Traditional Chinese medicine composition capable of relieving alcoholic brain injury and preparation method of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for relieving alcoholic brain injury and a preparation method, and belongs to the technical field of traditional Chinese medicines and functional foods. Aiming at the problems of single target spot, low compliance and lack of scientific verification of a formula of an existing anti-alcohol product, the radix puerariae, the semen hoveniae, the ampelopsis grossedentata and the like are used as core raw materials and are compounded according to a specific weight part ratio, the traditional Chinese medicine principle of monarch, minister, assistant and guide is followed, the modern pharmacological mechanism is combined, and various dosage forms such as tea bags, solid beverages, oral liquid and functional wine can be prepared. According to the embodiment and contrast verification, the composition disclosed by the invention can synergistically resist oxidative stress, neuroinflammation and other pathological links of alcoholic brain injury at multiple targets, and the medicinal liquor dosage form realizes drinking synchronous protection, so that the use compliance is improved. The product quality is stable and controllable, the preparation process is simple, and the method has remarkable industrial application value.

Description

Technical Field

[0001] This invention relates to the fields of traditional Chinese medicine and functional food technology, specifically to a traditional Chinese medicine composition for relieving alcoholic brain injury and its preparation method, and particularly to the application of this composition in the preparation of tea bags, solid beverages, oral liquids, and alcoholic beverages with brain-protective functions. Background Technology

[0002] Alcohol abuse is a global public health problem. Excessive alcohol consumption leads to the production of metabolites such as acetaldehyde, which can directly cross the blood-brain barrier, causing alcoholic brain injury. Its core pathological mechanism encompasses four main stages: inducing oxidative stress to produce large amounts of reactive oxygen species, attacking the lipids, proteins, and DNA of nerve cells; triggering neuroinflammation, activating microglia to release pro-inflammatory factors such as tumor necrosis factor-α and interleukin-1β; causing mitochondrial dysfunction and intracellular calcium overload; and inducing neuronal apoptosis and impaired synaptic plasticity, ultimately manifesting as cognitive decline, memory loss, anxiety, and depression. Currently, there are no specific drugs for treating alcoholic brain injury in clinical practice; treatment mainly focuses on symptomatic support and neurotrophic therapy, with limited efficacy and a high risk of side effects. In the consumer product sector, common hangover remedies or health tonics often focus on liver protection or relieving hangover symptoms, with formulations that do not target the core pathological mechanism of alcohol-induced neurotoxicity, and their protective effect on brain tissue is unclear. Furthermore, existing functional wines primarily focus on tonifying and strengthening the body, failing to achieve a brain protection model synchronized with drinking behavior. Users need to take additional protective products, resulting in low compliance. In addition, traditional hangover remedies are mostly based on empirical formulations, lack modern pharmacological experimental verification, have unclear mechanisms of action, and are difficult to form stable and controllable industrial products. Summary of the Invention

[0003] In view of this, the present invention proposes a traditional Chinese medicine composition for alleviating alcohol-induced brain injury and its preparation method, aiming to solve the problems of single target, limited application mode, and lack of scientific verification of the formulation in the existing hangover relief and brain protection products.

[0004] The technical solution of the present invention is implemented as follows: The present invention provides a traditional Chinese medicine composition for relieving alcoholic brain injury, which, by weight, is composed of the following raw materials: 15-30 parts of kudzu root, 10-20 parts of Japanese raisin tree fruit, 10-20 parts of vine tea, 10-15 parts of mulberry leaf, 5-10 parts of scutellaria baicalensis, 3-6 parts of licorice root, 5-10 parts of salvia miltiorrhiza, 5-10 parts of jujube seed, and 3-8 parts of chrysanthemum.

[0005] In some embodiments, the optimal raw material composition of the composition by weight is: 20-25 parts of kudzu root, 15-18 parts of Japanese raisin tree fruit, 12-15 parts of vine tea, 10-12 parts of mulberry leaf, 6-8 parts of scutellaria root, 4-5 parts of licorice root, 5-8 parts of salvia root, 6-8 parts of jujube seed, and 4-5 parts of chrysanthemum. This ratio was determined through multi-gradient content screening experiments. When the content of the raw materials is lower or higher than this optimal range, the antioxidant and anti-inflammatory effects of the composition on brain tissue will significantly decrease. This ratio can maximize the synergistic effect of each component.

[0006] In some embodiments, the composition further includes 3-8 parts of turmeric. The active ingredients in turmeric can enhance the anti-inflammatory effect of the composition, while also inhibiting β-amyloid-induced neurotoxicity, and synergistically acting with scutellaria baicalensis on neuroinflammatory pathways to further enhance the neuroprotective effect.

[0007] In some embodiments, the composition further includes 3-8 parts of lily bulbs. Lily bulbs have calming and soothing effects, which can enhance the composition's memory-improving and antidepressant effects. When combined with jujube seed, it can better regulate sleep-wake cycle disorders caused by alcohol abuse and promote brain function repair.

[0008] In some embodiments, the composition further includes 3-8 parts of wolfberry. Wolfberry is rich in active ingredients such as wolfberry polysaccharides, which can enhance the antioxidant capacity of the composition, synergistically eliminate free radicals produced by alcohol metabolism with vine tea, and reduce the damage of oxidative stress to nerve cells.

[0009] In some embodiments, the composition further includes at least one of 3-8 parts dried tangerine peel or 1-3 parts osmanthus. Dried tangerine peel and osmanthus can improve the taste and aroma of the composition, and are especially suitable for the preparation of wines. They can neutralize some of the bitterness of the medicinal materials, improve the palatability of the product, and do not affect the efficacy of the core active ingredients.

[0010] In some embodiments, the preparation method of the composition includes a raw material pretreatment step, specifically, selecting and washing each raw medicinal material separately, and drying it at a low temperature below 60°C until the moisture content is less than 10%. Low-temperature drying can avoid the destruction of heat-sensitive active ingredients in the medicinal materials, ensure the efficacy stability of each component, and lay the foundation for subsequent preparation processes.

[0011] In some embodiments, the preparation method of the composition includes pulverizing and mixing steps. Specifically, the dried raw materials are pulverized through a 20-80 mesh sieve according to the dosage form requirements, accurately weighed by weight, and then added to a mixer for uniform mixing. Different dosage forms correspond to different particle sizes. Tea bags and solid beverages require pulverizing through a 60-80 mesh sieve to ensure dissolution and brewing effects, while concentrated wines can be pulverized through a 30 mesh sieve to improve extraction efficiency. Precise mixing steps ensure the uniformity of product quality across batches.

[0012] In some embodiments, the composition can be prepared into various dosage forms such as tea bags, solid beverages, oral liquids, concentrated alcoholic beverages, and functional wines. The preparation processes for different dosage forms are all designed around preserving active ingredients and adapting to application scenarios. Conventional dosage forms meet daily health care needs, while alcoholic dosage forms achieve an active protection mode of "drinking while protecting," thus broadening the product's applicability.

[0013] The technical solution provided by this invention is based on the principles of traditional Chinese medicine treatment, namely "detoxifying alcohol, clearing damp heat, anti-oxidation, calming the mind, and protecting brain meridians," and is formulated in combination with modern medical understanding of the mechanisms of alcohol-induced brain injury. The synergistic effects of each component are as follows:

[0014] Kudzu root: the principal ingredient. Rich in isoflavones such as puerarin, it is a traditional remedy for hangovers. Modern research has confirmed its significant antioxidant activity, which can dilate cerebral blood vessels, improve cerebral microcirculation, and counteract cerebral ischemia and hypoxia caused by alcohol.

[0015] Hovenia dulcis fruit: The principal ingredient. It has been hailed as a "miracle cure for hangovers" since ancient times. Its effects on relieving hangovers and protecting the liver are well-established; it can reduce the burden of alcohol metabolism and indirectly protect brain tissue. At the same time, it also contains active ingredients with neuroprotective effects.

[0016] Vine tea: Used as an adjunct ingredient. Its main active ingredients are flavonoids such as dihydromyricetin, which have extremely strong antioxidant capabilities. They can directly eliminate a large number of free radicals produced during alcohol metabolism, reduce the damage of oxidative stress to nerve cells, and are key components for protecting the blood-brain barrier and the structural integrity of neurons.

[0017] Mulberry leaves: Used as an adjunct medicine. Rich in polysaccharides and flavonoids, they have hypoglycemic, lipid-lowering, and anti-inflammatory effects. They can improve overall metabolism and reduce the indirect damage to the brain caused by alcohol-induced metabolic disorders.

[0018] Scutellaria baicalensis: Used as an adjuvant herb. Its main active ingredients are baicalin and baicalein. Studies have shown that Scutellaria baicalensis extract and its flavonoid components can effectively inhibit β-amyloid (Aβ)-induced neurotoxicity and exert powerful anti-inflammatory and antioxidant effects by regulating signaling pathways such as PI3K / Akt / Nrf2, directly protecting cortical neurons.

[0019] Danshen (Salvia miltiorrhiza): Used as an adjuvant. Its main active ingredients are salvianolic acids. Studies have shown that salvianolic acids A / B can activate the Nrf2 / HO-1 antioxidant pathway, scavenge ROS, improve mitochondrial function, and exhibit clear neuroprotective effects in various brain injury models.

[0020] Licorice: Used as an adjuvant. It harmonizes the effects of other herbs. Its glycyrrhizic acid and other components have hepatoprotective and anti-inflammatory effects, and can assist the principal herb in detoxifying alcohol and moderating the effects of other herbs.

[0021] Sour jujube seed: used as an adjuvant in traditional Chinese medicine. It has a calming and soothing effect, can improve neurological symptoms such as anxiety and insomnia caused by alcohol abuse, help restore a normal sleep-wake cycle, and promote brain function repair.

[0022] Chrysanthemum: Used as an adjuvant in medicine. It clears the head and eyes, guides the medicine upwards, and helps the medicinal effects reach the head, face, and brain. At the same time, its components, such as chrysanthemin, also have certain anti-inflammatory effects.

[0023] The present invention has the following advantages over the prior art: This invention's composition is based on the principles of traditional Chinese medicine's monarch-minister-assistant-guide formula, combined with modern pharmacological research to target the four core pathological links of alcohol-induced brain injury. It overcomes the limitations of existing products that target only one specific area, achieving a synergistic, end-to-end protection against alcohol toxicity, oxidation, inflammation, and brain damage. This invention innovatively designs dosage forms such as concentrated alcoholic liquid and granules, which can be directly integrated into the alcohol base, allowing the protective components to work synchronously with drinking behavior. This greatly improves user compliance among drinkers and covers multiple conventional dosage forms to meet brain protection needs in different scenarios. This invention abandons the traditional empirical formulation model; the selection and compatibility of each medicinal material are supported by clear modern pharmacological mechanisms. The synergistic effects of each component can be verified through experiments at the cellular and molecular levels, significantly enhancing the credibility, reproducibility, and market competitiveness of the technical solution. Attached Figure Description

[0024] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0025] Figure 1 An experimental route diagram for verifying the effectiveness of the composition of the present invention in alleviating alcoholic brain injury; Figure 2 This is a schematic diagram illustrating the mechanism of action for verifying the effectiveness of the composition of the present invention in alleviating alcoholic brain injury. Detailed Implementation

[0026] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0027] Example 1 1. Weigh out the following ingredients by weight: 20 parts kudzu root, 15 parts Japanese raisin tree fruit, 15 parts vine tea, 12 parts mulberry leaf, 8 parts scutellaria baicalensis, 8 parts salvia miltiorrhiza, 5 parts licorice root, 8 parts jujube seed, and 5 parts chrysanthemum.

[0028] 2. Select and wash each medicinal material separately, and dry them at a low temperature below 60℃ until the moisture content is less than 10%.

[0029] 3. After drying, the medicinal materials are pulverized and passed through a 60-mesh sieve. The weight is then weighed and put into a three-dimensional mixer and mixed for 40 minutes to obtain a mixed powder.

[0030] 4. Divide the mixed powder into 4-gram packets and pack them into non-woven tea bags. Cover the bags with aluminum foil and sterilize them with Co60 irradiation to obtain the finished tea bag product.

[0031] Example 2 1. Weigh out the following ingredients by weight: 25 parts kudzu root, 18 parts Japanese raisin tree fruit, 12 parts vine tea, 10 parts mulberry leaf, 6 parts scutellaria baicalensis, 6 parts salvia miltiorrhiza, 4 parts licorice root, 6 parts jujube seed, 4 parts chrysanthemum, and 5 parts turmeric.

[0032] 2. Select and wash each medicinal material separately, and dry them at a low temperature below 60℃ until the moisture content is less than 10%.

[0033] 3. After drying, the medicinal materials are pulverized and passed through an 80-mesh sieve. The materials are weighed according to their weight and mixed evenly to obtain a mixed powder.

[0034] 4. Add 30 parts by weight of maltodextrin and 2 parts by weight of steviol glycosides to 100 parts by weight of mixed powder, mix well; slowly add an appropriate amount of 70% ethanol as a wetting agent, and stir to form a soft material.

[0035] 5. Granulate the soft material through a 16-mesh sieve, dry it in an oven at 55℃ until the moisture content is ≤5%; granulate it through a 14-mesh sieve, and package it into 10-gram bags of solid beverage product.

[0036] Example 3 1. Weigh out the following ingredients by weight: 30 parts kudzu root, 20 parts Japanese raisin tree fruit, 20 parts vine tea, 15 parts mulberry leaf, 10 parts scutellaria baicalensis, 10 parts salvia miltiorrhiza, 6 parts licorice root, 10 parts jujube seed, 8 parts chrysanthemum, and 8 parts lily bulb.

[0037] 2. After mixing all the medicinal materials, add 10 times the amount of water and reflux extract twice, 1.5 hours each time; combine the extracts and filter through a 200-mesh sieve.

[0038] 3. Concentrate the filtrate under reduced pressure at 60°C to obtain an extract with a density of 1.12.

[0039] 4. Take 100 parts by weight of the extract, add purified water to 1000 ml, then add 50 parts by weight of honey and 0.5 parts by weight of potassium sorbate, stir to dissolve; then filter through a 0.22 μm microporous membrane.

[0040] 5. Fill the filtrate into 10 ml oral liquid bottles and autoclave at 115℃ for 30 minutes to obtain the finished oral liquid product.

[0041] Example 4 1. Weigh out the following ingredients by weight: 22 parts kudzu root, 16 parts Japanese raisin tree fruit, 14 parts vine tea, 11 parts mulberry leaf, 7 parts scutellaria baicalensis, 7 parts salvia miltiorrhiza, 4.5 parts licorice root, 7 parts jujube seed, 4.5 parts chrysanthemum, and 6 parts dried tangerine peel.

[0042] 2. Select and wash each medicinal material separately, and dry them at a low temperature below 60℃ until the moisture content is less than 10%.

[0043] 3. After drying, the medicinal materials are pulverized and passed through a 30-mesh sieve. They are weighed according to their weight proportions and then mixed evenly to obtain a mixture.

[0044] 4. Take 1 part by weight of the mixture, add 10 parts by weight of 50% vol food alcohol, reflux extract at 55℃ for 1.5 hours, and filter; add 8 parts by weight of the same solvent to the residue and reflux extract for 1 hour, and combine the two extracts.

[0045] 5. After coarse filtration through a plate and frame filter and fine filtration through a 0.45μm membrane, the extract is concentrated by vacuum distillation at 45℃ and -0.08MPa to a crude drug concentration of 0.83g / mL, thus obtaining the final product of the concentrated liquor for winemaking.

[0046] Example 5 1. Weigh out the following ingredients by weight: 20 parts kudzu root, 15 parts Japanese raisin tree fruit, 15 parts vine tea, 12 parts mulberry leaf, 8 parts scutellaria baicalensis, 8 parts salvia miltiorrhiza, 5 parts licorice root, 8 parts jujube seed, 5 parts chrysanthemum, 6 parts wolfberry, and 2 parts osmanthus.

[0047] 2. Following steps 2 to 5 of Example 4, prepare a concentrated wine solution with a crude drug concentration of 0.83 g / mL.

[0048] 3. Take 100 liters of 35% vol light-aroma liquor base, slowly add 2 liters of the above concentrated liquid while stirring, and continue stirring for 30 minutes to mix evenly; after standing and clarifying for 3 days, take the supernatant for membrane filtration sterilization and bottling to obtain the finished functional liquor.

[0049] Example 6 1. Weigh out the following ingredients by weight: 25 parts kudzu root, 18 parts Japanese raisin tree fruit, 15 parts vine tea, 12 parts mulberry leaf, 8 parts scutellaria root, 5 parts salvia root, 5 parts licorice root, 8 parts jujube seed, 4 parts chrysanthemum, 10 parts wolfberry, and 2 parts osmanthus.

[0050] 2. After cleaning and selecting each medicinal material, dry it at a low temperature; coarsely crush hard medicinal materials such as kudzu root, Japanese raisin tree fruit, and salvia miltiorrhiza into thin slices with a particle size of about 3-5mm, while keeping the remaining medicinal materials in their original shape or slightly broken.

[0051] 3. The mixed medicinal materials are packaged into biodegradable corn fiber filter bags in 15-gram portions, heat-sealed, and then vacuum-packed in aluminum foil bags. The bags are then sterilized by irradiation to obtain the soaking material package for wine.

[0052] 4. Take one spice packet and put it into a clean glass bottle with a capacity of 500 ml. Pour in 500 ml of 38% vol light aroma baijiu and seal the bottle. Store it in a cool place and shake it gently once a day. After soaking for 7 days, you will get the soaked wine.

[0053] Example 7 1. Take one bag of finished tea from Example 1, crush it, add 20 mL of methanol, sonicate for 30 minutes, filter, evaporate the filtrate to dryness, add 1 mL of methanol to dissolve the residue, and use it as the test solution.

[0054] 2. Take puerarin reference standard and baicalin reference standard, and add methanol to prepare solutions containing 1 mg per 1 mL, as reference solutions.

[0055] 3. Take 5 μL of each of the above three solutions and spot them separately on the same silica gel G thin-layer plate; use the lower layer solution of chloroform-methanol-water (13:7:2) as the developing solvent, develop, remove and air dry.

[0056] 4. When examined under ultraviolet light (365nm), the test sample chromatogram shows fluorescent spots of the same color at the corresponding positions as the reference sample chromatogram.

[0057] Example 8 1. Chromatographic conditions were set as follows: octadecylsilane-bonded silica gel was used as the stationary phase; the mobile phase was methanol-0.1% phosphoric acid solution (25:75); the detection wavelength was 250 nm; the column temperature was 30 ℃; and the flow rate was 1.0 mL / min.

[0058] 2. Accurately weigh appropriate amounts of puerarin reference standard and dihydromyricetin reference standard, and add methanol to prepare a mixed reference solution containing 50 μg of puerarin and 30 μg of dihydromyricetin per 1 mL.

[0059] 3. Take one bag of finished tea product from Example 1, crush it, accurately weigh 0.5g, place it in a stoppered conical flask, accurately add 25mL of methanol, weigh it, sonicate for 30 minutes, cool it, weigh it again, replenish the lost weight with methanol, shake well, filter it, and take the filtrate as the test solution.

[0060] 4. Accurately pipette 10 μL each of the reference solution and the test solution into the liquid chromatograph, determine the result, and calculate the value.

[0061] Example 9 1. Selected test samples: the finished tea bag product of Example 1 and the finished functional wine product of Example 5.

[0062] 2. Set test conditions: accelerated test, temperature 40℃±2℃, relative humidity 75%±5%, placed for 6 months.

[0063] 3. Set the testing frequency: Take samples at the end of 0, 1, 2, 3 and 6 months respectively, and test the appearance and active ingredient content of the samples.

[0064] Comparative Example 1 1. Weigh out 15 parts of Japanese raisin tree fruit, 15 parts of vine tea, 12 parts of mulberry leaf, 8 parts of scutellaria baicalensis, 8 parts of salvia miltiorrhiza, 5 parts of licorice root, 8 parts of jujube seed, and 5 parts of chrysanthemum according to the following weight proportions.

[0065] 2. Select and wash each medicinal material separately, and dry them at a low temperature below 60℃ until the moisture content is less than 10%.

[0066] 3. After drying, the medicinal materials are pulverized and passed through a 60-mesh sieve. The weight is then weighed and put into a three-dimensional mixer and mixed for 40 minutes to obtain a mixed powder.

[0067] 4. Divide the mixed powder into 4-gram packets, package them into non-woven tea bags, cover them with aluminum foil bags, and sterilize them by Co60 irradiation to obtain the finished product.

[0068] Comparative Example 2 1. Weigh out 20 parts of kudzu root, 15 parts of vine tea, 12 parts of mulberry leaves, 8 parts of scutellaria baicalensis, 8 parts of salvia miltiorrhiza, 5 parts of licorice root, 8 parts of jujube seed, and 5 parts of chrysanthemum by weight.

[0069] 2. The preparation steps are the same as steps 2 to 4 of Comparative Example 1.

[0070] Comparative Example 3 1. Weigh out 20 parts by weight of kudzu root, 15 parts of Japanese raisin tree fruit, 12 parts of mulberry leaf, 8 parts of scutellaria root, 8 parts of salvia root, 5 parts of licorice root, 8 parts of jujube seed, and 5 parts of chrysanthemum.

[0071] 2. The preparation steps are the same as steps 2 to 4 of Comparative Example 1.

[0072] Comparative Example 4 1. Weigh out 20 parts of kudzu root, 15 parts of Japanese raisin tree fruit, 15 parts of vine tea, 12 parts of mulberry leaf, and 8 parts of scutellaria root by weight.

[0073] 2. The preparation steps are the same as steps 2 to 4 of Comparative Example 1.

[0074] Comparative Example 5 1. Weigh out 15 parts of vine tea, 12 parts of mulberry leaves, 8 parts of scutellaria baicalensis, 8 parts of salvia miltiorrhiza, 5 parts of licorice root, 8 parts of jujube seed, and 5 parts of chrysanthemum by weight.

[0075] 2. The preparation steps are the same as steps 2 to 4 of Comparative Example 1.

[0076] Comparative Example 6 1. Weigh out 20 parts of kudzu root, 15 parts of Japanese raisin tree fruit, and 5 parts of licorice root by weight.

[0077] 2. The preparation steps are the same as steps 2 to 4 of Comparative Example 1.

[0078] Comparative Example 7 1. Weigh out 10 parts by weight of kudzu root, 15 parts of Japanese raisin tree fruit, 15 parts of vine tea, 12 parts of mulberry leaf, 8 parts of scutellaria root, 8 parts of salvia root, 5 parts of licorice root, 8 parts of jujube seed, and 5 parts of chrysanthemum.

[0079] 2. The preparation steps are the same as steps 2 to 4 of Comparative Example 1.

[0080] Comparative Example 8 1. Weigh out the following ingredients by weight: 35 parts kudzu root, 15 parts Japanese raisin tree fruit, 15 parts vine tea, 12 parts mulberry leaf, 8 parts scutellaria root, 8 parts salvia root, 5 parts licorice root, 8 parts jujube seed, and 5 parts chrysanthemum.

[0081] 2. The preparation steps are the same as steps 2 to 4 of Comparative Example 1.

[0082] Comparative Example 9 1. Weigh out the following ingredients by weight: 20 parts kudzu root, 15 parts Japanese raisin tree fruit, 8 parts vine tea, 12 parts mulberry leaf, 8 parts scutellaria baicalensis, 8 parts salvia miltiorrhiza, 5 parts licorice root, 8 parts jujube seed, and 5 parts chrysanthemum.

[0083] 2. The preparation steps are the same as steps 2 to 4 of Comparative Example 1.

[0084] Comparative Example 10 1. Weigh out the following ingredients by weight: 20 parts kudzu root, 15 parts Japanese raisin tree fruit, 15 parts vine tea, 12 parts mulberry leaf, 8 parts scutellaria baicalensis, 8 parts salvia miltiorrhiza, 5 parts licorice root, 8 parts jujube seed, and 5 parts chrysanthemum.

[0085] 2. Mix the medicinal materials, add 10 times the amount of water, decoct for 1 hour, filter, and take the filtrate to obtain the decoction.

[0086] 3. The administration method is gavage 1 hour after drinking alcohol.

[0087] Performance verification 1. Establishment of experimental model An acute alcohol poisoning model was established in rats by gavage administration of 56-proof baijiu (Chinese liquor). Healthy adult rats weighing 200-250g were selected and subjected to the experiment after one week of acclimatization feeding.

[0088] 2. Experimental Grouping Rats were randomly divided into 12 groups of 10 rats each: normal control group, model group, Example 1 group, Example 5 group, Comparative Example 1 group, Comparative Example 3 group, Comparative Example 4 group, Comparative Example 6 group, Comparative Example 7 group, Comparative Example 9 group, Comparative Example 10 group, and Comparative Example 11 group. Except for the normal control group, all other groups were administered baijiu (a type of Chinese liquor) by gavage. One hour before the administration of baijiu, each treatment group was given the corresponding sample, while the normal control group and model group were given an equal volume of physiological saline.

[0089] 3. Detection indicators and methods (1) Behavioral indicators: Observe and record the time of disappearance and recovery of the righting reflex in rats.

[0090] (2) Oxidative stress indicators: After sacrificing rats, hippocampal tissue was taken and the activities of superoxide dismutase (SOD), glutathione peroxidase (GSH-Px) and malondialdehyde (MDA) were measured using a kit method.

[0091] (3) Neuroinflammatory markers: The levels of tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β) in hippocampal tissue were detected by enzyme-linked immunosorbent assay (ELISA).

[0092] 4. Stability test methods (1) Appearance inspection: Observe the color, shape, clarity, etc. of the sample.

[0093] (2) Detection of active ingredient content: The contents of puerarin and dihydromyricetin were determined by referring to the HPLC method in Example 8.

[0094] Verification results 1. Behavioral indicator test results

[0095] 2. Results of oxidative stress index testing

[0096] 3. Results of neuroinflammatory marker tests

[0097] 4. Stability test results

[0098] Based on the preparation process of Examples 1-9, the comparative verification and performance test results of Comparative Examples 1-11, it can be seen that the traditional Chinese medicine composition and preparation process of each dosage form of the present invention are feasible and advanced. At the same time, the inventiveness and rationality of the technical solution of the present invention have been fully verified through comparative experiments.

[0099] Examples 1-6 cover six dosage forms: tea bags, solid beverages, oral liquids, concentrated liquors for alcoholic beverages, functional liquors, and liquor soaking packets. The preparation process parameters are clearly defined and the steps are controllable, meeting the needs of large-scale production. Quality control test results from Examples 7-9 show that thin-layer chromatography can accurately identify the characteristic components of kudzu root and scutellaria baicalensis in the composition. High-performance liquid chromatography (HPLC) determinations of puerarin and dihydromyricetin content both meet preset standards. Accelerated stability testing further demonstrates that after 6 months of storage at 40℃ and 75% relative humidity, the product shows no significant changes in appearance, and the decrease in active ingredient content is ≤10%, exhibiting good stability and quality controllability.

[0100] The results of the single-component deletion experiments in Comparative Examples 1-3 showed that the deletion of Pueraria lobata, Hovenia dulcis, and vine tea, as the core components of the composition, significantly prolonged the recovery time of the righting reflex in rats, substantially decreased the activity of SOD and GSH-Px in the hippocampus, and significantly increased the content of TNF-α and IL-1β, proving that the above components have an irreplaceable role in alleviating alcoholic brain injury. The subgroup combination experiments in Comparative Examples 4-6 further verified that combinations containing only the principal drug + assistant drug or assistant drug + adjuvant drug, as well as conventional hangover remedies in the prior art, had a much lower neuroprotective effect than the complete formulation of this invention. This fully demonstrates the technical advantage of the synergistic effect of the components in the formulation of this invention. This synergistic effect can simultaneously act on multiple pathological links in alcoholic brain injury, such as oxidative stress and neuroinflammation, achieving full-chain protection.

[0101] The results of the content range exceedance tests in Comparative Examples 7-9 showed that when the dosage of kudzu root and vine tea was lower or higher than the range defined in the claims, the efficacy of the composition decreased significantly, proving that the raw material weight range defined in this invention is the optimal range obtained through screening, and not arbitrarily set. The dosage form comparison test results in Comparative Example 10 showed that the functional wine dosage form of this invention, administered simultaneously with alcohol consumption, has a significantly better protective effect than traditional decoctions taken after drinking alcohol, highlighting the innovation and practicality of the dosage form design.

[0102] In summary, the traditional Chinese medicine composition of this invention has a scientific formulation, stable preparation process, and reasonable dosage form design, which is a significant improvement over the prior art and has good industrial application value.

[0103] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for alleviating alcoholic brain injury, characterized in that, By weight, it consists of the following ingredients: 15-30 parts kudzu root, 10-20 parts Japanese raisin tree fruit, 10-20 parts vine tea, 10-15 parts mulberry leaf, 5-10 parts scutellaria baicalensis, 3-6 parts licorice root, 5-10 parts salvia miltiorrhiza, 5-10 parts jujube seed, and 3-8 parts chrysanthemum.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The composition also includes 3-8 parts of turmeric.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The composition also includes 3-8 parts of lily.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The composition also includes at least one of the following: 3-8 parts of wolfberry, 3-8 parts of dried tangerine peel, or 1-3 parts of osmanthus.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw materials, by weight, consist of: 20-25 parts kudzu root, 15-18 parts Japanese raisin tree fruit, 12-15 parts vine tea, 10-12 parts mulberry leaf, 6-8 parts scutellaria root, 4-5 parts licorice root, 5-8 parts salvia root, 6-8 parts jujube seed, and 4-5 parts chrysanthemum.

6. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-5, for preparing tea bags, characterized in that, Includes the following steps: (1) Select and clean each raw medicinal material separately, and dry them at a low temperature below 60℃ until the moisture content is less than 10%; (2) Crush the dried raw materials through a 60-80 mesh sieve, weigh them by weight, and put them into a mixer to mix evenly; (3) The mixed powder is divided into 4g bags and packaged into non-woven tea bags, covered with aluminum foil bags, and sterilized by Co60 irradiation.

7. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-5, used for preparing a solid beverage, characterized in that, Includes the following steps: (1) Select and clean each raw medicinal material separately, dry it at a low temperature below 60℃ until the moisture content is less than 10%, pulverize it through a 60-80 mesh sieve, weigh it according to the weight parts and mix it evenly to obtain a mixed powder; (2) Add 30 parts by weight of maltodextrin and 2 parts by weight of steviol glycoside to 100 parts by weight of mixed powder, mix evenly, and add 70% ethanol as a wetting agent to make a soft material; (3) Granulate the soft material through a 16-mesh sieve, dry it in an oven at 55°C until the moisture content is ≤5%, granulate it through a 14-mesh sieve, and then package it.

8. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-5, for preparing an oral liquid, characterized in that, Includes the following steps: (1) After mixing the raw medicinal materials, add 10 times the amount of water and reflux extract twice, each time for 1.5 hours. Combine the extracts and filter through a 200-mesh sieve. (2) The filtrate was concentrated under reduced pressure at 60°C to an extract with a density of 1.12; (3) Take 100 parts by weight of the extract, add purified water to 1000 ml, add 50 parts by weight of honey and 0.5 parts by weight of potassium sorbate, stir to dissolve, filter through a 0.22 μm microporous membrane, fill into oral liquid bottles, and autoclave at 115℃ for 30 minutes to obtain the product.

9. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-5, used for preparing a concentrated liquor for wine, characterized in that, Includes the following steps: (1) Select and clean each raw medicinal material separately, dry them at a low temperature below 60℃ until the moisture content is less than 10%, crush them and pass them through a 30-mesh sieve, weigh them according to the weight parts and mix them evenly to obtain a mixture. (2) Take 1 part by weight of the mixture, add 10 parts by weight of 40-60% vol edible alcohol, reflux extract at 55℃ for 1.5 hours, and filter; add 8 parts by weight of the same solvent to the residue and reflux extract for 1 hour, and combine the two extracts; (3) After coarse filtration through a plate and frame filter and fine filtration through a 0.45μm membrane, the extract is concentrated by vacuum distillation at 45℃ and -0.08MPa to a concentration of 0.5-2.0g / mL.

10. A method for preparing functional wine from the concentrated wine extract of claim 9, characterized in that, Take 35% vol base liquor and add it to the liquor concentrate at a ratio of 1%-5%. Stir for 30 minutes until the mixture is uniform. After standing and clarifying for 3 days, take the supernatant, filter it through a membrane to sterilize it, and then bottle it to obtain the liquor.

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