Traditional Chinese medicine composition, preparation method thereof, traditional Chinese medicine preparation and application of traditional Chinese medicine preparation

Abstract

The invention discloses a traditional Chinese medicine composition, a preparation method of the traditional Chinese medicine composition, a traditional Chinese medicine preparation and application of the traditional Chinese medicine preparation, and relates to the technical field of medicine production. 9 to 12 parts of ginkgo leaf; 9-30 parts of radix astragali; 9 to 15 parts of hypericum perforatum; 6 to 15 parts of jujube; 3-9 parts of red ginseng; 9-15 parts of semen ziziphi spinosae; and 3-6 parts of valerian. All the medicines in the traditional Chinese medicine composition have a synergistic effect, the curative effect is enhanced, and the depressive symptom is improved together.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical production, and particularly relates to a traditional Chinese medicine composition, a preparation method thereof, a traditional Chinese medicine preparation and an application thereof. Background Art

[0002] Depression is a common mental illness, belonging to a clinical subtype of depressive disorder. It is clinically manifested by low mood, decreased interest, and lack of energy, and it needs to persist for more than 2 weeks to be diagnosed. The cause of the disease is still unclear. From the perspective of traditional Chinese medicine, depression is mostly caused by the seven emotions such as anger, thinking, sorrow, and worry, resulting in the failure of the liver to disperse and dredge, the failure of the spleen to transport and transform, the loss of nourishment of the heart spirit, and the imbalance of the yin and yang qi and blood of the zang-fu organs. Among them, the stagnation of liver qi is the core of mild depression, and the unsmooth qi movement is the pathogenesis of this disease.

[0003] At present, the mainstream drugs for treating depression are still Western medicines, such as fluoxetine (SSRI), monoamine oxidase A inhibitors (MAO inhibitor drugs, MAOIs), tricyclic antidepressants (TCA), DA selective inhibitors, and 5-HT2 receptor antagonists. Western medicines are often accompanied by various side effects and are prone to form drug resistance. Western medicine treats diseases with the purpose of symptomatic treatment, targeting the characteristics of the disease, but it is easy to rebound and relapse after treatment. In addition, Western medicines often treat a single target in the mechanism, while the pathogenesis of depression is complex, often causing changes in multiple pathways. The treatment of a single site can only improve, and long-term medication is required. Summary of the Invention

[0004] The main object of the present invention is to propose a traditional Chinese medicine composition, a traditional Chinese medicine preparation and an application thereof, aiming to solve the problems of large side effects and poor treatment effects of Western medicines in the treatment of depression in the prior art.

[0005] To achieve the above object, the present invention proposes a traditional Chinese medicine composition, comprising the following raw materials in parts by mass:

[0006] Poria cocos 9 - 15 parts;

[0007] Ginkgo biloba leaves 9 - 12 parts;

[0008] Astragalus membranaceus 9 - 30 parts;

[0009] Hypericum perforatum 9 - 15 parts;

[0010] Jujube 6 - 15 parts;

[0011] Red ginseng 3 - 9 parts;

[0012] Semen Ziziphi Spinosae 9 - 15 parts; and,

[0013] Valeriana officinalis 3 - 6 parts.

[0014] In one embodiment, the traditional Chinese medicine composition comprises raw materials in the following parts by mass:

[0015] Poria cocos 9 - 12 parts;

[0016] Ginkgo biloba leaves 9 - 12 parts;

[0017] Astragalus membranaceus 9 - 20 parts;

[0018] Hypericum perforatum 10 - 14 parts;

[0019] Jujube 8 - 13 parts;

[0020] Red ginseng 5 - 7 parts;

[0021] Ziziphus jujuba var. spinosa 11 - 14 parts; and,

[0022] Valeriana officinalis 4 - 6 parts.

[0023] In one embodiment, the traditional Chinese medicine composition comprises raw materials in the following parts by mass:

[0024] Poria cocos 12 parts;

[0025] Ginkgo biloba leaves 10 parts;

[0026] Astragalus membranaceus 15 parts;

[0027] Hypericum perforatum 12 parts;

[0028] Jujube 10 parts;

[0029] Red ginseng 6 parts;

[0030] Ziziphus jujuba var. spinosa 12 parts; and,

[0031] Valeriana officinalis 5 parts.

[0032] The present invention provides a preparation method of a traditional Chinese medicine composition, comprising the following steps:

[0033] Mix and pulverize the raw materials in the traditional Chinese medicine composition as described above to obtain a first powder;

[0034] Perform multiple sieving on the first powder, and collect the second powder after sieving;

[0035] Mix the second powder with water, perform water bath heating, filtration, concentration, and suction filtration to obtain a finished preparation.

[0036] The present invention also provides a traditional Chinese medicine preparation, comprising the traditional Chinese medicine composition prepared by the preparation method of the traditional Chinese medicine composition as described above.

[0037] In one embodiment, the type of the traditional Chinese medicine preparation includes tablets, powders, granules or capsules.

[0038] Use of the traditional Chinese medicine composition according to any one of the above or the traditional Chinese medicine preparation according to any one of the above in the preparation of drugs for treating and / or improving depression.

[0039] The present invention provides a traditional Chinese medicine composition, a preparation method thereof, a traditional Chinese medicine preparation and applications thereof. According to the compatibility principles of traditional Chinese medicine, the traditional Chinese medicine composition uses astragalus membranaceus as the monarch drug to enhance qi supplementation and spleen strengthening. Using astragalus membranaceus is beneficial to the taste of the traditional Chinese medicine on the one hand and can also have a therapeutic effect on depression on the other hand. Hypericum perforatum and poria cocos are used as ministerial drugs to enhance qi supplementation, spleen strengthening, relieve depression and calm the mind; ginkgo biloba, ziziphus jujuba seed and valerian are used as adjuvant drugs to assist in calming the mind, promoting blood circulation and relieving depression. Among them, ginkgo biloba can improve cerebral circulation, thereby improving the learning and memory ability of depression patients. Jujube is used as the guiding drug to harmonize various drugs, enhance the overall curative effect and increase the sweetness of the traditional Chinese medicine, improving the taste of the traditional Chinese medicine. The various drugs act synergistically to enhance the curative effect and jointly improve depressive symptoms. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on the structures shown in these drawings without creative efforts.

[0041] Figure 1 It is a graph showing the weight changes of mice for the blank control group (CON group), chronic stress model group (CUMS group) and stress administration group (CUMS+Drug group) provided by the present invention;

[0042] Figure 2 It is a graph showing the experimental results of the depressive-like behavior defects of mice for the blank control group (CON group), chronic stress model group (CUMS group) and stress administration group (CUMS+Drug group) provided by the present invention;

[0043] Figure 3 It is a graph showing the results of the exploration times of mice for the blank control group (CON group), chronic stress model group (CUMS group) and stress administration group (CUMS+Drug group) provided by the present invention;

[0044] Figure 4 It is a product picture of the traditional Chinese medicine composition of the experimental group (Example 1) provided by the present invention;

[0045] Figure 5 It is a microscopic image and a statistical chart of cell counting results of the experimental group provided by the present invention, that is, the blank control group (CON group), chronic stress model group (CUMS group) and stress administration group (CUMS+Drug group) using Nissl staining technique;

[0046] Figure 6 The flowchart of the drug action points of the experimental group provided by the present invention.

[0047] The realization, functional features and advantages of the object of the present invention will be further described in conjunction with the embodiments with reference to the accompanying drawings. Detailed implementation manners

[0048] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. For those not specified in the embodiments, the conventional conditions or the conditions recommended by the manufacturer are followed. For the reagents or instruments whose manufacturers are not specified, they are all conventional products that can be obtained through commercial purchase. In addition, the meaning of "and / or" appearing throughout the text includes three parallel solutions. Taking "A and / or B" as an example, it includes solution A, solution B, or the solution where A and B are satisfied simultaneously. In addition, the technical solutions between the embodiments can be combined with each other, but it must be based on the fact that those of ordinary skill in the art can implement it. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the protection scope required by the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the protection scope of the present invention.

[0049] Depression is a common mental illness and a clinical subtype of depressive disorder. Its clinical manifestations include low mood, decreased interest, and lack of energy, and it needs to persist for more than 2 weeks to be diagnosed. The cause of the disease is still unclear. From the perspective of traditional Chinese medicine, depression is mostly caused by the seven emotions such as anger, worry, grief, and sorrow, which lead to the failure of the liver to disperse and dredge, the failure of the spleen to transport and transform, the failure of the mind to be nourished, and the imbalance of the yin and yang qi and blood of the zang-fu organs. Among them, the stagnation of liver qi is the core of mild depression, and the unsmooth qi movement is the pathogenesis of this disease.

[0050] Currently, the mainstream drugs for treating depression are still Western medicines, such as fluoxetine (SSRI), monoamine oxidase A inhibitors (MAO inhibitor drugs, MAOIs), tricyclic antidepressants (TCA), DA selective inhibitors, and 5-HT2 receptor antagonists. Western medicines are often accompanied by various side effects and are prone to form drug resistance. Western medicine treats diseases with the purpose of symptomatic treatment, targeting the characteristics of the disease, but it is easy to rebound and relapse after treatment. In addition, Western medicines often treat a single target in the mechanism, while the pathogenesis of depression is complex, often causing changes in multiple pathways. The treatment of a single site can only improve and requires long-term use.

[0051] Therefore, in the current prior art for treating depression, Western medicines have significant side effects and poor treatment effects.

[0052] In view of this, the present invention provides a traditional Chinese medicine composition, comprising raw materials in the following parts by mass:

[0053] Poria cocos 9 - 15 parts;

[0054] Ginkgo biloba leaves 9 - 12 parts;

[0055] Astragalus membranaceus 9 - 30 parts;

[0056] Hypericum perforatum 9 - 15 parts;

[0057] Jujube 6 - 15 parts;

[0058] Red ginseng 3 - 9 parts;

[0059] Suanzaoren 9 - 15 parts; and,

[0060] Valeriana officinalis 3 - 6 parts.

[0061] In the above formula, according to the compatibility principles of traditional Chinese medicine, the traditional Chinese medicine composition uses Astragalus membranaceus as the monarch drug to enhance invigorating qi and strengthening the spleen. Using Astragalus membranaceus is beneficial to the taste of traditional Chinese medicine on the one hand and can also have a therapeutic effect on depression on the other hand. Hypericum perforatum and Poria cocos are ministerial drugs to enhance invigorating qi and strengthening the spleen, relieving depression and calming the mind; Ginkgo biloba leaves, Suanzaoren, and Valeriana officinalis are adjuvant drugs to assist in calming the mind, promoting blood circulation, and relieving depression. Among them, Ginkgo biloba leaves can improve cerebral circulation, thereby enhancing the learning and memory ability of depression patients. Jujube is the guiding drug to harmonize various drugs, enhancing the overall curative effect and increasing the sweetness of traditional Chinese medicine while improving the taste of traditional Chinese medicine. The various drugs act synergistically to enhance the curative effect and jointly improve depressive symptoms.

[0062] It should be noted that Poria cocos: Poria cocos is the dried sclerotium of the fungus Poria cocos in the family Polyporaceae, with the effects of promoting diuresis and excreting dampness, strengthening the spleen, and calming the mind. It is an important medicinal flavor in the prescriptions for treating neurodegenerative diseases. Preferably, specifically considering the differences in individual body weights, the dosage of Poria cocos is 150 mg / kg, Ginkgo biloba leaves is 150 mg / kg, Astragalus membranaceus is 150 mg / kg, Hypericum perforatum is 50 mg / kg, jujube is 150 mg / kg, red ginseng is 100 mg / kg, Suanzaoren is 50 mg / kg, and Valeriana officinalis is 5 mg / kg for better effects.

[0063] Ginkgo biloba leaves: The important medicinal parts of Ginkgo biloba are fresh or dried leaves and seeds. The research on the active ingredients of Ginkgo biloba extract with antidepressant effects mainly focuses on flavonoids and ginkgolides. A large number of studies have shown that the mechanism of Ginkgo biloba extract in treating depression may be related to protecting neurons, regulating neurotransmitters, promoting BDNF secretion, and reducing inflammatory responses.

[0064] Astragalus: Astragalus membranaceus mainly contains flavonoids, saponins and other ingredients, while Mongolian Astragalus mainly contains astragalus polysaccharides, which have multiple pharmacological effects such as enhancing the body's immune function, protecting the liver, diuresis, anti-aging, anti-stress, lowering blood pressure and a wide range of antibacterial effects. It can improve depressive behavior and protect brain tissue by regulating endocrine and monoamine neurotransmitters, regulating immune function, etc.

[0065] Hypericum perforatum: The active ingredients of Hypericum perforatum for treating mild to moderate depression include quercetin, kaempferol, luteolin, (+)-catechin, epicatechin, and sitosterol.

[0066] Jujube: It is an important medicinal ingredient in Ganmai Dazao Decoction and is often used in Chinese medicine compound prescriptions to treat diseases. It has the functions of tonifying the middle and replenishing Qi, nourishing blood and calming the mind, moistening dryness and relieving urgency.

[0067] Red ginseng: Red ginseng has the effects of promoting fluid production and replenishing qi, nourishing the spleen and lungs, and calming the mind and improving intelligence.

[0068] Ziziphus jujuba seed: Ziziphus jujuba seed is the dried seed of the plant Ziziphus jujuba of the Rhamnaceae family. It is mild in nature, sweet and sour in taste, and enters the heart, liver, gallbladder, and spleen meridians. It has the effects of calming the mind, nourishing the heart and liver, and astringing sweat and promoting body fluid. Studies have shown that Ziziphus jujuba seed has antidepressant pharmacological activity, and its active ingredients mainly include Ziziphus jujuba saponins, Ziziphus jujuba flavonoids and Ziziphus jujuba volatile oil. Among them, saponins are considered to be the main active ingredients of Ziziphus jujuba seed for antidepressant effects.

[0069] Valerian: On the one hand, valerian promotes hippocampal neurogenesis by increasing the level of 5-HT in the hippocampus of depressed rats; on the other hand, it protects damaged neurons in the hippocampus of depressed rats and prevents them from dying, thereby stabilizing the hippocampal structure and achieving the purpose of alleviating and treating depression. In addition, it also has the effects of calming the nerves, regulating qi, and relieving pain.

[0070] Moreover, there is no pharmacological conflict between the above-mentioned Chinese medicines. The new antidepressant Chinese medicine formula has the functions of calming the mind and regulating qi, moistening dryness and relieving urgency, promoting fluid production and replenishing qi, and nourishing the spleen and lungs.

[0071] In the technical scheme of the present invention, the Chinese medicine composition is based on the compatibility principle of traditional Chinese medicine, and is aimed at the basic pathogenesis of mild depression caused by the seven emotions, such as liver failure to vent, spleen failure to transport and transform, mind failure to nourish, visceral yin and yang qi and blood imbalance, and liver qi stagnation and qi stagnation. The above-mentioned Chinese medicinal materials are mostly Chinese medicinal components that are used to soothe the liver and relieve depression, regulate qi and strengthen the spleen, and nourish blood and activate blood circulation. Through the above-mentioned multiple Chinese medicine compatibility, the body's nervous, endocrine, immune and other system functions are regulated as a whole, depression symptoms are improved, the treatment purpose is achieved, and it is not easy to rebound. For example, astragalus enhances the body's immune function, synergizes with other drugs, helps the body restore a balanced state, and reduces the possibility of recurrence of depression.

[0072] It is understandable that the treatment cycle of severe depression is relatively long, and it is difficult to achieve ideal treatment effects in a short period. This application focuses more on treating mild depression or preventing the further aggravation of depressive symptoms, thereby reducing the occurrence of severe depression. Mild depression is mostly caused by the seven emotions such as anger, worry, grief, and sorrow, which lead to the failure of the liver to disperse and dredge, the failure of the spleen to transport and transform, the loss of nourishment of the mind, and the imbalance of yin, yang, qi, and blood in the zang-fu organs. Among them, the stagnation of liver qi is the core cause of mild depression, and the stagnation of qi movement is the basic pathogenesis of this disease. Therefore, the traditional Chinese medicine components adopted in this patent are mostly those that soothe the liver and relieve depression, regulate qi and strengthen the spleen, nourish blood and promote blood circulation, so as to achieve ideal treatment effects.

[0073] In some embodiments of the present invention, the traditional Chinese medicine composition comprises raw materials in the following parts by mass:

[0074] Poria cocos 9 - 12 parts; Ginkgo biloba leaves 9 - 12 parts; Astragalus membranaceus 9 - 20 parts; Hypericum perforatum 10 - 14 parts;

[0075] Jujube 8 - 13 parts; Red ginseng 5 - 7 parts; Ziziphus jujuba var. spinosa 11 - 14 parts; and, Valeriana officinalis 4 - 6 parts. Under this formula, the effect of treating depression is better.

[0076] Further, in some embodiments of the present invention, the traditional Chinese medicine composition comprises raw materials in the following parts by mass: Poria cocos 12 parts; Ginkgo biloba leaves 10 parts; Astragalus membranaceus 15 parts; Hypericum perforatum 12 parts; Jujube 10 parts; Red ginseng 6 parts; Ziziphus jujuba var. spinosa 12 parts; and Valeriana officinalis 5 parts. Under this formula, the effect of treating depression is better.

[0077] The present invention provides a preparation method of a traditional Chinese medicine composition, comprising the following steps:

[0078] Mix and pulverize the raw materials in the above-mentioned traditional Chinese medicine composition to obtain a first powder;

[0079] Perform multiple sieving operations on the first powder, and collect the second powder after sieving;

[0080] Mix the second powder with water, perform water bath heating, filtration, concentration, and suction filtration to obtain a finished preparation. By adopting the above preparation steps, the curative effects of each component in the traditional Chinese medicine composition can be fully utilized.

[0081] The present invention also provides a traditional Chinese medicine preparation, comprising the traditional Chinese medicine composition prepared by the preparation method of the traditional Chinese medicine composition as described above.

[0082] In some embodiments of the present invention, the types of the traditional Chinese medicine preparation include tablets, powders, granules or capsules, and no excessive restrictions are imposed here, and it can be adjusted according to actual needs to meet the needs of different patients.

[0083] Use of a traditional Chinese medicine composition or a traditional Chinese medicine preparation as described in any one of the above in the preparation of a medicament for treating and / or improving depression.

[0084] The said use includes all technical solutions of the said pharmaceutical composition, and thus also has all the beneficial effects brought by the above solutions, which will not be elaborated one by one herein.

[0085] The technical solutions of the present invention will be further described in detail below in conjunction with specific embodiments and drawings. It should be understood that the following embodiments are only used to explain the present invention and are not used to limit the present invention.

[0086] Experimental materials:

[0087] Poria cocos is produced by Huadingtang in Anhui;

[0088] Ginkgo biloba leaves are produced by Renxin Medicine in Hebei;

[0089] Astragalus membranaceus is produced by Yaozhiyuan in Anhui;

[0090] Hypericum perforatum is produced in Sichuan;

[0091] Jujube is produced by Xianghui in Yunnan;

[0092] Red ginseng is produced by Jingui in Hubei;

[0093] Semen ziziphi spinosae is produced by Huadingtang in Anhui;

[0094] Valeriana officinalis is produced in Yunnan.

[0095] Example 1

[0096] A traditional Chinese medicine composition, comprising:

[0097] 12 g of Poria cocos, 10 g of Ginkgo biloba leaves, 15 g of Astragalus membranaceus, 12 g of Hypericum perforatum, 10 g of jujube, 6 g of red ginseng, 12 g of Semen ziziphi spinosae and 5 g of Valeriana officinalis.

[0098] Example 2

[0099] A traditional Chinese medicine composition, comprising:

[0100] 9 g of Poria cocos, 9 g of Ginkgo biloba leaves, 9 g of Astragalus membranaceus, 9 g of Hypericum perforatum, 6 g of jujube, 3 g of red ginseng, 9 g of Semen ziziphi spinosae and 3 g of Valeriana officinalis.

[0101] Example 3

[0102] 15 g of Poria cocos, 12 g of Ginkgo biloba leaves, 30 g of Astragalus membranaceus, 15 g of Hypericum perforatum, 15 g of jujube, 9 g of red ginseng, 15 g of Semen ziziphi spinosae and 6 g of Valeriana officinalis.

[0103] Performance test

[0104] Preparation of traditional Chinese medicine composition: Put various traditional Chinese medicine components in the examples and comparative examples into a wall breaker respectively and crush them into powders. Among them, since Chinese dates contain a certain amount of moisture, they must be dried in an oven first and then crushed. Pour the powdered traditional Chinese medicine onto a 40-mesh sieve. First, use a brush labeled No. 1 to brush off the traditional Chinese medicine powder in the wall breaker and the lid, sieve it onto oiled paper, and conduct a second sieving. Collect the traditional Chinese medicine powder after the second sieving. After all the traditional Chinese medicine is crushed, place the weighed samples in a large beaker according to the formula dosage, add 400 ml of pure water, stir evenly with a glass rod, put it into a water bath pot, heat it at a constant temperature of 90 °C for 2 h. After slightly cooling, filter it with a gauze. The medicinal liquid after filtration is heated and concentrated. When the medicinal liquid is concentrated to 100 ml, stop. Pour the concentrated medicinal liquid into a Buchner funnel for suction filtration. The medicinal liquid after suction filtration is the traditional Chinese medicine composition. Specifically, the traditional Chinese medicine composition obtained in Example 1 of the present invention is as shown in Figure 4 shown, the color is light yellowish brown, and there is a sweet smell of tonics, which can reduce the pain of patients taking traditional Chinese medicine.

[0105] To verify the improvement effect of the new traditional Chinese medicine formula on depression, 30 Kunming mice were selected and divided into three experimental groups: a blank control group (CON group), a chronic stress model group (CUMS group), and a stress-administered drug group (CUMS+Drug group).

[0106] The CUMS model was continuously carried out for 35 days. The stress stimuli used were fasting (24 h), water deprivation (24 h), tilting the cage (24 h), co-housing (24 h), wet cage (24 h), tail clamping (10 min), night lighting (12 h), cage shaking (10 min), and restraint (6 h). Randomly select a stress stimulus to stimulate the animals every day, and the corresponding stress stimuli are different within seven days of a week to prevent the mice from developing adaptability.

[0107] The CUMS+Drug group was given intragastric administration of traditional Chinese medicine based on that less than that in Example 1 on the basis of chronic stress every day.

[0108] The stress-administered drug group was given the traditional Chinese medicine composition in Example 1 by intragastric administration to mice at a dose of 0.01 ml / g, and the blank control group and the chronic stress model group were given normal saline according to the same standard.

[0109] Weigh the mice every day. After the modeling is completed, conduct depression-like behavioral tests on the mice. After the behavioral tests, sacrifice the mice and conduct subsequent tests such as the detection of the morphology and quantity of neurons.

[0110] Experimental results

[0111] 1. Weight change graphs of rats in each group before and after treatment

[0112] From Figure 1It can be seen that compared with the CON group, the weekly body weight gain in the CUMS group was significantly reduced (P<0.001), and the weekly body weight gain in the CUMS+D group was also significantly decreased (P = 0.002). However, there was also a significant difference between the CUMS group and the CUMS+D group (p = 0.041). After statistical analysis of the body weight gain, there were significant differences between any two of the three groups. From Figure 1 It can be seen that in the CUMS+Drug group, the mice reduced the decrease in body weight gain caused by CUMS because they took the important composition prepared in Example 1.

[0113] 2 The formula of the traditional Chinese medicine composition of the present application improved the depressive-like behavior defects caused by CUMS

[0114] Test method: Figure 2 The behavioral data obtained from the forced swimming experiment. Using the number of climbs (which can also be called struggles), climbing time, immobility time, and number of immobilities as the main indicators to detect the despair behavior of animals, it is a common test experiment for the primary screening of antidepressant drugs and detecting whether "depressive-like" behavior appears in model animals. The experiment uses a cylindrical box with dimensions of 25 cm × 10 cm, and a diving area and a floating area are set. Fill 3 / 4 of pure water in the cylindrical container, and there should be a shield between each container so that the experimental animals cannot see the mice in the adjacent compartment. In a quiet environment, hold the root of the mouse's tail and carefully put it into the cylindrical container, and use a camera system to record the struggling state of the animal for 6 minutes. Analyze the last four minutes and record the struggling time and immobility time, etc. The test results are as Figure 2 shown:

[0115] Figure 2 In A of Figure 2 is the average number of climbs (climbing number) in the forced swimming experiment of each group of mice;

[0116] From Figure 2 A and B in Figure 2C and D in it also showed that compared with the control group, the immobility time and the number of different times of the mice in the CUMS group increased significantly. However, the immobility time and the number of different times of the mice in the CUMS+Drug group decreased to a certain extent compared with those in the CUMS group, but there was no significant difference. It can be seen that the despair time of the mice in the CUMS group increased, while the CUMS+Drug group improved the depressive-like behavior defects caused by CUMS because they took the traditional Chinese medicine composition prepared in Example 1.

[0117] It should be noted that the forced swimming is a classic behavioral experiment used to evaluate depressive-like behaviors. The climbing behavior and the immobility time can reflect the despair behavior of the mice. Climbing represents the willingness of the mice to escape from this space, and depressed mice will show a low willingness to climb.

[0118] Figure 3 The traditional Chinese medicine composition improved the decrease in the number of exploration times caused by CUMS.

[0119] Test method: A square box with dimensions of 30 cm×30 cm×35 cm was used in the experiment, and objects 01, 02, and 03 (01 and 02 are the same kind of objects) were set. In a quiet environment, hold the root of the mouse's tail and carefully place it in the center of the open field, allowing the mouse to freely explore for 10 min, and record it with a camera. After the adaptation period, catch the mouse by the root of the tail and take it out, then put it back into the cage to rest for ten minutes. During the rest period, clean the experimental area with 75% alcohol to remove excrement and residual body odor. After the rest time ends, put objects 01 and 02, and then put the mouse back into the experimental area at the same position. Record the exploration process and behavioral changes of the animal for 10 min with a camera system. The records include the total distance, exploration time, exploration latency, etc. of the mouse. After the experiment, take out the mouse and put it back into the cage to rest for 10 min. At the same time, disinfect the experimental area with 75% alcohol again. After the second rest time ends, replace object 02 in the experimental area with object 03, then put the mouse into the experimental area to freely explore for 5 min, and record it with a camera system. After five minutes, take out the mouse and disinfect it with 75% alcohol again. After the alcohol smell has dissipated, conduct the detection of the next mouse. The test results are as Figure 3 shown:

[0120] Figure 3Among them, O1 is the old object, O3 is the new object. Compared with the old object, the exploration frequency of the new object in the CON group and the CUMS+Drug group has a significant increase. However, there is no significant difference in the exploration frequency of the old and new objects in the CUMS group. It can be seen that CUMS causes a decrease in the exploratory desire of mice. The CUMS+Drug group took the traditional Chinese medicine composition of Example 1, so it improved the reduction of exploratory behavior caused by CUMS. This is mainly due to the addition of Astragalus membranaceus, Ginkgo biloba, Hypericum perforatum, and Poria cocos in the formula of this drug. This can not only treat depression but also restore the problem of brain damage caused by depression, thereby improving the learning and memory functions of mice.

[0121] Figure 5 The traditional Chinese medicine composition improved the morphology and quantity of neurons

[0122] The test method is as follows:

[0123] 5.1 Sacrifice the mice in the CON, CUMS, and CUMS+Drug groups. First, remove the fur on the heads of the mice, then open the skull to take out the complete brain tissues of the mice. Transfer the dissected brain tissues to 4% PFA (Paraformaldehyde) for fixation. After overnight at 4°C, wash with phosphate buffer and gradient alcohol, and finally store in 70% ethanol at 4°C.

[0124] 5.2 Paraffin embedding and sectioning

[0125] After the samples are treated with gradient alcohol, xylene, and paraffin, transfer them to a plastic embedding mold for paraffin embedding. Then, perform paraffin sectioning and floating to obtain paraffin sample sections. Collect sections with a thickness of 7μm. Bake the paraffin section samples in a low-temperature drying oven at 42°C overnight (about 8h), and then store them in a slide box.

[0126] 5.3 Nissl staining

[0127] Successively dewax and rehydrate with xylene and gradient alcohol, wash with tap water and distilled water, then transfer to Nissl stain for staining for 25 minutes. Then, treat with 95% ethanol for 30 minutes, then pass through absolute ethanol three times, make it transparent with xylene, and finally seal with resin. The whole process is completed in a ventilated place.

[0128] The test results are as Figure 5 shown: Figure 5 The upper figure in the middle contains microscopic images of the PVH (paraventricular nucleus of hypothalamus, PVN) region under three experimental conditions. Among them, compared with the control group, the number of PVH neurons in the CUMS group is significantly reduced, and the number of PVH neurons in the CUMS+Drug group has recovered. Figure 5The following figure shows the number of PVH neurons in different groups. Compared with the control group, the number of neurons in the CUMS group was significantly reduced, indicating that CUMS caused damage to the paraventricular nucleus neurons in mice. Compared with the CUMS group, the number of paraventricular nucleus neurons in the drug-administered group was significantly increased, and there was no significant difference from the control group, suggesting that the traditional Chinese medicine with the new formula protected and treated the paraventricular nucleus neurons, effectively reducing the damage to PVN neurons caused by CUMS.

[0129] Therefore, in summary, after taking the traditional Chinese medicine composition of the present application, as can be seen from the morphology of the mice, most of the neuron cells in the PVH nucleus were restored, indicating that the drug can relieve or reverse the neuron damage caused by CUMS to a certain extent. However, its effect may be partial or it may take a longer time to fully recover to the normal level. That is, the effectiveness of this traditional Chinese medicine composition as a potential therapy for treating related diseases can improve the behavioral or physiological changes caused by stressors such as CUMS by promoting neuron recovery.

[0130] Figure 6 The following is the flowchart of the drug action points of the traditional Chinese medicine composition of the present application:

[0131] Stress stimulation (CUMS) activates the HPA axis system. First, the hypothalamus will release CRH (corticotropin-releasing hormone) and AVP (vasopressin);

[0132] CRH and AVP act on the pituitary gland, prompting the pituitary gland to release ACTH (adrenocorticotropic hormone);

[0133] ACTH acts on the Adrenal Cortex, prompting the adrenal cortex to release GCs (glucocorticoids);

[0134] Glucocorticoids negatively feedback regulate the pituitary gland and the hypothalamus.

[0135] In summary, due to Figure 5 the changes in the tissue morphology of the PVN nucleus in [], its neurons were even damaged. Since the PVN nucleus plays an important role in the HPA axis, the drug of the present invention can affect the stress response by regulating the HPA axis.

[0136] It should be noted that the thalamus-pituitary-adrenal axis (HTPA axis or HPA axis), also known as the limbic system-hypothalamus-pituitary-adrenal axis, is one of the key regulatory mechanisms of the human body's stress response. In this complex network, the paraventricular nucleus of the hypothalamus (PVN) plays an important role. The PVN is located within the hypothalamus, on both sides of the third ventricle. It is an important neuroendocrine center and is crucial for initiating and regulating the stress response.

[0137] According to cell volume, neurons in the PVN can be divided into two major categories: magnocellular neurons and parvocellular neurons. Magnocellular neurons are responsible for synthesizing oxytocin (OXT) and arginine vasopressin (AVP), and releasing these hormones into the bloodstream through the axon terminals that project to the neurohypophysis. On the other hand, parvocellular neurons include corticotropin-releasing hormone (CRH) neurons, thyrotropin-releasing hormone (TRH) neurons, and somatostatin neurons, etc. Their axons project to the median eminence, enabling the release of hormones that affect the activities of the anterior pituitary. These hormones then control various physiological processes related to the HPA axis. Long-term exposure to stress can lead to repeated activation of the HPA axis, which may change its normal response pattern and affect an individual's ability to adapt to stress.

[0138] The above are only the preferred embodiments of the present invention, and do not limit the patent scope of the present invention. For those skilled in the art, the present invention can have various changes and modifications. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included within the patent protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, Comprising the following raw materials in parts by mass: Poria cocos 9 - 15 parts; Ginkgo biloba leaves 9 - 12 parts; Astragalus membranaceus 9 - 30 parts; Hypericum perforatum 9 - 15 parts; Jujube 6 - 15 parts; Red ginseng 3 - 9 parts; Semen Ziziphi Spinosae 9 - 15 parts; and Valeriana officinalis 3 - 6 parts.

2. The traditional Chinese medicine composition according to claim 1, wherein The traditional Chinese medicine composition comprises the following raw materials in parts by mass: Poria cocos 9 - 12 parts; Ginkgo biloba leaves 9 - 12 parts; Astragalus membranaceus 9 - 20 parts; Hypericum perforatum 10 - 14 parts; Jujube 8 - 13 parts; Red ginseng 5 - 7 parts; Semen Ziziphi Spinosae 11 - 14 parts; and Valeriana officinalis 4 - 6 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by mass: Poria cocos 12 parts; Ginkgo biloba leaves 10 parts; Astragalus membranaceus 15 parts; Hypericum perforatum 12 parts; Jujube 10 parts; Red ginseng 6 parts; Semen Ziziphi Spinosae 12 parts; and Valeriana officinalis 5 parts.

4. A preparation method of a traditional Chinese medicine composition, characterized in that, Comprising the following steps: Mixing and pulverizing the raw materials in the traditional Chinese medicine composition according to any one of claims 1 to 3 to obtain a first powder; Subjecting the first powder to multiple sieving operations and collecting the sieved second powder; Mixing the second powder with water, heating in a water bath, filtering, concentrating, and suction filtering to obtain a finished preparation.

5. A traditional Chinese medicine preparation, characterized in that, Comprising the traditional Chinese medicine composition prepared by the preparation method of the traditional Chinese medicine composition according to claim 4.

6. The traditional Chinese medicine preparation according to claim 5, characterized in that, The types of the traditional Chinese medicine preparations include tablets, powders, granules, or capsules.

7. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the traditional Chinese medicine preparation according to any one of claims 5 to 6 in the preparation of medicaments for treating and / or improving depression.

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