A traditional Chinese medicine composition for treating depression and application thereof

Abstract

The application provides a traditional Chinese medicine composition for treating depression and application thereof, and relates to the technical field of traditional Chinese medicine pharmacy; the traditional Chinese medicine composition is composed of ten traditional Chinese medicines, namely, flowers of Chinese sweet gum, white daphne, cyperus rotundus, lycium ruthenicifolium, citrus medica, seven mile incense, saussurea lappa, zanthoxylum arms, radix zanthoxyli and lignum aquilariae resiniferum, and the combined use of the medicines has the effects of soothing liver and relieving depression and regulating and smoothing qi movement; the traditional Chinese medicine composition can improve the depressive behavior of a mouse with depression, significantly reduces the levels of inflammatory related factors IL-6, IL-1beta and TNF-alpha in serum of a mouse model with depression, and obviously improves the levels of monamine neurotransmitters 5-HT, DA and NE of the mouse; the traditional Chinese medicine composition can significantly reduce the HAMD score, PSQI score and TCM syndrome integral of a patient with depression, has a high total effective rate for treating depression, and provides a traditional Chinese medicine composition with remarkable effect and no toxic side effect for treating depression.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine pharmaceutical technology, specifically to a traditional Chinese medicine composition for treating depression and its application. Background Technology

[0002] Depression, also known as depressive disorder, is a common affective mental illness characterized by low mood, loss of interest, slowed thinking, and weakened willpower. It has become a significant burden on global public health. Western medicine's treatment of depression is based on hypothalamic-pituitary-adrenal axis dysfunction, the neuroplasticity hypothesis, and monoamine neurotransmitters, but the specific mechanisms of action remain unclear. Currently, there is no specific treatment in clinical practice. Treatment typically involves a combination of monoamine oxidase inhibitors, tricyclic antidepressants, and selective serotonin reuptake inhibitors (SSRIs) with psychotherapy. While these treatments can achieve good short-term results, long-term use can lead to adverse reactions such as dizziness, nausea, vomiting, weight gain, and sexual dysfunction.

[0003] Traditional Chinese medicine (TCM) does not have a specific disease name for depression. Based on clinical symptoms, it can be categorized under terms such as "depression," "anxiety," and "restlessness." The disease is often located in the heart, liver, and spleen, and clinical findings suggest it is frequently related to pathological factors such as phlegm and heat. It is a disease characterized by both deficiency of vital energy and excess of pathogenic factors. TCM has advantages in the clinical treatment of depression, including high safety, significant efficacy, few adverse reactions, multiple targets, and diverse treatment pathways. However, there is currently a lack of TCM preparations specifically for treating depression on the market. Most practitioners believe that any TCM preparation with the effects of soothing the liver, relieving depression, calming the mind, and soothing the nerves has some degree of antidepressant effect. Therefore, further searching for drugs with significant efficacy and few adverse reactions to treat depression is an urgent need in clinical practice. Summary of the Invention

[0004] (a) Technical problems to be solved

[0005] In view of the shortcomings of the prior art, the present invention provides a traditional Chinese medicine composition for treating depression and its application.

[0006] (II) Technical Solution

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] On one hand, the present invention provides a traditional Chinese medicine composition for treating depression, the traditional Chinese medicine composition being composed of the following raw materials in parts by weight: 5-25 parts of Albizia julibrissin flower, 5-25 parts of Daphne odora, 5-20 parts of Cyperus rotundus, 5-20 parts of Dalbergia odorifera, 5-20 parts of Citronella arvense, 5-20 parts of Murraya paniculata, 5-20 parts of Aucklandia lappa, 5-20 parts of Aquilaria sinensis, 5-20 parts of Aquilaria agallocha, and 5-25 parts of Aquilaria sinensis.

[0009] Furthermore, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-20 parts of Albizia julibrissin flower, 10-20 parts of Daphne odora, 8-15 parts of Cyperus rotundus, 8-15 parts of Dalbergia odorifera, 8-15 parts of Citronella arvense, 8-15 parts of Murraya paniculata, 8-15 parts of Aucklandia lappa, 8-15 parts of Cymbidium faberi, 8-15 parts of Aquilaria sinensis, and 10-20 parts of Aquilaria agallocha.

[0010] Furthermore, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 15 parts of Albizia julibrissin flower, 15 parts of Daphne odora, 12 parts of Cyperus rotundus, 9 parts of Dalbergia odorifera, 9 parts of Citronella arvense, 9 parts of Murraya paniculata, 9 parts of Aucklandia lappa, 9 parts of Aquilaria sinensis, 9 parts of Aquilaria agallocha, and 15 parts of Aquilaria sinensis.

[0011] This invention provides a traditional Chinese medicine composition for treating depression, wherein the traditional Chinese medicine composition is prepared into an acceptable oral dosage form by conventional traditional Chinese medicine manufacturing methods and with medically acceptable excipients.

[0012] The oral dosage forms include granules, powders, decoctions, pills, ointments, freeze-dried powders, etc.

[0013] Furthermore, a traditional Chinese medicine granule for treating depression is prepared according to the following steps:

[0014] (1) Weigh each raw material according to the above weight proportions, chop them, add 1-3 times the weight of water and soak for 30-60 min, filter, and concentrate the extract under reduced pressure to a relative density of 1-1.2 to obtain the extract concentrate.

[0015] (2) Extract the volatile oil from the above raw materials by steam distillation for 8-12 h, collect the volatile oil, grind the β-cyclodextrin with 2-5 times the amount of purified water, add the volatile oil, and place it in a grinder to encapsulate the volatile oil, thus obtaining the volatile oil β-cyclodextrin inclusion complex.

[0016] (3) Mix the extract concentrate with the volatile oil β-cyclodextrin inclusion complex evenly, adjust the relative density to 1-1.2, and spray dry to obtain spray-dried powder.

[0017] (4) Mix the spray-dried powder with dextrin or lactose evenly, granulate by dry method, and granulate to obtain the Chinese medicine granules of the present invention.

[0018] This invention provides the application of the aforementioned traditional Chinese medicine composition in the preparation of drugs for the prevention and / or treatment of depression.

[0019] The pharmacological effects of each herbal component in the herbal composition of this invention are as follows:

[0020] Albizia flower: sweet in taste, neutral in nature, and enters the heart and liver meridians; it has the effect of relieving depression and calming the mind, and is used for restlessness, depression and insomnia; Albizia flower mainly contains flavonoids, flavonols, steroids, volatile oils and other components. Modern pharmacological studies have shown that Albizia flower has sedative, hypnotic, antidepressant and anti-anxiety pharmacological activities.

[0021] Daphne odora: It has a pungent and sweet taste and is slightly warm in nature. It has the effects of dispelling wind and dampness, regulating menstruation and relieving pain. It is used for rheumatic numbness, muscle and bone pain, traumatic injuries, epilepsy, irregular menstruation, dysmenorrhea, and cold pain in the hands and feet during menstruation.

[0022] Cyperus rotundus: It has a pungent, slightly bitter, and slightly sweet taste, and is neutral in nature. It enters the liver, spleen, and triple burner meridians. It has the effects of soothing the liver and relieving depression, regulating qi and relieving chest tightness, regulating menstruation and relieving pain. It is used for liver qi stagnation, chest and rib distension and pain, hernia pain, breast distension and pain, spleen and stomach qi stagnation, abdominal distension and pain, irregular menstruation, amenorrhea and dysmenorrhea. Cyperus rotundus contains volatile oil, flavonoids, alkaloids, triterpenes, sterols, anthraquinones and other chemical components. Modern pharmacological studies have shown that Cyperus rotundus can act on the central nervous system, cardiovascular system and digestive system. It can relax uterine smooth muscle and has antidepressant, blood sugar and lipid-lowering, antibacterial, anti-inflammatory, antitumor and estrogen-like effects.

[0023] Dalbergia odorifera: It has a pungent taste and warm properties, and enters the liver and spleen meridians. It has the effects of removing blood stasis and stopping bleeding, regulating qi and relieving pain. It is used for hematemesis, epistaxis, traumatic bleeding, liver stagnation and hypochondriac pain, chest pain, traumatic injuries, vomiting and abdominal pain. Dalbergia odorifera contains volatile oils, sesquiterpenes, flavonoids, cinnamylphenol and other chemical components. Modern pharmacological studies have shown that Dalbergia odorifera has antioxidant, antithrombotic, anti-inflammatory, anti-allergic and central nervous system depressant effects.

[0024] Citron: It has a pungent, bitter, and sour taste, and is warm in nature. It enters the liver, spleen, and lung meridians. It has the effects of soothing the liver and regulating qi, relieving chest congestion, and resolving phlegm. It is used for liver and stomach qi stagnation, chest and rib pain, abdominal distension, vomiting and belching, and cough with excessive phlegm. Citron mainly contains volatile oils, flavonoids, coumarins, alkaloids, terpenes and other chemical components. Modern pharmacological studies have shown that citron has pharmacological activities such as anti-oxidation, anti-inflammation, anti-allergy, antibacterial, anti-tumor, hypoglycemic and hypolipidemic effects.

[0025] Murraya paniculata (also known as seven-mile fragrance): It has a pungent and bitter taste, is warm in nature, and enters the heart and liver meridians. It has the effects of calming the mind, regulating qi, and relieving pain. It is used for neurasthenia, insomnia, hysteria, irregular menstruation, epilepsy, abdominal distension, lower back and leg pain, and traumatic injuries. Murraya paniculata mainly contains triterpenes, flavonoids, iridoids, diterpenes and other chemical components. Modern pharmacological studies have shown that Murraya paniculata has analgesic, anti-inflammatory and antioxidant pharmacological effects.

[0026] Costus root: It has a pungent and bitter taste, and is warm in nature. It enters the spleen, stomach, large intestine, triple burner, and gallbladder meridians. It has the effects of promoting qi circulation and relieving pain, strengthening the spleen and promoting digestion. It is used for chest and rib pain, abdominal distension and pain, tenesmus after diarrhea, food stagnation and loss of appetite. Costus root mainly contains sesquiterpenoid compounds. Modern pharmacological studies have shown that costus root has pharmacological activities such as anti-tumor, anti-inflammatory, antibacterial, hepatoprotective, and myocardial injury protection.

[0027] Daphne odora: It has a sweet taste and warm nature, and enters the kidney and liver meridians. It has the effects of relaxing muscles and tendons, reducing swelling and relieving pain, dispelling wind and improving eyesight. It is used for rheumatic joint pain, back pain, red and painful eyes, and night blindness. Daphne odora contains chemical components such as coumarins, flavonoids, steroids, organic acids, and alkaloids. Modern pharmacological studies have shown that Daphne odora has antibacterial, anti-inflammatory, analgesic, and hypoglycemic pharmacological activities.

[0028] Ligenxiang: It has a pungent taste and warm nature. It enters the liver and spleen meridians. It has the effects of dispelling wind and cold, promoting qi and blood circulation, and detoxifying snake venom. It is used for wind-cold arthralgia, stomach pain, abdominal pain, traumatic injuries, and snake bites.

[0029] Agarwood: It has a pungent and bitter taste, and is warm in nature. It enters the spleen, stomach, and kidney meridians. It has the effects of promoting qi circulation and relieving pain, warming the middle jiao and relieving nausea, and calming the mind and relieving asthma. It is used for chest and abdominal distension and pain, stomach cold, vomiting and hiccups, and kidney deficiency with shortness of breath. Agarwood mainly contains terpenes, sterols, flavonoids, chromones, phenolic acids, aliphatic and other chemical components. Modern pharmacological studies have shown that agarwood has sedative and analgesic, antibacterial, antitumor and acetylcholinesterase inhibitory pharmacological activities.

[0030] (III) Beneficial Effects

[0031] This invention provides a traditional Chinese medicine composition for treating depression and its application. The composition comprises ten herbs: Albizia julibrissin flower, Daphne odora, Cyperus rotundus, Dalbergia odorifera, Citronella arvense, Murraya paniculata, Aucklandia lappa, Daphne odora, Aquilaria sinensis, and Aquilaria agallocha. Albizia julibrissin flower has the effects of relieving depression and calming the mind, regulating qi and invigorating the stomach, and promoting blood circulation and relieving pain. Aquilaria agallocha has the effects of promoting qi circulation and relieving pain, warming the middle jiao and stopping vomiting, and regulating qi and relieving asthma. These two herbs work synergistically and together serve as the principal herbs. Daphne odora and Cyperus rotundus are the assistant herbs. Daphne odora has the effects of dispelling wind and dampness, promoting blood circulation and relieving pain, which can enhance the calming and pain-relieving effects of the principal herbs. Cyperus rotundus has the effects of soothing the liver and relieving depression, regulating qi and relieving chest tightness, and regulating menstruation and relieving pain, which can strengthen the qi-regulating and pain-relieving effects of the principal herbs. The formula, with its ability to alleviate depression, works synergistically with the principal ingredient to regulate emotions and Qi. It uses Dalbergia odorifera, Citronella foenum-graecum, and Murraya paniculata as adjuvant ingredients. Dalbergia odorifera has the effects of removing blood stasis, stopping bleeding, regulating Qi, and relieving pain, thus assisting the principal and adjuvant ingredients in enhancing their effects. Citronella foenum-graecum has the effects of soothing the liver, regulating Qi, and resolving phlegm, thus assisting the principal and adjuvant ingredients in regulating Qi. Murraya paniculata has the effects of promoting blood circulation, reducing swelling, detoxifying, and stopping dysentery, thus assisting other ingredients in promoting blood circulation and facilitating Qi and blood flow. The formula uses Aucklandia lappa, Polygonum aviculare, and Aquilaria sinensis as guiding ingredients. Aucklandia lappa promotes Qi circulation, relieves pain, strengthens the spleen, and aids digestion; Polygonum aviculare relaxes muscles and tendons, reduces inflammation, and relieves pain; Aquilaria sinensis dispels wind and cold, regulates Qi, and relieves pain, thus enhancing the formula's effects of promoting Qi circulation and relieving pain. This formula combines various aromatic herbs for a concentrated and potent effect, working together to soothe the liver, relieve depression, and regulate Qi.

[0032] Animal experiments have shown that the herbal composition of this invention can improve depressive-like behavior in mice with depression, reduce serum levels of inflammatory factors IL-6, IL-1β, and TNF-α in mice with depression, and increase levels of monoamine neurotransmitters 5-HT, DA, and NE in mice with depression. Clinical efficacy verification shows that the herbal composition of this invention can significantly reduce HAMD scores, PSQI scores, and TCM syndrome scores in patients with depression, significantly improve clinical symptoms, and has a high overall effective rate in the treatment of depression. The herbal composition provided by this invention offers new ideas and methods for preparing drugs to treat depression. Detailed Implementation

[0033] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0034] Example 1

[0035] A traditional Chinese medicine composition for treating depression, the composition comprising the following raw materials in parts by weight: 15 parts of Albizia julibrissin flower, 15 parts of Daphne odora, 12 parts of Cyperus rotundus, 9 parts of Dalbergia odorifera, 9 parts of Citronella arvense, 9 parts of Murraya paniculata, 9 parts of Aucklandia lappa, 9 parts of Daphne odora, 9 parts of Aquilaria sinensis, and 15 parts of Aquilaria sinensis.

[0036] Example 2

[0037] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 18 parts of Albizia julibrissin, 18 parts of Daphne odora, 15 parts of Cyperus rotundus, 12 parts of Dalbergia odorifera, 12 parts of Citronella arvense, 12 parts of Murraya paniculata, 12 parts of Aucklandia lappa, 12 parts of Aquilaria sinensis, 12 parts of Aquilaria agallocha, and 18 parts of Aquilaria sinensis.

[0038] Example 3

[0039] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 5 parts of Albizia julibrissin flower, 5 parts of Daphne odora, 5 parts of Cyperus rotundus, 5 parts of Dalbergia odorifera, 5 parts of Citronella arvense, 5 parts of Murraya paniculata, 5 parts of Aucklandia lappa, 5 parts of Daphne odora, 5 parts of Aquilaria sinensis, and 5 parts of Aquilaria agallocha.

[0040] Example 4

[0041] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 22 parts of Albizia julibrissin, 22 parts of Daphne odora, 20 parts of Cyperus rotundus, 18 parts of Dalbergia odorifera, 18 parts of Citronella arvense, 18 parts of Murraya paniculata, 18 parts of Aucklandia lappa, 18 parts of Aquilaria sinensis, 18 parts of Aquilaria agallocha, and 22 parts of Aquilaria sinensis.

[0042] Example 5

[0043] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Albizia julibrissin flower, 10 parts of Daphne odora, 8 parts of Cyperus rotundus, 7 parts of Dalbergia odorifera, 7 parts of Citronella arvense, 7 parts of Murraya paniculata, 7 parts of Aucklandia lappa, 7 parts of Daphne odora, 7 parts of Aquilaria sinensis, and 10 parts of Aquilaria sinensis.

[0044] Example 6

[0045] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 12 parts of Albizia julibrissin, 12 parts of Daphne odora, 10 parts of Cyperus rotundus, 8 parts of Dalbergia odorifera, 8 parts of Citronella arvense, 8 parts of Murraya paniculata, 8 parts of Aucklandia lappa, 8 parts of Aquilaria sinensis, 8 parts of Aquilaria agallocha, and 12 parts of Aquilaria sinensis.

[0046] Example 7

[0047] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 25 parts of Albizia julibrissin, 25 parts of Daphne odora, 20 parts of Cyperus rotundus, 20 parts of Dalbergia odorifera, 20 parts of Citronella arvense, 20 parts of Murraya paniculata, 20 parts of Aucklandia lappa, 20 parts of Aquilaria sinensis, 20 parts of Aquilaria agallocha, and 25 parts of Aquilaria sinensis.

[0048] Example 8

[0049] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 20 parts of Albizia julibrissin flower, 20 parts of Daphne odora, 18 parts of Cyperus rotundus, 15 parts of Dalbergia odorifera, 15 parts of Citronella arvense, 15 parts of Murraya paniculata, 15 parts of Aucklandia lappa, 15 parts of Aquilaria sinensis, 15 parts of Aquilaria agallocha, and 20 parts of Aquilaria sinensis.

[0050] Experimental Example 1

[0051] 1. Materials and Methods

[0052] 1.1 Experimental Animals

[0053] SPF-grade male Kunming mice, weighing 20-22g, were purchased from Jinan Pengyue Experimental Animal Breeding Co., Ltd.

[0054] 1.2 Test Drugs

[0055] The herbal composition of this invention consists of: 15 parts of Albizia julibrissin flower, 15 parts of Daphne odora, 12 parts of Cyperus rotundus, 9 parts of Dalbergia odorifera, 9 parts of Citronella arvense, 9 parts of Murraya paniculata, 9 parts of Aucklandia lappa, 9 parts of Daphne odora, 9 parts of Aquilaria sinensis, and 15 parts of Aquilaria agallocha. Each raw material is weighed according to the above weights, washed, boiled in 8 times the amount of water for 30 minutes, filtered, and the filtrate is obtained. The process is repeated twice, and the two filtrates are combined and concentrated to a raw herb content of 1 g / mL to obtain the original herbal liquid. It is stored at 4°C for later use.

[0056] Control drug: Fluoxetine hydrochloride.

[0057] 1.3 Establishment, grouping, and drug treatment of a mouse model of depression caused by chronic unpredictable stress (CUMS).

[0058] Male Kunming mice were acclimatized for one week, and their weight was recorded. Before grouping, the mice underwent saccharin acclimatization training. After 24 hours of water deprivation, a saccharin preference experiment was conducted. Unsuitable mice that were overly sensitive to or extremely averse to saccharin were excluded to ensure that the saccharin preference rate of the mice remained relatively consistent. The eligible mice were randomly divided into 6 groups of 7 mice each: normal group, model group, low-dose group of the herbal composition of the present invention (hereinafter referred to as low-dose group), medium-dose group of the herbal composition of the present invention (hereinafter referred to as medium-dose group), high-dose group of the herbal composition of the present invention (hereinafter referred to as high-dose group), and positive control group. After 3 days of acclimatization, except for the normal group, the other groups were kept in an isolated rearing mode, and 1-2 kinds of stimuli were randomly given every day to replicate the chronic stress depression model. The stimuli included fasting (12 h), water deprivation (12 h), day-night reversal, swimming in cold water (4℃, 5 min), swimming in hot water (45 min, 5 min), tilted cage, damp bedding, restraint, tail clamping, electric shock to the soles of the feet (1 min), and shaking. A random, non-continuous stimulus was administered to the mice at 9:00 AM each day, making the stimulus unpredictable. The modeling process lasted for 7 weeks. Before modeling, mouse body weight, sucrose preference, and open field behavioral experiments were recorded. After modeling, mice showed weight loss, decreased sucrose preference, and reduced spontaneous activity and exploratory behavior, indicating successful modeling. One week after modeling, all groups were administered medication by gavage while continuing the CUMS (Cumulative, Multi-Stage, Multi-Stage) procedure. The low-dose group received 50 mg / kg of the original Chinese medicine extract, the medium-dose group received 100 mg / kg, the high-dose group received 200 mg / kg, the positive control group received 3.3 mg / kg of fluoxetine hydrochloride, and the normal and model groups were administered an equal volume of physiological saline by gavage. All groups were administered medication once daily for 4 consecutive weeks.

[0059] 1.4 Behavioral indicators for detecting depressive-like behavior in mice

[0060] 1.4.1 Sugar Water Preference Test

[0061] Before modeling, mice were trained to adapt to 1% sucrose solution in a quiet environment. Mice were housed individually in cages, with two identical water bottles placed in each cage. During the first 24 hours, both bottles contained 1% sucrose solution; during the second 24 hours, one bottle contained 1% sucrose solution and the other contained pure water. Afterward, both bottles were removed and weighed. Before the experiment and at week 7, each mouse underwent a sucrose preference test. Before the experiment, the mice were fasted and deprived of water for 24 hours, then given two pre-quantified bottles of water: one containing 1% sucrose solution and the other pure water. After 24 hours, the bottles were removed and weighed, and the consumption of sucrose solution and pure water was recorded. The sucrose preference rate was calculated.

[0062] Sugar water preference rate = (sugar water consumption / total liquid consumption) × 100%.

[0063] 1.4.2 Forced Swimming Experiment

[0064] Mice were placed in a glass cylinder 24 cm high and 15 cm in diameter. Under water temperature of (25±1)℃, they were forced to swim for 6 minutes. The cumulative immobility time of the mice in the last 4 minutes was observed and recorded. The cumulative immobility time was defined as the time when the mice stopped struggling, floated in the water and remained still, or made only some necessary slight movements to keep their heads on the surface of the water.

[0065] 1.4.3 Suspended Tail Experiment

[0066] The mouse's tail (about 1 cm from the tip) was fixed to a self-made tail suspension device (a cube made of opaque material, 40 cm long, wide and high, made by fixing small wooden clips with an iron frame), so that the mouse's head was about 10 cm from the bottom of the box. Three people simultaneously observed the mouse's activity over 6 minutes, recorded the cumulative immobility time of the mouse in the last 4 minutes, and calculated the average value.

[0067] 1.4.4 Open Field Experiment

[0068] Each mouse was gently placed in the center of the open field test chamber, and its movement trajectory was recorded by the camera above it over 5 minutes. The horizontal movement score (total horizontal movement distance) and vertical score (number of standing) were analyzed. Before each mouse was tested, the bottom of the chamber was thoroughly cleaned with 75% ethanol to avoid odor interference with the experimental results of the next mouse.

[0069] 1.5 Sample Collection and Biometric Measurement

[0070] Following behavioral testing, mice were euthanized by anesthesia with 50 mg / kg sodium pentobarbital. Serum was collected and frozen at -20°C for later use. The brain was immediately isolated, and hippocampal tissue was washed with physiological saline and stored in liquid nitrogen for later analysis.

[0071] The levels of serum inflammatory factors TNF-α, IL-1β, and IL-10 were detected according to the method described in the ELISA kit instructions.

[0072] The levels of 5-HT, DA, and NE in hippocampal tissue were detected according to the method described in the ELISA kit instructions.

[0073] 1.6 Statistical Analysis

[0074] Data statistical analysis and graphing were performed using Graphpad Prism 8.0 software. The results are expressed as mean ± standard deviation (Mean ± SD). One-way ANOVA was used to compare differences between groups, and P < 0.05 was considered statistically significant.

[0075] 2 Results

[0076] 2.1 Effects on the behavior of a mouse model of depression

[0077] As shown in Table 1, compared with the blank group, the sucrose consumption of mice in the model group was significantly reduced (P<0.01), the forced swimming and tail suspension immobility time was significantly increased (P<0.01), and the movement distance was significantly shortened (P<0.01). Compared with the model, in the positive control group, the high-dose, medium-dose, and low-dose groups of the traditional Chinese medicine composition increased the sucrose consumption (P<0.05 or P<0.01) and movement distance (P<0.05 or P<0.01) of the model mice, and reduced the tail suspension and swimming immobility time of the model mice (P<0.05 or P<0.01), suggesting that the traditional Chinese medicine compound composition has the effect of improving depressive-like behavior in mice, with the high-dose group showing better results.

[0078] Table 1. Effects on depression-like behavior in a mouse model of depression.

[0079]

[0080] Note: Compared with the blank group, # P<0.01, ## P<0.01; compared with the model group, * P<0.05, ** P<0.01.

[0081] 2.2 Effects on biomarkers of a depressed mouse model

[0082] 2.2.1 Effects on serum levels of inflammatory cytokines TNF-α, IL-1β, and IL-6 in depressed model mice

[0083] As shown in Table 2, compared with the blank group, the serum levels of IL-1β, TNF-α, and IL-4 in the model group mice were significantly increased (P<0.01 or P<0.05). Compared with the model group, the positive control group, the high-dose, medium-dose, and low-dose groups of the traditional Chinese medicine compound composition significantly reduced the serum levels of IL-6, IL-1β, and TNF-α in the depressed model mice (P<0.01 or P<0.05), suggesting that the traditional Chinese medicine compound composition has an inhibitory effect on the inflammatory response in mice, with the high-dose group showing better results.

[0084] Table 2. Effects on serum levels of inflammatory cytokines IL-6, IL-1β, and TNF-α in depressed model mice.

[0085]

[0086] Note: Compared with the blank group, # P<0.01, ## P<0.01; compared with the model group, * P<0.05, **P<0.01.

[0087] 2.2.2 Effects on the levels of 5-HT, DA, and NE in the hippocampus of depressed mouse models

[0088] As shown in Table 3, compared with the blank group, the levels of 5-HT, DA, and NE in the hippocampus of mice in the model group were significantly decreased (P<0.01 or P<0.05). Compared with the model group, the levels of 5-HT, DA, and NE in the positive control group, the high-dose group, the medium-dose group, and the low-dose group of the traditional Chinese medicine compound composition were significantly increased (P<0.01 or P<0.05), suggesting that the traditional Chinese medicine compound composition has the effect of increasing the level of monoamine neurotransmitters in mice, with the high-dose group showing better results.

[0089] Table 3 Effects on 5-HT, DA, and NE levels in the hippocampus of depressed mouse models

[0090]

[0091] Note: Compared with the blank group, # P<0.01, ## P<0.01; compared with the model group, * P<0.05, ** P<0.01.

[0092] 3. Conclusion

[0093] The above experimental results show that the herbal composition of this invention can significantly increase sucrose consumption and open field movement distance in mice, and reduce tail suspension and immobility time during swimming, thus significantly improving depressive-like behavior in depressed mice. Simultaneously, it can significantly reduce the serum levels of inflammatory factors IL-6, IL-1β, and TNF-α in depressed model mice, and increase the levels of monoamine neurotransmitters 5-HT, DA, and NE in the mice. The herbal composition of this invention can be developed and prepared as a drug for treating depression.

[0094] Experimental Example 2

[0095] 1. Materials and Methods

[0096] 1.1 General Information

[0097] Seventy-two adolescent patients with depression admitted to a hospital in Zhengzhou from January 2023 to June 2024 were selected and randomly divided into an observation group and a control group, with 36 patients in each group. The observation group consisted of 15 males and 21 females, with a mean age of (16.89±3.61) years and a mean duration of illness of (36.18±4.09) days. The control group consisted of 13 males and 23 females, with a mean age of (17.06±2.44) years and a mean duration of illness of (34.46±3.51) days. There were no statistically significant differences in general characteristics between the two groups (P>0.05), indicating comparability.

[0098] 1.2 Case screening criteria

[0099] 1.2.1 Western Medicine Diagnostic Criteria

[0100] The diagnostic criteria for depression were developed with reference to the Classification of Mental and Behavioral Disorders (ICD-10). The main symptoms of depression include: sleep disturbances, loss of interest or pleasure, poor concentration or decreased thinking ability, decreased mental capacity or fatigue, low self-esteem, self-harm or suicidal behavior / ideas, and increased feelings of guilt or self-blame.

[0101] 1.2.2 Traditional Chinese Medicine Diagnostic Standards

[0102] If the patient meets the diagnostic criteria for depression in the "Standards for Diagnosis and Efficacy of Diseases in Traditional Chinese Medicine", and the syndrome is diagnosed as liver qi stagnation syndrome, with reference to the tongue and pulse, and the main symptoms must be accompanied by at least two secondary symptoms, a diagnosis can be made.

[0103] 1.2.3 Inclusion Criteria

[0104] The patient was initially diagnosed with depression, aged 11-18 years, met the diagnostic criteria of both traditional Chinese medicine and Western medicine, and was able to cooperate with taking traditional Chinese medicine decoctions; hearing, vision, and mental state did not affect the completion of neuropsychological and scale assessment tests; and nutritional status was good.

[0105] 1.2.4 Exclusion Criteria

[0106] Patients with severe self-harm or suicidal tendencies; intellectual disability or schizophrenia; a history of antidepressant medication or psychotherapy; allergy to medications; severe dysfunction of organs such as the heart, brain, liver, kidneys, and lungs; or poor adherence to treatment are also considered.

[0107] 1.3 Treatment methods

[0108] Control group: Paroxetine hydrochloride tablets, 20 mg each time, once a day, for 6 consecutive weeks.

[0109] Observation group: In addition to the control group, the patients were given an oral decoction of the herbal composition of this invention. The prescription was as follows: 15 parts of Albizia julibrissin, 15 parts of Daphne odora, 12 parts of Cyperus rotundus, 9 parts of Dalbergia odorifera, 9 parts of Citronella arvense, 9 parts of Murraya paniculata, 9 parts of Aucklandia lappa, 9 parts of Daphne odora, 9 parts of Aquilaria sinensis, and 15 parts of Aquilaria agallocha. The above raw materials were weighed according to their weight, and decocted in 4 times their weight of water for more than 30 minutes until 400 mL of decoction remained. The decoction was taken twice a day, morning and evening, for 6 consecutive weeks.

[0110] 1.4 Observation Indicators

[0111] 1.4.1 Hamilton Depression Rating Scale (HAMD) score

[0112] Used to assess the severity of depression, a higher score indicates a more severe depression. The HAMD scale has a total score of 54 points, with the following grading criteria: Normal <8 points; 8 points ≤ Possible depression ≤20 points; 20 points < Mild to moderate depression ≤35 points; Severe depression >35 points.

[0113] 1.4.2 Pittsburgh Sleep Quality Index (PSQI) score

[0114] This scale includes 7 items such as daytime functioning, sleep onset time, and sleep disorders. It uses the Likert 4-point scoring method with scores ranging from 0 to 3, for a total score of 0 to 21. The lower the total score, the better the sleep quality.

[0115] 1.4.4 Traditional Chinese Medicine Syndrome Scoring

[0116] The symptoms of chest and rib distension, insomnia, and depression before and after treatment were evaluated and scored according to the severity of the symptoms, ranging from 0 to 6 points. The higher the score, the more severe the patient's symptoms.

[0117] 1.4.5 Efficacy Criteria

[0118] The efficacy criteria were formulated with reference to "Psychiatry". Clinical cure: HAMD score reduction ≥75%; Significant effect: HAMD score reduction ≥50%; Effective: HAMD score reduction ≥25%; Ineffective: HAMD score reduction <25%.

[0119] Overall effective rate = (number of clinically cured cases + number of cases with significant effect + number of cases with effect) / total number of cases × 100%.

[0120] 1.5 Statistical Methods

[0121] SPSS 18.0 statistical software was used. Quantitative data were expressed as mean ± standard deviation. Independent samples t-tests were used between groups, and paired samples t-tests were used within groups. Count data were expressed as percentages (%). Chi-square tests were used for comparisons between groups. 2 The test showed that P < 0.05 was statistically significant.

[0122] 2 Results

[0123] 2.1 Clinical efficacy

[0124] As shown in Table 4, after treatment, the total effective rate of the observation group was 94.4%, which was significantly higher than the total effective rate of 77.8% in the control group. The difference was statistically significant (P<0.05).

[0125] Table 4 Comparison of clinical efficacy between the two groups of patients (cases, %)

[0126]

[0127] 2.2 HAMD score, PSQI score and TCM syndrome score

[0128] Table 5 shows that there were no significant differences in HAMD scores, PSQI scores, and TCM syndrome scores between the two groups before treatment (P>0.05). After treatment, the HAMD scores, PSQI scores, and TCM syndrome scores in both the control and observation groups were significantly lower than before treatment, with statistically significant differences (P<0.05). After treatment, the HAMD scores, PSQI scores, and TCM syndrome scores in the observation group were also significantly lower than those in the control group, with statistically significant differences (P<0.05 or P<0.01).

[0129] Table 5. Comparison of HAMD scores, PSQI scores, and TCM syndrome scores before and after treatment in the two groups of patients (points)

[0130]

[0131] Note: Compared with the pre-treatment group, * P<0.05, ** P<0.01; compared with the control group after treatment, # P<0.01, ## P<0.01.

[0132] 3. Conclusion

[0133] This invention, based on the principles of traditional Chinese medicine (TCM) syndrome differentiation and treatment, comprises a TCM composition consisting of Albizia julibrissin flower, Daphne odora, Cyperus rotundus, Dalbergia odorifera, Citronella arvense, Murraya paniculata, Aucklandia lappa, Daphne odora, Aquilaria sinensis, and Aquilaria sinensis. Albizia julibrissin flower has the effects of relieving depression and calming the mind, regulating qi and invigorating the stomach, and promoting blood circulation and relieving pain. Aquilaria sinensis has the effects of promoting qi circulation and relieving pain, warming the middle jiao and stopping vomiting, and regulating qi and relieving asthma. These two herbs work synergistically and together serve as the principal herbs. Daphne odora and Cyperus rotundus are the assistant herbs. Daphne odora has the effects of dispelling wind and dampness, promoting blood circulation and relieving pain, which can enhance the calming and pain-relieving effects of the principal herbs. Cyperus rotundus has the effects of soothing the liver and relieving depression, regulating qi and relieving chest congestion, and regulating menstruation and relieving pain, which can strengthen the qi-regulating and depression-relieving effects of the principal herbs. This formula works synergistically with the principal herb to regulate emotions and Qi. It uses Dalbergia odorifera, Citronella foenum-graecum, and Murraya paniculata as adjuvant herbs. Dalbergia odorifera has the effects of removing blood stasis, stopping bleeding, regulating Qi, and relieving pain, thus assisting the principal and adjuvant herbs in enhancing their effects. Citronella foenum-graecum has the effects of soothing the liver, regulating Qi, and resolving phlegm, thus assisting the principal and adjuvant herbs in regulating Qi. Murraya paniculata has the effects of promoting blood circulation, reducing swelling, detoxifying, and stopping dysentery, thus assisting other herbs in promoting blood circulation and facilitating Qi and blood flow. It uses Aucklandia lappa, Polygonum aviculare, and Aquilaria sinensis as guiding herbs. Aucklandia lappa promotes Qi circulation, relieves pain, strengthens the spleen, and aids digestion; Polygonum aviculare relaxes muscles and tendons, reduces inflammation, and relieves pain; Aquilaria sinensis dispels wind and cold, regulates Qi, and relieves pain, thus enhancing the formula's effects of promoting Qi circulation and relieving pain. This formula combines various aromatic herbs, resulting in a potent and targeted effect, working together to soothe the liver, relieve depression, and regulate Qi. The combination of the traditional Chinese medicine composition of this invention with paroxetine hydrochloride tablets can significantly reduce the HAMD score, PSQI score and TCM syndrome score of patients with depression, effectively improve the clinical symptoms of patients with depression, and significantly improve the overall effective rate of treatment for depression.

[0134] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for treating depression, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 15 parts of Albizia julibrissin, 15 parts of Daphne odora, 12 parts of Cyperus rotundus, 9 parts of Dalbergia odorifera, 9 parts of Citronella arvense, 9 parts of Murraya paniculata, 9 parts of Aucklandia lappa, 9 parts of Aquilaria sinensis, 9 parts of Aquilaria agallocha, and 15 parts of Aquilaria sinensis.

2. The method for preparing a traditional Chinese medicine composition for treating depression as described in claim 1, characterized in that, The traditional Chinese medicine composition is prepared into an acceptable oral dosage form using conventional traditional Chinese medicine manufacturing methods and with medically acceptable excipients.

3. The use of the traditional Chinese medicine composition as described in claim 1 in the preparation of drugs for the prevention and / or treatment of depression.

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