Traditional Chinese medicine composition for treating digestive tract diseases as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating digestive tract diseases and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine preparation. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 80 to 180 parts of herba patriniae, 80 to 180 parts of rhizoma atractylodis macrocephalae, 50 to 150 parts of poria cocos, 30 to 100 parts of fructus amomi, 70 to 170 parts of radix paeoniae alba, 30 to 100 parts of radix aucklandiae, 80 to 180 parts of herba hedyotidis diffusae, 70 to 170 parts of caulis sargentodoxae, 250 to 350 parts of Chinese fevervine herb, 30 to 80 parts of rhizoma curcumae, 40 to 90 parts of herba rhodiolae, 40 to 90 parts of endothelium corneum gigeriae galli, 10 to 60 parts of rhizoma coptidis, 20 to 70 parts of semen arecae, 20 to 70 parts of rhizoma corydalis, 70 to 170 parts of fructus hordei germinatus, 20 to 70 parts of rhizoma zingiberis, the traditional Chinese medicine composition has a good treatment effect on chronic gastritis, the chronic gastritis is not prone to relapse after treatment, no side effect exists, and the problems existing in the prior art can be effectively solved.

Description

Technical Field

[0001] The invention belongs to the technical field of Chinese medicine preparation, and specifically relates to a Chinese medicine composition for treating digestive tract diseases, and a preparation method and application thereof. Background Art

[0002] Gastritis is divided into acute gastritis and chronic gastritis. Acute gastritis is an acute inflammation of the gastric mucosa caused by various pathogenic factors (ethanol, infection, eating irritating food, eating contaminated food, certain drugs, severe trauma, surgery, shock, extreme mental stress, etc.). Pathological examination of the gastric mucosa shows a large number of inflammatory cells (neutrophils) infiltrating. The main clinical symptoms are stomach pain, gastric bleeding, loss of appetite, nausea, vomiting, etc. In severe cases, symptoms such as vomiting blood, blood in the stool, hypovolemic shock, acidosis, and arrhythmia may occur. If not treated in time, it may lead to the development of ulcers and gastric cancer.

[0003] Chronic gastritis is an inflammatory response of the gastric mucosa to various stimuli in the stomach. Infection with Helicobacter pylori (Hp), improper diet, emotional influence, drug stimulation and other factors can all lead to the onset of chronic gastritis, among which infection with Helicobacter pylori is particularly important. Patients with chronic gastritis do not have specific symptoms. Some patients may show symptoms of indigestion, such as fullness or pain in the upper abdomen, loss of appetite, belching, nausea and other discomfort symptoms; while some patients often have no obvious discomfort symptoms. Moreover, chronic gastritis has a development trend of "non-atrophic gastritis → atrophic gastritis → atrophic gastritis with intestinal metaplasia → atrophic gastritis with atypical hyperplasia → gastric adenocarcinoma".

[0004] At present, Western medicine treatment for chronic gastritis generally uses drugs such as H2 receptor antagonists and proton pump inhibitors, and auxiliary use of year-end protective agents to promote gastric mucosal repair; however, most Western medicines have serious side effects and are prone to relapse after treatment. Summary of the invention

[0005] In view of the above-mentioned deficiencies in the prior art, the present invention provides a Chinese medicine composition for treating digestive tract diseases, a preparation method and an application thereof. The Chinese medicine composition has a good therapeutic effect on chronic gastritis, is not prone to recurrence after treatment, has no side effects, and can effectively solve the problems existing in the prior art.

[0006] To achieve the above purpose, the technical solution adopted by the present invention to solve the technical problem is:

[0007] A traditional Chinese medicine composition for treating digestive tract diseases comprises the following components in parts by weight: 80-180 parts of Patrinia sibiricum, 80-180 parts of Atractylodes macrocephala, 50-150 parts of Poria cocos, 30-100 parts of Amomum villosum, 70-170 parts of White Peony Root, 30-100 parts of Costusroot, 80-180 parts of Hedyotis diffusa, 70-170 parts of Sargentodoxae, 250-350 parts of Caulis Patriniae, 30-80 parts of Curcuma, 40-90 parts of Rhodiola rosea, 40-90 parts of Gallus gallifolia, 10-60 parts of Coptis chinensis, 20-70 parts of Areca catechu, 20-70 parts of Corydalis yanhusuo, 70-170 parts of malt, 20-70 parts of dried ginger, 80-180 parts of Morinda officinalis and 10-60 parts of Licorice.

[0008] Further, the invention comprises the following components in parts by weight: 130-160 parts of northern Patrinia sauce, 130-160 parts of Atractylodes macrocephala, 90-130 parts of Poria cocos, 50-70 parts of Amomum villosum, 110-140 parts of white peony root, 50-70 parts of costusroot, 130-160 parts of Hedyotis diffusa, 110-140 parts of Sargentodoxa chinensis, 280-310 parts of Caulis Patriniae, 50-60 parts of Curcuma, 55-75 parts of Rhodiola rosea, 55-75 parts of Gallus gallus domesticus, 30-45 parts of Coptis chinensis, 45-55 parts of Areca catechu, 45-55 parts of Corydalis yanhusuo, 110-140 parts of malt, 45-55 parts of dried ginger, 130-160 parts of Morinda officinalis, and 30-45 parts of Licorice.

[0009] Further, the invention comprises the following components in parts by weight: 160 parts of Patrinia japonica, 160 parts of Atractylodes macrocephala, 90 parts of Poria cocos, 60 parts of Amomum villosum, 120 parts of White Peony Root, 70 parts of Costusroot, 130 parts of Oldenlandia diffusa, 120 parts of Sargentodoxa chinensis, 290 parts of Caulis Patriniae, 55 parts of Curcuma zedoaria, 65 parts of Rhodiola rosea, 75 parts of Gallus gallus domesticus, 35 parts of Coptis chinensis, 55 parts of Areca catechu, 55 parts of Corydalis yanhusuo, 120 parts of malt, 55 parts of dried ginger, 160 parts of Morinda officinalis, and 30 parts of Licorice.

[0010] Further, the invention comprises the following components in parts by weight: 130 parts of Patrinia japonica, 130 parts of Atractylodes macrocephala, 130 parts of Poria cocos, 70 parts of Amomum villosum, 140 parts of White Peony Root, 60 parts of Costusroot, 160 parts of Oldenlandia diffusa, 140 parts of Sargentodoxa chinensis, 300 parts of Caulis Patriniae, 60 parts of Curcuma zedoaria, 75 parts of Rhodiola rosea, 55 parts of Gallus gallifolia, 45 parts of Coptis chinensis, 50 parts of Areca catechu, 45 parts of Corydalis yanhusuo, 140 parts of malt, 45 parts of dried ginger, 150 parts of Morinda officinalis, and 45 parts of Licorice.

[0011] Furthermore, Curcuma zedoaria is vinegared Curcuma zedoaria; Corydalis yanhusuo is vinegared Corydalis yanhusuo; Morinda officinalis is salted Morinda officinalis; and Licorice root is roasted Licorice root.

[0012] The preparation method of the above-mentioned Chinese medicine composition for treating digestive tract diseases includes the steps of crushing the raw materials and then mixing them; or mixing the raw materials or extracting them separately to obtain an extract; or further refining and purifying the extract to obtain the effective ingredient; or adding pharmaceutically acceptable excipients to the extract / effective ingredient.

[0013] Furthermore, the prepared dosage form is one of pills, granules, capsules, powders, mixtures or oral liquids.

[0014] Furthermore, the specific preparation method is as follows: the above 19 ingredients, including northern Patrinia, Atractylodes, Amomum, White Peony, Costusroot, Sargentodoxae, Millettia, Gallus gallus domestica, Coptis chinensis slices, and vinegar Corydalis, are ground into fine powder, sieved, mixed, and set aside; the remaining nine ingredients, including Poria, Hedyotis diffusa, vinegar Curcuma, Rhodiola rosea, Areca nut, malt, dried ginger slices, salt Morinda officinalis, and roasted Licorice, are added with water, decocted, filtered, and the filtrate is concentrated to an extract with a relative density of 1.2-1.30, mixed with the above fine powder, dried, ground into fine powder, made into pills, and dried to obtain the extract.

[0015] Application of the above-mentioned Chinese medicine composition in the preparation of medicines for digestive tract diseases.

[0016] The beneficial effects produced by the present invention are:

[0017] 1. In the composition, the Radix Patriniae has the effects of clearing away heat, detoxifying and removing dampness, and the Rhizoma Atractylodis Macrocephalae has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis. The two are the main drugs, playing the effects of clearing away heat, removing dampness, replenishing qi and strengthening the spleen;

[0018] Poria has the effects of promoting diuresis and eliminating dampness, strengthening the spleen and tonifying the middle, roasted licorice has the effects of tonifying the spleen and stomach, invigorating qi, removing dampness and tonifying the spleen, Amomum villosum has the effects of removing dampness and appetizing, warming the spleen and stopping diarrhea, white peony has the effect of softening the liver and relieving pain, costus root has the effects of promoting qi and relieving pain, strengthening the stomach and digestion, and warming the middle. The above-mentioned drugs are all ministerial drugs, which work together to tonify the spleen and eliminate dampness, promote qi and stop pain, and assist in strengthening the effects of the monarch drug;

[0019] White flower snake tongue grass has the effects of clearing away heat, detoxifying and promoting dampness, large sedge vine has the effects of clearing heat, detoxifying, dispelling wind and dampness, millet feces vine has the effects of dispelling wind and dampness, digesting food and resolving accumulation, coptis chinensis has the effect of clearing heat and drying dampness, dried ginger has the effect of warming the middle and dispersing cold, and the above medicines used together can assist and strengthen the effect of removing dampness of the monarch and minister medicines; malt has the effect of digesting food and strengthening the stomach, betel nut has the effect of eliminating accumulation, promoting qi and promoting diuresis, chicken gizzard lining has the effect of digesting food and strengthening the stomach, and the above medicines used together can play the effects of clearing heat, strengthening the spleen, removing dampness, promoting qi and eliminating accumulation, and assist and strengthen the effect of the monarch medicine; Corydalis has the effect of promoting qi and relieving pain, Curcuma has the effect of breaking blood, promoting qi, eliminating accumulation and relieving pain, It has the effect of invigorating qi and activating blood circulation. The above medicines are used together to play the effect of activating blood circulation, promoting qi and relieving pain. On the basis of assisting the main medicine to strengthen the effect of promoting qi, it also has the effect of relieving stomach discomfort caused by gastritis; the above medicines are collectively adjuvant medicines; this prescription focuses on removing dampness, promoting qi and activating blood circulation. In order to prevent excessive cutting, Morinda officinalis, which can replenish kidney yang, is used for balance so as to adjust the body's functions; the above medicines in this prescription work together to play the effects of clearing away heat and dampness, harmonizing the middle and strengthening the spleen, regulating qi and relieving pain. It has a good therapeutic effect on digestive tract diseases such as damp-heat obstruction in the middle, acute and chronic gastritis due to spleen dysfunction, and can effectively relieve symptoms such as epigastric fullness, epigastric pain, nausea and vomiting, poor appetite and poor appetite. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 The figures are actual pictures of gastric mucosa of mice in different groups; A is the blank group; B is the model group; C is the positive group; D is the low-dose group of the drug in Example 3; E is the medium-dose group of the drug in Example 3; and F is the high-dose group of the drug in Example 3. DETAILED DESCRIPTION

[0021] In order to make the purpose, technical scheme and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention, that is, the embodiments described are only part of the embodiments of the present invention, rather than all of the embodiments.

[0022] Therefore, the following detailed description of the embodiments of the present invention is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without making creative work are within the scope of protection of the present invention.

[0023] It should be noted that relational terms such as "first" and "second" are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprises" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "comprises a ..." does not exclude the existence of other identical elements in the process, method, article or device including the element.

[0024] The features and performance of the present invention are further described in detail below in conjunction with the embodiments and drawings.

[0025] The features and performance of the present invention are further described in detail below in conjunction with the embodiments.

[0026] Example 1

[0027] A traditional Chinese medicine composition for treating digestive tract diseases is prepared from the following components in parts by weight: 180g of Patrinia japonica, 180g of Atractylodes macrocephala, 150g of Poria cocos, 100g of Amomum villosum, 70g of White Peony Root, 100g of Costusroot, 80g of Hedyotis diffusa, 70g of Sargentodoxa chinensis, 350g of Caulis datura, 80g of Curcuma zedoaria, 40g of Rhodiola rosea, 90g of Gallus gallus domestica, 10g of Coptis chinensis, 20g of Areca catechu, 70g of Corydalis yanhusuo, 70g of Malt, 20g of Dry Ginger, 180g of Morinda officinalis, and 10g of Licorice.

[0028] The treatment method of the above Chinese medicine composition includes: the above 19 ingredients, including northern Patrinia, Atractylodes, Amomum, White Peony, Costusroot, Sarsopus, Millettia, Gallus gallus domestica, Coptis slices, and vinegar Corydalis, are ground into fine powder, sieved, mixed, and set aside; the remaining nine ingredients, including Poria, Hedyotis diffusa, vinegar Curcuma, Rhodiola, Areca, malt, dried ginger slices, salt Morinda officinalis, and roasted Licorice, are added with water, decocted, filtered, and the filtrate is concentrated to a relative density of 1.2 extract, mixed with the above fine powder, dried, ground into fine powder, made into pills, and dried to obtain.

[0029] Example 2

[0030] A traditional Chinese medicine composition for treating digestive tract diseases is prepared from the following components in parts by weight: 80g of Patrinia japonica, 160g of Atractylodes macrocephala, 50g of Poria cocos, 80g of Amomum villosum, 170g of White Peony Root, 90g of Costusroot, 180g of Hedyotis diffusa, 170g of Sargentodoxae, 250g of Caulis Terrestris, 30g of Curcuma, 90g of Rhodiola rosea, 40g of Gallus gallus domestica, 60g of Coptis chinensis, 70g of Areca catechu, 20g of Corydalis yanhusuo, 170g of Malt, 70g of Dry Ginger, 80g of Morinda officinalis, and 60g of Licorice.

[0031] The treatment method of the above Chinese medicine composition includes: the above 19 ingredients, including northern Patrinia, Atractylodes, Amomum, White Peony, Costusroot, Sarsopus, Millettia, Gallus gallus domestica, Coptis slices, and vinegar Corydalis, are ground into fine powder, sieved, mixed, and set aside; the remaining nine ingredients, including Poria, Hedyotis diffusa, vinegar Curcuma, Rhodiola, Areca, malt, dried ginger slices, salt Morinda officinalis, and roasted Licorice, are added with water, decocted, filtered, and the filtrate is concentrated to an extract with a relative density of 1.30, mixed with the above fine powder, dried, ground into fine powder, made into pills, and dried to obtain.

[0032] Example 3

[0033] A traditional Chinese medicine composition for treating digestive tract diseases is prepared from the following components in parts by weight: 160 parts of Patrinia scabra, 160 parts of Atractylodes macrocephala, 90 parts of Poria cocos, 60 parts of Amomum villosum, 120 parts of White Peony Root, 70 parts of Costusroot, 130 parts of Oldenlandia diffusa, 120 parts of Sargentodoxa chinensis, 290 parts of Caulis Patriniae, 55 parts of Curcuma, 65 parts of Rhodiola rosea, 75 parts of Gallus gallifolia, 35 parts of Coptis chinensis, 55 parts of Areca catechu, 55 parts of Corydalis yanhusuo, 120 parts of malt, 55 parts of dried ginger, 160 parts of Morinda officinalis, and 30 parts of Licorice.

[0034] The treatment method of the above Chinese medicine composition includes: the above 19 ingredients, including northern Patrinia, Atractylodes, Amomum, White Peony, Costusroot, Sarsopus, Millettia, Gallus gallus domestica, Coptis slices, and vinegar Corydalis, are ground into fine powder, sieved, mixed, and set aside; the remaining nine ingredients, including Poria, Hedyotis diffusa, vinegar Curcuma, Rhodiola, Areca, malt, dried ginger slices, salt Morinda officinalis, and roasted Licorice, are added with water, decocted, filtered, and the filtrate is concentrated to an extract with a relative density of 1.30, mixed with the above fine powder, dried, ground into fine powder, made into pills, and dried to obtain.

[0035] Example 4

[0036] A traditional Chinese medicine composition for treating digestive tract diseases is prepared from the following components in parts by weight: 130 parts of Patrinia scabra, 130 parts of Atractylodes macrocephala, 130 parts of Poria cocos, 70 parts of Amomum villosum, 140 parts of White Peony Root, 60 parts of Costusroot, 160 parts of Hedyotis diffusa, 140 parts of Sargentodoxa chinensis, 300 parts of Caulis Terrestris, 60 parts of Curcuma zedoaria, 75 parts of Rhodiola rosea, 55 parts of Gallus gallifolia, 45 parts of Coptis chinensis, 50 parts of Areca catechu, 45 parts of Corydalis yanhusuo, 140 parts of malt, 45 parts of dried ginger, 150 parts of Morinda officinalis, and 45 parts of Licorice.

[0037] The treatment method of the above Chinese medicine composition includes: the above 19 ingredients, including northern Patrinia, Atractylodes, Amomum, White Peony, Costusroot, Sarsopus, Millettia, Gallus gallus domestica, Coptis slices, and vinegar Corydalis, are ground into fine powder, sieved, mixed, and set aside; the remaining nine ingredients, including Poria, Hedyotis diffusa, vinegar Curcuma, Rhodiola, Areca, malt, dried ginger slices, salt Morinda officinalis, and roasted Licorice, are added with water, decocted, filtered, and the filtrate is concentrated to a relative density of 1.2 extract, mixed with the above fine powder, dried, ground into fine powder, made into pills, and dried to obtain.

[0038] Example 5

[0039] A traditional Chinese medicine composition for treating digestive tract diseases is prepared from the following components in parts by weight: 140 parts of Patrinia scabra, 160 parts of Atractylodes macrocephala, 120 parts of Poria cocos, 60 parts of Amomum villosum, 110 parts of White Peony Root, 70 parts of Aucklandia lappa, 160 parts of Hedyotis diffusa, 130 parts of Sargentodoxa chinensis, 300 parts of Caulis daturae, 55 parts of Curcuma zedoaria, 60 parts of Rhodiola rosea, 60 parts of Gallus gallifolia, 40 parts of Coptis chinensis, 50 parts of Areca catechu, 50 parts of Corydalis yanhusuo, 130 parts of malt, 50 parts of dried ginger, 150 parts of Morinda officinalis, and 35 parts of Licorice.

[0040] The treatment method of the above traditional Chinese medicine composition comprises: the above 19 ingredients, including northern Patrinia, Atractylodes macrocephala, Amomum villosum, White Peony Root, Costus Root, Sarsopus Root, Millettia Sinensis, Gallus Gallus Ternifolia, Coptis chinensis slices, and vinegar Corydalis yanhusuo, are ground into fine powder, sieved, mixed, and set aside; the remaining nine ingredients, including Poria, Hedyotis diffusa, vinegar Curcuma, Rhodiola rosea, Areca nut, malt, dried ginger slices, salt Morinda officinalis, and roasted Licorice, are added with water, decocted, filtered, and the filtrate is concentrated to an extract with a relative density of 1.2-1.30, mixed with the above fine powder, dried, ground into fine powder, made into pills, and dried to obtain the extract.

[0041] Comparative Example 1

[0042] A traditional Chinese medicine composition for treating digestive tract diseases is prepared from the following components in parts by weight: 160 parts of Atractylodes macrocephala, 90 parts of Poria cocos, 60 parts of Amomum villosum, 120 parts of White Peony Root, 70 parts of Aucklandia lappa, 290 parts of Caulis Terrestris, 55 parts of Curcuma zedoaria, 65 parts of Rhodiola rosea, 75 parts of Gallus gallifolia, 55 parts of Areca catechu, 55 parts of Corydalis yanhusuo, 120 parts of malt, 55 parts of dried ginger, 160 parts of Morinda officinalis, and 30 parts of Licorice.

[0043] The treatment method of the above Chinese medicine composition includes: the above 19 ingredients, including Atractylodes macrocephala, Amomum villosum, White Peony Root, Costusroot, Croton Root, Gallus Gallus Gallus Ternifolia, and Vinegar Corydalis, are ground into fine powder, sieved, mixed and set aside; the remaining nine ingredients, including Poria cocos, Vinegar Curcuma, Rhodiola rosea, Areca nut, malt, dried ginger slices, Salt Morinda officinalis and Roasted Licorice, are added with water, decocted, filtered, and the filtrate is concentrated to an extract with a relative density of 1.30, mixed with the above fine powder, dried, ground into fine powder, made into pills, and dried to obtain the extract.

[0044] Comparative Example 2

[0045] A traditional Chinese medicine composition for treating digestive tract diseases is prepared from the following components in parts by weight: 160 parts of Patrinia japonica, 160 parts of Atractylodes lancea, 90 parts of Coix seeds, 60 parts of Amomum villosum, 120 parts of Paeonia lactiflora, 70 parts of Aucklandia lappa, 130 parts of Hedyotis diffusa, 120 parts of Sargentodoxa chinensis, 290 parts of Cyperus rotundus, 55 parts of Curcuma zedoaria, 65 parts of Rhodiola rosea, 75 parts of Gallus gallifolia, 35 parts of Coptis chinensis, 55 parts of Areca catechu, 55 parts of Corydalis yanhusuo, 120 parts of malt, 55 parts of dried ginger, 160 parts of Morinda officinalis, and 30 parts of Licorice.

[0046] The treatment method of the above Chinese medicine composition includes: the above 19 ingredients, including northern Patrinia, Atractylodes, Amomum, Red Peony Root, Costus Root, Sargentodoxae, Cyperus Root, Chicken Gizzard Stone, Coptis chinensis slices, and Vinegar Corydalis, are ground into fine powder, sieved, mixed, and set aside; the remaining nine ingredients, including Coix seeds, Hedyotis diffusa, Vinegar Curcuma, Rhodiola rosea, Areca nut, malt, dried ginger slices, salt Morinda officinalis, and roasted Licorice, are added with water, decocted, filtered, and the filtrate is concentrated to an extract with a relative density of 1.30, mixed with the above fine powder, dried, ground into fine powder, made into pills, and dried to obtain.

[0047] Test example

[0048] 1. Clinical Cases

[0049] 1. General information: 60 patients with acute gastritis, 60 patients with chronic non-atrophic gastritis and 60 patients with chronic atrophic gastritis came to the hospital for treatment, aged 18-65 years old, with an average age of 46 years old;

[0050] 2. Diagnostic criteria

[0051] 2.1 Western medicine diagnostic criteria for acute gastritis

[0052] According to the Internal Medicine:

[0053] (1) There is a history of eating chemical or physical irritants or foods containing microorganisms or bacterial toxins, and the disease often develops within hours.

[0054] (2) Symptoms include upper abdominal discomfort, pain, nausea, and vomiting. Severe cases may include fever, dehydration, acidosis, and even shock. Erosive gastritis often causes upper gastrointestinal bleeding.

[0055] (3) There is abdominal or periumbilical tenderness.

[0056] (4) Gastroscopy may reveal congestion, edema, increased secretions, bleeding, erosion, or superficial ulcers of the gastric mucosa.

[0057] 2.2 Western medicine diagnostic criteria for chronic gastritis

[0058] Chronic inflammatory diseases of the gastric mucosa are called chronic gastritis (CG). It is a disease caused by different reasons and is common and frequent in clinical practice. Non-atrophic gastritis, atrophic gastritis and special types of gastritis are classified according to the mucosal conditions under gastroscopy. The three are collectively referred to as chronic gastritis.

[0059] Formulated with reference to the "Expert Consensus on the Diagnosis and Treatment of Chronic Gastritis in Traditional Chinese Medicine (2017)"

[0060] (1) Endoscopic diagnosis

[0061] ① Non-atrophic gastritis: Endoscopic findings include mucosal erythema, mucosal hemorrhage spots or plaques, and mucosal roughness with or without edema, congestion and exudation;

[0062] ② Atrophic gastritis: Endoscopically, the mucosa is red and white, with the white phase being the main phase. The folds become flat or even disappear, and some mucosal blood vessels are exposed, which may be accompanied by mucosal granules or nodules.

[0063] ③If accompanied by bile reflux, erosion, intramucosal bleeding, etc., it is atrophic gastritis or non-atrophic gastritis accompanied by bile reflux, erosion, intramucosal bleeding, etc.

[0064] (2) Pathological diagnosis

[0065] If gastric mucosal biopsy shows atrophy of intrinsic glands (including metaplastic atrophy and non-metaplastic atrophy), it can be diagnosed as atrophic gastritis. If there are no intrinsic glands, it can be diagnosed as non-atrophic gastritis.

[0066] 2.3 TCM diagnostic criteria

[0067] With reference to the clinical treatment guidelines in the Consensus on the Diagnosis and Treatment of Chronic Gastritis with Integrated Traditional Chinese and Western Medicine, Traditional Chinese Medicine Internal Medicine (11th Edition), and Clinical Guidelines for New Chinese Medicines (2002 Edition), the following contents are formulated for the syndromes of damp-heat obstruction in the middle and spleen dysfunction:

[0068] Main symptoms: epigastric pain, epigastric distension, and poor appetite.

[0069] Secondary symptoms: nausea and vomiting, thirst without desire to drink, yellow urine, and constipation.

[0070] Tongue and pulse: red tongue, yellow and greasy coating, slippery and rapid pulse.

[0071] The diagnosis can be made based on 2 or more main symptoms and 2 or more secondary symptoms combined with tongue and pulse.

[0072] 2.4 Quantitative Standards for TCM Syndrome Symptom Scoring

[0073] Table 1: Quantitative criteria for main symptom scores

[0074]

[0075] Table 2: Quantitative criteria for sub-symptom scores

[0076] secondary symptoms Light (1 point) Medium (2 points) Heavy (3 points) Nausea and vomiting Occasionally nausea Nausea and occasional vomiting Frequent nausea and sometimes vomiting Thirst but no desire to drink Occasionally feel thirsty but don't want to drink Sometimes you feel thirsty but don't want to drink Feeling thirsty all day long but not wanting to drink Yellow urine Slightly yellow urine Yellow and scanty urine Dark yellow urine, with a significant decrease in urine volume Stool Slight bowel movement Difficult bowel movement Stool is difficult to pass

[0077] 3. Criteria for inclusion of cases

[0078] (1) Those who meet the Western medical diagnostic criteria for acute or chronic gastritis.

[0079] (2) Patients with damp-heat obstruction in the middle part of the body and spleen dysfunction.

[0080] (3) Age range: 18 to 70 years old.

[0081] 4. Exclusion criteria

[0082] (1) Those with a history of allergies.

[0083] (2) Patients with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system diseases, and mental illness.

[0084] (3) Patients who have used other similar therapeutic drugs in the past two weeks.

[0085] (4) Pregnant or lactating women, or those with abnormal liver function (ALT / AST ≥ 60U / L).

[0086] 5. Treatment methods

[0087] The different types of patients were randomly divided into 3 groups, each with 20 patients. The patients in each group were respectively given the Chinese medicine composition of Example 3 and Comparative Examples 1-2, three times a day, 6 g each time (equivalent to 11 g of crude drug), for 2 consecutive weeks, and the symptom changes of the patients before and after treatment were observed.

[0088] 6. Efficacy evaluation criteria

[0089] Refer to "Guidelines for Clinical Research of New Chinese Medicines" (2002 edition)

[0090] Clinical control: TCM clinical symptoms and signs disappear or basically disappear, and syndrome scores decrease by ≥95%.

[0091] Markedly effective: Clinical symptoms and signs of TCM were significantly improved, and the syndrome score was reduced by ≥70% and <95%.

[0092] Effective: Clinical symptoms and signs of TCM were improved, and the syndrome score was reduced by 30%, <70%.

[0093] Ineffective: There is no significant improvement in TCM clinical symptoms and signs, or they may even get worse, and the syndrome score is reduced by less than 30%.

[0094] Calculation formula:

[0095] Clinical symptom score reduction rate = (symptom and sign score before treatment - symptom and sign score after treatment) / symptom and sign score before treatment × 100%.

[0096] 7. Results

[0097] Table 3: Acute gastritis results

[0098] Clinical control (example) Significantly effective (example) Valid (Example) Invalid (Example) Total effective rate (%) Example 3 4 8 7 1 95％ Comparative Example 1 0 4 4 12 40％ Comparative Example 2 0 3 6 11 45％

[0099] Table 4: Results of chronic non-atrophic gastritis

[0100] Clinical control (example) Significantly effective (example) Valid (Example) Invalid (Example) Total effective rate (%) Example 3 3 7 8 2 90％ Comparative Example 1 0 2 6 12 40％ Comparative Example 2 0 4 5 11 45％

[0101] Table 5: Results of chronic atrophic gastritis

[0102] Clinical control (example) Significantly effective (example) Valid (Example) Invalid (Example) Total effective rate (%) Example 3 4 7 7 2 90％ Comparative Example 1 0 3 4 13 35％ Comparative Example 2 0 3 5 12 40％

[0103] It can be seen from the data in Tables 3-5 that the drugs in Example 3 have good therapeutic effects on acute gastritis, chronic non-atrophic gastritis and chronic atrophic gastritis, while the application of Patrinia scabra, Hedyotis diffusa, Sargentodoxae and Coptis chinensis is cancelled in Comparative Example 1, and the application of Atractylodes macrocephala, Poria cocos, White Peony Root and Cistanche deserticola is cancelled in Comparative Example 2, and the application of Atractylodes macrocephala, Coix lachryma-jobi, Red Peony Root and Cyperus rotundus is added. After the composition is adjusted in Comparative Examples 1 and 2, the therapeutic effect of the drug is significantly deteriorated. It can be seen that there is an interaction relationship between different drugs in the composition of the present application, so that the composition has a good therapeutic effect on gastric diseases.

[0104] 2. Animal Experiments

[0105] Based on the above results, the drug in Example 3 was subjected to animal experiments, and the specific operation was as follows:

[0106] 1. Experimental Materials

[0107] (1) Test drug: the drug in Example 3

[0108] (2) Positive drugs: Metoclopramide tablets, national medicine standard H14021025, batch number: 230201, specification: 0.1 g (content 5 mg) / tablet, produced by Shanxi Fenhe Pharmaceutical Co., Ltd.;

[0109] (3) Ranitidine hydrochloride capsules, national medicine standard H44021173, batch number: 230907, specification: 0.3 g (content 0.15 g) / capsule, produced by Guangdong Hengjian Pharmaceutical Co., Ltd.

[0110] (3) Animals

[0111] KM mice, 50, ♀ Half each, weight 18-22g, provided by the Experimental Animal Center of Xi'an Jiaotong University, certificate number: N O 3408, license number: SCXK(Shaanxi)2023-002.

[0112] KM mice, 60, ♀ Half each, weight 18-22g, provided by the Experimental Animal Center of Xi'an Jiaotong University, certificate number: N O 3569, license number: SCXK(Shaanxi)2023-002.

[0113] 2. Drug configuration

[0114] Calculation of dosage in Example 3: It is known to those skilled in the art that the equivalent dose ratio of the body surface area of ​​humans and mice is 1:9.1, so the clinical equivalent dose of mice after conversion is 2.73 g / kg (0.3 g / kg×9.1). This dose is used as the medium dose, and the medium dose is doubled and halved respectively as the high dose and the low dose. Therefore, the high, medium and low doses of mice administered by oral administration are 5.46, 2.73 and 1.37 g / kg, respectively, equivalent to 8.68, 4.34 and 2.18 g / kg of crude drugs, which are equivalent to 18.2, 9.1 and 4.55 times of the clinical dose, respectively. Since the administration volume is 20 ml / kg, the high, medium and low administration concentrations are 28%, 14% and 7%, respectively (administration concentration = administration dose / administration volume);

[0115] The clinical daily dosage of metoclopramide tablets is 600 mg (100 mg / tablet × 2 tablets × 3 times), the same below. Based on a human body weight of 60 kg, the human dosage is 10 mg / kg (600 mg / 60 kg). Based on the equivalent dose ratio of human and mouse body surface area of ​​1:9.1, the clinical equivalent dose for mice is 91 mg / kg. Since the administration volume is 20 ml / kg, the administration concentration of metoclopramide tablets is 4.55 mg / ml (91 mg / kg ÷ 20 ml / kg).

[0116] The clinical daily dosage of ranitidine hydrochloride is 600 mg (300 mg × 1 tablet × 2 times). Based on the human body weight of 60 kg, the human dosage is 10 mg / kg (600 mg / 60 kg). Based on the equivalent dose ratio of human and mouse body surface area of ​​1:9.1, the clinical equivalent dose of mice is 91 mg / kg. Since the administration volume is 20 ml / kg, the administration concentration of ranitidine hydrochloride is 4.55 mg / ml (91 mg / kg ÷ 20 ml / kg).

[0117] Preparation of nutritional semi-solid paste: Take 15g of feed, grind it into powder, add water to 100mL, add 5g of activated carbon and stir evenly, and prepare 100mL of a mixture of nutritional paste and activated carbon at 1.125g / mL.

[0118] 3. Experimental methods

[0119] 3.1 Effects on gastric emptying and small intestinal propulsion in mice

[0120] (1) Grouping and dosing: 50 rats were divided into The mice weighing 18-22 g were divided into 5 groups according to their weight, with 10 mice in each group. Each half, blank group, positive group, high, medium and low drug groups in Example 3. Each group was gavaged with 20ml / kg volume, the blank group was gavaged with pure water, the positive group was gavaged with metoclopramide 91mg / kg, and the high, medium and low drug groups in Example 3 were gavaged with 5.46g / kg, 2.73g / kg and 1.37g / kg. Once a day, for a total of 7 days.

[0121] (2) Modeling

[0122] After administration on the 7th day, the mice were fasted for 12 hours but not water. On the 8th day, each mouse was gavaged with 0.8 ml of nutrient semisolid paste and killed by cervical dislocation 20 minutes later.

[0123] (3) Dissection and measurement

[0124] Open the abdominal cavity, take out the stomach, wipe it with filter paper and weigh the total weight. Then cut the stomach body along the greater curvature of the stomach, wash out the stomach contents and wipe it dry, weigh the net weight, and take the difference between the total weight of the stomach and the net weight of the stomach as the weight of the stomach contents. At the same time, quickly take out the small intestine, gently peel off the mesentery and spread it on a tray. The distance from the pylorus to the ileocecum is the total length of the small intestine, and the distance from the pylorus to the front of the nutrient semi-solid paste is the distance of the nutrient semi-solid paste in the small intestine.

[0125] Observation indicators:

[0126] A. Calculate gastric residual rate, gastric residual rate = gastric content weight (g) / nutritional semi-solid carbon paste weight (g) × 100%

[0127] B. Calculate the small intestinal propulsion rate, which is: small intestinal propulsion rate = propulsion distance in the small intestine (cm) / total length of the small intestine (cm) × 100%

[0128] (4) Results

[0129] As shown in Table 6, compared with the blank group, the gastric residual rate of mice in each drug administration group in Example 3 was reduced, and the high-dose group (5.46 g / kg) and the positive group were significantly reduced (P < 0.05 or P < 0.01); compared with the blank group, the small intestinal propulsion rate of mice in each drug administration group in Example 3 was increased, and the high-dose group (5.46 g / kg) and the positive group were significantly increased (P < 0.05 or P < 0.01). It indicates that this product and the positive drug have the effect of promoting gastrointestinal motility and promoting small intestinal propulsion.

[0130] Table 6 Effects of different groups of drugs on gastric residual rate and small intestinal propulsion rate in mice

[0131]

[0132] Note: Compared with the blank group, * P<0.05, ** P<0.01.

[0133] 3.2 Effects of gastritis on mice

[0134] (1) 60 The mice weighing 18-22 g were divided into 6 groups according to their weight, with 10 mice in each group. Half each, blank group, positive group, model group, high, medium and low drug groups in Example 3.

[0135] (2) Each group was given drugs by gavage at a volume of 20 ml / kg. Except for the blank group and the model group which were given purified water, the positive group was given 91 mg / kg of ranitidine hydrochloride, and the high, medium and low drug groups in Example 3 were given 5.46 g / kg, 2.73 g / kg and 1.37 g / kg respectively, once a day for 7 days.

[0136] On the 7th day, mice were fasted for 12 hours but not water after administration. On the 8th day, the blank group was gavaged with purified water, and the other mice were gavaged with anhydrous ethanol (0.1 ml / 10 g). The experimental animals were killed after 1.5 hours.

[0137] (3) Open the abdominal cavity and ligate the pyloric part of the stomach. Inject 1 ml of 1% formaldehyde solution into the stomach from the cardia and then ligate the cardia. Remove the entire stomach and soak it in 10% formaldehyde solution for 15 minutes. Cut the stomach open along the greater curvature of the stomach, gently rinse the inner wall of the stomach with saline, unfold the stomach and lay it flat, observe and calculate the gastritis score and ulcer index.

[0138] Observation indicators:

[0139] A. Observe the occurrence of gastric ulcers in mice and score the occurrence of gastritis: no gastritis, 0 points; local congestion and mild inflammation, 1 point; severe congestion and obvious local inflammation, 2 points; diffuse inflammatory changes in the whole stomach, 3 points.

[0140] B. Calculation of gastric ulcer index of mice (Calculation method of ulcer index: observe gastric mucosal bleeding, the number, size and distribution of ulcer surfaces under a dissecting microscope, measure the long diameter of each ulcer surface, 1 point for those with a long diameter ≤ 1 mm; 2 points for those with a long diameter > 1-2 mm; 3 points for those with a long diameter > 2-3 mm; 4 points for those with a long diameter > 3-4 mm; 5 points for those with a width > 1 mm; multiply the score by 2, and the sum of the scores of each ulcer surface is the ulcer index.)

[0141] (4) Results

[0142] Depend on Figure 1 As shown, it can be seen with the naked eye that the gastric mucosal tissue of the mice in the blank group was normal in color, without ulcers or bleeding spots; a large number of bleeding spots appeared on the gastric lining of the mice in the model group, forming a continuous bleeding surface, with severe erosion and ulcers; there were very few bleeding spots on the gastric lining of the mice in the positive group, without ulcers or erosion; there were very few bleeding spots on the gastric lining of the mice in the high-dose Jinxiang group, with a few ulcers and no erosion; there were a small number of bleeding spots on the gastric lining of the mice in the medium-dose Jinxiang group, with ulcers and slight erosion; there were more bleeding spots on the gastric lining of the mice in the low-dose Jinxiang group, with a larger area of ​​local ulcers and obvious erosion.

[0143] As shown in Table 7, compared with the blank group, the gastritis occurrence score and gastric ulcer index of the model group were significantly increased (P < 0.01), indicating that the mouse gastritis and gastric ulcer model was successfully established. Compared with the model group, the gastritis occurrence scores of the mice in the Jinxiang Shunqi Pills administration groups and the positive group were reduced, among which the high dose (5.46g / kg), medium dose group (2.73g / kg) and positive group were significantly reduced (P < 0.05 or P < 0.01); compared with the model group, the gastric ulcer index of the mice in the Jinxiang Shunqi Pills administration groups and the positive group was reduced, among which the high dose group (5.46g / kg) and the positive group were significantly reduced (P < 0.05 or P < 0.01), indicating that this product and the positive drug have the effect of reducing gastritis and relieving gastric ulcer.

[0144] Table 7 Effect of Jinxiang Jianpi Shunqi Pills on acute gastritis in mice

[0145]

[0146] Note: Compared with the blank group, the model group ## P<0.01; compared with the model group, * P<0.05, ** P<0.01.

Claims

1. A Chinese medicine composition for treating digestive tract diseases, characterized in that: The invention comprises the following components in parts by weight: 80-180 parts of northern patrinia sauce, 80-180 parts of atractylodes macrocephala, 50-150 parts of tuckahoe, 30-100 parts of amomum villosum, 70-170 parts of white peony root, 30-100 parts of costusroot, 80-180 parts of oldenlandia diffusa, 70-170 parts of saffron caulis, 250-350 parts of scutellaria baicalensis, 30-80 parts of zedoaria, 40-90 parts of rhodiola rosea, 40-90 parts of chicken's gizzard lining, 10-60 parts of coptis root, 20-70 parts of areca catechu, 20-70 parts of yanhusuo, 70-170 parts of malt, 20-70 parts of dried ginger, 80-180 parts of morinda officinalis and 10-60 parts of liquorice.

2. The Chinese medicine composition for treating digestive tract diseases according to claim 1, characterized in that: The invention comprises the following components in parts by weight: 130-160 parts of northern patrinia sauce, 130-160 parts of atractylodes macrocephala, 90-130 parts of tuckahoe, 50-70 parts of amomum villosum, 110-140 parts of white peony root, 50-70 parts of costusroot, 130-160 parts of oldenlandia diffusa, 110-140 parts of saffron caulis, 280-310 parts of scutellaria baicalensis, 50-60 parts of zedoaria, 55-75 parts of rhodiola rosea, 55-75 parts of chicken's gizzard lining, 30-45 parts of coptis root, 45-55 parts of areca catechu, 45-55 parts of yanhusuo, 110-140 parts of malt, 45-55 parts of dried ginger, 130-160 parts of morinda officinalis, and 30-45 parts of liquorice.

3. The Chinese medicine composition for treating digestive tract diseases according to claim 1, characterized in that: The invention comprises the following components in parts by weight: 160 parts of northern patrinia sauce, 160 parts of atractylodes macrocephala, 90 parts of tuckahoe, 60 parts of amomum villosum, 120 parts of white peony root, 70 parts of costusroot, 130 parts of oldenlandia diffusa, 120 parts of saffron caulis, 290 parts of scutellaria baicalensis, 55 parts of zedoaria, 65 parts of rhodiola rosea, 75 parts of chicken gizzard lining, 35 parts of coptis root, 55 parts of areca catechu, 55 parts of yanhusuo, 120 parts of malt, 55 parts of dried ginger, 160 parts of morinda officinalis and 30 parts of liquorice.

4. The Chinese medicine composition for treating digestive tract diseases according to claim 1, characterized in that: The invention comprises the following components in parts by weight: 130 parts of northern patrinia sauce, 130 parts of atractylodes macrocephala, 130 parts of tuckahoe, 70 parts of amomum villosum, 140 parts of white peony root, 60 parts of costusroot, 160 parts of oldenlandia diffusa, 140 parts of saffron caulis, 300 parts of scutellaria baicalensis, 60 parts of zedoaria, 75 parts of rhodiola rosea, 55 parts of chicken's gizzard lining, 45 parts of coptis chinensis, 50 parts of areca catechu, 45 parts of yanhusuo, 140 parts of malt, 45 parts of dried ginger, 150 parts of morinda officinalis and 45 parts of liquorice.

5. The Chinese medicine composition for treating digestive tract diseases according to claim 1, characterized in that: The zedoaria is pickled zedoaria; the corydalis is pickled corydalis; the morinda officinalis is salted morinda officinalis; and the licorice is roasted licorice.

6. The method for preparing the Chinese medicine composition for treating digestive tract diseases according to any one of claims 1 to 5, characterized in that: It includes the steps of crushing and mixing the raw materials; or the extract obtained by mixing or extracting the raw materials separately; or the active ingredient obtained by further refining and purifying the extract; or the extract / active ingredient is added with pharmaceutically acceptable excipients.

7. The method for preparing the Chinese medicine composition for treating digestive tract diseases as claimed in claim 6, characterized in that: The prepared dosage form is one of pills, granules, capsules, powders, mixtures or oral liquids.

8. The method for preparing the Chinese medicine composition for treating digestive tract diseases as claimed in claim 6 or 7, characterized in that: The specific preparation method is as follows: the above 19 ingredients, including Patrinia serrata, Atractylodes macrocephala, Amomum villosum, White Peony Root, Costusroot, Sarsopus dahurica, Cistanche deserticola, Gallus gallus domesticus, Coptis chinensis slices, and Corydalis yanhusuo in vinegar, are ground into fine powder, sieved, mixed, and set aside; the remaining nine ingredients, including Poria cocos, Hedyotis diffusa, Curcuma zedoaria in vinegar, Rhodiola rosea, Areca nut, malt, dried ginger slices, Morinda officinalis in salt, and Glycyrrhiza uralensis, are added with water, decocted, filtered, and the filtrate is concentrated to an extract with a relative density of 1.2-1.30, mixed with the above fine powder, dried, ground into fine powder, made into pills, and dried to obtain the extract.

9. Use of the Chinese medicine composition according to any one of claims 1 to 5 in the preparation of drugs for digestive tract diseases.

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