Depression-dispersing and meridian-stimulating granules for treating depression and application thereof

By preparing Xuanyu Tongjing Granules, the synergistic effect of traditional Chinese medicine components has been utilized to overcome the shortcomings of existing antidepressants, achieving effective treatment of depression and significantly improving depressive symptoms and neurological function.

CN121243327APending Publication Date: 2026-01-02SHANDONG LUKANG SANYE PHARM CO LTD
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Patent Information

Application Number
CN202511814837.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-12-04
Publication Date
2026-01-02

AI Technical Summary

Technical Problem

Existing antidepressants have problems such as slow onset of action, many adverse reactions, large individual differences in efficacy, and limited efficacy for patients with severe depression. In addition, traditional Chinese medicine has not yet fully utilized its unique advantages in the treatment of depression.

Method used

A granule for relieving depression and promoting menstruation was developed, containing Chinese herbal ingredients such as white peony root, angelica root, peony bark, stir-fried gardenia fruit, bupleurum root, wine-processed cyperus rhizome, vinegar-processed turmeric root, wine-processed scutellaria root, and licorice root. Following the principles of soothing the liver and relieving depression and regulating qi and promoting circulation in traditional Chinese medicine, the granule was prepared through decoction, concentration, and drying processes for the treatment of depression.

Benefits of technology

It significantly improves anxiety and despair in patients with depression, alleviates neuroinflammation and hippocampal tissue damage, increases serum anti-inflammatory factor levels, regulates hippocampal BDNF and TrkB protein expression, and improves depressive behavior, demonstrating safe and effective therapeutic effects.

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Abstract

The invention discloses depression-dispersing and meridian-stimulating granules for treating depression and application of the depression-dispersing and meridian-stimulating granules, and belongs to the technical field of traditional Chinese medicine compositions. The depression-dispersing and menstruation-stimulating granules for treating depression comprise the following components in parts by weight: 10-15 parts of white paeony root, 10-15 parts of angelica sinensis, 10-15 parts of moutan bark, 6-10 parts of fried gardenia, 5-8 parts of fried semen brassicae, 2-6 parts of radix bupleuri, 2-6 parts of wine-processed rhizoma cyperi, 2-6 parts of vinegar-processed turmeric, 2-6 parts of wine-processed scutellaria baicalensis and 2-6 parts of liquorice. The depression-dispersing and menstruation-stimulating granules prepared by the invention are optimized on the basis of a traditional Chinese medicine classical famous prescription, a plurality of components have a synergistic effect, and the depression-dispersing and menstruation-stimulating granules have the effects of soothing liver, regulating qi, activating blood and clearing heat, and effectively treat depression aiming at the core pathogenesis of liver depression, qi stagnation and unsmooth qi and blood.
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Description

Technical Field

[0001] The present invention relates to a Xuan Yu Tong Jing Granule for treating depression and its application, belonging to the technical field of traditional Chinese medicine compositions. Background Art

[0002] Depression is a mental and emotional disorder with a core feature of persistent low mood, which can be accompanied by anxiety, reduced interest, cognitive decline, and even suicidal tendencies. Depression has a high prevalence rate, a low cure rate, and a high recurrence rate, which has an extremely serious negative impact on the quality of life of patients, and also brings a heavy burden to the families of patients and society. According to statistics from the World Health Organization, the number of global depression patients has exceeded 300 million, and nearly 800,000 people die of depression suicide every year. It is expected that depression will rank first in the global disease burden by 2030. At present, the exact pathogenesis of depression has not been fully clarified. The main pathogenesis hypotheses include the monoamine neurotransmitter hypothesis, the neuroplasticity and neurotrophic factor hypothesis, the neuroinflammation hypothesis, the gut microbiota imbalance hypothesis, etc. Currently, studies generally believe that its pathogenesis is complex and there is an interaction between these hypotheses.

[0003] Currently, traditional antidepressant drugs, such as selective serotonin reuptake inhibitors (SSRIs) fluoxetine developed based on the monoamine neurotransmitter hypothesis, glutamate receptor antagonists such as S-ketamine, and neurosteroid GABAA receptor positive allosteric modulators such as brexanolone, still have problems such as slow onset, many adverse reactions, large individual differences in efficacy, etc., and have no efficacy for most patients with severe depressive disorders. In recent years, the newly discovered isomer of ketamine, S-ketamine, has a rapid and significant antidepressant effect, and its mechanism of action is different from that of traditional antidepressant drugs, which has brought a breakthrough in the research and development of antidepressant drugs. However, it has problems such as easy hallucination, tolerance, and addiction. Therefore, it is urgent to explore antidepressant drugs with better efficacy and fewer adverse reactions.

[0004] In this context, traditional Chinese medicine, relying on its unique theoretical framework and diagnosis and treatment concepts, provides new ideas for the treatment of depression. Traditional Chinese medicine theory mainly classifies depression into the category of "depressive disorder", and its core pathogenesis is highly summarized as "liver qi stagnation and qi and blood disharmony". It is believed that its onset is closely related to the failure of the liver to disperse qi, the failure of the spleen to transport and transform, and the failure of the heart to nourish. It is necessary to achieve the treatment goal of regulating qi movement and balancing the zang-fu organs through therapies such as soothing the liver and relieving depression, invigorating the spleen and replenishing qi, and nourishing the heart and calming the mind, so as to improve the physical and mental state of patients from the root. Based on this theory, traditional Chinese medicine has developed traditional Chinese medicine compounds with the effects of soothing the liver and relieving depression and regulating qi and promoting qi movement. Currently, in traditional Chinese medicine compounds, bupleurum and scutellaria are commonly used medicine pairs. Bupleurum dispels pathogenic factors in the shaoyang meridian, and scutellaria purges the ministerial fire in the shaoyang meridian. The two are combined to relieve the pivot of the shaoyang meridian together, and can play a therapeutic role in depression from the perspective of reconciling the shaoyang meridian, and have relatively few side effects, reflecting the unique advantages of traditional Chinese medicine in treating depression.

[0005] Therefore, targeting the core pathogenesis of depression, namely "liver qi stagnation and blood stasis," a new type of herbal granule for relieving depression and promoting blood circulation has been developed by optimizing the formulation and processing of traditional Chinese medicine, providing a safe and effective new option for the treatment of depression. Summary of the Invention

[0006] In view of the shortcomings of the existing technology, the purpose of this invention is to provide a depressive and meridian-clearing granule for treating depression and its application, which can effectively treat depression by targeting the core pathogenesis of "liver qi stagnation and blood stasis".

[0007] To solve the above-mentioned technical problems, the technical solution provided by the present invention is as follows: A type of granule for treating depression, comprising the following components by weight: 10-15 parts of white peony root, 10-15 parts of angelica root, 10-15 parts of peony bark, 6-10 parts of stir-fried gardenia fruit, 5-8 parts of stir-fried white mustard seed, 2-6 parts of bupleurum root, 2-6 parts of wine-processed cyperus rhizome, 2-6 parts of vinegar-processed turmeric, 2-6 parts of wine-processed scutellaria root, and 2-6 parts of licorice root.

[0008] This invention follows the traditional Chinese medicine theory of "liver qi stagnation as the guiding principle, while also regulating qi, blood, phlegm, and fire." Targeting the core pathogenesis of depression—liver qi stagnation and blood stasis—it prepares a formula for relieving depression and promoting menstruation. The formula follows the classic TCM formula Xuanyu Tongjing Tang, with white peony root and angelica root as the chief herbs to nourish blood and soften the liver; peony bark, stir-fried gardenia fruit, and wine-processed scutellaria root to clear heat, purge fire, cool blood, and soothe the liver as the assistant herbs; bupleurum root, wine-processed cyperus rhizome, and vinegar-processed turmeric to regulate qi, relieve depression, invigorate blood, and relieve pain as adjuvant herbs; stir-fried white mustard seed to resolve phlegm and dissipate nodules; and licorice root to harmonize the other herbs as the guiding herb. Together, these herbs achieve the effects of soothing the liver and relieving depression, clearing heat and cooling blood, and promoting qi and dissipating nodules. Through the synergistic effects of soothing the liver and relieving depression, nourishing blood and invigorating blood, clearing heat and resolving phlegm, and harmonizing qi and blood, the formula restores the body's physiological state of smooth qi flow, harmonious qi and blood, and peaceful internal organs. The Xuanyu Tongjing granules prepared by this invention can significantly improve the anxiety and despair levels of depressed individuals, thus playing a role in the treatment of depression.

[0009] Furthermore, the Xuanyu Tongjing granules comprise the following components by weight: 10 parts white peony root, 10 parts angelica root, 10 parts peony bark, 6 parts stir-fried gardenia fruit, 5 parts stir-fried white mustard seed, 2 parts bupleurum root, 2 parts wine-processed cyperus rhizome, 2 parts vinegar-processed turmeric, 2 parts wine-processed scutellaria root, and 2 parts licorice root. Bupleurum root and wine-processed cyperus rhizome can relieve liver stagnation, restore qi circulation, and alleviate the core symptom of low mood; gardenia fruit and scutellaria root clear heat and inhibit liver stagnation from transforming into fire; angelica root and white peony root nourish blood to prevent liver yin depletion; white mustard seed and turmeric resolve phlegm, invigorate blood, and break up phlegm and blood stasis, blocking the further development of the pathogenesis chain; licorice root harmonizes the medicinal properties, protects the spleen and stomach, and addresses the spleen and stomach weakness of patients with depression, avoiding damage to the body's vital energy and achieving the goal of treating the disease without harming the body's vital energy.

[0010] Furthermore, the preparation method of the stir-fried white mustard seeds is as follows: clean the white mustard seeds, stir-fry them over low heat until they turn from light yellow to dark yellow and have a slightly spicy aroma; the preparation method of the vinegar turmeric is as follows: clean the turmeric, moisten it for 30 minutes, cut it into 2-4 mm thin slices, dry it, add rice vinegar, stir-fry it over low heat until the color darkens and deepens, remove it and let it cool; the preparation method of the wine-processed scutellaria is as follows: clean the scutellaria, moisten the medicinal material for 30 minutes, cut it into 1-2 mm thin slices, dry it, add rice wine and stir-fry it over low heat until it turns slightly yellow.

[0011] Furthermore, the preparation method of the Xuanyu Tongjing granules for treating depression includes the following steps: (1) Weigh out the following ingredients according to the formula dosage: white peony root, angelica root, peony bark, stir-fried gardenia fruit, stir-fried white mustard seed, bupleurum root, wine-processed cyperus rhizome, vinegar-processed turmeric, wine-processed scutellaria root, and licorice root. After washing, put them into an extraction tank, add 8 times the weight of water and decoct for 2 hours. Filter to obtain the first decoction. (2) Add 6 times the weight of water to the dregs and boil for 2 hours to obtain the second decoction; (3) Combine the first decoction and the second decoction, filter them, and then heat and concentrate them using a concentrator to obtain an extract; (4) Vacuum dry the extract until the moisture content is ≤3%, then pulverize it into fine powder to obtain dry extract powder; (5) Add excipient solution to dry extract powder to obtain wet granules, then dry them until the moisture content is ≤5.0%, and pass them through a 10-mesh sieve and an 80-mesh sieve in sequence to obtain Xuanyu Tongjing granules for treating depression.

[0012] Furthermore, in step (3), the heating and concentration temperature is 55-60℃, the vacuum degree is ≥-0.06Mpa, and the steam pressure is 0.02-0.08MPa.

[0013] Furthermore, in step (3), the relative density of the extract is 1.20-1.25 (60°C).

[0014] Furthermore, in step (4), the vacuum degree of the vacuum drying is -60kPa to 95kPa, the temperature is 60-65℃, and the time is 8h.

[0015] Furthermore, in step (5), the mass ratio of the dry extract powder to the excipients is 4:1.

[0016] Furthermore, in step (5), the excipient solution is prepared by adding povidone to 95% ethanol at a mass ratio of 1:12 and stirring until dissolved to prepare the excipient solution.

[0017] Application of Xuanyu Tongjing Granules for the treatment of depression.

[0018] Furthermore, the dosage of Xuanyu Tongjing Granules is 1.25-5 g of raw medicinal material / kg.

[0019] Compared with the prior art, the beneficial effects of the present invention are: 1. The Xuanyu Tongjing Granules of the present invention are based on the optimization of a classic Chinese medicine formula. Multiple components work synergistically to take into account the functions of soothing the liver, regulating qi, promoting blood circulation, and clearing heat. They effectively treat depression by targeting the core pathogenesis of "liver qi stagnation and poor blood circulation".

[0020] 2. The Xuanyu Tongjing granules of the present invention can significantly shorten the immobility time of tail suspension and forced swimming in depressed model mice, increase the movement distance in open field experiments, and improve anxiety and despair behaviors; alleviate LPS-induced hippocampal tissue pathological damage in depressed mice; reduce serum levels of pro-inflammatory factors such as IL-6, IL-1β, and TNF-α, and increase serum levels of anti-inflammatory factor IL-10; upregulate the expression of hippocampal BDNF and TrkB proteins, and alleviate neuroinflammation and hippocampal neuronal damage.

[0021] 3. The preparation process of the Xuanyu Tongjing Granules of this invention is stable, and standardized steps of water extraction, concentration and drying are adopted to ensure the retention of effective ingredients. The granules are convenient to take and easy to store. Attached Figure Description

[0022] Figure 1 This is a process flow diagram of the preparation of Xuanyu Tongjing granules according to the present invention; Figure 2 The study investigated the effect of Xuanyu Tongjing Granules on the immobility time of mice in the forced swimming experiment; compared with the model group, ** indicates p<0.01, *** indicates p<0.001; compared with the control group, # indicates p<0.05. Figure 3 The study investigated the effect of Xuanyu Tongjing Granules on the immobility time of mice in the tail suspension test; compared with the model group, ** indicates p < 0.01, *** indicates p < 0.001; compared with the control group, # indicates p < 0.05. Figure 4 The study investigated the effects of Xuanyu Tongjing Granules on the total distance and central distance of movement in mice during an open field experiment. * indicates p < 0.05, ** indicates p < 0.01 compared to the model group; ## indicates p < 0.01 compared to the control group. Figure 5 The effect of Xuanyu Tongjing Granules on the movement trajectory of mice in an open field experiment; Figure 6 These are the morphological observation results of the DG and CA1 regions of the hippocampus in each group of mice; scale bar = 200 μm; Figure 7This study investigated the effects of Xuanyu Tongjing Granules on the levels of various inflammatory factors in mouse serum. Compared with the model group, * indicates p<0.05, ** indicates p<0.01, and *** indicates p<0.001; compared with the control group, # indicates p<0.05, and ## indicates p<0.01. Figure 8 The study investigated the effects of Xuanyu Tongjing Granules on the levels of BDNF and TrkB, marker proteins of depression, in the hippocampus of mice. Compared with the model group, * indicates p<0.05, ** indicates p<0.01, and *** indicates p<0.001; compared with the control group, ### indicates p<0.001. Detailed Implementation

[0023] Example 1 A type of granule for treating depression, comprising the following components by weight: 10 parts white peony root, 10 parts angelica root, 10 parts peony bark, 6 parts stir-fried gardenia fruit, 5 parts stir-fried white mustard seed, 2 parts bupleurum root, 2 parts wine-processed cyperus rhizome, 2 parts vinegar-processed turmeric, 2 parts wine-processed scutellaria root, and 2 parts licorice root.

[0024] A method for preparing Xuanyu Tongjing granules for treating depression includes the following steps: (1) Preparation of medicinal materials: Clean white mustard seeds (remove impurities), stir-fry over low heat until light yellow to dark yellow and slightly spicy, to obtain stir-fried white mustard seeds; clean turmeric (remove impurities), moisten for 30 minutes, cut into 2-4 mm thin slices, dry, add rice vinegar, stir-fry over low heat until the color darkens and deepens, remove and cool to obtain vinegar turmeric; clean scutellaria (remove impurities), moisten the medicinal material for 30 minutes, cut into 1-2 mm thin slices, dry, add yellow wine, stir-fry over low heat until slightly yellow, to obtain wine scutellaria.

[0025] (2) Weigh out the following ingredients according to the formula dosage: white peony root, angelica root, peony bark, stir-fried gardenia fruit, stir-fried white mustard seed, bupleurum root, wine-processed cyperus rhizome, vinegar-processed turmeric, wine-processed scutellaria root, and licorice root. After washing, put them into an extraction tank, add 8 times the weight of water and decoct for 2 hours. Filter to obtain the first decoction. (3) Add 6 times the weight of water to the dregs and boil for 2 hours to obtain the second decoction; (4) Combine the first decoction and the second decoction, filter them, and then heat and concentrate them in a concentrator to a relative density of 1.2 (60°C) to obtain the extract; (5) Pack 2.00 kg of extract into each tray and vacuum dry it for 8 hours under vacuum conditions of -75 kPa and 60-65℃ until the moisture content is ≤3%. Then pulverize it into fine powder to obtain dry extract powder. (6) Add excipient solution to dry extract powder to obtain wet granules, then place them in a hot air circulating oven to dry until the moisture content is ≤5.0%, and pass them through a 10-mesh sieve and an 80-mesh sieve in sequence to obtain Xuanyu Tongjing granules for treating depression.

[0026] Example 2 A type of granule for treating depression, comprising the following components by weight: 12 parts white peony root, 12 parts angelica root, 12 parts peony bark, 8 parts stir-fried gardenia fruit, 6 parts stir-fried white mustard seed, 4 parts bupleurum root, 4 parts wine-processed cyperus rhizome, 4 parts vinegar-processed turmeric, 4 parts wine-processed scutellaria root, and 4 parts licorice root.

[0027] The preparation method of the above-mentioned Xuanyu Tongjing Granules for treating depression is the same as that in Example 1.

[0028] Example 3 A type of granule for treating depression, comprising the following components by weight: 15 parts white peony root, 15 parts angelica root, 15 parts peony bark, 10 parts stir-fried gardenia fruit, 8 parts stir-fried white mustard seed, 6 parts bupleurum root, 6 parts wine-processed cyperus rhizome, 6 parts vinegar-processed turmeric, 6 parts wine-processed scutellaria root, and 6 parts licorice root.

[0029] The preparation method of the above-mentioned Xuanyu Tongjing Granules for treating depression is the same as that in Example 1.

[0030] Application Example 1 An application of Xuanyu Tongjing granules for treating depression, wherein the dosage of Xuanyu Tongjing granules is 1.25 g crude drug / kg.

[0031] Experimental Example 1: Establishment of an Animal Depression Model (a) Laboratory animals SPF-grade C57BL / 6 mice, male, weighing 18-22 g, were purchased from the Nanhu Brain-Computer Interdisciplinary Research Institute (approval number: 202502281200) and housed in the SPF-grade laboratory of the Experimental Animal Center of the Nanhu Brain-Computer Interdisciplinary Research Institute. The relative temperature was 23±2°C, the relative humidity was 45-65%, and the animals were fed conventional feed with free access to food and water.

[0032] (II) Experimental Design 1. Animal grouping Sixty C57BL / 6 mice were randomly divided into six groups of 10 each: control group, model group, positive control group, low-dose group, medium-dose group, and high-dose group.

[0033] 2. Dosing regimen Mice were administered 10 mL / kg of fluoxetine hydrochloride (HCl) via gavage daily according to their assigned groups. The positive control group received 5 mg / kg of fluoxetine HCl (Flu 5 mg / kg); the low-dose group received 1.25 g / kg of Xuanyu Tongjing granules prepared in Example 1 (XY 1.25 g / kg); the medium-dose group received 2.5 g / kg of Xuanyu Tongjing granules prepared in Example 1 (XY 2.5 g / kg); and the high-dose group received 5 g / kg of Xuanyu Tongjing granules prepared in Example 2 (XY 5 g / kg). The control and model groups received the same volume of distilled water via gavage once daily for 14 consecutive days.

[0034] 3. Establishment of a depression model After 14 days of continuous administration, control mice were intraperitoneally injected with sterile saline on days 14-16 at a volume of 10 mL / kg (equivalent to a dose of 1 mg / kg), designated as Control. LPS was dissolved in sterile saline to a concentration of 0.1 mg / mL for later use. Mice in the model group, low-dose group, medium-dose group, high-dose group, and positive control group were intraperitoneally injected with 10 mL / kg (equivalent to a dose of 1 mg / kg) of LPS saline solution on days 14-16, designated as LPS 1 mg / kg, LPS+XY 1.25 g / kg, LPS+XY 2.5 g / kg, LPS+XY 5 g / kg, and LPS+XY Flu 5 mg / kg, respectively.

[0035] Experiment Example 2: Forced Swimming Test (FST) in Mice The forced swimming test can assess the level of behavioral despair in mice. Following the steps in Experiment Example 1, 0.5 h after the end of drug administration on day 16, the mice in the six groups were placed in a transparent bucket with a depth of 20 cm and a diameter of 40 cm at a water temperature of 25°C. The mice were allowed to acclimatize in the water for 2 minutes, and the duration of immobility during forced swimming was recorded within the next 4 minutes. The criterion for deemed immobility during forced swimming was: only the mouse's head floated on the surface, and the body remained motionless without struggling.

[0036] Experimental results are as follows Figure 2 As shown.

[0037] from Figure 2It can be seen that the immobility time of the model group mice during forced swimming was significantly increased compared with that of the control group. The longer the immobility time during forced swimming, the more depressed the mice were. It can be seen that the mice exhibited obvious despair behavior after modeling, indicating that the modeling was successful. Compared with the model group, the immobility time of the mice in the low-dose group, medium-dose group, high-dose group and positive drug group was significantly reduced, indicating that the Xuanyu Tongjing Granules of the present invention can significantly reduce the level of despair in the forced swimming experiment and have a good antidepressant effect.

[0038] Experiment Example 3: Mouse Tail Suspension Test (TST) TST was used to evaluate despair behavior in mice. After following the steps in Experiment Example 1, medical tape was used to attach the mice to the tails of the six groups of mice treated above, 1 cm from the tail tip, and they were suspended 15 cm from the table. The mice were allowed to pre-acclimatize for 2 minutes, and the immobility time of the mice was recorded within the next 4 minutes. Only when the mice were completely still was it considered behavioral despair.

[0039] Experimental results are as follows Figure 3 As shown.

[0040] from Figure 3 It was found that, compared with the control group, the tail suspension immobility time of mice in the model group was significantly increased, indicating that the mice exhibited obvious despair behavior after modeling, thus demonstrating successful modeling. Compared with the model group, the tail suspension immobility time of mice in the low-dose group, medium-dose group, high-dose group, and positive drug group all decreased to varying degrees, indicating that the Xuanyu Tongjing granules of this invention can significantly reduce the level of behavioral despair in mice during the tail suspension experiment, thereby alleviating depressive behavior in mice and exhibiting good antidepressant effects.

[0041] Experiment Example 4: Mouse Open Field Test (OFT) OFT is used to evaluate autonomous behavior, exploratory activities, and stress levels in laboratory animals in novel environments. Following the steps in Experiment Example 1, mice were placed in a 40×40 cm white square frame and allowed to acclimatize for 2 minutes. The total distance traveled and the central distance traveled were recorded after 4 minutes. The experimental results are as follows: Figure 4-5 As shown.

[0042] from Figure 4-5It was found that, in the open field experiment, compared with the control group, the model group mice had a shorter total distance traveled in the open field and a decreased distance traveled in the central area of ​​the open field, indicating that the anxiety level of the mice increased after modeling, and the modeling was successful. Compared with the model group, the total distance traveled in the open field and the distance traveled in the central area of ​​the open field were both increasing in the low-dose group, medium-dose group, high-dose group, and positive drug group, indicating that the Xuanyu Tongjing granules of the present invention played a role in improving the depressive behavior of mice, significantly reducing the anxiety level of mice in the open field experiment, and had a good antidepressant effect.

[0043] Results from the forced swimming test, tail suspension test, and open field test in mice showed that, based on a mouse model of depression, the Xuanyu Tongjing granules prepared in this invention significantly reduced the behavioral despair level in mice during the forced swimming test, improved the despair behavior in mice during the tail suspension test, and improved the anxiety level in mice during the open field test. This indicates that the Xuanyu Tongjing granules prepared in this invention can play an antidepressant, anti-anxiety, and mental state-improving role, and have a good antidepressant effect, and can be used to treat depression.

[0044] Experimental Example 5 After the experiment, serum was collected from mice in Examples 1-4 for biochemical analysis, and brain tissue was collected to observe hippocampal morphology and measure the levels of serum inflammatory factors and depression marker proteins in the hippocampus. The experimental results are shown below. Figure 6-8 .

[0045] Among them, the morphological observation of hippocampal tissue: hippocampal tissue fixed with 4% paraformaldehyde was routinely embedded in paraffin, dewaxed after 4μm sectioning, washed with water stepwise with graded ethanol, stained with hematoxylin-eosin (HE) solution, dehydrated, and mounted with neutral resin. The morphological changes of hippocampal cells were observed under a light microscope.

[0046] Detection of inflammatory factor levels in serum: The levels of inflammatory factors in serum were detected according to the method described in the ELISA kit instructions.

[0047] from Figure 6 It was observed that after HE staining of mouse hippocampal tissue, the control group of normal mice showed that hippocampal neurons were tightly and orderly arranged, without inflammatory cell infiltration or deep staining of shrunken nuclei. In the model group, the number of hippocampal neurons was reduced, their arrangement was disordered, and some neuronal nuclei showed condensation and spindle-shaped morphology, with deeper staining and slight hemorrhage. The low-dose, medium-dose, high-dose, and positive control groups showed significant improvement in hippocampal tissue lesions, with an increase in the number of neurons, a more orderly arrangement, and most neurons regaining normal morphology, clear staining, and intact cell structure. This indicates that the Xuanyu Tongjing granules prepared in this invention can reduce the disordered arrangement of hippocampal neurons and alleviate hippocampal damage.

[0048] from Figure 7 The results showed that, compared with the control group, the levels of inflammatory cytokines IL-6, IL-1β, and TNF-α in the serum of mice with LPS-induced depression were significantly increased, while the level of anti-inflammatory cytokine IL-10 was decreased. Compared with the model group, the levels of inflammatory cytokines IL-6, IL-1β, and TNF-α in the serum of mice in the low-dose group, medium-dose group, high-dose group, and positive drug group were significantly decreased, while the level of anti-inflammatory cytokine IL-10 was significantly increased. This indicates that the Xuanyu Tongjing Granules of the present invention can effectively alleviate the occurrence of neuroinflammation.

[0049] from Figure 8 It can be seen that, compared with the control group, the expression of depression marker proteins BDNF and TrkB in the hippocampus of mice in the model group was significantly reduced; compared with the model group, the expression of BDNF and TrkB proteins in the hippocampus of mice in the low-dose group, medium-dose group, high-dose group and positive drug group all showed an upward trend, indicating that the Xuanyu Tongjing Granules of the present invention can effectively promote the expression of depression marker proteins in the hippocampus of mice.

[0050] In summary, the Xuanyu Tongjing Granules of this invention can significantly improve depressive behavior in a mouse model of depression, alleviate neuroinflammation and hippocampal damage, and have a clear antidepressant effect.

Claims

1. A granule for treating depression, characterized in that: It includes the following components by weight: 10-15 parts white peony root, 10-15 parts angelica root, 10-15 parts peony bark, 6-10 parts stir-fried gardenia fruit, 5-8 parts stir-fried white mustard seed, 2-6 parts bupleurum root, 2-6 parts wine-processed cyperus rhizome, 2-6 parts vinegar-processed turmeric, 2-6 parts wine-processed scutellaria root, and 2-6 parts licorice root.

2. The Xuanyu Tongjing Granules for treating depression according to claim 1, characterized in that: The Xuanyu Tongjing Granules comprise the following components by weight: 10 parts white peony root, 10 parts angelica root, 10 parts peony bark, 6 parts stir-fried gardenia fruit, 5 parts stir-fried white mustard seed, 2 parts bupleurum root, 2 parts wine-processed cyperus rhizome, 2 parts vinegar-processed turmeric, 2 parts wine-processed scutellaria root, and 2 parts licorice root.

3. A method for preparing the Xuanyu Tongjing granules for treating depression as described in claim 1, characterized in that: Includes the following steps: (1) Weigh out the following ingredients according to the formula dosage: white peony root, angelica root, peony bark, stir-fried gardenia fruit, stir-fried white mustard seed, bupleurum root, wine-processed cyperus rhizome, vinegar-processed turmeric, wine-processed scutellaria root, and licorice root. After washing, put them into an extraction tank, add 8 times the mass of water and decoct for 2 hours. Filter to obtain the first decoction. (2) Add 6 times the weight of water to the dregs and boil for 2 hours to obtain the second decoction; (3) Combine the first decoction and the second decoction, filter them, and then heat and concentrate them using a concentrator to obtain an extract; (4) Vacuum dry the extract until the moisture content is ≤3%, then pulverize it into fine powder to obtain dry extract powder; (5) Add excipient solution to dry extract powder to obtain wet granules, then dry them until the moisture content is ≤5.0%, and pass them through a 10-mesh sieve and an 80-mesh sieve in sequence to obtain Xuanyu Tongjing granules for treating depression.

4. The method for preparing the Xuanyu Tongjing granules for treating depression according to claim 3, characterized in that: In step (2), the relative density of the extract is 1.20-1.

25.

5. The application of the Xuanyu Tongjing granules for treating depression as described in claim 1, characterized in that: This Xuanyu Tongjing Granules can be used to treat depression.

6. The application of the Xuanyu Tongjing Granules for treating depression according to claim 5, characterized in that: The dosage of Xuanyu Tongjing Granules is 1.25-5 g of raw medicinal material / kg.