Gastro-protective composition, process for its preparation and use thereof

Abstract

The present application relates to the technical field of traditional Chinese medicine, in particular to a kind of stomach-protecting composition and its preparation method and application, the stomach-protecting composition, according to weight fraction, preparation raw material is as follows: Gegen 10-15 parts, white cardamom 5-15 parts, Amomum villosum 5-10 parts, Fuling 10-15 parts, Baizhu 10-20 parts, Muxiang 3-5 parts, Chenpi 5-10 parts, Ganjiang 3-6 parts, Gancao 5-10 parts, Jujie 10-15 parts, Shenqu 10-15 parts and iron bark 10-15 parts, the composition of the present application improves the protection effect of gastric mucosa and the effect of alcoholism.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a gastric protective composition, its preparation method, and its application. Background Technology

[0002] The dangers of alcohol consumption are undeniable, especially the intake of large amounts of alcohol in a short period. When a large amount of alcohol enters the stomach in a short time, it irritates the gastric mucosa, and in severe cases, can even lead to gastric mucosal erosion and bleeding. Furthermore, alcohol is primarily metabolized by the liver; excessive drinking in a short period not only increases the burden on the liver, leading to liver damage, but can also cause alcohol poisoning in severe cases, affecting the central nervous system and causing symptoms such as shock and coma. Therefore, finding a safe and effective hangover remedy that protects the stomach and liver is an urgent problem that needs to be solved.

[0003] The main mechanisms by which alcohol detoxifies are as follows: First, it inhibits the absorption of alcohol in the gastrointestinal tract, reducing the concentration of ethanol and its metabolite acetaldehyde in the blood; second, it accelerates the breakdown of ethanol and acetaldehyde by increasing the activity of alcohol dehydrogenase and acetaldehyde dehydrogenase; and third, it protects the liver and enhances its detoxification ability. Current hangover remedies mainly include chemical drugs, traditional Chinese medicine preparations, and health foods.

[0004] Chemical drugs such as naloxone are primarily used to treat coma caused by alcohol poisoning, and while effective in treating alcohol poisoning, their effects on relieving hangovers are not prominent and lack specificity. They can also cause varying degrees of damage to the liver and kidneys. Traditional Chinese medicine preparations such as Xiaochaihu granules and compound fresh dendrobium granules rely on the liver-soothing, qi-regulating, heat-clearing, and detoxifying effects of Chinese herbs to regulate the body's health, thereby exerting a hangover-relieving effect. However, their onset of action is long and their specificity is poor. Health supplements claim to have hangover-relieving effects based on protecting against chemically induced liver damage; therefore, their actual hangover-relieving mechanism is singular, and their specificity in relieving hangovers is insufficient.

[0005] Furthermore, current hangover remedies generally focus on the damage alcohol causes to the liver, with most developed based on the mechanism of protecting the liver and preventing chemical liver damage. In reality, excessive alcohol intake not only damages the liver but also has direct and indirect effects on the gastric mucosa. Alcohol can dissolve in lipids and enter the stomach wall. Hydrogen ions in gastric juice seep back into the mucosal epithelial cells, leading to the release of histamine, serotonin, and heparin. This causes submucosal arterial short circuits, increased capillary pressure and permeability, resulting in gastric mucosal damage such as mucosal congestion, red blood cell exudation, and gastric mucosal erosion and bleeding.

[0006] Gehua Jiecheng Tang, a traditional Chinese medicine formula, has the following raw materials: 15 g of Puerariae Flos, 10 g of Aucklandiae Radix, 15 g of Amomi Fructus, 10 g of Poria, 10 g of Polypori Umbellati Fungus, 10 g of Ginseng Radix et Rhizoma, 10 g of Atractylodis Macrocephalae Rhizoma, 15 g of Amomi Rotundus Fructus, 10 g of Citri Reticulatae Viride Pericarpium, 10 g of Citri Reticulatae Pericarpium, 10 g of Massa Medicata Fermentata, 10 g of Zingiberis Rhizoma, and 10 g of Alismatis Rhizoma. It is recorded in *Lan Shi Mi Cang (Secret Records of the Orchid Chamber)*. It has the effects of resolving alcohol toxicity, dispelling dampness, warming the middle energizer and harmonizing the stomach. It is mainly used for treating excessive drinking and dampness damaging spleen and stomach. The symptoms include dizziness and vomiting, oppression in chest and diaphragm, reduced appetite, dysphoria, inconvenient urination or diarrhea. It is clinically commonly used for treating alcohol retention.

[0007] However, Gehua Jiecheng Tang has no protective effect on gastric mucosa, and its anti-alcohol intoxication effect needs to be further improved. Summary of the Invention

[0008] The object of the present invention is to overcome the shortcomings of the prior art and provide a composition with better gastric protection effect and / or anti-alcohol intoxication effect, and a preparation method and use thereof.

[0009] The present invention is achieved by the following technical solutions: In a first aspect of the present invention, there is provided a composition for gastric protection, wherein the preparation raw materials by weight parts are as follows: 10-15 parts of Puerariae Flos, 5-15 parts of Amomi Rotundus Fructus, 5-10 parts of Amomi Fructus, 10-15 parts of Poria, 10-20 parts of Atractylodis Macrocephalae Rhizoma, 3-5 parts of Aucklandiae Radix, 5-10 parts of Citri Reticulatae Pericarpium, 3-6 parts of Zingiberis Rhizoma, 10-15 parts of Aurantii Fructus, 10-15 parts of Massa Medicata Fermentata, 10-15 parts of Dendrobii Officinalis Caulis and 5-10 parts of Glycyrrhizae Radix et Rhizoma.

[0010] As one embodiment of the present invention, the preparation raw materials of the composition for gastric protection by weight parts are as follows: 12-15 parts of Puerariae Flos, 10-15 parts of Amomi Rotundus Fructus, 8-10 parts of Amomi Fructus, 12-15 parts of Poria, 12-18 parts of Atractylodis Macrocephalae Rhizoma, 3-5 parts of Aucklandiae Radix, 8-10 parts of Citri Reticulatae Pericarpium, 3-5 parts of Zingiberis Rhizoma, 12-15 parts of Aurantii Fructus, 12-15 parts of Massa Medicata Fermentata, 12-15 parts of Dendrobii Officinalis Caulis and 8-10 parts of Glycyrrhizae Radix et Rhizoma.

[0011] As one embodiment of the present invention, the preparation raw materials of the composition for gastric protection by weight parts are as follows: 15 parts of Puerariae Flos, 15 parts of Amomi Rotundus Fructus, 10 parts of Amomi Fructus, 15 parts of Poria, 15 parts of Atractylodis Macrocephalae Rhizoma, 3 parts of Aucklandiae Radix, 10 parts of Citri Reticulatae Pericarpium, 3 parts of Zingiberis Rhizoma, 15 parts of Aurantii Fructus, 15 parts of Massa Medicata Fermentata, 15 parts of Dendrobii Officinalis Caulis and 10 parts of Glycyrrhizae Radix et Rhizoma.

[0012] As one embodiment of the present invention, the composition for gastric protection further comprises pharmaceutically acceptable excipients.

[0013] As a preferred embodiment of the present invention, the pharmaceutically acceptable excipients comprise at least one of a binder and a lubricant.

[0014] In a more preferred embodiment of the present invention, the binder comprises at least one of dextrin, maltodextrin, lactose, and microcrystalline cellulose.

[0015] In a more preferred embodiment of the present invention, the lubricant includes at least one of magnesium stearate and silicon dioxide.

[0016] In a further preferred embodiment of the present invention, the mass ratio of the powder to the binder is 2-12:1.

[0017] In a further preferred embodiment of the present invention, the lubricant accounts for 0.1%-0.5% of the total mass of the composition.

[0018] A second aspect of the present invention provides a method for preparing the above-mentioned gastric protective composition, comprising the following steps: Weigh out each medicinal ingredient, mix them, decoct them in water to extract the flavor, concentrate and dry them to obtain the final product. Alternatively, each medicinal ingredient can be weighed, mixed, and then extracted by decoction. The extract can be concentrated, dried, pulverized, and sieved to obtain medicinal powder, which can then be mixed with binders and lubricants to obtain the final product.

[0019] In one embodiment of the present invention, the extraction is performed 1-4 times.

[0020] As one embodiment of the present invention, 4-16 times the amount of water is added each time.

[0021] As one embodiment of the present invention, extraction takes 0.5-3 hours each time.

[0022] In a preferred embodiment of the present invention, the extraction steps are as follows: extraction is performed twice, with 10-16 times the amount of water added for the first extraction and 4-10 times the amount of water added for the second extraction, each extraction lasting 0.5-3 hours.

[0023] In one embodiment of the present invention, the concentration parameter is a relative density of 1.00-2.00 at 60°C.

[0024] As one embodiment of the present invention, the drying method includes, but is not limited to, vacuum freeze drying, vacuum decompression drying, hot air drying, spray drying, etc., with vacuum freeze drying being preferred.

[0025] In one embodiment of the present invention, the powdered medicine is first mixed with the binder, then a lubricant is added, and the mixture is dry-pressed into granules. After granulation, compound granules are obtained.

[0026] A third aspect of the present invention provides the use of the above-described composition or the composition prepared by the above-described preparation method in the preparation of products for relieving hangovers and / or protecting the gastric mucosa.

[0027] In one embodiment of the present invention, the product is a pharmaceutical product.

[0028] Solution of the composition of the present invention: Principal ingredient: Kudzu flower; Kudzu flower is particularly beneficial to the spleen and stomach. Its nature is light, clear, and fragrant, which can invigorate the stomach and relieve hangovers.

[0029] Assistant herbs: white cardamom, amomum villosum, poria cocos, and atractylodes macrocephala; White cardamom resolves dampness, promotes qi circulation, warms the middle jiao, and stops vomiting; Amomum villosum is pungent and warm, invigorates the spleen, resolves dampness, and stimulates appetite. The two herbs work synergistically to invigorate the spleen, resolve dampness, and relieve vomiting. Atractylodes macrocephala strengthens the spleen and dries dampness; Poria cocos promotes diuresis and eliminates dampness. The two herbs, one tonifying and one purging, one drying and one draining, work together to eliminate dampness from alcohol, allowing water and dampness to drain through a proper channel, and improving the spleen's function.

[0030] Medicated ingredients: Costus root, dried tangerine peel, immature bitter orange, dried ginger, medicated leaven, and Dendrobium officinale; Costus root relieves stagnation of Qi in the spleen and stomach; dried tangerine peel regulates Qi, dries dampness, and harmonizes the middle Jiao; immature bitter orange peel widens the middle Jiao and lowers Qi. The combination of these three herbs effectively regulates the stagnant Qi in the middle Jiao, eliminates abdominal distension, and promotes the flow of Qi to resolve dampness and relieve bloating. Dried ginger warms the middle Jiao and dispels cold, invigorates spleen Yang, prevents the internal generation of cold and dampness, and enhances the warming effects of white cardamom and amomum. Shenqu (medicated leaven) promotes digestion and harmonizes the stomach, aiding in the digestion of indigestion caused by alcohol. Dendrobium officinale, sweet and cool in nature, nourishes Yin and generates fluids, preventing the pungent, warm, and drying herbs in the formula from damaging Yin, reflecting the principle of "protecting Yin while sobering up."

[0031] Dendrobium officinale and Citrus aurantium are both used as adjuvant herbs, and their combined use embodies the principle of "combining movement and stillness, and balancing dryness and moistness" in traditional Chinese medicine formulation. Citrus aurantium can alleviate the cloying nature of Dendrobium officinale. Dendrobium officinale is a yin-nourishing herb with a cloying texture, and its use alone may cause stagnation of qi in the stomach, especially when there is already dampness and qi stagnation in the spleen and stomach, which may aggravate abdominal distension. The qi-regulating and stagnation-relieving effects of Citrus aurantium can promote qi circulation and resolve the cloying nature of Dendrobium officinale, making it nourishing without causing stagnation. Dendrobium officinale can restrain the warming and drying nature of Citrus aurantium: Although Citrus aurantium is slightly cold in nature, it works synergistically with many pungent and warm herbs in the formula (dried ginger, Amomum villosum, Aucklandia lappa, etc.), and the overall medicinal properties tend to be warming, drying, and dispersing. The sweet and cold yin-nourishing nature of Dendrobium officinale can gently restrain the warming and drying tendency of the whole formula, preventing damage to the body fluids in the stomach. The two ingredients work synergistically in the middle jiao, one moistening and the other drying, one regulating and the other tonifying, together targeting the complex pathogenesis of "dual injury of qi and yin" or "dampness obstruction and yin injury". While regulating qi and resolving dampness, they protect stomach yin and promote the generation and distribution of body fluids, so as to eliminate pathogens without harming the body's vital energy and regulate qi without depleting yin.

[0032] Medicinal herb: Licorice; Licorice invigorates qi and harmonizes the middle jiao, coordinating the effects of various herbs. It not only assists Poria and Atractylodes macrocephala in strengthening the spleen, but also moderates the properties of the herbs, allowing them to work synergistically.

[0033] The formula eliminates pathogens without harming the body's vital energy, balances dryness and moisture, and combines elimination with tonification, thus achieving the effects of relieving alcohol intoxication and dampness, strengthening the spleen and stomach, regulating qi and relieving chest congestion, and nourishing yin and generating fluids.

[0034] The composition of this invention differs from that of Gehua Jiecheng Decoction in the following ways: ①Remove Polyporus umbellatus and Alisma plantago-aquatica to reduce the dampness-draining effect and avoid damaging the spleen and stomach's vital energy.

[0035] ②Use immature bitter orange peel instead of green tangerine peel. Immature bitter orange peel mainly regulates the spleen and stomach qi stagnation and relieves abdominal distension, and is more mild; green tangerine peel mainly soothes the liver, breaks up qi stagnation, and eliminates stagnation and nodules, and is more drastic. This formula uses immature bitter orange peel instead of green tangerine peel to avoid damaging the body's vital energy; ③ When combined with Dendrobium officinale, the Gehua Jiecheng Decoction is warm and drying. Although alcohol-related illnesses are dampness-related illnesses, they are prone to heat symptoms. This is because dampness can stagnate and transform into heat, and alcohol itself is hot in nature. Adding the sweet and cold Dendrobium officinale can counteract the warm and drying properties of the main group of pungent and warm herbs, thus preventing damage to the stomach yin.

[0036] ④ Adding licorice: It not only helps Poria cocos and Atractylodes macrocephala to strengthen the spleen, but also moderates the medicinal properties, allowing each medicine to work synergistically.

[0037] The beneficial effects of this invention are: This invention uses kudzu flower as the principal ingredient, white cardamom, amomum villosum, poria cocos, and atractylodes macrocephala as assistant ingredients, costus root, tangerine peel, immature bitter orange, dried ginger, medicated leaven, and dendrobium officinale as adjuvant ingredients, and licorice root as the guiding ingredient. The entire formula eliminates pathogenic factors without harming the body's vital energy, balances dryness and moisture, and combines elimination with tonification, working together to relieve alcohol intoxication and dampness, strengthen the spleen and stomach, regulate qi and relieve chest congestion, and nourish yin and generate fluids. Its effects on alcohol intoxication relief, liver protection, and stomach protection are particularly significant. Attached Figure Description

[0038] Figure 1 The images are taken using an L3CMOS microscope camera of the gastric tissue of rats in each group in Test Example 1.

[0039] Figure 2 HE-stained pathological images of gastric tissue from rats in each group of test case 1. Detailed Implementation

[0040] The present invention will be further described below with reference to specific embodiments, and the advantages and features of the present invention will become clearer as a result. However, these embodiments are merely exemplary and do not constitute any limitation on the scope of the present invention. Those skilled in the art should understand that modifications or substitutions can be made to the details and form of the technical solutions of the present invention without departing from the spirit and scope of the present invention, but all such modifications and substitutions fall within the protection scope of the present invention.

[0041] Example 1 A gastric protective composition, prepared by weight of the following raw materials: 10 parts kudzu flower, 5 parts white cardamom, 5 parts amomum villosum, 10 parts poria cocos, 10 parts atractylodes macrocephala, 5 parts costus root, 5 parts tangerine peel, 6 parts dried ginger, 5 parts licorice root, 10 parts immature bitter orange peel, 10 parts medicated leaven, and 10 parts dendrobium officinale.

[0042] The composition is prepared as follows: The following ingredients were used: 10 parts kudzu flower, 5 parts white cardamom, 5 parts amomum villosum, 10 parts poria cocos, 10 parts atractylodes macrocephala, 5 parts costus root, 5 parts dried tangerine peel, 6 parts dried ginger, 5 parts licorice root, 10 parts immature bitter orange peel, 10 parts medicated leaven, and 10 parts dendrobium officinale. The twelve ingredients were extracted using the traditional decoction method, and the extraction was performed once. 16 times the amount of water was added for 3 hours of extraction. The mixture was concentrated to a relative density of 1.25 (60℃), freeze-dried under vacuum, pulverized, and sieved to obtain the composition.

[0043] Example 2 A gastric protective composition, prepared by weight of the following raw materials: 12 parts of kudzu flower, 10 parts of white cardamom, 8 parts of amomum villosum, 12 parts of poria cocos, 20 parts of atractylodes macrocephala, 4 parts of costus root, 8 parts of dried tangerine peel, 5 parts of dried ginger, 8 parts of licorice root, 12 parts of immature bitter orange peel, 12 parts of medicated leaven, and 12 parts of dendrobium officinale.

[0044] The composition is prepared as follows: The following ingredients were used: 12 parts kudzu flower, 10 parts white cardamom, 8 parts amomum villosum, 12 parts poria cocos, 20 parts atractylodes macrocephala, 4 parts costus root, 8 parts dried tangerine peel, 5 parts dried ginger, 8 parts licorice root, 12 parts immature bitter orange peel, 12 parts medicated leaven, and 12 parts dendrobium officinale. The twelve herbs were extracted using the traditional decoction method, with the extracts combined and extracted four times, each extraction lasting 0.5 hours. Ten times the amount of water was added for the first extraction, and four times the amount of water was added for the second to fourth extractions. The mixture was concentrated to a relative density of 1.00 (60℃), then freeze-dried under vacuum. The dried material was pulverized, sieved, and the final composition was obtained.

[0045] Example 3 A gastric protective composition, prepared by weight of the following raw materials: 15 parts of kudzu flower, 15 parts of white cardamom, 10 parts of amomum villosum, 15 parts of poria cocos, 15 parts of atractylodes macrocephala, 3 parts of costus root, 10 parts of dried tangerine peel, 3 parts of dried ginger, 10 parts of licorice root, 15 parts of immature bitter orange peel, 15 parts of medicated leaven, and 15 parts of dendrobium officinale.

[0046] The composition is prepared as follows: The following ingredients were used: 15 parts kudzu flower, 15 parts white cardamom, 10 parts amomum villosum, 15 parts poria cocos, 15 parts atractylodes macrocephala, 3 parts costus root, 10 parts dried tangerine peel, 3 parts dried ginger, 10 parts licorice root, 15 parts immature bitter orange peel, 15 parts medicated leaven, and 15 parts dendrobium officinale. The twelve ingredients were extracted using the traditional decoction method, combined and extracted twice, each time for 2 hours. For the first extraction, 12 times the amount of water was added, and for the second, 8 times the amount of water was added. The mixture was concentrated to a relative density of 2.00 (60℃), then freeze-dried under vacuum. The dried material was pulverized, sieved, and the final composition was obtained.

[0047] Comparative Example 1 Compared with Example 3, the only difference is that 15 parts of Citrus aurantium and 15 parts of Dendrobium officinale are replaced with 15 parts of Polygonatum odoratum and 15 parts of Cyperus rotundus, which have the same efficacy. Details are as follows: The following ingredients were used: 15 parts kudzu flower, 15 parts white cardamom, 10 parts amomum villosum, 15 parts poria cocos, 15 parts atractylodes macrocephala, 3 parts costus root, 10 parts dried tangerine peel, 3 parts dried ginger, 10 parts licorice root, 15 parts polygonatum odoratum, 15 parts medicated leaven, and 15 parts cyperus rotundus. The twelve ingredients were extracted using the traditional decoction method, combined and extracted twice, each time for 2 hours. For the first extraction, 12 times the amount of water was added, and for the second extraction, 8 times the amount of water was added. The mixture was concentrated to a relative density of 2.00 (60℃), then freeze-dried under vacuum. The dried material was pulverized, sieved, and the final composition was obtained.

[0048] Comparative Example 2 Compared to Example 3, the only difference is that Dendrobium officinale is not added, and the amount of Citrus aurantium is adjusted to 30 parts. Details are as follows: The following ingredients were used: 15 parts kudzu flower, 15 parts white cardamom, 10 parts amomum villosum, 15 parts poria cocos, 15 parts atractylodes macrocephala, 3 parts costus root, 10 parts dried tangerine peel, 3 parts dried ginger, 10 parts licorice root, 30 parts immature bitter orange peel, and 15 parts medicated leaven. The twelve ingredients were extracted using the traditional decoction method, combined and extracted twice, each time for 2 hours. For the first extraction, 12 times the amount of water was added, and for the second, 8 times the amount of water was added. The mixture was concentrated to a relative density of 2.00 (60℃), then freeze-dried under vacuum. The dried material was pulverized, sieved, and the final composition was obtained.

[0049] Comparative Example 3 Compared to Example 3, the only difference is that no bitter orange peel is added, and the amount of Dendrobium officinale is adjusted to 30 parts. Details are as follows: The following ingredients were used: 15 parts kudzu flower, 15 parts white cardamom, 10 parts amomum villosum, 15 parts poria cocos, 15 parts atractylodes macrocephala, 3 parts costus root, 10 parts dried tangerine peel, 3 parts dried ginger, 10 parts licorice root, 15 parts medicated leaven, and 30 parts dendrobium officinale. The twelve ingredients were extracted using the traditional decoction method, with extraction performed twice, each extraction lasting 2 hours. For the first extraction, 12 times the amount of water was added, and for the second, 8 times the amount of water was added. The mixture was concentrated to a relative density of 2.00 (60℃), then freeze-dried under vacuum. The dried material was pulverized, sieved, and the final composition was obtained.

[0050] Comparative Example 4 Compared with Example 3, the only difference is the ratio of the amounts of each component, as detailed below: A gastric protective composition, prepared by weight of the following raw materials: 15 parts of kudzu flower, 15 parts of white cardamom, 15 parts of amomum villosum, 15 parts of poria cocos, 15 parts of atractylodes macrocephala, 10 parts of costus root, 10 parts of dried tangerine peel, 10 parts of dried ginger, 10 parts of licorice root, 15 parts of immature bitter orange peel, 15 parts of medicated leaven, and 15 parts of dendrobium officinale.

[0051] The preparation process is as follows: 15 parts of kudzu flower, 15 parts of white cardamom, 15 parts of amomum villosum, 15 parts of poria cocos, 15 parts of atractylodes macrocephala, 10 parts of costus root, 10 parts of dried tangerine peel, 10 parts of dried ginger, 10 parts of licorice root, 15 parts of immature bitter orange peel, 15 parts of medicated leaven, and 15 parts of dendrobium officinale were extracted using the traditional decoction method. The twelve herbs were combined and extracted twice, each extraction lasting 2 hours. For the first extraction, 12 times the amount of water was added, and for the second extraction, 8 times the amount of water was added. The mixture was concentrated to a relative density of 2.00 (60℃), then freeze-dried under vacuum. The dried material was pulverized, sieved, and the final composition was obtained.

[0052] Comparative Example 5 A kudzu flower decoction for relieving hangovers, prepared by weight, consists of the following ingredients: 15 parts kudzu flower, 10 parts costus root, 15 parts amomum villosum, 10 parts poria cocos, 10 parts polyporus umbellatus, 10 parts ginseng, 10 parts atractylodes macrocephala, 15 parts white cardamom, 10 parts green tangerine peel, 10 parts dried tangerine peel, 10 parts medicated leaven, 10 parts dried ginger, and 10 parts alisma plantago-aquatica.

[0053] The preparation process is as follows: 15 parts of kudzu flower, 10 parts of costus root, 15 parts of amomum villosum, 10 parts of poria cocos, 10 parts of polyporus umbellatus, 10 parts of ginseng, 10 parts of atractylodes macrocephala, 15 parts of cardamom, 10 parts of green tangerine peel, 10 parts of dried tangerine peel, 10 parts of medicated leaven, 10 parts of dried ginger, and 10 parts of alisma plantago-aquatica. The traditional decoction method was used, with all twelve herbs combined and extracted twice, each extraction lasting 2 hours. For the first extraction, 12 times the amount of water was added, and for the second extraction, 8 times the amount of water was added. The mixture was concentrated to a relative density of 2.00 (60℃), then freeze-dried under vacuum. The dried material was pulverized, sieved, and the final composition was obtained.

[0054] Test Example 1: Gastric Protection and Alcohol Relief Experiment SD rats, weighing 180-220g, were used in the experiment, with an equal number of males and females. The rats were fasted for 24 hours and deprived of water for 2 hours. After weighing, they were randomly divided into 10 groups: normal group, model group, Example 1, Example 2, Example 3, Comparative Example 1, Comparative Example 2, Comparative Example 3, Comparative Example 4, and Comparative Example 5. Each group consisted of 10 rats, with an equal number of males and females. Each group was administered the drug according to its assigned dosage of 15.0g crude drug / kg via gavage at a volume of 10mL / kg body weight. The normal group and model group were administered an equal volume of distilled water via gavage. One hour after drug administration, all groups except the normal group were administered anhydrous ethanol via gavage at a volume of 4mL / kg, while the normal group was administered an equal volume of distilled water via gavage. One hour later, all animals were administered 0.5 mL / animal of 1.5 wt% sodium carboxymethyl cellulose paste (containing 0.05 wt% phenol red) by gavage. Thirty minutes later, the rats were anesthetized, blood was collected from the abdominal aorta, serum was separated, and ALT (alanine aminotransferase), AST (aspartate aminotransferase), and ethanol concentrations were measured. The cardia and pylorus were ligated, and the stomach was dissected along the greater curvature. The gastric contents were flushed with 10 mL of 0.5 mol / L NaOH solution. The collected gastric flushing fluid was centrifuged at 3000 r / min for 10 min, the supernatant was collected, and the OD value was measured at 560 nm. The gastric emptying rate was calculated using the formula: Gastric emptying rate (%) = (OD value of 0.5 mL standard phenol red - OD value of residual phenol red) / OD value of 0.5 mL standard phenol red × 100%. The standard phenol red OD value was measured at 0 min after rats were administered sodium carboxymethyl cellulose paste (containing 0.05 wt% phenol red) via gavage; the residual phenol red OD value was measured at 30 min after rats were administered sodium carboxymethyl cellulose paste (containing 0.05 wt% phenol red) via gavage. Gastric emptying rate is an important indicator of gastric motility. In a model of post-alcohol abdominal distension, this indicator can be used to assess whether a drug has a spleen-strengthening and stomach-regulating effect.

[0055] Stomach tissue was dissected, cut along the greater curvature, and spread out. Images were acquired using an L3 CMOS microscope and an OVT (OmniVision Technologies) DVL510 digital camera system. The results are as follows: Figure 1 As shown. Gastric bleeding was observed, and the extent of gastric mucosal damage was scored. The gross scoring criteria for gastric mucosal damage were as follows: 1. Large hemorrhage patches, bleeding area >20%, scored 5 points; 2. Large hemorrhage patches, bleeding area 10%-20%, scored 4 points; 3. Bleeding area <10% or small spots, number of bleeding points >10, scored 3 points; 4. Small spots, 5 < number of bleeding points ≤ 10, scored 2 points; 5. Number of bleeding points 1-5, scored 1 point. The average gross score of gastric mucosal damage for each group of rats was calculated according to the above scoring criteria.

[0056] Gastric tissue was fixed in formaldehyde and stained with hematoxylin and eosin (HE). Pathological images at 40x and 100x magnification are shown below. Figure 2 As shown.

[0057] The pathological score uses the damage to gastric mucosal epithelial cells, the degree of inflammatory cell infiltration, the degree of mucosal edema, and the degree of mucosal congestion as scoring indicators. The specific scoring criteria are shown in Table 1.

[0058] Table 1 Pathological Scoring Criteria

[0059] The results of rat body weight, gastric emptying rate, gross score and pathological score of gastric mucosal damage are shown in Table 2.

[0060] Table 2. Effects on gastric mucosa protection and gastric emptying rate (n=10)

[0061] Note: Compared with the model group, * P<0.05 ** P<0.01 *** P<0.001; compared with Example 3, # P<0.05 ## P<0.01 ### P<0.001.

[0062] Table 3 shows the serum ALT and AST levels. Elevated serum ALT and AST are classic indicators for diagnosing acute liver injury. Acute liver injury caused by excessive alcohol consumption is typically characterized by a significant increase in the levels of these two transaminases. Therefore, inhibiting the elevation of transaminases can serve as an important indicator for assessing the protective effect of drugs against liver injury.

[0063] Table 3. Protective effects on the liver (n=10)

[0064] Note: Compared with the model group, * P<0.05 *** P<0.001; compared with Example 3, # P<0.05 ## P<0.01.

[0065] The serum ethanol content is shown in Table 4. Ethanol is mainly metabolized into water and carbon dioxide by alcohol dehydrogenase and aldehyde dehydrogenase in the liver. The lower the content, the faster the liver metabolizes and clears it, and the better the effect of sobering up.

[0066] Table 4. Hangover Relief Effects (n=10)

[0067] Note: Compared with the model group, * P<0.05 ** P<0.01 ***P<0.001; compared with Example 3, # P<0.05.

[0068] Test Example 2: Mouse Righting Reflex Experiment The experiment used ICR mice, half male and half female, weighing 18–22 g, and randomly divided into 9 groups: model group, Example 1, Example 2, Example 3, Comparative Example 1, Comparative Example 2, Comparative Example 3, Comparative Example 4, and Comparative Example 5, with 10 mice in each group, half male and half female. After fasting for 12 hours, the mice were administered drugs by gavage according to their assigned groups. The dosage was 21.2 g crude drug / kg, administered by gavage at a volume of 10 mL / kg body weight. The model group was administered an equal volume of distilled water by gavage. One hour later, 56° Red Star Erguotou (a type of Chinese liquor) was administered by gavage at a volume of 0.4 mL / 10 g body weight. The time T0 was recorded immediately after administration. The latency period was observed: every 2 minutes after administration, the mice were placed back-down, and the timing was recorded the instant the mice were released. If the mice could not roll back to the chest position within 30 seconds, it was recorded as "disappearance of righting reflex". The time at this moment = T1, and the latency period = T1–T0. Observation period: After the reflex disappeared, the mouse was tested every 2 minutes. A recovery of the reflex within 30 seconds after three consecutive tests was recorded as "reflex recovery," with time T2. Intoxication time = T2 – T1. The results are shown in Table 5. A longer latency period and shorter intoxication time in mice indicate a better sobering effect.

[0069] Table 5. Effects of the righting reflex test on the latency and duration of intoxication in mice (n=10)

[0070] Note: Compared with the model group, * P<0.05 ** P<0.01 *** P<0.001; compared with Example 3, # P<0.05 ## P<0.01 ### P<0.001.

[0071] The above detailed description is a specific description of one of the feasible embodiments of the present invention. This embodiment is not intended to limit the patent scope of the present invention. All equivalent implementations or modifications that do not depart from the present invention should be included within the scope of the technical solution of the present invention.

Claims

1. A gastric protective composition, characterized in that, The raw materials prepared according to the following weight parts are as follows: 10-15 parts of kudzu flower, 5-15 parts of white cardamom, 5-10 parts of amomum villosum, 10-15 parts of poria cocos, 10-20 parts of atractylodes macrocephala, 3-5 parts of costus root, 5-10 parts of dried tangerine peel, 3-6 parts of dried ginger, 10-15 parts of immature bitter orange peel, 10-15 parts of medicated leaven, 10-15 parts of dendrobium officinale, and 5-10 parts of licorice.

2. The gastric protection composition according to claim 1, characterized in that, The raw materials prepared according to the following weight parts are as follows: 12-15 parts of kudzu flower, 10-15 parts of white cardamom, 8-10 parts of amomum villosum, 12-15 parts of poria cocos, 12-18 parts of atractylodes macrocephala, 3-5 parts of costus root, 8-10 parts of dried tangerine peel, 3-5 parts of dried ginger, 12-15 parts of immature bitter orange peel, 12-15 parts of medicated leaven, 12-15 parts of dendrobium officinale, and 8-10 parts of licorice.

3. The gastric protection composition according to claim 2, characterized in that, The raw materials prepared according to the following weight proportions are as follows: 15 parts of kudzu flower, 15 parts of white cardamom, 10 parts of amomum villosum, 15 parts of poria cocos, 15 parts of atractylodes macrocephala, 3 parts of costus root, 10 parts of dried tangerine peel, 3 parts of dried ginger, 15 parts of immature bitter orange peel, 15 parts of medicated leaven, 15 parts of dendrobium officinale, and 10 parts of licorice.

4. The gastric protection composition according to any one of claims 1-3, characterized in that, It also includes pharmaceutically acceptable excipients.

5. The gastric protection composition according to claim 4, characterized in that, The pharmaceutically acceptable excipients include at least one of adhesives and lubricants.

6. The gastric protection composition according to claim 5, characterized in that, The binder comprises at least one of dextrin, maltodextrin, lactose, and microcrystalline cellulose; the lubricant comprises at least one of magnesium stearate and silicon dioxide.

7. A method for preparing a gastric protective composition according to any one of claims 1-3, characterized in that, Includes the following steps: Weigh all the raw materials, mix them, extract them by decoction, concentrate and dry them to obtain the final product.

8. A preparation method according to claim 7, characterized in that, The extraction is performed 1-4 times, and / or 4-16 times the amount of water is added each time, and / or each extraction lasts 0.5-3 hours; and / or the concentration parameters are a relative density of 1.00-2.00 at 60°C; and / or the drying method is vacuum freeze drying.

9. The use of a composition according to any one of claims 1-6 or a composition prepared by any one of claims 7-8 in the preparation of products for relieving hangovers and / or protecting the gastric mucosa.

10. The application according to claim 9, characterized in that, The product in question is a pharmaceutical product.

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