A traditional Chinese medicine composition that can relieve hangovers and protect the liver, and its preparation method.

Abstract

This invention discloses a traditional Chinese medicine composition that can relieve hangovers and protect the liver, and its preparation method. The composition is prepared from the following raw materials in parts by weight: 14-20 parts of Salvia miltiorrhiza, 9-13 parts of Ligusticum chuanxiong, 6-10 parts of Cinnamomum cassia, 6-10 parts of Crataegus pinnatifida, and 2-5 parts of Panax notoginseng.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and more specifically to a traditional Chinese medicine composition that can relieve hangovers and protect the liver, and its preparation method. Background Technology

[0002] my country is the birthplace of wine and the world's earliest wine-producing country. Wine and its culture have accompanied people for thousands of years, becoming an indispensable part of life. Moderate and small amounts of alcohol can be beneficial to health, such as improving blood circulation, preventing rheumatism, strengthening the spleen and stomach, promoting sleep, and relieving fatigue. However, excessive drinking can have adverse effects on the body, especially on the liver, potentially leading to conditions like alcoholic liver disease and cirrhosis. This is because over 90% of the alcohol absorbed after drinking enters the liver for metabolism, and excessive alcohol can have a toxic effect on the liver.

[0003] Therefore, there is a widespread demand for drugs that can relieve hangovers and prevent and reduce alcohol-induced liver damage, and many related Western and traditional Chinese medicine products exist in the current technology. For example, for acute alcohol poisoning, Western medicines such as metadoxine and naloxone can usually be used for treatment; however, Western medicines generally have significant side effects, cannot be taken for a long time, and cannot be used as preventive drugs. For example, Yang Muxiang et al., in their research (Yang Muxiang, Li Rongyan et al., Clinical observation on the efficacy of a hangover-relieving and liver-protecting drink in treating alcoholic liver disease, China Journal of Traditional Chinese Medicine Information, 2001, 01: 59-60), recorded a hangover-relieving and liver-protecting drink made from kudzu flower, kudzu root, Japanese raisin tree fruit, artemisia capillaris, polygonum cuspidatum, salvia miltiorrhiza, codonopsis pilosula, atractylodes macrocephala, and imperata cylindrica, as well as a hangover-relieving and liver-protecting drink made from kudzu flower, amomum villosum, cardamom, green tangerine peel, dried tangerine peel, costus root, medicated leaven, poria cocos, alisma plantago-aquatica, atractylodes macrocephala, dried ginger, and ginseng; for example, the patent application with application number 202211657416.1, entitled "A traditional Chinese medicine composition, preparation and preparation method for alcoholic liver injury", proposed a formula including atractylodes macrocephala, lily bulb, bupleurum chinense, dried tangerine peel, rhubarb, jujube, angelica sinensis, poria cocos, raspberry, kudzu root, wolfberry, and cinnamon. Branches, Polygonatum, Astragalus, Scutellaria, Curcuma, Lotus Seed, Ephedra, Ophiopogon, Ginseng, Cistanche, Mulberry, Cimicifuga, Ginger, Rehmannia, Cynomorium, Asparagus, Polygonatum, Hoveniae Fructus, Prepared Licorice Root, Coptis, Vinegar-processed Schisandra, Morinda Root, Saposhnikovia Root, Achyranthes Root, Stalactite Powder, Vitex Fruit, Salted Cuscuta, Cuscuta Seed, Plantago Seed, Dendrobium, Dioscorea, Eucommia, Prepared Polygala, Aconite, Cnidium Fruit, Ligusticum Rhizome, Cornus Fruit, Aconitum Carmichaelii Traditional Chinese medicine compositions of amethyst and calamus; for example, patent application No. 202211471899.6, entitled "A Traditional Chinese Medicine Composition for Relieving Hangovers, Its Preparation Method and Application", discloses a composition including Polyporus umbellatus, Poria cocos, Alisma plantago-aquatica, stir-fried Atractylodes macrocephala, Milk thistle, Astragalus membranaceus, Ligustrum lucidum, Nelumbo nucifera seed heart, Dendrobium nobile, Ophiopogon japonicus, Prunus mume, Lilium brownii, Lophatherum gracile, Cinnamomum cassia, and Glycyrrhiza uralensis.

[0004] The aforementioned traditional Chinese medicine products generally suffer from drawbacks such as a wide variety of raw materials, unclear effective components, high costs, and potential side effects due to reactions between various raw materials. Therefore, there is an urgent need for medications that offer definite efficacy, low cost, and minimal side effects. Summary of the Invention

[0005] In the course of researching the prevention of cardiovascular and cerebrovascular diseases, the inventors unexpectedly discovered that some traditional Chinese medicine ingredients commonly used to treat and prevent cardiovascular and cerebrovascular diseases, including Salvia miltiorrhiza, Ligusticum chuanxiong, Cinnamomum cassia, and Crataegus pinnatifida, when combined with Panax notoginseng, have the effect of relieving hangovers and reducing alcohol damage to the liver. Furthermore, this pharmaceutical composition is characterized by its simple composition, low cost, and good efficacy. Based on this unexpected discovery, the present invention was proposed.

[0006] Salvia miltiorrhiza: It is bitter and slightly cold in nature. It enters the heart and liver meridians; its functions are to invigorate blood and regulate menstruation, remove blood stasis and relieve pain, cool blood and reduce swelling, clear the heart and relieve irritability, nourish blood and calm the mind; it is mainly used to treat irregular menstruation, amenorrhea and dysmenorrhea, abdominal masses, chest and abdominal pain, hot arthralgia, sores and swelling, irritability and insomnia; hepatosplenomegaly, angina pectoris. Chuanqiong: It has a pungent taste and warm properties. It enters the liver, gallbladder, and pericardium meridians. Its functions and indications are: to invigorate blood and promote qi circulation, dispel wind and relieve pain; it is used to soothe nerves, relieve headaches caused by wind, abdominal pain due to masses, chest and rib pain, swelling and pain from falls, headaches, and rheumatic pain. Cinnamon twigs: It has a pungent and sweet taste, and is warm in nature; it enters the lung, heart, and bladder meridians; its functions are to induce sweating and relieve muscle tension, warm the meridians and unblock the vessels. It treats wind-cold exterior syndrome, soreness and pain in the shoulders, back, and limbs, chest pain with phlegm retention, amenorrhea, and abdominal masses. hawthorn: Sour and sweet, slightly warm; enters the spleen, stomach, and liver meridians; functions and indications: eliminates food stagnation, disperses blood stasis, and expels tapeworms; promotes digestion and strengthens the stomach, regulates qi and disperses blood stasis; used for food stagnation, abdominal distension, diarrhea and abdominal pain, amenorrhea due to blood stasis, postpartum blood stasis, stabbing pain in the heart and abdomen, hernia pain, and hyperlipidemia. Sanqi: It is warm in nature, sweet and slightly bitter in taste, and enters the liver and stomach meridians; it is used for hemoptysis, hematemesis, epistaxis, hematochezia, metrorrhagia, traumatic bleeding, chest and abdominal pain, and swelling and pain from falls.

[0007] We believe that among the above-mentioned herbs, Danshen, Chuanxiong, hawthorn, and Sanqi all enter the liver meridian. Cinnamon twig enters the lung, heart, and bladder meridians, while hawthorn enters the spleen and stomach meridians. By synergistically promoting the connection between the meridians of the various organs, they can achieve the effects of clearing the meridians and removing blood stasis, soothing the liver and nourishing blood, and relieving alcohol poisoning and protecting the liver.

[0008] According to one aspect of the present invention, a traditional Chinese medicine composition that can relieve hangovers and protect the liver is provided, which is prepared from the following raw materials in parts by weight: 14-20 parts of Salvia miltiorrhiza, 9-13 parts of Ligusticum chuanxiong, 6-10 parts of Cinnamomum cassia, 6-10 parts of Crataegus pinnatifida, and 2-5 parts of Panax notoginseng.

[0009] According to an embodiment of the present invention, the traditional Chinese medicine composition that can relieve hangovers and protect the liver is prepared from the following raw materials in parts by weight: 15 parts of Salvia miltiorrhiza, 10 parts of Ligusticum chuanxiong, 8 parts of Cinnamomum cassia, 8 parts of Crataegus pinnatifida, and 3 parts of Panax notoginseng.

[0010] According to embodiments of the present invention, the pharmaceutical composition is a pill, tablet, capsule, granule, oral liquid, or decoction.

[0011] According to another aspect of the present invention, a method for preparing a traditional Chinese medicine composition that can relieve hangovers and protect the liver is provided, comprising the following steps:

[0012] (1) Take 14-20 parts of Salvia miltiorrhiza, 9-13 parts of Ligusticum chuanxiong, 6-10 parts of Cinnamomum cassia, 6-10 parts of Crataegus pinnatifida and 2-5 parts of Panax notoginseng, put them in a container and add 6-10 times the amount of water to soak for a certain period of time;

[0013] (2) Heat the container to a boil and simmer for 1-2 hours, stirring occasionally.

[0014] (3) Cool and filter to obtain primary filter media and primary filtrate;

[0015] (4) Add 6-10 times the amount of water back to the primary filter media and repeat steps (2) and (3) to obtain secondary filter media and secondary filtrate;

[0016] (5) Mix the primary filtrate and the secondary filtrate to obtain the drug solution.

[0017] According to an embodiment of the present invention, the method further includes further processing the liquid obtained in step (5) to prepare a pharmaceutical composition in the form of pills, tablets, capsules, granules, oral liquids or decoctions.

[0018] According to an embodiment of the present invention, the method further includes: after step (4), adding 6-10 times the amount of water to the secondary filter media to perform the operations of steps (2) and (3) to obtain a tertiary filtrate, and mixing the tertiary filtrate with the primary filtrate and the secondary filtrate in step (5) to obtain a drug solution.

[0019] According to an embodiment of the present invention, step (5) includes a low-pressure concentration operation after mixing, for example, the concentration can be made to a relative density of about 1.05 to 1.10, 1.20 to 1.30 (80 degrees), etc.

[0020] According to another aspect of the invention, the use of the pharmaceutical composition in the preparation of a medicament for reducing alcohol-induced liver damage is also provided.

[0021] In addition, the pharmaceutical compositions of the present invention can also be used to prevent diseases such as cardiovascular and cerebrovascular diseases.

[0022] The pharmaceutical composition of the present invention has the characteristics of having a small number of medicinal ingredients, abundant raw materials, simple preparation process, low production / treatment cost, and virtually no toxic side effects, and is worthy of vigorous promotion. Detailed Implementation

[0023] The present invention will be further described in detail below with reference to embodiments. The following description is merely exemplary and is not intended to limit the application or use of this disclosure.

[0024] Unless otherwise specified, the experimental methods mentioned in the examples are conventional methods; unless otherwise specified, the experimental materials used in the examples can be purchased from conventional reagent stores.

[0025] The following experiments use oral liquids and granules as examples. It should be understood that the present invention can also be formulated into other dosage forms such as tablets and capsules. The methods for manufacturing these dosage forms are well known in the art and will not be described in detail here.

[0026] Example 1: Oral liquid

[0027] Raw materials: 15 parts of Salvia miltiorrhiza, 10 parts of Ligusticum chuanxiong, 8 parts of Cinnamomum cassia, 8 parts of Crataegus pinnatifida, and 3 parts of Panax notoginseng. All raw materials are dried medicinal materials.

[0028] The preparation method is as follows:

[0029] Place all the above-mentioned raw materials in a container, add approximately 10 times the amount of water, and soak the drugs for about 8 hours. Then, heat in a water bath to a gentle boil, stirring intermittently, and continue heating for 1.5 hours. Let it stand and filter, separating the filtrate. Add 6 times the amount of water to the filtered residue and repeat the above operation, obtaining a second filtrate. Combine the two filtrates, let them stand for about 12 hours, and collect the supernatant to prepare an oral liquid.

[0030] Example 2: Oral liquid

[0031] Raw materials: 17 parts Salvia miltiorrhiza, 11 parts Ligusticum chuanxiong, 9 parts Cinnamomum cassia, 9 parts Crataegus pinnatifida, 5 parts Panax notoginseng

[0032] Everything else is the same as in Example 1.

[0033] Example 3: Oral liquid

[0034] Except for the following operations, everything else is the same as in Example 1: After the second filtration, add 6 times the amount of water to the filtered residue, repeat the above operation (heating time is 1 hour), and filter for the third time to obtain three filtrates. Combine the three filtrates.

[0035] Example 4: Granules

[0036] Raw materials: 18 parts of Salvia miltiorrhiza, 13 parts of Ligusticum chuanxiong, 10 parts of Cinnamomum cassia, 9 parts of Crataegus pinnatifida, and 4 parts of Panax notoginseng. All raw materials are dried medicinal materials.

[0037] The preparation method is as follows:

[0038] Place all the above-mentioned raw materials in a container, add approximately 10 times the amount of water, and soak the drugs for about 8 hours. Then, heat in a water bath to a gentle boil, stirring intermittently, and continue heating for 1.5 hours. Let it stand and filter, separating the filtrate. Add 8 times the amount of water to the filtered residue and repeat the above operation, filtering a second time to obtain a second filtrate. Then, add 6 times the amount of water to the filtered residue and repeat the above operation (heating time is 1 hour), filtering a third time to obtain a third filtrate. Combine the three filtrates, let them stand for about 12 hours, and take the supernatant for vacuum concentration to obtain an extract. Then, prepare granules (the obtained granules are in the specification of 10g per sachet, one sachet per dose).

[0039] To verify the effects of the drug of the present invention on relieving hangovers and protecting the liver, the following experiments were conducted:

[0040] (a) Animal experiments

[0041] 1. Animal alcohol metabolism test

[0042] Seventy-five healthy male Kunming mice, weighing 18–24 g, were selected. The mice were randomly divided into five groups of 15 mice each: a control group, a model group, and experimental groups 1–3. The alcohol used was Beijing Niulanshan Erguotou, 52% ABV.

[0043] Control group: 0.2 ml / 10 g of distilled water was administered by gavage, followed by 0.15 ml / 10 g of distilled water 20 minutes later.

[0044] Model group: Distilled water was administered by gavage at a rate of 0.2 ml / 10 g, followed by alcohol by gavage at a rate of 0.15 ml / 10 g 20 minutes later.

[0045] Experiment 1: The oral solution of Example 1 was administered by gavage at a dose of 0.2 ml / 10 g, followed by 0.15 ml / 10 g of alcohol by gavage 20 minutes later.

[0046] Experiment 2: The oral solution of Example 2 was administered by gavage at a dose of 0.2 ml / 10 g, followed by 0.15 ml / 10 g of alcohol by gavage 20 minutes later.

[0047] Experimental Group 3: The oral solution of Example 3 was administered by gavage at a dose of 0.2 ml / 10 g, followed by 0.15 ml / 10 g of alcohol by gavage 20 minutes later.

[0048] Timing was started after alcohol consumption. The latency period from the disappearance of the righting reflex to the recovery time and the number of mice were observed and recorded. The intoxication rate and tolerance time of the mice were calculated. The results are shown in Table 1 below:

[0049] Table 1: Results of animal alcohol excretion experiments

[0050]

[0051] Compared with the model group, the number of mice that became intoxicated, the rate of intoxication, and the duration of intoxication were significantly reduced in each experimental group, while the tolerance time to intoxication was longer. This indicates that the drugs in each experimental group have a significant preventive effect against intoxication in mice, can effectively prolong the latency period of intoxication in mice, and have the effect of preventing intoxication.

[0052] 2. Effects of the experiment on ethanol in animal blood

[0053] Forty healthy male Kunming mice, weighing 18–24 g, were selected. The mice were randomly divided into four groups of 10 mice each: the model group and experimental groups 4–6. The alcohol used was Beijing Niulanshan Erguotou, 52% ABV.

[0054] Model group: Distilled water was administered by gavage at a dose of 0.2 ml / 10 g, followed by 0.15 ml / 10 g of alcohol by gavage 20 minutes later. Blood was collected from the orbital region of each mouse at 15, 30 and 80 minutes after alcohol administration.

[0055] Experimental Group 4: The oral solution of Example 1 was administered by gavage at a dose of 0.2 ml / 10 g. After 20 minutes, 0.15 ml / 10 g of alcohol was administered by gavage. Blood was collected from the orbital cavity of each mouse at 15 minutes, 30 minutes and 80 minutes after the administration of alcohol.

[0056] Experiment 5: The oral solution of Example 2 was administered by gavage at a dose of 0.2 ml / 10 g. After 20 minutes, 0.15 ml / 10 g of alcohol was administered by gavage. Blood was collected from the orbital cavity of each mouse at 15 minutes, 30 minutes and 80 minutes after the administration of alcohol.

[0057] Experiment 6: The oral solution of Example 3 was administered by gavage at a dose of 0.2 ml / 10 g. After 20 minutes, 0.15 ml / 10 g of alcohol was administered by gavage. Blood was collected from the orbital cavity of each mouse at 15 minutes, 30 minutes and 80 minutes after the administration of alcohol.

[0058] The concentration of ethanol in the treated blood samples was determined by gas chromatography, and the results are shown in Table 2 below:

[0059] Table 2: Results of experiments on the effect of ethanol in animal blood

[0060]

[0061] The results showed that, compared with the model group, the oral liquid of the present invention could significantly reduce the ethanol content in the blood and had a sobering effect.

[0062] 3. Effects on ALT, AST, SOD, and MDA in animals

[0063] Fifty healthy male Kunming mice, weighing 18–24 g, were selected. The mice were randomly divided into 5 groups of 10 mice each: control group, model group, and experimental groups 7–9. The alcohol used was Beijing Niulanshan Erguotou, 52% ABV.

[0064] Control group: Distilled water was administered by gavage at a dose of 0.2 ml / 10 g / day for 3 weeks.

[0065] Model group: Distilled water was administered by gavage at a rate of 0.2 ml / 10 g / day, followed by 0.10 ml / 10 g / day of alcohol by gavage 20 minutes later, for 3 weeks.

[0066] Experimental Group 7: The oral solution of Example 1 was administered by gavage at a dose of 0.2 ml / 10 g / day, followed by 0.10 ml / 10 g / day of alcohol by gavage 20 minutes later, for 3 weeks.

[0067] Group 8 of the experiment: The oral solution of Example 2 was administered by gavage at a dose of 0.2 ml / 10 g / day, followed by 0.10 ml / 10 g / day of alcohol by gavage 20 minutes later, and the diet was continued for 3 weeks.

[0068] Experimental Group 9: The oral solution of Example 3 was administered by gavage at a dose of 0.2 ml / 10 g / day, followed by 0.10 ml / 10 g / day of alcohol by gavage 20 minutes later, for 3 weeks.

[0069] On day 22, all mice were euthanized by exsanguination, and blood and liver samples were collected. Serum ALT (alanine aminotransferase) and AST (aspartate aminotransferase) levels were measured using a biochemical analyzer, and superoxide dismutase (SOD) and malondialdehyde (MDA) levels in liver tissue were detected using spectrophotometry. The results are shown in Table 3 below:

[0070] Table 3: Experimental results on the effects of ALT, AST, SOD, and MDA in animals

[0071]

[0072] Serum ALT (alanine aminotransferase) and AST (aspartate aminotransferase) levels are key biological indicators for evaluating liver function and can reflect the degree of liver damage. Experimental results showed that serum ALT and AST levels were significantly elevated in the model group of mice, indicating that prolonged alcohol consumption impairs the normal function of hepatocytes. However, after the drug intervention of this invention, serum ALT and AST levels were significantly reduced, demonstrating that the drug composition of this invention has hepatoprotective effects.

[0073] Superoxide dismutase (SOD) is a free radical scavenger in the body. The SOD content in the model group was significantly reduced, but after drug intervention, the SOD content in all experimental groups increased, indicating increased SOD activity in the liver. Malondialdehyde (MDA) is the main end product of lipid peroxidation, and its content reflects the degree of lipid peroxidation damage in the body; higher levels indicate greater liver damage. The MDA content in the model group was significantly increased, and similarly, after drug intervention, the content in all experimental groups decreased. These results indicate that the composition of the present invention can improve the liver's ability to scavenge free radicals and its antioxidant capacity, thereby achieving a protective effect on the liver.

[0074] (II) Prevention of intoxication test

[0075] To further verify the efficacy of the composition of the present invention in relieving hangovers and preventing intoxication, we conducted an experiment using the granules of Example 4.

[0076] Thirty-nine volunteers participated in the test. All were attendees of a banquet and consumed alcohol between 100-500 ml, aged 22-60, including 9 women and 30 men. Each volunteer took one sachet of the granules described in Example 3 before drinking. After the banquet (approximately one hour later), the volunteers' reactions were assessed and recorded. The results are shown in Table 4 below.

[0077] Table 4: Survey Results After Drinking

[0078]

[0079] The above results indicate that the composition of the present invention has a good effect in preventing drunkenness, can increase the drinker's alcohol tolerance, reduce the drinker's discomfort after drinking, and reduce the occurrence of drunkenness.

[0080] This document uses specific examples to illustrate the principles and implementation methods of the present invention. The descriptions of the above embodiments are only for the purpose of helping to understand the device and core ideas of the present invention. At the same time, for those skilled in the art, there will be changes in the specific implementation methods and application scope based on the ideas of the present invention. Therefore, the content of this specification should not be construed as a limitation of the present invention.

Claims

1. A traditional Chinese medicine composition for relieving hangovers and protecting the liver, characterized in that, It is prepared from the following raw materials in parts by weight: 14-20 parts of Salvia miltiorrhiza, 9-13 parts of Ligusticum chuanxiong, 6-10 parts of Cinnamomum cassia, 6-10 parts of Crataegus pinnatifida, and 2-5 parts of Panax notoginseng.

2. The traditional Chinese medicine composition for relieving hangovers and protecting the liver according to claim 1, characterized in that, It is prepared from the following raw materials in parts by weight: 15 parts of Salvia miltiorrhiza, 10 parts of Ligusticum chuanxiong, 8 parts of Cinnamomum cassia, 8 parts of Crataegus pinnatifida, and 3 parts of Panax notoginseng.

3. The traditional Chinese medicine composition for relieving hangovers and protecting the liver according to claim 1 or 2, characterized in that, The pharmaceutical composition is in the form of pills, tablets, capsules, granules, oral liquids, or decoctions.

4. A method for preparing a traditional Chinese medicine composition for relieving hangovers and protecting the liver, characterized in that, Includes the following steps: (1) Take 14-20 parts of Salvia miltiorrhiza, 9-13 parts of Ligusticum chuanxiong, 6-10 parts of Cinnamomum cassia, 6-10 parts of Crataegus pinnatifida and 2-5 parts of Panax notoginseng, put them in a container and add 6-10 times the amount of water to soak for a certain period of time; (2) Heat the container to a boil and simmer for 1-2 hours, stirring intermittently. (3) Cool and filter to obtain primary filter media and primary filtrate; (4) Add 6-10 times the amount of water to the primary filter media and repeat steps (2) and (3) to obtain secondary filter media and secondary filtrate; (5) Mix the first and second filtrates to obtain the drug solution.

5. The method according to claim 4, characterized in that, It also includes further processing the liquid obtained in step (5) to prepare a pharmaceutical composition in the form of pills, tablets, capsules, granules, oral liquids or decoctions.

6. The method according to claim 4, characterized in that, Also includes: After step (4), 6-10 times the amount of water is added to the secondary filter media to perform the operations of steps (2) and (3) to obtain the tertiary filtrate. In step (5), the tertiary filtrate is mixed with the primary and secondary filtrates to obtain the drug solution.

7. The method according to claim 4 or 6, characterized in that, Step (5) includes a low-pressure concentration operation after mixing.

8. Use of the pharmaceutical composition according to any one of claims 1-3 in the preparation of a medicament for reducing alcohol-induced liver damage.

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