CN115429864B - Traditional Chinese medicine composition for treating depression - Google Patents

Traditional Chinese medicine composition for treating depression Download PDF

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CN115429864B
CN115429864B CN202211148732.6A CN202211148732A CN115429864B CN 115429864 B CN115429864 B CN 115429864B CN 202211148732 A CN202211148732 A CN 202211148732A CN 115429864 B CN115429864 B CN 115429864B
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parts
composition
chinese medicine
traditional chinese
depression
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CN115429864A (en
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王宇红
韩远山
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Hunan University of Chinese Medicine
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Abstract

The invention discloses a traditional Chinese medicine composition for treating depression, which comprises the following traditional Chinese medicine raw materials, by weight, 0.5-6 parts of radix bupleuri, 0.5-6 parts of hypericum perforatum, 1-5 parts of white paeony root, 0.8-5 parts of radix curcumae, 0.8-5 parts of fingered citron, 1-6 parts of radix pseudostellariae, 1-5 parts of bighead atractylodes rhizome, 0.5-4 parts of poria with hostwood, 0.8-5 parts of spina date seed, 1-5 parts of valerian root and 1-6 parts of cortex albiziae. The composition has effects of dispersing stagnated liver qi, invigorating spleen, nourishing heart, tranquilizing mind, and resolving stagnation, and can be used for treating mild and moderate depression caused by liver qi stagnation, spleen deficiency, and malnutrition of heart and mind. The research results of pharmacodynamics and clinical curative effects show that the traditional Chinese medicine composition is an effective medicine for treating depression and promoting sleep.

Description

Traditional Chinese medicine composition for treating depression
The patent application is a divisional application of Chinese patent application of a traditional Chinese medicine composition for treating depression, which is named as application number 201911211392.5, of which the application date is 2019, 11 and 29.
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a traditional Chinese medicine composition for treating depression.
Background
Depression is a common affective and mental disorder disease, and along with the acceleration of the pace of life, depression has become a high-rise disease in today's society. According to world health organization statistics, the prevalence rate of various depression accounts for about 11% of the global population, and the risk of large-scale outbreaks of depression is 15% -20%. Many patients with multiple depression die from suicide due to lack of timely regular treatment, and it is expected that depression in 2020 will be the second greatest disease threatening human health.
At present, monoamine oxidase inhibitors, tricyclic antidepressants, tetracyclic antidepressants, 5-HT reuptake inhibitors, 5-HT-NE reuptake inhibitors and the like are mostly adopted for clinical treatment of depression, but most of the synthetic antidepressants have the defects of single action mechanism, large toxic and side effects, easy tolerance and recurrence, high drug value and the like. The traditional Chinese medicine considers that the depression belongs to the depression category, and the traditional Chinese medicine treats the depression in order to treat the depression integrally and based on syndrome differentiation, can realize multi-link, multi-target and multi-path regulation and control, and has the advantages of treating both principal and secondary aspect of disease, small toxic and side effects, obvious curative effect and difficult recurrence after healing. In addition, the development and the development of antidepressants are increasingly focused on traditional medicines at home and abroad, and even European and American countries with long synthetic medicine development are taking some traditional medicines with curative effects as main force medicines for treating depression. The anti-depression traditional Chinese medicine with good curative effect and small side effect is an urgent need for improving the incidence rate of depression, and has wide hazard and poor treatment effect.
The core symptoms of depression mainly include sleep disorder, drowsiness, debilitation, lack of interest, and pain in certain parts of the body, wherein sleep disorder and anorexia are the most common symptoms. Epidemiological studies have shown that over 80% of depressed patients have insomnia as the primary symptom (Insomnia in patients with depression: a STAR D report. Cns spectra, 2010,15 (6): 394-404), whereas depressed patients with insomnia as the primary clinical symptom reach 61.8%, and patients are mostly accompanied by symptoms with loss of appetite and weight (Residual symptoms after remission of major depressive disorder with citalopram and risk of relapse: a STAR D report. Psycholology Health & mediacic, 2010,40 (1): 41-50). Clinical investigation shows that depression with liver depression and spleen deficiency is the most frequent symptom, and depression starts in the liver, if the emotion is unsmooth, liver depression is loose, the spleen is affected by the transverse adverse qi, wood Yu Tu is obstructed, spleen is not healthy and is transported, and dyspepsia symptoms such as spleen deficiency and anorexia are easy to occur; for liver depression, qi stagnation and blood stasis, spleen deficiency and biochemical fatigue, heart failing to nourish, being unconscious, dreaminess and easy awakening are symptoms of insomnia. Depression patients often have poor appetite and sleep disorders. Therefore, the traditional Chinese medicine for soothing liver, strengthening spleen, nourishing heart, regulating qi, soothing nerves and relieving depression has great potential advantages in treating depression with insomnia and spleen and stomach disorder as core symptoms. However, the traditional Chinese medicine for resisting depression is lack of medicines which not only improve sleep but also condition spleen and stomach as target for resisting depression. Therefore, the traditional Chinese medicine composition with unique curative effects of improving sleep, conditioning spleen and stomach and resisting depression is developed and has good social significance and economic significance.
Disclosure of Invention
Based on the defects of the prior art, the invention aims to provide an antidepressant traditional Chinese medicine composition which has the advantages of soothing liver, regulating qi, strengthening spleen, nourishing heart, soothing nerves and relieving depression.
The invention relates to a traditional Chinese medicine composition for treating depression, which comprises the following raw materials: 0.5 to 6 parts of bupleurum, 0.5 to 6 parts of hyperforin, 1 to 5 parts of white peony root, 0.8 to 5 parts of radix curcumae and 0.8 to 5 parts of fingered citron.
Preferably, the bulk drug also comprises 1-6 parts of radix pseudostellariae and/or 1-5 parts of bighead atractylodes rhizome.
Preferably, the bulk drug also comprises one or more of poria with hostwood 0.5-4 parts, wild jujube seed 0.8-5 parts, valerian 1-5 parts and cortex albiziae 1-6 parts.
Preferably, the bulk drug also comprises 0.5-3 parts of liquorice.
Preferably, the bulk drugs are: 0.5 to 6 parts of bupleurum, 0.5 to 6 parts of hyperforin, 1 to 5 parts of white peony root, 0.8 to 5 parts of radix curcumae, 0.8 to 5 parts of fingered citron, 1 to 6 parts of radix pseudostellariae and/or 1 to 5 parts of bighead atractylodes rhizome.
Preferably, the bulk drugs are: 0.5 to 6 parts of bupleurum, 0.5 to 6 parts of hypericum perforatum, 1 to 5 parts of white paeony root, 0.8 to 5 parts of radix curcumae, 0.8 to 5 parts of fingered citron, 0.5 to 4 parts of poria with hostwood, 0.8 to 5 parts of spina date seed, 1 to 5 parts of valerian and 1 to 6 parts of cortex albiziae.
Preferably, the bulk drugs are: 0.5 to 6 parts of bupleurum, 0.5 to 6 parts of hypericum perforatum, 1 to 5 parts of white paeony root, 0.8 to 5 parts of radix curcumae, 0.8 to 5 parts of fingered citron, 1 to 6 parts of radix pseudostellariae and/or 1 to 5 parts of bighead atractylodes rhizome, 0.5 to 4 parts of poria with hostwood, 0.8 to 5 parts of spina date seed, 1 to 5 parts of valerian root and 1 to 6 parts of cortex albiziae.
Most preferably, the bulk drugs are: 0.5 to 6 parts of bupleurum, 0.5 to 6 parts of hyperforin, 1 to 5 parts of white peony root, 0.8 to 5 parts of radix curcumae, 0.8 to 5 parts of fingered citron, 1 to 6 parts of radix pseudostellariae and/or 1 to 5 parts of bighead atractylodes rhizome, 0.5 to 4 parts of poria with hostwood, 0.8 to 5 parts of spina date seed, 1 to 5 parts of valerian, 1 to 6 parts of cortex albiziae and 0.5 to 3 parts of liquorice.
In the formula, bupleurum root is used as a monarch for soothing liver and relieving depression. The ministerial drugs are hyperforin to strengthen the force of soothing liver and relieving depression of the monarch drug; white peony root nourishes blood and softens liver to prevent liver Yu Ri from consuming yin blood for a long time; radix Curcumae has effects of activating qi-flowing and resolving stagnation; the fingered citron has the effects of soothing liver, regulating qi and regulating middle warmer, and the combination of the curcuma aromatica and the fingered citron has the effect of regulating liver qi; radix Pseudostellariae and Atractylodis rhizoma have effects of invigorating spleen and qi, and strengthening soil to prevent wood counter-restriction. With Poria and semen Ziziphi Spinosae for nourishing heart and tranquilizing; valerian tranquillizes and regulates qi; cortex Albiziae tranquillizing and resolving stagnation. Licorice root, radix Glycyrrhizae Praeparata has the effects of invigorating spleen and replenishing qi, and harmonizing the drugs, and is used as a guide. The whole formula has the functions of liver-soothing, qi-regulating, spleen-strengthening, heart-nourishing, nerve-soothing and depression-relieving.
The invention also aims to provide a preparation method of the traditional Chinese medicine composition for treating depression or depression state, which comprises the following steps: can be decocted for administration, or extracted with water or ethanol for administration, or pulverized into powder for administration.
The preparation method of the traditional Chinese medicine composition preparation can be carried out by adopting a conventional method in the pharmaceutical field and using conventional auxiliary materials. For example, the extract can be mixed with any one or more pharmaceutically acceptable carriers or adjuvants by conventional method, and made into various oral dosage forms. Such as excipients, fillers, diluents, lubricants, wetting agents, disintegrants, surfactants, preservatives, sweeteners, flavoring agents and the like. Specifically, the carrier is exemplified by starch, dextrin, lactose, microcrystalline cellulose, hydroxypropyl methylcellulose, polyethylene glycol, magnesium stearate, colloidal silicon dioxide, glucose, mannitol, xylitol, glycine, and the like.
According to the needs, the traditional Chinese medicine composition can be prepared into a preparation suitable for oral administration; can be any of the following dosage forms: decoction, tablet, capsule, soft capsule, powder, granule, dripping pill, oral liquid, syrup, etc. The tablet comprises a dispersible tablet and an orally disintegrating tablet.
The invention provides a preferred preparation method of a traditional Chinese medicine composition for treating depression, which comprises the following steps: the method comprises the following steps:
weighing the traditional Chinese medicine raw materials, adding 0-70% ethanol water solution, extracting for 2-3 times, and adding 4-12 times of solvent each time; extracting for 1-2 hours each time, mixing the extracting solutions, filtering, recovering the solvent, concentrating, drying, crushing, adding auxiliary materials as raw materials of the composition preparation, and preparing clinically acceptable dosage forms.
The invention also aims to provide the application of the traditional Chinese medicine composition and the preparation thereof in the aspect of treating depression and the like.
The prescription disclosed by the invention has the functions of soothing liver, regulating qi, strengthening spleen, nourishing heart, soothing nerves and relieving depression, and is used for treating light and moderate depression caused by liver depression, spleen deficiency and malnutrition of heart spirit. Pharmacodynamic studies have shown that: the Chinese medicinal composition has obvious antidepressant and sleep promoting effects. The clinical curative effect research results show that the traditional Chinese medicine composition has remarkable anti-depression curative effect, can improve the sleep quality of patients, effectively improve various traditional Chinese medicine symptoms of patients with depression liver-qi depression spleen deficiency, improves the life quality of the patients, has fewer adverse reactions and has high safety.
Detailed Description
For the purpose of illustrating the invention in further detail, specific examples are given for the purpose of illustration only and are not intended to limit the scope of the invention.
EXAMPLE 1 granule formulation of the Chinese medicinal composition of the present invention
The preparation method of the granule comprises the steps of taking 6 parts of bupleurum, 6 parts of hypericum perforatum, 5 parts of white peony root, 5 parts of radix curcumae, 5 parts of fingered citron, 6 parts of radix pseudostellariae, 5 parts of bighead atractylodes rhizome, 4 parts of poria with hostwood, 5 parts of spina date seed, 5 parts of valerian, 6 parts of cortex albiziae and 3 parts of liquorice, soaking in water for 0.5 hour, extracting for 2 times, adding 10 times and 8 times of water respectively, extracting for 2 hours for the first time, extracting for 1.5 hours for the second time, filtering, merging the filtrates, concentrating, drying, crushing, adding a proper amount of auxiliary materials, uniformly mixing, granulating, sieving and drying to obtain the granule-type pharmaceutical composition preparation.
EXAMPLE 2 tablet dosage form of the pharmaceutical composition of the invention
By adopting a conventional method for preparing tablets, 0.5 part of bupleurum, 0.5 part of hypericum perforatum, 1 part of white paeony root, 0.8 part of radix curcumae, 0.8 part of fingered citron, 1 part of radix pseudostellariae, 1 part of bighead atractylodes rhizome, 0.5 part of poria with hostwood, 0.8 part of semen zizyphi spinosae, 1 part of valerian, 1 part of cortex albiziae and 0.5 part of liquorice are taken, are soaked in 70% ethanol for 0.5 hour and then extracted for 2 times, the water addition amount is 6 times and 4 times respectively, the first extraction is carried out for 2 hours, the second extraction is carried out for 1 hour, the filtrate is filtered, the filtrate is combined, the mixture is concentrated, dried and crushed, and then a proper amount of auxiliary materials is added, and the mixture is uniformly mixed, granulated, sieved and dried, and the prepared granules are further pressed into tablets, and dried, so that the pharmaceutical composition preparation in a tablet formulation is prepared.
EXAMPLE 3 Capsule dosage form of the pharmaceutical composition of the invention
The preparation method of the capsule comprises the steps of taking 1 part of bupleurum, 1 part of hypericum perforatum, 2 parts of white paeony root, 2 parts of radix curcumae and 1.5 parts of fingered citron, adding 60% ethanol, soaking for 0.5 hour, extracting for 2 times, adding water with the amount of 7 times and 5 times respectively, extracting for 2 hours for the first time, extracting for 1 hour for the second time, filtering, combining filtrates, concentrating, drying, crushing, adding a proper amount of auxiliary materials, uniformly mixing, granulating, sieving, drying, filling the prepared particles into capsule shells, and preparing the capsule, thus obtaining the pharmaceutical composition preparation in a capsule form.
EXAMPLE 4 dripping pill-type composition of the present invention
By adopting the conventional process for preparing the dripping pill, 2 parts of bupleurum, 1.5 parts of hypericum perforatum, 3 parts of white paeony root, 3 parts of radix curcumae, 2 parts of fingered citron and 3 parts of radix pseudostellariae are taken, 50% ethanol is added for soaking for 0.5 hour, then the dripping pill is extracted for 2 times, the water addition amount is respectively 6 times and 4 times, the first extraction is carried out for 2 hours, the second extraction is carried out for 1 hour, the filtering is carried out, the filtrate is combined, the concentration, the drying and the crushing are carried out, and then a proper amount of auxiliary materials is added, thus preparing the dripping pill of the pharmaceutical composition.
EXAMPLE 5 Soft Capsule dosage form of the composition of the invention
The preparation method comprises the steps of adopting a conventional process for preparing soft capsules, taking 3 parts of bupleurum, 2 parts of hypericum perforatum, 4 parts of white paeony root, 4 parts of radix curcumae, 3 parts of fingered citron and 3 parts of bighead atractylodes rhizome, adding 40% ethanol, soaking for 0.5 hour, extracting for 2 times, adding water for 7 times and 5 times respectively, extracting for 2 hours for the first time, extracting for 1 hour for the second time, filtering, merging filtrate, concentrating, drying, crushing, adding a proper amount of auxiliary materials, mixing uniformly, using gelatin as a capsule shell material, and pressing into soft capsules to prepare the soft capsules of the pharmaceutical composition.
EXAMPLE 6 pellets of the composition of the invention
By adopting the conventional process for preparing the micropill, 2 parts of bupleurum, 3 parts of hypericum perforatum, 2.5 parts of white peony root, 4.5 parts of radix curcumae, 4 parts of fingered citron, 5 parts of radix pseudostellariae, 3 parts of bighead atractylodes rhizome, 2.5 parts of poria with hostwood, 4.5 parts of semen zizyphi spinosae, 3.5 parts of valerian, 5 parts of cortex albiziae and 2.5 parts of liquorice are taken, are soaked in 30% ethanol for 0.5 hour and then are extracted for 2 times, the water addition amounts are 6 times and 4 times respectively, the first extraction is carried out for 2 hours, the second extraction is carried out for 1 hour, the filtration is carried out, the filtrate is combined, and the appropriate auxiliary materials are added after concentration, drying and crushing, thus obtaining the micropill of the pharmaceutical composition.
EXAMPLE 7 orally disintegrating tablet of the composition of the invention
By adopting the conventional process for preparing the orally disintegrating tablet, 2.5 parts of bupleurum, 1 part of hypericum perforatum, 3 parts of white paeony root, 2 parts of radix curcumae, 2 parts of fingered citron, 2.5 parts of radix pseudostellariae, 3 parts of bighead atractylodes rhizome, 3 parts of poria with hostwood and 4 parts of wild jujube seed are taken, extracted for 2 times after adding 60% of ethanol, the water addition amount is 6 times and 4 times respectively, the first extraction is carried out for 2 hours, the second extraction is carried out for 1 hour, the filtration is carried out, the filtrates are combined, and a proper amount of auxiliary materials are added after concentration, drying and crushing, thus obtaining the orally disintegrating tablet of the pharmaceutical composition.
EXAMPLE 8 dispersible tablet form of the composition of the invention
By adopting a conventional process for preparing dispersible tablets, 0.5 part of bupleurum, 1 part of hypericum perforatum, 5 parts of white paeony root, 0.8 part of radix curcumae, 0.8 part of fingered citron, 6 parts of radix pseudostellariae, 4 parts of bighead atractylodes rhizome, 2 parts of valerian, 2 parts of cortex albiziae and 1 part of liquorice are taken, 70% ethanol is added for soaking for 0.5 hour, then the water adding amount is 6 times and 4 times respectively, the first extraction is carried out for 2 hours, the second extraction is carried out for 1 hour, the filtrates are filtered, and the filtrates are combined, concentrated, dried and crushed, and then an appropriate amount of auxiliary materials is added, so that the dispersible tablet of the pharmaceutical composition is prepared.
EXAMPLE 9 pharmacological toxicity test of the invention
The purpose of this test is to observe the pharmacological and toxicological effects of the traditional Chinese medicine composition of the present invention on depression models. The composition A, B, C, D, E of the invention adopts dry extract powder, and the required concentration is prepared by purified water when in use. The dosages are crude drug dosages.
The preparation method of the tested composition is the same, and the specific steps are as follows:
composition A: 3 parts of bupleurum, 1 part of hypericum perforatum, 3 parts of white peony root, 3 parts of curcuma aromatica and 3 parts of fingered citron, soaking in water for 0.5 hour, extracting for 2 times, wherein the water adding amount is 12 times and 10 times respectively, extracting for 2 hours for the first time, extracting for 1 hour for the second time, filtering respectively, merging filtrate, concentrating, drying and crushing to obtain dry extract powder of the composition A.
Composition B: 3 parts of bupleurum, 1 part of hypericum perforatum, 3 parts of white peony root, 3 parts of curcuma aromatica, 3 parts of fingered citron, 4 parts of radix pseudostellariae and 2 parts of bighead atractylodes rhizome, soaking in water for 0.5 hour, extracting for 2 times, wherein the water adding amount is 12 times and 10 times respectively, extracting for 2 hours for the first time, extracting for 1 hour for the second time, filtering respectively, merging filtrate, concentrating, drying and crushing to obtain dry extract powder of the composition B.
Composition C: 3 parts of bupleurum, 1 part of hypericum perforatum, 3 parts of white peony root, 3 parts of curcuma aromatica, 3 parts of fingered citron, 3 parts of poria with hostwood, 3 parts of spina date seed, 2 parts of valerian and 3 parts of cortex albiziae, soaking in water for 0.5 hour, extracting for 2 times, wherein the water adding amount is respectively 12 times and 10 times, extracting for 2 hours for the first time, extracting for 1 hour for the second time, filtering respectively, merging the filtrates, concentrating, drying and crushing to obtain the dry extract powder of the composition C.
Composition D: 3 parts of bupleurum, 1 part of hypericum perforatum, 3 parts of white peony root, 3 parts of curcuma aromatica, 3 parts of fingered citron, 4 parts of radix pseudostellariae, 2 parts of bighead atractylodes rhizome, 3 parts of poria with hostwood, 3 parts of spina date seed, 2 parts of valerian, 3 parts of cortex albiziae, soaking in water for 0.5 hour, extracting for 2 times, adding water in an amount which is 12 times and 10 times respectively, extracting for 2 hours for the first time, extracting for 1 hour for the second time, filtering respectively, merging filtrate, concentrating, drying and crushing to obtain the composition D dry extract powder.
Composition E: 3 parts of radix bupleuri, 1 part of hypericum perforatum, 3 parts of white peony root, 3 parts of radix curcumae, 3 parts of fingered citron, 4 parts of radix pseudostellariae, 2 parts of bighead atractylodes rhizome, 3 parts of poria with hostwood, 3 parts of semen ziziziphi spinosae, 2 parts of valerian, 3 parts of cortex albiziae and 1 part of liquorice, soaking in water for 0.5 hour, extracting for 2 times, respectively 12 times and 10 times of water, extracting for 2 hours for the first time, extracting for 1 hour for the second time, respectively filtering, merging filtrate, concentrating, drying and crushing to obtain the dry extract powder of the composition E.
1. Influence on the behaviours of rats in the model of chronic stress depression
Preparation of animal groups and models: 80 rats scored similarly by the Open-Field method were selected and randomly divided into 8 groups of 10 rats: namely, a blank group, a model group, a venlafaxine group, a composition A group, a composition B group, a composition C group, a composition D group and a composition E group, wherein each group is fed in a single cage except the blank group, and a model of depressed rats is established by giving chronic unpredictable temperature and stress, and stimulus factors comprise: the water bath at 4 ℃ is reversed for 24 hours, ice water bath at 4 ℃ is carried out for 4 minutes, fasted for 24 hours, water forbidden for 24 hours, cage tilting for 45 DEG for 24 hours, tail clamping for 1 minute, noise is carried out for 4 hours, wherein the ice water bath at 4 ℃ and tail clamping are respectively carried out once a week, and the rest stimulation is randomly carried out every day for 31 days. Sleep deprivation was performed on days 29-31 in a plateau aqueous environment for 72 hours. The administration is performed by stomach irrigation during molding, and the administration doses are shown in tables 1, 2 and 3. The composition dosage is crude drug dosage.
(1) Effects of each composition on the syrup bias of depressed model rats: after the rats are fasted and forbidden for 12 hours, two bottles of water (pre-weighed initial weight) are placed in the cage, one bottle is 1% sucrose water, the other bottle is distilled water, and after 30 minutes, the two bottles of water are exchanged in position and are timed for 30 minutes. Rats 1% sucrose intake in 1 hour were calculated, and the syrup preference = sucrose intake/(sucrose intake + distilled water intake) ×100%. The test was performed once a week for 4 weeks. The results are shown in Table 1.
Table 1 comparison of sugar water preference degree of rats in each groupn＝10)
Note that: in contrast to the blank group, * P<0.05; in contrast to the group of chronic stress, # P<0.05， ## P<0.01; compared to composition a: ▲ P<0.05, ▲▲ P<0.01; comparison with composition B: ■ P<0.05, ■■ P<0.01; comparison with composition C: ☆ P<0.05， ☆☆ P<0.01.
as can be seen from table 1, the sugar water preference of rats in the second and third weeks was significantly increased (P <0.05 or P < 0.01) in the venlafaxine group and the composition B, C, D, E of the present invention as compared to the model group; on the fourth week of molding, the sugar water preference of rats in both the group A, B, C, D, E of the composition of the invention and the group venlafaxine was significantly increased (P <0.05 or P < 0.01). The second and third week compositions B, D, E group rats had significantly increased sugar water preference (P < 0.05) compared to composition a; group B, C, D, E rats with the fourth group had significantly increased sugar water preference (P < 0.05). Rats in group D, E had significantly increased sugar water preference (P < 0.05) compared to group B, C.
The results show that the composition A, B, C, D, E can improve the responsiveness of depressed rats to pleasure. Wherein, compared with composition a, composition B, D, E has the characteristic of quick effect, and the drug effect of composition D, E is better than that of composition A, B, C; composition B, C also performs better than composition a.
(2) Effects of each composition on rat voluntary activity: and after the molding is finished, observing the autonomous activity by adopting an open-field method. The number of animals crossing the ground was used as the horizontal activity score, the number of standing (two forepaws were separated simultaneously) was used as the vertical activity score, and each rat was measured only once for 3min 28 days after the drug. The results are shown in Table 2.
TABLE 2 comparison of independent activities of rats in each groupn＝10)
Note that: in contrast to the blank group, * P<0.05; in contrast to the group of chronic stress, # P<0.05， ## P<0.01; compared to composition a: ▲ P<0.05, ▲▲ P<0.01; comparison with composition B: ■ P<0.05, ■■ P<0.01; comparison with composition C: ☆ P<0.05， ☆☆ P<0.01.
as can be seen from table 2, the number of independent activities was increased (P <0.05 or P < 0.01) in rats in the present composition A, B, C, D, E group and venlafaxine group compared to the model group; the number of independent activities was significantly increased in rats in group B, C, D, E (P <0.05 or P < 0.01) compared to group a; the number of autonomous activities was significantly increased in the group of rats with composition D, E (P < 0.05) compared to the group with composition B, C. The results show that the composition A, B, C, D, E can improve the autonomous activity of rats in a chronic stress depression model, improve the interest loss and relieve depression-like behaviors. Wherein, the drug effect of the composition D, E is obviously better than that of the composition A, B, C; composition B, C also performs better than composition a.
(3) Effects of each composition on the feeding of rats: after the rats are fasted and not fasted for 24 hours, a layer of wood with the thickness of about 1.5cm is paved at the bottom of a square uncovered open box (specification: 80cm multiplied by 40 cm), thirty equal volumes of food are placed in the center of the box, animals are placed in the test box from the same position facing the box wall, after the rats are adapted for 30 seconds, the incubation period of the first foraging of the rats within 5 minutes is observed and recorded. The results are shown in Table 3.
TABLE 3 comparison of foraging latency for rats in each groupn＝10)
Note that: in contrast to the blank group, * P<0.05; in contrast to the group of chronic stress, # P<0.05， ## P<0.01; compared to composition a: ▲ P<0.05, ▲▲ P<0.01; comparison with composition B: ■ P<0.05, ■■ P<0.01; comparison with composition C: ☆ P<0.05， ☆☆ P<0.01.
from table 3, the foraging latency of rats was significantly reduced in the present compositions A, B, C, D, E and venlafaxine groups (P <0.05 or P < 0.01) compared to the model group. Group B, D, E rats had significantly reduced foraging latency (P <0.05 or P < 0.01) compared to group a; the foraging latency was significantly reduced in the group of rats with composition D, E (P < 0.05) compared to the group with composition B, C.
The results show that the composition A, B, C, D, E can improve the desire of the rats with chronic stress depression model to explore and ingest under the conditions of hunger and environmental fear, and the effect of the composition B, D, E is better than that of the composition A; composition D, E also has an effect superior to B, C.
2. Effect of compositions on sleep State in mice
(1) Effect of each composition on sodium pentobarbital induced sleep time and latency
SPF-class male ICR mice were randomized into 7 groups: blank, ballast, composition a, composition B, composition C, composition D, composition E,20 each. The administration doses are shown in Table 4 after 7 days of continuous gastric lavage. The dosages are crude drug dosages. The water is not forbidden for 12 hours before the last administration, and 48mg/kg of pentobarbital sodium is injected intraperitoneally after the last administration for 1 hour (the dosage is determined in a pre-experiment). The time from the intraperitoneal injection to the extinction of the specular reflection is recorded as a sleep latency period, the duration of the extinction of the specular reflection is recorded as a sleep time, and the statistical analysis is carried out on all experimental data of the part by adopting single-factor analysis of variance. The results are shown in Table 4.
TABLE 4 influence of each drug on sleep conditions in micen＝20)
Note that: in contrast to the blank group, # P<0.05， ## P<0.01; compared to composition a: ▲ P<0.05, ▲▲ P<0.01; comparison with composition B: ■ P<0.05, ■■ P<0.01; comparison with composition C: ☆ P<0.05， ☆☆ P<0.01.
as can be seen from table 4, the mice in the stable group and composition C, D, E group and the stable group have significantly shortened sleep latency and significantly prolonged sleep duration (P < 0.01) compared to the blank group. The mice in group C, D, E had significantly longer sleep latency and sleep duration (P < 0.05) compared to groups a and B.
The results indicate that the composition C, D, E can shorten the sleep latency of the mice and prolong the sleep time. And composition C, D, E works better than composition A, B.
(2) Effect of each composition on pentobarbital sodium subthreshold dose hypnotic experiments
SPF-class male ICR mice 140 were randomly divided into 7 groups, each of which was blank, stable, composition A, composition B, composition C, composition D, and composition E, each of which was 20, and administered continuously for 7 days, and the administration doses are shown in Table 5. The administration dosage is crude drug dosage. Abdominal injection of pentobarbital sodium 30mg/kg (pre-experiment confirmed dosage) after the last administration for 1h takes the disappearance of the regular reflection for 1min as the falling asleep index, records the falling asleep number and falling asleep rate of the mice, and adopts chi-square test to carry out statistical analysis on the data. The results are shown in Table 5.
TABLE 5 influence of each drug on the sleep occurrence in micen＝20)
Note that: in contrast to the blank group, # P<0.05， ## P<0.01; compared to composition a: ▲ P<0.05, ▲▲ P<0.01; comparison with composition B: ■ P<0.05, ■■ P<0.01; comparison with composition C: ☆ P<0.05， ☆☆ P<0.01.
as can be seen from table 5, the mice in the group C, D, E and the stable group of the present invention had significantly increased numbers of falls asleep and rates of falls asleep (P <0.05 or P < 0.01) compared to the blank group; the mice in group C, D, E had significantly increased numbers of falls asleep and rates of falls asleep (P <0.05 or P < 0.01) compared to groups a and B. The results indicate that composition C, D, E has a sleep-promoting effect and is superior to composition A, B.
Pharmacological test results show that the composition A, B, C, D, E can improve the shortness of sense and lack of interest of rats with chronic stress depression models and relieve the action of depression-like behaviors of the rats; the composition C, D, E can shorten sleep latency and prolong sleep time of mice. Suggesting that composition A, B, C, D, E has significant antidepressant effect and that composition B, D, E has a faster onset than composition a, composition D, E has better antidepressant effect than composition A, B, C; composition C, D, E has sleep promoting effect and is superior to composition A, B.
3. Acute toxicity test of the inventive composition
The experimental method comprises the following steps: 30 ICR mice with the weight of 18-22 g are taken, and SPF grade male and female mice are divided into 3 groups: blank, composition D, composition E, 10 per group. Fasted for 12 hours before administration, and single administration of oral gastric lavage is adopted, wherein the administration dosage is 186 times of the clinical dosage of an adult of 70 kg. The subjects were fasted for another 3-4 hours after administration of the drug, closely observed for common symptoms for 8 hours, and observed for a duration of 14 days.
Experimental results: after administration, mice showed reduced activity times, somnolence, fluffy hair, darker stool, etc. to varying degrees. 1 female mouse dies at 16h after the composition D is dosed, and no macroscopic main organ pathological change is seen after dissection; all animals did not die during the composition group E trial. There were no statistical differences in body weights of mice in both group D and group E compared to the blank.
Conclusion of experiment: composition D, E is safer and composition E is better than composition D.
EXAMPLE 11 observation of the clinical efficacy of the composition of the present invention for treating depression
The aim of this test was to observe the therapeutic effect of the traditional Chinese medicine composition of the invention on depression patients, composition E: 3 parts of bupleurum, 1 part of hypericum perforatum, 3 parts of white peony root, 3 parts of curcuma aromatica, 3 parts of fingered citron, 4 parts of radix pseudostellariae, 2 parts of bighead atractylodes rhizome, 3 parts of poria with hostwood, 3 parts of semen ziziziphi spinosae, 2 parts of valerian, 3 parts of cortex albiziae and 1 part of liquorice, soaking in water for 0.5 hour, extracting for 2 times, respectively 12 times and 10 times of water, extracting for 2 hours for the first time, extracting for 1 hour for the second time, respectively filtering, merging filtrate, concentrating, drying, crushing, adding an appropriate amount of auxiliary materials, mixing, granulating, tabletting the prepared granules further, and preparing tablets, wherein each tablet contains 2g of crude drugs.
1 data and method
1.1 clinical data
1.1.1 Western diagnostic criteria referring to relevant diagnostic criteria in the third edition of the Chinese mental disorder Classification and diagnostic criteria (mental disorder Classification): clinical manifestations of mental retardation and at least 4 or more of the following can be diagnosed: (1) loss of interest, no pleasure; (2) reduced energy or fatigue; (3) psychomotor retardation or agitation; (4) self-assessment is too low, self-responsibility, or there is guilt; (5) difficulty in association or reduced conscious thinking ability; (6) Repeatedly appearing thinking of death or having suicide and suicide behavior; (7) Sleep disorders such as insomnia, wakefulness, or hypersomnia; (8) reduced appetite or significantly reduced weight; (9) decreased sexual desire.
1.1.2 diagnosis criteria for traditional Chinese medical science and diagnosis are formulated by referring to the diagnosis criteria of traditional Chinese medical science. Syndrome of liver depression and spleen deficiency: (1) main symptoms: (1) mental depression or restlessness; (2) distending pain in the hypochondrium or gastric cavity; (3) abdominal distension; (4) poor appetite and anorexia; (5) loose stool. (2) concomitant diseases: (1) irritability; (2) frequent sighing; (3) borborygmus and flatus; (4) abdominal pain is the relief of diarrhea and pain after diarrhea. Pulse condition of tongue: a white or greasy tongue coating, a wiry or wiry and thready pulse. When the diagnosis is carried out, the symptoms of depression or restlessness are one of the main symptoms, the other main symptoms and secondary symptoms are 2 or more, and the patients with tongue pulse condition support can be diagnosed.
1.1.3 cases inclusion criteria (1) meets the criteria for western medicine diagnosis of depression; (2) the traditional Chinese medicine syndrome waiting diagnosis accords with the syndrome of liver depression and spleen deficiency; (3) patients between the ages of 16-80 years, signed informed consent: (4) patients who do not take the traditional Chinese medicine and the western medicine related to the disease in about 1 month.
1.1.4 cases exclusion criteria (1) aged under 16 years old or over 80 years old; (2) Organic mental disorders, or high risk depression caused by psychoactive and non-addictive substances; (3) The patients do not meet the Western diagnosis standard of depression and the diagnosis standard of liver depression and spleen deficiency in traditional Chinese medicine; (4) pregnant or lactating women; (5) suspected or confirmed alcohol, drug abuse history; (6) Allergy to composition E and sertraline, or similar medical allergy history in the past; (7) Severe target organ damage, or severe primary diseases incorporating heart, brain, liver, kidney and hematopoietic systems.
1.2 method
1.2.1 treatment methods all observed cases were divided into positive drug control and composition E groups according to the random number table method using the randomized, blind, control principles. The positive drug control group is prepared from sertraline hydrochloride tablet (Zhejiang Hua Hai pharmaceutical Co., ltd., national drug standard character: H20080141) for treatment: the initial dose is 50mg daily, gradually increasing to 100mg daily over 2 weeks, 1 time daily, and taken in the morning. Composition E group: 5 tablets (0.5 g/tablet) each time, orally taken 3 times a day. Each group was treated with 4 weeks as a course of treatment, and 2 courses of treatment were observed for 8 weeks.
1.2.2 observations and method evaluation of each scale were recorded at weeks 0,4, 8 of the experimental group. (1) symptom score of depression liver depression spleen deficiency syndrome: major symptoms (vexation and irritability, mental depression, restlessness): none (0 score), mild (2 score), moderate (4 score), severe (6 score); secondary symptoms (happiness of the patient to get the wrong, distending pain in the wrist and hypochondrium, abdominal distention, poor appetite, loose stool, borborygmus and flatus): none (0 score), mild (1 score), moderate (2 score), severe (3 score); (2) Changes in the hamilton depression scale (HAMD-17), the pittsburgh sleep quality index scale (PSQI), the total integral of the symptoms of the traditional Chinese medicine, the efficacy evaluation of the single symptom and the efficacy evaluation of the disease before and after treatment.
1.2.3 evaluation of disease efficacy referring to the "guidelines for prevention and treatment of depressive disorder in China" (edition 2015, main edition of China medical society), judgment of antidepressant efficacy (1) clinical recent cure: the integral of the Hamiltonian depression scale (HAMD-17) is less than or equal to 7 points, the depression symptoms basically disappear, the interest is improved, the fatigue is eliminated, the sleep is improved, the self evaluation of patients is improved, and the social function is improved; (2) obvious effect: the integral of the Hamiltonian depression scale (HAMD-17) is reduced by more than or equal to 50 percent, the depression symptom is improved, the interest is improved, the fatigue is relieved, the sleep is improved, the self evaluation of patients is improved, and the social function is improved; (3) effective: the integral of the Hamiltonian depression scale (HAMD-17) is reduced by more than or equal to 25%, depression symptoms are relieved, interests are slightly improved, fatigue is relieved, sleep is improved, and self evaluation of patients is improved. (4) ineffective: the integral of the hamilton depression scale (HAMD-17) is reduced by less than 25%, and symptoms and signs of depression are not obviously changed or aggravated, or the behavior of self-injury, suicide and the like occurs.
1.2.4 total integral curative effect criteria of traditional Chinese medical science symptoms (1) clinical recent cure: the integral reduction of clinical symptoms and signs is more than or equal to 95%; (2) obvious effect: the integral reduction of clinical symptoms and signs is more than or equal to 70 percent and less than 95 percent; (3) effective: the integral reduction of clinical symptoms and signs is more than or equal to 30 percent and less than 70 percent. (4) ineffective: symptoms and signs of depression decrease less than 30%.
1.2.5 evaluation of the curative effect of the single symptom, namely happiness and tai chi, distending pain in the hypochondrium, abdominal distension, anorexia, loose stool and borborygmus. Evaluation criteria: (1) clinically recent recovery: all the single symptoms disappear; (2) obvious effect: the symptoms of the finger items are obviously improved, and the score of more than 2 symptoms in the multiple symptoms is reduced by 2-3 points; (3) effective: improvement of the symptoms of the finger, wherein the score of more than 2 symptoms in the multiple symptoms is reduced by 1 score; (4) ineffective: the symptoms of the single item are unchanged or aggravated.
1.2.6 statistical methods SPSS 21.0 software was used for data analysis. The measurement data adopts mean ± standard deviationThe data accords with normal distribution, the variance is uniform, the t-test is adopted, and the non-uniformity is corrected; the counting data is checked by X2. P <0.05 indicates that the difference is statistically significant.
2 results
2.1 general case comparison
The number, sex and age distribution of the two groups of patients are not different before treatment (P is more than 0.05), and the patients have equilibrium comparability.
2.2 comparison of the antidepressant Effect of two groups
2.2.1 effects on hamilton depression scale (HAMD-17), positive drug control and composition E groups were compared to pre-treatment hamilton depression scale (HAMD-17), the differences were statistically significant (P > 0.05), with balanced comparability.
As shown in Table 6, at each evaluation time point after treatment, the positive drug control group HAMD-17 was statistically significant at week 8 compared with week 4 ▲ P<0.05 A) is provided; the composition E has statistical significance compared with the 8 th week and the 4 th week of HAMD-17 ▲ P<0.05)；
The HAMD-17 scores were close at week 4 and week 8 after both treatment, with no statistical significance (P > 0.05) for group E compared to the positive drug control group.
The medicine effect of the composition E is similar to that of the positive medicine, and the result shows that the antidepressant effect of the composition E has no obvious difference from that of the positive medicine.
TABLE 6 comparison of HAMD before and after treatment of two groupsDividing into two parts
Note that: comparison with week 4: ▲ P<0.05， ▲▲ P<0.01, composition E group compared to positive drug control group: # P<0.05， ## P<0.01。
2.2.2 effects on the quality index of Pittsburgh Sleep (PSQI), the comparison of the quality index of Pittsburgh Sleep (PSQI) before treatment of the positive drug control group and the composition E group, the difference was not statistically significant (P > 0.05), and the comparison was balanced.
As shown in Table 7, at each evaluation time point after treatment, the positive drug control group PSQI was statistically significant at week 8 and week 4 ▲ P<0.05 A) is provided; the composition E has statistical significance compared with the PSQI group at week 8 and week 4 ▲ P<0.05)；
Compared with the positive drug control group, the PSQI scores at the 4 th week and the 8 th week after the treatment of the composition E group are lower than those of the positive drug control group, and the difference is statistically significant # P<0.05)。
It is demonstrated that both composition E and the positive drug can improve the sleep quality of the patient, wherein the effect of composition E on improving sleep is faster and more pronounced than that of the positive drug.
TABLE 7 comparison of PSQI before and after treatment of two groupsDividing into two parts
Note that: comparison with week 4: ▲ P<0.05， ▲▲ P<0.01, composition E group compared to positive drug control group: # P<0.05， ## P<0.01。
2.3 comparison of curative effects of Chinese traditional medicine syndromes
2.3.1 influence on traditional Chinese medicine syndrome score, comparing the traditional Chinese medicine syndrome score before treatment of the positive medicine control group and the composition E group, wherein the difference has no statistical significance (P is more than 0.05), and each group has balanced comparability.
As shown in Table 8, the Chinese medicine symptoms of the positive medicine control group are compared with the Chinese medicine symptoms of the positive medicine control group in the 8 th week and the 4 th week, and the Chinese medicine symptoms have statistical significance ▲ P<0.05 A) is provided; the composition E has statistical significance compared with the traditional Chinese medicine syndrome score of the fourth week 8 ▲ P<0.05)。
Compared with the positive drug control group, the traditional Chinese medicine symptoms score of the composition E group at the 4 th week and the 8 th week after treatment is close, and the composition E group has no statistical significance (P is more than 0.05).
The Chinese medicine symptoms of the composition E group and the positive medicine control group are similar in score, and the two groups have no obvious difference.
Table 8 comparison of Chinese medical Condition scores before and after treatment of each groupDivide)/(>
Note that: comparison with week 4: ▲ P<0.05， ▲▲ P<0.01, composition E group compared to positive drug control group: # P<0.05， ## P<0.01。
2.3.2 As shown in Table 9, at each evaluation time point after treatment, the positive drug control group and the composition E group were respectively 84.2%, 94.6%, 88.6% and 94.3% in terms of efficacy (total efficacy) at week 4 and week 8, and the composition E group was higher in terms of efficacy than the positive drug at week 4 and week 8Control group, wherein the difference in effective rate between the two groups at week 4 is statistically significant # P<0.05)。
Both composition E and the positive drug were suggested to improve patient singles, where composition E improved singles earlier in onset and better than the positive drug.
Table 9 evaluation of the efficacy of treatment for the patients with one symptom of both groups of patients [ example (%)
Note that: during the treatment period of 4-8 weeks, 3 patients in sertraline hydrochloride tablet group fall off, 2 in composition E group fall off, and the falling patient does not count in the 8-week result data. Comparison with week 4: ▲ P<0.05， ▲▲ P<0.01, composition E group compared to positive drug control group: # P<0.05， ## P<0.01。
2.3.3 As shown in Table 10, at each evaluation time point after treatment, the total integral curative effect (total effective rate) of the positive drug control group and the traditional Chinese medicine symptoms in the composition E group in the 4 th week and the 8 th week is 65.8%, 78.4%, 80.0% and 91.4%, and the effective rate of the positive drug control group in the 8 th week is higher than that in the 4 th week, thus having statistical significance ▲ P<0.05 A) is provided; the effective rate of the composition E in week 8 is higher than that in week 4, and the composition E has statistical significance ▲ P<0.05 A) is provided; the effective rate of the curative effect of the traditional Chinese medicine symptoms of the group E after treatment is higher than that of the positive medicine control group at the 4 th week and the 8 th week, and the composition has statistical significance # P<0.05)。
Both the composition E and the positive medicine can be used for improving the traditional Chinese medicine symptoms of patients, wherein the composition E has earlier effect of improving the traditional Chinese medicine symptoms than the positive medicine, and has lasting and obvious curative effect.
Table 10 evaluation of total integral curative effects of traditional Chinese medicine syndromes of two groups of patients [ example (%) ]
Note that: during the treatment period of 4-8 weeks, 3 patients in sertraline hydrochloride tablet group fall off, 2 patients in composition E group fall off, and the falling patients do not count for 8 weeksData. Comparison with week 4: ▲ P<0.05， ▲▲ P<0.01, composition E group compared to positive drug control group: # P<0.05， ## P<0.01。
2.4 As shown in Table 11, at each evaluation time point after treatment, the effective rates (total effective rates) of the positive drug control group and the composition E group for evaluating the curative effect of the disease at the 4 th week and the 8 th week are respectively 84.2%, 78.4%, 88.6% and 91.4%, and the effective rate of the composition E group at the 8 th week is remarkably higher than that at the 4 th week, thus having statistical significance ▲ P<0.05 A) is provided; compared with the positive drug control group, the effective rate of the treatment effect evaluation of the composition E group for the disease at the 4 th week after treatment is obviously smaller than that of the positive drug control group, and has statistical significance # P<0.05 But the effective rate at week 8 is higher than that of the positive drug control group, and the statistical significance is not achieved (P > 0.05).
Both composition E and sertraline are suggested to improve the depressive behavior of patients, wherein composition E has a slower antidepressant effect than sertraline, but a more pronounced sustained effect.
Table 11 evaluation of disease efficacy of two groups of patients comparative [ example (%)
Note that: during the treatment period of 4-8 weeks, 3 patients in sertraline hydrochloride tablet group fall off, 2 in composition E group fall off, and the falling patient does not count in the 8-week result data. Comparison with week 4: ▲ P<0.05， ▲▲ P<0.01, composition E group compared to positive drug control group: # P<0.05， ## P<0.01。
2.5 abscission and adverse reaction recording
During the whole experimental observation treatment process, 2 cases of composition E fall off because 1 case of study is lost and 1 case of drug taking person cannot be adhered to; the positive drug control group had 3 cases of falling off because 1 case of side effect cannot be tolerated, and the difference has no statistical significance (P > 0.05) for 2 cases of unsatisfactory curative effect. In the actual completed patients, the group E of the composition had 3 cases (8.10%) of adverse reactions, 1 case of headache and 2 cases of dry mouth; the positive drug control group showed 8 adverse reactions (21.05%), 2 cases of dry mouth, 3 cases of nausea and vomiting, 2 cases of somnolence and 1 case of fatigue. The difference between the two groups has statistical significance (P is less than 0.05), which proves that the adverse reaction of the composition E is lower than that of sertraline, and the safety is high.
Conclusion 3
Clinical shows that the invention can effectively improve each traditional Chinese medicine symptom of patients with depression liver depression and spleen deficiency, has obvious antidepressant effect and has no obvious adverse reaction of medicines.
In conclusion, pharmacodynamic research results show that the invention has obvious antidepressant and sleep-promoting effects. The clinical curative effect research results show that the Chinese medicinal composition has remarkable anti-depression curative effect, can improve the sleep quality of patients, has the effects of soothing liver, regulating qi, strengthening spleen, nourishing heart, soothing nerves and relieving depression, can effectively improve each Chinese medicinal symptom of patients with depression and liver depression and spleen deficiency, improves the life quality of the patients, has fewer adverse reactions and is high in safety.

Claims (10)

1. A traditional Chinese medicine composition for treating depression is characterized in that: is prepared from (by weight parts) bupleurum root 0.5-6, hypericum perforatum 0.5-6, white peony root 1-5, curcuma aromatica 0.8-5, fingered citron 0.8-5, pseudostellaria root 1-6, white atractylodes rhizome 1-5, poria with hostwood 0.5-4, wild jujube seed 0.8-5, valerian root 1-5, albizia bark 1-6.
2. A traditional Chinese medicine composition for treating depression is characterized in that: is prepared from (by weight parts) bupleurum root 0.5-6, hypericum perforatum 0.5-6, white peony root 1-5, curcuma aromatica 0.8-5, fingered citron 0.8-5, pseudostellaria root 1-6, white atractylodes rhizome 1-5, poria with hostwood 0.5-4, wild jujube seed 0.8-5, valerian root 1-5, albizia bark 1-6 and licorice root 0.5-3.
3. The Chinese medicinal composition for treating depression according to claim 1 or 2, wherein the composition is prepared into clinically acceptable dosage forms.
4. A Chinese medicinal composition for treating depression according to claim 3, wherein the composition is in the form of decoction, tablet, capsule, powder, granule, pill, oral liquid, or syrup.
5. The composition for treating depression according to claim 4, wherein the composition is formulated into soft capsule, dispersible tablet, orally disintegrating tablet, or dripping pill.
6. The preparation method of the traditional Chinese medicine composition for treating depression according to claim 1 or 2, which is characterized by comprising the steps of adding 0-70% ethanol water solution into traditional Chinese medicine raw materials, extracting for 2-3 times, and adding 4-12 times of solvent each time; extracting for 1-2 hours each time, combining the extracting solutions, filtering, taking filtrate, recovering solvent and concentrating.
7. The preparation method according to claim 6, wherein 0-70% ethanol is added, extraction is performed 2 times, and 4-10 times of solvent is added each time; extracting for 1-2 hours each time, filtering the extracting solution, recovering the solvent and concentrating to prepare the extract.
8. The preparation method according to claim 7, wherein 0-70% ethanol is added for 2 times, the first time of adding 6-10 times of solvent for 2 hours, the second time of adding 4-8 times of solvent for 1 hour; filtering the extractive solution, recovering solvent, and concentrating.
9. The preparation method according to any one of claims 6 to 8, characterized in that 60% ethanol is added for extraction.
10. Use of a traditional Chinese medicine composition according to any one of claims 1-5 in the preparation of a medicament for treating depression.
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