Traditional Chinese medicine composition for promoting alcohol metabolism and preparation of oral liquid of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of food and traditional Chinese medicine, and particularly relates to oral liquid for promoting alcohol metabolism. Through wide screening and compatibility tests, it is found that the radix puerariae extract, the hericium erinaceus extract, the schisandra chinensis extract, the taurine and the sodium alginate have a synergistic interaction effect in the process of promoting alcohol metabolism, and meanwhile the liver and stomach protecting effect is achieved. The separation aperture in the preparation process of the extract is optimized in the oral liquid preparation process, and specific embedding treatment is performed on water-insoluble components in the schisandra chinensis extract, so that the oral liquid disclosed by the invention can endure high-temperature sterilization without layering or precipitation and is good in stability, and a foundation is laid for promoting the development of alcohol metabolism products; and the method has important popularization and application values.

Description

Technical Field

[0001] The invention belongs to the technical field of food and traditional Chinese medicine, and in particular, the invention relates to an oral liquid for promoting alcohol metabolism. Background Art

[0002] Wine is a product based on fermentation technology. It is an alcoholic product obtained by microorganisms decomposing starch- or sugar-rich substances and then producing and processing them. The consumption of wine is currently an important product for human daily social interaction, but some people have health problems caused by poor alcohol metabolism and excessive drinking, such as gastritis, gastric ulcers, alcoholic liver damage, cirrhosis and other problems. Alcohol is absorbed into the human body mainly through the mouth, esophagus, stomach, intestinal mucosa and other pathways, mainly absorbed by the stomach, partly absorbed in the small intestine, and then enters the liver for metabolism. Most of the alcohol in the body is converted into acetaldehyde by alcohol dehydrogenase in the liver, and acetaldehyde is then oxidized and converted by acetaldehyde dehydrogenase, and finally converted into CO2 and water and excreted from the body. Therefore, promoting alcohol metabolism after drinking and reducing the adverse effects of excessive alcohol on the stomach, intestines and liver of the human body is a topic of widespread concern.

[0003] There are many traditional Chinese medicines that have been proven to promote alcohol metabolism, protect the liver and protect the stomach, such as Pueraria root, Salvia miltiorrhiza, Hovenia dulcis, Mung bean, Licorice, Turmeric, Milk thistle, etc. CN201710168541.9 discloses a health food with auxiliary protective effect on alcoholic liver damage, the dosage form is an oral liquid, which is prepared from 5-10 parts of Tremella fuciformis, 5-10 parts of Hericium erinaceus, 4-8 parts of Hovenia dulcis, 5-8 parts of Pueraria root, 1-3 parts of Schisandra chinensis, 1-3 parts of chitosan oligosaccharide and 1-5 parts of Licorice. It uses Tremella as the main drug, which has the effects of moistening the lungs and nourishing yin, calming the liver and benefiting the stomach; the ministerial drug Hericium erinaceus has the effects of protecting the liver and nourishing the stomach, reducing fire and nourishing yin; with the four flavors of Hovenia dulcis, Pueraria root, Schisandra chinensis, and chitosan oligosaccharide, it can play the effects of clearing away heat and detoxifying, calming the liver and purging fire, nourishing yin and promoting body fluid, nourishing the liver and tonifying the kidney; with Licorice as the messenger, it can nourish the spleen and replenish qi, and harmonize all the medicines to achieve the purpose of calming the liver and detoxifying, protecting the liver and relieving alcohol. However, the oral liquid Tremella is the main drug, mainly protecting the stomach and liver and reducing fire, and has limited effect on promoting the metabolism of alcohol. At the same time, the Chinese medicine extracts used in the patent, such as Schisandra chinensis, are polysaccharide components obtained by water extraction and alcohol precipitation, lacking the main water-insoluble functional ingredients in Schisandra chinensis. It has always been a problem that technicians in the field are committed to solving to prepare water-insoluble functional ingredients as oral liquids and maintain the long-term stability of oral liquid preparations in a multi-component system without stratification or precipitation. Summary of the invention

[0004] To further enhance the application of traditional Chinese medicine in promoting alcohol metabolism, protecting the liver and protecting the stomach, the present invention has prepared an oral liquid for promoting alcohol metabolism after a large number of tests and research verifications, which can significantly enhance the alcohol metabolism ability of the human body, and at the same time protect the liver and reduce gastric mucosal irritation. Furthermore, the oral liquid of the present invention solves the instability problem of water-insoluble functional ingredients in the oral liquid formula.

[0005] The technical solution of the present invention is as follows:

[0006] In a first aspect of the present invention, an oral liquid for promoting alcohol metabolism is disclosed, wherein the oral liquid is made of the following ingredients, by weight: 6-30 parts of Pueraria extract, 4-35 parts of Hericium erinaceus extract, 1-12 parts of Schisandra chinensis extract, 2-30 parts of taurine, and 4-25 parts of sodium alginate.

[0007] In one embodiment, the present invention discloses an oral liquid for promoting alcohol metabolism, which is made of the following ingredients, by weight: 10-30 parts of Pueraria extract, 4-22 parts of Hericium erinaceus extract, 2-8 parts of Schisandra chinensis extract, 5-20 parts of taurine, and 5-13 parts of sodium alginate.

[0008] Preferably, the oral liquid for promoting alcohol metabolism of the present invention is made of the following ingredients, by weight: 18 parts of Pueraria extract, 10 parts of Hericium erinaceus extract, 4 parts of Schisandra chinensis extract, 10 parts of taurine, and 10 parts of sodium alginate.

[0009] It is understood by those skilled in the art that, as an oral liquid, the majority of the components in the oral liquid of the present invention are water. As an oral liquid preparation, the oral liquid also includes excipients acceptable in food, medicine, and health food. The excipients include suspending agents, emulsifiers, flavoring agents, flavors, and spices.

[0010] In the present invention, the flavoring agent includes one or more of bitter masking agent, sweetener, edible acid and edible alkali. The sweetener includes stevioside, mogroside, honey, sucrose, erythritol, acesulfame potassium, sucralose and xylitol. The edible acid includes citric acid, acetic acid, malic acid, carbonic acid, phosphoric acid, lactic acid, tartaric acid and fumaric acid; the edible alkali includes sodium citrate, sodium carbonate and sodium bicarbonate.

[0011] In the present invention, the emulsifier includes one or more of sorbitan monopalmitate, sucrose fatty acid ester or monoglyceride, soybean lecithin, and sodium stearoyl lactylate.

[0012] In the present invention, the suspending agent includes beeswax, plant gum, plant polysaccharide, cellulose and its derivatives, chitin, chitosan and agar.

[0013] In a second aspect of the present invention, the present invention provides a method for preparing an oral liquid for promoting alcohol metabolism, the method comprising dissolving Pueraria extract, Hericium erinaceus extract, Schisandra chinensis extract, taurine, sodium alginate and auxiliary materials completely in purified water, and then mixing, filtering, fixing the volume, filling, sterilizing and packaging to obtain the oral liquid of the present invention.

[0014] In one embodiment, the preparation process of the kudzu root extract is as follows: the kudzu root medicinal material after impurities are removed is coarsely crushed by a grinder, put into a medicinal material extraction tank, boiled twice with water, filtered, concentrated, filtered again, spray dried, crushed, and sieved to prepare the extract. Preferably, the pore size of the feed liquid filter during the preparation of the extract is ≤53 μm.

[0015] In one embodiment, the preparation process of the Hericium erinaceus extract is as follows: the Hericium erinaceus medicinal material after impurities are removed is coarsely crushed with a grinder, put into a medicinal material extraction tank, boiled twice with water, filtered, concentrated, alcohol precipitated, concentrated, spray dried, crushed, and sieved to prepare. Preferably, the pore size of the feed liquid filter during the preparation of the extract is ≤20 μm.

[0016] In one embodiment, the preparation process of Schisandra chinensis extract is as follows: the Schisandra chinensis medicinal material after impurities are removed is coarsely crushed by a grinder, put into a medicinal material extraction tank, and refluxed and extracted twice with ethanol, filtered, concentrated, formulated, spray-dried, crushed, and sieved to prepare the extract. Preferably, the pore size of the liquid filter is ≤10μm, and the pore size of the powder after crushing is ≤157μm;

[0017] In one embodiment, after the schisandra extract is concentrated during the extraction process, γ-cyclodextrin and maltodextrin are added to encapsulate the water-insoluble schisandra lignans. Preferably, the encapsulation components contain: 10 parts of schisandra extract, 2 parts of γ-cyclodextrin, and 3 parts of maltodextrin.

[0018] Pueraria root is the dried rhizome of the leguminous plant Pueraria lobata. According to Shennong's Herbal Classic, Pueraria root is "sweet and mild in taste, grows in rivers and valleys, treats thirst, fever, vomiting, and arthritis, raises yin qi, and resolves various toxins". Pueraria root has the effects of relieving muscles and fever, promoting body fluid, clearing rashes, raising yang and stopping diarrhea, unblocking meridians, and relieving alcohol. Puerarin in Pueraria root extract is one of the most important active ingredients in Pueraria root, which can reduce ethanol-induced liver damage by inhibiting inflammatory response, enhancing ethanol metabolism and mitochondrial biosynthesis, and reducing oxidative stress levels.

[0019] Hericium erinaceus is an edible mushroom from the family Odontaceae. The cap of Hericium erinaceus has fleshy thorns and the cap is shaped like a golden monkey head, hence the name "hericium erinaceus". Hericium erinaceus is rich in protein, amino acids, vitamins and trace mineral elements, as well as polysaccharides, terpenes and sterols, and has high nutritional value. Studies have shown that Hericium erinaceus can play an anti-inflammatory role and protect the gastric mucosa, and has a good effect on gastric diseases such as peptic ulcers, chronic gastritis and gastric ulcers.

[0020] Schisandra chinensis, also known as five plums and mountain pepper, is the mature fruit of the Magnoliaceae plant Schisandra chinensis, and is a Chinese medicine for both medicine and food. According to the "Shennong's Herbal Classic", Schisandra chinensis has the effects of nourishing the lungs and kidneys, promoting fluid production and sweating, astringing semen and stopping pain, and calming the mind. The main components of Schisandra chinensis are Schisandra chinensis lignins and Schisandra chinensis polysaccharides. Schisandra chinensis lignin components are mainly obtained by alcohol extraction, which is not easily soluble in water and is also unstable in aqueous solution.

[0021] The present invention is a health food made of kudzu root extract, schisandra chinensis extract, hericium erinaceus extract, taurine and sodium alginate as main raw materials. The kudzu root extract in the prescription of the present invention is the main drug. The kudzu root has the effects of relieving muscle and fever, promoting body fluid and quenching thirst, clearing rash, raising yang and stopping diarrhea, promoting blood circulation and activating collaterals, and detoxifying alcohol. It is recorded in "Ben Cao Yan Yi": "It is very good for those who are sick with alcohol and thirsty"; "Dian Nan Ben Cao" records: "It can relieve alcohol heat toxins"; modern pharmacological studies have shown that kudzu root has the effects of dilating coronary arteries and cerebral blood vessels, reducing myocardial oxygen consumption, improving myocardial contractile function, reducing blood viscosity, improving circulation, etc., and can reduce the amount of alcohol absorbed by mice, accelerate alcohol metabolism, and improve the effect of alcohol tolerance. Schisandra chinensis and hericium erinaceus are both ministerial drugs. Schisandra chinensis has the effects of astringent, invigorating qi and promoting body fluid, and tonifying the kidney and calming the mind; modern pharmacological studies have shown that the lignan components in Schisandra chinensis can promote the repair of damaged liver cells, increase glutathione levels, and reduce serum alanine aminotransferase and aspartate aminotransferase activities. Hericium erinaceus has the effects of promoting qi and digestion, strengthening the spleen and appetizing, calming the mind and improving intelligence; modern pharmacological studies have shown that Hericium erinaceus polysaccharides can promote the increase of gastric mucosal blood flow, catalyze the protective effects of various gastric mucosal factors, and play an anti-ulcer, gastric mucosal protection and treatment of stress-induced gastric mucosal damage. Schisandra chinensis and Hericium erinaceus have significant liver and stomach protection effects, thereby assisting the synergistic effect of Pueraria lobata to effectively promote alcohol metabolism. Taurine and sodium alginate are compounded to strengthen the health care effects of the monarch and minister drugs in protecting the liver and stomach and promoting alcohol metabolism. Taurine is a conditionally essential amino acid for humans and most animals. It is mainly synthesized in the liver and has a good effect of protecting the liver, sobering up and preventing drunkenness. Modern pharmacological studies have shown that taurine can prolong the body's tolerance to alcohol, shorten the duration of drunkenness, and significantly reduce the ethanol concentration in the blood and increase the activity of ADH and ALDH in the liver. Sodium alginate is a hydrophilic natural polysaccharide component extracted from brown algae. After it comes into contact with gastric acid, it will form a material barrier, thereby effectively reducing the damage of alcohol to the gastric mucosa. The formula of the invention achieves the effects of protecting the liver and stomach, soothing alcohol and preventing drunkenness through the scientific combination of monarch, minister, assistant and guiding ingredients.

[0022] Beneficial Effects

[0023] (1) The components of the present invention, such as kudzu root, hericium erinaceus, schisandra chinensis, taurine and sodium alginate, synergize with each other in promoting alcohol metabolism, and can quickly and effectively increase the activities of alcohol dehydrogenase and acetaldehyde dehydrogenase, reduce the ethanol concentration in the blood, and simultaneously exert antioxidant stimulation and barrier effects to reduce the burden on the liver and stomach and reduce alcohol absorption.

[0024] (2) The present invention solves the technical problem that water-insoluble components in a multi-component solution system are difficult to mix in an oral liquid and are prone to stratification and precipitation. The oral liquid of the present invention has high mixing uniformity and is free of stratification and precipitation.

[0025] (3) Conventional multi-component suspension systems containing water-soluble ingredients cannot withstand high-temperature sterilization. Once sterilized at high temperature, the internal balance of the suspension system is destroyed, and solid-liquid stratification problems are likely to occur. However, the oral liquid prepared in the present invention has good stability and can withstand high-temperature sterilization, which lays a foundation for promoting the development of alcohol metabolism products and has important promotion and application value. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 , HPLC detection chart of the effective ingredients of Schisandra chinensis contained in sample No. 005 in Example 81.

[0027] Figure 2 , product sedimentation comparison, where the left picture is the sedimentation stratification test of comparative example 328, and the right picture is the sedimentation stratification test of embodiment 81. DETAILED DESCRIPTION

[0028] The embodiments of the present invention will be described in detail below in conjunction with the examples, but those skilled in the art will appreciate that the following examples are only used to illustrate the present invention and should not be considered to limit the scope of the present invention. If no specific conditions are specified in the examples, they are carried out according to normal conditions or the conditions recommended by the manufacturer. If the manufacturer is not specified for the reagents or instruments used, they are all conventional products that can be obtained commercially.

[0029] Example 1

[0030] The present embodiment provides an oral liquid for promoting alcohol metabolism, wherein the oral liquid is prepared by weight from 18 parts of Pueraria root extract, 10 parts of Hericium erinaceus extract, 4 parts of Schisandra chinensis extract, 10 parts of taurine, and 10 parts of sodium alginate.

[0031] The preparation method of the traditional Chinese medicine composition of Example 1 comprises the following steps: respectively dissolving the kudzu root extract, hericium erinaceus extract, schisandra chinensis extract, taurine, sodium alginate, and auxiliary materials (including bitter essence, steviol glycoside, and citric acid) accounting for 8% of the weight of the oral solution in purified water, mixing, and adjusting the volume to 500 parts, stirring evenly, filtering, filling, and sterilizing at 121° C. for 15 minutes to prepare an oral solution.

[0032] In this embodiment, the preparation method of the kudzu root extract includes coarsely crushing the kudzu root with a grinder, extracting, concentrating, and drying to obtain the kudzu root extract. The specific preparation method of the kudzu root extract is: the coarsely crushed kudzu root is firstly extracted with 8-10 times the amount of water at 100°C for 1.5 hours, and the second time is extracted with 5-7 times the amount of water at 100°C for 1 hour, concentrated and filtered, and spray dried (inlet air temperature 185°C, outlet air temperature 95°C), wherein the pore size of the concentrated liquid filtration is 53μm.

[0033] In this embodiment, the preparation method of the Hericium erinaceus extract comprises coarsely crushing the Hericium erinaceus with a pulverizer, extracting, concentrating, precipitating with alcohol, concentrating, and drying to obtain the Hericium erinaceus extract. The specific preparation method of the Hericium erinaceus extract is: the Hericium erinaceus after coarse crushing is extracted for 1.5 hours at 100°C for the first time with 10-12 times the amount of water, extracted for 1 hour at 100°C for the second time with 8-10 times the amount of water, concentrated, precipitated with 2.5 times the amount of ethanol, filtered after concentration, and spray dried (inlet air temperature 180°C, outlet air temperature 85°C), wherein the aperture of the concentrated liquid filtration is 20μm.

[0034] In this embodiment, the preparation method of the schisandra extract comprises coarsely crushing the schisandra with a pulverizer, extracting, concentrating, drying, and crushing to obtain the schisandra extract. The specific preparation method of the schisandra extract is: after the coarse crushing, 4-5 times the amount of 60% ethanol is added for the first time to reflux and extract for 1.5 hours, and 3-4 times the amount of 60% ethanol is added for the second time to reflux and extract for 1 hour, after concentration, filtering, embedding, spray drying (inlet air temperature 190°C, outlet air temperature 97°C), crushing and sieving, wherein the aperture of the concentrated liquid filtration is 10μm; the embedding ratio is 10 parts of schisandra extract, 2 parts of γ-cyclodextrin, and 3 parts of maltodextrin; the powder after crushing has a sieve aperture of ≤157μm.

[0035] Example 2

[0036] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 6 parts of Pueraria extract, 35 parts of Hericium erinaceus extract, 1 part of Schisandra chinensis extract, 2 parts of taurine, and 25 parts of sodium alginate.

[0037] Example 3

[0038] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 30 parts of Pueraria extract, 4 parts of Hericium erinaceus extract, 12 parts of Schisandra chinensis extract, 30 parts of taurine, and 4 parts of sodium alginate.

[0039] Example 4

[0040] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 13 parts of Pueraria extract, 22 parts of Hericium erinaceus extract, 8 parts of Schisandra chinensis extract, 20 parts of taurine, and 5 parts of sodium alginate.

[0041] Example 5

[0042] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 24 parts of Pueraria extract, 8 parts of Hericium erinaceus extract, 2 parts of Schisandra chinensis extract, 5 parts of taurine, and 13 parts of sodium alginate.

[0043] Example 6

[0044] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 10 parts of Pueraria extract, 9 parts of Hericium erinaceus extract, 10 parts of Schisandra chinensis extract, 3 parts of taurine, and 20 parts of sodium alginate.

[0045] Example 7

[0046] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 20 parts of Pueraria extract, 4 parts of Hericium erinaceus extract, 6 parts of Schisandra chinensis extract, 12 parts of taurine, and 10 parts of sodium alginate.

[0047] Comparative Example 1

[0048] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 5 parts of Pueraria extract, 40 parts of Hericium erinaceus extract, 0.5 parts of Schisandra chinensis extract, 35 parts of taurine, and 2 parts of sodium alginate.

[0049] Comparative Example 2

[0050] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 35 parts of Pueraria extract, 2 parts of Hericium erinaceus extract, 15 parts of Schisandra chinensis extract, 1 part of taurine, and 30 parts of sodium alginate.

[0051] Comparative Example 3

[0052] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 18 parts of Pueraria root extract.

[0053] Comparative Example 4

[0054] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 10 parts of Hericium erinaceus extract.

[0055] Comparative Example 5

[0056] The only difference between this embodiment and embodiment 1 is that the raw materials of the Chinese medicine composition are as follows: 4 parts of Schisandra chinensis extract.

[0057] Comparative Example 6

[0058] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 10 parts of taurine.

[0059] Comparative Example 7

[0060] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 10 parts of sodium alginate.

[0061] Comparative Example 8

[0062] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 18 parts of Pueraria extract, 10 parts of Hericium erinaceus extract, 4 parts of Schisandra chinensis extract, and 10 parts of taurine.

[0063] Comparative Example 9

[0064] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 18 parts of Pueraria extract, 10 parts of Hericium erinaceus extract, 4 parts of Schisandra chinensis extract, and 10 parts of sodium alginate.

[0065] Comparative Example 10

[0066] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 18 parts of Pueraria extract, 10 parts of Hericium erinaceus extract, 10 parts of taurine, and 10 parts of sodium alginate.

[0067] Comparative Example 11

[0068] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 18 parts of Pueraria extract, 4 parts of Schisandra chinensis extract, 10 parts of taurine, and 10 parts of sodium alginate.

[0069] Comparative Example 12

[0070] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 10 parts of Hericium erinaceus extract, 4 parts of Schisandra chinensis extract, 10 parts of taurine, 10 parts of sodium alginate, and 18 parts of Hovenia dulcis extract.

[0071] Comparative Example 13

[0072] The only difference between this embodiment and embodiment 1 is that the raw material components of the oral liquid are as follows: 18 parts of kudzu root extract, 4 parts of schisandra chinensis extract, 10 parts of taurine, 10 parts of sodium alginate, and 10 parts of yam extract.

[0073] 1.1 Test on the alcohol metabolism promoting function of Examples 1-7 and Comparative Examples 1-13

[0074] 1. Instruments and reagents

[0075] R550lP small animal anesthesia machine (Shenzhen Ruiwode Life Science Co., Ltd.); Agilent 6890Plus PETurbo Matrix 40 headspace-gas chromatograph (Agilent); Red Star Erguotou (alcohol content 56% vol, Beijing Red Star Co., Ltd.);

[0076] 2. Animal selection

[0077] SPF male KM mice, weighing 20-25 g, 8 mice per group.

[0078] 3. Methods

[0079] The experiment set up 22 groups, Group 1 was the blank group, Group 2 was the model group, and the mice in the other groups were gavaged with the corresponding test substances at 10 mL / kg body weight. The blank group and the model group were gavaged with an equal volume of deionized water, once a day for 14 consecutive days. The mice were fasted for 12 hours before the last administration. 1 hour after the last administration, the mice in the other groups except the blank group were gavaged with Red Star Erguotou at 15 mL / kg body weight to prepare the mouse drunkenness model.

[0080] 4. Test steps:

[0081] Plasma was collected 1, 2, and 3 hours after modeling, and the blood ethanol volume fraction was detected by gas chromatography.

[0082] 5. Test results:

[0083] Table 1. Test results of ethanol volume fraction in different groups (* indicates P < 0.05 compared with the model group, ** indicates P < 0.01 compared with the model group)

[0084]

[0085] Referring to Table 1, compared with the model group, Example Groups 1-7, Comparative Examples 1-3, Comparative Examples 8-11, 13 can all reduce the ethanol concentration in the blood to varying degrees and promote alcohol metabolism (P < 0.05 or 0.01). When 6-30 parts of Pueraria extract, 4-35 parts of Hericium erinaceus extract, 1-12 parts of Schisandra extract, 2-30 parts of taurine, and 4-25 parts of sodium alginate are used, the effect of promoting alcohol metabolism is better; among them, when 18 parts of Pueraria extract, 10 parts of Hericium erinaceus extract, 4 parts of Schisandra extract, 10 parts of taurine, and 10 parts of sodium alginate are used, the effect of promoting alcohol metabolism is the strongest (P < 0.01), indicating that Example 1 is the best combination. The alcohol metabolism promoting effect of the Example Group at 1h, 2h, and 3h after drinking is significantly different from that of the Model Group, indicating that the composition of the present invention takes effect quickly, and can continuously exert a significant alcohol sobering effect, and maintain the blood ethanol concentration at a relatively low level at the observation end point 3h. Comparative Examples 3-7 lack four of the oral liquid raw materials of the present invention, Comparative Examples 8-12 lack one of the oral liquid raw materials of the present invention, and in Comparative Example 13, a certain component of the oral liquid raw materials of the present invention is replaced by a yam extract, and the total amount of active ingredients remains unchanged. Comparative Examples 1-2 contain all the components of the oral liquid raw materials of the present invention, and the proportion is not within the scope of protection of the present invention. From the above results, although there is a certain effect of promoting alcohol metabolism, the final blood residual alcohol concentration is very different from that of the embodiment of the present invention, and the ability to promote alcohol metabolism is insufficient. Comparative Examples 1-3, Comparative Example 9, and Comparative Example 11 only show significant differences with the model group at 2h. At the third hour, only Comparative Example 2 still has significant differences, and the blood residual alcohol concentration is also significantly higher than the embodiment group, indicating that Comparative Examples 1-3, Comparative Example 9, and Comparative Example 11 promote alcohol metabolism slowly, have a short duration, and have insufficient ability to promote alcohol metabolism. Comparative Example 10 showed a significant difference with the blood residual alcohol concentration model group at 1 hour, but there was no significant difference at the 2nd and 3rd hours, indicating that although it can take effect quickly, it cannot be maintained for a long time; Comparative Example 8 showed a significant difference with the model group at 3 hours, indicating that it has a slow effect in promoting alcohol metabolism. It can be seen that only the oral liquid prepared under the specific weight parts of the present invention's Pueraria extract, Hericium erinaceus extract, Schisandra chinensis extract, taurine, and sodium alginate has a very obvious synergistic effect of promoting alcohol metabolism.

[0086] Embodiment 81

[0087] In this embodiment, the preparation method of the kudzu root extract includes coarsely crushing the kudzu root with a grinder, extracting, concentrating, and drying to obtain the kudzu root extract. The specific preparation method of the kudzu root extract is: the coarsely crushed kudzu root is first extracted with 8-10 times the amount of water at 100°C for 1.5 hours, and the second extraction is 5-7 times the amount of water at 100°C for 1 hour, concentrated and filtered, and spray dried (inlet air temperature 185°C, outlet air temperature 95°C), wherein the pore size of the concentrated liquid filtration is 53μm;

[0088] In this embodiment, the preparation method of the Hericium erinaceus extract comprises coarsely crushing the Hericium erinaceus with a pulverizer, extracting, concentrating, precipitating with alcohol, concentrating, and drying to obtain the Hericium erinaceus extract. The specific preparation method of the Hericium erinaceus extract is: the Hericium erinaceus after coarse crushing is extracted for 1.5 hours at 100°C for the first time with 10-12 times the amount of water, extracted for 1 hour at 100°C for the second time with 8-10 times the amount of water, concentrated, precipitated with 2.5 times the amount of ethanol, filtered after concentration, and spray dried (inlet air temperature 180°C, outlet air temperature 85°C), wherein the aperture of the concentrated liquid filtration is 20μm.

[0089] In this embodiment, the preparation method of the schisandra extract comprises coarsely crushing the schisandra with a pulverizer, extracting, concentrating, drying, and crushing to obtain the schisandra extract. The specific preparation method of the schisandra extract is: after the coarse crushing of the schisandra, add 4-5 times the amount of 60% ethanol for the first time, reflux extract for 1.5h, add 3-4 times the amount of 60% ethanol for the second time, reflux extract for 1h, concentrate and filter, embed auxiliary materials, spray dry (inlet air temperature 190°C, outlet air temperature 97°C), crush and screen, wherein the aperture of the concentrated liquid filtration is 10μm; the ratio of auxiliary material embedding is 10 parts of schisandra extract, 2 parts of γ-cyclodextrin, and 3 parts of maltodextrin; the aperture of the powder after crushing is ≤157μm.

[0090] Take 18 parts of Pueraria extract, 10 parts of Hericium erinaceus extract, 4 parts of Schisandra chinensis extract, 10 parts of taurine, and 10 parts of sodium alginate, which account for 8% of the weight of the excipients of the oral solution, add appropriate amount of purified water, stir to dissolve, mix, and make up to 500 parts. Stir evenly, filter, and sterilize at 121°C for 15 minutes. After sterilization, take 2 samples from the top, middle, and bottom of the container respectively (the corresponding sample numbers are 001, 002, 003, 004, 005, and 006).

[0091] Embodiment 82

[0092] The only difference between this embodiment and Embodiment 81 is that the preparation method of the raw materials is as follows: the sieve aperture of the Pueraria extract after concentration is 43 μm; the sieve aperture of the Hericium erinaceus extract after alcohol precipitation and concentration is 10 μm; the sieve aperture of the Schisandra extract after concentration is 5 μm, and the sieve aperture after drying and crushing is 147 μm.

[0093] Embodiment 83

[0094] The only difference between this embodiment and Embodiment 81 is that the preparation method of the raw materials is as follows: the sieve aperture of the Pueraria lobata extract after concentration is 30 μm; the sieve aperture of the Hericium erinaceus extract after alcohol precipitation and concentration is 5 μm; the sieve aperture of the Schisandra chinensis extract after concentration is 1 μm, and the sieve aperture after drying and crushing is 130 μm.

[0095] Comparative Example 321

[0096] The only difference between this embodiment and Embodiment 81 is that the preparation method of the raw materials is as follows: the sieve aperture of the Pueraria lobata extract after concentration is 60 μm; the sieve aperture of the Hericium erinaceus extract after alcohol precipitation and concentration is 20 μm; the sieve aperture of the Schisandra chinensis extract after concentration is 10 μm, and the sieve aperture after drying and crushing is 157 μm.

[0097] Comparative Example 322

[0098] The only difference between this embodiment and Embodiment 81 is that the preparation method of the raw materials is as follows: the sieve aperture of the Pueraria lobata extract after concentration is 53 μm; the sieve aperture of the Hericium erinaceus extract after alcohol precipitation and concentration is 25 μm; the sieve aperture of the Schisandra chinensis extract after concentration is 10 μm, and the sieve aperture after drying and crushing is 157 μm.

[0099] Comparative Example 323

[0100] The only difference between this embodiment and Embodiment 81 is that the preparation method of the raw materials is as follows: the sieve aperture of the Pueraria lobata extract after concentration is 53 μm; the sieve aperture of the Hericium erinaceus extract after alcohol precipitation and concentration is 20 μm; the sieve aperture of the Schisandra chinensis extract after concentration is 15 μm, and the sieve aperture after drying and crushing is 157 μm.

[0101] Comparative Example 324

[0102] The only difference between this embodiment and Embodiment 81 is that the preparation method of the raw materials is as follows: the sieve aperture of the Pueraria lobata extract after concentration is 53 μm; the sieve aperture of the Hericium erinaceus extract after alcohol precipitation and concentration is 20 μm; the sieve aperture of the Schisandra chinensis extract after concentration is 10 μm, and the sieve aperture after drying and crushing is 167 μm.

[0103] Comparative Example 325

[0104] The only difference between this embodiment and Embodiment 81 is that the preparation method of the raw materials is as follows: the sieve aperture of the Pueraria lobata extract after concentration is 53 μm; the sieve aperture of the Hericium erinaceus extract after alcohol precipitation and concentration is 20 μm; the sieve aperture of the Schisandra chinensis extract after concentration is 10 μm, and the sieve aperture after drying and crushing is 157 μm; the proportion of auxiliary materials used in the Schisandra chinensis extract is: 15 parts of Schisandra chinensis extract, 2 parts of γ-cyclodextrin, and 3 parts of maltodextrin.

[0105] Comparative Example 326

[0106] The only difference between this embodiment and Embodiment 81 is that the preparation method of the raw materials is as follows: the sieve aperture of the Pueraria lobata extract after concentration is 53 μm; the sieve aperture of the Hericium erinaceus extract after alcohol precipitation and concentration is 20 μm; the sieve aperture of the Schisandra chinensis extract after concentration is 10 μm, and the sieve aperture after drying and crushing is 157 μm; the proportion of auxiliary materials used in the Schisandra chinensis extract is: 5 parts of Schisandra chinensis extract, 2 parts of γ-cyclodextrin, and 3 parts of maltodextrin.

[0107] Comparative Example 327

[0108] The only difference between this embodiment and Embodiment 81 is that the preparation method of the raw materials is as follows: the sieve aperture of the Pueraria lobata extract after concentration is 53 μm; the sieve aperture of the Hericium erinaceus extract after alcohol precipitation and concentration is 20 μm; the sieve aperture of the Schisandra chinensis extract after concentration is 10 μm, and the sieve aperture after drying and crushing is 157 μm; the proportion of auxiliary materials used in the Schisandra chinensis extract is: 10 parts of Schisandra chinensis extract, 3 parts of γ-cyclodextrin, and 3 parts of maltodextrin.

[0109] Comparative Example 328

[0110] The only difference between this embodiment and Embodiment 81 is that the preparation method of the raw materials is as follows: the sieve aperture of the Pueraria lobata extract after concentration is 53 μm; the sieve aperture of the Hericium erinaceus extract after alcohol precipitation and concentration is 20 μm; the sieve aperture of the Schisandra chinensis extract after concentration is 10 μm, and the sieve aperture after drying and crushing is 157 μm; the proportion of auxiliary materials used in the Schisandra chinensis extract is: 10 parts of Schisandra chinensis extract, 1 part of γ-cyclodextrin, and 3 parts of maltodextrin.

[0111] Comparative Example 329

[0112] The only difference between this embodiment and Embodiment 81 is that the preparation method of the raw materials is as follows: the sieve aperture of the Pueraria lobata extract after concentration is 53 μm; the sieve aperture of the Hericium erinaceus extract after alcohol precipitation and concentration is 20 μm; the sieve aperture of the Schisandra chinensis extract after concentration is 10 μm, and the sieve aperture after drying and crushing is 157 μm; the proportion of auxiliary materials used in the Schisandra chinensis extract is: 10 parts of Schisandra chinensis extract, 2 parts of γ-cyclodextrin, and 4 parts of maltodextrin.

[0113] Comparative Example 330

[0114] The only difference between this embodiment and Embodiment 81 is that the preparation method of the raw materials is as follows: the sieve aperture of the Pueraria lobata extract after concentration is 53 μm; the sieve aperture of the Hericium erinaceus extract after alcohol precipitation and concentration is 20 μm; the sieve aperture of the Schisandra chinensis extract after concentration is 10 μm, and the sieve aperture after drying and crushing is 157 μm; the proportion of auxiliary materials used in the Schisandra chinensis extract is: 10 parts of Schisandra chinensis extract, 2 parts of γ-cyclodextrin, and 2 parts of maltodextrin.

[0115] Comparative Example 331

[0116] The only difference between this embodiment and Embodiment 81 is that the preparation method of the raw materials is as follows: the sieve aperture of the Pueraria lobata extract after concentration is 53 μm; the sieve aperture of the Hericium erinaceus extract after alcohol precipitation and concentration is 20 μm; the sieve aperture of the Schisandra chinensis extract after concentration is 10 μm, and the sieve aperture after drying and crushing is 157 μm; the proportion of auxiliary materials used in the Schisandra chinensis extract is: 10 parts of Schisandra chinensis extract, 2 parts of α-cyclodextrin, and 3 parts of maltodextrin.

[0117] Comparative Example 332

[0118] The only difference between this embodiment and Embodiment 81 is that the preparation method of the raw materials is as follows: the sieve aperture of the Pueraria lobata extract after concentration is 53 μm; the sieve aperture of the Hericium erinaceus extract after alcohol precipitation and concentration is 20 μm; the sieve aperture of the Schisandra chinensis extract after concentration is 10 μm, and the sieve aperture after drying and crushing is 157 μm; the proportion of auxiliary materials used in the Schisandra chinensis extract is: 10 parts of Schisandra chinensis extract, 2 parts of β-cyclodextrin, and 3 parts of maltodextrin.

[0119] Comparative Example 333

[0120] The only difference between this embodiment and Embodiment 81 is that the preparation method of the raw materials is as follows: the sieve aperture of the Pueraria lobata extract after concentration is 53 μm; the sieve aperture of the Hericium erinaceus extract after alcohol precipitation and concentration is 20 μm; the sieve aperture of the Schisandra chinensis extract after concentration is 10 μm, and the sieve aperture after drying and crushing is 157 μm; the proportion of auxiliary materials used in the Schisandra chinensis extract is: 10 parts of Schisandra chinensis extract, 2 parts of phospholipids, and 3 parts of maltodextrin.

[0121] Comparative Example 334

[0122] The only difference between this embodiment and Embodiment 81 is that the preparation method of the raw materials is as follows: the sieve aperture of the Pueraria lobata extract after concentration is 53 μm; the sieve aperture of the Hericium erinaceus extract after alcohol precipitation and concentration is 20 μm; the sieve aperture of the Schisandra chinensis extract after concentration is 10 μm, and the sieve aperture after drying and crushing is 157 μm; the proportion of auxiliary materials used in the Schisandra chinensis extract is: 10 parts of Schisandra chinensis extract, 2 parts of γ-cyclodextrin, and 3 parts of dextrin.

[0123] Comparative Example 335

[0124] In this comparative example, according to CN201710168541.9, a health food with auxiliary protective effect on alcoholic liver damage, the mass ratio of each ingredient is: 8 parts of Tremella fuciformis, 8 parts of Hericium erinaceus, 6 parts of Hovenia dulcis, 6 parts of Pueraria root, 2 parts of Schisandra chinensis, 2 parts of chitosan oligosaccharide, and 3 parts of licorice.

[0125] The preparation method in this comparative example is as follows: add 20 times the amount of water to Tremella fuciformis and Hericium erinaceus and boil them twice, each time for 2 hours, and concentrate the filtrate to contain 0.15 grams of raw materials per milliliter to obtain a water extract for later use; add 8 times the amount of water to Hovenia dulcis, Pueraria root, Schisandra chinensis and Licorice and boil them twice, each time for 2 hours, and concentrate the filtrate to contain 0.3 grams of raw materials per milliliter, add ethanol to the alcohol concentration of 50%, let it stand, centrifuge, recover ethanol from the supernatant to contain 0.3 grams of raw materials per milliliter, and obtain an alcohol precipitate extract for later use; mix the two parts of the water extract and the alcohol precipitate extract, add chitosan oligosaccharide, stir to dissolve, centrifuge at 3000rps / 5min, add distilled water to the centrifuge to make it 200 milliliters, and sterilize at high temperature and high pressure to obtain the extract.

[0126] 1.2 Determination of product sedimentation volume ratio

[0127] (1) Measurement method

[0128] According to the 2020 edition of the Chinese Pharmacopoeia, the sedimentation volume ratio test method is: use a stoppered measuring cylinder to measure 50 ml of the test sample sterilized by high temperature and high pressure, seal it tightly, shake it vigorously for 1 minute, record the starting height H0 of the suspension, let it stand for 3 hours, record the final height H of the suspension, and calculate it according to the following formula: sedimentation volume ratio = H / H0

[0129] (2) Standard requirements

[0130] The 2020 edition of the "Chinese Pharmacopoeia" has the following preparation requirements for oral suspensions: the sedimentation volume ratio should not be less than 0.90.

[0131] (3) Test results

[0132] Referring to Table 2, after standing for 3 hours, Examples 81-83 showed no precipitation or stratification, which met the requirements of the Chinese Pharmacopoeia for oral suspensions; Comparative Examples 321-335 showed precipitation or stratification to varying degrees, which in turn affected the uniform dispersion of the effective ingredients in the product, and some comparative examples did not even meet the requirements of the Chinese Pharmacopoeia.

[0133] Table 2 Sedimentation volume ratio determination of products

[0134]

[0135]

[0136] 1.3 Determination of uniform dispersion of active ingredients in the products of the embodiments and comparative examples

[0137] HPLC detection was performed on the effective ingredients represented by schisandrin A, schisandrin B and schisandrin B which are poorly soluble in water in the products of the examples and comparative examples to determine the uniformity of the effective ingredients obtained by different treatment methods.

[0138] The test results are shown in Table 3. Example 81, Example 82, and Example 83 can all meet the quality standard requirement of uniformity of active ingredient content of the product RSD ≤ 5%; the sieving apertures of Example 82 and Example 83 are smaller, resulting in lower production efficiency of the product. Considering the product quality control requirements and production efficiency, Example 81 is the best preparation method.

[0139] In Comparative Examples 321-324, only one raw material sieving aperture in the traditional Chinese medicine composition is not within the protection scope of the present invention. According to the results in Tables 2 and 3, since the coarser sieving aperture cannot retain the plant crude fiber or large particles in the liquid, it is easy to entrain the effective ingredients of the product after high-temperature sterilization in the later process, resulting in insufficient dispersion of the solution system, thereby affecting the content uniformity and exceeding the quality requirements. The sedimentation test after standing for 3 hours also showed precipitation and slight stratification problems, which did not meet the product quality requirements.

[0140] Comparative Examples 325-330 differ only in the proportion of excipients added to Schisandra chinensis extract. From the above results, only the uniformity of Comparative Examples 326 and 330 meets the quality requirements, but the sedimentation test after standing for 3 hours shows precipitation and slight stratification problems, which do not meet the product quality requirements.

[0141] In Comparative Examples 331-334, α-cyclodextrin, β-cyclodextrin, phospholipid or dextrin is used to replace the types of excipients in the Schisandra chinensis extract of the present invention. From the above results, it can be seen that after the excipients are replaced, the uniformity requirements of the active ingredients of the product cannot be met.

[0142] The test results of the insoluble functional components of Schisandrae Chinensis (schisandrin A, schisandrin B) in Comparative Example 335 are significantly lower than those in the embodiments of the present invention and Comparative Examples 321-324, which is mainly related to its processing and extraction method. The method of water extraction and alcohol precipitation (supernatant) is adopted in this comparative example, and the water-soluble components in Schisandrae Chinensis are mainly obtained. In addition, Comparative Example 335 also has a certain degree of unevenness in the fraction of functional substances.

[0143] Table 3 Determination of uniform dispersion of active ingredient content in products

[0144]

[0145]

[0146]

[0147] 1.4 Product stability investigation and index determination

[0148] (1) Instrument

[0149] Drug stability test chamber (equipment model: SHH-1000SD-2TA), high performance liquid chromatograph: Agilent 1260 InfinityⅡ.

[0150] (2) Methods

[0151] Since comparative examples 321-335 all showed precipitation and stratification to varying degrees and did not meet the quality requirements of the product, the stability study was no longer carried out; the three groups of evenly dispersed examples 81-83 were placed in a constant temperature and humidity chamber for accelerated stability study for 3 months under the following conditions: temperature 37°C ± 2°C, relative humidity 75% ± 5%, and samples were taken at 0 month, 1 month, 2 months, and 3 months, and HPLC was used to detect schisandrin A, schisandrin B, and sedimentation volume ratio indicators.

[0152] (3) Test results: As shown in Table 4, after accelerated stability study for 3 months, the contents of water-insoluble active ingredients (schisandrin A, schisandrin B) of Examples 81-83 were normal; and the sedimentation volume ratios of the products were all 1.0, without precipitation or stratification, and the products were stable and controllable, meeting the quality standard requirements of the products.

[0153] Table 4 Product stability investigation and index determination

[0154]

[0155] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. An oral liquid for promoting alcohol metabolism, characterized in that: The oral liquid is prepared from the following ingredients, by weight: 6-30 parts of kudzu root extract, 4-35 parts of hericium erinaceus extract, 1-12 parts of schisandra chinensis extract, 2-30 parts of taurine, and 4-25 parts of sodium alginate.

2. The oral liquid according to claim 1, characterized in that The oral liquid is prepared from the following ingredients, by weight: 10-30 parts of kudzu root extract, 4-22 parts of hericium erinaceus extract, 2-8 parts of schisandra chinensis extract, 5-20 parts of taurine, and 5-13 parts of sodium alginate.

3. The oral liquid according to claim 2, characterized in that By weight, 18 parts of kudzu root extract, 10 parts of hericium erinaceus extract, 4 parts of schisandra chinensis extract, 10 parts of taurine and 10 parts of sodium alginate.

4. The oral liquid according to claim 1, characterized in that The preparation process of the kudzu root extract is as follows: the kudzu root medicinal material after impurities are removed is coarsely crushed by a grinder, put into a medicinal material extraction tank, boiled twice with water, filtered, concentrated, filtered again, spray-dried, crushed, and sieved to prepare the extract; preferably, the filter pore size of the feed liquid during the preparation of the extract is ≤53μm.

5. The oral liquid according to claim 1, characterized in that The preparation process of the Hericium erinaceus extract is as follows: the Hericium erinaceus medicinal material after impurities are removed is coarsely crushed by a grinder, put into a medicinal material extraction tank, boiled twice with water, filtered, concentrated, alcohol precipitated, concentrated, spray-dried, crushed, and sieved to prepare the extract; preferably, the pore size of the liquid filter during the preparation of the extract is ≤20μm.

6. The oral liquid according to claim 1, characterized in that The preparation process of Schisandra chinensis extract is as follows: the Schisandra chinensis medicinal material after impurities are removed is coarsely crushed by a grinder, put into a medicinal material extraction tank, and refluxed and extracted twice with ethanol, filtered, concentrated, formulated, spray-dried, crushed, and sieved to prepare the extract; preferably, the pore size of the liquid filter is ≤10μm, and the pore size of the powder after crushing is ≤157μm.

7. The oral liquid according to claim 6, characterized in that The preparation is that after the liquid is concentrated, gamma-cyclodextrin and maltodextrin are added to embed the water-insoluble Schisandra chinensis lignans effective ingredients; wherein the embedding components contain: 10 parts of Schisandra chinensis extract, 2 parts of gamma-cyclodextrin, and 3 parts of maltodextrin.

8. The oral liquid according to claim 1, characterized in that The oral liquid also includes auxiliary materials acceptable to foods, medicines and health foods.

9. The oral liquid according to claim 8, characterized in that The auxiliary materials include suspending agents, emulsifiers, flavoring agents, essences and spices.

10. The oral liquid according to claim 9, characterized in that The suspending agent includes beeswax, plant gum, plant polysaccharide, cellulose and its derivatives, chitin, chitosan, and agar; the flavoring agent is one or more of sweeteners, edible acids, edible alkalis, and bitter masking agents; the emulsifier includes one or more of sorbitan monopalmitate, sucrose fatty acid esters or monoglycerides, soybean lecithin, and sodium stearoyl lactylate.

Images