Traditional Chinese medicine composition capable of effectively treating or improving depression as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating or improving depression as well as a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from fructus aurantii, fructus gardeniae, fermented soybean, ginseng, rhizoma atractylodis macrocephalae, scorched hawthorn fruit and semen cuscutae. According to the traditional Chinese medicine composition, heat clearing, restlessness relieving, spleen tonifying, qi replenishing and liver and kidney simultaneous treatment are taken as syndrome differentiation basis, all the medicines of the traditional Chinese medicine composition are combined to achieve the effects of soothing liver-qi stagnation, tonifying liver and kidney, clearing heat, relieving restlessness, tonifying qi, invigorating spleen, dredging meridians and collaterals and warming kidney yang, so that liver fire can be cleared, liver depression can be relieved, spleen and kidney can be replenished, qi activity can be smooth, and depression syndrome can be eliminated. The traditional Chinese medicine composition provided by the invention has a remarkable improvement effect on depression-like behaviors of mice with depression, not only takes effect quickly, but also has a remarkable anti-depression effect and a stable drug effect, and provides a new thought for treating depression with traditional Chinese medicine.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and particularly to a traditional Chinese medicine composition that can effectively treat or improve depression. Background Art

[0002] Depression is a common mental and emotional disorder disease, with a significant and persistent low mood as the core symptom, often accompanied by typical symptoms such as reduced interest, anhedonia, slow thinking and action, etc., and is characterized by high prevalence and high recurrence rate. Survey data from the World Health Organization (WHO) shows that more than 450 million people globally suffer from depression, which has become a serious public social problem. The treatment of depression mainly includes drug treatment, psychotherapy, physical therapy, etc. Currently, the commonly used drugs for treating depression in clinical practice are mainly divided into tricyclics, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors, atypical and other antidepressants, but there are still about 1 / 3 of patients who show ineffectiveness to the drugs, or have disadvantages such as slow onset, easy development of drug resistance, and high recurrence rate. Therefore, it is particularly important to find drugs that can treat or improve depression.

[0003] Traditional Chinese medicine believes that depression is an emotional disorder disease, and the occurrence of depression is closely related to factors such as stagnation of liver qi, dysfunction of the spleen in transportation, and insufficiency of nourishment of the heart. Analyzing the above symptoms from this perspective, negative emotions such as low mood and loss of interest belong to the category of sorrow among the seven emotions in traditional Chinese medicine. Sorrow is an emotional experience of anticipating or going through something unpleasant and being immersed in a bad mood of worry and melancholy. "The Plain Questions of Huangdi Neijing" states: "The spleen is the foundation of the four zang-organs, and the will is mainly related to sorrow. Therefore, when the heart is affected, it shows sorrow, which is the sorrow of the will; or when the lung is affected, it shows sorrow, which is also the sorrow of the will... Therefore, it can be said that sorrow is related to the spleen." As can be seen from the above, whether it is sorrow affecting the lung or overthinking affecting the spleen, it will lead to qi stagnation, and qi stagnation is precisely the pathological basis of "depression syndrome" in traditional Chinese medicine. Traditional Chinese medicine believes that anger injures the liver, and when the liver fails to disperse and dredge, it leads to the transformation of liver qi into fire; the "fire stagnation" of the liver and gallbladder results in the stagnation of heat in the liver and gallbladder; when the son affects the mother, liver depression leads to kidney deficiency, the obstruction of yang qi, and then the deficiency of kidney yang and insufficiency of kidney essence. The liver insults the spleen and stomach, resulting in the disorder of the middle jiao in rotation, or qi stagnation, the obstruction of yang qi and failure to disperse, or weakness of the spleen and failure to transport, resulting in insufficient source of qi transformation, all of which can lead to the deficiency of qi and blood in the heart and spleen. In recent years, more and more studies have shown that traditional Chinese medicine prescriptions can achieve the purpose of treating diseases by regulating the balance of yin and yang and the functions of zang-fu organs in the human body. Due to its characteristics such as multiple pathways, multiple targets, and small side effects, it has significant effects in improving depression and enhancing the quality of life of patients. Currently, the traditional Chinese medicine used in clinical practice for treating depression mostly starts from "soothing the liver and clearing liver fire" to achieve the effect of "relieving depression". Summary of the Invention

[0004] Object of the Invention: In order to better prevent and treat depression, the object of the present invention is to provide a safe, effective and excellent therapeutic traditional Chinese medicine composition for treating or improving depression. Another object of the present invention is to provide its preparation method.

[0005] Technical solution: To achieve the above object, the present invention is realized through the following technical solutions: A traditional Chinese medicine composition that can effectively treat or improve depression, the traditional Chinese medicine composition comprising the following raw materials: Fructus Aurantii, Gardenia jasminoides Ellis, Semen Sojae Preparatum, Ginseng, Rhizoma Atractylodis Macrocephalae, Fructus Crataegi Praeparatus, Cuscuta chinensis Lam.

[0006] As a preferred embodiment, for the above-mentioned traditional Chinese medicine composition that can effectively treat or improve depression, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 1-20 parts of Fructus Aurantii, 5-25 parts of Gardenia jasminoides Ellis, 1-10 parts of Semen Sojae Preparatum, 1-10 parts of Ginseng, 1-20 parts of Rhizoma Atractylodis Macrocephalae, 1-20 parts of Fructus Crataegi Praeparatus, 5-25 parts of Cuscuta chinensis Lam.

[0007] As a further preferred embodiment, the above-mentioned traditional Chinese medicine composition is made from the following raw materials in parts by weight: 5-15 parts of Fructus Aurantii, 10-20 parts of Gardenia jasminoides Ellis, 5-10 parts of Semen Sojae Preparatum, 5-10 parts of Ginseng, 5-15 parts of Rhizoma Atractylodis Macrocephalae, 5-15 parts of Fructus Crataegi Praeparatus, 10-20 parts of Cuscuta chinensis Lam.

[0008] As a particularly preferred embodiment, the above-mentioned traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10 parts of Fructus Aurantii, 12 parts of Gardenia jasminoides Ellis, 6 parts of Semen Sojae Preparatum, 6 parts of Ginseng, 10 parts of Rhizoma Atractylodis Macrocephalae, 10 parts of Fructus Crataegi Praeparatus, 12 parts of Cuscuta chinensis Lam.

[0009] The preparation method of the traditional Chinese medicine composition of the present invention comprises the following steps: Weigh Fructus Aurantii, Gardenia jasminoides Ellis, Semen Sojae Preparatum, Ginseng, Rhizoma Atractylodis Macrocephalae, Fructus Crataegi Praeparatus, Cuscuta chinensis Lam. according to the parts by weight and set aside; Mix the weighed medicinal materials, decoct with water, collect the decoction, and concentrate to obtain.

[0010] As a preferred embodiment, the above-mentioned preparation method comprises the following steps: add water equivalent to 6-15 times the total amount of the medicinal materials to the mixed medicinal materials, decoct 1-3 times, each time for 1.0-2 h, combine the decoctions, filter, and concentrate to obtain.

[0011] As a more preferred embodiment, the above-mentioned preparation method comprises the following steps: add water equivalent to 6-10 times the total amount of the medicinal materials to the mixed medicinal materials, decoct 2-3 times, each time for 1.0-1.5 h, combine the decoctions, filter, and concentrate to obtain.

[0012] The application of the traditional Chinese medicine composition provided by the present invention in the preparation of drugs for treating or improving depression, the traditional Chinese medicine composition is formulated into granules, powders, oral liquids, pills, decoctions or other pharmaceutically acceptable oral dosage forms according to the conventional pharmaceutical methods in pharmacy, in combination with pharmaceutically acceptable excipients.

[0013] Based on the pathogenesis characteristics of depression and in accordance with traditional Chinese medicine theory and clinical experience, this invention selects medicinal flavors to form a prescription using the traditional Chinese medicine theory of syndrome differentiation and treatment. The unique prescription analysis rule of this invention is as follows: Fructus Aurantii: Bitter, pungent, sour, slightly cold; attributive to the spleen and stomach meridians; having the effects of regulating qi and relieving distension, promoting qi movement and relieving flatulence, capable of dredging qi mechanism and alleviating the qi stagnation manifestation in depressive symptoms; mainly used for chest and hypochondrium qi stagnation, distending pain, indigestion, retention of phlegm-fluid, and visceral ptosis; it mainly contains various components such as flavonoids, volatile oils, alkaloids, and coumarins; modern pharmacological studies have shown that Fructus Aurantii has various pharmacological activities such as analgesia and anti-gastric ulcer.

[0014] Fructus Gardeniae: Bitter and cold in nature; attributive to the heart, lung, and triple energizer meridians; having the effects of purging fire and relieving restlessness, clearing heat and promoting diuresis, cooling blood and detoxifying, capable of clearing heart fire and improving depressive symptoms such as restlessness and insomnia; mainly used for febrile disease with restlessness, damp-heat jaundice, stranguria with pain, hematemesis and epistaxis due to blood heat, red and swollen eyes, and pyogenic infections; externally used for sprains and contusions; Fructus Gardeniae contains various active chemical substances such as volatile oils, flavonoids, and iridoid glycosides. Modern pharmacological studies have shown that it has pharmacological effects such as protecting the liver and gallbladder, antibacterial and anti-inflammatory, antioxidant, sedative, anti-convulsive, and anti-tumor.

[0015] Semen Sojae Preparatum: Cool in nature, bitter and pungent in taste; attributive to the lung and stomach meridians; its main effects are inducing sweating to relieve exterior syndrome, dispelling vexation, and diffusing stagnated heat, capable of dispersing exogenous pathogenic factors and promoting qi movement, helping to relieve the emotional discomfort in depressive symptoms. Mainly used for cold, aversion to cold and headache, restlessness and chest distress, and vexation and insomnia. It contains various active ingredients such as isoflavones and amino acids; modern pharmacological studies have shown that Semen Sojae Preparatum has pharmacological effects such as sedation, anti-anxiety, anti-inflammatory, antioxidant, and regulating blood lipid.

[0016] Ginseng: Sweet and slightly bitter in taste, slightly warm in nature; attributive to the spleen, lung, heart, and kidney meridians; having the effects of greatly tonifying primordial qi, restoring pulse and arresting collapse, invigorating the spleen and benefiting the lung, promoting fluid production and nourishing blood, calming the mind and improving intelligence, capable of tonifying the qi of the heart and spleen and improving the qi deficiency and weakness, listlessness in depressive symptoms; mainly used for deficiency of vital energy with tendency to collapse, cold limbs and feeble pulse, anorexia due to spleen deficiency, cough and asthma due to lung deficiency, internal heat and thirst, deficiency of qi and blood, impotence and cold uterus; Ginseng contains active ingredients such as ginsenosides, volatile oils, polysaccharides, amino acids, and various trace elements; modern pharmacological studies have shown that it has pharmacological activities such as antioxidant, anti-inflammatory, protecting the liver, improving intelligence, lowering blood sugar, and regulating immunity.

[0017] Atractylodes Macrocephala: Bitter and sweet in taste, warm in nature; attributive to the spleen and stomach meridians; having the functions of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and preventing miscarriage, capable of strengthening the spleen and drying dampness, enhancing the function of the spleen and stomach, and helping to ensure the sufficiency of the source of qi and blood production; can be used for anorexia due to spleen deficiency, abdominal distension and diarrhea, dizziness and palpitation due to retention of phlegm-fluid, edema, spontaneous sweating, and threatened abortion. It mainly contains chemical components such as volatile oils, terpenoids, flavonoids, polysaccharides, and amino acids; modern pharmacological studies have shown that Atractylodes Macrocephala has pharmacological effects such as anti-inflammatory, regulating the gastrointestinal tract, lowering blood sugar, and immune regulation.

[0018] Fried Hawthorn Fruit: Sour and sweet in taste, slightly warm in nature; attributive to the spleen, stomach and liver meridians; having the effects of promoting digestion and strengthening the stomach, promoting qi circulation to disperse stasis, and resolving turbidity to reduce lipid, capable of promoting digestion and guiding stagnation, and improving indigestion manifestations such as loss of appetite and abdominal distension in depressive symptoms; mainly used for food retention, fullness in the epigastric region, diarrhea and abdominal pain, stabbing pain in the heart and abdomen, chest impediment pain, and hernia pain; it contains various components such as flavonoids, triterpenoids, organic acids, and sugars; modern pharmacological research shows that fried hawthorn fruit has pharmacological activities such as promoting digestion, antioxidation, anti-cancer, reducing blood sugar, blood pressure, and blood lipid.

[0019] Cuscuta Chinensis: Pungent and sweet in taste, neutral in nature; attributive to the liver, kidney and spleen meridians; having the effects of tonifying the liver and kidney, astringing essence and reducing urination, preventing miscarriage, improving eyesight, and stopping diarrhea, capable of tonifying the kidney and replenishing essence, filling the essence in the kidney, and helping to improve the kidney deficiency manifestations in depressive symptoms; mainly used for liver and kidney deficiency, soreness and weakness of the waist and knees, impotence and spermatorrhea, enuresis and frequent urination, threatened abortion due to kidney deficiency, fetal movement restlessness, blurred vision and tinnitus, spleen and kidney deficiency diarrhea, and externally can be used to treat vitiligo; the main active components in cuscuta chinensis include flavonoids, polysaccharides, phenolic acids, alkaloids, fatty acids, etc.; modern pharmacological research shows that it has pharmacological effects such as anti-aging, immune regulation, liver protection, blood sugar reduction, and regulation of reproductive endocrine hormone levels.

[0020] The traditional Chinese medicine composition provided by the present invention is prepared by taking "clearing away heat and relieving vexation, tonifying the spleen and replenishing qi, treating the liver and kidney simultaneously" as the starting point, combining Zhizi Chi Decoction in Treatise on Febrile Diseases and the basic formula for tonifying qi and strengthening the spleen, Sijunzi Decoction, removing Poria and roasted Glycyrrhiza, and adding Fructus Aurantii Immaturus, Cuscuta Chinensis, and Fried Hawthorn Fruit with modifications. The liver is in charge of dredging and dispersing. Anger and depression can damage the liver. When the liver fails to dredge and disperse smoothly, it is easy to transform into liver fire. Liver fire has the nature of aggregation and latent stagnation, and should be dispersed and promoted in accordance with the upward-flaming tendency of fire. Adding Fructus Aurantii Immaturus can regulate qi and relieve fullness in the middle energizer, fried hawthorn fruit can strengthen the spleen and guide stagnation, and cuscuta chinensis can tonify the kidney and nourish the liver, making the effects of soothing the liver and relieving depression, strengthening the spleen and tonifying the kidney more prominent. Therefore, it is particularly suitable for those with liver depression and spleen deficiency, and kidney essence deficiency in depression.

[0021] The traditional Chinese medicine composition provided by the present invention is made from seven medicinal materials, namely, Fructus Aurantii, Fructus Gardeniae, Semen Sojae Praeparatum, Radix Ginseng, Rhizoma Atractylodis Macrocephalae, Fructus Crataegi Praeparatus, and Semen Cuscutae. In the formula, Fructus Gardeniae is bitter and cold, and belongs to the heart, lung, and triple energizer meridians. Its main function is to purge fire and relieve vexation. Because of its light nature and upward floating property, it has the effect of clearing heat and promoting qi movement while purging fire, and is the first choice for those with vexation caused by fire stagnation. Semen Cuscutae nourishes the kidney and liver, mainly used for treating fractures, tonifying deficiencies, and boosting qi and strength. It is an important medicinal herb for tonifying the kidney, spleen, and liver meridians. The combination of the two promotes each other, clearing heat and relieving vexation while tonifying the liver and kidney, with the property of promoting qi movement while tonifying the middle-jiao, so that fire stagnation can be resolved, the liver and kidney can be tonified, and depression syndrome can be eliminated. They are used as the monarch drugs together. Semen Sojae Praeparatum is pungent, dispersing, light, and floating, with the effect of dispersing exogenous pathogens. It is slightly bitter and cold, can disperse pathogenic heat, and also has the function of relieving vexation. Together with Rhizoma Atractylodis Macrocephalae for tonifying qi and strengthening the spleen, drying dampness and promoting diuresis, and Fructus Aurantii for regulating qi, widening the middle-jiao, promoting qi movement, and dissipating stagnation, the combination of the three can not only dispel stasis and obstruction, but also prevent the tonifying herbs from causing stagnation. It can regulate both the liver and spleen, dredge the meridians, and warm the kidney yang, and they are used as the minister drugs together. The combination of Radix Ginseng and Fructus Crataegi Praeparatus is used as the assistant. Radix Ginseng tonifies the qi of the heart and spleen, and also has the function of calming the mind and enhancing intelligence. Fructus Crataegi Praeparatus is sour and sweet in taste, slightly warm and not hot, and is good at promoting the spleen and stomach function. It also benefits the liver when entering the liver meridian. All the above medicinal herbs are used in combination with cold and hot properties, jointly exerting the functions of clearing and dispersing vexation, soothing the liver and relieving depression, strengthening the spleen and tonifying the kidney.

[0022] The traditional Chinese medicine composition provided by the present invention has a scientific and reasonable proportion of each medicinal ingredient, is safe, effective, non-toxic and has no side effects. It can avoid the toxic and side effects caused by the use of large doses of western medicine. At the same time, compared with the basic prescriptions of Zhizi Chitang Decoction and Sijunzi Decoction, the traditional Chinese medicine composition provided by the present invention has a better therapeutic effect on depression with the syndrome types of liver depression and spleen deficiency, and kidney essence deficiency.

[0023] In addition, the results of animal experiments of the present invention show that the traditional Chinese medicine composition of the present invention has a significant improvement effect on the depressive-like behaviors of depressive mice.

[0024] To facilitate the public's better understanding of the present invention, the following will detail this description through the accompanying drawings and specific embodiments, but it should not be construed as a limitation of the present invention. Unless otherwise specified, the technical means used in the following embodiments are conventional means well-known to those skilled in the art. The materials, reagents, etc. used in the following embodiments, unless otherwise specified, can be obtained from commercial channels. Description of the Drawings

[0025] Figure 1 It is a result diagram of the sucrose preference test. Compared with the blank group, #P < 0.05, ##P < 0.01; compared with the model group, *P < 0.05, **P < 0.01.

[0026] Figure 2 It is a result diagram of the forced swimming test. Compared with the blank group, #P < 0.05, ##P < 0.01; compared with the model group, *P < 0.05, **P < 0.01.

[0027] Figure 3Result graph of the social interaction test. Compared with the blank group, #P<0.05, ##P<0.01; compared with the model group, *P<0.05, **P<0.01.

[0028] Figure 4 Result graph of the time of the mice in the interaction area during the social interaction test. Compared with the blank group, #P<0.05, ##P<0.01; compared with the model group, *P<0.05, **P<0.01. Detailed implementation method

[0029] Example 1 1. A traditional Chinese medicine composition capable of effectively treating or improving depression, which is made from the following raw materials by weight: Fructus Aurantii 10g, Gardenia jasminoides Ellis 12g, Semen Sojae Praeparatum 6g, Ginseng 6g, Rhizoma Atractylodis Macrocephalae 10g, Fructus Crataegi 10g, Cuscuta chinensis Lam. 12g.

[0030] 2. The traditional Chinese medicine composition is prepared by the following method: Weigh Fructus Aurantii 10g, Gardenia jasminoides Ellis 12g, Semen Sojae Praeparatum 6g, Ginseng 6g, Rhizoma Atractylodis Macrocephalae 10g, Fructus Crataegi 10g, Cuscuta chinensis Lam. 12g by weight, mix the medicinal materials, add water equivalent to 8 times the total weight of the medicinal materials for the first time and decoct for 1.5 hours, filter, collect the first decoction liquid, add water equivalent to 6 times the total weight of the medicinal materials to the filter residue and decoct for 1.5 hours, filter, collect the second decoction liquid, combine the two decoction liquids, and concentrate to obtain.

[0031] Example 2

[0032] 1. A traditional Chinese medicine composition capable of effectively treating or improving depression, which is made from the following raw materials by weight: Fructus Aurantii 8g, Gardenia jasminoides Ellis 10g, Semen Sojae Praeparatum 10g, Ginseng 9g, Rhizoma Atractylodis Macrocephalae 9g, Fructus Crataegi 8g, Cuscuta chinensis Lam. 10g.

[0033] 2. The traditional Chinese medicine composition is prepared by the following method: Weigh Fructus Aurantii 8g, Gardenia jasminoides Ellis 10g, Semen Sojae Praeparatum 10g, Ginseng 9g, Rhizoma Atractylodis Macrocephalae 9g, Fructus Crataegi 8g, Cuscuta chinensis Lam. 10g by weight, mix the medicinal materials, add water equivalent to 10 times the total weight of the medicinal materials for the first time and decoct for 2 hours, filter, collect the first decoction liquid, add water equivalent to 8 times the total weight of the medicinal materials to the filter residue and decoct for 1 hour, filter, collect the second decoction liquid, combine the two decoction liquids, and concentrate to obtain.

[0034] Example 3

[0035] 1. A traditional Chinese medicine composition capable of effectively treating or improving depression, which is made from the following raw materials by weight: 12 g of Fructus Aurantii, 15 g of Gardenia jasminoides Ellis, 10 g of Semen Sojae Preparatum, 10 g of Radix Ginseng, 10 g of Rhizoma Atractylodis Macrocephalae, 6 g of Fructus Crataegi Praeparata, 15 g of Semen Cuscutae.

[0036] 2. The traditional Chinese medicine composition is prepared by the following method: Weigh 12 g of Fructus Aurantii, 15 g of Gardenia jasminoides Ellis, 10 g of Semen Sojae Preparatum, 10 g of Radix Ginseng, 10 g of Rhizoma Atractylodis Macrocephalae, 6 g of Fructus Crataegi Praeparata, and 15 g of Semen Cuscutae by weight. Mix the medicinal materials, add water equivalent to 10 times the total amount of the medicinal materials for the first time and decoct for 2 hours, filter, and collect the first decoction. Add water equivalent to 8 times the total amount of the medicinal materials to the residue and decoct for 1.5 hours, filter, and collect the second decoction. Add water equivalent to 6 times the total amount of the medicinal materials to the residue and decoct for 1 hour, filter, and collect the third decoction. Combine the three decoctions and concentrate to obtain the product.

[0037] Experimental Example 4 Observation of Pharmacodynamic Experiments 1. Experimental Animals and Their Grouping 60 adult male ICR mice, aged 6 - 8 weeks, with a body weight of 18 - 22 g. The animals were housed in an SPF - level animal room throughout the experiment. The temperature of the animal room was maintained at 22 ± 2°C, and the humidity was controlled at 50% ± 10%. One week before the experiment, the animals were normally fed and adapted, and all animals had free access to food and water. The experiment was carried out with the approval of the Animal Experiment Ethics Committee. The 60 adult male ICR mice were divided into a blank group, a model group, a low - dose group of the traditional Chinese medicine composition extract, a medium - dose group, a high - dose group, and a positive drug group, with 10 mice in each group, and the grouping was random.

[0038] 2. Establishment of a Chronic Stress - Induced Depression Model To establish a chronic stress model, which simulates the disease state of depression patients under long - term stress in animals and can be used for the screening of antidepressant drugs and experimental research on the pathophysiological mechanisms of depression. The types of stress that mice received were as follows: water deprivation for 24 hours, food deprivation for 24 hours, 12 - hour circadian rhythm inversion, 1 - hour noise exposure, 18 - hour tilting of the mouse cage at 45 degrees, and 24 - hour wet cage. The stress cycle was 4 weeks. During this period, the blank mice did not receive any stress and were normally fed and had free access to water. At the end of the model establishment, the mice were randomly assigned to the blank group, the model group, the low - dose group, the medium - dose group, the high - dose group, and the positive drug group for further drug administration and behavioral detection.

[0039] 3. Test Drugs, Administration Methods, and Dosages Blank group: Given 0.9% normal saline, and administered by gavage according to 0.1 ml / 10 g of the mouse body weight.

[0040] Model group: Given 0.9% normal saline, and administered by gavage according to 0.1 m1 / 10 g of the mouse body weight.

[0041] Low-dose group: The traditional Chinese medicine composition extract prepared by the method of Example 1 above was diluted to a crude drug amount of 3.25 g / kg, and intragastric administration was performed according to 0.1 ml / 10 g of the mouse body weight.

[0042] Medium-dose group: The traditional Chinese medicine composition extract prepared by the method of Example 1 above was diluted to a crude drug amount of 6.5 g / kg, and intragastric administration was performed according to 0.1 ml / 10 g of the mouse body weight.

[0043] High-dose group: The traditional Chinese medicine composition extract prepared by the method of Example 1 above was diluted to a crude drug amount of 13 g / kg, and intragastric administration was performed according to 0.1 ml / 10 g of the mouse body weight.

[0044] Positive drug group: Fluoxetine, and intragastric administration was performed according to 0.1 ml / 10 g of the mouse body weight.

[0045] Each of the above groups had 10 animals, and intragastric administration was continuously performed for 3 weeks. After the last administration, the depressive-like behaviors of the mice in each group were evaluated by the sucrose preference test, forced swimming test, and social interaction test.

[0046] 4. Behavioral tests 4.1 Sucrose preference test (SPT) The sucrose preference test (SPT), as a classic behavioral detection method, is widely used to evaluate whether there is anhedonia, a core symptom of depression, in rodents (such as mice). This experiment is based on the natural preference of animals for sweetness. By comparing the consumption of sucrose solution and pure water by animals after fasting, the change in their hedonic experience is quantified. Before the experiment, 1% sucrose solution needs to be prepared. On the first day at 09:00, the sucrose solution and drinking water were given for sucrose adaptation, and the positions were exchanged after 6 h. After the sucrose adaptation was completed, the animals were deprived of water and food for 12 h. On the second day at the same time, 1% sucrose solution and drinking water with pre-weighed weights were given, and the water bottle positions were exchanged after 6 h. After 12 h, the water bottles were collected and weighed, and the intake ratio of the sucrose solution and drinking water was calculated (sucrose preference rate = sucrose consumption / (sucrose + pure water consumption) × 100%) to evaluate the preference degree of the mice for the sucrose solution.

[0047] 4.2 Forced swimming test (FST) The Forced Swimming Test (FST) is a behavioral despair experimental method. By placing animals in a restricted environment (such as water), the animals struggle desperately to escape but are unable to do so. After a period of time, the animals exhibit a typical "immobile state". Observing and recording a series of parameters during the process of the experimental animals showing despair immobile state can be used to evaluate the efficacy of drugs. Mice were separately placed into a transparent glass tank filled with tap water at 25 °C and forced to swim for 6 minutes. The activities of the mice within 6 minutes were recorded by video. The activities of the mice in the last 4 minutes were selected to calculate the duration of continuous immobility.

[0048] 4.3 Social interaction test The Social interaction test is commonly used to evaluate the changes in social behavior of mice with depressive-like symptoms and the effects of antidepressant drugs. First, a test mouse was placed into an empty test box, its movement was tracked, and the duration of its stay in the interaction area was recorded. After 2.5 minutes, an ICR mouse was placed into the wire cage, and the time it stayed in the interaction area for another 2.5 minutes was continuously tracked and recorded. The time the mouse stayed in the interaction area in the first and second stages was analyzed. The formula for calculating the social interaction ratio is: Social interaction ratio = Target time (time stayed in the interaction area in the second stage) / No target time (time stayed in the interaction area in the first stage). The analysis was carried out according to the social interaction ratio as follows: Mice with a social interaction ratio < 1 were defined as having social avoidance behavior, and vice versa as having normal social interaction.

[0049] 5. Statistical methods SPSS 26.0 statistical software was used for data processing. Measurement data conforming to a normal distribution were expressed as mean ± standard deviation (`x±s), and one-way analysis of variance was used for comparison between groups. P < 0.05 was considered statistically significant, and P < 0.01 was considered extremely significant.

[0050] 6. Experimental results As attached Figures 1-4 shown, compared with the blank control group, after 4 weeks of stress, the sucrose preference rate of the mice in the model group decreased extremely significantly (P < 0.01), the time of the mice in the Target of the interaction area decreased significantly (P < 0.01), the social interaction ratio < 1, which could be defined as having social avoidance behavior, and the immobile time of forced swimming increased significantly (P < 0.01). This result indicated that the model was successfully established.

[0051] Compared with the model group, the sucrose preference rates of mice in each administration group were significantly increased (P<0.05 or P<0.01). Among them, the experimental results of the high-dose group and the medium-dose group of the traditional Chinese medicine composition were similar to those of the positive control group, and both extremely significantly increased the sucrose preference rate (P<0.01). Compared with the model group, the positive control group, the low-dose group, the medium-dose group and the high-dose group of the traditional Chinese medicine composition all significantly reduced the immobility time of depressed mice in the forced swimming test (P<0.05 or P<0.01). In the social interaction test, the time of the medium-dose group of the traditional Chinese medicine composition in the interaction area was significantly increased (P<0.05), and the positive drug group and the high-dose group of the traditional Chinese medicine composition were both extremely significantly increased (P<0.01). Moreover, the social interaction rates of the mice in these three groups were all greater than 1, which could be defined as normal social interaction. However, there was no significant difference in the time in the interaction area and the social interaction rate between the low-dose group of the traditional Chinese medicine composition and the model group.

[0052] Based on the above results, the traditional Chinese medicine composition of the present invention can significantly improve the depressive behavior of depressed mice. In the sucrose preference test, the sucrose preference rate of depressed mice increased significantly after administration, indicating that the positive drug and the traditional Chinese medicine composition can relieve anhedonia caused by depression. In the forced swimming test, the mice in each group modeled by CUMS showed a significant prolongation of the immobility time; while the immobility time of the mice after administration was significantly reduced, indicating that the resistance of depressed mice to the non-ideal environment decreased, and the positive drug and the traditional Chinese medicine composition can both improve the despair and lethargy state of mice. In the social interaction test, the time and social interaction rate of depressed mice in the interaction area were significantly reduced, showing social avoidance behavior. The medium-dose and high-dose of the traditional Chinese medicine composition can both improve this phenomenon.

[0053] The above are only the preferred embodiments of the present invention. It should be understood that the present invention is not limited to the form disclosed herein, and should not be regarded as excluding other embodiments, but can be used in various other combinations, modifications and environments, and can be changed within the scope of the concept described herein through the above teachings or the technology or knowledge in related fields. And the changes and modifications made by those skilled in the art without departing from the spirit and scope of the present invention should fall within the protection scope of the appended claims of the present invention.

Claims

1. A Chinese medicine composition that can effectively treat or improve depression, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials: fructus aurantii, gardenia, light black beans, ginseng, atractylodes macrocephala, charred hawthorn and dodder seed.

2. A Chinese medicine composition for effectively treating or improving depression according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 1-20 parts of Citrus aurantium, 5-25 parts of Gardenia jasminoides, 1-10 parts of Fructus sojae, 1-10 parts of Ginseng, 1-20 parts of Atractylodes macrocephala, 1-20 parts of Crataegus pinnatifida and 5-25 parts of Cuscuta australis.

3. A Chinese medicine composition for effectively treating or improving depression according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 5-15 parts of Citrus aurantium, 10-20 parts of Gardenia jasminoides, 5-10 parts of Fructus sojae, 5-10 parts of Ginseng, 5-15 parts of Atractylodes macrocephala, 5-15 parts of Crataegus pinnatifida, and 10-20 parts of Cuscuta australis.

4. A Chinese medicine composition for effectively treating or improving depression according to claim 3, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 parts of Citrus aurantium, 12 parts of Gardenia jasminoides, 6 parts of Fructus sojae, 6 parts of Ginseng, 10 parts of Atractylodes macrocephala, 10 parts of Crataegus pinnatifida, and 12 parts of Cuscuta australis.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The following steps are involved: Weigh Fructus Aurantii Immaturus, Fructus Gardeniae, Fructus Sojae Indici, Ginseng, Atractylodes Macrocephalae, Fructus Crataegi, and Fructus Cuscutae according to weight and set aside; Mix the weighed medicinal materials, add water and boil them, collect the decoction and concentrate it to obtain the product.

6. The preparation method according to claim 5, characterized in that: The following steps are involved: Add water in an amount equivalent to 6-15 times the total amount of the medicinal materials to the mixed medicinal materials, decoct for 1-3 times, each time for 1.0-2 hours, combine the decoctions, filter, and concentrate to obtain the product.

7. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for treating depression.

8. The use according to claim 7, characterized in that: The depression is a depression of the liver depression, spleen deficiency and kidney essence deficiency syndrome type.

9. The use according to claim 7 or 8, characterized in that: The extract of the Chinese medicine composition is prepared into Chinese medicine preparations such as decoctions, granules, powders, oral liquids, pills, capsules and tablets according to conventional pharmaceutical methods in pharmacy, together with pharmaceutically acceptable excipients.

10. Use of the Chinese medicine composition according to any one of claims 1 to 4 in combination with other antidepressants in the preparation of a medicine for treating depression.

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