in a 100ml measuring flask, washing the container with a small amount of methanol for several times, filtering the filtrate into the same measuring flask, adding the methanol to the scale, and shaking uniformly to obtain the product. The determination method comprises the following steps: precisely sucking 5 μ l of each of the reference solution and the sample solution, injecting into liquid chromatograph, and measuring. The product contains hesperidin not less than 3.5% calculated on dry product.

(3) Taking original medicinal material of bupleurum chinense, removing impurities, removing residual stems, cleaning silt, taking out, moistening thoroughly, timely slicing, and then drying in the sun. And (3) identification: taking 0.5g of the product powder, adding 20ml of methanol, carrying out ultrasonic treatment for 10 minutes, filtering, and concentrating the filtrate to 5ml to be used as a test solution. 0.5g of bupleurum chinense reference medicinal material is prepared into a reference medicinal material solution by the same method. Then taking saikosaponin a reference substance and saikosaponin d reference substance, adding methanol to make into mixed solution containing 0.5mg each per 1ml as reference substance solution. Testing by thin layer chromatography (general rule 0502), sucking 5 μ l of the above three solutions, respectively dropping on the same silica gel G thin layer plate, developing with ethyl acetate-ethanol-water (8: 2:1) as developing agent, taking out, air drying, spraying 2% p-dimethylaminobenzaldehyde 40% sulfuric acid solution, heating at 60 deg.C until the color of spots is clear, and respectively inspecting under sunlight and ultraviolet lamp (365 nm). In the chromatogram of the test solution, spots or fluorescent spots of the same color appear at the positions corresponding to the chromatograms of the reference material and the reference solution.

(4) Hangzhou white peony root: cleaning dried root of radix Paeoniae in Hangzhou of Zhejiang, removing head, tail and fine root, decocting in boiling water, removing outer skin or peeling, decocting, and sun drying. And (3) identification: 1. the powder is yellow-white. Much gelatinized starch aggregates. The calcium oxalate clusters have a diameter of 11-35 μm, are present in parenchymal cells, and are often arranged in rows, or one cell contains a plurality of clusters. The diameter of the conduit with the edge grain holes and the diameter of the reticulated conduit are 20-65 mu m. The fiber is long fusiform, has the diameter of 15-40 mu m, has a wall thickness and is slightly lignified, and has large circular grain holes. 2. Taking 0.5g of the product powder, adding 10ml of ethanol, shaking for 5 minutes, filtering, evaporating the filtrate to dryness, and dissolving the residue with 1ml of ethanol to obtain a test solution. Adding ethanol into penoniflorin control to obtain solution containing 1mg per 1ml as control solution. Performing thin layer chromatography (general rule 0502) test, sucking 10 μ l of the above two solutions, respectively dropping on the same silica gel G thin layer plate, developing with chloroform-ethyl acetate-methanol-formic acid (40: 5:10: 0.2) as developing agent, taking out, air drying, spraying 5% vanillin sulfuric acid solution, and heating until the spots are clearly developed. The same bluish purple spots appear in the chromatogram of the test solution at the positions corresponding to those in the chromatogram of the control solution.

(5) Frying the perilla seeds: taking the raw perilla seed medicinal material, removing impurities and drying in the sun. Putting fructus Perillae into a pan, parching with slow fire until there is a popping sound and fragrance is emitted, taking out, and air drying. Content determination: measuring by high performance liquid chromatography (general rule 0512). Chromatographic conditions and system applicability test: octadecylsilane chemically bonded silica is used as a filling agent; methanol-0.1% formic acid solution (40:60) is used as a mobile phase; the detection wavelength was 330 nm. The number of theoretical plates is not less than 3000 calculated according to the peak of rosmarinic acid. Preparation of control solutions: taking a proper amount of rosmarinic acid reference substance, precisely weighing, and adding methanol to obtain a solution containing 80 μ g of rosmarinic acid per 1 ml. Preparation of a test solution: weighing about 0.5g of the powder (sieved by a second sieve), precisely weighing, placing in a conical flask with a plug, precisely adding 50ml of 80% methanol, sealing the plug, weighing, heating and refluxing for 2 hours, cooling, weighing again, supplementing the lost weight with 80% methanol, shaking uniformly, filtering, and taking the subsequent filtrate. The determination method comprises the following steps: precisely sucking 10 μ l of the reference solution and 20 μ l of the sample solution, respectively, injecting into a liquid chromatograph, and measuring. The product contains rosmarinic acid (C18H 1608) not less than 0.20% of dry product.

(6) Blighted wheat: drying light and thin wheat fruits, selecting light and thin wheat grains without peeling, removing impurities, sieving to remove ash and bits, rinsing with water, and sun drying. Taking clean wheat, putting the clean wheat in a pot, heating the clean wheat with slow fire, frying the clean wheat to brown yellow, taking out the clean wheat and cooling the clean wheat. And (4) microscopic identification, namely, the transverse section of the caryopsis, and the fruit skin and the seed coat are healed. 1 row of epidermal cells of the pericarp, thicker wall, especially on the level of the peripheral wall; the mesolamella cells of the pericarp are arrayed in a row, and the wall is thicker; 1 row of transverse cells, which are vertically staggered with pericarp epidermis and mesolamella cells and have pores; sometimes 4 tubal cells are visible below the transverse cell layer. The seed coat is brownish yellow, the cells are wasted and shriveled, the inner part of the seed coat is the residual nucellar, the cells are square, and the laminar texture is invisible. The outermost wild of the endosperm is the aleurone layer, and the rest are the parenchyma cells rich in starch granules. Powder characteristics: white with small yellow-brown peel. Firstly, the starch grains are mainly flat, round, oval or round triangular, the diameter is 30-40 mu m, the side surface is in a double-lens shape and a shell shape, the width is 11-19 mu m, the two ends are slightly sharp or blunt, and the umbilical point is in a crack shape; few compound grains, consisting of 2-4 or more grains. Secondly, the transverse cells are flaky, thin and cylindrical, 28-232 mu m long, 6-21 mu m in diameter, and the wall can be thickened like beads. ③ the epidermal cells of the pericarp are rectangular or polygonal, the length is 64 to 220 mu m, the diameter is 16 to 42 mu m, and the pericarp is thickened like beads. Fourthly, the mesocyte of the pericarp is in a strip shape or an irregular shape, and the wall is thickened like a pearl. Fifthly, non-glandular hair single cells with the length of 40-950 microns, the diameter of 10-30 microns and the wall thickness of 5-10 microns. Identifying a thin layer angular spectrum: 0.1g of the fine powder is taken, 1ml of 70 percent ethanol is added, the mixture is soaked overnight, and the supernatant is used for spotting. And fructose, sucrose and cotton seed bran solution are used as control solution. Spotting on silica gel G-1% CMC sheet, spreading with n-butanol-glacial acetic acid-water (4: 1: 5) supernatant, spreading at a distance of 10cm, and repeating for 1 time. Spraying alpha-naphthol sulfuric acid solution, and heating to make fructose, sucrose and raffinose appear bluish purple.

(7) And (3) green calyx plum: dried flower buds of flos Pruni mume produced in Jiangsu and Zhejiang are dried in the sun. The microwave equipment for the experiment is a rotating disc type tray (a net leakage type) microwave equipment, and the power is 1-6 kW and is adjustable. The processing of the green calyx plum adopts a method of firstly 'deactivating enzyme' and then drying by microwave: spreading fresh flos Pruni mume on a tray, sealing the tray with polyethylene film, heating at high temperature with microwave for a short time (deactivating enzyme), removing the polyethylene film, air drying flos Pruni mume to room temperature, and microwave drying at regulated temperature. The optimal microwave drying process of the Prunus mume is determined by combining process analysis, namely de-enzyming at 90 ℃ for 2 minutes and drying at 50 ℃ for 10 minutes.

(8) Vinegar rhizoma corydalis: taking rhizoma corydalis raw medicinal materials, removing impurities, separating, cleaning, slightly soaking, and moistening. Taking the clean corydalis tuber, placing the clean corydalis tuber into a boiling container, adding a certain amount of rice vinegar (20 kg of 10-20% per 100kg of corydalis tuber) and a proper amount of clear water (preferably flat medicine powder), heating by slow fire, and boiling together until the corydalis tuber is thoroughly mixed. Taking out the vinegar liquid when the vinegar liquid is absorbed completely, cooling, slicing into thick slices, and drying in the sun. And (3) identification: 1. the powder is green-yellow. The gelatinized starch granule mass is yellowish or nearly colorless. The hypodermis sclerenchyma cells are green yellow, the cells are polygonal, square or strip-shaped, the walls are slightly bent and lignified, and some cells are thickened in a shape of continuous beads, and the pores are fine. The stone cells are yellowish, round or oblong, have a diameter of about 60 mu m, thick walls and fine pores. The diameter of the threaded conduit is 16-32 μm. 2.2 g of the product powder is taken, 20ml of 0.25mol/L sulfuric acid solution is added, and the mixture is shaken for a moment and filtered. Taking 2ml of filtrate, adding a mixed solution of 0.4ml of 1% potassium ferricyanide solution and 0.3ml of 1% ferric trichloride solution to obtain a dark green color, gradually changing to dark blue color, and leaving the bottom of the mixture to have more dark blue precipitates. And 2ml of filtrate is taken, 1 drop of potassium chromate solution is added, and yellow precipitate is generated. 3. Taking 1g of the powder, adding 50ml of methanol, performing ultrasonic treatment for 30 minutes, filtering, evaporating the filtrate to dryness, dissolving the residue in water, adding concentrated ammonia solution to adjust to alkalinity, extracting with diethyl ether for 3 times, 10ml each time, mixing the diethyl ether solution, evaporating to dryness, and dissolving the residue in 1ml of methanol to obtain a sample solution. Preparing 1g of rhizoma corydalis reference material, and preparing reference material solution by the same method. Then adding methanol into tetrahydropalmatine control to obtain 1mg solution per 1ml, and making into control solution. Performing thin-layer chromatography (appendix VI B), sucking 2-3 μ l of each of the three solutions, respectively dropping on the same silica gel G thin-layer plate prepared with 1% sodium hydroxide, placing in a developing tank pre-saturated with developing agent with n-hexane-chloroform-methanol (7.5: 4: 1) as developing agent, developing, taking out, air drying, and fumigating with iodine vapor until the spots are clear. Inspecting under sunlight, wherein spots of the same color appear in the chromatogram of the test solution at the positions corresponding to the chromatograms of the reference medicinal material and the reference solution; after the iodine adsorbed on the plate is volatilized in the air, the plate is placed under an ultraviolet lamp (365nm) for inspection, and fluorescent spots with the same color appear in the chromatogram of the test sample at the positions corresponding to the chromatograms of the reference medicinal material and the reference substance.

(9) Ginger magnolia bark: scraping crude cortex Magnolia officinalis, cleaning, moistening, shredding, and drying in sunlight. Slicing rhizoma Zingiberis recens (10 kg per 100kg of cortex Magnolia officinalis), and decocting with water. Putting shredded cortex Magnolia officinalis in the ginger decoction, heating with slow fire, decocting until the ginger decoction is absorbed completely, putting into a stir-frying container, heating with slow fire, and parching to dry. Identification, 1, the cross section of the product: the cork layer is 10 more cells; some visible layers of exfoliation. The cortex has a stone cell annulus on the outside and a plurality of oil cells and stone cell groups on the inside. Phloem ray width is 1-3 rows of cells; a plurality of fibers are bundled; there are also oil cells scattered. Brown powder. The fiber is much, the diameter is 15-32 μm, the wall is thick, some fibers are wavy or have saw-toothed shape on one side, and the pores and grooves are not obvious. The stone cells are square, oval or irregularly branched, the diameter is 11-65 μm, and lamellar striations can be seen sometimes. The oil cells are oval or round-like, have a diameter of 50-85 μm, and contain yellowish brown oil. 2. Collecting powder 0.5g, adding methanol 5ml, sealing, shaking for 30 min, filtering, collecting filtrate as sample solution, and collecting magnolol and honokiol control, adding methanol to obtain mixed solution containing 1mg of magnolol per 1ml as control solution. Performing thin layer chromatography (appendix VI B), sucking the two solutions, respectively dropping on the same silica gel G thin layer plate, developing with benzene-methanol (27: 1) as developing agent, taking out, air drying, spraying 1% vanillin-sulfuric acid solution, and heating at 100 deg.C until the spots are clearly developed. Spots of the same color appear in the chromatogram of the test solution at positions corresponding to those in the chromatogram of the control solution.

Compared with the prior art, the invention has the following advantages and effects:

1. compared with the monarch, minister, assistant and guide medicaments of the 'soup for regulating viscera and transporting qi' in the prior art, the invention specifically limits the medicaments

2. The invention takes bran-fried bighead atractylodes rhizome as the monarch drug, and has the effects of strengthening spleen, tonifying qi, excreting dampness and promoting diuresis; the bupleurum chinense and the white peony root have the effects of soothing liver and liver, the rice-flavored old qi-regulating and dampness-eliminating have the effects of regulating taste, the fried perilla frutescens has the effects of reducing lung qi, reducing stomach qi, reducing phlegm and relaxing bowels, and the four medicines are used as ministerial medicines to strengthen the effects of strengthening spleen, soothing liver and regulating qi; the fructus Tritici Levis has effects of invigorating heart-qi, strengthening spleen-qi, nourishing heart, tranquilizing mind, removing dysphoria, calming liver, regulating stomach function, regulating qi, relieving epigastric distention, regulating qi-flowing, eliminating dampness, resolving stagnation, promoting qi circulation, relieving pain, and assisting principal and ministerial drugs to invigorate spleen, regulate qi, and regulate viscera. The traditional Chinese medicine compound preparation takes spleen invigorating and qi tonifying medicines as monarch medicines, takes liver soothing and qi regulating medicines as ministerial medicines, is assisted by heart calming, liver calming and stomach harmonizing, spleen and stomach soothing and qi regulating, qi circulation promoting and pain relieving, and is assisted by monarch medicines and ministerial medicines to dredge qi activity and regulate five internal organs. The traditional Chinese medicine compound preparation is prepared according to a formula by a traditional method aiming at the core pathogenesis of spleen deficiency and liver depression and qi stagnation of chronic atrophic gastritis, and is used for treating spleen strengthening, liver soothing and qi regulating;

3. the traditional Chinese medicine composition has obvious curative effect, can be clinically used for years, effectively improves various clinical symptoms of epigastric pain or discomfort, fullness, dull pain, burning pain, early satiety, eructation, nausea and the like of patients with spleen deficiency, liver depression and qi stagnation syndrome type chronic atrophic gastritis, and has high curative effect on reversing and slowing down the progression of atrophy;

4. the traditional Chinese medicine can also change the symptoms of distending pain, dyspepsia, inappetence and the like of various digestive system diseases, and can promote the curative effects of inflammation absorption, ulcer surface healing and the like on the basis, and other medicines cannot substitute the traditional Chinese medicine;

5. the traditional Chinese medicine composition can cure early superficial gastritis in time, prevent gastric ulcer and chronic atrophic gastritis from developing, promote healing of ulcer surfaces and prevent canceration of patients suffering from gastric ulcer and atrophic gastritis for a long time;

6. the traditional Chinese medicine composition has no toxic or side effect, and has no adverse reaction after being continuously taken for 3-6 months by patients with chronic atrophic gastritis through clinical application.

In addition, the traditional Chinese medicine compound preparation of the invention also has other characteristics:

1. the treatment direction is specific, and the main functions are strengthening spleen, soothing liver, regulating qi and relieving pain;

2. not only regulates the qi movement of the spleen and stomach, but also takes other visceral functions into consideration, and the herbs entering the lung meridian, heart meridian and liver meridian are added to comprehensively regulate the viscera.

The process of the traditional Chinese medicine granule of the invention is characterized in that: the method changes the method of one-time decoction after mixing of the traditional decoction, strictly requires the processing flow of each traditional Chinese medicine, and performs treatment according to the physicochemical properties of different components contained in different medicinal materials, and adopts the processes of water extraction, alcohol extraction, volatile oil extraction and the like to ensure the full extraction of effective components, so that the preparation achieves the optimal treatment effect according to the intention of the prescription.

The traditional Chinese medicine compound preparation is prepared by utilizing the respective effects of the traditional Chinese medicine components and mutually matching, and is used for treating spleen-tonifying qi-regulating, liver-soothing pain-relieving and the like of patients with spleen-deficiency liver-depression qi-stagnation type chronic atrophic gastritis. Is especially suitable for treating gastric cavity pain, swelling and discomfort, and dyspepsia caused by chronic atrophic gastritis due to spleen deficiency and stagnation of liver-qi. The traditional Chinese medicine granule has the characteristics of reasonable formula, advanced process, convenient taking, small dosage, controllable quality, safety, reliability and the like, is a traditional Chinese medicine granule which closely combines the traditional Chinese medicine experience and theory with the modern medicine production technology and embodies the modernization of the traditional Chinese medicine and is worthy of popularization and application in treating common diseases and frequently encountered diseases.

The quality standard of the preparation of the invention is characterized in that: a method for measuring the content of the main medicine is established, and chromatography is adopted; identifying a part of medicine thin layers; thereby ensuring the quality controllability in the production process of the preparation and the treatment effect of the preparation.

The invention mainly treats the following diseases: the traditional Chinese medicine composition has the effects of tonifying spleen, regulating qi, soothing liver and relieving pain, is used for relieving and treating symptoms related to chronic gastritis, particularly chronic atrophic gastritis, and can reverse atrophy of stomach-resident glands.

The effects of the traditional Chinese medicines of the invention are as follows:

stir-frying white atractylodes rhizome with bran: invigorating spleen, invigorating qi, eliminating dampness, promoting diuresis, arresting sweating, and preventing miscarriage, and can be used for treating spleen deficiency, anorexia, abdominal distention, diarrhea, phlegm and fluid retention, dizziness, edema, spontaneous perspiration, and threatened abortion. Record of "medical enlightenment": the traditional Chinese medicine composition has the effects of removing dampness and benefiting dryness, regulating the middle warmer and replenishing qi, warming the middle warmer, removing dampness in the spleen and stomach, removing stomach heat, strengthening the spleen and stomach, taking food and preventing miscarriage. "modern pharmacological action: 1. strengthening action: the largehead atractylodes rhizome decoction is filled into 1mol or 6g/kg of stomach, can promote the weight gain and the swimming endurance of the mice, and the largehead atractylodes rhizome can enhance the phagocytic function of the reticuloendothelial system, activate the reticuloendothelial system of the mice, promote the phagocytic function of macrophages in abdominal cavities of the mice, and obviously increase the phagocytic percentage, the phagocytic index and the lysosome digestion of the macrophages compared with a control group. In leukopenia, Atractylodis rhizoma has effect of increasing leukocyte. The white atractylodes rhizome can also improve the lymphocyte transformation rate and the natural rose forming rate, promote the cellular immune function and obviously increase IgG. It is indicated that Bai Zhu has the actions of strengthening spleen and stomach, strengthening body and improving disease resistance. 2. The anti-tumor effect is as follows: in vitro experiments show that the neutral oil in the bighead atractylodes rhizome volatile oil has an obvious inhibition effect on esophageal cancer cells. When the concentration is 10mcg/ml, all cancer cells can be exfoliated within 24 hours. When the concentration is 5mcg/ml, most cancer cells can be exfoliated, residual small cells or scattered cells are in the form of nucleus compaction, unclear nucleoli and vacuole with large vacuole quality. 50-100 mg/kg of bighead atractylodes rhizome volatile oil has a remarkable inhibiting effect on ehrlich ascites carcinoma through intraperitoneal injection. When administered systemically, the efficacy of substantial solid cancers is reported to be inconsistent. When 358 plant medicines and single and compound traditional Chinese medicines are screened, the bighead atractylodes rhizome volatile oil has the strongest inhibition effect (the inhibition rate is 31-49%) on mouse sarcoma-180, S-180, U-14 and W-256, and a leukemia model (L615 has no obvious effect; recently, the activity of the bighead atractylodes rhizome on methA tumor is obviously increased compared with that of a control group, delayed hypersensitivity of the methA tumor is obviously enhanced, and juvenile allelopathy induced by plant hemagglutinin-P and lipopolysaccharide is promoted.3. the effect on gastrointestinal smooth muscle is reported in the past, the bighead atractylodes rhizome has no influence on gastrointestinal tract functions (such as gastric secretion of gastric acid, propulsive intestinal peristalsis and the like), has no anti-ulcer, anti-inflammatory and analgesic effects, does not influence normal body temperature, has no obvious inhibition effect on a central nervous system, and the latter is considered as a basis for distinguishing from rhizoma atractylodis, the influence of the white atractylodes rhizome on the spontaneous activity of the isolated small intestine of the rabbit is different, the white atractylodes rhizome can enhance the spontaneous contraction activity of the isolated small intestine of the rabbit, so that the contraction amplitude is increased, and the white atractylodes rhizome oil inhibits the spontaneous movement of the intestinal canal, or the influence of the white atractylodes rhizome on the spontaneous movement of the isolated small intestine of the rabbit is not obvious. The white atractylodes rhizome has obvious antagonism to rabbit vitro small intestine tonic contraction caused by acetylcholine and barium dichloride, and can antagonize the action of the white atractylodes rhizome to the inhibition of the in vitro rabbit small intestine activity caused by adding adrenaline. However, no significant antagonism has been reported. The largehead atractylodes decoction is 10g per day (crude drugs/kg are continuously infused into the stomach of a mouse to obviously promote the synthesis of small intestinal protein, the largehead atractylodes extract is infused into the stomach of 50mg and 200mg/kg to inhibit stress ulcer caused by animal water immersion, and the largehead atractylodes extract has obvious inhibiting effect.4, the antibacterial effect is that the water immersion liquid has inhibiting effect on flocculus epidermophyton and Y-shaped nocardia in a test tube, the decoction also has inhibiting effect on meningococcus.

Bupleurum chinense nakai: relieve exterior syndrome, allay fever, soothe liver, relieve depression and ascend yang qi. Modern pharmacological actions: 1. has stable and reliable antipyretic effect. 2. Tranquilizing, relieving pain, relieving chest distress and distending pain, and resolving stagnation for regulating menstruation. 3. Antibacterial, enhancing phagocytic function, enhancing natural killer cell function, increasing virus specific antibody titer, and increasing lymphocyte nuclear transfer rate. 4. Has liver injury resisting effect. 5. Has antiviral, strong inhibitory effect on influenza virus, and has inhibitory effect on cytopathy caused by type 1 myelopolisis virus. Bupleurum scorzonerifolium and flos Pruni mume are combined to enhance the actions of soothing liver and promoting qi. Bupleurum chinense, radix bupleuri, radix Paeoniae alba, radix bupleuri, radix Paeoniae alba, radix bupleuri, radix Paeoniae alba.

Hangzhou white peony root: nourish blood and regulate menstruation, astringe yin and check sweating, soften liver and relieve pain, and calm liver yang. Modern pharmacological actions: 1. effects on the central nervous system: paeoniflorin has obvious analgesic effect on writhing reaction caused by acetic acid, and when combined with methanol complex of Glycyrrhrizae radix, the two have synergistic analgesic effect on writhing reaction of acetic acid. Total Glucosides of Paeony (TGP) have synergistic effect on morphine and clonidine inhibiting mouse writhing response. The analgesic effect of the total glucosides of paeony cannot be blocked by naloxone, and the contraction of longitudinal muscles of guinea pig ileum stimulated by low-frequency electric field is not influenced. Suggesting that the analgesic action of Paeonia lactiflora pall is not due to stimulation of opioid receptors. The total glucosides of paeony (1-40 mg/kg) inhibits writhing, hoarseness and hot plate reaction of mice dose-dependently, prolongs the hot plate reaction latency of rats, and has a peak action time of 0.5-1 hour. Different pain indexes reflect different functional activities of pain integration centers, tail flick reaction is mainly completed by the participation of spinal cords, and reaction of feet after hoarse and licking is completed in high-grade centers, so that emotional activities can be reflected to a certain extent. The total glucosides of paeony has no obvious influence on the tail flick reaction, but can inhibit the hoarseness and licking reaction, which indicates that the action part of the total glucosides of paeony is in the high-level center. The total glucosides of paeony can obviously inhibit the activity of mice and the irritability reaction of the mice caused by electric stimulation. The intraperitoneal injection of the total glucosides of paeony (5-40 mg/kg) can reduce the normal body temperature of mice and rats, and is in a dose-dependent relationship, the peak of the effect is 0.5-1 hour, and the cooling effect is influenced by the environment. Injecting small amount of total glucosides of paeony (2.4 mg/kg) into lateral ventricle of rat also has obvious effect of lowering temperature. H1-receptor blocker chlorpheniramine (10 mg/kg, 20mg/kg subcutaneous injection) can significantly antagonize the cooling effect of total glucosides of paeony on rats and mice. Therefore, it is believed that the cooling effect of total glucosides of paeony is related to the sensitization of H1-receptors in the brain. However, the total glucosides of paeony (40 mg/kg intraperitoneal or subcutaneous injection) has no obvious cooling effect on normal guinea pigs and rabbits. 2. Spasmolysis: paeoniflorin has better spasmolytic effect, which is the result of direct action on intestinal canal smooth muscle. The lixivium of paeoniflorin and radix Paeoniae has effects of inhibiting spontaneous contraction and reducing tonicity of guinea pig in vitro small intestine, has no obvious effect on intestinal canal contraction caused by acetylcholine, but can inhibit intestinal canal contraction caused by barium chloride. Through the research on the spasmolytic effect of the peony and licorice decoction, the radix paeoniae alba is considered to inhibit the dissociation of parasympathetic nerve terminal acetylcholine and has presynaptic inhibition effect. The action of white peony root is considered to be related to adenosine-like substances, but theophylline cannot completely inhibit the action of peony root, so that the action of peony root is related to adenosine-like substances and other substances are involved. The glycoside of peony is excitatory at low concentration and inhibitory at high concentration for the isolated uterine movement of mice. Paeoniflorin has obvious inhibition effect on uterine contraction caused by oxytocin. 3. Protective action on liver: the radix Paeoniae alba extract has obvious effects of resisting liver injury and SGPT increase caused by D-galactosamine, reducing SGPT, and recovering liver cell pathological changes and necrosis. The ethanol extract of the white paeony root can reduce the total activity increase of lactate dehydrogenase and isozyme which are shown by acute liver injury of rats caused by aflatoxin B1. The total glucosides of paeony can inhibit the increase of GPT and lactate dehydrogenase in blood plasma of mice caused by carbon tetrachloride, and has certain resistance to the acid degeneration and necrosis of liver tissues. It is believed that the liver damage caused by carbon tetrachloride is damaged by the peroxidation of the cell membrane structure, which increases glutamic-pyruvic transaminase and lactic dehydrogenase in blood, and that total glucosides of paeony may protect against liver cell damage, thus reducing transaminase. 4. Anti-inflammatory action: the total glucosides of paeony has obvious prevention and treatment effects on rat adjuvant arthritis, can simultaneously reduce the level of excessive hydrogen peroxide and interleukin-1 produced by macrophages in abdominal cavities of rats, and can restore the normal capability of low thymopoietic reaction and spleen lymphocytes to produce interleukin-2 caused by the rat adjuvant arthritis. It is suggested that the total glucosides of paeony have anti-inflammatory and function-dependent immunoregulation effects on adjuvant arthritis rats. The white peony root extract can obviously inhibit egg white acute inflammatory edema of rats and has the function of inhibiting cotton ball granuloma from proliferating. 5. Effects on the immune system: radix Paeoniae alba can enhance phagocytic function of macrophage. The mice are fed with 0.8 ml/mouse of 50% white paeony root decoction every day for 5 consecutive days, and the phagocytosis percentage and the phagocytosis index of the macrophages in the abdominal cavity of the mice are obviously improved compared with those in a control group. The administration of 40mg/kg of total glucosides of paeony to mice per day can also promote the phagocytic function of macrophages in abdominal cavity. The total glucosides of paeony has a regulating effect on the phagocytic function of abdominal macrophages, has low-concentration promotion and high-concentration inhibition effects on the generation of interleukin-1 by rat abdominal macrophages induced by lipopolysaccharide, and plays an important role in immune regulation and the formation of chronic inflammatory diseases, so that the regulation of the generation of the interleukin-1 by the total glucosides of paeony can be one of mechanisms for playing immune regulation and preventing and treating arthritis. The total glucosides of paeony has an inhibition effect on the production of leukotriene B4 by rat abdominal cavity macrophages, and has a dose-dependent relationship, and the inhibition effect of 100mg/L is equivalent to that of the non-steroidal anti-inflammatory drug flufenamic acid with the same dose, but the effect is slower. The 50% inhibition rate is 0.66 mg/L. Therefore, the anti-inflammatory and immunomodulatory effects of total glucosides of paeony may also be associated with their effects on the production of leukotriene B4. Hangzhou white peony root, radix Paeoniae alba relieves spasm and pain, can tonify liver yin, and is combined with Bei chai Hu to enhance the action of softening liver and relieving spasm.

Aging with rice fragrance: regulating qi-flowing, invigorating spleen, eliminating dampness and phlegm, and can be used for treating abdominal distention, anorexia, vomiting and diarrhea, cough and excessive phlegm. Modern pharmacological actions: action on digestive system: has mild stimulation effect on gastrointestinal tract, can promote secretion of digestive juice, eliminate pneumatosis in intestinal canal, and has the effects of invigorating stomach, dispelling pathogenic wind and descending qi. The tangerine peel decoction has the similar effect to adrenaline in vitro intestinal canal of rabbit and white mouse, in-situ stomach and intestinal movement of anesthetized rabbit and dog, and in-vitro uterus of white mouse is inhibited and has tonic contraction in-situ uterus of anesthetized rabbit. Hangzhou white peony root is combined with Bei chai Hu to enhance the action of nourishing liver and relieving spasm. Hangzhou white peony root is combined with Lu Cao Mei to strengthen the actions of soothing liver and promoting qi.

Frying the perilla seeds: direct qi downward and resolve phlegm, relieve cough and dyspnea, moisten intestines and relieve constipation. Modern pharmacological actions: 1. the feed containing 10% perilla oil (rich in alpha-linolenic acid) has anticancer effect by feeding to rats with breast cancer, colon cancer and nephroblastoma induced by 7, 12-dimethylbenzanthracene and 1, 2-dimethylhydrazine. 2. Experiments show that: perilla oil (0.1%) has inhibitory effect on Proteus, Aspergillus niger, Penicillium and mould in nature. Wherein the action on mould and yeast is obviously stronger than that of 0.05 percent of nipagin and 0.3 percent of benzoic acid. The purple perilla has strong inhibition effect on staphylococcus, and also has inhibition effect on escherichia coli and shigella dysenteriae. 3. The parched fructus Perillae can promote secretion of digestive juice and enhance gastrointestinal peristalsis. In the basic prescription treatment of the spleen and stomach diseases, the fried perilla seeds entering the lung meridian are added, so that the effects of reducing lung qi to reduce stomach qi, strengthening qi reduction, eliminating phlegm and relaxing bowel are achieved. The stir-fried perilla fruit is matched with the ginger magnolia bark to enhance the effects of descending qi, reducing phlegm, regulating qi and clearing hollow viscera.

Blighted wheat: strengthen superficies to check sweating, tonify qi and remove heat. Modern pharmacological actions: 1. the light wheat has the function of reducing blood fat, and can obviously reduce the contents of serum cholesterol and triglyceride. 2. The fructus Tritici Levis can remarkably reduce lipid and lipid peroxide content in liver tissue, and protect liver. In the basic prescription treatment of the spleen and stomach diseases, the blighted wheat which enters heart meridian is added, so that the medicine has the effects of benefiting heart qi to strengthen spleen qi, nourishing heart to calm mind and removing dysphoria with smothery sensation, and has obvious effect on treating various symptoms caused by spleen yang qi deficiency and heart failure nourishment in chronic gastritis.

And (3) green calyx plum: soothing liver, harmonizing stomach, resolving phlegm. It can be used for treating liver and stomach pain due to qi stagnation and anorexia. Flos Pruni mume is effective in treating liver and stomach qi pain: flos Pruni mume has the effects of activating qi-flowing, dispersing stagnated liver qi, relieving qi stagnation, activating spleen, regulating qi-flowing and regulating stomach; lucalyx mume can be used for treating hypochondriac pain, abdominal distention and fullness, belch and anorexia due to liver-stomach qi stagnation, and can be combined with bupleuri radix to reinforce the actions of soothing liver, activating qi and regulating qi.

Ginger magnolia bark: dry dampness and resolve phlegm, descend qi and remove fullness. Modern pharmacological actions: for the effect on the digestive tract, the magnoline gradually increases the tension of the duodenum of the isolated rabbit within the range of 0.1-1 ml (10mg/ml), when the tension reaches 1.5ml, the muscle tension is gradually inhibited, the frequency is slowed down, and when the tension reaches 2.5ml, the contraction activity of the intestinal muscle is completely stopped. The cortex Magnolia officinalis ethanol extract has effect in resisting HCL-ethanol ulcer of rat, and the weight of rat is 200g, and 50% ethanol extract of cortex Magnolia officinalis is administered orally to administration group, and is administered to control group 1 hr later, and then HCL-ethanol 15% methanol is administered 1 hr later, and animals are sacrificed 1 hr later. The ulcer index was determined as the sum of the lengths (mm) of the ulcers formed on the mucosal portion, and compared with the control group. The result shows that the administration group has obvious inhibition effect on gastric mucosal ulcer, and one of the active ingredients is determined to be honokiol and magnolol. The water immersion stimulation method is adopted to cause stress acute gastric ulcer of a rat, the gastric secretion of the rat is measured by the intragastric perfusion method, the gastric hemorrhage of the stress-loaded rat under the condition of artificial gastric perfusion is measured, and the result shows that magnolol has the effect of preventing stress gastric dysfunction. The combination of cortex Magnolia officinalis, rhizoma Atractylodis Macrocephalae parched with bran, and Oryza sativa Chen can enhance the effects of invigorating spleen and regulating qi-flowing. The combination of the ginger-processed magnolia bark and the stir-fried perilla fruit can enhance the functions of descending qi, resolving phlegm, regulating qi and clearing hollow viscera.

Vinegar rhizoma corydalis: activate blood, move qi and alleviate pain. 1. The analgesic effect is as follows: the method of electrically stimulating the tail of the mouse proves that the corydalis tuber powder has the analgesic effect, the potency of the corydalis tuber powder is 1/10 of opium, and the effect lasts for 2 hours. The mouse hot plate method proves that the corydalis A and the ugu have obvious analgesic effect. The rabbit heat stimulation method and the electric sum stimulation method prove that 15-20mg/kg of the IV B, 10-15mg/kg of the pharbitis or 30-40mg/kg of the A have analgesic effect. The second and the last two are the strongest, the first one. Rat sc B50 mg/kg or ugu essence 40mg/kg also had analgesic potency similar to rabbits. The third one also has obvious analgesic effect on writhing reaction caused by injection of acetic acid into abdominal cavity of mouse and analgesic experiment by electric stimulation. The analgesic effect of the rats on the ethyl and the ugnin can generate tolerance, the generation speed is 1 time slower than that of morphine, and the tolerance with the morphine is crossed; experiments also show that the B element is not found to have addiction. 2. Action on digestive system: the rhizoma corydalis infusion has excitation effect on guinea pig isolated intestinal canal (1: 1000-1: 10, 000), but has no significant effect on rabbit and rat isolated small intestine. While ethocel is in the ratio of 1: at a concentration of 2 × 10, the composition can inhibit the activity of isolated intestinal canal of rabbit, and block the excitation of acetylcholine, barium chloride, hypophysin and 5-HT to intestinal muscle. The insulin is effective against 5-HT-induced contraction of isolated stomach and colon in rats. However, in the test of the whole animals, such as dogs in pavlov's stomach, the element B is 20-40mg/kg, which has no obvious influence on gastric secretion and gastric acid, the gastric secretion is obviously inhibited when a large dose (80 mg/kg) is applied, and the gastric acidity and the digestive power are also weakened. Dehydrocorydaline can protect experimental ulcer of rat caused by hunger or medicine (Cordyson, reserpine, etc.), reduce gastric secretion, gastric acid and pepsin amount, and has antisecretory effect after cutting vagus nerve, and no blocking effect on parasympathetic nerve. After the racemic tetrahydropalmatine is anesthetized to the thoracotomy dog iv, indexes such as LVSP, dp/dtmax, VcE +/-dp/dtmax and the like have obvious bidirectional effects of excitation before inhibition, and the dl-tetrahydropalmatine has the effect of resisting arrhythmia. The vinegar rhizoma corydalis is combined with the Hangzhou white peony root to enhance the effect of relieving pain.

Detailed Description

The present invention will be described in further detail with reference to specific embodiments, but the present invention is not limited to these specific embodiments. (hereinafter, 1g for each 1 part by weight)

Example 1

A Chinese medicinal compound preparation (granule) for treating chronic atrophic gastritis due to spleen deficiency and stagnation of liver-qi: the active ingredients of the traditional Chinese medicine compound preparation for treating spleen deficiency and liver depression qi stagnation type chronic atrophic gastritis are prepared from the following raw material medicines in parts by weight: 15 parts of bran-fried bighead atractylodes rhizome, 6 parts of rice-scented tangerine peel, 9 parts of bupleurum chinense, 15 parts of radix paeoniae alba, 10 parts of fried perilla fruit, 30 parts of light wheat, 6 parts of flos mume, 9 parts of vinegar rhizoma corydalis and 10 parts of cortex magnoliae officinalis.

The preparation method of the traditional Chinese medicine compound preparation (granule) comprises the following steps:

Example 2

A Chinese medicinal compound preparation (granule) for treating chronic atrophic gastritis due to spleen deficiency and stagnation of liver-qi: the active ingredients of the traditional Chinese medicine compound preparation for treating spleen deficiency and liver depression qi stagnation type chronic atrophic gastritis are prepared from the following raw material medicines in parts by weight: 10 parts of bran-fried bighead atractylodes rhizome, 3 parts of rice-scented tangerine orange, 6 parts of bupleurum chinense, 9 parts of radix paeoniae alba, 6 parts of fried perilla fruit, 25 parts of blighted wheat, 3 parts of flos mume, 6 parts of vinegar rhizoma corydalis and 9 parts of cortex magnoliae officinalis.

(1) taking 9 parts of radix Paeoniae alba, 3 parts of Oryza sativa, 25 parts of fructus Tritici Levis and 3 parts of flos Pruni mume, adding 10 times of water, decocting by conventional method for 3 times, each for 1 hr, mixing extractive solutions, filtering, concentrating at below 60 deg.C to obtain extract with relative density of 1.10-1.20 at 60 deg.C;

(2) taking 10 parts of bran-fried bighead atractylodes rhizome, 6 parts of bupleurum chinense, 6 parts of vinegar-processed corydalis tuber and 9 parts of ginger-processed magnolia officinalis, adding 8 times of 75% ethanol, placing the mixture in a multifunctional extraction tank for reflux extraction for 3 times, extracting the mixture for 1 hour each time, combining the ethanol extracts, recovering the ethanol, concentrating the extract at the temperature of below 60 ℃ to obtain an extract, and keeping the relative density of the extract at the temperature of 60 ℃ to be 1.10-1.20 for later use;

(3) taking 6 parts of fried perilla seeds, adding 8 times of water, placing the fried perilla seeds in a multifunctional extraction tank for boiling, and performing reflux extraction for 6 hours to obtain volatile oil for later use;

Example 3

A Chinese medicinal compound preparation (granule) for treating chronic atrophic gastritis due to spleen deficiency and stagnation of liver-qi: the active ingredients of the traditional Chinese medicine compound preparation for treating spleen deficiency and liver depression qi stagnation type chronic atrophic gastritis are prepared from the following raw material medicines in parts by weight: 20 parts of bran-fried bighead atractylodes rhizome, 9 parts of rice-scented tangerine peel, 15 parts of bupleurum chinense, 20 parts of radix paeoniae alba, 15 parts of fried perilla fruit, 35 parts of blighted wheat, 9 parts of flos mume, 15 parts of vinegar rhizoma corydalis and 15 parts of cortex magnoliae officinalis.

(1) taking 20 parts of radix Paeoniae alba, 9 parts of Oryza sativa, 35 parts of fructus Tritici Levis and 9 parts of flos Pruni mume, adding 10 times of water, decocting by conventional method for 3 times, each for 1 hr, mixing extractive solutions, filtering, concentrating at below 60 deg.C to obtain extract with relative density of 1.10-1.20 at 60 deg.C;

(2) taking 20 parts of bran-fried bighead atractylodes rhizome, 15 parts of bupleurum chinense, 15 parts of vinegar-processed corydalis tuber and 15 parts of ginger-processed magnolia officinalis, adding 8 times of 75% ethanol, placing the mixture in a multifunctional extraction tank for reflux extraction for 3 times, extracting the mixture for 1 hour each time, combining the ethanol extracts, recovering the ethanol, concentrating the extract at the temperature of below 60 ℃ to obtain an extract, and keeping the relative density of the extract at the temperature of 60 ℃ to be 1.10-1.20 for later use;

(3) taking 15 parts of fried perilla seeds, adding 8 times of water, placing the fried perilla seeds in a multifunctional extraction tank for boiling, and performing reflux extraction for 6 hours to obtain volatile oil for later use;

Example 4

A Chinese medicinal compound preparation (tablet) for treating chronic atrophic gastritis due to spleen deficiency and stagnation of liver-qi: the active ingredients of the traditional Chinese medicine compound preparation for treating spleen deficiency and liver depression qi stagnation type chronic atrophic gastritis are prepared from the following raw material medicines in parts by weight: 15 parts of bran-fried bighead atractylodes rhizome, 6 parts of rice-scented tangerine peel, 9 parts of bupleurum chinense, 15 parts of radix paeoniae alba, 10 parts of fried perilla fruit, 30 parts of light wheat, 6 parts of flos mume, 9 parts of vinegar rhizoma corydalis and 10 parts of cortex magnoliae officinalis.

The preparation method of the traditional Chinese medicine compound preparation (tablet) comprises the following steps:

(4) and (3) combining the extracts in the steps (1) and (2), drying to obtain a dry extract, crushing, adding the volatile oil in the step (3), granulating, adding an appropriate amount of auxiliary materials, mixing, sieving by a 100-mesh sieve, performing dry compression granulation or wet granulation, drying at the temperature of below 60 ℃, sieving by a 16-mesh sieve, granulating, mixing uniformly, adding an appropriate amount of magnesium stearate, mixing uniformly, and tabletting to obtain the traditional Chinese medicine composition.

Example 5

A Chinese medicinal compound preparation (tablet) for treating chronic atrophic gastritis due to spleen deficiency and stagnation of liver-qi: the active ingredients of the traditional Chinese medicine compound preparation for treating spleen deficiency and liver depression qi stagnation type chronic atrophic gastritis are prepared from the following raw material medicines in parts by weight: 10 parts of bran-fried bighead atractylodes rhizome, 3 parts of rice-scented tangerine orange, 6 parts of bupleurum chinense, 9 parts of radix paeoniae alba, 6 parts of fried perilla fruit, 25 parts of blighted wheat, 3 parts of flos mume, 6 parts of vinegar rhizoma corydalis and 9 parts of cortex magnoliae officinalis.

Example 6

A Chinese medicinal compound preparation (tablet) for treating chronic atrophic gastritis due to spleen deficiency and stagnation of liver-qi: the active ingredients of the traditional Chinese medicine compound preparation for treating spleen deficiency and liver depression qi stagnation type chronic atrophic gastritis are prepared from the following raw material medicines in parts by weight: 20 parts of bran-fried bighead atractylodes rhizome, 9 parts of rice-scented tangerine peel, 15 parts of bupleurum chinense, 20 parts of radix paeoniae alba, 15 parts of fried perilla fruit, 35 parts of blighted wheat, 9 parts of flos mume, 15 parts of vinegar rhizoma corydalis and 15 parts of cortex magnoliae officinalis.

The Chinese herbal compound preparation of the components has the effects of strengthening spleen, soothing liver, regulating qi and relieving pain by scientific preparation, is effectively used for treating spleen deficiency and liver depression qi stagnation type chronic atrophic gastritis, and obtains satisfactory effect by clinical test, and the clinical data are as follows:

object and method

1 general data

101 patients with spleen-stomach weakness (spleen-stomach deficiency-cold syndrome) or chronic atrophic gastritis with liver-stomach qi stagnation syndrome are selected for clinic visit during 6 months to 2018 and 6 months in 2017. All accord with the diagnosis standard of Chronic Atrophic Gastritis (CAG) formulated by 'Chinese consensus opinion on chronic gastritis' proposed in the national conference on diagnosis and treatment of chronic gastritis in 2012. And the traditional Chinese medicine composition meets the symptoms of weakness of the spleen and the stomach (spleen and stomach deficiency-cold syndrome) or qi stagnation of the liver and the stomach in chronic atrophic gastritis related to the opinion on the diagnosis and treatment consensus of the traditional Chinese medicine node of chronic atrophic gastritis in the medical society of spleen and stomach in 2010.

2 diagnostic criteria

2.1 Western diagnostic standards

The diagnosis standard of Chronic Atrophic Gastritis (CAG) is formulated according to ' Chinese Chronic gastritis consensus opinion ' proposed in the China's Nippon national Consortium of the Chinese medical society for digestive diseases 2012: (1) the diagnosis is confirmed according to 2 pieces of pathological examination of gastric mucosa tissue, and diagnosis and differential diagnosis are carried out according to the medical history, symptoms and physical signs of the patient; (2) the atrophy of gastric mucosa is divided into four grades (no (0), no atrophy of inherent glands, mild (+), reduction of the number of inherent glands <1/3 original glands, moderate (+ +), reduction of the number of inherent glands to 1/3-2/3 original glands, severe (+ +), reduction of the number of inherent glands >2/3 original glands, only a few glands remained and even completely disappeared); (3) the intestinal metaplasia is divided into four grades (no (0): no intestinal metaplasia; mild (+): the total area of the intestinal metaplasia area in the gland and the surface epithelium is less than 1/3; moderate (+ +): the total area of the intestinal metaplasia area in the gland and the surface epithelium is 1/3-2/3; severe (+ +): the total area of the intestinal metaplasia area in the gland and the surface epithelium is 2/3); (4) heterotypic hyperplasia: (ii) low-grade intraepithelial neoplasia/dysplasia: presenting minimal structural disturbance, and mild to moderate cytological abnormalities. The nucleus is slender and polar, the nucleus is positioned at the basal part, and the nuclear fission image is rare; high grade intraepithelial neoplasia/dysplasia: high ratio of nucleo-plasma, obvious amphotropism of nucleolus, more obvious structural disorder and increased nuclear division. Importantly, the nucleus often extends into the cell cavity, and the nuclear polarity often disappears. Most are classified as high-grade dysplasia, with the risk of malignant change to invasive cancer or rapid progression.

2.2 Chinese medicine diagnostic Standard

Refer to the findings of the TCM Joint diagnosis and treatment of Chronic atrophic gastritis (2009, Shenzhen) in the TCM Association of the spleen and stomach of the TCM society of TCM, which are related to chronic atrophic gastritis, and satisfy the syndrome of weakness of the spleen and stomach (spleen-stomach deficiency-cold syndrome) or the syndrome of qi stagnation of the liver and stomach

The syndrome of weakness of the spleen and stomach (spleen-stomach deficiency-cold syndrome) has the main symptoms of fullness or dull pain in the stomach; ② the stomach is good for pressing or warm.

The secondary symptoms are that food is poor and anorexia is caused; ② loose stool; third, lassitude and hypodynamia; fourthly, shortness of breath and no speaking desire; fifthly, the stomach is stuffy after eating; sixthly, the tongue is pale and the pulse is thready and weak.

Liver-stomach qi stagnation syndrome, the main symptoms are: firstly, the stomach is full or distending pain; ② hypochondriac swelling pain.

The secondary symptoms are that the symptoms are induced or aggravated by emotional factors; second, frequent belching; thirdly, chest distress is uncomfortable; fourthly, the tongue coating is thin and white; the pulse is wiry.

The syndrome is determined that the main symptoms are necessary and more than 2 secondary symptoms can be diagnosed. In addition, the above syndromes may appear alone or in combination, and clinically, the compound syndromes should be distinguished based on the single syndrome. Meanwhile, the syndromes may change dynamically over time, and need to be carefully discriminated.

3 inclusion, rejection and termination test criteria

3.1 inclusion criteria

The diagnosis in 1 month meets the clinical diagnosis standards of the traditional Chinese medicine and the western medicine, and the CAG patient is diagnosed as the spleen-stomach deficiency syndrome (spleen-stomach deficiency-cold syndrome) or the liver-stomach qi stagnation syndrome; ② the presence or absence of helicobacter pylori (Hp) infection; age 20-70 years old; fourthly, the compliance is good, the prescription, the compatibility treatment and the inspection are followed, and the quitting is avoided; signing an informed consent.

3.2 rejection criteria

Not meeting the diagnosis standard; ② other gastropathy and gastric complication, or peptic ulcer, severe abnormal hyperplasia of gastric mucosa or malignant change in pathological diagnosis; ③ acute and critical parenchymal organ pathological changes, endocrine, infectious diseases and psychoneurosis are merged; patients with allergic constitution, allergy to various drugs or drug dependence; fifth age <20 or >70 years old; coma, obnubilation, speech failure and word incomprehension; seventhly, patients who are treated by related medicines and participate in clinical medicine tests or people with allergic constitution recently; eighthly, nursing, pregnant or planning pregnant women; ninthly, the patient can not be taken with the medicine, the compliance is poor, the medical advice can be changed at will, or the patient does not cooperate with diagnosis, treatment and inspection; the other is not suitable for inclusion.

3.3 standards for termination of the test

In the treatment process, if serious adverse reactions such as gastrointestinal hemorrhage, obstruction, diarrhea and the like occur, patients who cannot insist on treatment or have serious complications in the test process are treated, the test is stopped, active measures are immediately taken for treatment, the life safety of the patients is ensured, and the patients are timely reported to a responsible person and a superior competent department.

4 random grouping

After the patients are selected, the patients are divided into 34 cases of the invention groups (the traditional Chinese medicine compound preparation (granules) for treating the spleen deficiency and liver depression and qi stagnation type chronic atrophic gastritis), the qi stagnation group (qi stagnation stomachache granules) and the viscera regulating group (the viscera regulating and qi transporting decoction (granules) in the prior art) by adopting a random digital table method. Wherein, 3 cases are dropped during the intervention period of the invention group, and the final obtained effective data is 31 cases. 4 cases of qi stagnation group are dropped during the intervention period, and 30 cases of effective data are finally obtained. 5 cases of intervention period of the dirty group are dropped, and 29 cases of effective data are finally obtained.

The data of age, disease course, sex, whether helicobacter pylori (Hp) infection exists and the like of patients in the invention group and the qi stagnation group and the invention group and the viscera regulating group have no significant difference (P is more than 0.05), and the data are comparable. (see tables 1 to 6)

5 method

(1) HP treatment: for patients with combined Hp infection, a scheme of' Proton Pump Inhibitor (PPI) + amoxicillin + clarithromycin + bismuth agent (bismuth tripotassium dicitrato) for radical treatment of Hp for 2 weeks is given before treatment. For the patients who have no effect on the primary anti-Hp treatment, the Proton Pump Inhibitor (PPI), the carbostyril, the furazolidone and the bismuth agent (bismuth tripotassium dicitrate) are treated again after the drug is stopped for 1 month, the examination is carried out again after 1 month, and the patients are treated in the group after 1 week (without any intervention within 1 week).

(2) The invention provides a traditional Chinese medicine compound preparation (granules) (each 1 part by weight is 1 g) for treating spleen deficiency and liver depression qi stagnation type chronic atrophic gastritis (15 parts of bran-fried bighead atractylodes rhizome, 6 parts of rice-scented tangerine orange, 9 parts of bupleurum chinense, 15 parts of white peony root, 10 parts of fried perilla fruit, 30 parts of light wheat, 6 parts of prunus mume, 9 parts of vinegar rhizoma corydalis and 10 parts of magnolia officinalis). 1 dose per day, 3 times in the morning, noon and evening, and continuously taking for 8 weeks; the qi stagnation group is administered with qi stagnation stomachache granule (2.5 g/bag) for 3 times per day, and is administered with 1 bag of boiled water in the morning, noon and evening, and continuously for 8 weeks. The viscera regulating group is viscera regulating qi-transporting decoction (granule) (each 1 part is 1 g) (Atractylodis rhizoma 15 parts (parched), bupleuri radix 9 parts, radix Paeoniae alba 15 parts, Poria 15 parts, folium Hordei Germinatus 15 parts (parched), Oryza sativa mature 6 parts, rhizoma corydalis 9 parts (vinegar), fructus Perillae 10 parts (cloth bag), fructus Tritici Levis 30 parts, and Glycyrrhrizae radix 3 parts). 1 dose per day, 3 times in the morning, noon and evening, and is administered with boiled water for 8 weeks.

6 Observation of therapeutic effects

Refer to 2011 Chinese Association of Chinese and Western medicine Committee for digestive system diseases consensus opinion of Chronic gastritis and Combined traditional Chinese and Western medicine diagnosis and treatment (2011 Tianjin), which establishes clinical curative effect, gastroscope, pathology and traditional Chinese medicine curative effect standards.

6.1 clinical Standard of therapeutic Effect

Firstly, curing: the main clinical symptoms and physical signs disappear, the secondary symptoms basically disappear or disappear, the gastroscope rechecks that the active inflammation disappears and the chronic inflammation changes to mild degree, and the pathological histology proves that the gland atrophy, the intestinal metaplasia and the abnormal hyperplasia recover to normal or disappear; secondly, effect is displayed: clinical main symptoms disappear, secondary symptoms disappear basically, acute inflammation of mucosa disappears basically and chronic inflammation improves after repeated examination by a gastroscope, and gland atrophy, intestinal metaplasia and abnormal hyperplasia are obviously relieved after pathological and histological examination; ③ effective: the main symptoms and physical signs are obviously reduced, the lesion range of mucosa is reduced by more than 1/2 in the repeated examination of gastroscope, the chronic acute and chronic inflammation is reduced, and the gland atrophy, the intestinal metaplasia and the abnormal hyperplasia are reduced; fourthly, invalidation: the symptoms, endoscopes and pathology are not improved, or the improvement can not reach the effective standard, or the improvement is worsened. The total effective rate is (cure + effect) ÷ case number × 100%.

7 statistical analysis

All data are statistically processed by SPSS 20.0 statistical software, the measured data are expressed by mean value plus or minus standard deviation (QUOTE plus or minus s), and t test is adopted according to normal distribution; the person who does not conform to the normal distribution adopts the rank sum test. The grade data was checked by rank sum and the count data was checked by X2.

Second, research results

1 clinical efficacy

The results are shown in table 7, after treatment, patients in the invention group recover 8 cases, 17 cases with obvious effect, 5 cases with effect and 1 case with no effect, the total effective rate is about 96.8% (one bit after decimal point is reserved below), while the qi stagnation group recovers 3 cases, 9 cases with obvious effect, 13 cases with effect and 5 cases with no effect, the total effective rate is about 83.3%, the two groups have significant difference in curative effect (Z = -3.142, P =0.002 < 0.05), and the invention group is seen to have better total curative effect than the qi stagnation group.

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The results are shown in table 8, after treatment, patients in the invention group recover 8 cases, 17 cases with obvious effect, 5 cases with effect and 1 case with no effect, the total effective rate is about 96.8% (one bit after decimal point is reserved below), while the patients in the invention group recover 4 cases, 11 cases with obvious effect, 11 cases with effect and 3 cases with no effect, the total effective rate is about 89.7%, the two groups have significant difference in curative effect (Z = -2.250, P =0.024 < 0.05), and the invention group is seen to have better total curative effect than the patients in the invention group.

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Specific cases

Case 1, old man, age 53, driver. The patient is admitted to the hospital by taking 'repeatedly treating the upper abdomen for 4 years'. The current medical history: the abdominal distension and fullness in the middle and upper abdomen and the abdominal distension and fullness after hunger appear after the patient is exposed to cold for 4 years before admission. The lower symptoms of the two days: pain and distension in the upper middle and upper abdomen, distending sensation after hunger, occasional upset with pantothenic acid, no preference for drinking, hard stools, 1 row a day, little appetite, no appetite, poor sleep, difficulty in going to sleep, pale red, swollen, white and thick teeth marks on the tongue, and slippery pulse. Auxiliary inspection: electronic gastroscopy: chronic atrophic gastritis (type C-2), Hp (-). Biopsy of gastric antrum pathological tissue: "antrum of stomach" type mucosa severe chronic atrophic inflammation with severe enterogenesis (chronic inflammation + +, activity + +, atrophy + + +, enterogenesis + +). The granule of the compound preparation example 1 of the invention is taken 1 dose per day, 3 times in the morning, at noon and evening, with boiled water for 8 weeks. The symptoms are obviously improved, no special discomfort exists, and after 10 months, the electronic gastroscopy is rechecked: superficial gastritis, Hp (-). Biopsy of gastric antrum pathological tissue: "antrum" full antrum mucosa mild non-atrophic inflammation (chronic inflammation +, activity +).

Case 2 Xie, woman, age 59, clerk. The patient is admitted with the chief complaint that the pain in the gastric cavity is repeated for more than 5 years and aggravated for 4 days. The current medical history: the epigastric pain appears 5 years before admission, after eating unclean food, and the epigastric pain appears 4 days before the admission without systemic treatment. The lower symptoms of the two days: the pain in the epigastrium, which is aggravated after the onset of spleen qi, is relieved in quiet state and refused to press when the pain is relieved. Stool for 2-3 times per day and thin in nature. Poor appetite, poor sleep, a red tongue with yellow and thick coating, and a slippery and wiry pulse. Auxiliary inspection: electronic gastroscopy: chronic atrophic gastritis (type C-1) with erosion, Hp (+). Biopsy of gastric antrum pathological tissue: "antrum of the stomach" full-thickness antrum mucosa moderate chronic atrophic inflammation with moderate enterogenesis (chronic inflammation + +, activity + +, atrophy + +, enterogenesis + +). Because of Hp (+), the patient is given a 'Proton Pump Inhibitor (PPI) + amoxicillin + clarithromycin + bismuth agent (bismuth tripotassium dicitrate)' scheme for radical treatment of Hp for 2 weeks, and the treatment is carried out after 1 month and 1 week (without any intervention within 1 week). The granule of the compound preparation example 1 of the invention is taken 1 dose per day, 3 times in the morning, at noon and evening, with boiled water for 8 weeks. The symptoms are obviously improved, no special discomfort exists, and after 9 months, the electronic gastroscopy is rechecked: superficial gastritis with erosion, Hp (-). Biopsy of gastric antrum pathological tissue: "antrum" full antral mucosa mild non-atrophic inflammation (chronic inflammation +).

Case 3 Liu Ji, male, 57 years old, worker. The patient is admitted with complaints of 'failure of repeated defecating for 3 years'. The current medical history: the reason is that loose stool appears after raw and cold food is eaten 3 years before admission. The lower symptoms of the two days: stool is unformed, 2-5 times per day, thin in nature and smelly. Gastric upset and acid regurgitation, dry mouth without drinking, urination regulated, frequent micturition, poor sleep, normal sleep, easy wakefulness, dark red tongue with yellow and greasy coating, and slippery and rapid pulse. Auxiliary inspection: electronic gastroscopy: chronic atrophic gastritis (type C-3) with bile reflux, Hp (+). Biopsy of gastric antrum pathological tissue: the 'antrum stomach' full-thickness antrum stomach mucosa is severe chronic atrophic inflammation with moderate enteromorpha, and low grade intraepithelial neoplasia (chronic inflammation + +, activity + +, atrophy + + +, enteromorpha + +). Electronic colonoscopy: no obvious abnormality of colon was observed. Because of Hp (+), the patient is given a 'Proton Pump Inhibitor (PPI) + amoxicillin + clarithromycin + bismuth agent (bismuth tripotassium dicitrate)' scheme for radical treatment of Hp for 2 weeks, and the treatment is carried out after 1 month and 1 week (without any intervention within 1 week). The granule of the compound preparation example 1 of the invention is taken 1 dose per day, 3 times in the morning, at noon and evening, with boiled water for 8 weeks. The symptoms are obviously improved, no special discomfort exists, and after 6 months, the electronic gastroscopy is rechecked: chronic atrophic gastritis (type C-1) with bile reflux, Hp (-). Biopsy of gastric antrum pathological tissue: "antral stomach" mucosa mild chronic atrophic inflammation with moderate enteronitis (chronic inflammation + +, activity + +, atrophy +, enteronitis + +).

Case 4, Guanzhi, female, age 41, farmer. The patient is admitted to the hospital by taking 'repeated constipation for more than 5 years'. The current medical history: the reason is that the excrement period is prolonged due to no obvious inducement in 5 years before admission, and the excrement is dry and hard to discharge in one line in 2-5 days without systemic treatment. The lower symptoms of the two days: dry stool, difficult discharge, abdominal pain, abdominal distension, nausea, vomiting, acid regurgitation, belching, foul breath, dry mouth, bitter taste, odor, preference for drinking, yellow urine, anorexia, insomnia, red tongue with yellow and greasy coating, and slippery and wiry pulse. Auxiliary inspection: electronic gastroscopy: chronic atrophic gastritis (type C-2), Hp (-). Biopsy of gastric antrum pathological tissue: "antrum of stomach" full-thickness antral mucosa moderate chronic atrophic inflammation with mild enterolysis (chronic inflammation + +, motility + +, atrophy + +, enterolysis +). The granule of the compound preparation example 1 of the invention is taken 1 dose per day, 3 times in the morning, at noon and evening, with boiled water for 8 weeks. The symptoms are obviously improved, no special discomfort exists, and after 10 months, the electronic gastroscopy is rechecked: chronic atrophic gastritis (type C-1), Hp (-). Biopsy of gastric antrum pathological tissue: "antrum" full antral mucosa mild non-atrophic inflammation (chronic inflammation +).

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features. The examples only express a few embodiments of the invention, and the description is more specific and detailed, but not understood as the limitation of the invention patent scope. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. The traditional Chinese medicine compound preparation for treating spleen deficiency and liver depression qi stagnation type chronic atrophic gastritis is characterized in that active ingredients of the traditional Chinese medicine compound preparation are prepared from the following raw material medicines in parts by weight: 10-20 parts of bran-fried bighead atractylodes rhizome, 3-9 parts of rice-scented mature, 6-15 parts of bupleurum chinense, 9-20 parts of radix paeoniae alba, 6-15 parts of fried perilla fruit, 25-35 parts of blighted wheat, 3-9 parts of flos mume, 6-15 parts of vinegar rhizoma corydalis and 9-15 parts of cortex magnoliae officinalis.

2. The compound traditional Chinese medicine preparation for treating spleen deficiency and liver depression and qi stagnation type chronic atrophic gastritis as claimed in claim 1, is characterized in that the active ingredients of the compound traditional Chinese medicine preparation are prepared from the following traditional Chinese medicine raw materials in parts by weight: 15 parts of bran-fried bighead atractylodes rhizome, 6 parts of rice-scented tangerine peel, 9 parts of bupleurum chinense, 15 parts of radix paeoniae alba, 10 parts of fried perilla fruit, 30 parts of light wheat, 6 parts of flos mume, 9 parts of vinegar rhizoma corydalis and 10 parts of cortex magnoliae officinalis.

3. The compound traditional Chinese medicine preparation for treating spleen deficiency and liver depression and qi stagnation type chronic atrophic gastritis as claimed in claim 1, is characterized in that the active ingredients of the compound traditional Chinese medicine preparation are prepared from the following traditional Chinese medicine raw materials in parts by weight: 10 parts of bran-fried bighead atractylodes rhizome, 3 parts of rice-scented tangerine orange, 6 parts of bupleurum chinense, 9 parts of radix paeoniae alba, 6 parts of fried perilla fruit, 25 parts of blighted wheat, 3 parts of flos mume, 6 parts of vinegar rhizoma corydalis and 9 parts of cortex magnoliae officinalis.

4. The compound traditional Chinese medicine preparation for treating spleen deficiency and liver depression and qi stagnation type chronic atrophic gastritis as claimed in claim 1, is characterized in that the active ingredients of the compound traditional Chinese medicine preparation are prepared from the following traditional Chinese medicine raw materials in parts by weight: 20 parts of bran-fried bighead atractylodes rhizome, 9 parts of rice-scented tangerine peel, 15 parts of bupleurum chinense, 20 parts of radix paeoniae alba, 15 parts of fried perilla fruit, 35 parts of blighted wheat, 9 parts of flos mume, 15 parts of vinegar rhizoma corydalis and 15 parts of cortex magnoliae officinalis.

5. A preparation method of the traditional Chinese medicine compound preparation for treating spleen deficiency and liver depression qi stagnation type chronic atrophic gastritis of any one of claims 1 to 4, which is characterized by comprising the following steps:

(1) taking radix Paeoniae alba, Oryza sativa, fructus Tritici Levis, and flos Pruni mume, adding 10 times of water, decocting by conventional method, extracting for 3 times, each for 1 hr, mixing extractive solutions, filtering, concentrating at below 60 deg.C to obtain extract with relative density of 1.10-1.20 at 60 deg.C;

(2) collecting Atractylodis rhizoma parched with bran, bupleuri radix, rhizoma corydalis processed with vinegar, and cortex Magnolia officinalis, adding 8 times of 75% ethanol, placing in a multifunctional extraction tank, reflux-extracting for 3 times (1 hr each time), mixing the ethanol extractive solutions, recovering ethanol, concentrating the extract at below 60 deg.C to obtain extract with relative density of 1.10-1.20 at 60 deg.C;

(3) adding 8 times of water into parched fructus Perillae, placing in a multifunctional extraction tank, boiling, reflux-extracting for 6 hr to obtain volatile oil;