Composition containing Angelica dahurica, preparation method thereof, traditional Chinese medicine preparation and application thereof

Abstract

The present invention discloses a composition containing Angelica dahurica and a preparation method, a Chinese medicine preparation and application thereof, belonging to the technical field of compositions. The composition is composed of Angelica dahurica and radish extract, wherein the radish extract is a dried product obtained by filtering fresh radish juice; the preparation method comprises the step of mixing the Angelica dahurica and the radish extract; the Chinese medicine preparation comprises the composition and pharmaceutically acceptable excipients. The application is the application of the composition and / or the Chinese medicine preparation in the preparation of a drug, wherein the drug comprises at least one of increasing the function of learning and memory, improving cognitive function, promoting intelligence, neuroprotective effect, improving depression, and preventing and / or treating Alzheimer's disease. The composition of the present invention uses medicinal materials that are both medicinal and edible as raw materials, has good safety, and has a good improvement effect on learning and memory disorders.

Description

Technical Field

[0001] The present invention belongs to the technical field of compositions, and relates to a composition containing Angelica dahurica, a preparation method thereof, a Chinese medicine preparation and an application thereof, and specifically relates to a composition containing Angelica dahurica, a preparation method thereof, a Chinese medicine preparation and an application thereof in preparing drugs related to preventing and / or treating Alzheimer's disease, improving depression, increasing learning and memory functions, improving cognitive functions, promoting intelligence and having neuroprotective effects. Background Art

[0002] Learning and memory disorders are common clinical diseases with a very complex pathogenesis. They not only affect people's work and life, but also induce other diseases in severe cases. In recent years, traditional Chinese medicine has attracted more and more attention from researchers in improving learning and memory disorders.

[0003] At present, most drugs used to improve learning and memory disorders are chemical drugs, such as cholinesterase inhibitors, drugs that regulate intestinal flora, and drugs that promote neurotransmitter function. These drugs have clear mechanisms of action and targets, but they cannot meet clinical needs. Learning and memory disorders belong to the categories of "dementia" and "forgetfulness" in traditional Chinese medicine. The etiology and pathogenesis are malnutrition of the brain orifices, malfilling of the marrow sea, or evil blocking the brain orifices and turbidity of the marrow sea. Compared with chemical drugs with single components, single targets, and single pathways, which are difficult to deal with learning and memory disorders with complex pathogenesis, traditional Chinese medicine has become more and more important due to its characteristics of multiple components, multiple targets, multiple pathways, and few toxic and side effects. It is increasingly used in clinical practice and has achieved good application results.

[0004] Angelica dahurica is warm in nature, pungent in taste, enters the lung, spleen, and stomach meridians, has the effects of dispelling cold, dispelling wind and relieving pain, clearing the nasal passages, drying dampness and stopping leukorrhea, reducing swelling and draining pus, dispelling wind and relieving itching, and is mainly used to treat headache, supraclavicular pain, toothache, sinusitis, cold and damp abdominal pain, intestinal wind hemorrhoids, leukorrhea, carbuncle, ulcer, dry and itchy skin, and scabies. Its main components are isoimperatorin, imperatorin, bergapten, phelopterin, oxypeucedanin, etc. It is reported that imperatorin has an inhibitory effect on acetylcholinesterase, thereby affecting the metabolism of acetylcholine, and oxypeucedanin can improve the loss of hippocampal nerves, and can be used to prepare drugs for the treatment of vascular dementia.

[0005] Angelica dahurica is a traditional medicinal material that can be used as both medicine and food. Therefore, studying the role of Angelica dahurica in treating learning and memory disorders has important practical significance for the safe and effective treatment of learning and memory disorders. Summary of the invention

[0006] The purpose of the present invention is to provide a composition containing Angelica dahurica and a preparation method thereof, a Chinese medicine preparation and application thereof. The composition uses medicinal materials that are both medicinal and edible as raw materials, has good safety, and has a good improvement effect on learning and memory disorders.

[0007] In order to achieve the above object, the present invention adopts the following technical solutions:

[0008] In a first aspect, the present invention provides a composition containing Angelica dahurica, which consists of Angelica dahurica and radish extracts.

[0009] The angelica dahurica in the present invention is Angelica dahurica (Fisch.ex Hoffm.) Benth.et Hook.f. or Angelica dahurica (Fisch.ex Hoffm.) Benth.et Hook.f. var.formosana (Boiss.) Shan et Yuan, which belongs to the Umbelliferae family, and the used part is the root. The angelica dahurica in the present invention is fresh angelica dahurica or dried angelica dahurica, dried angelica dahurica powder or angelica dahurica decoction slices.

[0010] The radish (Raphanus sativus L.) in the present invention belongs to the cruciferous family, and the used part is the root. Preferably, the radish in the present invention is a radish rich in anthocyanins, more preferably a red heart radish and / or a carmine radish; more preferably a carmine radish; most preferably, the carmine radish is a carmine radish with a completely red carpel.

[0011] The radish extract of the present invention is a dried product obtained by filtering fresh radish juice. The drying is conventional in the art, and suitable drying techniques include various ones, such as freeze drying, vacuum drying, spray drying, oven drying, air drying or shade drying.

[0012] In some specific embodiments, the composition is composed of the following raw materials in parts by weight: 5-15 parts of Angelica dahurica and 1-10 parts of radish extract.

[0013] In some specific embodiments, the amount of Angelica dahurica in the composition is 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts and any value within any two of the above numerical ranges, by weight.

[0014] In some specific embodiments, the amount of radish extract in the composition is 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts and any value within any two of the above numerical ranges, by weight.

[0015] In some specific embodiments, the composition is composed of the following raw materials in parts by weight: 5-15 parts of Angelica dahurica and 1-5 parts of radish extract.

[0016] In some specific embodiments, the composition is composed of the following raw materials in parts by weight: 12 parts of Angelica dahurica and 3 parts of radish extract.

[0017] In a second aspect, the present invention provides a method for preparing the above composition, comprising the following steps: mixing angelica dahurica and radish extracts to obtain the angelica dahurica-containing composition.

[0018] Preferably, the preparation method further comprises a crushing step, specifically crushing and sieving the composition.

[0019] In a third aspect, the present invention provides the above-mentioned Chinese medicine preparation, comprising the above-mentioned composition and pharmaceutically acceptable excipients.

[0020] In some specific embodiments, the dosage form of the traditional Chinese medicine preparation is granules, tablets, capsules, powders, pills, suspensions or liquid preparations.

[0021] The present invention does not impose corresponding limitations on the preparation methods and auxiliary materials of the traditional Chinese medicine preparations. Those skilled in the art can select corresponding auxiliary materials according to conventional preparation methods in the art to prepare corresponding dosage forms.

[0022] For example:

[0023] In some specific embodiments, the Chinese medicine preparation further includes honey, and those skilled in the art can prepare honey pills with the Chinese medicine preparation using honey as a binder according to conventional methods.

[0024] In some specific embodiments, the Chinese medicine preparation further includes tea leaves and honey. Then, those skilled in the art can prepare honey pills from the Chinese medicine preparation using honey as a binder and tea leaves as a flavoring agent according to conventional methods.

[0025] In some specific embodiments, the Chinese medicine preparation further includes tea leaves and honey. Then, those skilled in the art can use honey as a binder according to conventional methods to make the Chinese medicine preparation into honey pills, and then take the honey pills with tea leaves.

[0026] In the present invention, the honey and tea leaves can be common commercial products, and the tea leaves can be prepared into tea powder or tea leaves extract in advance.

[0027] Specifically, the weight ratio of the composition to honey is 1:1.0-3.0; and the added amount of the tea leaves is 2%-20% of the weight of the composition.

[0028] In some specific embodiments, the honey is preferably linden honey. Modern research shows that linden honey has excellent antioxidant, antibacterial and nervous system protective effects. It can be used as medicine to replenish qi, relieve cough, moisten the intestines, detoxify, and aid digestion. It can also replenish qi and kidney, relieve pain and detoxify, and has the effect of treating and alleviating hypertension, heart disease, constipation, insomnia and other diseases.

[0029] In some specific embodiments, the tea is preferably Xanthoceras sorbifolia leaf tea. Modern research shows that flavonoids in Xanthoceras sorbifolia leaves are good medicines for the clinical treatment of cardiovascular diseases, and have the effects of strengthening the heart, dilating coronary vessels, anti-arrhythmic, lowering blood pressure, lowering blood cholesterol, and reducing capillary permeability. At the same time, flavonoids are natural antioxidants, and many flavonoids such as quercetin and its derivatives have anti-cancer effects.

[0030] The present invention unexpectedly finds that taking Angelica dahurica as the main component, taking radish extract as the auxiliary component, supplemented with linden honey and Xanthoceras sorbifolia tea can improve the taste and at the same time exert a better effect of improving memory impairment.

[0031] In a fourth aspect, the present invention provides use of the above-mentioned composition and / or Chinese medicine preparation in the preparation of medicines.

[0032] The drug of the present invention includes at least one of increasing learning and memory functions, improving cognitive functions, promoting intelligence, neuroprotective effects, improving depression, and preventing and / or treating Alzheimer's disease.

[0033] Preferably, the composition has at least one of the following effects:

[0034] (a) Reduce Aβ aggregation and / or p-Tau accumulation;

[0035] (b) reduce TNF-α and / or IL-1β levels in hippocampal tissue;

[0036] (c) Inhibit the activity of AChE in brain tissue and promote the production of Ach;

[0037] (d) Antioxidant stress;

[0038] (e) Repair of hippocampal neuron damage.

[0039] The beneficial effects of the present invention are:

[0040] (1) The present invention uses medicinal and edible medicinal materials as raw materials, has good safety, and has a good improvement effect on learning and memory disorders.

[0041] (2) Experimental results show that the composition of the present invention can enhance learning and memory, improve cognitive function, promote intelligence, protect neurons, improve depression, and prevent and / or treat Alzheimer's disease by reducing Aβ aggregation and / or p-Tau accumulation, reducing TNF-α and / or IL-1β levels in hippocampal tissue, inhibiting AChE activity in brain tissue and promoting Ach production, resisting oxidative stress, and repairing hippocampal neuron damage.

[0042] (3) The present invention unexpectedly discovered that using Angelica dahurica as the main ingredient, radish extract as the auxiliary ingredient, and supplemented with linden honey and Xanthoceras sorbifolia tea can improve the taste and at the same time exert a better effect of improving memory impairment. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 Arrange the timeline for behavioral experiments;

[0044] Figure 2 This is the Morris water maze setup diagram;

[0045] Figure 3 Figure 1: Open field experimental setup DETAILED DESCRIPTION

[0046] The following describes the embodiments of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention.

[0047] Before further describing the specific embodiments of the present invention, it should be understood that the scope of protection of the present invention is not limited to the specific embodiments described below; it should also be understood that the terms used in the examples of the present invention are for describing specific embodiments rather than for limiting the scope of protection of the present invention.

[0048] When the embodiment gives a numerical range, it should be understood that, unless otherwise specified in the present invention, the two endpoints of each numerical range and any numerical value between the two endpoints can be selected. Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those of ordinary skill in the art to which the present invention belongs.

[0049] The present invention does not limit the sources of the raw materials used. Unless otherwise specified, the raw materials used in the present invention are common commercial products in the technical field.

[0050] The angelica dahurica and radish extracts described in the present invention can also be replaced by fresh angelica dahurica and fresh radish. When fresh angelica dahurica and fresh radish are used, the amount of fresh angelica dahurica used is about 30 parts by weight, and the amount of fresh radish used is about 60 parts by weight.

[0051] The "pharmaceutical preparation" or "drug" described in the present invention comprises the composition (hereinafter referred to as the only active ingredient) and pharmaceutically acceptable excipients. In a specific embodiment, the only active ingredient described in the present invention is provided in the pharmaceutical preparation or drug in an effective amount (e.g., a therapeutically effective amount).

[0052] The "pharmaceutically acceptable" ingredients described in the present invention are substances that are suitable for human beings and / or animals without excessive adverse side effects (such as toxicity, irritation and allergic reactions), that is, substances with a reasonable benefit / risk ratio. The "pharmaceutically acceptable excipients" include inert diluents, dispersants and / or granulating agents, surfactants and / or emulsifiers, disintegrants, binders, preservatives, buffers, lubricants and / or oils. Excipients (such as cocoa butter and suppository wax), colorants, coating agents, sweeteners and flavoring agents may also be present in the "pharmaceutical preparations" or "drugs".

[0053] The "pharmaceutical preparation" or "drug" described in the present invention can be prepared by any method known in pharmacy. Generally speaking, these preparation methods include associating the active ingredient with a carrier or excipient and / or one or more other auxiliary ingredients, and if necessary and / or desired, the product can be formed and / or packaged into a desired single dose or multiple dose unit.

[0054] The "pharmaceutical preparation" or "drug" of the present invention can be prepared according to known methods, such as the methods described in the general rules for preparation of the 16th edition of the Japanese Pharmacopoeia, the United States Pharmacopoeia, and the 9th edition of the European Pharmacopoeia. The specific preparation method depends on the dosage form.

[0055] The sole active ingredient, pharmaceutically acceptable excipient in the "pharmaceutical preparation" or "drug" described herein will vary depending on the identity, body size and / or condition of the subject being treated and further on the route of administration. The "pharmaceutical preparation" or "drug" may contain between 0.1% and 100% (w / w) of the sole active ingredient.

[0056] The "composition", "drug preparation" or "drug" described in the present invention may also optionally contain other therapeutic ingredients for use in combination, especially those additional therapeutic ingredients disclosed herein, such as "other neuroprotective drugs" (i.e., the second active ingredient), wherein the other neuroprotective drugs are chemical drugs, traditional Chinese medicines or Chinese patent medicine preparations.

[0057] "Treatment" as used herein, unless otherwise indicated, means reversing, alleviating, inhibiting the progression of, or preventing the condition or disorder or one or more symptoms of such condition or disorder to which the term applies, unless otherwise indicated. The term "treat" as used herein refers to the act of treating, as "treat" is defined immediately above.

[0058] The "effective amount" described in the present invention refers to an amount sufficient to induce a desired biological response. The effective amount of the sole active ingredient of the present invention may vary depending on factors such as the desired biological endpoint, the pharmacokinetics of the compound, the condition being treated, the mode of administration, and the age and health of the subject. In certain embodiments, the effective amount is a therapeutically effective amount. The effective amount is the amount of the sole active ingredient described in the present invention in a single dose. In certain embodiments, the effective amount is the combined amount of the sole active ingredient described in the present invention in multiple doses.

[0059] The "therapeutically effective amount" described in the present invention is an amount sufficient to provide a therapeutic benefit in the treatment of a disorder or sufficient to delay or minimize one or more symptoms associated with the disorder. The therapeutically effective amount of an active ingredient means an amount of a therapeutic agent that provides a therapeutic benefit in the treatment of a disorder alone or in combination with other therapies. The term "therapeutically effective amount" may encompass an amount that improves overall therapy, reduces or avoids symptoms, signs or causes of a disorder, and / or enhances the therapeutic efficacy of another therapeutic agent. In certain embodiments, a therapeutically effective amount is an amount sufficient to treat any disease or disorder described.

[0060] Model Description

[0061] Scopolamine is a non-selective competitive muscarinic cholinergic receptor antagonist that can easily pass through the blood-brain barrier into the central nervous system, reversibly block M receptors in the central nervous system, delay cholinergic neurotransmission, and thus interfere with the ability to acquire recent memory. It is currently the most widely used method for modeling learning and memory disorders.

[0062] 1. Safety evaluation of Baizhi pills

[0063] In this study, SD rats were used as experimental subjects. The levels of AST, ALT, BUN and CRE in the serum of rats treated with Baizhi Pills were detected to determine the safety of the effective dose in the treatment group.

[0064] 1. Experimental Materials

[0065] 1.1 Experimental animals

[0066] 70 healthy SPF-grade SD rats (200 g), male, were purchased from Guangdong Medical Laboratory Animal Center, with the license number of the experimental unit: SYXK (Guangdong) 2022-0125, and the production license number: SYXK (Guangdong) 2022-0002. The animal was kept in an environment of 18-23°C, with a relative humidity of 45%-55%, and was fed and watered freely for three days. All animal experiments were conducted in accordance with the guidelines of the Laboratory Animal Center and approved by the Animal Ethics Committee.

[0067] 1.2 Reagents and Materials

[0068] Angelica dahurica (Batch No.: B5222911, Guangdong Provincial Medicinal Materials Company Chinese Medicine Piece Factory); Carmine radish (commercially available); Honey (Batch No.: 2023072201, Beijing Baihua Bee Industry Technology Development Co., Ltd.); Xanthoceras sorbifolia leaves (Batch No.: 2023091801, Jingtai County Zhenglubao Trading Co., Ltd.); Isoflurane (Batch No.: 2023071501, Shenzhen Ruiwode Life Science and Technology Co., Ltd.); Scopolamine (Batch No.: J2129103, Aladdin Company); Donepezil (Batch No.: 02230150, Zhien Biotechnology Co., Ltd.); 0.9% sodium chloride injection (Batch No.: 220818501, Guangdong Daxiang Pharmaceutical Co., Ltd.); Double distilled water (prepared in the laboratory);

[0069] Alanine aminotransferase (ALT) kit (Batch number: 20230923, Nanjing Jiancheng Bioengineering Institute); aspartate amino transferase (AST) kit (Batch number: 20230922, Nanjing Jiancheng Bioengineering Institute); urea nitrogen (blood urea nitrogen, BUN) kit (Batch number: 20231108, Nanjing Jiancheng Bioengineering Institute); Creatinine (CRE) kit (Batch number: 20231108, Nanjing Jiancheng Bioengineering Institute).

[0070] Specifically,

[0071] Baizhi Pill 1 (BZ1): composed of 50g of Baizhi and 10g of radish extract;

[0072] The preparation method is as follows: 72g of honey is used as a binder, and angelica dahurica and radish extracts are made into angelica dahurica pills.

[0073] Baizhi Pill 2 (BZ2): composed of 150g of Baizhi and 50g of radish extract;

[0074] The preparation method is as follows: 240g of honey is used as a binder, and angelica dahurica and radish extracts are made into angelica dahurica pills.

[0075] Baizhi Pill 3 (BZ3): composed of 120g of Baizhi and 30g of radish extract;

[0076] Preparation method: Use 180g honey as a binder and mix angelica dahurica and radish extracts to make angelica dahurica pills.

[0077] Wherein, the angelica dahurica powder is crushed and passed through an 80-mesh sieve;

[0078] Baizhi Pill 4 (BZ4): composed of 120g Baizhi and 30g Radish Extract;

[0079] Preparation method: 180g honey is used as a binder, 72g Xanthoceras sorbifolia leaf tea is used as a flavoring agent, and angelica dahurica and radish extracts are made into angelica dahurica pills.

[0080] Wherein, the angelica dahurica powder is crushed and passed through an 80-mesh sieve; the Xanthoceras sorbifolia leaf tea is crushed and passed through an 80-mesh sieve;

[0081] The radish extract is prepared by squeezing fresh carmine radish juice, filtering to remove residue, freezing the filtrate to -20°C, and vacuum drying at 5 Pa for 20 hours to obtain a dry product with a moisture content of less than 5%.

[0082] 1.3 Experimental instruments

[0083] Multifunctional microplate reader (model: SpectraMax i3X, Meigu Molecular Instruments (Shanghai) Co., Ltd.)

[0084] 2 Experimental methods

[0085] 2.1 Animal grouping and drug administration

[0086] Seventy SPF male rats (200 g) were adaptively fed for three days and randomly divided into 7 groups according to their body weight, namely blank control group (CON), model group (MOD), positive drug donepezil group (DNPQ), and Baizhi pill group (BZ1-4), with 10 rats in each group.

[0087] The CON group and the MOD group were gavaged with an equivalent volume of distilled water; the DNPQ group was given donepezil at 0.52 mg / kg / d; the Baizhi pill group was given Baizhi pill at 2.052 g / 100 g / d. The drugs were administered at a fixed time every day for 30 consecutive days. After 18 days of administration, the learning and memory improvement model was established. 30 minutes after the drug administration, the MOD group and the drug group were intraperitoneally injected with scopolamine 3 mg / kg / d (prepared with normal saline), and the CON group was injected with an equal volume of normal saline. The model was established for 12 consecutive days.

[0088] 2.2 Sample collection

[0089] 12 hours after the last injection of scopolamine, all rats were anesthetized with isoflurane. Blood was collected from the abdominal aorta of the rats, and the blood in the procoagulant blood collection tube was centrifuged at 3500rpm for 10 minutes at 4°C. The upper serum was separated and stored in a -80°C refrigerator. After the blood was collected, the brain, heart, liver, lung, kidney, colon, and feces of the rats were collected by dissection, quenched with liquid nitrogen, and stored in a -80°C refrigerator. The removed brain tissue was cut about 3mm along the transverse coronal plane and placed in an embedding box and immersed in 4% tissue cell fixative.

[0090] 2.3 Serum biochemical test

[0091] Serum was collected and the activities of AST, ALT, BUN and CRE in rat serum were detected. The specific operation was carried out according to the instructions of the biochemical kit of Nanjing Jiancheng Biotechnology Co., Ltd.

[0092] 2.4 Statistical analysis

[0093] SPSS25.0 statistical software was used to analyze the data, and the results were expressed as mean ± standard deviation. GraphPadPrism9.0 was used for drawing, independent sample t test was used for comparison between groups, one-way analysis of variance was used for comparison of means among multiple groups, and LSD was used for pairwise comparison. P<0.05 was considered statistically significant, and P<0.01 was considered highly statistically significant.

[0094] 3 Experimental results and analysis

[0095] In order to determine the safety of the effective dose in the drug-treated group, the levels of AST, ALT, BUN and CRE in the serum of rats treated with Baizhi Pills were detected in this experiment.

[0096] The results in Table 1 show that after 30 days of administration of Baizhi Pills 1-4, there were no significant differences in the above biochemical indicators in the serum compared with the CON group (P>0.05), indicating that Baizhi Pills are safe at this dose.

[0097] Among them, the ALT index test results show that compared with the CON group, the ALT level in the serum of rats in the MOD group was significantly different (P < 0.05), indicating that after scopolamine modeling, it caused certain liver cell membrane damage and the ALT level increased.

[0098] After intragastric administration of Baizhi Pills, the serum ALT levels of rats in the BZ1-4 groups were significantly decreased compared with those in the MOD group (P<0.05), indicating that Baizhi Pills have a certain protective effect on liver function.

[0099] Table 1 Effects of Baizhi Pills on AST, ALT, BUN and CRE in rat serum ( n=10)

[0100]

[0101] Note: Compared with the CON group, # P<0.05; compared with the MOD group, ** P<0.01, * P<0.05.

[0102] 2. Baizhi Pills Improve Learning and Memory

[0103] This study used SD rats as experimental subjects, and established a model for improving learning and memory to observe the efficacy of Baizhi Pills in improving rats' learning and memory.

[0104] 1. Experimental Materials

[0105] 1.1 Experimental animals

[0106] Healthy SPF grade SD rats (200 g), male, were purchased from Guangdong Medical Laboratory Animal Center, with the license number of the experimental unit: SYXK (Guangdong) 2022-0125, and the production license number: SYXK (Guangdong) 2022-0002. The animal was kept in an environment of 18-23 °C, with a relative humidity of 45%-55%, and had free access to food and water, and was adaptively fed for three days. All animal experiments were conducted in accordance with the guidelines of the Laboratory Animal Center and approved by the Animal Ethics Committee.

[0107] 1.2 Reagents and Materials

[0108] Angelica dahurica (Batch No.: B5222911, Guangdong Provincial Medicinal Materials Company Chinese Medicine Piece Factory); Carmine radish (commercially available); Honey (Batch No.: 2023072201, Beijing Baihua Bee Industry Technology Development Co., Ltd.); Xanthoceras sorbifolia leaves (Batch No.: 2023091801, Jingtai County Zhenglubao Trading Co., Ltd.); Isoflurane (Batch No.: 2023071501, Shenzhen Ruiwode Life Science and Technology Co., Ltd.); Scopolamine (Batch No.: J2129103, Aladdin Company); Donepezil (Batch No.: 02230150, Zhien Biotechnology Co., Ltd.); 0.9% sodium chloride injection (Batch No.: 220818501, Guangdong Daxiang Pharmaceutical Co., Ltd.);

[0109] The composition and preparation method of Baizhi Pills 1-4 (BZ1-4) are the same as those in Section 1.2 of the aforementioned “I. Safety Evaluation of Baizhi Pills”, and the preparation method of Baizhi powder and radish extract is the same as that in Section 1.2 of the aforementioned “I. Safety Evaluation of Baizhi Pills”.

[0110] 1.3 Experimental instruments

[0111] Morris water maze system (Guangzhou Bit Biotechnology Co., Ltd.), open field test system (Anhui Zhenghua Biological Equipment Co., Ltd.). The data were analyzed by video tracking software (SMART3.0).

[0112] 2. Experimental methods

[0113] 2.1 Animal grouping and drug administration

[0114] 63 SPF male rats (200g) were adaptively fed for three days and randomly divided into 9 groups according to body weight, namely blank control group (CON), model group (MOD), positive drug donepezil group (DNPQ), Baizhi pills 1-4 groups (BZ1-4), Baizhi group (BZ0) and radish group (LB0), with 7 rats in each group. The CON group and MOD group were given equivalent volume of distilled water by gavage; the DNPQ group rats were given donepezil at 0.52mg / kg / d; the Baizhi pill group was given Baizhi pill at 0.228g / 100g / d. The Baizhi group was given Baizhi powder at 0.2288g / 100g / d, and the radish group was given radish extract at 0.2288g / 100g / d. The drugs were administered at a fixed time every day for 30 consecutive days. After 18 days of administration, the learning and memory improvement model was established.

[0115] 30 minutes after drug administration every day, rats in the MOD group and the drug administration group were intraperitoneally injected with scopolamine 3 mg / kg / d (prepared with normal saline), and rats in the CON group were injected with an equal volume of normal saline. The model was established for 12 consecutive days. 30 minutes after model establishment, behavioral experiments were started, and the results of behavioral experiments were used to evaluate whether the model was successfully replicated.

[0116] 2.2 Behavioral testing

[0117] Behavioral tests include water maze and open field tests to test the learning and memory abilities of rats. The schedule of each behavioral experiment is as follows: Figure 1 shown.

[0118] 2.2.1 Morris water maze test

[0119] Morris water maze was used to evaluate the learning and memory function of mice. Figure 2As shown in the figure, it is a cylindrical pool with a diameter of 150 cm and a height of 50 cm. Its interior is divided into 4 quadrants of equal size. A platform is placed in the center of one of the quadrants. Once the position of this platform is determined, it will remain unchanged throughout the behavioral test. Two vertical cross lines made from the center of the pool divide it into 4 quadrants: northwest, northeast, southeast, and southwest, which are respectively designated as quadrants I, II, III, and IV. Markers of different colors and shapes are pasted on the inner wall of each quadrant: circle, triangle, star, square, which is convenient for experimental rats to remember. The water temperature was controlled at 22±2℃ during the experiment. In the behavioral test, the swimming activities of the rats were recorded by a camera above the water maze pool and the data were processed by an image acquisition device and behavioral software and stored in a computer.

[0120] Morris water maze experiment content:

[0121] A. Adaptive training: One day before the experiment, water was placed in the water maze without a platform, and rats were trained to adapt to the water maze. Each rat underwent adaptive training for 1-2 minutes and then was taken out and wiped dry.

[0122] B. Positioning navigation experiment: 30 minutes after modeling. The experiment was carried out at the same time every day. During the experiment, the rats were placed in the water facing the pool wall, and the time (latency) for the rats to find the platform was recorded as an indicator of learning and memory. If the rats found the platform within 90 seconds, the time they took was recorded, and the rats were allowed to stay on the platform for 5 seconds; if the time reached 90 seconds and the platform was still not found, the rats were guided to swim to the platform and stay for 5 seconds, and the escape latency was recorded as 90 seconds. After the training of all groups of rats was completed, the second training was carried out. Continue for 5 days, 4 training sessions a day (rats were placed in four quadrants respectively). During the process, the position of the platform was fixed, and the entry point of the rats was determined in advance by pseudo-random method during training. The training order of rats on the same day should be the same. During the 5-day training, the escape latency gradually shortened, indicating that the rats' learning ability was enhanced.

[0123] C. Spatial exploration experiment: On the second day after the navigation experiment (i.e., the sixth day of the water maze experiment), the platform was removed and the rats were placed in the water from the fixed entry point (the diagonal position of the platform) facing the pool wall. The rats explored freely for 90 seconds, and the proportion of their swimming time in the quadrant where the original platform was located and the number of times they crossed the original platform position, i.e., the number of shuttles, were measured to reflect the spatial memory ability of the rats. The more times the rats passed the original platform position and the longer they stayed in the target quadrant, the stronger their spatial memory ability was.

[0124] 2.2.2 Open field experiment

[0125] Open field experimental apparatus, such as Figure 3As shown. Before the test, adjust the shooting screen so that the open field area can be fully displayed on the computer program. At the beginning of the test, turn on the video program, set the observation time to 5 minutes, gently place the rat in the center of the open field, and start recording the free movement trajectory of the rat in the open field, the movement distance in the central area, the total movement distance in the open field, the movement trajectory in the open field box, and the time spent in the peripheral and central areas, the number of standing times, the number of grooming times, the total movement distance, etc. The data were analyzed using video tracking software (SMART3.0). After each rat was tested, 75% medical alcohol was used to spray the plastic box to thoroughly remove the dirt in the box and minimize the fecal odor in the box to prevent the residual odor or dirt from affecting the activity of the next rat.

[0126] 2.3 Statistical analysis

[0127] SPSS 25.0 statistical software was used to analyze the data, and the results were expressed as mean ± standard deviation. GraphPad Prism 9.0 was used for drawing, independent sample t test was used for comparison between groups, one-way analysis of variance was used for comparison of means among multiple groups, and LSD was used for pairwise comparison. P<0.05 was considered statistically significant, and P<0.01 was considered highly statistically significant.

[0128] 3. Experimental results and analysis

[0129] 3.1 Behavioral Experimental Results

[0130] Table 2 Open field test results ( n=7)

[0131]

[0132]

[0133] Note: Compared with the CON group, **** P<0.0001, **P<0.01; *P<0.05; compared with the MOD group, ### P < 0.001, ## P<0.01.

[0134] The results in Table 2 show that compared with the CON group, the MOD group had significantly fewer standing times (P<0.0001), significantly fewer grooming times (P<0.05), and significantly less time spent in the central area (P<0.01). There were no significant differences in total distance and average speed (P>0.05), indicating that the learning and memory abilities of the rats were impaired and their desire to explore decreased after modeling, but their motor abilities were normal.

[0135] Compared with the MOD group, the number of standing times in the BZ1-4 group increased significantly (P < 0.01) and the number of modification times increased significantly (P < 0.05), indicating that intragastric administration of Baizhi pills can improve the learning and memory abilities of rats.

[0136] Compared with the MOD group, there were no significant differences in the number of standing and modifying times in the BZ0 and LB0 groups (P>0.05), indicating that oral administration of single Angelica dahurica powder or radish extract could not improve the learning and memory ability of rats.

[0137] 3.2. Water maze test results

[0138] Table 3 Results of the rat space exploration experiment ( n=6)

[0139]

[0140] Note: Compared with the CON group, **** P<0.0001, ***P<0.001; compared with the MOD group, #### P < 0.0001, ### P < 0.001, ## P<0.01; compared with BZ1 group, ΔP<0.05.

[0141] The results in Table 3 show that compared with the CON group, the MOD group had significant differences in the number of times the rats crossed the platform, the distance of activity in the target quadrant, the time they stayed in the target quadrant, and the time they first reached the platform (P < 0.001). This indicates that the learning and memory abilities of the rats after scopolamine intervention are poor, confirming that the modeling of this experiment was successful.

[0142] Compared with the MOD group, the number of times the rats in the BZ1-4 groups crossed the platform, the distance traveled in the target quadrant, and the time to first reach the platform showed significant differences (P < 0.01), while the number of times the rats in the BZ0 group and the LB0 group crossed the platform, the distance traveled in the target quadrant, and the time to first reach the platform showed no significant differences (P > 0.05), indicating that intragastric administration of Angelica dahurica pills can improve the learning and memory of rats, while single Angelica dahurica powder or radish extract cannot significantly improve the learning and memory of rats.

[0143] Compared with the BZ1 group, the BZ0 group and the LB0 group, there were significant differences in the number of times the rats crossed the platform, the distance of activity in the target quadrant and the time to first reach the platform (P < 0.01), indicating that Baizhi pills have a better effect on improving the learning ability of rats than Baizhi powder or radish extract.

[0144] 3. Baizhi Pills for the treatment of Alzheimer's disease

[0145] 1. Experimental Materials

[0146] 1.1 Experimental animals

[0147] Healthy SPF grade SD rats (200 g), male, were purchased from Guangdong Medical Laboratory Animal Center, with the license number of the experimental unit: SYXK (Guangdong) 2022-0125, and the production license number: SYXK (Guangdong) 2022-0002. The animal was kept in an environment of 18-23 °C, with a relative humidity of 45%-55%, and had free access to food and water, and was adaptively fed for three days. All animal experiments were conducted in accordance with the guidelines of the Laboratory Animal Center and approved by the Animal Ethics Committee.

[0148] 1.2 Reagents and Materials

[0149] Angelica dahurica (Batch No.: B5222911, Guangdong Provincial Medicinal Materials Company Chinese Medicine Piece Factory); Carmine radish (commercially available); Honey (Batch No.: 2023072201, Beijing Baihua Bee Industry Technology Development Co., Ltd.); Xanthoceras sorbifolia leaves (Batch No.: 2023091801, Jingtai County Zhenglubao Trading Co., Ltd.); Isoflurane (Batch No.: 2023071501, Shenzhen Ruiwode Life Science and Technology Co., Ltd.); Scopolamine (Batch No.: J2129103, Aladdin Company); Donepezil (Batch No.: 02230150, Zhien Biotechnology Co., Ltd.); 0.9% sodium chloride injection (Batch No.: 220818501, Guangdong Daxiang Pharmaceutical Co., Ltd.);

[0150] Rat acetylcholine (ACh) ELISA research kit (Batch number: 20231120R219, Jiangsu Enzyme Absorption Industry Co., Ltd.); Rat acetylcholinesterase (AChE) ELISA research kit (Batch number: 20231120R205, Jiangsu Enzyme Absorption Industry Co., Ltd.); Rat phosphorylated Tau protein (P-Tau) ELISA research kit (Batch number: 20231120R147, Jiangsu Enzyme Absorption Industry Co., Ltd.); Rat β-amyloid peptide 42 (Aβ42) ELISA research kit (Batch number: 20231120R048, Jiangsu Enzyme Absorption Industry Co., Ltd.); Rat Tumor necrosis factor α (TNF-α) ELISA research kit (Batch number: 20231120R036, Jiangsu Enzyme Absorption Industry Co., Ltd.); Rat interleukin 1β (IL-1β) ELISA research kit (Batch number: 20231120R107, Jiangsu Enzyme Absorption Industry Co., Ltd.); Rat lipopolysaccharide (LPS) ELISA research kit 96T (Batch number: 20231120R190, Jiangsu Enzyme Absorption Industry Co., Ltd.); Rat brain-derived neurotrophic factor (BDNF) ELISA research kit (Batch number: 20231120R167, Jiangsu Enzyme Absorption Industry Co., Ltd.);

[0151] ADS-W-KY011 Superoxide dismutase (SOD) kit - WST-8 method microplate method (Lot number: ADS20231121, Jiangsu Enzyme Absorption Industry Co., Ltd.); ADS-W-G003 Glutathione peroxidase (GPX) kit - visible colorimetric method microplate method (Lot number: ADS20231121, Jiangsu Enzyme Absorption Industry Co., Ltd.); ADS-W-YH002 Malondialdehyde (MDA) kit microplate method (Lot number: ADS20231121, Jiangsu Enzyme Absorption Industry Co., Ltd.);

[0152] The composition and preparation method of Baizhi Pills 1-4 (BZ1-4) are the same as those in Section 1.2 of the aforementioned “I. Safety Evaluation of Baizhi Pills”, and the preparation method of Baizhi powder and radish extract is the same as that in Section 1.2 of the aforementioned “I. Safety Evaluation of Baizhi Pills”.

[0153] 1.3 Experimental instruments

[0154] Multifunctional microplate reader (model: SpectraMax i3X, Meigu Molecular Instruments (Shanghai) Co., Ltd.).

[0155] 2. Experimental methods

[0156] 2.1 Animal grouping and drug administration

[0157] 90 SPF male rats (200g) were adaptively fed for three days and randomly divided into 9 groups according to body weight, namely blank control group (CON), model group (MOD), positive drug donepezil group (DNPQ), Baizhi pills 1-4 groups (BZ1-4), Baizhi group (BZ0) and radish group (LB0), with 10 rats in each group. The CON group and MOD group were given an equivalent volume of distilled water by gavage; the DNPQ group rats were given donepezil at 0.52mg / kg / d; the Baizhi pill group was given Baizhi pill at 0.228g / 100g / d. The Baizhi group was given Baizhi powder at 0.2288g / 100g / d, and the radish group was given radish extract at 0.2288g / 100g / d. The drugs were administered at a fixed time every day for 30 consecutive days. After 18 days of administration, the learning and memory improvement model was established.

[0158] 30 minutes after drug administration every day, rats in the MOD group and the drug-treated group were intraperitoneally injected with scopolamine 3 mg / kg / d (prepared in normal saline), and rats in the CON group were injected with an equal volume of normal saline. The model was established for 12 consecutive days.

[0159] 2.2 Sample collection

[0160] 12 hours after the last injection of scopolamine, all rats were anesthetized with isoflurane. Blood was collected from the abdominal aorta of the rats, and the blood in the procoagulant blood collection tube was centrifuged at 3500rpm for 10 minutes at 4°C. The upper serum was separated and stored in a -80°C refrigerator. After the blood was collected, the brain, heart, liver, lung, kidney, colon, and feces of the rats were collected by dissection, quenched with liquid nitrogen, and stored in a -80°C refrigerator. The removed brain tissue was cut about 3mm along the transverse coronal plane and placed in an embedding box and immersed in 4% tissue cell fixative.

[0161] 2.3 Elisa test and biochemical index test

[0162] Serum and brain tissue were collected to detect the levels of ACh, AChE, Aβ42, and p-Tau in the hippocampus of rats; the levels of TNF-α and IL-1β in the cerebral cortex and the levels of LPS and BDNF in serum. The specific operations were carried out according to the instructions of the enzyme-linked immunosorbent assay kit.

[0163] Brain tissues were collected and the contents of SOD, MDA and GSH-Px in the hippocampus of rats were detected. The specific operations were carried out according to the instructions of the analysis kit.

[0164] 2.4 Statistical analysis

[0165] GraphPad Prism 9.0 statistical software was used to analyze the data. The results were expressed as mean ± standard deviation. The independent sample t test was used for comparison between groups, one-way analysis of variance was used for comparison of means among multiple groups, and LSD was used for pairwise comparison. P < 0.05 was considered statistically significant, and P < 0.01 was considered highly statistically significant.

[0166] 3. Experimental results and analysis

[0167] 3.1 Elisa test data analysis

[0168] (1) ACh is an important bridge for information transmission between nerve cells and the nervous system. AChE catalyzes the hydrolysis of excess ACh after signal transduction. ACh and AChE play an important role in information transmission in the cholinergic system. Reduced ACh levels are an early pathological symptom of the nervous system. Changes in ACh and AChE levels can be used to evaluate the effect of Baizhi Pills on reducing the memory impairment of rats caused by scopolamine-induced imbalance of the cholinergic system.

[0169] Table 4 Effects of Baizhi Pills on ACh, AChE, Aβ42, p-tau and BDNNF in rats ( n=10)

[0170]

[0171] Note: Compared with CON group, ####P<0.0001; compared with MOD group, ****P<0.0001, ***P<0.001, **P<0.01, *P<0.05; compared with BZ1 group, ΔP<0.05.

[0172] From the results in Table 4, we can see that compared with the CON group, the ACh level in the hippocampus of the rats in the MOD group was significantly reduced (P<0.0001), and the AChE level was significantly increased (P<0.0001), indicating that the cholinesterase activity of the modeled rats was significantly increased, resulting in a decrease in choline content, indicating that the animal model was successfully established. Scopolamine can significantly reduce the ACh level in the rat brain tissue, resulting in impaired memory function in the rats.

[0173] Compared with the MOD group, the ACh level in the hippocampus of the rats in the BZ1-4 group was significantly increased (P<0.0001), and the AChE level was significantly decreased (P<0.0001). AChE is an important indicator of the function of the cholinergic system in the brain. It can degrade the content of ACh between cholinergic synapses and indirectly reflect the content of AChE in the body. This experiment found that after the intervention of Baizhi Pills, the ACh activity in the hippocampus of the model rats induced by scopolamine increased, while the AChE activity decreased, indicating that regulating the function of the cholinergic nervous system is the potential reason why Baizhi Pills improve the learning and memory disorders of the model rats.

[0174] Compared with the BZ1 group, the ACh level in the hippocampus of rats in the BZ0 and LB0 groups was significantly increased (P < 0.05), and the AChE level was significantly decreased (P < 0.05), indicating that Baizhi pills have better effects than single Baizhi powder or radish extract.

[0175] At the same time, compared with the COD group, the contents of Aβ42 and p-Tau in the hippocampus of rats in the MOD group were significantly increased (P<0.0001), indicating that scopolamine can induce the expression of Aβ42 and p-Tau proteins, leading to synaptic dysfunction and memory impairment.

[0176] Compared with the MOD group, the contents of Aβ42 and p-Tau in the hippocampus of rats in the BZ1-4 group were significantly decreased (P<0.0001), indicating that Baizhi Pills can downregulate the levels of Aβ42 and p-Tau, reduce Aβ aggregation and p-Tau accumulation to a certain extent, and thus improve memory impairment in rats.

[0177] Compared with the MOD group, the levels of Aβ42 and p-Tau in the hippocampus of rats in the BZ0 and LB0 groups were not significantly reduced (P>0.05). Compared with the BZ1 group, the levels of Aβ42 and p-Tau in the hippocampus of rats in the BZ0 and LB0 groups were significantly different (P<0.05), indicating that single Angelica dahurica powder or radish extract cannot downregulate the levels of Aβ42 and p-Tau, and has no effect on improving memory impairment in rats.

[0178] (2) Inflammatory response plays an important role in the process of scopolamine-induced learning and memory impairment in mice. The levels of TNF-α and IL-1β are elevated in patients with learning and memory impairment.

[0179] Table 5 Effects of Baizhi Pills on TNF-α, IL-1β and LPS in rats ( n=10)

[0180]

[0181]

[0182] Note: Compared with CON group, ####P<0.0001; compared with MOD group, ****P<0.0001, ***P<0.001, **P<0.01, *P<0.05; compared with BZ1 group, ΔP<0.05.

[0183] From the results in Table 5, we can see that, in terms of inflammatory factor indicators, compared with the CON group, the inflammatory response in the rats of the MOD group was significantly increased, as shown by the significant increase in the content of proinflammatory factors TNF-α and IL-1β (P<0.0001).

[0184] Compared with the MOD group, the levels of TNF-α and IL-1β in the rats of the BZ1-4 group were significantly decreased (P<0.05), indicating that Baizhi Pills can reduce the levels of TNF-α and IL-1β in the hippocampal tissue of SD rats and alleviate the memory dysfunction caused by scopolamine.

[0185] Compared with the MOD group, the TNF-α content in the rats of the BZ0 group and the LB0 group was significantly decreased (P<0.05), while the IL-1β content was not significantly decreased (P>0.05). At the same time, compared with the BZ1 group, the TNF-α content in the rats of the BZ0 group and the LB0 group was significantly different (P<0.05), indicating that single Angelica dahurica powder or radish extract has no effect on alleviating memory dysfunction caused by scopolamine.

[0186] At the same time, the results of the LPS content test in rat serum showed that compared with the CON group, the LPS level of rats in the MOD group increased significantly (P<0.0001), and compared with the MOD group, the LPS level of rats in the BZ1-4 group decreased significantly (P<0.05), indicating that Baizhi pills can maintain the intestinal barrier function and prevent harmful substances such as intestinal bacteria and toxins (such as LPS) from entering the blood circulation or other tissues through the intestinal mucosa. However, there was no significant difference in the LPS levels of the BZ0 group and the LB0 group compared with the MOD group (P>0.05), indicating that a single Baizhi powder or radish extract has no effect on maintaining the intestinal barrier function and preventing harmful substances such as intestinal bacteria and toxins (such as LPS) from entering the blood circulation or other tissues through the intestinal mucosa.

[0187] In summary, combined with Table 4 and Table 5, it can be seen that the Baizhi pill of the present invention can play an anti-dementia and intelligence-enhancing role through multiple pathways and multiple targets such as regulating abnormal tau protein, improving the cholinergic system, and anti-oxidation.

[0188] 3.2 Analysis of biochemical index detection data

[0189] Nervous tissue has a unique structure and is more susceptible to attack by oxygen free radicals, which damages macromolecular structures such as DNA, induces apoptosis and death of nerve cells, and leads to learning and memory disorders. Oxidative stress is an important mechanism of neuronal damage in neurodegenerative diseases, and scopolamine can induce oxidative stress. SOD is an important antioxidant enzyme in the body. Its activity decreases in patients with learning and memory disorders, and a large amount of free radicals are produced, causing damage to brain tissue function. MDA is a toxic metabolite that causes cell damage and cell death during oxidation. It can reflect the degree to which the body is affected by free radicals. It is also toxic in itself and can cause degeneration, apoptosis and necrosis of neuronal cells in patients with learning and memory disorders. When the SOD level decreases and the MDA content increases, an oxidative stress response can be triggered, leading to cell damage or even death, which affects memory. Therefore, SOD and MDA are regarded as the main markers reflecting the body's redox state.

[0190] As an important antioxidant and free radical scavenger, GSH can combine with free radicals, heavy metals, etc. to protect cells. Under normal circumstances, the body's oxidation-antioxidant system maintains a relatively dynamic equilibrium state, and excessive reactive oxygen species will be cleared by its own antioxidant enzyme GSH-px. However, when the degree of oxidation exceeds its own clearance capacity, the oxidative balance will be broken, leading to oxidative stress damage to neural tissue and ultimately causing impaired learning, memory and cognitive functions.

[0191] Table 6 Effects of Baizhi Pills on SOD, MDA and GPX in rats ( n=10)

[0192]

[0193] Note: Compared with the CON group, #### P<0.0001; compared with MOD group, ****P<0.0001, ***P<0.001,

[0194] **P<0.01, *P<0.05; compared with BZ1 group, ΔP<0.05.

[0195] From the results in Table 6, we can see that compared with the CON group, the SOD level and GSH-px in the brain tissue of rats in the MOD group were significantly decreased (P<0.001), and the MDA level was significantly increased (P<0.0001), indicating that the model was successfully established.

[0196] Compared with the MOD group, the SOD levels and GSH-px in the brain tissue of the rats in the BZ1-4 groups were significantly increased (P<0.01), and the MDA level was significantly decreased (P<0.05). Compared with the MOD group, the SOD levels, GSH-px and MDA levels in the brain tissue of the rats in the BZ0 and LB0 groups were significantly decreased without significant differences (P>0.05).

[0197] In conclusion, Baizhi Pills can increase the SOD activity in the hippocampus of rats with memory impairment, reduce the MDA content, and significantly improve the GSH-px content in the brain tissue of rats with memory impairment, indicating that anti-oxidative stress is the potential mechanism for the pills to improve the learning and memory impairment of model rats.

[0198] The above is a further description of the present invention in conjunction with specific embodiments, but these embodiments are merely exemplary and do not constitute any limitation on the scope of the present invention. It should be understood by those skilled in the art that the details and forms of the technical solution of the present invention may be modified or replaced without departing from the spirit and scope of the present invention, but these modifications and replacements all fall within the scope of protection of the present invention.

Claims

1. Application of a composition containing Angelica dahurica in the preparation of a drug for preventing and treating Alzheimer's disease; The composition is composed of the following raw materials in parts by weight: 5-15 parts of angelica dahurica and 1-10 parts of radish extract, wherein the angelica dahurica is fresh or dried, and the radish extract is a dried product obtained by squeezing and filtering fresh radish juice; and the radish is carmine radish.

2. The use according to claim 1, characterized in that: The preparation method of the composition comprises the following steps: mixing angelica dahurica and radish extracts to obtain the composition.

3. Use of a Chinese medicine preparation in the preparation of a drug for preventing and treating Alzheimer's disease, wherein the Chinese medicine preparation is made from a composition containing Angelica dahurica, honey, tea leaves and pharmaceutically acceptable excipients; The composition is composed of the following raw materials in parts by weight: 5-15 parts of angelica dahurica and 1-10 parts of radish extract, wherein the angelica dahurica is fresh or dried, the radish extract is a dried product obtained by squeezing and filtering fresh radish juice, and the radish is carmine radish; The honey is linden honey, and the tea is Xanthoceras sorbifolia leaf tea; The weight ratio of the composition to honey is 1:1.0-3.0; the added amount of the tea leaves is 2%-20% of the weight of the composition.

4. The use according to claim 3, characterized in that: The dosage form of the traditional Chinese medicine preparation is granules, tablets, capsules, powders, pills or liquid preparations.

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