Application of pharmaceutical compositions in the preparation of drugs for the prevention or treatment of alcoholic brain injury

Abstract

This application relates to the field of pharmaceutical use technology, disclosing the application of a pharmaceutical composition in the preparation of drugs for the prevention or treatment of chronic alcoholic brain injury, developing a new use for Tongrentang Niuhuang Qingxin Pills, providing new therapeutic drugs and methods for the intervention and treatment of chronic alcoholic brain injury, thereby providing technical support for the rational use of drugs. This application demonstrates the therapeutic effect of Tongrentang Niuhuang Qingxin Pills on alcoholic brain injury through experiments on model rats, including the detection of learning and memory abilities, balance ability indicators, pathological changes in brain tissue, and S100-β in cerebrospinal fluid.

Description

Technical Field

[0001] This application relates to the field of pharmaceutical use technology, specifically to the use of a pharmaceutical composition in the preparation of a drug for the prevention or treatment of alcoholic brain injury. Background Technology

[0002] The brain is a significant target organ for alcohol. Most current research suggests that even low doses of alcohol intake can impair motor control, judgment, and reaction time, due to the widespread effects of alcohol on multiple brain regions. Long-term heavy drinking leads to alcoholic brain injury and acute and chronic alcohol poisoning, ultimately causing both structural and functional changes in the central nervous system. This impairs judgment and thinking abilities, contributing to increased crime rates and causing serious harm and a series of problems for society. Therefore, in-depth and systematic research into alcoholic encephalopathy and the search for effective prevention and treatment measures are urgent and of profound significance.

[0003] In Traditional Chinese Medicine (TCM), alcoholic brain injury falls under the categories of "dementia," "mania," and "amnesia." Modern physicians tend to divide alcoholic brain injury into three stages: early, middle, and late. The early stage is often attributed to excessive alcohol consumption, leading to the accumulation of damp-heat in the middle jiao (middle burner), impaired spleen and stomach function, and disrupted qi circulation. Furthermore, phlegm and blood stasis obstruct the brain's pathways, resulting in dementia. This stage is characterized by excess heat due to alcohol damaging the spleen and stomach. The middle stage is often associated with alcohol addiction. At this point, damp-heat accumulates in the middle jiao, becoming stagnant and unable to transform. It can combine with qi, blood, and phlegm to form lumps that accumulate under the ribs. Simultaneously, dryness damages yin, causing water to fail to nourish wood, and yin to fail to control yang, leading to hyperactivity of liver yang, which disturbs the sensory orifices and worsens dementia. This stage is characterized by deficiency of the root and excess of the branch. In the later stages, it often presents as ascites, where damp-heat accumulates in the middle jiao (middle burner), damaging yin and depleting qi and blood over time, extending to the kidneys. Symptoms include hard masses under the ribs, abdominal distension and swelling, or internal retention of dampness, manifesting as a distended abdomen resembling a water-filled sac. Insufficient kidney essence leads to emptiness of the marrow sea, and deficiency of qi and blood results in malnourishment of the brain vessels, causing marrow depletion, brain atrophy, and impaired mental function. This stage is characterized by deficiency of vital energy and lingering pathogenic factors, with the root cause being deficient and the manifestation being excessive, affecting the brain, liver, spleen, and kidneys.

[0004] Therefore, traditional Chinese medicine (TCM) clinical treatment often focuses on clearing heat and detoxifying, and refreshing the mind and opening the orifices, all of which have achieved certain therapeutic effects, demonstrating the advantages of TCM in the diagnosis and treatment of chronic alcoholic brain injury. However, no TCM has yet been found that can comprehensively prevent or treat alcoholic brain injury with good efficacy. Summary of the Invention

[0005] In view of this, this application provides the use of a pharmaceutical composition in the preparation of a drug for the prevention or treatment of alcoholic brain injury. This drug has good preventive and therapeutic effects on alcoholic brain injury, solving the problem of the relative lack of preventive and therapeutic methods for alcoholic brain injury in the prior art.

[0006] In a first aspect, this application provides the use of a pharmaceutical composition in the preparation of a drug for the prevention or treatment of alcoholic brain injury, said pharmaceutical composition comprising Tongren Niuhuang Qingxin Pill or a pharmaceutical composition obtained by compounding or extracting the raw materials of Tongren Niuhuang Qingxin Pill.

[0007] In some specific embodiments, the pharmaceutical composition is used in the preparation of a drug for inhibiting the expression of a central nervous system-specific protein.

[0008] In some specific embodiments, alcoholic brain injury is chronic alcoholic brain injury; the chronic alcoholic brain injury includes at least one of memory impairment, balance disorder, and pathological changes in brain tissue caused by excessive drinking.

[0009] In some specific embodiments, the drug for preventing or treating alcoholic brain injury has the function of any one of the following (1)-(4):

[0010] (1) Improves pathological changes in brain tissue;

[0011] (2) Improve balance;

[0012] (3) Improve memory;

[0013] (4) Reduce the expression level of central nervous system-specific proteins in cerebrospinal fluid.

[0014] In some specific embodiments, the pathological changes in brain tissue include at least one of the following: significant congestion and edema of brain tissue, disordered arrangement of neurons in the cerebral cortex or hippocampus, severe reduction in the number of neurons, significant condensation and deep staining of neuronal cell bodies and nuclei, vacuolar degeneration of nerve cells, and significant dilation of some intracerebral blood vessels.

[0015] In some specific implementations, the application is applied to both humans and other animals.

[0016] In some specific embodiments, the drug for preventing or treating alcoholic brain injury includes Tongrentang Niuhuang Qingxin Pills or a pharmaceutical composition obtained by extracting the raw materials of Tongrentang Niuhuang Qingxin Pills.

[0017] In some specific embodiments, the drug for preventing or treating alcoholic brain injury also includes pharmaceutically acceptable excipients;

[0018] Optionally, the excipients include one or more of the following: solvent, solubilizer, cosolvent, emulsifier, colorant, binder, disintegrant, stabilizer, flavoring agent, preservative, suspending agent, coating material, fragrance, and thickener.

[0019] In some specific embodiments, the dosage form of the medicament for preventing or treating alcoholic brain injury includes any pharmaceutically acceptable formulation;

[0020] Optionally, the dosage form of the drug for preventing or treating chronic alcoholic brain injury is tablets, capsules, powders, drops, lyophilized substances, granules, ointments, patches, suspensions, syrups, oral liquids, injections, suppositories, or any combination thereof.

[0021] Compared with the prior art, the beneficial effects of this application are as follows:

[0022] This application provides an application of Tongren Niuhuang Qingxin Pill in the preparation of drugs for the prevention or treatment of alcoholic brain injury, develops a new use for Tongren Niuhuang Qingxin Pill, provides new therapeutic drugs and methods for the intervention and treatment of chronic alcoholic brain injury, and thus provides technical support for the rational use of drugs.

[0023] This application demonstrates the therapeutic effect of Tongren Niuhuang Qingxin Pill on alcoholic brain injury by detecting the learning and memory, balance ability, brain tissue pathological changes, and S100-β in the cerebrospinal fluid of model rats. Attached Figure Description

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

[0025] Figure 1 The effect of Tongren Niuhuang Qingxin Pill on the pathological changes of brain tissue in rats with chronic alcoholic brain injury;

[0026] Figure 2 The brain tissue morphology of the control group rats;

[0027] Figure 3 This shows the brain tissue morphology of the model group rats. Detailed Implementation

[0028] The following embodiments are provided to better understand this application and are not limited to the preferred embodiments described herein. They do not constitute a limitation on the content and scope of protection of this application. Any product that is the same as or similar to this application, derived by anyone under the guidance of this application or by combining features of this application with other prior art, falls within the scope of protection of this application.

[0029] Unless otherwise stated or in case of contradiction, the terms or phrases used herein shall have the following meanings:

[0030] In this application, the selection range involving "and / or", "or / and", and "and / or" includes any one of two or more related listed items, as well as any and all combinations of the related listed items, wherein any and all combinations include any two related listed items, any more related listed items, or a combination of all related listed items.

[0031] In this application, terms such as "preferred," "better," "more suitable," and "ideal" are used only to describe implementation methods or embodiments with better effects, and should be understood not to constitute a limitation on the scope of protection of this application.

[0032] In this application, terms such as "further," "even further," and "particularly" are used for descriptive purposes to indicate differences in content, but should not be construed as limiting the scope of protection of this application.

[0033] In this application, the terms "optionally," "optionally," and "optional" refer to options that are optional, meaning that they are selected from either "with" or "without."

[0034] In this application, the technical features described in an open-ended manner include both closed technical solutions consisting of the listed features and open technical solutions that include the listed features.

[0035] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0036] In order to explore effective measures for the prevention and treatment of alcoholic encephalopathy and solve the problems existing in the prevention and treatment technologies related to alcoholic brain injury, according to the first aspect of this application, this application provides the application of a pharmaceutical composition in the preparation of a drug for the prevention or treatment of chronic alcoholic brain injury. The raw materials of the pharmaceutical composition include 27 kinds of traditional Chinese medicinal materials such as artificial bezoar, antelope horn, artificial musk, ginseng, atractylodes macrocephala, angelica sinensis, white peony root, bupleurum, dried ginger, donkey-hide gelatin, platycodon grandiflorus, and concentrated buffalo horn powder.

[0037] Tongren Niuhuang Qingxin Pills are an existing finished drug. Based on years of research and practical experience, a deep understanding of the efficacy and interactions of each raw material has been achieved, and their related efficacy, safety, and stability have been scientifically evaluated. Therefore, compared with new drug development, Tongren Niuhuang Qingxin Pills have better safety and stability, and also have readily available production technology, greatly saving research time and resulting in higher economic benefits. Therefore, considering the above advantages of existing finished drugs, the pharmaceutical composition of this application is preferably Tongren Niuhuang Qingxin Pills.

[0038] Tongren Niuhuang Qingxin Pills are composed of 27 Chinese medicinal herbs, including artificial bezoar, antelope horn, artificial musk, ginseng, Atractylodes macrocephala (stir-fried with wheat bran), Angelica sinensis, white peony root, Bupleurum chinense, dried ginger, donkey-hide gelatin, Platycodon grandiflorus, and concentrated buffalo horn powder. The formula contains bezoar, musk, buffalo horn, antelope horn, and borneol, which have the functions of clearing the heart and opening the orifices, resolving phlegm and calming fright, clearing heat and detoxifying, and calming the liver and extinguishing wind. It is often used to treat delirium, convulsions, irritability, infantile convulsions, boils and carbuncles caused by high fever and toxic fire attacking the heart. Dried ginger and cinnamon restore yang and rescue from collapse, and strengthen the opening of the orifices. They are essential medicines for treating convulsions, spasms, delirium, convulsions, fainting, dysarthria, hemiplegia, numbness of limbs and chest pain caused by high fever and heart and brain diseases. Scutellaria baicalensis and soybean curd have the effects of clearing the fire in the upper burner and relieving irritability. Angelica sinensis, white peony root, chuanxiong rhizome, ophiopogon japonicus and cattail pollen have the effects of nourishing blood and yin, clearing headache, and promoting blood circulation and stopping bleeding. Saposhnikovia divaricata, bupleurum chinense, apricot kernel and platycodon grandiflorus soothe the liver and regulate qi, and promote the downward flow of lung qi. Ginseng, atractylodes macrocephala, poria cocos, yam and licorice tonify qi and strengthen the spleen to provide the source of qi and blood. Experiments have shown that Tongren Niuhuang Qingxin Pills have the effects of invigorating qi and nourishing blood, calming the mind and soothing the nerves, lowering blood pressure and protecting the liver, enhancing the body's ability to resist stress, improving cerebral ischemia and increasing blood flow in the meningeal microcirculation.

[0039] Based on the drug's indications and previous studies, this application conducted a pharmacodynamic study on Tongren Niuhuang Qingxin Pills in the treatment of chronic alcoholic brain injury. A simple, economical, stable, and reliable rat model of chronic alcoholic brain injury was established by gavage administration of high-concentration baijiu (Chinese liquor). Tongren Niuhuang Qingxin Pills were then administered to rats in this model. Previous studies showed that Tongren Niuhuang Qingxin Pills significantly improved the learning and memory abilities of rats with mild vascular cognitive impairment and had a good protective effect against brain injury in mice with acute alcohol poisoning. Through comprehensive analysis of the drug's formulation, indications, and modern pharmacodynamic studies, Tongren Niuhuang Qingxin Pills have potential therapeutic effects on chronic alcoholic brain injury.

[0040] Preferably, the composition is Tongren Niuhuang Qingxin Pill, and the use of Tongren Niuhuang Qingxin Pill in the preparation of drugs for the prevention or treatment of alcoholic brain injury.

[0041] Further research has found that Tongren Niuhuang Qingxin Pills can inhibit the expression of specific proteins in the central nervous system.

[0042] In some embodiments, Tongren Niuhuang Qingxin Pills are used in the preparation of drugs for inhibiting the expression of specific proteins in the central nervous system.

[0043] Further research revealed that Tongren Niuhuang Qingxin Pills can improve memory impairment, balance disorder, and pathological changes in brain tissue in model rats (significant congestion and edema of brain tissue, disordered arrangement of neurons in the cerebral cortex or hippocampus, severe reduction in the number of neurons, significant condensation and deep staining of neuronal cell bodies and nuclei, vacuolar degeneration of nerve cells, and significant dilation of some intracerebral blood vessels).

[0044] In some embodiments, alcoholic brain injury is chronic alcoholic brain injury; chronic alcoholic brain injury can cause memory impairment, balance disorder, pathological changes in brain tissue (at least one of the following: significant congestion and edema of brain tissue, disordered arrangement of neurons in the cerebral cortex or hippocampus, severe reduction in the number of neurons, significant condensation and deep staining of neuronal cell bodies and nuclei, vacuolar degeneration of nerve cells, and significant dilation of some intracerebral blood vessels).

[0045] In some embodiments, the drug for preventing or treating alcoholic brain injury has any one of the following functions (1)-(4):

[0046] (1) Improve the pathological changes in brain tissue (at least one of the following: obvious congestion and edema of brain tissue, disordered arrangement of neurons in the cerebral cortex or hippocampus, severe reduction in the number of neurons, obvious condensation and deep staining of neuronal cell bodies and nuclei, vacuolar degeneration of nerve cells, and obvious dilation of some intracerebral blood vessels).

[0047] (2) Improve balance;

[0048] (3) Improve memory;

[0049] (4) Reduce the expression level of central nervous system-specific proteins in cerebrospinal fluid.

[0050] In some embodiments, the application is applied to humans and other animals besides humans.

[0051] The usual dosage of Tongren Niuhuang Qingxin Pills for patients with alcoholic brain injury is 1-4 pills per day, with each pill weighing 3 grams. During the experimental process of this application, it was found that a dosage of 0.3-3 g / kg per day in rats had preventive and therapeutic effects on alcoholic brain injury.

[0052] In some embodiments, the dosage of Tongren Niuhuang Qingxin Pill is 1-4 pills per day, each pill weighing 3 grams, and the dosage for rats is 0.3-3 g / kg per day.

[0053] When Tongren Niuhuang Qingxin Pill is the only effective ingredient in a drug for the prevention or treatment of chronic alcoholic brain injury, the minimum effective dose of Niuhuang Qingxin Pill for rats is 0.3 g / kg / day.

[0054] In some embodiments, the drug for preventing or treating alcoholic brain injury includes Tongrentang Niuhuang Qingxin Pill or a pharmaceutical composition obtained by extracting the raw materials of Tongrentang Niuhuang Qingxin Pill.

[0055] In some embodiments, the drug for preventing or treating alcoholic brain injury further includes pharmaceutically acceptable excipients;

[0056] Optionally, the excipients include one or more of the following: solvent, solubilizer, cosolvent, emulsifier, colorant, binder, disintegrant, stabilizer, flavoring agent, preservative, suspending agent, coating material, fragrance, and thickener.

[0057] In some embodiments, the dosage form of the medicament for preventing or treating alcoholic brain injury includes any pharmaceutically acceptable formulation;

[0058] Optionally, the dosage form of the drug for preventing or treating chronic alcoholic brain injury is tablets, capsules, powders, drops, lyophilized substances, granules, ointments, patches, suspensions, syrups, oral liquids, injections, suppositories, or any combination thereof.

[0059] The present application will be further described in detail below with reference to specific embodiments, which should not be construed as limiting the scope of protection claimed in the present application.

[0060] For experiments not specifically described in the examples, the procedures or conditions should be followed according to the conventional experimental procedures described in the literature in this field. Reagents or instruments whose manufacturers are not specified are all commercially available conventional reagent products.

[0061] Example 1

[0062] The Tongrentang Niuhuang Qingxin Pill used in this embodiment has a prescription consisting of 27 ingredients, including artificial bezoar, antelope horn, artificial musk, ginseng, Atractylodes macrocephala (stir-fried with wheat bran), Angelica sinensis, Paeonia lactiflora, Bupleurum chinense, dried ginger, donkey-hide gelatin, Platycodon grandiflorus, and concentrated buffalo horn powder. It was purchased from Beijing Tongrentang.

[0063] 1. Experimental Objective

[0064] A rat model of chronic alcoholic brain injury was established by gavage administration of high-concentration baijiu (Chinese liquor) to observe the therapeutic effect of Tongren Niuhuang Qingxin Wan (a traditional Chinese medicine) on chronic brain injury.

[0065] 2. Experimental Design

[0066] Male Wistar rats (SPF grade, weighing 180-200g) were randomly divided into a control group and a model group after acclimatization. Rats in the model group were administered 8ml / kg·d of 56% ABV Erguotou liquor by gavage, while rats in the control group were given normal maintenance feed and drinking water. After 2 weeks, the model group was randomly divided into a model group and a Tongren Niuhuang Qingxin Wan dosage group (2.4g / kg, 1.2g / kg, 0.6g / kg, and 0.3g / kg).

[0067] In week 3, except for the control group, the dosage of baijiu (Chinese liquor) in all other groups was increased to 12 ml / kg·d, and administered by gavage for a total of 6 weeks. At the same time, in week 3, after daily gavage of baijiu in the modeling group, each group was given the corresponding dose of the test drug once a day for a total of 4 weeks.

[0068] Four weeks after drug administration, Morris water maze and rotarod tests were performed to evaluate the effects of the drug on the learning, memory, and balance abilities of model rats. After the last administration, rats were anesthetized, and cerebrospinal fluid was collected to measure the expression level of rat S100-β (central nervous system-specific protein) in the cerebrospinal fluid. Brain tissue samples were obtained for pathological examination, routinely stained with hematoxylin and eosin (HE), prepared, and observed under a microscope for histopathological changes.

[0069] 3. Experimental Results

[0070] (1) The results of the water maze experiment are shown in Table 1:

[0071] Table 1. Effects of Tongrentang Niuhuang Qingxin Pill on the water maze test in rats with chronic alcoholic brain injury.

[0072]

[0073] Compared with the model group: * P<0.05, ** P<0.01.

[0074] As shown in Table 1, the model group rats had shorter time spent in the test quadrant and shorter swimming path length in the test quadrant than the control group, with significant differences (p<0.01 and p<0.05, respectively). This indicates that the model established by this method has significant memory impairment in rats.

[0075] Rats in the Tongrentang Niuhuang Qingxin Pill dosage groups (2.4 g / kg, 1.2 g / kg, 0.6 g / kg, and 0.3 g / kg) showed significantly increased time spent in the test quadrant compared to the model group (all p < 0.01); the swimming path length in the test quadrant was significantly increased compared to the model group (all p < 0.01); and the latency to reach the test quadrant was significantly shortened compared to the model group (all p < 0.05). Therefore, Tongrentang Niuhuang Qingxin Pill has a significant effect on improving memory in rats with chronic alcoholic brain injury.

[0076] (2) The results of the rotating rod experiment are shown in Table 2:

[0077] Table 2. Effects of Tongrentang Niuhuang Qingxin Pill on the latency period of a rat model of chronic alcoholic brain injury.

[0078]

[0079] Compared with the model group: * P<0.01.

[0080] Table 2 shows that the drop latency of the rod in the model group was significantly shortened, with a significant difference compared to the control group (p<0.01), indicating that long-term alcohol consumption reduces the balance ability of the model rats. The drop latency of the rod in the Tongrentang Niuhuang Qingxin Wan dosage groups (2.4g / kg, 1.2g / kg, and 0.6g / kg) was significantly prolonged, with significant differences compared to the model group (all p<0.01). Therefore, Tongrentang Niuhuang Qingxin Wan can significantly improve the balance disorder caused by long-term alcohol consumption in the model rats.

[0081] (3) Effects on the expression level of S100-β (central nervous system-specific protein) in the cerebrospinal fluid of model rats

[0082] Table 3. Effects of Tongrentang Niuhuang Qingxin Pill on S100-β expression levels in cerebrospinal fluid of rats with chronic alcoholic brain injury.

[0083]

[0084]

[0085] Compared with the model group: * P<0.01.

[0086] As shown in Table 3, the expression level of S100-β in the cerebrospinal fluid of rats in the model group was significantly increased, showing a significant difference compared with the blank group (p<0.01), indicating that the model rats had significant brain damage. The expression level of S100-β in the cerebrospinal fluid of rats in each dose group of Tongren Niuhuang Qingxin Wan was significantly decreased, showing a significant difference compared with the model group (all p<0.01). This result indicates that Niuhuang Qingxin Wan has a significant therapeutic effect on alcohol-induced chronic brain injury.

[0087] (4) Effects on pathological changes in brain tissue of model rats

[0088] Figure 1 The study investigated the effects of Tongrentang Niuhuang Qingxin Pill on the pathological changes in brain tissue of rats with chronic alcoholic brain injury. The groups included Tongrentang Niuhuang Qingxin Pill at doses of 2.4 g / kg, 1.2 g / kg, 0.6 g / kg, and 0.3 g / kg. Figure 2 The brain tissue morphology of the control group rats; Figure 3 This shows the brain tissue morphology of the model group rats.

[0089] Will Figure 1-3Comparison of experimental results showed that the model group rats exhibited obvious congestion and edema in the brain tissue, disordered arrangement of neurons in the cerebral cortex and hippocampus, a severe reduction in the number of neurons, and significant condensation and deep staining of the cell bodies and nuclei of a large number of neurons; no abnormal proliferation of glial cells; vacuolar degeneration of some nerve cells; and significant dilation of some intracerebral blood vessels.

[0090] Tongren Niuhuang Qingxin Pills at various dosage levels significantly alleviated pathological damage to the brain tissue of model rats. The main improvement was in brain congestion and edema compared to the model group. Neuronal morphology in the cerebral cortex and hippocampus remained largely normal and neatly arranged; no cerebral vasodilation was observed. The degree of neuronal degeneration and necrosis, abnormal glial cell proliferation, and vacuolar degeneration of neuronal cells were all improved compared to the model group.

[0091] The above experiments demonstrate that Tongren Niuhuang Qingxin Pill can significantly improve the learning, memory, and balance abilities of model rats, improve pathological changes in brain tissue, reduce the expression level of S100-β in cerebrospinal fluid, and has a significant therapeutic effect on chronic alcoholic brain injury.

[0092] In summary, based on the drug's indications and previous research, this application conducted a pharmacodynamic study on Tongren Niuhuang Qingxin Pills in the treatment of chronic alcoholic brain injury. A simple, economical, stable, and reliable rat model of chronic alcoholic brain injury was established by gavage administration of high-concentration baijiu (Chinese liquor). Tongren Niuhuang Qingxin Pills were then administered to the rats. Through the detection of learning and memory abilities, balance capacity, pathological changes in brain tissue, and S100-β levels in cerebrospinal fluid, the experiment demonstrated that Tongren Niuhuang Qingxin Pills have a relatively comprehensive therapeutic effect on chronic alcoholic brain injury.

[0093] This application conducts a pharmacodynamic study on the effects of Tongren Niuhuang Qingxin Pill in the treatment of chronic alcoholic brain injury, clarifying the therapeutic effects and characteristics of the drug, expanding new applications of the drug, providing new therapeutic drugs and methods for the intervention and treatment of chronic alcoholic brain injury, and thus providing technical support for the rational use of the drug.

[0094] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this application.

Claims

1. The use of the pharmaceutical composition in the preparation of a drug for the prevention or treatment of alcoholic brain injury, characterized in that, The pharmaceutical composition is Tongren Niuhuang Qingxin Pill or a pharmaceutical composition obtained by compounding or extracting the raw materials of Tongren Niuhuang Qingxin Pill.

2. The application according to claim 1, characterized in that, The prevention or treatment of alcoholic brain injury involves inhibiting the expression of specific proteins in the central nervous system.

3. The application according to claim 1, characterized in that, Alcoholic brain injury is chronic alcoholic brain injury; the chronic alcoholic brain injury is at least one of the following caused by excessive drinking: memory impairment, balance disorder, and pathological changes in brain tissue.

4. The application according to claim 1, characterized in that, The drug for preventing or treating alcoholic brain injury has any of the following functions (1)-(4): (1) Improves pathological changes in brain tissue; (2) Improve balance ability; (3) Improve memory; (4) Reduce the expression level of central nervous system-specific proteins in cerebrospinal fluid.

5. The application according to claim 3 or 4, characterized in that, The pathological changes in the brain tissue include at least one of the following: brain tissue congestion and edema, disordered arrangement of neurons in the cerebral cortex or hippocampus, severe reduction in the number of neurons, condensation and deep staining of neuronal cell bodies and nuclei, neuronal vacuolar degeneration, and partial cerebral vasodilation.

6. The application according to any one of claims 1-4, characterized in that, The application can be applied to humans and other animals besides humans.

7. The application according to claim 1, characterized in that, The medications for the prevention or treatment of alcoholic brain injury also include pharmaceutically acceptable excipients.

8. The application according to claim 7, characterized in that, The excipients include one or more of the following: solvents, solubilizers, co-solvents, emulsifiers, colorants, binders, disintegrants, stabilizers, flavoring agents, preservatives, suspending agents, coating materials, fragrances, and thickeners.

9. The application according to any one of claims 1-4, characterized in that, The dosage form of the drug for the prevention or treatment of alcoholic brain injury is any pharmaceutically acceptable dosage form.

10. The application according to claim 9, characterized in that, The dosage forms of the drugs for preventing or treating alcoholic brain injury are tablets, capsules, powders, drops, lyophilized substances, granules, ointments, patches, suspensions, syrups, oral liquids, injections, or suppositories.

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