Traditional Chinese medicine composition for treating depression and application thereof

Abstract

The invention 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 prepared from albizia flowers, daphne odora, rhizoma cyperi, lignum dalbergiae odoriferae, citron, daphne odera, radix aucklandiae, edgeworthia chrysantha, calogyne pilosa and aquilaria sinensis, and all the medicines are combined to achieve the effects of soothing liver-qi stagnation and regulating qi activity. The traditional Chinese medicine composition can improve depression-like behaviors of mice with depression, significantly reduce levels of inflammation-related factors IL-6, IL-1beta and TNF-alpha in serum of depression model mice, and significantly improve levels of monoamine neurotransmitters 5-HT, DA and NE of mouse bodies; according to the traditional Chinese medicine composition, the HAMD score, the PSQI score and the traditional Chinese medicine syndrome score of a depression patient can be remarkably reduced, the traditional Chinese medicine composition has the high treatment total effective rate on depression treatment, and the traditional Chinese medicine composition which is remarkable in effect and free of toxic and side effects is provided for depression treatment.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine pharmaceutical manufacturing, and in particular to a traditional Chinese medicine composition for treating depression and application thereof. Background Art

[0002] Depression, also known as depressive disorder, is a common affective mental illness with main symptoms including low mood, decreased interest, slow thinking, and weakened willpower. It has become a major burden on global public health. Western medicine treatment of depression is based on hypothalamic-pituitary-adrenal axis imbalance, the neuroplasticity hypothesis, and the monoamine neurotransmitter hypothesis, but its specific mechanism of action is still unclear. Currently, there is no specific clinical treatment. Monoamine oxidase inhibitors, tricyclic antidepressants, selective serotonin reuptake inhibitors, and other drugs are usually combined with psychotherapy. While good short-term therapeutic effects can be achieved, long-term use can cause adverse reactions such as dizziness, nausea and vomiting, weight gain, and sexual dysfunction.

[0003] Traditional Chinese Medicine (TCM) doesn't have a specific disease name for depression. Based on clinical symptoms, it can be categorized as "depression," "anxiety," or "restlessness." The disease often affects the heart, liver, and spleen, and is often associated with pathological factors such as phlegm and heat. It presents a condition characterized by both deficiency of vital energy and excess of pathogenic factors. Traditional Chinese medicine (TCM) offers advantages in the clinical treatment of depression, including high safety, significant efficacy, few adverse reactions, multiple targets, and diverse therapeutic approaches. However, there are currently few Chinese patent medicines specifically designed to treat depression. Most physicians believe that any Chinese patent medicine that soothes the liver, relieves depression, and calms the mind possesses some degree of antidepressant activity. Therefore, further research into effective, low-side-effect treatments for depression is urgently needed in clinical practice. Summary of the Invention

[0004] (1) Technical problems solved

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

[0006] (2) Technical solution

[0007] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0008] On the one hand, the present invention provides a traditional Chinese medicine composition for treating depression, which is composed of the following raw materials in parts by weight: 5-25 parts of Albizia Julibrissin flowers, 5-25 parts of Daphne koreana, 5-20 parts of Cyperus rotundus, 5-20 parts of Dalbergia odorifera, 5-20 parts of Citron, 5-20 parts of Osmanthus fragrans, 5-20 parts of Costus root, 5-20 parts of Caragana chinensis, 5-20 parts of Cyperus rotundus, and 5-25 parts of Aquilaria sinensis.

[0009] Furthermore, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10-20 parts of Albizia Julibrissin flowers, 10-20 parts of Daphne koreana, 8-15 parts of Cyperus rotundus, 8-15 parts of Dalbergia odorifera, 8-15 parts of Citron, 8-15 parts of Osmanthus fragrans, 8-15 parts of Costus root, 8-15 parts of Rhizoma Citri Reticulatae, 8-15 parts of Rhizoma Citri Reticulatae, 8-15 parts of Rhizoma Citri Reticulatae, and 10-20 parts of Aquilaria woodii.

[0010] Furthermore, the Chinese medicine composition is composed of the following raw materials in parts by weight: 15 parts of Albizia Julibrissin flowers, 15 parts of Daphne koreana, 12 parts of Cyperus rotundus, 9 parts of Dalbergia odorifera, 9 parts of Citron, 9 parts of Osmanthus fragrans, 9 parts of Costus root, 9 parts of Rhizoma Citri Reticulatae ... and 15 parts of Aquilaria woodii.

[0011] The present invention provides a traditional Chinese medicine composition for treating depression. The traditional Chinese medicine composition is prepared into an acceptable oral dosage form by conventional traditional Chinese medicine pharmaceutical preparation methods and with medically acceptable excipients.

[0012] The oral dosage forms include granules, powders, decoctions, pills, pastes, freeze-dried powders, and the like.

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

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

[0015] (2) The above raw materials are subjected to steam distillation to extract volatile oil for 8-12 hours, the volatile oil is collected, β-cyclodextrin is ground with 2-5 times the amount of purified water, the volatile oil is added, and the mixture is placed in a grinder for inclusion of the volatile oil to obtain a volatile oil β-cyclodextrin inclusion complex.

[0016] (3) The extract concentrate and the volatile oil β-cyclodextrin inclusion complex are uniformly mixed, the relative density is adjusted to 1-1.2, and spray-dried to obtain a spray-dried powder.

[0017] (4) The spray-dried powder is uniformly mixed with dextrin or lactose, and dry granulated and granulated to obtain the Chinese medicine granules of the present invention.

[0018] The present invention provides use of the traditional Chinese medicine composition in preparing a drug for preventing and / or treating depression.

[0019] The pharmacological effects of the various Chinese medicinal components in the Chinese medicinal composition of the present invention are as follows:

[0020] Albizia Julibrissin: sweet in taste, neutral in nature, enters the heart and liver meridians; has the effect of relieving depression and calming the mind, and is used for restlessness, depression and insomnia; Albizia Julibrissin mainly contains flavonoids, flavonols, steroids, volatile oils and other ingredients. Modern pharmacological research shows that Albizia Julibrissin has pharmacological activities such as sedation, hypnosis, antidepression, and anti-anxiety.

[0021] Daphne odora: spicy, sweet, slightly warm in nature, has the effects of dispelling wind and dampness, regulating menstruation and relieving pain, and is used for rheumatism and numbness, pain in muscles and bones, injuries from falls, epilepsy, irregular menstruation, epilepsy, dysmenorrhea, and cold and painful hands and feet during menstruation.

[0022] Cyperus rotundus: It tastes pungent, slightly bitter and slightly sweet, is neutral in nature, and enters the liver, spleen, and triple burner meridians; it has the effects of soothing the liver and relieving depression, regulating qi and relieving fullness, regulating menstruation and relieving pain, and is used for liver depression and qi stagnation, chest and rib pain, hernia pain, breast pain, spleen and stomach qi stagnation, abdominal fullness, distension and pain, irregular menstruation, amenorrhea and dysmenorrhea; Cyperus rotundus contains chemical components such as volatile oils, flavonoids, alkaloids, triterpenes, sterols, anthraquinones, etc. Modern pharmacological research shows that Cyperus rotundus can act on the central nervous system, cardiovascular and cerebrovascular system, digestive system, can relax uterine smooth muscle, and has antidepressant, blood sugar and lipid lowering, antibacterial, anti-inflammatory, anti-tumor, and estrogen-like effects.

[0023] Dalbergia wood: It tastes spicy and is warm in nature. It 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 depression and flank pain, chest pain, pain from falls, vomiting and abdominal pain. Dalbergia wood contains chemical components such as volatile oils, sesquiterpenes, flavonoids, cinnamylphenols, etc. Modern pharmacological research shows that Dalbergia wood has antioxidant, anti-thrombotic, anti-inflammatory, anti-allergic, and central nervous system inhibitory effects.

[0024] Citron: It tastes pungent, bitter, and sour, 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 fullness, and resolving phlegm. It is used for liver and stomach qi stagnation, chest and flank pain, abdominal distension, vomiting and belching, and cough with excessive phlegm. Citron mainly contains chemical components such as volatile oils, flavonoids, coumarins, alkaloids, and terpenes. Modern pharmacological studies have shown that citron has pharmacological activities such as antioxidant, anti-inflammatory, anti-allergic, antibacterial, anti-tumor, and hypoglycemic and lipid-lowering properties.

[0025] Osmanthus fragrans: It tastes spicy and bitter, 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, stomach and abdominal distension, low back and leg pain, and traumatic injuries. Osmanthus fragrans mainly contains chemical components such as triterpenes, flavonoids, cycloether terpenes, and diterpenes. Modern pharmacological research shows that Osmanthus fragrans has pharmacological effects such as analgesia, anti-inflammatory, and antioxidant.

[0026] Costus root: It tastes spicy and bitter, and is warm in nature. It enters the spleen, stomach, large intestine, triple burner, and gallbladder meridians. It has the effects of promoting qi and relieving pain, strengthening the spleen and digesting food. It is used for chest and flank pain, abdominal distension and pain, heaviness after diarrhea, indigestion, 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, liver protection, and myocardial damage protection.

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

[0028] Li Genxiang: spicy in taste, warm in nature, enters the liver and spleen meridians, has the effects of dispelling wind and cold, promoting qi and blood circulation, and detoxifying snake venom, and is used for wind-cold pain, stomachache, abdominal pain, bruises, and snake bites.

[0029] Agarwood: It tastes spicy and bitter, is warm in nature, and enters the spleen, stomach, and kidney meridians. It has the effects of promoting qi and relieving pain, warming the middle and relieving adverse reactions, and relieving asthma. It is used for chest and abdominal distension and pain, stomach cold, vomiting and hiccups, and kidney deficiency, qi reversal and shortness of breath. Agarwood mainly contains chemical components such as terpenes, sterols, flavonoids, chromones, phenolic acids, and aliphatic acids. Modern pharmacological studies have shown that agarwood has pharmacological activities such as sedation and analgesia, antibacterial, anti-tumor, and inhibition of acetylcholinesterase.

[0030] (3) Beneficial effects

[0031] The present invention provides a traditional Chinese medicine composition for treating depression and its application. The traditional Chinese medicine composition is composed of ten traditional Chinese medicines, namely, Flos Julibrissin, Daphne koreana, Rhizoma Cyperi, Dalbergia odorifera, Citron, Osmanthus fragrans, Aucklandia lappa, Rhizoma Cyperi, Rhizoma Cyperi, and Aquilaria sinensis. The Flos Julibrissin has the effects of relieving depression and calming the mind, regulating qi and appetizing, activating blood circulation and relieving pain, and Aquilaria sinensis has the effects of promoting qi circulation and relieving pain, warming the middle and stopping vomiting, and promoting qi intake and relieving asthma. The two traditional Chinese medicines complement each other and serve as monarch medicines. Daphne koreana and Rhizoma Cyperi are auxiliary medicines. Daphne koreana has the effects of dispelling wind and dampness, activating blood circulation and relieving pain, and can enhance the tranquilizing and activating blood circulation and relieving pain effects of the monarch medicine. Rhizoma Cyperi has the effects of soothing the liver and relieving depression, regulating qi and relieving fullness, regulating menstruation and relieving pain, and can enhance the regulating qi and relieving pain effects of the monarch medicine. The effect of relieving depression can cooperate with the main medicine to play the role of regulating emotions and qi; with agarwood, citron, and osmanthus as adjuvants, agarwood has the effects of removing blood stasis and stopping bleeding, regulating qi and relieving pain, and can assist the main medicine and the minister medicine to enhance the effect of regulating qi and relieving pain. Citron has the effects of soothing the liver and regulating qi, relieving fullness and resolving phlegm, and can assist the main medicine and the minister medicine in regulating qi. Osmanthus has the effects of promoting blood circulation and reducing swelling, detoxifying and stopping dysentery, and can assist other medicines to play the role of promoting blood circulation and promoting the circulation of qi and blood; with costus root, knotwood, and lily root as guiding medicines, costus root promotes qi and relieves pain, strengthens the spleen and digestion, knotwood relaxes muscles and activates collaterals, reduces inflammation and relieves pain, and lily root dispels wind and cold, regulates qi and relieves pain, which can enhance the qi and pain-promoting effect of the prescription. This prescription brings together all the aromatic herbs, with a special effect and great power, to play the effect of soothing the liver and relieving depression, and regulating qi.

[0032] In addition, animal experiments have shown that the Chinese medicine composition of the present invention can improve the depressive-like behavior of depression mice, reduce the levels of inflammatory-related factors IL-6, IL-1β, and TNF-α in the serum of depression model mice, and increase the levels of monoamine neurotransmitters 5-HT, DA, and NE in the depression model mice. Clinical effect verification shows that the Chinese medicine composition of the present invention can significantly reduce the HAMD score, PSQI score, and TCM syndrome score of depression patients, significantly improve the clinical symptoms of depression patients, and have a high total effective rate for the treatment of depression. The Chinese medicine composition provided by the present invention provides a new idea and method for preparing drugs for treating depression. DETAILED DESCRIPTION

[0033] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in 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 part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0034] Example 1

[0035] A traditional Chinese medicine composition for treating depression, comprising the following raw materials in parts by weight: 15 parts of Flos Albizia Julibrissin, 15 parts of Daphne koreana, 12 parts of Rhizoma Cyperi, 9 parts of Dalbergia odorifera, 9 parts of Citron, 9 parts of Osmanthus fragrans, 9 parts of Costus root, 9 parts of Rhizoma Citri Reticulatae ... and 15 parts of Aquilaria woodii.

[0036] Example 2

[0037] The difference between this embodiment and embodiment 1 is that the Chinese medicine composition is composed of the following raw materials in parts by weight: 18 parts of Flos Albizia Julibrissin, 18 parts of Daphne koreana, 15 parts of Rhizoma Cyperi, 12 parts of Dalbergia odorifera, 12 parts of Citron, 12 parts of Osmanthus fragrans, 12 parts of Costus root, 12 parts of Rhizoma Citri Reticulatae ... and 18 parts of Aquilaria woodii.

[0038] Example 3

[0039] The difference between this embodiment and embodiment 1 is that the Chinese medicine composition is composed of the following raw materials in parts by weight: 5 parts of Flos Julibrissin, 5 parts of Daphne koreana, 5 parts of Cyperus rotundus, 5 parts of Dalbergia odorifera, 5 parts of Citron, 5 parts of Osmanthus fragrans, 5 parts of Costus root, 5 parts of Rhizoma Citri Reticulatae ... and 5 parts of Aquilaria woodii.

[0040] Example 4

[0041] The difference between this embodiment and embodiment 1 is that the Chinese medicine composition is composed of the following raw materials in parts by weight: 22 parts of Flos Albizia Julibrissin, 22 parts of Daphne koreana, 20 parts of Rhizoma Cyperi, 18 parts of Dalbergia odorifera, 18 parts of Citron, 18 parts of Osmanthus fragrans, 18 parts of Costus root, 18 parts of Rhizoma Citri Reticulatae ... and 22 parts of Aquilaria woodii.

[0042] Example 5

[0043] The difference between this embodiment and embodiment 1 is that the Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Albizia Julibrissin flowers, 10 parts of Daphne koreana, 8 parts of Cyperus rotundus, 7 parts of Dalbergia odorifera, 7 parts of Citron, 7 parts of Osmanthus fragrans, 7 parts of Costus root, 7 parts of Rhizoma Citri Reticulatae ... and 10 parts of Aquilaria woods.

[0044] Example 6

[0045] The difference between this embodiment and embodiment 1 is that the Chinese medicine composition is composed of the following raw materials in parts by weight: 12 parts of Flos Albizia Julibrissin, 12 parts of Daphne koreana, 10 parts of Cyperus rotundus, 8 parts of Dalbergia odorifera, 8 parts of Citron, 8 parts of Osmanthus fragrans, 8 parts of Costus root, 8 parts of Rhizoma Citri Reticulatae ... and 12 parts of Aquilaria woodii.

[0046] Example 7

[0047] The difference between this embodiment and embodiment 1 is that the Chinese medicine composition is composed of the following raw materials in parts by weight: 25 parts of julibrissin flowers, 25 parts of white daphne, 20 parts of cyperus rotundus, 20 parts of dalbergia odorifera, 20 parts of citron, 20 parts of osmanthus fragrans, 20 parts of costus root, 20 parts of cinnamomum camphora, 20 parts of licorice root, and 25 parts of agarwood.

[0048] Example 8

[0049] The difference between this embodiment and embodiment 1 is that the Chinese medicine composition is composed of the following raw materials in parts by weight: 20 parts of Albizia Julibrissin flowers, 20 parts of Daphne koreana, 18 parts of Cyperus rotundus, 15 parts of Dalbergia odorifera, 15 parts of Citron, 15 parts of Osmanthus fragrans, 15 parts of Costus root, 15 parts of Rhizoma Citri Reticulatae ... and 20 parts of Aquilaria woodii.

[0050] Test Example 1

[0051] 1 Materials and Methods

[0052] 1.1 Experimental Animals

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

[0054] 1.2 Trial Drugs

[0055] The traditional Chinese medicine composition of the present invention comprises the following steps: 15 parts of Flos Albizia Julibrissin, 15 parts of Daphne koreana, 12 parts of Rhizoma Cyperi, 9 parts of Dalbergia odorifera, 9 parts of Citron, 9 parts of Osmanthus fragrans, 9 parts of Costus root, 9 parts of Rhizoma Citri Reticulatae, 9 parts of Rhizoma Citri Reticulatae, 9 parts of Rhizoma Citri Reticulatae, and 15 parts of Aquilaria woodii. The raw materials are weighed according to the above weight, washed, boiled in 8 times the amount of water for 30 minutes, filtered to obtain a filtrate, and the process is repeated twice. The two filtrates are combined and concentrated to a crude drug content of 1 g / mL to obtain a traditional Chinese medicine stock solution, which is stored at 4°C for standby use.

[0056] Control drug: fluoxetine hydrochloride.

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

[0058] Male Kunming mice were acclimated for one week, and their body weights were recorded. Before grouping, mice underwent sucrose water acclimation training. After 24 hours of water deprivation, a sucrose water preference test was performed. Mice that were overly sensitive or strongly disliked sucrose water were removed to maintain a consistent sucrose water preference. Eligible mice were randomly divided into six groups of seven: a normal group, a model group, a low-dose group (referred to as the low-dose group), a medium-dose group (referred to as the medium-dose group), a high-dose group (referred to as the high-dose group), and a positive control group. After three days of acclimation, all groups except the normal group were housed in solitary confinement and randomly administered one or two stimuli daily to replicate a chronic stress-induced depression model. These stimuli included fasting (12 hours), water deprivation (12 hours), day / night reversal, cold water swimming (4°C, 5 minutes), hot water swimming (45 minutes, 5 minutes), cage tilting, damp bedding, restraint, tail clamping, foot shock (1 minute), and shock. Each day, a randomized stimulus was administered at 9:00 AM, with no consecutive doses to prevent the mice from predicting the stimulus. The modeling time lasted for 7 weeks. Before modeling, the body weight of mice was recorded, and sugar preference and open field test behavioral experiments were recorded. After modeling, the mice showed weight loss, decreased sugar preference, and weakened spontaneous activity and exploratory behavior, indicating that the modeling was successful. One week after modeling, each group was gavage-administered while continuing the CUMS operation. The low-dose group was given 50 mg / kg of the Chinese medicine stock solution of the present invention, the medium-dose group was given 100 mg / kg of the Chinese medicine stock solution of the present invention, the high-dose group was given 200 mg / kg of the Chinese medicine stock solution of the present invention, and the positive control group was given 3.3 mg / kg of fluoxetine hydrochloride. The normal group and the model group were gavaged with equal amounts of normal saline. Each group was given once a day for 4 consecutive weeks.

[0059] 1.4 Detection of depressive-like behavior in mice using behavioral indicators

[0060] 1.4.1 Sugar water preference test

[0061] Before modeling, mice were trained to acclimate to 1% sucrose water in a quiet environment. Mice were housed individually in cages, with two identical water bottles placed in each cage. For the first 24 hours, both bottles contained 1% sucrose water. During the second 24 hours, one bottle contained 1% sucrose water and the other contained pure water. Afterward, both bottles of water were removed and weighed. Before the experiment and at week 7, each mouse underwent a sugar water preference test. Before the experiment, mice were deprived of food and water for 24 hours. Afterward, two pre-measured bottles of water were given to the mice: one containing 1% sucrose water and one containing pure water. After 24 hours, the mice were weighed and the amounts of sucrose and pure water consumed were recorded. Sugar water preference was calculated.

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

[0063] 1.4.2 Forced swimming test

[0064] The mice were placed in a glass cylinder 24 cm high and 15 cm in diameter at a water temperature of (25±1)°C and forced to swim for 6 min. The cumulative immobility time of the mice within the next 4 min was observed and recorded. The cumulative immobility time was when the mice stopped struggling, floated in the water and remained motionless, or only made some necessary slight movements to keep their heads floating on the water.

[0065] 1.4.3 Tail suspension test

[0066] The mouse's tail (about 1 cm from the tip of the tail) was fixed on a homemade tail suspension device (made of opaque material, a cube with a length, width and height of 40 cm, and a small wooden clamp fixed on an iron stand), so that the mouse's head was about 10 cm from the bottom of the box. Three people observed the mouse's activities for 6 minutes at the same time, recorded the cumulative immobility time of the mouse in the next 4 minutes, and calculated the average value.

[0067] 1.4.4 Open field test

[0068] Each mouse was gently placed in the middle of the open field test box. The mouse's movement trajectory was recorded for 5 minutes using the camera above. The horizontal movement score (total horizontal movement distance) and vertical score (number of standing times) were analyzed. Before testing each mouse, the bottom of the box was thoroughly cleaned with 75% ethanol to prevent odor from interfering with the experimental results of the next mouse.

[0069] 1.5 Sample collection and biological indicator determination

[0070] After behavioral testing, mice were anesthetized with 50 mg / kg sodium pentobarbital and sacrificed. Serum was collected and frozen at -20°C until further use. The brains were immediately dissected, and the hippocampal tissue was washed with saline and stored in liquid nitrogen until further use.

[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] Graphpad Prism 8.0 software was used for data statistical analysis and graphing. The results were expressed as mean ± standard deviation (Mean ± SD). The differences between the groups were compared using one-way analysis of variance, and P < 0.05 was considered statistically significant.

[0075] 2 Results

[0076] 2.1 Effects on the behavior of depression model mice

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

[0078] Table 1 Effects on depressive-like behaviors in depression model mice

[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 biological indicators of depression model mice

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

[0083] As shown in Table 2, compared with the blank group, the levels of IL-1β, TNF-α, and IL-4 in the serum of 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 Chinese herbal compound composition could significantly reduce the levels of IL-6, IL-1β, and TNF-α in the serum of the depression model mice (P<0.01 or P<0.05), indicating that the Chinese herbal compound composition has the effect of inhibiting the inflammatory response of the mouse body, among which the high-dose group has a better effect.

[0084] Table 2 Effects on the levels of inflammatory factors IL-6, IL-1β, and TNF-α in the serum of depression 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 5-HT, DA, and NE levels in the hippocampus of depression model mice

[0088] As shown in Table 3, compared with the blank group, the levels of 5-HT, DA, and NE in the hippocampus of the mice in the model group were significantly decreased (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 Chinese herbal compound composition could significantly increase the levels of 5-HT, DA, and NE (P<0.01 or P<0.05), indicating that the Chinese herbal compound composition has the effect of increasing the level of monoamine neurotransmitters in mice, among which the high-dose group has a better effect.

[0089] Table 3 Effects on 5-HT, DA and NE levels in the hippocampus of depression model mice

[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 Chinese medicine composition of the present invention can significantly increase the sugar consumption and open field movement distance of mice, reduce the tail suspension and swimming immobility time, and has a significant effect on improving the depressive-like behavior of depressed mice. At the same time, it can also significantly reduce the levels of inflammatory-related factors IL-6, IL-1β, and TNF-α in the serum of depression model mice, and increase the levels of monoamine neurotransmitters 5-HT, DA, and NE in mice. The Chinese medicine composition of the present invention can be developed and prepared as a drug for treating depression.

[0094] Test 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 between January 2023 and June 2024 were randomly divided into an observation group and a control group, with 36 patients in each group. The observation group included 15 males and 21 females, with a mean age of (16.89±3.61) years and a mean disease duration of (36.18±4.09) days. The control group included 13 males and 23 females, with a mean age of (17.06±2.44) years and a mean disease duration of (34.46±3.51) days. No statistically significant differences in general information were found between the two groups (P>0.05), indicating comparability between the two groups.

[0098] 1.2 Case screening criteria

[0099] 1.2.1 Western medicine diagnostic criteria

[0100] The diagnostic criteria for depression were formulated with reference to the Classification of Mental and Behavioral Disorders (ICD-10); the main symptoms of depression are: sleep disorders, loss of interest or pleasure, inattention or decreased thinking ability, mental decline or fatigue, low self-esteem, self-harm or suicidal behavior / ideas, and increased guilt or self-blame.

[0101] 1.2.2 Standards of TCM Dialectical Dialectics

[0102] If the patient meets the relevant diagnostic criteria for depression in the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases", the syndrome is diagnosed as liver qi stagnation syndrome, with reference to tongue and pulse, and the main symptoms must be combined with secondary symptoms (more than 2 items) to confirm the diagnosis.

[0103] 1.2.3 Inclusion criteria

[0104] The first diagnosis of depression was 11-18 years old, and they met the diagnostic criteria of traditional Chinese and Western medicine and were able to take Chinese herbal decoctions; their hearing, vision and mental state did not affect the completion of neuropsychological and scale assessment tests; and their nutritional status was good.

[0105] 1.2.4 Exclusion criteria

[0106] The patient has severe self-harm or suicidal tendencies; mental retardation or schizophrenia; a history of antidepressant medication or psychotherapy; allergy to medication; combined with severe organ dysfunction such as the heart, brain, liver, kidney, and lungs; poor compliance, etc.

[0107] 1.3 Treatment

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

[0109] The observation group took the water decoction of the Chinese medicine composition of the present invention orally on the basis of the control group, with the prescription as follows: 15 parts of Flos Albiziae, 15 parts of Daphne koreana, 12 parts of Rhizoma Cyperi, 9 parts of Dalbergia odorifera, 9 parts of Citron, 9 parts of Osmanthus fragrans, 9 parts of Costus root, 9 parts of Rhizoma Cyperi, 9 parts of Rhizoma Cyperi, and 15 parts of Aquilaria sinensis. The above raw materials were weighed by weight, decocted with 4 times the weight of water for more than 30 minutes, and decocted until 400 mL of the juice remained. The medicine 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 evaluate the severity of depression. Higher scores indicate more severe depression. The total score of the HAMD scale is 54 points. The grading criteria are: 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] The scale contains 7 items, including daytime function, sleep onset time, sleep disorders, etc., and uses the Likert 4-level scoring method with a score of 0-3 points, totaling 0-21 points. The lower the total score, the better the sleep quality.

[0115] 1.4.4 Traditional Chinese Medicine Symptom Score

[0116] Symptoms such as chest and flank distension, insomnia, and depression were evaluated before and after treatment, and scored according to the severity of the symptoms, with a total score of 0-6 points. The higher the score, the more severe the patient's symptoms.

[0117] 1.4.5 Efficacy criteria

[0118] The efficacy criteria were established in accordance with the Psychiatry Standards. Clinical cure: HAMD score decreased by ≥75%; marked effect: HAMD score decreased by ≥50%; effective: HAMD score decreased by ≥25%; ineffective: HAMD score decreased by <25%.

[0119] Total effective rate = (number of clinically cured + markedly effective + effective) cases / total number of cases × 100%.

[0120] 1.5 Statistical methods

[0121] SPSS 18.0 statistical software was used to express measurement data as mean ± standard deviation. Non-independent sample t-test was used between groups, paired sample t-test was used within groups, and enumeration data were expressed as percentage (%). Intergroup comparison was performed using χ2 test. 2 Test, P < 0.05 indicates that the difference is statistically significant.

[0122] 2 Results

[0123] 2.1 Clinical efficacy

[0124] As shown in Table 4, after treatment in each group, the total effective rate of the observation group was 94.4%, which was significantly higher than the total effective rate of the control group (77.8%), and 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] As shown in Table 5, there were no significant differences in the 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 those 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 between the two groups (points)

[0130]

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

[0132] 3 Conclusion

[0133] The present invention is based on the principle of TCM syndrome differentiation and treatment, and is compatible with a Chinese medicine composition consisting of Flos Julibrissin, Daphne koreana, Rhizoma Cyperi, Dalbergia odorifera, Citron, Osmanthus fragrans, Aucklandia lappa, Rhizoma Cyperi, Rhizoma Cyperi, Rhizoma Cyperi and Aquilaria sinensis. The Flos Julibrissin has the effects of relieving depression and calming the mind, regulating qi and appetizing, activating collaterals and relieving pain, and Aquilaria sinensis has the effects of promoting qi and relieving pain, warming the middle and stopping vomiting, and promoting qi and relieving asthma. The two complement each other and serve as the main medicine. Daphne koreana and Rhizoma Cyperi are auxiliary medicines. Daphne koreana has the effects of dispelling wind and dampness, activating blood circulation and relieving pain, and can enhance the calming and activating blood circulation and relieving pain effects of the main medicine. Rhizoma Cyperi has the effects of soothing the liver and relieving depression, regulating qi and relieving fullness, regulating menstruation and relieving pain, and can enhance the effects of regulating qi and relieving depression of the main medicine. It can cooperate with the main medicine to play the role of regulating emotions and qi; with agarwood, citron, and osmanthus as adjuvants, agarwood has the effects of removing blood stasis and stopping bleeding, regulating qi and relieving pain, and can assist the main medicine and the minister medicine to enhance the effect of regulating qi and relieving pain; citron has the effects of soothing the liver and regulating qi, relieving fullness and resolving phlegm, and can assist the main medicine and the minister medicine in regulating qi; osmanthus has the effects of promoting blood circulation and reducing swelling, detoxifying and stopping dysentery, and can assist other medicines to play the role of promoting blood circulation and promoting the circulation of qi and blood; with costus root, knotwood, and lily root as guiding medicines, costus root promotes qi and relieves pain, strengthens the spleen and digestion, knotwood relaxes muscles and activates collaterals, reduces inflammation and relieves pain, and lily root dispels wind and cold, regulates qi and relieves pain, and can enhance the qi and pain-promoting effect of the prescription. This prescription brings together all the aromatic herbs, with a special effect and great power, to play the role of soothing the liver and relieving depression, and regulating qi. The combination of the Chinese medicine composition of the present invention and 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 depression treatment.

[0134] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A Chinese medicine composition for treating depression, characterized in that: The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 5-25 parts of flos julibrissin, 5-25 parts of daphne koreana, 5-20 parts of cyperus rotundus, 5-20 parts of dalbergia odorifera, 5-20 parts of citron, 5-20 parts of osmanthus fragrans, 5-20 parts of costusroot, 5-20 parts of osmanthus fragrans, 5-20 parts of osmanthus fragrans, 5-20 parts of scutellaria baicalensis, and 5-25 parts of aquilaria sinensis.

2. A Chinese medicine composition for treating depression according to claim 1, characterized in that: The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10-20 parts of Flos Albiziae, 10-20 parts of Daphne koreana, 8-15 parts of Cyperus rotundus, 8-15 parts of Dalbergia odorifera, 8-15 parts of Citron, 8-15 parts of Osmanthus fragrans, 8-15 parts of Costusroot, 8-15 parts of Rhizoma Citri Reticulatae, 8-15 parts of Rhizoma Citri Reticulatae, 8-15 parts of Rhizoma Citri Reticulatae and 10-20 parts of Aquilaria Sinensis.

3. A Chinese medicine composition for treating depression according to claim 1, characterized in that: The Chinese medicine composition is composed of the following raw materials in parts by weight: 15 parts of Flos Albiziae, 15 parts of Daphne koreana, 12 parts of Rhizoma Cyperi, 9 parts of Dalbergia odorifera, 9 parts of Citron, 9 parts of Osmanthus fragrans, 9 parts of Costusroot, 9 parts of Rhizoma Citronellae ... and 15 parts of Aquilaria sinensis.

4. A method for preparing a Chinese medicine composition for treating depression according to any one of claims 1 to 3, characterized in that: The drug is prepared into an acceptable oral dosage form by conventional Chinese medicine pharmaceutical methods and combined with medically acceptable auxiliary materials.

5. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of drugs for preventing and / or treating depression.

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