Medicinal and edible composition for dispelling effects of alcohol, protecting liver and protecting stomach as well as preparation method and application of medicinal and edible composition

Abstract

The invention provides a medicinal and edible composition for alleviating hangover and protecting liver and stomach as well as a preparation method and application of the medicinal and edible composition. The medicinal and edible composition is prepared from the following components in parts by weight: 10 to 30 parts of radix puerariae, 6 to 20 parts of herba dendrodii officinalis, 2 to 12 parts of semen coicis, 2 to 12 parts of pericarpium citri reticulatae, 2 to 12 parts of semen hoveniae, 2 to 12 parts of flos chrysanthemi, 1 to 8 parts of liquorice root, 1 to 8 parts of herba menthae, 1 to 8 parts of fructus crataegi and optional pharmaceutically and / or food acceptable auxiliary materials. The medicinal and edible composition can effectively exert the effects of dispelling the effects of alcohol, protecting the liver, protecting the gastric mucosa and the like in a dietary therapy mode, and has the advantages of being derived from food, good in effect, low in toxicity, low in price, easy to popularize and the like.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine and food. Specifically, the present invention relates to a medicine-food homologous composition for sobering up, protecting liver and stomach, and a preparation method and use thereof. Background Art

[0002] With the development of society and economy, people's living standards are constantly improving, while life pressure is gradually increasing. Drinking has become a common behavior, and the drinking population tends to be younger. Long-term or short-term heavy drinking can cause acute liver damage and gastric mucosal damage.

[0003] About 90% of the ethanol that enters the body is metabolized in the liver. Alcoholic liver damage is one of the common liver diseases in clinical practice. Its early stage usually manifests as alcoholic fatty liver. If there is no effective treatment, it may develop into alcoholic hepatitis, liver fibrosis, cirrhosis and even hepatocellular carcinoma. Studies have shown that more than 80% of heavy drinkers have a certain degree of fatty liver, 10-35% may develop into alcoholic hepatitis, and 10-20% will develop into cirrhosis. Currently, alcoholic liver damage has become the second largest type of liver disease, which seriously endangers human health and social development. How to prevent and treat alcoholic liver damage has become a public health issue of global concern. At present, most of the clinical treatments for alcoholic liver damage adopt alcohol abstinence and nutritional support. In severe cases, Western medicines such as glucocorticoids and metoprolol can be used for treatment, but Western medicine treatments have certain side effects.

[0004] The stomach is an important part of the digestive system and plays a key role in nutrient absorption. The occurrence of gastric disease is often closely related to gastric mucosal damage. Ethanol is an organic solvent that is miscible with water. It will destroy the mucus layer of the gastric mucosa, damage the gastric mucosal barrier, break the normal physiological balance of the gastric mucosal barrier, damage mucus cells, and cause acute inflammation of the gastric mucosa. Symptoms such as congestion, edema, bleeding, erosion and ulcer formation appear in the mucosa. Acetaldehyde produced during the metabolism of ethanol can denature proteins, aggravate gastric mucosal damage, and even increase the incidence of gastric cancer. The drugs used clinically to treat gastric mucosal damage are mainly Western medicines, such as gastric acid neutralizers, H2 receptor antagonists, and H+ pump inhibitors.

[0005] Compared with Western medicine, Chinese medicine has the characteristics of multiple targets, multiple links and high safety. Chinese medicine focuses on the overall treatment of the disease and emphasizes the treatment based on syndrome differentiation. The long-term effect is satisfactory and it is worth promoting in daily life. Substances with the same origin as medicine and food can be used to prevent and treat diseases, and can also be used as part of daily diet to provide the human body with necessary nutrition. They come from nature, without chemical substances added, and have no toxic side effects on the human body, which is more in line with modern people's pursuit of healthy food. The same origin of medicine and food is suitable for conditioning from multiple angles and multiple channels. It can not only help treat diseases, but also strengthen physical fitness, prevent diseases, and play an important role in maintaining physical health.

[0006] Therefore, providing a medicine-food composition that can effectively sober up, protect the liver and protect the stomach is an urgent problem to be solved. Summary of the invention

[0007] In view of the above problems, the purpose of the present invention is to provide a medicine-food composition for sobering up, protecting the liver and protecting the stomach, and its preparation method and use. The medicine-food composition can effectively play the role of sobering up, protecting the liver and protecting the stomach through diet therapy, thereby improving people's quality of life.

[0008] The above object of the present invention is achieved by providing the following technical solutions:

[0009] In a first aspect, the present invention provides a medicinal and edible composition for sobering up, protecting the liver and protecting the stomach, which comprises or is composed of the following components by weight: 10-30 parts of Pueraria root, 6-20 parts of Dendrobium officinale, 2-12 parts of Coix seeds, 2-12 parts of dried tangerine peel, 2-12 parts of Hovenia dulcis, 2-12 parts of chrysanthemum, 1-8 parts of licorice, 1-8 parts of mint, 1-8 parts of hawthorn, and optional pharmaceutically and / or food acceptable excipients.

[0010] In the edible-medicinal composition of the present invention, kudzu root, dendrobium officinale, coix seed, tangerine peel, Hovenia dulcis, chrysanthemum, licorice, mint and hawthorn are all edible-medicinal substances announced by the National Health Commission of China.

[0011] In the medicine-food composition of the present invention, Pueraria root is pungent, sweet and cool in nature, can promote yang and relieve alcohol, promote blood circulation and activate collaterals, promote fluid production and quench thirst; Dendrobium is sweet and slightly cool in taste, can benefit the stomach and promote fluid production, nourish yin and clear heat, and the two medicines are matched as the main medicine. The sweet one can be harmonious and slow, so as to lead the whole prescription to play the effect of harmonizing the middle and relieving urgency, relieving alcohol and nourishing the stomach. Coix seed is sweet and mild in nature, can promote diuresis and eliminate dampness, strengthen the spleen and detoxify; Tangerine peel is bitter and pungent in nature, can regulate qi and strengthen the spleen, dry dampness and resolve phlegm; Hovenia dulcis is sweet and flat, can eliminate alcohol poisoning, quench thirst and relieve restlessness, and promote urination. The three medicines are combined as the minister medicine, enter the spleen and stomach meridians, strengthen the spleen and harmonize the middle, dry dampness and resolve alcohol, promote diuresis and eliminate dampness, help the main medicine to harmonize the middle and resolve alcohol, and lead the alcohol poisoning from the lower part of the body. Chrysanthemum is sweet, bitter and slightly cold, can soothe the liver and detoxify; Mint is pungent and cool in nature, can soothe the liver and promote qi; Hawthorn is sour, sweet and slightly warm, can disperse blood stasis and resolve turbidity. The three herbs are combined as adjuvants, entering the liver and lung meridians, helping the liver to vent, helping the lungs to regulate the water channels, activating the collaterals and dispersing blood stasis to clear the alcohol poison. Licorice is sweet and mild, and is a guiding drug that harmonizes the other herbs. The whole formula is mainly sweet, warm and cool, entering the spleen and stomach to harmonize the middle, entering the liver and lungs to relieve alcohol, and playing the effect of nourishing the stomach and liver, without the risk of excessive cold or heat.

[0012] Preferably, the medicine-food composition comprises or consists of the following components, by weight: 12-18 parts of Pueraria root, 8-12 parts of Dendrobium officinale, 4-8 parts of Coix seeds, 4-8 parts of dried tangerine peel, 4-8 parts of Hovenia dulcis, 4-8 parts of chrysanthemum, 2-6 parts of liquorice, 1-5 parts of mint, 1-5 parts of hawthorn, and optional pharmaceutically and / or food acceptable excipients.

[0013] Preferably, the edible and medicinal composition comprises or consists of the following components in parts by weight: 15 parts of Pueraria root, 10 parts of Dendrobium officinale, 6 parts of Coix seeds, 6 parts of dried tangerine peel, 6 parts of Hovenia dulcis, 6 parts of chrysanthemum, 4 parts of liquorice, 3 parts of mint, 3 parts of hawthorn and optional pharmaceutically and / or food acceptable excipients.

[0014] According to some embodiments of the present invention, the pharmaceutically and / or food acceptable excipient is selected from one or more of a preservative, an antioxidant, a flavoring agent, a thickener and an absorption enhancer.

[0015] Preferably, the flavoring agent is a sweetener and / or an aromatic.

[0016] Further preferably, the sweetener is selected from one or more of sorbitol, xylitol, erythritol, mogroside and steviol glycoside, preferably mogroside and erythritol; more preferably, the weight ratio of mogroside to erythritol in the medicine and food composition is 1:200-300, preferably 1:250.

[0017] Further preferably, the fragrance is fresh lemon and / or dried osmanthus.

[0018] Further preferably, in the edible and medicinal composition, the sweetener is 0-100 parts by weight, preferably 10-65 parts by weight.

[0019] Further preferably, in the edible-medicinal composition, the aromatic agent is 0-50 parts by weight, preferably 0.5-30 parts by weight.

[0020] In a second aspect, the present invention provides a medicine-food product for sobering up, protecting the liver and protecting the stomach, which is prepared from the medicine-food composition according to the first aspect of the present invention.

[0021] Preferably, the dosage form of the medicine-food homologous product is selected from one or more of powders, tablets, granules, capsules, solutions, emulsions and suspensions, preferably solutions.

[0022] In a third aspect, the present invention provides a method for preparing the medicine-food homologous product according to the second aspect of the present invention, comprising the following steps:

[0023] (1) preparing an extract of the edible-medicinal composition;

[0024] (2) preparing the extract into a concentrated solution;

[0025] (3) preparing the concentrated liquid into a medicine-food product.

[0026] According to some embodiments of the present invention, step (1) comprises the following steps:

[0027] (a) extracting kudzu root, coix seed, dried orange peel, Hovenia dulcis, chrysanthemum, liquorice and hawthorn by heating with an extraction solvent, and then filtering to obtain an extract A1 and a filter residue, respectively;

[0028] (b) extracting the mint and the filter residue by heating with an extraction solvent to obtain an extract A2, and then combining the extract A1 and the extract A2 to obtain an extract A;

[0029] (c) extracting the Dendrobium officinale by heating with an extraction solvent to obtain an extract B, and then combining the extract A with the extract B to obtain an extract.

[0030] Preferably, in steps (a) and (b), the heating extraction is independently carried out under the following conditions: the extraction temperature is 90-100°C, preferably 93-97°C; the extraction time is 15-30min, preferably 18-22min; the weight ratio of the extract to the extraction solvent is 1:8-12, preferably 1:9-11.

[0031] Preferably, in step (a), the Hovenia dulcis fruit is crushed and sieved before extraction; further preferably, the mesh size of the sieve is 10-30 meshes, preferably 15-25 meshes.

[0032] Preferably, in step (c), the heating extraction is carried out under the following conditions: the extraction temperature is 90-100°C, preferably 93-97°C; the extraction time is 1.5-2.5h, preferably 1.8-2.2h; the weight ratio of the extract to the extraction solvent is 1:15-25, preferably 1:18-22; the number of extractions is 2-4 times, preferably 3 times.

[0033] Preferably, in step (c), the Dendrobium officinale is crushed and sieved before extraction; further preferably, the mesh size of the sieve is 10-30 meshes, preferably 15-25 meshes.

[0034] Preferably, in steps (a) to (c), the extraction solvents are each independently selected from one or more of water, 50% by volume ethanol and 70% by volume ethanol, preferably water.

[0035] According to some embodiments of the present invention, the step (2) comprises the following steps: filtering, centrifuging and concentrating the extract in sequence to obtain a concentrated solution.

[0036] Preferably, the centrifugation is carried out under the following conditions: the centrifugal speed is 6000-10000 rpm, preferably 7000-9000 rpm; the centrifugal time is 20-40 min, preferably 25-35 min.

[0037] Preferably, the ratio of the total weight of the edible and medicinal composition to the volume of the concentrated solution is 1g: 5-15mL, preferably 1g: 8-12mL.

[0038] According to some embodiments of the present invention, the step (3) comprises the following steps: optionally adding pharmaceutically and / or food acceptable excipients to the concentrated solution to obtain the medicine and food product.

[0039] In a fourth aspect, the present invention provides use of the medicine-food composition according to the first aspect of the present invention or the medicine-food product according to the second aspect of the present invention in the preparation of a medicament for preventing and / or treating liver injury and / or gastric injury.

[0040] Preferably, the liver injury is acute liver injury; further preferably, the acute liver injury is selected from one or more of alcoholic fatty liver, alcoholic hepatitis, alcoholic liver fibrosis and alcoholic cirrhosis.

[0041] Preferably, the gastric injury is gastric mucosal injury.

[0042] In a fifth aspect, the present invention provides use of the medicine-food composition according to the first aspect of the present invention or the medicine-food product according to the second aspect of the present invention in the preparation of food for providing auxiliary protection against chemical liver damage and / or auxiliary protection of gastric mucosa.

[0043] Preferably, the chemical liver injury is alcoholic liver injury.

[0044] Preferably, the auxiliary protection of gastric mucosa provides auxiliary protection against alcoholic gastric mucosal damage.

[0045] The present invention has at least the following beneficial effects:

[0046] 1. The inventors unexpectedly found that the medicine-food combination of the present invention can effectively relieve alcohol, protect the liver and nourish the stomach through diet therapy, and the therapeutic effect is definite. The inventors evaluated the effects of the prepared medicine-food combination on relieving alcohol, protecting the liver and nourishing the stomach, and found that it has a good therapeutic effect on alcoholic liver damage and alcoholic gastric mucosal damage.

[0047] 2. All components in the medicine-food combination of the present invention are medicine-food varieties announced by the National Health Commission of China, and have the advantages of good effect, low toxicity and easy promotion, and are safer than Western medicine. In addition, the present invention uses mogroside and erythritol to replace traditional flavoring agents such as sucrose, making the product also suitable for special groups such as diabetes. In addition, the present invention uses osmanthus and lemon to replace additives such as flavors, making it safer.

[0048] 3. The present invention extracts Hovenia dulcis and Dendrobium officinale after crushing and sieving, and fully considers factors such as the extraction time and number of extractions of Dendrobium officinale, so that the effective ingredients can be extracted as much as possible, thereby being able to exert their efficacy to a greater extent. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] The embodiments of the present invention are described in detail below with reference to the accompanying drawings, wherein:

[0050] Figure 1 The figure shows the weight changes of experimental animals.

[0051] Figure 2 The liver index of the experimental animals is statistically shown in Figure 2. Compared with the model group, # P<0.05, ## P<0.01, ### P < 0.001, #### P<0.0001; compared with the control group, **** P<0.0001.

[0052] Figure 3 The gastric mucosa photos and gastric mucosal injury index statistics of rats are shown in Figure 2. Compared with the model group, # P<0.05, ## P<0.01, ### P < 0.001, #### P<0.0001; compared with the control group, **** P<0.0001.

[0053] Figure 4 The gastric mucosa photos and gastric mucosal injury index statistics of mice show that compared with the model group, # P<0.05, ## P<0.01, ### P < 0.001, #### P<0.0001; compared with the control group, **** P<0.0001.

[0054] Figure 5 This is a pathological section of the gastric mucosal tissue of the experimental animals.

[0055] Figure 6 This is a pathological section of the liver tissue of the experimental animal.

[0056] Figure 7 This is a statistical graph of the intestinal flora analysis results of mice in Example 1 and an analysis of inter-group differences. DETAILED DESCRIPTION

[0057] The present invention is further described in detail below in conjunction with specific embodiments. The given examples are only for illustrating the present invention, but not for limiting the scope of the present invention.

[0058] Example 1

[0059] (1) Crush Hovenia dulcis and Dendrobium officinale separately and pass through a 20-mesh sieve.

[0060] (2) Take 15 g of Pueraria root, 6 g of Coix seed, 6 g of dried tangerine peel, 6 g of sieved Hovenia dulcis, 6 g of chrysanthemum, 4 g of liquorice, and 3 g of hawthorn, add water at a weight ratio of 1:10 to the extract and water, then heat to 95°C, extract for 20 min, and filter to obtain extract A1 and a residue; take 3 g of mint and the above-mentioned residue, add water at a weight ratio of 1:10 to the total weight of mint and the residue and water, then heat to 95°C, extract again for 20 min, and filter to obtain extract A2, and combine extract A1 and extract A2 to obtain extract A.

[0061] (3) Take 10 g of the sieved Dendrobium officinale, add water at a ratio of 1:20 of the weight of the Dendrobium officinale to the weight of water, heat to 95°C, extract for 2 hours, and then filter to obtain a Dendrobium officinale extract and a filter residue. The filter residue is extracted again under the same conditions for a total of three extractions. The Dendrobium officinale extracts are combined to obtain an extract B, which is then combined with the extract A to obtain an extract.

[0062] (4) The extract was centrifuged at 8000 rpm for 30 min, the supernatant was collected, and the concentrate was concentrated to a solid-liquid ratio of 1 g: 10 mL (i.e., the ratio of the total weight of the edible-medicinal composition to the volume of the concentrated solution was 1 g: 10 mL) to obtain a concentrated solution.

[0063] (5) Add 15 g of erythritol and 0.06 g of mogroside to the concentrated solution and stir evenly to obtain a medicine-food oral solution.

[0064] Example 2

[0065] (1) Crush Hovenia dulcis and Dendrobium officinale separately and pass through a 20-mesh sieve.

[0066] (2) Take 12 g of Pueraria root, 4 g of Coix seed, 4 g of dried tangerine peel, 4 g of sieved Hovenia dulcis fruit, 4 g of chrysanthemum, 2 g of liquorice, and 1 g of hawthorn, add water at a weight ratio of 1:10 to the extract and water, then heat to 95°C, extract for 20 min, and filter to obtain extract A1 and a residue; take 1 g of mint and the above-mentioned residue, add water at a weight ratio of 1:10 to the total weight of mint and the residue and water, then heat to 95°C, extract again for 20 min, and filter to obtain extract A2, and combine extract A1 and extract A2 to obtain extract A.

[0067] (3) Take 8 g of the sieved Dendrobium officinale, add water at a ratio of 1:20 of the weight of the Dendrobium officinale to the weight of water, heat to 95°C, extract for 2 hours, and then filter to obtain a Dendrobium officinale extract and a filter residue. The filter residue is extracted again under the same conditions for a total of three extractions. The Dendrobium officinale extracts are combined to obtain an extract B, which is then combined with the extract A to obtain an extract.

[0068] (4) The extract was centrifuged at 8000 rpm for 30 min, the supernatant was collected and concentrated to a solid-liquid ratio of 1 g: 10 mL to obtain a concentrated solution.

[0069] (5) Add 10 g of erythritol and 0.04 g of mogroside to the concentrated solution and stir evenly to obtain a medicine-food oral solution.

[0070] Example 3

[0071] (1) Crush Hovenia dulcis and Dendrobium officinale separately and pass through a 20-mesh sieve.

[0072] (2) Take 18 g of Pueraria root, 8 g of Coix seed, 8 g of dried orange peel, 8 g of sieved Hovenia dulcis, 8 g of chrysanthemum, 6 g of liquorice, and 5 g of hawthorn, add water at a weight ratio of 1:10 to the extract and water, then heat to 95°C, extract for 20 min, and filter to obtain extract A1 and a residue; take 5 g of mint and the above-mentioned residue, add water at a weight ratio of 1:10 to the total weight of mint and the residue and water, then heat to 95°C, extract again for 20 min, and filter to obtain extract A2, and combine extract A1 and extract A2 to obtain extract A.

[0073] (3) Take 12 g of the sieved Dendrobium officinale, add water at a ratio of 1:20 of the weight of the Dendrobium officinale to the weight of water, heat to 95°C, extract for 2 hours, and then filter to obtain a Dendrobium officinale extract and a filter residue. The filter residue is extracted again under the same conditions for a total of three extractions. The Dendrobium officinale extracts are combined to obtain an extract B, which is then combined with the extract A to obtain an extract.

[0074] (4) The extract was centrifuged at 8000 rpm for 30 min, the supernatant was collected and concentrated to a solid-liquid ratio of 1 g: 10 mL to obtain a concentrated solution.

[0075] (5) Add 20 g of erythritol and 0.08 g of mogroside to the concentrated solution and stir evenly to obtain a medicine-food oral solution.

[0076] Example 4

[0077] (1) Crush Hovenia dulcis and Dendrobium officinale separately and pass through a 20-mesh sieve.

[0078] (2) Take 10 g of Pueraria root, 2 g of Coix seed, 2 g of dried tangerine peel, 2 g of sieved Hovenia dulcis fruit, 2 g of chrysanthemum, 1 g of liquorice, and 1 g of hawthorn, add water at a weight ratio of 1:10 between the weight of the extract and water, then heat to 95°C, extract for 20 min, and filter to obtain extract A1 and a residue; take 1 g of mint and the above-mentioned residue, add water at a weight ratio of 1:10 between the total weight of mint and the residue and the weight of water, then heat to 95°C, extract again for 20 min, and filter to obtain extract A2, and combine extract A1 and extract A2 to obtain extract A.

[0079] (3) Take 6 g of the sieved Dendrobium officinale, add water at a ratio of 1:20 of the weight of the Dendrobium officinale to the weight of water, heat to 95°C, extract for 2 hours, and then filter to obtain a Dendrobium officinale extract and a filter residue. The filter residue is extracted again under the same conditions for a total of three extractions. The Dendrobium officinale extracts are combined to obtain an extract B, which is then combined with the extract A to obtain an extract.

[0080] (4) The extract was centrifuged at 8000 rpm for 30 min, the supernatant was collected and concentrated to a solid-liquid ratio of 1 g: 10 mL to obtain a concentrated solution.

[0081] (5) Add 6.9 g of erythritol and 0.03 g of mogroside to the concentrated solution and stir evenly to obtain a medicine-food oral solution.

[0082] Example 5

[0083] (1) Crush Hovenia dulcis and Dendrobium officinale separately and pass through a 20-mesh sieve.

[0084] (2) Take 30 g of Pueraria root, 12 g of Coix seed, 12 g of dried tangerine peel, 12 g of sieved Hovenia dulcis fruit, 12 g of chrysanthemum, 8 g of liquorice, and 8 g of hawthorn, add water at a weight ratio of 1:10 to the extract to water, then heat to 95°C, extract for 20 min, and filter to obtain extract A1 and a residue; take 8 g of mint and the above residue, add water at a weight ratio of 1:10 to the total weight of mint and the residue to the weight of water, then heat to 95°C, extract again for 20 min, and filter to obtain extract A2, and combine extract A1 and extract A2 to obtain extract A.

[0085] (3) Take 20 g of the sieved Dendrobium officinale, add water at a ratio of 1:20 of the weight of the Dendrobium officinale to the weight of water, heat to 95°C, extract for 2 hours, and then filter to obtain a Dendrobium officinale extract and a filter residue. The filter residue is extracted again under the same conditions for a total of three extractions. The Dendrobium officinale extracts are combined to obtain an extract B, which is then combined with the extract A to obtain an extract.

[0086] (4) The extract was centrifuged at 8000 rpm for 30 min, the supernatant was collected and concentrated to a solid-liquid ratio of 1 g: 10 mL to obtain a concentrated solution.

[0087] (5) Add 31 g of erythritol and 0.12 g of mogroside to the concentrated solution and stir evenly to obtain a medicine-food oral solution.

[0088] Comparative Example 1

[0089] (1) Crush Hovenia dulcis and Dendrobium officinale separately and pass through a 20-mesh sieve.

[0090] (2) Take 2.5 g of Pueraria root, 6 g of Coix seed, 6 g of dried orange peel, 6 g of sieved Hovenia dulcis, 6 g of chrysanthemum, 4 g of liquorice, and 3 g of hawthorn, add water at a weight ratio of 1:10 to the extract to water, then heat to 95°C, extract for 20 min, and filter to obtain extract A1 and a residue; take 3 g of mint and the above-mentioned residue, add water at a weight ratio of 1:10 to the total weight of mint and the residue to the weight of water, then heat to 95°C, extract again for 20 min, filter to obtain extract A2, and combine extract A1 and extract A2 to obtain extract A.

[0091] (3) Take 10 g of the sieved Dendrobium officinale, add water at a ratio of 1:20 of the weight of the Dendrobium officinale to the weight of water, heat to 95°C, extract for 2 hours, and then filter to obtain a Dendrobium officinale extract and a filter residue. The filter residue is extracted again under the same conditions for a total of three extractions. The Dendrobium officinale extracts are combined to obtain an extract B, which is then combined with the extract A to obtain an extract.

[0092] (4) The extract was centrifuged at 8000 rpm for 30 min, the supernatant was collected and concentrated to a solid-liquid ratio of 1 g: 10 mL to obtain a concentrated solution.

[0093] (5) Add 11.8 g of erythritol and 0.05 g of mogroside to the concentrated solution and stir evenly to obtain a medicine-food oral solution.

[0094] Comparative Example 2

[0095] (1) Take 15 g of Pueraria root, 6 g of Coix seed, 6 g of dried orange peel, 6 g of chrysanthemum, 4 g of liquorice and 3 g of hawthorn, add water at a weight ratio of 1:10 to the extract and water, then heat to 95°C, extract for 20 min, filter and obtain extract A1 and filter residue; take 3 g of mint and the above filter residue, add water at a weight ratio of 1:10 to the total weight of mint and filter residue and water, then heat to 95°C, extract again for 20 min, filter and obtain extract A2, combine extract A1 and extract A2 to obtain extract A.

[0096] (2) Centrifuge the extract A at 8000 rpm for 30 min, take the supernatant, and concentrate it to a solid-liquid ratio of 1 g: 10 mL to obtain a concentrated solution.

[0097] (3) Add 10.9 g of erythritol and 0.04 g of mogroside to the concentrated solution and stir evenly to obtain a medicine-food oral solution.

[0098] Test example-Pharmacodynamic evaluation

[0099] The inventors evaluated the effects of alcohol sobering, liver protection and stomach nourishing on the medicinal and edible products prepared in the above examples, and found that they have good therapeutic effects on alcoholic liver damage and alcoholic gastric mucosal damage. The following is a specific scheme and test results of the pharmacodynamic evaluation.

[0100] 1. Test Materials

[0101] Experimental animals: male SD rats, 180-220g, Elite / SPF grade; male KM mice, 18-22g, Elite / SPF grade, provided by Beijing Weitonglihua Experimental Animal Technology Co., Ltd., certificate number SCXK (Beijing) 2021-0006.

[0102] Experimental reagents and drugs: Anhydrous ethanol was purchased from Yongda Reagent, batch number 20221010; Silybin capsules were purchased from Tianjin Tasly Saint Pharmaceutical Co., Ltd., batch number 250612019; Omeprazole enteric-coated capsules were purchased from Yuekang Pharmaceutical Group Co., Ltd., batch number 14321033; 4% tissue fixative was purchased from solarbio, batch number 20230227; PBS buffer was purchased from solarbio, batch number 20230808; Heparin sodium was purchased from Yuanye Biotechnology, batch number J07HS186383.

[0103] 2. Test methods

[0104] 2.1 Dosage regimen

[0105] Table 1 Dosage regimen for rats

[0106] Group Daily dosage (raw drug amount) Control group 0g / kg Model Group 0g / kg Omeprazole group 3.60mg / kg Silybin Capsules Group 28.35mg / kg Examples 1-5 and Comparative Examples 1 and 2 5.31g / kg

[0107] Table 2 Dosing regimen for mice

[0108] Group Daily dosage (raw drug amount) Control group 0g / kg Model Group 0g / kg Omeprazole group 5.20mg / kg Silybin Capsules Group 40.95mg / kg Examples 1-5 and Comparative Examples 1 and 2 7.67g / kg

[0109] The human body weight is 70kg, the equivalent dose ratio between humans and rats is 6.3, the equivalent dose ratio between humans and mice is 9.1, the daily dose of silybin capsules is 315mg, and the daily dose of omeprazole enteric-coated capsules is 40mg.

[0110] 2.2 Model Building

[0111] After one week of adaptive feeding of rats and mice, the experiments were carried out according to the above grouping. Starting from the first day, the drug administration group was gavaged with drugs, and the control group and the model group were gavaged with an equal amount of pure water, once in the morning and afternoon every day. The gavage dose is shown in the table above, and the gavage is continued for 13 days. Starting from the 8th day, 2 hours after gavage of drugs in the afternoon, the model group and the drug administration group rats were gavaged with 2ml of 50% ethanol, the model group and the drug administration group mice were gavaged with 0.2ml of 50% ethanol, and the control group was gavaged with an equal amount of pure water, once a day, for 5 consecutive days. During the modeling period, the experimental animals were weighed every day before the start of the experiment. Fasting was performed after the end of the last day of the experiment. On the thirteenth day, the experimental animals were weighed, and 4-6 fresh feces of the mice in the control group, model group and drug administration group were taken and frozen in dry ice. After blood was taken from the orbit, the liver and stomach of the experimental animals were dissected. After the liver was weighed, the same part was taken and fixed in 4% tissue fixative, and then the same part was taken and frozen in dry ice. The stomach of the experimental animal was cut open from the pylorus along the greater curvature to the cardia, washed with PBS buffer, photographed, and scored according to Table 3. The stomach was cut open in the middle, the left half was fixed in 4% tissue fixative, and the right half was frozen in dry ice.

[0112] Table 3 Scoring criteria for gastric mucosal injury

[0113] Damage level 1 point 2 points 3 points 4 points Bleeding Point 1 - - - Bleeding zone (mm) 1~5 6~10 10~15 >15

[0114] 2.3 Histopathological examination

[0115] The stomach and liver tissues were immersed in 4% paraformaldehyde for 24 hours. The tissues were dehydrated, embedded and sliced ​​(5 μm). The tissue sections were stained using the hematoxylin and eosin (H&E) method. The structure of the lung tissue was photographed using a microscope (Leica, Germany).

[0116] 2.4 Sequencing analysis of intestinal flora

[0117] The 16S rRNA sequencing of mouse fecal intestinal flora was completed by Wuhan Saiweier Biotechnology Co., Ltd. The experimenters took 30 ng of qualified genomic DNA samples for PCR amplification, established a library after purification, and used Agilent 2100 Bioanalyzer to screen the library. After screening, the qualified library was introduced into Illumina high-throughput sequencing.

[0118] 2.5 Data Statistics

[0119] The data obtained in this experiment were statistically analyzed using GraphPad Prism 8.0, and the analysis method was one-way analysis of variance. The statistical results were shown as mean ± standard deviation (SD). P < 0.05 was considered statistically significant.

[0120] 3. Test results

[0121] 3.1 Weight change results

[0122] Figure 1 The figure is a graph of the weight change of the experimental animals during the modeling period. The results show that compared with the model group, the weight loss of rats and mice in Example 1-5 groups was significantly reduced, and the effect was comparable to that of the positive drugs omeprazole and silybin capsule. It can be seen that the medicine-food oral liquid of the present invention significantly reduced the weight loss of rats and mice caused by ethanol.

[0123] 3.2 Liver index results

[0124] Figure 2 The results are statistical results of the liver index of the experimental animals. The results show that compared with the model group, the increase in the liver index of rats and mice in Example 1-5 groups was significantly reduced, and the effect was equivalent to that of the positive drug Silybin Capsule. It can be seen that the medicine-food oral liquid of the present invention significantly reduced the increase in the liver index of rats and mice induced by ethanol.

[0125] 3.3 Gastric mucosal injury index results

[0126] Figure 3 The gastric mucosa of rats and the statistical diagram of gastric mucosal damage degree are shown. The gastric mucosa of the rats in the control group is light brown, with a smooth and shiny surface. The gastric mucosa of the rats in the model group is bright red, with a wrinkled surface and full of bleeding spots and bleeding bands. Compared with the model group, the gastric mucosal damage degree of the rats in Example 1-5 groups is significantly reduced, and the reduction degree of Example 1 and 3 groups is equivalent to that of the positive drug omeprazole. The results show that the medicine and food oral liquid of the present invention effectively reduces the gastric mucosal damage of rats induced by ethanol.

[0127] Figure 4 The gastric mucosa of mice and the statistical diagram of gastric mucosal damage degree are shown. The gastric mucosa of mice in the control group is light brown, with a smooth and shiny surface. The gastric mucosa of mice in the model group is bright red, with a wrinkled surface and full of bleeding spots and bleeding bands. Compared with the model group, the gastric mucosal damage of rats and mice in Example 1-5 groups was significantly reduced, among which the reduction degree of Example 1 and 3 groups was equivalent to that of the positive drug omeprazole. The results show that the medicine-food oral liquid of the present invention effectively reduces the gastric mucosal damage of mice induced by ethanol.

[0128] 3.4 Gastric mucosal pathological section results

[0129] Figure 5 The gastric mucosal pathological sections of the experimental animals are shown in Figure 2. The gastric mucosal H&E results showed that compared with the control group, the gastric mucosa of the rats and mice in the model group had obvious glandular stomach erosion, while the gastric mucosal damage of the rats and mice in the Example 1-5 group and the omeprazole group was significantly alleviated, and the alleviation effect of the Example 1-5 group was equivalent to that of the positive drug omeprazole.

[0130] 3.5 Results of liver tissue pathology

[0131] Figure 6 The following are pictures of pathological sections of liver tissue of experimental animals. The results of H&E of mouse liver tissue showed that compared with the control group, the liver cells of mice in the model group showed obvious increase in nuclear division and vesicular cavitation. The damage to the liver tissue of mice in the Example 1-5 group and the omeprazole group was significantly alleviated, and the alleviation effect of the Example 1-5 group was equivalent to that of the positive drug omeprazole. The results of H&E of rat liver showed that the liver tissue of rats in the model group had obvious vesicular cavitation, while the damage to the liver tissue of rats in the Example 1-5 group and the omeprazole group was significantly alleviated, and the alleviation effect of the Example 1-5 group was equivalent to that of the positive drug omeprazole.

[0132] 3.6 Analysis of mouse intestinal flora results

[0133] Figure 7 This is a statistical diagram of the mouse intestinal flora analysis results of Example 1. Figure 7 As shown in A, compared with the control group, the species distribution of the fecal flora of mice in the model group changed significantly, among which the proportion of Bacteroidetes, Lactobacillaceae and Verrucomicrobiaceae decreased, and the proportion of Lachnospiraceae and Oscillospiraceae increased. The medicinal and edible oral liquid of Example 1 adjusted the species proportion of the above species and greatly increased the population of Lactobacillaceae. Figure 7 B in the figure is the difference analysis between the intestinal flora groups of mice. The results showed that compared with the model group, the medicine-food oral solution of Example 1 increased the number of flora of the family Murine Bacillus, Lactobacillaceae and Akkermansia muciniphila in the feces of mice induced by 50% ethanol, and decreased the number of flora of the family Ruminococcaceae and Oscillospiraceae.

[0134] The above are only several exemplary embodiments of the present invention, and are not intended to limit the present invention in any form. Although the present invention is disclosed as above with preferred embodiments, they are not intended to limit the present invention. Any technician familiar with the profession, without departing from the scope of the technical solution of the present invention, can make some changes or modifications to obtain equivalent or equivalent embodiments using the above disclosed technical content, all of which belong to the scope of the present invention.

Claims

1. A medicinal and edible composition for sobering up, protecting the liver and stomach, comprising or consisting of the following components by weight: 10-30 parts of kudzu root, 6-20 parts of dendrobium officinale, 2-12 parts of coix seeds, 2-12 parts of tangerine peel, 2-12 parts of hovenia dulcis, 2-12 parts of chrysanthemum, 1-8 parts of liquorice, 1-8 parts of mint, 1-8 parts of hawthorn, and optional pharmaceutically and / or food acceptable excipients.

2. The edible-medicinal composition according to claim 1, wherein: The medicine-food composition comprises or consists of the following components by weight: 12-18 parts of Pueraria root, 8-12 parts of Dendrobium officinale, 4-8 parts of Coix seeds, 4-8 parts of dried orange peel, 4-8 parts of Hovenia dulcis, 4-8 parts of chrysanthemum, 2-6 parts of liquorice, 1-5 parts of mint, 1-5 parts of hawthorn, and optional pharmaceutically and / or food acceptable excipients; Preferably, the edible and medicinal composition comprises or consists of the following components in parts by weight: 15 parts of Pueraria root, 10 parts of Dendrobium officinale, 6 parts of Coix seeds, 6 parts of dried tangerine peel, 6 parts of Hovenia dulcis, 6 parts of chrysanthemum, 4 parts of liquorice, 3 parts of mint, 3 parts of hawthorn and optional pharmaceutically and / or food acceptable excipients.

3. The medicine-food composition according to claim 1 or 2, wherein the pharmaceutically and / or food-acceptable auxiliary material is selected from one or more of a preservative, an antioxidant, a flavoring agent, a thickener and an absorption promoter; Preferably, the flavoring agent is a sweetener and / or a fragrance; Further preferably, the sweetener is selected from one or more of sorbitol, xylitol, erythritol, mogroside and steviol glycoside, preferably mogroside and erythritol; more preferably, the weight ratio of mogroside to erythritol in the medicine-food composition is 1: 200-300, preferably 1: 250; Further preferably, the fragrance is fresh lemon and / or dried osmanthus; Further preferably, in the medicine-food composition, the sweetener is 0-100 parts by weight, preferably 10-65 parts; Further preferably, in the edible-medicinal composition, the aromatic agent is 0-50 parts by weight, preferably 0.5-30 parts by weight.

4. A medicinal and edible product for sobering up, protecting the liver and stomach, which is prepared from the medicinal and edible composition according to any one of claims 1 to 3; Preferably, the dosage form of the medicine-food homologous product is selected from one or more of powders, tablets, granules, capsules, solutions, emulsions and suspensions, preferably solutions.

5. A method for preparing the medicine-food homologous product according to claim 4, comprising the following steps: (1) preparing an extract of the edible-medicinal composition; (2) preparing the extract into a concentrated solution; (3) preparing the concentrated liquid into a medicine-food product.

6. The method according to claim 5, wherein: The step (1) comprises the following steps: (a) extracting kudzu root, coix seed, dried orange peel, Hovenia dulcis, chrysanthemum, liquorice and hawthorn by heating with an extraction solvent, and then filtering to obtain an extract A1 and a filter residue, respectively; (b) extracting the mint and the filter residue by heating with an extraction solvent to obtain an extract A2, and then combining the extract A1 and the extract A2 to obtain an extract A; (c) extracting the Dendrobium officinale by heating with an extraction solvent to obtain an extract B, and then combining the extract A with the extract B to obtain an extract.

7. The method according to claim 6, wherein: In steps (a) and (b), the heating extraction is independently carried out under the following conditions: the extraction temperature is 90-100° C., preferably 93-97° C.; the extraction time is 15-30 min, preferably 18-22 min; the weight ratio of the extract to the extraction solvent is 1: 8-12, preferably 1: 9-11; Preferably, in step (a), the Hovenia dulcis fruit is crushed and sieved before extraction; further preferably, the mesh number of the sieve is 10-30 mesh, preferably 15-25 mesh; Preferably, in step (c), the heating extraction is carried out under the following conditions: the extraction temperature is 90-100°C, preferably 93-97°C; the extraction time is 1.5-2.5h, preferably 1.8-2.2h; the weight ratio of the extract to the extraction solvent is 1:15-25, preferably 1:18-22; the number of extractions is 2-4 times, preferably 3 times; Preferably, in step (c), the Dendrobium officinale is crushed and sieved before extraction; further preferably, the mesh number of the sieve is 10-30 meshes, preferably 15-25 meshes; Preferably, in steps (a) to (c), the extraction solvents are each independently selected from one or more of water, 50% by volume ethanol and 70% by volume ethanol, preferably water.

8. The method according to any one of claims 5 to 7, wherein: The step (2) comprises the following steps: filtering, centrifuging and concentrating the extract in sequence to obtain a concentrated solution; Preferably, the centrifugation is carried out under the following conditions: the centrifugal speed is 6000-10000 rpm, preferably 7000-9000 rpm; the centrifugal time is 20-40 min, preferably 25-35 min; Preferably, the ratio of the total weight of the edible and medicinal composition to the volume of the concentrated solution is 1g: 5-15mL, preferably 1g: 8-12mL.

9. The method according to any one of claims 5 to 8, wherein: The step (3) comprises the following steps: optionally adding pharmaceutically and / or food acceptable auxiliary materials to the concentrated solution to obtain the medicine and food homologous product.

10. Use of the medicine-food composition according to any one of claims 1 to 3 or the medicine-food product according to claim 4 in the preparation of a medicament for preventing and / or treating liver damage and / or gastric damage; Preferably, the liver injury is acute liver injury; further preferably, the acute liver injury is selected from one or more of alcoholic fatty liver, alcoholic hepatitis, alcoholic liver fibrosis and alcoholic cirrhosis; Preferably, the gastric injury is gastric mucosal injury.

11. Use of the medicine-food composition according to any one of claims 1 to 3 or the medicine-food product according to claim 4 in preparing a food for providing auxiliary protection against chemical liver damage and / or auxiliary protection of gastric mucosa; Preferably, the chemical liver injury is alcoholic liver injury; Preferably, the auxiliary protection of gastric mucosa provides auxiliary protection against alcoholic gastric mucosal damage.

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