A traditional Chinese medicine composition for treating depression, a traditional Chinese medicine preparation, a preparation method and application thereof

Abstract

The application provides a traditional Chinese medicine composition for treating depression, a traditional Chinese medicine preparation and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition comprises Astragalus membranaceus, Bupleurum chinense, Atractylodes macrocephala, Suanzaoren, Crocus sativus, Atractylodes lancea and Glycyrrhiza uralensis. The above-mentioned drugs are combined in the application, and jointly play the functions of activating qi and soothing liver, promoting blood circulation and relieving depression, especially can improve depression induced or aggravated by improper emotion and accompanied by psychotic symptoms, are suitable for clinical popularization and application, and have wide application prospect.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine composition, and particularly relates to a traditional Chinese medicine composition for treating depression, a traditional Chinese medicine preparation and a preparation method and application thereof. BACKGROUND

[0002] Depression is a common emotional and mental disorder, and with the acceleration of social life, depression has become a high-incidence disease in today's society. Depression is the most common depressive disorder, and the main clinical feature is significant and persistent mood depression, which is the main type of mood disorder. Clinically, mood depression is not commensurate with the situation, emotional depression, self-deprecating depression, pessimism, and suicidal behavior, even catatonia, and some cases have obvious anxiety and motor excitement; severe cases may have hallucinations, delusions and other psychotic symptoms. Each episode lasts at least 2 weeks or even years, and most cases have a tendency to relapse, and most episodes can be relieved, and some may have residual symptoms or become chronic.

[0003] The modern treatment methods for depression mainly include psychological treatment, drug treatment and electric shock (convulsion) treatment. The psychological treatment method is only suitable for mild cases, drug treatment is needed for moderate and severe cases, and electric shock treatment is used for severe cases. At present, the most commonly used method is drug treatment, and the most commonly used antidepressants in clinical practice are western medicines, which have a large side effect and need to be taken for a long time, and rebound easily after stopping taking the medicine.

[0004] Therefore, it is urgent to find an anti-depression traditional Chinese medicine preparation with definite curative effect, small side effect and low recurrence rate. SUMMARY

[0005] The present application aims to provide a traditional Chinese medicine composition for treating depression.

[0006] In order to achieve the above-mentioned application purpose, the present application provides the following technical scheme:

[0007] The present application provides a traditional Chinese medicine composition for treating depression, which comprises the following traditional Chinese medicine raw materials in the following weight ratio: 15-25 parts of Astragalus, 10-20 parts of Bupleurum, 10-20 parts of Atractylodes, 5-10 parts of Suanzaoren, 1-3 parts of Saffron, 5-10 parts of Atractylodes lancea, and 1-5 parts of Glycyrrhiza.

[0008] Preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in the following weight ratio: 18-23 parts of Astragalus, 14-18 parts of Bupleurum, 12-17 parts of Atractylodes, 6-8 parts of Suanzaoren, 1.5-2.5 parts of Saffron, 7-9 parts of Atractylodes lancea, and 2-4 parts of Glycyrrhiza.

[0009] The present application also provides a preparation method of the traditional Chinese medicine composition, comprising the following steps:

[0010] (1) saffron is extracted with ethanol solution to obtain saffron extract and saffron residue;

[0011] (2) the saffron residue is mixed with astragalus, bupleurum, atractylodes, hovenia dulcis, atractylodes lancea, and licorice, and extracted with water to obtain a mixed extract;

[0012] (3) the mixed extract is mixed with the saffron extract, concentrated, and dried to obtain the traditional Chinese medicine composition.

[0013] Preferably, the volume fraction of the ethanol solution is 60-70%.

[0014] Preferably, the extraction in step (1) is reflux extraction, the extraction is performed 1-2 times, each time for 0.5-1.5 h, and the volume of the ethanol solution added each time is 5-10 mL per 1 g of saffron.

[0015] Preferably, the water decoction in step (2) is performed 2-3 times, each time for 1-2 h, and the amount of water added each time is 10-15 times the total weight of astragalus, bupleurum, atractylodes, hovenia dulcis, atractylodes lancea, and licorice.

[0016] The application also provides a traditional Chinese medicine preparation for treating depression, which comprises a traditional Chinese medicine composition and excipients; the traditional Chinese medicine composition is the traditional Chinese medicine composition prepared by the preparation method.

[0017] Preferably, the dosage form of the traditional Chinese medicine preparation comprises decoction, tablet, capsule, soft capsule, powder, granule, dripping pill, pill, oral liquid, and syrup.

[0018] The application also provides the use of the traditional Chinese medicine composition in the preparation of a medicine for preventing and / or treating depression.

[0019] By adopting the above technical scheme, the application has the following beneficial effects: the traditional Chinese medicine composition in the application has mild nature, treats both deficiency and excess, dredges the qi, has the functions of promoting qi and soothing liver, and activating blood and relieving depression, and has a therapeutic effect on depression induced or aggravated by improper emotions and accompanied by psychotic symptoms, and can treat the disease with the main clinical manifestations of depressed mood, emotional unrest, distending pain in the lateral chest, irritability, and crying, and insomnia. The application uses the above-mentioned drugs together to jointly play the functions of promoting qi and soothing liver, activating blood and relieving depression, and especially can improve depression induced or aggravated by improper emotions and accompanied by psychotic symptoms, is suitable for clinical popularization and application, and has a wide application prospect. DETAILED DESCRIPTION

[0020] The application provides a traditional Chinese medicine composition for treating depression, which comprises the following traditional Chinese medicine raw materials in parts by weight: 15-25 parts of Astragalus membranaceus, 10-20 parts of Bupleurum chinense, 10-20 parts of Atractylodes macrocephala, 5-10 parts of Suanzaoren, 1-3 parts of Safran, 5-10 parts of Atractylodes lancea, and 1-5 parts of Glycyrrhiza uralensis.

[0021] In the traditional Chinese medicine composition, the Astragalus membranaceus is 15-25 parts by weight, preferably 18-23 parts by weight, and more preferably 20 parts by weight;

[0022] The Bupleurum chinense is 10-20 parts by weight, preferably 14-18 parts by weight, and more preferably 16 parts by weight;

[0023] The Atractylodes macrocephala is 10-20 parts by weight, preferably 12-17 parts by weight, and more preferably 15 parts by weight;

[0024] The Suanzaoren is 5-10 parts by weight, preferably 6-8 parts by weight, and more preferably 7 parts by weight;

[0025] The Safran is 1-3 parts by weight, preferably 9-12 parts by weight, and more preferably 10 parts by weight;

[0026] The Atractylodes lancea is 5-10 parts by weight, preferably 7-9 parts by weight, and more preferably 8 parts by weight;

[0027] The Glycyrrhiza uralensis is 1-5 parts by weight, preferably 2-4 parts by weight, and more preferably 3 parts by weight.

[0028] In the application, the Bupleurum chinense is the monarch herb for soothing liver and relieving depression, the Atractylodes macrocephala is the ministerial herb for strengthening the monarch herb in soothing liver and relieving depression and tonifying spleen and replenishing qi, the Astragalus membranaceus is used for tonifying qi and nourishing blood to prevent the long-term liver depression from consuming yin blood, the Safran is used for activating blood and resolving stasis, relieving depression and soothing the mind, and cooling blood and detoxifying, the Atractylodes lancea is used for tonifying spleen and drying dampness, and the Suanzaoren is used for calming the heart and soothing the mind, the Glycyrrhiza uralensis is used for tonifying spleen and replenishing qi, and the whole prescription has the functions of soothing liver and regulating qi, tonifying spleen and nourishing heart, and soothing the mind and relieving depression.

[0029] The application further provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:

[0030] (1) the Safran is extracted with an ethanol solution to obtain Safran extract and Safran residue;

[0031] (2) the Safran residue is mixed with the Astragalus membranaceus, the Bupleurum chinense, the Atractylodes macrocephala, the Suanzaoren, the Atractylodes lancea and the Glycyrrhiza uralensis, and then extracted with water to obtain a mixed extract;

[0032] (3) the mixed extract is mixed with the Safran extract, concentrated, dried and obtained as the traditional Chinese medicine composition.

[0033] In this invention, saffron is extracted with an ethanol solution to obtain saffron extract and saffron residue; the volume fraction of the ethanol solution is 60-70%, more preferably 62-68%, and more preferably 65%; the extraction is a reflux extraction, and the extraction is performed 1-2 times, with each extraction lasting 0.5-1.5 hours, more preferably 50-70 minutes, and more preferably 1 hour; the ratio of the volume of ethanol solution added each time to the weight of saffron is 5-10 mL:1 g, more preferably 6-9 mL:1 g, and more preferably 8 mL:1 g; after extraction, saffron extract and saffron residue are obtained.

[0034] This invention involves mixing saffron residue with Astragalus membranaceus, Bupleurum chinense, Atractylodes macrocephala, Ziziphus jujuba var. spinosa, Atractylodes lancea, and Glycyrrhiza uralensis, and extracting with water, preferably by decoction. The extraction is performed 2 to 3 times, with each extraction lasting 1 to 2 hours, more preferably 80 to 100 minutes, and even more preferably 1.5 hours. The amount of water added for each extraction is 10 to 15 times the total weight of Astragalus membranaceus, Bupleurum chinense, Atractylodes macrocephala, Ziziphus jujuba var. spinosa, Atractylodes lancea, and Glycyrrhiza uralensis, more preferably 11 to 14 times, and even more preferably 12 times.

[0035] This invention involves mixing the aforementioned mixed extract with saffron extract, concentrating, and drying to obtain the traditional Chinese medicine composition. The concentration and drying are carried out under reduced pressure. The concentration and drying temperature is 50–60°C, more preferably 52–58°C, and even more preferably 55°C. The vacuum degree of the concentration and drying is -0.075–-0.095 MPa, more preferably -0.08–-0.09 MPa, and even more preferably -0.085 MPa. The product is dried to a density of 1.2–1.4 g / cm³. 3 After extracting the extract, spray drying is performed to obtain the traditional Chinese medicine composition.

[0036] This invention also provides a traditional Chinese medicine preparation for treating depression, comprising the aforementioned traditional Chinese medicine composition or a traditional Chinese medicine composition prepared by any of the methods described above, and further comprising pharmaceutically acceptable excipients. The excipients include excipients, fillers, diluents, lubricants, humectants, disintegrants, surfactants, preservatives, sweeteners, and flavorings. Specifically, the carrier may be, for example, starch, dextrin, lactose, microcrystalline cellulose, hydroxypropyl methylcellulose, polyethylene glycol, magnesium stearate, micronized silica gel, glucose, mannitol, xylitol, glycine, etc.

[0037] The dosage forms of the traditional Chinese medicine preparations described in this invention include decoctions, tablets, capsules, soft capsules, powders, granules, drop pills, pills, oral liquids, and syrups.

[0038] The present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of drugs for the prevention and / or treatment of depression.

[0039] The technical solutions provided by the present application are described in detail below in combination with examples, but they should not be understood as limiting the scope of protection of the present application.

[0040] Example 1

[0041] The traditional Chinese medicine composition for treating depression comprises Astragalus 15 kg, Bupleurum 10 kg, Atractylodes 10 kg, Suanzaoren 5 kg, safflower 1 kg, Atractylodes 5 kg, and Licorice 1 kg.

[0042] The preparation method of the traditional Chinese medicine composition for treating depression is as follows: safflower is extracted once with 5 L of 60% ethanol by heating and refluxing, for a total of 0.5 h, to obtain safflower extract and safflower residue. The safflower residue is mixed with Astragalus, Bupleurum, Atractylodes, Suanzaoren, Atractylodes, and Licorice, and is decocted twice with water, with 460 L of water added each time, and each decoction lasting for 1 h, to obtain a mixed extract. The mixed extract is mixed with the safflower extract, and is concentrated to a density of 1.2 g / cm 3 of extract at 50℃ and -0.075 MPa, and is then spray-dried to obtain the traditional Chinese medicine composition.

[0043] Example 2

[0044] The traditional Chinese medicine composition for treating depression comprises Astragalus 17 kg, Bupleurum 15 kg, Atractylodes 15 kg, Suanzaoren 8 kg, safflower 2 kg, Atractylodes 7 kg, and Licorice 3 kg.

[0045] The preparation method of the traditional Chinese medicine composition for treating depression is as follows: safflower is extracted once with 12 L of 65% ethanol by heating and refluxing, for a total of 1 h, to obtain safflower extract and safflower residue. The safflower residue is mixed with Astragalus, Bupleurum, Atractylodes, Suanzaoren, Atractylodes, and Licorice, and is decocted twice with water, with 780 L of water added each time, and each decoction lasting for 1.5 h, to obtain a mixed extract. The mixed extract is mixed with the safflower extract, and is concentrated to a density of 1.3 g / cm 3 of extract at 55℃ and -0.08 MPa, and is then spray-dried to obtain the traditional Chinese medicine composition.

[0046] Example 3

[0047] The traditional Chinese medicine composition for treating depression comprises Astragalus 25 kg, Bupleurum 20 kg, Atractylodes 20 kg, Suanzaoren 10 kg, safflower 3 kg, Atractylodes 10 kg, and Licorice 5 kg.

[0048] A method for preparing a traditional Chinese medicine composition for treating depression: saffron is extracted twice by heating reflux with 30 L of 70% ethanol, each time for 1.5 h, to obtain saffron extract and saffron dregs. The saffron dregs are mixed with radix astragali, radix bupleuri, radix atractylodis macrocephalae, semen ziziphi spinosae, rhizoma atractylodis lanceae, and radix glycyrrhizae, and decocted with water three times, each time with 1215 L of water, and each time for 2 h, to obtain a mixed extract. The mixed extract is mixed with the saffron extract, and then concentrated at 60°C and -0.09 MPa to a density of 1.4 g / cm 3 of the extract, and then spray-dried to obtain the traditional Chinese medicine composition.

[0049] Comparative Example 1

[0050] Unlike Example 1, the traditional Chinese medicine composition of Comparative Example 1 does not contain radix astragali.

[0051] Comparative Example 2

[0052] Unlike Example 1, the traditional Chinese medicine composition of Comparative Example 2 does not contain saffron.

[0053] Experimental Example Animal Experiment

[0054] The experimental animals are 7-week-old male and female BALB / c mice, which are purchased from Shanghai Jihui Experimental Animal Feeding Co., Ltd. After adaptive feeding for 7 days, 63 mice are randomly divided into 7 groups, namely, Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, depression model group, and blank group.

[0055] The mice in Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, and the depression model group are subjected to chronic unpredictable mild stress (CUMS), which includes 11 kinds of stress: 45°C inclined mouse cage for 24 h, wet bedding for 24 h, behavior restriction for 24 h, 4°C ice water swimming for 5 min, 42°C hot water swimming for 5 min, food deprivation for 24 h, water deprivation for 24 h, tail clamping for 1 min, mouse cage shaking for 15 min, continuous light for 36 h, and predator sound for 30 min. The 11 kinds of stress are randomly distributed within 21 days, one kind of stress is given per day, each kind of stress occurs an average of 2 times, and the same kind of stress does not occur continuously.

[0056] At the same time of modeling, the mice in Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, and Comparative Example 2 group are intragastrically administered with the traditional Chinese medicine compositions prepared in Example 1, Example 2, Example 3, Comparative Example 1, and Comparative Example 2, respectively, at a dose of 400 mg / kg of body weight, and the mice in the depression model group are administered with an equal amount of normal saline once a day.

[0057] The mice in the blank group are subjected to the same treatment as the mice in the depression model group, except that the mice in the blank group are grabbed once a day and administered with normal saline for intragastric administration.

[0058] 1. Tail Suspension Test

[0059] The tail suspension test was performed according to the method of Dunn and Swiergiel. The postpartum mother mouse was suspended at a position 30 cm away from the table with medical tape, and the tape was fixed at a position about 1 cm away from the tip of the tail. During the test period of 6 min, the resting time in the last 4 min was observed and recorded. When the mouse was motionless and passively suspended, it was judged as resting.

[0060] 2. Sugar water preference test

[0061] The postpartum mother mouse was given drinking water with a sugar water and tap water double bottle, and the sugar water and tap water consumption of the postpartum mother mouse within 1 h after 2.5 h of water deprivation was measured to calculate the sugar water preference percentage (sugar water consumption / total liquid consumption x 100%).

[0062] Depression is mainly manifested as low mood, loss of interest, memory impairment, etc. The mouse is subjected to 11 kinds of stimulation to produce corresponding symptoms, and then various drugs are used for intervention. The results are shown in Table 1:

[0063] Table 1 Comparison of sugar water preference percentage and immobility time in tail suspension test of mice in each group

[0064]

[0065]

[0066] The tail suspension test (TST) is a classic method for evaluating antidepressant drugs and is widely used in basic research of psychoneuropharmacology. TST is to induce depressive despair behavior by being unable to overcome an abnormal body position, that is, to cause despair behavior by using animals that cannot escape from a bad environment.

[0067] Rodents have a strong desire for sweets by nature, and when they are provided with two drinking water devices that can be freely chosen, i.e., containing sucrose solution and ordinary water respectively, they will selectively drink sweet sucrose solution. However, when rodents are in a depression model caused by chronic stress, they will not tend to drink sucrose solution. Therefore, detecting the preference degree of animals for sucrose solution can be a useful means to assess the symptoms of animals lacking pleasure and the degree of depression.

[0068] The experimental results show that, compared with the depression model group, the sugar water preference percentage of the mice in each drug administration group is significantly increased, and the tail suspension immobility time is significantly reduced. Among them, the example group of the present application can better adjust the emotional disorders of depressed mice compared with other drug administration groups, and has a good effect of preventing and / or treating depression.

[0069] Clinical cases

[0070] Clinical data:

[0071] 1. Western medicine diagnostic criteria refer to the relevant diagnostic criteria in Chinese Classification and Diagnostic Criteria of Mental Disorders, 3rd edition (Classification of Mental Disorders): there are clinical manifestations of low mood, and at least 4 of the following items can be diagnosed: (1) loss of interest, no pleasure; (2) decreased energy or fatigue; (3) psychomotor retardation or agitation; (4) self-evaluation is too low, self-blame, or guilt; (5) difficulty in association or self-conscious thinking; (6) repeated thoughts of death or suicidal behavior; (7) sleep disorders, such as insomnia, early awakening, or excessive sleep; (8) decreased appetite or significant weight loss; (9) decreased sexual desire.

[0072] 2. TCM syndrome diagnostic criteria refer to the syndrome differentiation criteria in Internal Medicine of Traditional Chinese Medicine. Liver stagnation and spleen deficiency syndrome: (1) main symptoms: ①depression or emotional unrest; ②chest or stomach distension; ③abdominal distension; ④poor appetite; ⑤loose stools. (2) accompanying symptoms: ①irritability; ②sighing; ③borborygmus and gas; ④abdominal pain relieved by defecation. Tongue and pulse: white or greasy tongue fur, stringy or stringy and thin pulse. In the diagnosis of syndromes, one of the main symptoms is depression or emotional unrest, two or more of the other main symptoms and secondary symptoms, and tongue and pulse support.

[0073] Inclusion criteria: (1) meet the western medicine diagnostic criteria for depression; (2) meet the TCM syndrome diagnostic criteria for liver stagnation and spleen deficiency syndrome; (3) aged 16-80 years old, signed informed consent; (4) no relevant Chinese and Western medicine for 1 month.

[0074] Exclusion criteria: (1) under 16 years old or over 80 years old; (2) organic mental disorders, or high-risk depression caused by psychoactive substances and non-addictive substances; (3) do not meet the western medicine diagnostic criteria for depression and the diagnostic criteria for liver stagnation and spleen deficiency syndrome in TCM; (4) pregnant or preparing to be pregnant women, lactating women; (5) suspected or confirmed history of alcohol and drug abuse; (6) allergic to Composition E and sertraline, or have a history of similar drug allergy; (7) severe target organ damage, or combined with severe primary diseases of heart, brain, liver, kidney and hematopoietic system.

[0075] Methods: The positive drug control group was given oral sertraline hydrochloride tablets (manufacturer: Pfizer Pharmaceutical Co., Ltd.; approval number: GMP H10980141; specification: 50mg) treatment, initial dose 50mg / time, 1 time / d, increased to 50mg / time, 2 times / d after 2 weeks.

[0076] The TCM group was given the TCM composition in Example 2 on the basis of the control group.

[0077] Prescription composition: Radix Astragali 17g, Radix Bupleuri 15g, Rhizoma Atractylodis Macrocephalae 15g, Semen Ziziphi Spinosae 8g, Crocus sativus 2g, Rhizoma Atractylodis 7g, Radix Glycyrrhizae 3g. After extracting Crocus sativus with ethanol solution and recovering the solvent, the Crocus sativus extract was obtained, and the residue of Crocus sativus and Radix Astragali, Radix Bupleuri, Rhizoma Atractylodis Macrocephalae, Semen Ziziphi Spinosae, Rhizoma Atractylodis, Radix Glycyrrhizae were decocted with water to obtain juice 300mL, which was mixed with the Crocus sativus extract, and taken in the morning and evening.

[0078] The patients were randomly divided into two groups, with 60 patients in each group, and both groups were treated for 8 weeks.

[0079] 3. Observation index and efficacy evaluation criteria

[0080] (1) Psychological state. Before treatment and after treatment for 2, 4, 6 and 8 weeks, the psychological state of patients in both groups was evaluated by HAMD-17 and Hamilton Anxiety Scale (HAMA). HAMD-17 score <7 points was normal, 7-17 points was possible depression, 18-24 points was definitely depression, and >24 points was severe depression.

[0081] (2) Clinical efficacy. The clinical efficacy was evaluated by HAMD-17 reduction rate: recovery was depression symptoms disappeared, normal mood, reduction rate ≥75%; marked effect was depression symptoms basically disappeared, basically normal mood, reduction rate ≥50%; effectiveness was depression symptoms relieved, stable mood, reduction rate ≥25%; no effect was depression symptoms did not alleviate, mood did not improve, reduction rate <25%. Total effective rate = 1-ineffective rate.

[0082] (3) TCM syndrome score. Before treatment and after treatment for 8 weeks, the TCM syndrome score of patients in both groups was evaluated, including 4 symptoms of restlessness, forgetfulness, mental depression and fatigue, 0 points for symptom disappearance; 2 points for occasional appearance; 4 points for frequent appearance; 6 points for persistent existence or aggravation.

[0083] (4) Adverse reaction occurrence. After 8 weeks of treatment, the adverse reaction occurrence of patients in both groups was evaluated by Treatment Emergent Symptom Scale (TESS), including insomnia, somnolence, nausea and vomiting, anorexia, dry mouth, constipation, which was divided into 0-4 points according to severity, 0 point for no such symptoms; 1 point for occasional symptoms; 2 points for mild, no effect on normal function; 3 points for moderate, affecting normal function; 4 points for severe, significantly damaging normal function.

[0084] The comparison of HAMD-17 and HAMA scores of patients in both groups before treatment and after treatment for 2, 4, 6 and 8 weeks is shown in Table 2.

[0085] Table 2 Comparison of HAMD-17 scores of patients in both groups before treatment and after treatment for 2, 4, 6 and 8 weeks (n=60)

[0086]

[0087] The HAMD-17 scores of the traditional Chinese medicine group and the positive drug control group are close after 4 weeks and 8 weeks of treatment, and there is no statistical significance. It is indicated that the efficacy of the traditional Chinese medicine group is similar to that of the positive drug, and the antidepressant effect of the traditional Chinese medicine group has no significant difference from that of the positive drug.

[0088] The clinical efficacy of the two groups of patients after 8 weeks of treatment is shown in Table 3, and the TCM syndrome score comparison of the two groups of patients before treatment and after 8 weeks of treatment is shown in Table 4.

[0089] Table 3 Comparison of clinical efficacy of two groups of patients (n=60)

[0090] Group Healing Effective Effective Ineffective Total effective rate Positive drug control group 8 32 16 4 93.4％ Traditional Chinese medicine group 10 28 20 2 96.7％

[0091] Table 4 Comparison of TCM syndrome scores of two groups of patients before treatment and after 8 weeks of treatment

[0092]

[0093] As shown in Tables 3 and 4, the effective rate of the traditional Chinese medicine composition of the present application in treating TCM syndrome after 8 weeks of treatment is higher than that of the positive drug control group, and there is statistical significance (P<0.05).

[0094] The TESS scores of the two groups of patients after 8 weeks of treatment are shown in Table 5.

[0095] Table 5 Comparison of TESS scores of two groups of patients after 8 weeks of treatment (n=60)

[0096]

[0097] As shown in Table 5, after 8 weeks of treatment, the adverse reactions of the patients in the traditional Chinese medicine group are significantly lower than those in the positive drug control group, and the difference has statistical significance (P<0.05).

[0098] As shown in the above examples, the present application provides a traditional Chinese medicine composition for treating depression, which can effectively treat or improve depression and has small side effects.

[0099] The above only describes the preferred embodiments of the present application, and it should be noted that for ordinary skilled persons in the art, some improvements and refinements can be made without departing from the principles of the present application, and these improvements and refinements should also be considered as the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition for treating depression, characterized in that, It is composed of the following Chinese herbal raw materials in the following weight proportions: Astragalus membranaceus 15-25 parts, Bupleurum chinense 10-20 parts, Atractylodes macrocephala 10-20 parts, Ziziphus jujuba var. spinosa 5-10 parts, Saffron 1-3 parts, Atractylodes lancea 5-10 parts, and Glycyrrhiza uralensis 1-5 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is composed of the following Chinese herbal raw materials in the following weight ratios: Astragalus membranaceus 18-23 parts, Bupleurum chinense 14-18 parts, Atractylodes macrocephala 12-17 parts, Ziziphus jujuba var. spinosa 6-8 parts, Crocus sativus 1.5-2.5 parts, Atractylodes lancea 7-9 parts, and Glycyrrhiza uralensis 2-4 parts.

3. The method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Includes the following steps: (1) Saffron was extracted with ethanol solution to obtain saffron extract and saffron residue; (2) The saffron residue is mixed with Astragalus membranaceus, Bupleurum chinense, Atractylodes macrocephala, Ziziphus jujuba var. spinosa, Atractylodes lancea and Glycyrrhiza uralensis, and decocted in water to extract the mixed extract. (3) The mixed extract is mixed with saffron extract, concentrated and dried to obtain the traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that, The volume fraction of the ethanol solution is 60-70%.

5. The preparation method according to claim 4, characterized in that, The extraction in step (1) is a reflux extraction, which is performed 1 to 2 times. Each extraction takes 0.5 to 1.5 hours. The ratio of the volume of ethanol solution added to the weight of saffron is 5 to 10 mL: 1 g.

6. The preparation method according to claim 5, characterized in that, The decoction in step (2) is performed 2 to 3 times, with each decoction lasting 1 to 2 hours. The amount of water added each time is 10 to 15 times the total weight of Astragalus membranaceus, Bupleurum chinense, Atractylodes macrocephala, Ziziphus jujuba var. spinosa, Atractylodes lancea, and Glycyrrhiza uralensis.

7. A traditional Chinese medicine preparation for treating depression, characterized in that, The traditional Chinese medicine preparation is composed of a traditional Chinese medicine composition and excipients; the traditional Chinese medicine composition is the traditional Chinese medicine composition according to claim 1 or the traditional Chinese medicine composition prepared by any one of claims 3 to 6.

8. The traditional Chinese medicine preparation according to claim 7, characterized in that, The dosage forms of the traditional Chinese medicine preparations include decoctions, tablets, capsules, powders, granules, pills, oral liquids, and syrups.

9. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a drug for treating depression.

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